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Inpatient Smoking Cessation Program
In 1992, the Joint Commission on Accreditation of Healthcare Organizations (Joint Commission) introduced standards to make hospital buildings smoke‐free, resulting in the nation's first industry‐wide ban on smoking in the workplace. This hospital smoking ban has led to increased smoking cessation among employees.1 Since 2003, core measures from the Joint Commission and quality indicators from the Centers for Medicare and Medicaid Services have included inpatient smoking cessation counseling for acute myocardial infarction, pneumonia, and heart failure, as national guidelines strongly recommend smoking cessation counseling for patients with these diseases who smoke.25
The Department of Health and Human Services (DHHS) 2008 update on Clinical Practice Guidelines for Treating Tobacco Use and Dependence6 recommends that clinicians use hospitalization as an opportunity to promote smoking cessation and to prescribe medications to alleviate withdrawal symptoms. Hospitalization is an opportune time for smoking cessation because patients are restricted to a smoke‐free environment in the hospital and, increasingly, on hospital campuses.6 The illness leading to hospitalization may be attributable, at least in part, to tobacco use, thereby increasing the patient's receptivity to cessation counseling. Last, medications used in‐hospital to treat nicotine withdrawal symptoms may lead to continued or future use of these medications that, in turn, may ultimately lead to a successful quit attempt.
We report on the outcomes of our hospital's attempt to do this in the context of implementation of a smoke‐free medical campus.7 This study was designed to measure whether an inpatient smoking cessation intervention increases the likelihood of smoking cessation 6 months post‐hospital discharge. Because effectiveness studies are the next step to improving translation of research into health promotion practice,8 we set out to measure what the impact of this intervention would be in routine clinical practice as opposed to a carefully structured efficacy trial.
Methods
Intervention
The Smoking Cessation service for inpatients began on April 3, 2006. Upon admission, all patients were screened regarding their current smoking status. The nurse asked the patient if s/he currently smoked and then entered the responses into the hospital electronic medical record (EMR). A current smoker was defined as smoking every day or some days within the past 30 days. A roster of newly admitted current smokers was electronically transmitted to the Respiratory Care office daily. Only current smokers received counseling. The Smoking Cessation Specialist (SCS) subsequently saw inpatients within a 24‐hour time frame of admission, except for weekends and holidays. Each patient received 1 to 2 intensive follow‐up counseling sessions during hospitalization. An average of 10 patients per day were seen.
The goal of the inpatient smoking cessation service was to counsel patients on the health effects of smoking, address nicotine withdrawal symptoms, explain the different pharmacotherapies available, advise on how to quit, give self‐help materials, counsel family members, and refer to the New York State (NYS) Smokers' Fax‐to‐Quit program.9 Following the consult, the SCS documented the encounter in the patient's chart, including recommendations for nicotine replacement therapy (NRT) or bupropion (varenicline was not addressed as it was not on the formulary). The chart documentation informed the physician and nursing staff of the intervention and included the date/time, stage of change, and support action taken.
The SCS was part‐time, had nursing training, smoking cessation training,10 and was also trained by the Seton Health Cessation Center in the Butt Stops Here Program.11 She also implemented a performance improvement plan to increase the provision of smoking cessation counseling, increase NRT or bupropion prescriptions to smokers admitted to the hospital, and increase referrals to the NYS telephone quitline through the Fax‐to‐Quit program for outpatient resources and help following hospital discharge. The Fax‐to‐Quit program allows health care providers to refer patients to the NYS quitline via fax, with the patient's signature (patient permission) on the fax to quit form. After hospital discharge, the quitline then contacts the patient at a time that the patient requested.
The SCS visited patients with all admitting diagnoses on the medical, surgical, and special care units who were current smokers. Inpatients admitted to psychiatry, obstetrics, and the intensive care unit (ICU) were not seen by the SCS, except for ICU patients referred by a physician. Inpatients who had short stays or who were admitted and discharged in 1 day or during the weekend were not seen.
The intervention included either a brief 3‐minute to 5‐minute intervention or a more intensive intervention, that required 10 to 20 minutes (18 minutes average). The length of the intervention was determined by how receptive the patient was to the intervention. All interventions began with patient identification, an introduction to the SCS, and an explanation of the purpose of the visit. The SCS then inquired about the patient's comfort level vis‐a‐vis nicotine withdrawal and if s/he was receiving any NRT while in the hospital (NRT on the inpatient formulary included the nicotine patch or gum). If the patient was receptive to counseling, the SCS then began to work through the 5 A's, as described in the 2000 DHHS Clinical Practice Guidelines.12 The 2000 DHHS Clinical Practice Guidelines were used because the 2008 update had not been released at the time this study was initiated in 2006. These include: asking about smoking status, advising on how to quit, assessing readiness to quit, and assisting in arranging treatment options that include pharmacotherapy, counseling, as well as referral to the NYS Smokers' Quitline. A workbook was provided to reinforce counseling but was not necessarily used during counseling session. A compact disc (CD) with relaxation exercises5 was provided to those inpatients who were interested in stress reduction. If family members were present, and were also smokers, they were included in the counseling session, if willing. Each patient was offered a referral via the Fax‐to‐Quit program to continue treatment on an outpatient basis.
If the patient was not motivated to quit or declined the consult, the visits were short and focused on the patient's experience with nicotine withdrawal. These patients were also given self‐help materials and, if possible, the relevance of and roadblocks to quitting were reviewed. Patients were prompted to think about why quitting was relevant and often the reason for hospitalization was used to motivate the quitting process.
Upon hospital discharge, the patient's primary care provider was notified of the cessation intervention by a letter from the SCS. The letter described the intervention and stated whether or not the patient agreed to be referred to the Fax‐to‐Quit Program.
Study Participants
Patients were recruited from July 1, 2006 (after the smoking ban went into effect) through June 1, 2008. Inpatients who currently smoked were informed of this study and were asked to sign informed consent to participate after they were seen by the SCS. Current smokers of all admitting diagnoses were recruited into the study. Patients provided informed consent for a telephone interview 6 months posthospital discharge. A written Health Insurance Portability and Accountability Act (HIPAA) release was obtained to allow access to an individual's specific EMR.
A comparison group of inpatients who were also current smokers, but who did not receive the intervention were also contacted six months after hospitalization. Reasons for not receiving the intervention included the fact the SCS was part‐time and also took a leave of absence during the study and therefore could not see all inpatients who currently smoked. Other reasons for not receiving the intervention include too short a stay for the SCS to see the patient or the patient was out of the room for tests or procedures when the SCS was available. These patients provided informed consent to be interviewed 6 months after hospital discharge and HIPAA consent for access to their medical record. Not all inpatients in the comparison group provided written HIPAA release for use of their medical record; therefore, these patients were excluded because their baseline demographic and diagnostic data were missing.
Sample‐size considerations were driven around having adequate numbers of subjects to measure the prevalence of smoking cessation at 6 months post‐hospital discharge with an acceptable degree of precision. Prevalence estimates from previous studies for 6‐month cessation typically range from 20% to 30%, with cessation rates as high as 67% (this estimate applies to postmyocardial infarction patients.)13 For conservative estimation, we used 50% as the 6‐month prevalence of cessation in the current study, which placed binomial variance at its theoretical maximum. In this case, a sample of 300 subjects provides a margin of error of 0.058 for a 95% confidence interval around this point estimate.
Data Sources
The hospital EMR database was used to monitor several components of the program: nursing screening, smoking cessation counseling, and pharmacy dispensing of NRT and bupropion. The screening data were also used to monitor the proportion of current smokers admitted during the study period. Elements of the EMR were used to define the following covariates: patient age, gender, ethnicity, and the primary discharge diagnosis (via International Statistical Classification of Diseases and Related Health Problems, 9th edition [ICD9] codes) and readmission during the six month follow‐up period. Mean length of stay (LOS) was computed. The Elixhauser Comorbidity Index that utilizes ICD9 codes was used for comorbidity risk adjustment.14
Study participants were contacted by phone 6 months posthospital discharge. Data collection began July 1, 2006 and was completed January 1, 2009. The interview focused on self‐reported point prevalence of smoking and 6‐month quit status. The point prevalence for self‐reported abstinence was derived from the question Do you now smoke cigarettes every day, some days, or not at all?15 Self‐reported quit status was derived from question Have you quit smoking since you were discharged from the hospital? In addition, respondents were queried about their number of years smoked, post‐hospital discharge number of quit attempts, and cessation efforts (NRT, self‐help groups, quitline use, etc.). Last, they were surveyed about barriers to cessation (exposure to secondhand smoke, rules about smoking in the home or car), educational level, employment, and health ratings.
To determine the status of those lost to follow‐up, administrative and EMR databases for appointments and follow‐up visits were accessed to determine if the patient was alive during the 6 months between discharge and the follow‐up call. To confirm mortality, we searched the Internet, Ancestry.com, and/or local newspaper obituaries for dates of death for all patients to validate that they had not died during the 6‐month follow‐up. World wide web searches can identify 97% of deaths listed in the Centers for Disease Control and Prevention (CDC)/National Death Index, which is considered the gold standard in epidemiologic studies.16
Analysis
Univariate analysis of all covariates was completed to examine the normal distribution curves for these variables. Bivariate correlation analysis of all the independent variables by study group was performed to assess comparability of the study groups at baseline. The self‐reported cessation outcomes were calculated by dividing the number of patients who said they were not using tobacco or had quit, at 6 months posthospital discharge by the number of individuals in the study group at baseline minus those who had died. Both the intent to treat method, which assumes patients lost to follow‐up were still smoking, and the responder method, which does not include nonresponders in the analysis, were used to adjust the denominators for these outcomes.
Multivariate regression analysis was then used to model receipt of the intervention as predictor of self‐reported quit status adjusted for significant covariates. Statistical significance was defined by a P value of less than 0.05.
Survival analysis was employed to model differences in mortality between the study groups, controlling for any baseline imbalances (eg, comorbidity). Because baseline data were used in this model, the model includes only patients with signed a HIPAA release.
Internal review boards of our hospital and the NYS Department of Health reviewed and approved this study.
Results
From January 1, 2007 to May 30, 2008, 660 inpatients who were current smokers were recruited into the study. Figure 1 summarizes patient flow through the study and explains the final sample size of 607. Exclusions include 52 inpatients from the study who completed the 6‐month interview but who did not return a written HIPAA release. Without a HIPAA release to access the EMR, baseline comparison of the study groups and adjustment for comorbidity could not be completed for these patients. At 6 months posthospital discharge, 53 subjects refused the interview when contacted by telephone.
As might be expected in a quasiexperimental design, the study groups were not equivalent at baseline (Table 1). The intervention and comparison groups differed with regard to age, length of stay (LOS), proportion of acute admissions, and the Elixhauser comorbidity index. These differences suggest that the intervention group was older, had a longer LOS, higher acuity at the time of admission, and more comorbidities. In addition, as a result of the intervention, the intervention group was more likely to receive NRT or bupropion in hospital and a Fax‐to‐Quit referral to the NYS Smokers' Quitline. In the intervention group, most patients received 1 visit from the SCS, only 2% received 2 visits. Family members were included in smoking cessation counseling for 58% of the intervention group.
| Intervention (n = 275) | Comparison (n = 335) (P value) | |
|---|---|---|
| ||
| Sex (% male) | 51 | 51 |
| Mean age (years) | 51.4 | 48.5 (0.03) |
| Ethnicity (% white) | 98 | 97 |
| Marital status (% married) | 48 | 47 |
| Elective admission (vs. acute) (%) | 25 | 31 |
| Inpatient (vs. outpatient observation or outpatient surgical admission) (%) | 86 | 68 (0.00) |
| LOS (days) | 3.80 | 2.68 (0.00) |
| Elixhauser comorbidity index (mean) | 1.66 | 1.17 (0.00) |
| Used NRT in hospital (%) | 37 | 19 (0.00) |
| Used bupropion in hospital (%) | 4 | 1 (0.00) |
| Referred to NYS Smokers' Quitline using Fax‐to‐Quit | 10 | 0 (0.00) |
| Mean cigarettes per day* | 17.7 (n = 213) | 15.9 (n = 192) |
As shown in Table 2, there was a significant amount of diagnostic heterogeneity in the discharge diagnoses codes of patients included in the study. However, there were significantly more patients in the intervention group with a first discharge diagnosis of cardiovascular disease (25%) compared to the comparison group (12%; P = 0.00).
| Intervention (n = 274)* (%) | Comparison (n = 333)* (%) | |
|---|---|---|
| ||
| Cardiovascular | 25 | 12, P = 0.00 |
| Pulmonary | 16 | 7 |
| Orthopedics | 12 | 12 |
| Injury | 10 | 15 |
| GI | 8 | 16 |
| Cancer | 6 | 8 |
| GU | 3 | 6 |
| Endocrine | 3 | 3 |
| Other | 17 | 21 |
Readmission outcomes based on EMR and administrative data were available for 607 inpatients with signed HIPAA releases. The readmission rate was higher for the intervention (41%) than the comparison group (20%). Despite a higher readmission rate, the crude mortality within the 6 months posthospital discharge was lower for the intervention group, ie, 0.02 (6/276), than the comparison group, which had a crude mortality of 0.04 (16/384) during this period.
A multivariate survival model, controlling for age, sex, Elixhauser comorbidity index, LOS, and cardiovascular diagnosis, showed a significantly reduced mortality in the intervention group (hazard ratio [HR] = 0.37; P = 0.04). Although cardiac status (P = 0.09) and LOS (P = 0.15) were not significant in this model, they were retained because both of these variables showed significantly higher levels (along with the Elixhauser Index) at baseline in the intervention group, implying that the intervention group was sicker than the comparison group. The Elixhauser comorbidity index (HR = 1.42; P < 0.00) and age (HR = 1.07; P < 0.00) were the only other significant predictors of mortality in this model.
Among those responding to the interview at 6 months post‐hospital discharge (n = 326), there were no significant differences between the study groups with regard to age first started smoking, gender, educational level, employment status, ethnicity, or physical health status (data not shown). Table 3 summarizes the outcomes by the intervention and comparison groups at 6 months post‐hospital discharge. The point prevalence for abstinence was 27% in the intervention group compared to 19% in the comparison group (P = 0.09). Using the intent to treat analysis, the point prevalence for abstinence was 16% in the intervention group compared to 9.8% in the comparison group (P = 0.02). Self‐reported quit status was 63% in the intervention group vs. 48% in the comparison group (P = 0.00). Using the intent to treat analysis, quit status was 44% in the intervention group vs. 30% in the comparison group (P = 0.00). Exclusion of the 52 patients without signed HIPAA releases (Figure 1) did not significantly alter these outcomes.
| Intervention (n = 161) | Comparison (n = 165) (P value) | |
|---|---|---|
| ||
| Self‐reported now smoking not at all (%) | 16 | 10 (0.02) |
| Self‐reported quit within 6 months (%) | 63 | 48 (0.00 |
| Tried to quit (%) | 68 | 62 |
| Used NRT post‐D/C (%) | 26 | 17 (0.04) |
| Used other intervention (%) | 21 | 14 |
| Heard of the NYS Smokers' Quitline (%) | 92 | 90 |
| Aware that NYS Quitline offers NRT (%) | 73 | 49 (0.00) |
| Received free NRT from NYS Smokers' Quitline (%) | 9 | 6 |
| Used NYS Smokers' Quitline (%) | 15 | 9 |
| Called by the NYS Smokers' Quitline (%) | 11 | 5 |
| Self‐rated health status as fair or poor (%) | 48 | 36 |
| Another smoker living at home (%) | 54 | 48 |
| Mean hours spent in same room where someone else was smoking (n) | 20 | 21 (0.04) |
| Households in which smoking is not allowed in the home (%) | 40 | 33 |
| Patients Still Smoking at the 6‐Month Interview | Intervention (n = 118) | Comparison (n = 134) |
| Mean cigarettes currently smoked (n) | 10.5 | 12.7 |
| Mean quit attempts post‐D/C (n) | 3.2 | 3.5 |
| Mean reduction in smoking* (cigarettes/day) | 5.83 | 4.09 |
Patients who received the inpatient smoking cessation counseling were more likely to be called by or use the NYS Smokers' Quitline; however, these differences were not statistically significant. There was no difference between the study groups in awareness of the Quitline but the intervention group was more aware that free NRT was offered by the NYS Quitline. In terms of quit methods used during the 6‐month period (Table 4), NRT or bupropion use was higher in the intervention group. There were no other significant differences between the study groups, except for the use of acupuncture.
| Intervention (n = 91) | Comparison (n = 93) (P value) | |
|---|---|---|
| ||
| Got help from friends or family (%) | 58 | 50 |
| Used any medication to quit (%) | 44 | 28 (0.02) |
| Used nicotine patch (%) | 43 | 25 (0.00) |
| Used bupropion (%) | 10 | 1 (0.00) |
| Used varenicline (%) | 32 | 25 |
| Cut back (%) | 43 | 46 |
| Quit with a friend (%) | 20 | 13 |
| Switched to lights (%) | 18 | 13 |
| Used print material (%) | 14 | 16 |
| Got help from the NYS Smokers' Quitline (%) | 11 | 9 |
| Called by the NYS Smokers' Quitline (%) | 11 | 5 (0.09) |
| Counseling (%) | 9 | 3 |
| Acupuncture (%) | 5 | 0 (0.02) |
| Switched to chew (%) | 2 | 4 |
| Attended classes (%) | 3 | 1 |
| Used NYS Smokers' Quitline website (%) | 2 | 4 |
Multivariate analysis predicting quit status at 6 months post‐hospital discharge included covariates controlling for age, sex, LOS, study group, and comorbidity. This analysis showed that patients with a cardiovascular discharge diagnosis were more likely to quit than patients who had other discharge diagnoses (odds ratio [OR], 3.02; 95% confidence interval [CI], 1.65.7; P = 0.00). Another statistically significant covariate in this model included sex (men were more likely to quit: OR, 0.61; 95% CI, 0.390.97; P = 0.04). Participating in the inpatient intervention group was marginally significant when controlling for these other variables (OR, 1.54; 95% CI, 0.982.45; P = 0.06). Hospital LOS, age, receipt of NRT in hospital, and the Elixhauser comorbidity index were not predictive of quit status at 6 months.
Discussion
This study demonstrates how effective an inpatient smoking cessation program can be for increasing the success of quitting smoking after hospital discharge. At 6 months posthospital discharge, the intervention group had significantly higher intent to treat outcomes for point prevalence abstinence and quit status as well as lower crude and adjusted mortality than the comparison group.
Although at baseline the intervention group was older, had a longer LOS, more cardiovascular diagnoses, and higher comorbidity index, crude post‐hospital discharge mortality was significantly less in the intervention group (0.02) than in the comparison group (0.04). This finding is more significant in light of the higher comorbidity and acuity of the intervention group at baseline. Our multivariate survival model that controlled for these imbalances at baseline demonstrated that the intervention group had significantly less mortality than the comparison group (HR = 0.37; P = 0.04). Reduction in mortality, as soon as 30 days after inpatient smoking cessation counseling, has been demonstrated postmyocardial infarction.17, 18 Intensive smoking cessation quit services were also linked with lower all cause mortality among cardiovascular disease patients 2 years posthospitalization.19 Our study, despite its relatively small sample size, demonstrates that the intervention retains its impact on mortality in real‐world settings.
Following participation in an inpatient smoking cessation program, self‐reported quit status at 6 months post‐hospital discharge in the intervention group was significantly higher in the intervention group (63%) than the comparison group (48%; P = 0.00). Using the intent to treat method, the differences between the study groups was still significant (44% in the intervention group, 30% in the comparison group; P = 0.00). Given the limitations of self‐report and responder bias, the actual outcomes fall somewhere between these 2 estimates. In an effectiveness study of inpatient smoking cessation involving 6 hospitals in California, self‐reported quit rates of 26% at 6 months were reported; however, different methods were used so the results are not strictly comparable.20
Our multivariate analysis suggests that patients with cardiovascular discharge diagnosis were more likely to quit than patients who had other discharge diagnoses (OR, 3.02; 95% CI, 1.65.7; P = 0.0007). This study extends findings of other studies that show that the success of smoking cessation may vary by diagnosis, particularly for smokers admitted for cardiovascular disease.21, 22 Other studies have shown that smoking cessation rates among patients post‐myocardial infarction were higher in admitting facilities that had hospital‐based smoking cessation programs and for those patients referred to cardiac rehabilitation.23 Thus, the availability of a hospital‐based smoking cessation program may be considered a structural measure of health care quality as suggested by Dawood et al.23
The use of NRT greatly increased in our hospital, coincident with the start of the inpatient cessation program7 and, in this study, NRT use appears to continue after hospital discharge. Some studies show an additive effect of NRT combined with cessation counseling.24, 25 Although a Cochrane review did not find a statistically significant difference, there was a trend toward higher quit rates with the addition of NRT.21, 22
Because hospitalized smokers may be more motivated to stop smoking, the updated 2008 DHHS clinical practice guidelines for Treating Tobacco Use and Dependence now recommend that all inpatients who currently smoke be given medications, advised, counseled, and receive follow‐up after discharge.26 Although our inpatient cessation program was started before these clinical practice guidelines were updated, we have had the opportunity to evaluate the recommended practice of inpatient tobacco cessation counseling. Compared to effects shown in efficacy studies, clinical interventions often lose effect size in daily practice and real‐world settings.27, 28 It is reassuring that, in this effectiveness study, the impact of this intervention is still demonstrable.
Provision of inpatient smoking cessation has been shown to be an effective smoking cessation intervention if combined with outpatient follow‐up.29 Reviews by Rigotti et al.21, 22 recommend that inpatient high‐intensity behavioral interventions should be followed by at least 1 month of supportive contact after discharge to promote smoking cessation among hospitalized patients. In our study, specific cessation‐related outpatient follow‐up was not provided by our program. Although letters were sent to primary care providers describing the cessation service provided during the inpatient stay, our study could not ascertain what specific cessation service was offered by either primary‐care or specialty‐care providers during posthospitalization follow‐up visits. An efficient alternative to outpatient visits may be follow‐up delivered via a quitline. Follow‐up in our study included referrals to the NYS Smokers' Quitline; however, only about 10% of inpatient reported using this service. While feasible, the effectiveness of quitline follow‐up is as yet unknown.30
Limitations
This study targets a later phase in research progression from hypothesis development, pilot studies, efficacy (empirically supported) trials, effectiveness trials (real‐world settings), and dissemination studies.31 Because this study addresses the effectiveness rather than the efficacy of inpatient smoking cessation counseling, the use of a quasiexperimental rather than randomized controlled clinical trial design led to measured differences in the study groups at baseline. An important imbalance arose in the intervention group that had twice the percentage of patients with cardiovascular‐related discharge diagnoses as the comparison group. While we were able to adjust for these differences in our analysis, there may be unmeasured differences due to the fact that the inpatients were not randomized to the study groups.
The outcomes of this study cannot be attributed to any one component of the intervention (eg, NRT) vs. the combined effect of the inpatient smoking cessation program. The program components were implemented simultaneously in order to maximize synergistic effects; therefore, the effects of program components are difficult to disaggregate.
The results are limited by the validity of self‐report of smoking status. It is well known that research studies which validate smoking status biochemically have lower efficacy (OR, 1.44; 95% CI, 0.992.11) than those that do not validate smoking status (OR, 1.92; 95% CI, 1.262.93).32 Although it was impractical in this effectiveness study to biochemically validate smoking status 6 months posthospital discharge, we have documented a significant difference between the study groups that confirms the direction of the effect, if not the effect size.
Self‐reports tend to underestimate smoking status in population studies33; however, the discrepancy between self‐reported smoking and biochemical measurements among clinical trial participants is small.34 However, a small but significant bias toward a socially desirable response in intervention groups compared to control groups of 3% with carbon monoxide and 5% for cotinine has been documented.35 If social desirability bias is operative in this study, and if we apply the above correction factor of 4% to correct this classification error, then the difference between the intervention and comparison group would be 10 percentage points (40% in the intervention group vs. 30% in the comparison group using the intention to treat estimates). That difference is still clinically relevant.
The observed difference between the intervention and comparison group is underestimated because the comparison group was exposed to smoking cessation as well both at the time of admission and following discharge (Table 4). The comparison group in this study could thus be viewed as a usual care group rather than a control group. That exposure does cloud the measurement of quit rates as the comparison group is contaminated to some degree by exposure to various cessation methods. The impact of this exposure is to reduce the effect size observed in this study or underestimate the effect of the inpatient smoking cessation counseling because the comparison group was exposed other cessation methods, although to a lesser extent.
The social desirability bias inherent in self‐reported smoking status may increase the effect size while the use of comparison group that received usual care may decrease the effect size. Because neither of these biases could be measured in this study, it is impossible to say whether they negated each other.
As with any administrative database, use of EMR as a data source in this study led to missing data that precluded use of certain variables in the analysis. In addition, lack of written and signed HIPAA releases also precluded inclusion of several inpatients, mostly in the comparison group, in the analytic database. However, it is reassuring that the results of the 6‐month survey did not differ significantly when these individuals were included or excluded from a separate analysis of the survey data. Last, our study population is almost 100% Caucasian thus limiting how generalizable the results are to more heterogenous patient populations.
Conclusions
This quasiexperimental effectiveness study showed that inpatient smoking cessation intervention improved smoking cessation outcomes, use of NRT, and was associated with a decreased mortality 6 months post‐hospital discharge. The effectiveness of this inpatient intervention is maintained in real world settings but may be improved with posthospital discharge follow‐up.
Acknowledgements
The authors are grateful to the many Mary Imogene Bassett Hospital staff in administration, nursing, inpatient pharmacy, medical education, patient care service, and respiratory care who provided data needed to evaluate this program. They also acknowledge the NYS Smokers' Quitline website for data provided about monthly Fax‐to‐Quit program referrals from our county.
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- The Smoking Cessation Clinical Practice Guideline Panel and Staff: the Agency for Health Care Policy and Research Smoking Cessation Clinical Practice Guideline.JAMA.1996;275(16):1270–1280.
- , , , et al.ACC/AHA clinical performance measures for adults with chronic heart failure: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures (Writing Committee to Develop Heart Failure Clinical Performance Measures). Endorsed by the Heart Failure Society of America.J Am Coll Cardiol.2005;46(6):1144–1178.
- , , , et al.ACC/AHA guidelines for the management of patients with ST‐elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines for the Management of Patients with Acute Myocardial Infarction).Circulation.2004;110(9):e82–e292.
- , , , et al.ACC/AHA clinical performance measures for adults with ST‐elevation and non‐ST elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures (Writing Committee to Develop Performance Measures on ST‐Elevation and Non‐ST‐Elevation Myocardial Infarction).J Am Coll Cardiol.2006;47(1):236–265.
- Treating Tobacco Use and Dependence‐Clinicians Packet. A How‐To Guide For Implementing the Public Health Service Clinical Practice Guideline, March2003. Rockville, MD: U.S. Public Health Service, Agency for Healthcare Research and Quality. Available at: http://www.ahrq.gov/clinic/tobacco. Accessed November 2009.
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- , , , et al.The future of behavior change research: what is needed to improve translation of research into health promotion practice?Ann Behav Med.2004;27:3–12.
- The New York State Smokers' Quitline. Available at: http://www.nysmokefree.com. Accessed November2009.
- Tobacco Cessation Continuing Education for Healthcare Professionals and Counselors. Available at: http://www.tobaccocme.com. Accessed November2009.
- Seton Health Cessation Center. The Butt Stops Here. Relaxation Exercises for Smoking Cessation. 2001. The Butt Stops Here Program. Available at: http://www.setonhealth.org. Accessed November2009.
- U.S. Department of Health and Human Services.Treating Tobacco Use and Dependence. Clinical Practice Guideline.Rockville, MD:Public Health Service;2000.
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- Tobacco Use Supplement to the Current Population Survey (TUS‐CPS). Available at: http://riskfactor.cancer.gov/studies/tus‐cps/info.html. Accessed November 2009.
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- , , , et al.Clinical trial comparing nicotine replacement therapy (NRT) plus brief counseling, brief counseling alone, and minimal intervention on smoking cessation in hospital inpatients.Thorax.2003;58:484–488.
- Department of Health and Human Services (DHHS). Treating Tobacco Use and Dependence: 2008 Update. Chapter 7. Available at: http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.section.28504. Accessed November2009.
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- , , .Psychosocial interventions for smoking cessation in patients with coronary heart disease.Cochrane Database Syst Rev.2008;23(1):CD006886.
- , , , , .The accuracy of self‐reported smoking: a systematic review of the relationship between self‐reported and cotinine‐assessed smoking status.Nicotine Tob Res2009;11(1):12–24.
- , , , , .Relations of cotinine and carbon monoxide to self‐reported smoking in a cohort of smokers and ex‐smokers followed over 5 years.Nicotine Tob Res.2002;4(3):287–294.
- , , , .Error in smoking measures: effects of intervention on relations of cotinine and carbon monoxide to self‐reported smoking. The Lung Health Study Research Group.Am J Public Health.1993;83(9):1251–1257.
In 1992, the Joint Commission on Accreditation of Healthcare Organizations (Joint Commission) introduced standards to make hospital buildings smoke‐free, resulting in the nation's first industry‐wide ban on smoking in the workplace. This hospital smoking ban has led to increased smoking cessation among employees.1 Since 2003, core measures from the Joint Commission and quality indicators from the Centers for Medicare and Medicaid Services have included inpatient smoking cessation counseling for acute myocardial infarction, pneumonia, and heart failure, as national guidelines strongly recommend smoking cessation counseling for patients with these diseases who smoke.25
The Department of Health and Human Services (DHHS) 2008 update on Clinical Practice Guidelines for Treating Tobacco Use and Dependence6 recommends that clinicians use hospitalization as an opportunity to promote smoking cessation and to prescribe medications to alleviate withdrawal symptoms. Hospitalization is an opportune time for smoking cessation because patients are restricted to a smoke‐free environment in the hospital and, increasingly, on hospital campuses.6 The illness leading to hospitalization may be attributable, at least in part, to tobacco use, thereby increasing the patient's receptivity to cessation counseling. Last, medications used in‐hospital to treat nicotine withdrawal symptoms may lead to continued or future use of these medications that, in turn, may ultimately lead to a successful quit attempt.
We report on the outcomes of our hospital's attempt to do this in the context of implementation of a smoke‐free medical campus.7 This study was designed to measure whether an inpatient smoking cessation intervention increases the likelihood of smoking cessation 6 months post‐hospital discharge. Because effectiveness studies are the next step to improving translation of research into health promotion practice,8 we set out to measure what the impact of this intervention would be in routine clinical practice as opposed to a carefully structured efficacy trial.
Methods
Intervention
The Smoking Cessation service for inpatients began on April 3, 2006. Upon admission, all patients were screened regarding their current smoking status. The nurse asked the patient if s/he currently smoked and then entered the responses into the hospital electronic medical record (EMR). A current smoker was defined as smoking every day or some days within the past 30 days. A roster of newly admitted current smokers was electronically transmitted to the Respiratory Care office daily. Only current smokers received counseling. The Smoking Cessation Specialist (SCS) subsequently saw inpatients within a 24‐hour time frame of admission, except for weekends and holidays. Each patient received 1 to 2 intensive follow‐up counseling sessions during hospitalization. An average of 10 patients per day were seen.
The goal of the inpatient smoking cessation service was to counsel patients on the health effects of smoking, address nicotine withdrawal symptoms, explain the different pharmacotherapies available, advise on how to quit, give self‐help materials, counsel family members, and refer to the New York State (NYS) Smokers' Fax‐to‐Quit program.9 Following the consult, the SCS documented the encounter in the patient's chart, including recommendations for nicotine replacement therapy (NRT) or bupropion (varenicline was not addressed as it was not on the formulary). The chart documentation informed the physician and nursing staff of the intervention and included the date/time, stage of change, and support action taken.
The SCS was part‐time, had nursing training, smoking cessation training,10 and was also trained by the Seton Health Cessation Center in the Butt Stops Here Program.11 She also implemented a performance improvement plan to increase the provision of smoking cessation counseling, increase NRT or bupropion prescriptions to smokers admitted to the hospital, and increase referrals to the NYS telephone quitline through the Fax‐to‐Quit program for outpatient resources and help following hospital discharge. The Fax‐to‐Quit program allows health care providers to refer patients to the NYS quitline via fax, with the patient's signature (patient permission) on the fax to quit form. After hospital discharge, the quitline then contacts the patient at a time that the patient requested.
The SCS visited patients with all admitting diagnoses on the medical, surgical, and special care units who were current smokers. Inpatients admitted to psychiatry, obstetrics, and the intensive care unit (ICU) were not seen by the SCS, except for ICU patients referred by a physician. Inpatients who had short stays or who were admitted and discharged in 1 day or during the weekend were not seen.
The intervention included either a brief 3‐minute to 5‐minute intervention or a more intensive intervention, that required 10 to 20 minutes (18 minutes average). The length of the intervention was determined by how receptive the patient was to the intervention. All interventions began with patient identification, an introduction to the SCS, and an explanation of the purpose of the visit. The SCS then inquired about the patient's comfort level vis‐a‐vis nicotine withdrawal and if s/he was receiving any NRT while in the hospital (NRT on the inpatient formulary included the nicotine patch or gum). If the patient was receptive to counseling, the SCS then began to work through the 5 A's, as described in the 2000 DHHS Clinical Practice Guidelines.12 The 2000 DHHS Clinical Practice Guidelines were used because the 2008 update had not been released at the time this study was initiated in 2006. These include: asking about smoking status, advising on how to quit, assessing readiness to quit, and assisting in arranging treatment options that include pharmacotherapy, counseling, as well as referral to the NYS Smokers' Quitline. A workbook was provided to reinforce counseling but was not necessarily used during counseling session. A compact disc (CD) with relaxation exercises5 was provided to those inpatients who were interested in stress reduction. If family members were present, and were also smokers, they were included in the counseling session, if willing. Each patient was offered a referral via the Fax‐to‐Quit program to continue treatment on an outpatient basis.
If the patient was not motivated to quit or declined the consult, the visits were short and focused on the patient's experience with nicotine withdrawal. These patients were also given self‐help materials and, if possible, the relevance of and roadblocks to quitting were reviewed. Patients were prompted to think about why quitting was relevant and often the reason for hospitalization was used to motivate the quitting process.
Upon hospital discharge, the patient's primary care provider was notified of the cessation intervention by a letter from the SCS. The letter described the intervention and stated whether or not the patient agreed to be referred to the Fax‐to‐Quit Program.
Study Participants
Patients were recruited from July 1, 2006 (after the smoking ban went into effect) through June 1, 2008. Inpatients who currently smoked were informed of this study and were asked to sign informed consent to participate after they were seen by the SCS. Current smokers of all admitting diagnoses were recruited into the study. Patients provided informed consent for a telephone interview 6 months posthospital discharge. A written Health Insurance Portability and Accountability Act (HIPAA) release was obtained to allow access to an individual's specific EMR.
A comparison group of inpatients who were also current smokers, but who did not receive the intervention were also contacted six months after hospitalization. Reasons for not receiving the intervention included the fact the SCS was part‐time and also took a leave of absence during the study and therefore could not see all inpatients who currently smoked. Other reasons for not receiving the intervention include too short a stay for the SCS to see the patient or the patient was out of the room for tests or procedures when the SCS was available. These patients provided informed consent to be interviewed 6 months after hospital discharge and HIPAA consent for access to their medical record. Not all inpatients in the comparison group provided written HIPAA release for use of their medical record; therefore, these patients were excluded because their baseline demographic and diagnostic data were missing.
Sample‐size considerations were driven around having adequate numbers of subjects to measure the prevalence of smoking cessation at 6 months post‐hospital discharge with an acceptable degree of precision. Prevalence estimates from previous studies for 6‐month cessation typically range from 20% to 30%, with cessation rates as high as 67% (this estimate applies to postmyocardial infarction patients.)13 For conservative estimation, we used 50% as the 6‐month prevalence of cessation in the current study, which placed binomial variance at its theoretical maximum. In this case, a sample of 300 subjects provides a margin of error of 0.058 for a 95% confidence interval around this point estimate.
Data Sources
The hospital EMR database was used to monitor several components of the program: nursing screening, smoking cessation counseling, and pharmacy dispensing of NRT and bupropion. The screening data were also used to monitor the proportion of current smokers admitted during the study period. Elements of the EMR were used to define the following covariates: patient age, gender, ethnicity, and the primary discharge diagnosis (via International Statistical Classification of Diseases and Related Health Problems, 9th edition [ICD9] codes) and readmission during the six month follow‐up period. Mean length of stay (LOS) was computed. The Elixhauser Comorbidity Index that utilizes ICD9 codes was used for comorbidity risk adjustment.14
Study participants were contacted by phone 6 months posthospital discharge. Data collection began July 1, 2006 and was completed January 1, 2009. The interview focused on self‐reported point prevalence of smoking and 6‐month quit status. The point prevalence for self‐reported abstinence was derived from the question Do you now smoke cigarettes every day, some days, or not at all?15 Self‐reported quit status was derived from question Have you quit smoking since you were discharged from the hospital? In addition, respondents were queried about their number of years smoked, post‐hospital discharge number of quit attempts, and cessation efforts (NRT, self‐help groups, quitline use, etc.). Last, they were surveyed about barriers to cessation (exposure to secondhand smoke, rules about smoking in the home or car), educational level, employment, and health ratings.
To determine the status of those lost to follow‐up, administrative and EMR databases for appointments and follow‐up visits were accessed to determine if the patient was alive during the 6 months between discharge and the follow‐up call. To confirm mortality, we searched the Internet, Ancestry.com, and/or local newspaper obituaries for dates of death for all patients to validate that they had not died during the 6‐month follow‐up. World wide web searches can identify 97% of deaths listed in the Centers for Disease Control and Prevention (CDC)/National Death Index, which is considered the gold standard in epidemiologic studies.16
Analysis
Univariate analysis of all covariates was completed to examine the normal distribution curves for these variables. Bivariate correlation analysis of all the independent variables by study group was performed to assess comparability of the study groups at baseline. The self‐reported cessation outcomes were calculated by dividing the number of patients who said they were not using tobacco or had quit, at 6 months posthospital discharge by the number of individuals in the study group at baseline minus those who had died. Both the intent to treat method, which assumes patients lost to follow‐up were still smoking, and the responder method, which does not include nonresponders in the analysis, were used to adjust the denominators for these outcomes.
Multivariate regression analysis was then used to model receipt of the intervention as predictor of self‐reported quit status adjusted for significant covariates. Statistical significance was defined by a P value of less than 0.05.
Survival analysis was employed to model differences in mortality between the study groups, controlling for any baseline imbalances (eg, comorbidity). Because baseline data were used in this model, the model includes only patients with signed a HIPAA release.
Internal review boards of our hospital and the NYS Department of Health reviewed and approved this study.
Results
From January 1, 2007 to May 30, 2008, 660 inpatients who were current smokers were recruited into the study. Figure 1 summarizes patient flow through the study and explains the final sample size of 607. Exclusions include 52 inpatients from the study who completed the 6‐month interview but who did not return a written HIPAA release. Without a HIPAA release to access the EMR, baseline comparison of the study groups and adjustment for comorbidity could not be completed for these patients. At 6 months posthospital discharge, 53 subjects refused the interview when contacted by telephone.
As might be expected in a quasiexperimental design, the study groups were not equivalent at baseline (Table 1). The intervention and comparison groups differed with regard to age, length of stay (LOS), proportion of acute admissions, and the Elixhauser comorbidity index. These differences suggest that the intervention group was older, had a longer LOS, higher acuity at the time of admission, and more comorbidities. In addition, as a result of the intervention, the intervention group was more likely to receive NRT or bupropion in hospital and a Fax‐to‐Quit referral to the NYS Smokers' Quitline. In the intervention group, most patients received 1 visit from the SCS, only 2% received 2 visits. Family members were included in smoking cessation counseling for 58% of the intervention group.
| Intervention (n = 275) | Comparison (n = 335) (P value) | |
|---|---|---|
| ||
| Sex (% male) | 51 | 51 |
| Mean age (years) | 51.4 | 48.5 (0.03) |
| Ethnicity (% white) | 98 | 97 |
| Marital status (% married) | 48 | 47 |
| Elective admission (vs. acute) (%) | 25 | 31 |
| Inpatient (vs. outpatient observation or outpatient surgical admission) (%) | 86 | 68 (0.00) |
| LOS (days) | 3.80 | 2.68 (0.00) |
| Elixhauser comorbidity index (mean) | 1.66 | 1.17 (0.00) |
| Used NRT in hospital (%) | 37 | 19 (0.00) |
| Used bupropion in hospital (%) | 4 | 1 (0.00) |
| Referred to NYS Smokers' Quitline using Fax‐to‐Quit | 10 | 0 (0.00) |
| Mean cigarettes per day* | 17.7 (n = 213) | 15.9 (n = 192) |
As shown in Table 2, there was a significant amount of diagnostic heterogeneity in the discharge diagnoses codes of patients included in the study. However, there were significantly more patients in the intervention group with a first discharge diagnosis of cardiovascular disease (25%) compared to the comparison group (12%; P = 0.00).
| Intervention (n = 274)* (%) | Comparison (n = 333)* (%) | |
|---|---|---|
| ||
| Cardiovascular | 25 | 12, P = 0.00 |
| Pulmonary | 16 | 7 |
| Orthopedics | 12 | 12 |
| Injury | 10 | 15 |
| GI | 8 | 16 |
| Cancer | 6 | 8 |
| GU | 3 | 6 |
| Endocrine | 3 | 3 |
| Other | 17 | 21 |
Readmission outcomes based on EMR and administrative data were available for 607 inpatients with signed HIPAA releases. The readmission rate was higher for the intervention (41%) than the comparison group (20%). Despite a higher readmission rate, the crude mortality within the 6 months posthospital discharge was lower for the intervention group, ie, 0.02 (6/276), than the comparison group, which had a crude mortality of 0.04 (16/384) during this period.
A multivariate survival model, controlling for age, sex, Elixhauser comorbidity index, LOS, and cardiovascular diagnosis, showed a significantly reduced mortality in the intervention group (hazard ratio [HR] = 0.37; P = 0.04). Although cardiac status (P = 0.09) and LOS (P = 0.15) were not significant in this model, they were retained because both of these variables showed significantly higher levels (along with the Elixhauser Index) at baseline in the intervention group, implying that the intervention group was sicker than the comparison group. The Elixhauser comorbidity index (HR = 1.42; P < 0.00) and age (HR = 1.07; P < 0.00) were the only other significant predictors of mortality in this model.
Among those responding to the interview at 6 months post‐hospital discharge (n = 326), there were no significant differences between the study groups with regard to age first started smoking, gender, educational level, employment status, ethnicity, or physical health status (data not shown). Table 3 summarizes the outcomes by the intervention and comparison groups at 6 months post‐hospital discharge. The point prevalence for abstinence was 27% in the intervention group compared to 19% in the comparison group (P = 0.09). Using the intent to treat analysis, the point prevalence for abstinence was 16% in the intervention group compared to 9.8% in the comparison group (P = 0.02). Self‐reported quit status was 63% in the intervention group vs. 48% in the comparison group (P = 0.00). Using the intent to treat analysis, quit status was 44% in the intervention group vs. 30% in the comparison group (P = 0.00). Exclusion of the 52 patients without signed HIPAA releases (Figure 1) did not significantly alter these outcomes.
| Intervention (n = 161) | Comparison (n = 165) (P value) | |
|---|---|---|
| ||
| Self‐reported now smoking not at all (%) | 16 | 10 (0.02) |
| Self‐reported quit within 6 months (%) | 63 | 48 (0.00 |
| Tried to quit (%) | 68 | 62 |
| Used NRT post‐D/C (%) | 26 | 17 (0.04) |
| Used other intervention (%) | 21 | 14 |
| Heard of the NYS Smokers' Quitline (%) | 92 | 90 |
| Aware that NYS Quitline offers NRT (%) | 73 | 49 (0.00) |
| Received free NRT from NYS Smokers' Quitline (%) | 9 | 6 |
| Used NYS Smokers' Quitline (%) | 15 | 9 |
| Called by the NYS Smokers' Quitline (%) | 11 | 5 |
| Self‐rated health status as fair or poor (%) | 48 | 36 |
| Another smoker living at home (%) | 54 | 48 |
| Mean hours spent in same room where someone else was smoking (n) | 20 | 21 (0.04) |
| Households in which smoking is not allowed in the home (%) | 40 | 33 |
| Patients Still Smoking at the 6‐Month Interview | Intervention (n = 118) | Comparison (n = 134) |
| Mean cigarettes currently smoked (n) | 10.5 | 12.7 |
| Mean quit attempts post‐D/C (n) | 3.2 | 3.5 |
| Mean reduction in smoking* (cigarettes/day) | 5.83 | 4.09 |
Patients who received the inpatient smoking cessation counseling were more likely to be called by or use the NYS Smokers' Quitline; however, these differences were not statistically significant. There was no difference between the study groups in awareness of the Quitline but the intervention group was more aware that free NRT was offered by the NYS Quitline. In terms of quit methods used during the 6‐month period (Table 4), NRT or bupropion use was higher in the intervention group. There were no other significant differences between the study groups, except for the use of acupuncture.
| Intervention (n = 91) | Comparison (n = 93) (P value) | |
|---|---|---|
| ||
| Got help from friends or family (%) | 58 | 50 |
| Used any medication to quit (%) | 44 | 28 (0.02) |
| Used nicotine patch (%) | 43 | 25 (0.00) |
| Used bupropion (%) | 10 | 1 (0.00) |
| Used varenicline (%) | 32 | 25 |
| Cut back (%) | 43 | 46 |
| Quit with a friend (%) | 20 | 13 |
| Switched to lights (%) | 18 | 13 |
| Used print material (%) | 14 | 16 |
| Got help from the NYS Smokers' Quitline (%) | 11 | 9 |
| Called by the NYS Smokers' Quitline (%) | 11 | 5 (0.09) |
| Counseling (%) | 9 | 3 |
| Acupuncture (%) | 5 | 0 (0.02) |
| Switched to chew (%) | 2 | 4 |
| Attended classes (%) | 3 | 1 |
| Used NYS Smokers' Quitline website (%) | 2 | 4 |
Multivariate analysis predicting quit status at 6 months post‐hospital discharge included covariates controlling for age, sex, LOS, study group, and comorbidity. This analysis showed that patients with a cardiovascular discharge diagnosis were more likely to quit than patients who had other discharge diagnoses (odds ratio [OR], 3.02; 95% confidence interval [CI], 1.65.7; P = 0.00). Another statistically significant covariate in this model included sex (men were more likely to quit: OR, 0.61; 95% CI, 0.390.97; P = 0.04). Participating in the inpatient intervention group was marginally significant when controlling for these other variables (OR, 1.54; 95% CI, 0.982.45; P = 0.06). Hospital LOS, age, receipt of NRT in hospital, and the Elixhauser comorbidity index were not predictive of quit status at 6 months.
Discussion
This study demonstrates how effective an inpatient smoking cessation program can be for increasing the success of quitting smoking after hospital discharge. At 6 months posthospital discharge, the intervention group had significantly higher intent to treat outcomes for point prevalence abstinence and quit status as well as lower crude and adjusted mortality than the comparison group.
Although at baseline the intervention group was older, had a longer LOS, more cardiovascular diagnoses, and higher comorbidity index, crude post‐hospital discharge mortality was significantly less in the intervention group (0.02) than in the comparison group (0.04). This finding is more significant in light of the higher comorbidity and acuity of the intervention group at baseline. Our multivariate survival model that controlled for these imbalances at baseline demonstrated that the intervention group had significantly less mortality than the comparison group (HR = 0.37; P = 0.04). Reduction in mortality, as soon as 30 days after inpatient smoking cessation counseling, has been demonstrated postmyocardial infarction.17, 18 Intensive smoking cessation quit services were also linked with lower all cause mortality among cardiovascular disease patients 2 years posthospitalization.19 Our study, despite its relatively small sample size, demonstrates that the intervention retains its impact on mortality in real‐world settings.
Following participation in an inpatient smoking cessation program, self‐reported quit status at 6 months post‐hospital discharge in the intervention group was significantly higher in the intervention group (63%) than the comparison group (48%; P = 0.00). Using the intent to treat method, the differences between the study groups was still significant (44% in the intervention group, 30% in the comparison group; P = 0.00). Given the limitations of self‐report and responder bias, the actual outcomes fall somewhere between these 2 estimates. In an effectiveness study of inpatient smoking cessation involving 6 hospitals in California, self‐reported quit rates of 26% at 6 months were reported; however, different methods were used so the results are not strictly comparable.20
Our multivariate analysis suggests that patients with cardiovascular discharge diagnosis were more likely to quit than patients who had other discharge diagnoses (OR, 3.02; 95% CI, 1.65.7; P = 0.0007). This study extends findings of other studies that show that the success of smoking cessation may vary by diagnosis, particularly for smokers admitted for cardiovascular disease.21, 22 Other studies have shown that smoking cessation rates among patients post‐myocardial infarction were higher in admitting facilities that had hospital‐based smoking cessation programs and for those patients referred to cardiac rehabilitation.23 Thus, the availability of a hospital‐based smoking cessation program may be considered a structural measure of health care quality as suggested by Dawood et al.23
The use of NRT greatly increased in our hospital, coincident with the start of the inpatient cessation program7 and, in this study, NRT use appears to continue after hospital discharge. Some studies show an additive effect of NRT combined with cessation counseling.24, 25 Although a Cochrane review did not find a statistically significant difference, there was a trend toward higher quit rates with the addition of NRT.21, 22
Because hospitalized smokers may be more motivated to stop smoking, the updated 2008 DHHS clinical practice guidelines for Treating Tobacco Use and Dependence now recommend that all inpatients who currently smoke be given medications, advised, counseled, and receive follow‐up after discharge.26 Although our inpatient cessation program was started before these clinical practice guidelines were updated, we have had the opportunity to evaluate the recommended practice of inpatient tobacco cessation counseling. Compared to effects shown in efficacy studies, clinical interventions often lose effect size in daily practice and real‐world settings.27, 28 It is reassuring that, in this effectiveness study, the impact of this intervention is still demonstrable.
Provision of inpatient smoking cessation has been shown to be an effective smoking cessation intervention if combined with outpatient follow‐up.29 Reviews by Rigotti et al.21, 22 recommend that inpatient high‐intensity behavioral interventions should be followed by at least 1 month of supportive contact after discharge to promote smoking cessation among hospitalized patients. In our study, specific cessation‐related outpatient follow‐up was not provided by our program. Although letters were sent to primary care providers describing the cessation service provided during the inpatient stay, our study could not ascertain what specific cessation service was offered by either primary‐care or specialty‐care providers during posthospitalization follow‐up visits. An efficient alternative to outpatient visits may be follow‐up delivered via a quitline. Follow‐up in our study included referrals to the NYS Smokers' Quitline; however, only about 10% of inpatient reported using this service. While feasible, the effectiveness of quitline follow‐up is as yet unknown.30
Limitations
This study targets a later phase in research progression from hypothesis development, pilot studies, efficacy (empirically supported) trials, effectiveness trials (real‐world settings), and dissemination studies.31 Because this study addresses the effectiveness rather than the efficacy of inpatient smoking cessation counseling, the use of a quasiexperimental rather than randomized controlled clinical trial design led to measured differences in the study groups at baseline. An important imbalance arose in the intervention group that had twice the percentage of patients with cardiovascular‐related discharge diagnoses as the comparison group. While we were able to adjust for these differences in our analysis, there may be unmeasured differences due to the fact that the inpatients were not randomized to the study groups.
The outcomes of this study cannot be attributed to any one component of the intervention (eg, NRT) vs. the combined effect of the inpatient smoking cessation program. The program components were implemented simultaneously in order to maximize synergistic effects; therefore, the effects of program components are difficult to disaggregate.
The results are limited by the validity of self‐report of smoking status. It is well known that research studies which validate smoking status biochemically have lower efficacy (OR, 1.44; 95% CI, 0.992.11) than those that do not validate smoking status (OR, 1.92; 95% CI, 1.262.93).32 Although it was impractical in this effectiveness study to biochemically validate smoking status 6 months posthospital discharge, we have documented a significant difference between the study groups that confirms the direction of the effect, if not the effect size.
Self‐reports tend to underestimate smoking status in population studies33; however, the discrepancy between self‐reported smoking and biochemical measurements among clinical trial participants is small.34 However, a small but significant bias toward a socially desirable response in intervention groups compared to control groups of 3% with carbon monoxide and 5% for cotinine has been documented.35 If social desirability bias is operative in this study, and if we apply the above correction factor of 4% to correct this classification error, then the difference between the intervention and comparison group would be 10 percentage points (40% in the intervention group vs. 30% in the comparison group using the intention to treat estimates). That difference is still clinically relevant.
The observed difference between the intervention and comparison group is underestimated because the comparison group was exposed to smoking cessation as well both at the time of admission and following discharge (Table 4). The comparison group in this study could thus be viewed as a usual care group rather than a control group. That exposure does cloud the measurement of quit rates as the comparison group is contaminated to some degree by exposure to various cessation methods. The impact of this exposure is to reduce the effect size observed in this study or underestimate the effect of the inpatient smoking cessation counseling because the comparison group was exposed other cessation methods, although to a lesser extent.
The social desirability bias inherent in self‐reported smoking status may increase the effect size while the use of comparison group that received usual care may decrease the effect size. Because neither of these biases could be measured in this study, it is impossible to say whether they negated each other.
As with any administrative database, use of EMR as a data source in this study led to missing data that precluded use of certain variables in the analysis. In addition, lack of written and signed HIPAA releases also precluded inclusion of several inpatients, mostly in the comparison group, in the analytic database. However, it is reassuring that the results of the 6‐month survey did not differ significantly when these individuals were included or excluded from a separate analysis of the survey data. Last, our study population is almost 100% Caucasian thus limiting how generalizable the results are to more heterogenous patient populations.
Conclusions
This quasiexperimental effectiveness study showed that inpatient smoking cessation intervention improved smoking cessation outcomes, use of NRT, and was associated with a decreased mortality 6 months post‐hospital discharge. The effectiveness of this inpatient intervention is maintained in real world settings but may be improved with posthospital discharge follow‐up.
Acknowledgements
The authors are grateful to the many Mary Imogene Bassett Hospital staff in administration, nursing, inpatient pharmacy, medical education, patient care service, and respiratory care who provided data needed to evaluate this program. They also acknowledge the NYS Smokers' Quitline website for data provided about monthly Fax‐to‐Quit program referrals from our county.
In 1992, the Joint Commission on Accreditation of Healthcare Organizations (Joint Commission) introduced standards to make hospital buildings smoke‐free, resulting in the nation's first industry‐wide ban on smoking in the workplace. This hospital smoking ban has led to increased smoking cessation among employees.1 Since 2003, core measures from the Joint Commission and quality indicators from the Centers for Medicare and Medicaid Services have included inpatient smoking cessation counseling for acute myocardial infarction, pneumonia, and heart failure, as national guidelines strongly recommend smoking cessation counseling for patients with these diseases who smoke.25
The Department of Health and Human Services (DHHS) 2008 update on Clinical Practice Guidelines for Treating Tobacco Use and Dependence6 recommends that clinicians use hospitalization as an opportunity to promote smoking cessation and to prescribe medications to alleviate withdrawal symptoms. Hospitalization is an opportune time for smoking cessation because patients are restricted to a smoke‐free environment in the hospital and, increasingly, on hospital campuses.6 The illness leading to hospitalization may be attributable, at least in part, to tobacco use, thereby increasing the patient's receptivity to cessation counseling. Last, medications used in‐hospital to treat nicotine withdrawal symptoms may lead to continued or future use of these medications that, in turn, may ultimately lead to a successful quit attempt.
We report on the outcomes of our hospital's attempt to do this in the context of implementation of a smoke‐free medical campus.7 This study was designed to measure whether an inpatient smoking cessation intervention increases the likelihood of smoking cessation 6 months post‐hospital discharge. Because effectiveness studies are the next step to improving translation of research into health promotion practice,8 we set out to measure what the impact of this intervention would be in routine clinical practice as opposed to a carefully structured efficacy trial.
Methods
Intervention
The Smoking Cessation service for inpatients began on April 3, 2006. Upon admission, all patients were screened regarding their current smoking status. The nurse asked the patient if s/he currently smoked and then entered the responses into the hospital electronic medical record (EMR). A current smoker was defined as smoking every day or some days within the past 30 days. A roster of newly admitted current smokers was electronically transmitted to the Respiratory Care office daily. Only current smokers received counseling. The Smoking Cessation Specialist (SCS) subsequently saw inpatients within a 24‐hour time frame of admission, except for weekends and holidays. Each patient received 1 to 2 intensive follow‐up counseling sessions during hospitalization. An average of 10 patients per day were seen.
The goal of the inpatient smoking cessation service was to counsel patients on the health effects of smoking, address nicotine withdrawal symptoms, explain the different pharmacotherapies available, advise on how to quit, give self‐help materials, counsel family members, and refer to the New York State (NYS) Smokers' Fax‐to‐Quit program.9 Following the consult, the SCS documented the encounter in the patient's chart, including recommendations for nicotine replacement therapy (NRT) or bupropion (varenicline was not addressed as it was not on the formulary). The chart documentation informed the physician and nursing staff of the intervention and included the date/time, stage of change, and support action taken.
The SCS was part‐time, had nursing training, smoking cessation training,10 and was also trained by the Seton Health Cessation Center in the Butt Stops Here Program.11 She also implemented a performance improvement plan to increase the provision of smoking cessation counseling, increase NRT or bupropion prescriptions to smokers admitted to the hospital, and increase referrals to the NYS telephone quitline through the Fax‐to‐Quit program for outpatient resources and help following hospital discharge. The Fax‐to‐Quit program allows health care providers to refer patients to the NYS quitline via fax, with the patient's signature (patient permission) on the fax to quit form. After hospital discharge, the quitline then contacts the patient at a time that the patient requested.
The SCS visited patients with all admitting diagnoses on the medical, surgical, and special care units who were current smokers. Inpatients admitted to psychiatry, obstetrics, and the intensive care unit (ICU) were not seen by the SCS, except for ICU patients referred by a physician. Inpatients who had short stays or who were admitted and discharged in 1 day or during the weekend were not seen.
The intervention included either a brief 3‐minute to 5‐minute intervention or a more intensive intervention, that required 10 to 20 minutes (18 minutes average). The length of the intervention was determined by how receptive the patient was to the intervention. All interventions began with patient identification, an introduction to the SCS, and an explanation of the purpose of the visit. The SCS then inquired about the patient's comfort level vis‐a‐vis nicotine withdrawal and if s/he was receiving any NRT while in the hospital (NRT on the inpatient formulary included the nicotine patch or gum). If the patient was receptive to counseling, the SCS then began to work through the 5 A's, as described in the 2000 DHHS Clinical Practice Guidelines.12 The 2000 DHHS Clinical Practice Guidelines were used because the 2008 update had not been released at the time this study was initiated in 2006. These include: asking about smoking status, advising on how to quit, assessing readiness to quit, and assisting in arranging treatment options that include pharmacotherapy, counseling, as well as referral to the NYS Smokers' Quitline. A workbook was provided to reinforce counseling but was not necessarily used during counseling session. A compact disc (CD) with relaxation exercises5 was provided to those inpatients who were interested in stress reduction. If family members were present, and were also smokers, they were included in the counseling session, if willing. Each patient was offered a referral via the Fax‐to‐Quit program to continue treatment on an outpatient basis.
If the patient was not motivated to quit or declined the consult, the visits were short and focused on the patient's experience with nicotine withdrawal. These patients were also given self‐help materials and, if possible, the relevance of and roadblocks to quitting were reviewed. Patients were prompted to think about why quitting was relevant and often the reason for hospitalization was used to motivate the quitting process.
Upon hospital discharge, the patient's primary care provider was notified of the cessation intervention by a letter from the SCS. The letter described the intervention and stated whether or not the patient agreed to be referred to the Fax‐to‐Quit Program.
Study Participants
Patients were recruited from July 1, 2006 (after the smoking ban went into effect) through June 1, 2008. Inpatients who currently smoked were informed of this study and were asked to sign informed consent to participate after they were seen by the SCS. Current smokers of all admitting diagnoses were recruited into the study. Patients provided informed consent for a telephone interview 6 months posthospital discharge. A written Health Insurance Portability and Accountability Act (HIPAA) release was obtained to allow access to an individual's specific EMR.
A comparison group of inpatients who were also current smokers, but who did not receive the intervention were also contacted six months after hospitalization. Reasons for not receiving the intervention included the fact the SCS was part‐time and also took a leave of absence during the study and therefore could not see all inpatients who currently smoked. Other reasons for not receiving the intervention include too short a stay for the SCS to see the patient or the patient was out of the room for tests or procedures when the SCS was available. These patients provided informed consent to be interviewed 6 months after hospital discharge and HIPAA consent for access to their medical record. Not all inpatients in the comparison group provided written HIPAA release for use of their medical record; therefore, these patients were excluded because their baseline demographic and diagnostic data were missing.
Sample‐size considerations were driven around having adequate numbers of subjects to measure the prevalence of smoking cessation at 6 months post‐hospital discharge with an acceptable degree of precision. Prevalence estimates from previous studies for 6‐month cessation typically range from 20% to 30%, with cessation rates as high as 67% (this estimate applies to postmyocardial infarction patients.)13 For conservative estimation, we used 50% as the 6‐month prevalence of cessation in the current study, which placed binomial variance at its theoretical maximum. In this case, a sample of 300 subjects provides a margin of error of 0.058 for a 95% confidence interval around this point estimate.
Data Sources
The hospital EMR database was used to monitor several components of the program: nursing screening, smoking cessation counseling, and pharmacy dispensing of NRT and bupropion. The screening data were also used to monitor the proportion of current smokers admitted during the study period. Elements of the EMR were used to define the following covariates: patient age, gender, ethnicity, and the primary discharge diagnosis (via International Statistical Classification of Diseases and Related Health Problems, 9th edition [ICD9] codes) and readmission during the six month follow‐up period. Mean length of stay (LOS) was computed. The Elixhauser Comorbidity Index that utilizes ICD9 codes was used for comorbidity risk adjustment.14
Study participants were contacted by phone 6 months posthospital discharge. Data collection began July 1, 2006 and was completed January 1, 2009. The interview focused on self‐reported point prevalence of smoking and 6‐month quit status. The point prevalence for self‐reported abstinence was derived from the question Do you now smoke cigarettes every day, some days, or not at all?15 Self‐reported quit status was derived from question Have you quit smoking since you were discharged from the hospital? In addition, respondents were queried about their number of years smoked, post‐hospital discharge number of quit attempts, and cessation efforts (NRT, self‐help groups, quitline use, etc.). Last, they were surveyed about barriers to cessation (exposure to secondhand smoke, rules about smoking in the home or car), educational level, employment, and health ratings.
To determine the status of those lost to follow‐up, administrative and EMR databases for appointments and follow‐up visits were accessed to determine if the patient was alive during the 6 months between discharge and the follow‐up call. To confirm mortality, we searched the Internet, Ancestry.com, and/or local newspaper obituaries for dates of death for all patients to validate that they had not died during the 6‐month follow‐up. World wide web searches can identify 97% of deaths listed in the Centers for Disease Control and Prevention (CDC)/National Death Index, which is considered the gold standard in epidemiologic studies.16
Analysis
Univariate analysis of all covariates was completed to examine the normal distribution curves for these variables. Bivariate correlation analysis of all the independent variables by study group was performed to assess comparability of the study groups at baseline. The self‐reported cessation outcomes were calculated by dividing the number of patients who said they were not using tobacco or had quit, at 6 months posthospital discharge by the number of individuals in the study group at baseline minus those who had died. Both the intent to treat method, which assumes patients lost to follow‐up were still smoking, and the responder method, which does not include nonresponders in the analysis, were used to adjust the denominators for these outcomes.
Multivariate regression analysis was then used to model receipt of the intervention as predictor of self‐reported quit status adjusted for significant covariates. Statistical significance was defined by a P value of less than 0.05.
Survival analysis was employed to model differences in mortality between the study groups, controlling for any baseline imbalances (eg, comorbidity). Because baseline data were used in this model, the model includes only patients with signed a HIPAA release.
Internal review boards of our hospital and the NYS Department of Health reviewed and approved this study.
Results
From January 1, 2007 to May 30, 2008, 660 inpatients who were current smokers were recruited into the study. Figure 1 summarizes patient flow through the study and explains the final sample size of 607. Exclusions include 52 inpatients from the study who completed the 6‐month interview but who did not return a written HIPAA release. Without a HIPAA release to access the EMR, baseline comparison of the study groups and adjustment for comorbidity could not be completed for these patients. At 6 months posthospital discharge, 53 subjects refused the interview when contacted by telephone.
As might be expected in a quasiexperimental design, the study groups were not equivalent at baseline (Table 1). The intervention and comparison groups differed with regard to age, length of stay (LOS), proportion of acute admissions, and the Elixhauser comorbidity index. These differences suggest that the intervention group was older, had a longer LOS, higher acuity at the time of admission, and more comorbidities. In addition, as a result of the intervention, the intervention group was more likely to receive NRT or bupropion in hospital and a Fax‐to‐Quit referral to the NYS Smokers' Quitline. In the intervention group, most patients received 1 visit from the SCS, only 2% received 2 visits. Family members were included in smoking cessation counseling for 58% of the intervention group.
| Intervention (n = 275) | Comparison (n = 335) (P value) | |
|---|---|---|
| ||
| Sex (% male) | 51 | 51 |
| Mean age (years) | 51.4 | 48.5 (0.03) |
| Ethnicity (% white) | 98 | 97 |
| Marital status (% married) | 48 | 47 |
| Elective admission (vs. acute) (%) | 25 | 31 |
| Inpatient (vs. outpatient observation or outpatient surgical admission) (%) | 86 | 68 (0.00) |
| LOS (days) | 3.80 | 2.68 (0.00) |
| Elixhauser comorbidity index (mean) | 1.66 | 1.17 (0.00) |
| Used NRT in hospital (%) | 37 | 19 (0.00) |
| Used bupropion in hospital (%) | 4 | 1 (0.00) |
| Referred to NYS Smokers' Quitline using Fax‐to‐Quit | 10 | 0 (0.00) |
| Mean cigarettes per day* | 17.7 (n = 213) | 15.9 (n = 192) |
As shown in Table 2, there was a significant amount of diagnostic heterogeneity in the discharge diagnoses codes of patients included in the study. However, there were significantly more patients in the intervention group with a first discharge diagnosis of cardiovascular disease (25%) compared to the comparison group (12%; P = 0.00).
| Intervention (n = 274)* (%) | Comparison (n = 333)* (%) | |
|---|---|---|
| ||
| Cardiovascular | 25 | 12, P = 0.00 |
| Pulmonary | 16 | 7 |
| Orthopedics | 12 | 12 |
| Injury | 10 | 15 |
| GI | 8 | 16 |
| Cancer | 6 | 8 |
| GU | 3 | 6 |
| Endocrine | 3 | 3 |
| Other | 17 | 21 |
Readmission outcomes based on EMR and administrative data were available for 607 inpatients with signed HIPAA releases. The readmission rate was higher for the intervention (41%) than the comparison group (20%). Despite a higher readmission rate, the crude mortality within the 6 months posthospital discharge was lower for the intervention group, ie, 0.02 (6/276), than the comparison group, which had a crude mortality of 0.04 (16/384) during this period.
A multivariate survival model, controlling for age, sex, Elixhauser comorbidity index, LOS, and cardiovascular diagnosis, showed a significantly reduced mortality in the intervention group (hazard ratio [HR] = 0.37; P = 0.04). Although cardiac status (P = 0.09) and LOS (P = 0.15) were not significant in this model, they were retained because both of these variables showed significantly higher levels (along with the Elixhauser Index) at baseline in the intervention group, implying that the intervention group was sicker than the comparison group. The Elixhauser comorbidity index (HR = 1.42; P < 0.00) and age (HR = 1.07; P < 0.00) were the only other significant predictors of mortality in this model.
Among those responding to the interview at 6 months post‐hospital discharge (n = 326), there were no significant differences between the study groups with regard to age first started smoking, gender, educational level, employment status, ethnicity, or physical health status (data not shown). Table 3 summarizes the outcomes by the intervention and comparison groups at 6 months post‐hospital discharge. The point prevalence for abstinence was 27% in the intervention group compared to 19% in the comparison group (P = 0.09). Using the intent to treat analysis, the point prevalence for abstinence was 16% in the intervention group compared to 9.8% in the comparison group (P = 0.02). Self‐reported quit status was 63% in the intervention group vs. 48% in the comparison group (P = 0.00). Using the intent to treat analysis, quit status was 44% in the intervention group vs. 30% in the comparison group (P = 0.00). Exclusion of the 52 patients without signed HIPAA releases (Figure 1) did not significantly alter these outcomes.
| Intervention (n = 161) | Comparison (n = 165) (P value) | |
|---|---|---|
| ||
| Self‐reported now smoking not at all (%) | 16 | 10 (0.02) |
| Self‐reported quit within 6 months (%) | 63 | 48 (0.00 |
| Tried to quit (%) | 68 | 62 |
| Used NRT post‐D/C (%) | 26 | 17 (0.04) |
| Used other intervention (%) | 21 | 14 |
| Heard of the NYS Smokers' Quitline (%) | 92 | 90 |
| Aware that NYS Quitline offers NRT (%) | 73 | 49 (0.00) |
| Received free NRT from NYS Smokers' Quitline (%) | 9 | 6 |
| Used NYS Smokers' Quitline (%) | 15 | 9 |
| Called by the NYS Smokers' Quitline (%) | 11 | 5 |
| Self‐rated health status as fair or poor (%) | 48 | 36 |
| Another smoker living at home (%) | 54 | 48 |
| Mean hours spent in same room where someone else was smoking (n) | 20 | 21 (0.04) |
| Households in which smoking is not allowed in the home (%) | 40 | 33 |
| Patients Still Smoking at the 6‐Month Interview | Intervention (n = 118) | Comparison (n = 134) |
| Mean cigarettes currently smoked (n) | 10.5 | 12.7 |
| Mean quit attempts post‐D/C (n) | 3.2 | 3.5 |
| Mean reduction in smoking* (cigarettes/day) | 5.83 | 4.09 |
Patients who received the inpatient smoking cessation counseling were more likely to be called by or use the NYS Smokers' Quitline; however, these differences were not statistically significant. There was no difference between the study groups in awareness of the Quitline but the intervention group was more aware that free NRT was offered by the NYS Quitline. In terms of quit methods used during the 6‐month period (Table 4), NRT or bupropion use was higher in the intervention group. There were no other significant differences between the study groups, except for the use of acupuncture.
| Intervention (n = 91) | Comparison (n = 93) (P value) | |
|---|---|---|
| ||
| Got help from friends or family (%) | 58 | 50 |
| Used any medication to quit (%) | 44 | 28 (0.02) |
| Used nicotine patch (%) | 43 | 25 (0.00) |
| Used bupropion (%) | 10 | 1 (0.00) |
| Used varenicline (%) | 32 | 25 |
| Cut back (%) | 43 | 46 |
| Quit with a friend (%) | 20 | 13 |
| Switched to lights (%) | 18 | 13 |
| Used print material (%) | 14 | 16 |
| Got help from the NYS Smokers' Quitline (%) | 11 | 9 |
| Called by the NYS Smokers' Quitline (%) | 11 | 5 (0.09) |
| Counseling (%) | 9 | 3 |
| Acupuncture (%) | 5 | 0 (0.02) |
| Switched to chew (%) | 2 | 4 |
| Attended classes (%) | 3 | 1 |
| Used NYS Smokers' Quitline website (%) | 2 | 4 |
Multivariate analysis predicting quit status at 6 months post‐hospital discharge included covariates controlling for age, sex, LOS, study group, and comorbidity. This analysis showed that patients with a cardiovascular discharge diagnosis were more likely to quit than patients who had other discharge diagnoses (odds ratio [OR], 3.02; 95% confidence interval [CI], 1.65.7; P = 0.00). Another statistically significant covariate in this model included sex (men were more likely to quit: OR, 0.61; 95% CI, 0.390.97; P = 0.04). Participating in the inpatient intervention group was marginally significant when controlling for these other variables (OR, 1.54; 95% CI, 0.982.45; P = 0.06). Hospital LOS, age, receipt of NRT in hospital, and the Elixhauser comorbidity index were not predictive of quit status at 6 months.
Discussion
This study demonstrates how effective an inpatient smoking cessation program can be for increasing the success of quitting smoking after hospital discharge. At 6 months posthospital discharge, the intervention group had significantly higher intent to treat outcomes for point prevalence abstinence and quit status as well as lower crude and adjusted mortality than the comparison group.
Although at baseline the intervention group was older, had a longer LOS, more cardiovascular diagnoses, and higher comorbidity index, crude post‐hospital discharge mortality was significantly less in the intervention group (0.02) than in the comparison group (0.04). This finding is more significant in light of the higher comorbidity and acuity of the intervention group at baseline. Our multivariate survival model that controlled for these imbalances at baseline demonstrated that the intervention group had significantly less mortality than the comparison group (HR = 0.37; P = 0.04). Reduction in mortality, as soon as 30 days after inpatient smoking cessation counseling, has been demonstrated postmyocardial infarction.17, 18 Intensive smoking cessation quit services were also linked with lower all cause mortality among cardiovascular disease patients 2 years posthospitalization.19 Our study, despite its relatively small sample size, demonstrates that the intervention retains its impact on mortality in real‐world settings.
Following participation in an inpatient smoking cessation program, self‐reported quit status at 6 months post‐hospital discharge in the intervention group was significantly higher in the intervention group (63%) than the comparison group (48%; P = 0.00). Using the intent to treat method, the differences between the study groups was still significant (44% in the intervention group, 30% in the comparison group; P = 0.00). Given the limitations of self‐report and responder bias, the actual outcomes fall somewhere between these 2 estimates. In an effectiveness study of inpatient smoking cessation involving 6 hospitals in California, self‐reported quit rates of 26% at 6 months were reported; however, different methods were used so the results are not strictly comparable.20
Our multivariate analysis suggests that patients with cardiovascular discharge diagnosis were more likely to quit than patients who had other discharge diagnoses (OR, 3.02; 95% CI, 1.65.7; P = 0.0007). This study extends findings of other studies that show that the success of smoking cessation may vary by diagnosis, particularly for smokers admitted for cardiovascular disease.21, 22 Other studies have shown that smoking cessation rates among patients post‐myocardial infarction were higher in admitting facilities that had hospital‐based smoking cessation programs and for those patients referred to cardiac rehabilitation.23 Thus, the availability of a hospital‐based smoking cessation program may be considered a structural measure of health care quality as suggested by Dawood et al.23
The use of NRT greatly increased in our hospital, coincident with the start of the inpatient cessation program7 and, in this study, NRT use appears to continue after hospital discharge. Some studies show an additive effect of NRT combined with cessation counseling.24, 25 Although a Cochrane review did not find a statistically significant difference, there was a trend toward higher quit rates with the addition of NRT.21, 22
Because hospitalized smokers may be more motivated to stop smoking, the updated 2008 DHHS clinical practice guidelines for Treating Tobacco Use and Dependence now recommend that all inpatients who currently smoke be given medications, advised, counseled, and receive follow‐up after discharge.26 Although our inpatient cessation program was started before these clinical practice guidelines were updated, we have had the opportunity to evaluate the recommended practice of inpatient tobacco cessation counseling. Compared to effects shown in efficacy studies, clinical interventions often lose effect size in daily practice and real‐world settings.27, 28 It is reassuring that, in this effectiveness study, the impact of this intervention is still demonstrable.
Provision of inpatient smoking cessation has been shown to be an effective smoking cessation intervention if combined with outpatient follow‐up.29 Reviews by Rigotti et al.21, 22 recommend that inpatient high‐intensity behavioral interventions should be followed by at least 1 month of supportive contact after discharge to promote smoking cessation among hospitalized patients. In our study, specific cessation‐related outpatient follow‐up was not provided by our program. Although letters were sent to primary care providers describing the cessation service provided during the inpatient stay, our study could not ascertain what specific cessation service was offered by either primary‐care or specialty‐care providers during posthospitalization follow‐up visits. An efficient alternative to outpatient visits may be follow‐up delivered via a quitline. Follow‐up in our study included referrals to the NYS Smokers' Quitline; however, only about 10% of inpatient reported using this service. While feasible, the effectiveness of quitline follow‐up is as yet unknown.30
Limitations
This study targets a later phase in research progression from hypothesis development, pilot studies, efficacy (empirically supported) trials, effectiveness trials (real‐world settings), and dissemination studies.31 Because this study addresses the effectiveness rather than the efficacy of inpatient smoking cessation counseling, the use of a quasiexperimental rather than randomized controlled clinical trial design led to measured differences in the study groups at baseline. An important imbalance arose in the intervention group that had twice the percentage of patients with cardiovascular‐related discharge diagnoses as the comparison group. While we were able to adjust for these differences in our analysis, there may be unmeasured differences due to the fact that the inpatients were not randomized to the study groups.
The outcomes of this study cannot be attributed to any one component of the intervention (eg, NRT) vs. the combined effect of the inpatient smoking cessation program. The program components were implemented simultaneously in order to maximize synergistic effects; therefore, the effects of program components are difficult to disaggregate.
The results are limited by the validity of self‐report of smoking status. It is well known that research studies which validate smoking status biochemically have lower efficacy (OR, 1.44; 95% CI, 0.992.11) than those that do not validate smoking status (OR, 1.92; 95% CI, 1.262.93).32 Although it was impractical in this effectiveness study to biochemically validate smoking status 6 months posthospital discharge, we have documented a significant difference between the study groups that confirms the direction of the effect, if not the effect size.
Self‐reports tend to underestimate smoking status in population studies33; however, the discrepancy between self‐reported smoking and biochemical measurements among clinical trial participants is small.34 However, a small but significant bias toward a socially desirable response in intervention groups compared to control groups of 3% with carbon monoxide and 5% for cotinine has been documented.35 If social desirability bias is operative in this study, and if we apply the above correction factor of 4% to correct this classification error, then the difference between the intervention and comparison group would be 10 percentage points (40% in the intervention group vs. 30% in the comparison group using the intention to treat estimates). That difference is still clinically relevant.
The observed difference between the intervention and comparison group is underestimated because the comparison group was exposed to smoking cessation as well both at the time of admission and following discharge (Table 4). The comparison group in this study could thus be viewed as a usual care group rather than a control group. That exposure does cloud the measurement of quit rates as the comparison group is contaminated to some degree by exposure to various cessation methods. The impact of this exposure is to reduce the effect size observed in this study or underestimate the effect of the inpatient smoking cessation counseling because the comparison group was exposed other cessation methods, although to a lesser extent.
The social desirability bias inherent in self‐reported smoking status may increase the effect size while the use of comparison group that received usual care may decrease the effect size. Because neither of these biases could be measured in this study, it is impossible to say whether they negated each other.
As with any administrative database, use of EMR as a data source in this study led to missing data that precluded use of certain variables in the analysis. In addition, lack of written and signed HIPAA releases also precluded inclusion of several inpatients, mostly in the comparison group, in the analytic database. However, it is reassuring that the results of the 6‐month survey did not differ significantly when these individuals were included or excluded from a separate analysis of the survey data. Last, our study population is almost 100% Caucasian thus limiting how generalizable the results are to more heterogenous patient populations.
Conclusions
This quasiexperimental effectiveness study showed that inpatient smoking cessation intervention improved smoking cessation outcomes, use of NRT, and was associated with a decreased mortality 6 months post‐hospital discharge. The effectiveness of this inpatient intervention is maintained in real world settings but may be improved with posthospital discharge follow‐up.
Acknowledgements
The authors are grateful to the many Mary Imogene Bassett Hospital staff in administration, nursing, inpatient pharmacy, medical education, patient care service, and respiratory care who provided data needed to evaluate this program. They also acknowledge the NYS Smokers' Quitline website for data provided about monthly Fax‐to‐Quit program referrals from our county.
- , , , , , .“Implementing smoking bans in American hospitals: results of a national survey.Tob Control.1998;7(1):47–55.
- The Smoking Cessation Clinical Practice Guideline Panel and Staff: the Agency for Health Care Policy and Research Smoking Cessation Clinical Practice Guideline.JAMA.1996;275(16):1270–1280.
- , , , et al.ACC/AHA clinical performance measures for adults with chronic heart failure: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures (Writing Committee to Develop Heart Failure Clinical Performance Measures). Endorsed by the Heart Failure Society of America.J Am Coll Cardiol.2005;46(6):1144–1178.
- , , , et al.ACC/AHA guidelines for the management of patients with ST‐elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines for the Management of Patients with Acute Myocardial Infarction).Circulation.2004;110(9):e82–e292.
- , , , et al.ACC/AHA clinical performance measures for adults with ST‐elevation and non‐ST elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures (Writing Committee to Develop Performance Measures on ST‐Elevation and Non‐ST‐Elevation Myocardial Infarction).J Am Coll Cardiol.2006;47(1):236–265.
- Treating Tobacco Use and Dependence‐Clinicians Packet. A How‐To Guide For Implementing the Public Health Service Clinical Practice Guideline, March2003. Rockville, MD: U.S. Public Health Service, Agency for Healthcare Research and Quality. Available at: http://www.ahrq.gov/clinic/tobacco. Accessed November 2009.
- , , , .Implementing a smoke‐free medical campus: impact on inpatient and employee outcomes.J Hosp Med.2010;5(1):51–54.
- , , , et al.The future of behavior change research: what is needed to improve translation of research into health promotion practice?Ann Behav Med.2004;27:3–12.
- The New York State Smokers' Quitline. Available at: http://www.nysmokefree.com. Accessed November2009.
- Tobacco Cessation Continuing Education for Healthcare Professionals and Counselors. Available at: http://www.tobaccocme.com. Accessed November2009.
- Seton Health Cessation Center. The Butt Stops Here. Relaxation Exercises for Smoking Cessation. 2001. The Butt Stops Here Program. Available at: http://www.setonhealth.org. Accessed November2009.
- U.S. Department of Health and Human Services.Treating Tobacco Use and Dependence. Clinical Practice Guideline.Rockville, MD:Public Health Service;2000.
- , , , , .A randomized controlled trial of smoking cessation counseling after myocardial infarction.Prev Med.2000;30(4):261–268.
- , , , .Comorbidity measures for use with administrative data.Med Care.1998:36(1):8–27.
- Tobacco Use Supplement to the Current Population Survey (TUS‐CPS). Available at: http://riskfactor.cancer.gov/studies/tus‐cps/info.html. Accessed November 2009.
- , , .Comparison of National Death Index and world wide web death searches.Am J of Epidemiol.2000;152(2):107–111.
- , , , et al.Post‐myocardial infarction smoking cessation counseling: associations with immediate and late mortality in older Medicare patients.Am J Med.2005;118(3):269–275.
- , , .Inpatient smoking‐cessation counseling and all‐cause mortality in patients with acute myocardial infarction.Am Heart J.2007;154(2):213–220.
- , , , et al.Intensive smoking cessation intervention reduces mortality in high‐risk smokers with cardiovascular disease.Chest.2007;131:446–452.
- , , , , .Dissemination of an effective inpatient tobacco use cessation program.Nicotine Tob Res.2005;7(1):129–137.
- , , .Interventions for smoking cessation in hospitalized patients.Cochrane Database Syst Rev.2007;3:CD001837.
- , , .Smoking cessation interventions for hospitalized smokers.Arch Intern Med.2008;168(18):1950–1960.
- , , , et al.Predictors of smoking cessation after a myocardial infarction.Arch Int Med.2008;168(18):1961–1967.
- , , , .The effectiveness of smoking cessation interventions prior to surgery: a systematic review.Nicotine Tob Res.2008;10(3):407–412.
- , , , et al.Clinical trial comparing nicotine replacement therapy (NRT) plus brief counseling, brief counseling alone, and minimal intervention on smoking cessation in hospital inpatients.Thorax.2003;58:484–488.
- Department of Health and Human Services (DHHS). Treating Tobacco Use and Dependence: 2008 Update. Chapter 7. Available at: http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.section.28504. Accessed November2009.
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- .Decreasing effect sizes for effectiveness studies—implications for the transport of evidence‐based treatments: comment on Curtis, Ronan, and Borduin (2004).J Fam Psychol.2004;18(3):420–423.
- , , , , , .Efficacy of a smoking cessation program for hospital patients.Arch Intern Med.1997;157(22):2653–2660.
- , , , et al.Feasibility, acceptability, and cost of referring surgical patients for postdischarge cessation support from a quitline.Nicotine Tob Res.2008;10(6):1105–1108.
- .Efficacy and effectiveness trials (and other phases of research) in the development of health promotion programs.Prev Med.1986;15:451–474.
- , , .Psychosocial interventions for smoking cessation in patients with coronary heart disease.Cochrane Database Syst Rev.2008;23(1):CD006886.
- , , , , .The accuracy of self‐reported smoking: a systematic review of the relationship between self‐reported and cotinine‐assessed smoking status.Nicotine Tob Res2009;11(1):12–24.
- , , , , .Relations of cotinine and carbon monoxide to self‐reported smoking in a cohort of smokers and ex‐smokers followed over 5 years.Nicotine Tob Res.2002;4(3):287–294.
- , , , .Error in smoking measures: effects of intervention on relations of cotinine and carbon monoxide to self‐reported smoking. The Lung Health Study Research Group.Am J Public Health.1993;83(9):1251–1257.
- , , , , , .“Implementing smoking bans in American hospitals: results of a national survey.Tob Control.1998;7(1):47–55.
- The Smoking Cessation Clinical Practice Guideline Panel and Staff: the Agency for Health Care Policy and Research Smoking Cessation Clinical Practice Guideline.JAMA.1996;275(16):1270–1280.
- , , , et al.ACC/AHA clinical performance measures for adults with chronic heart failure: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures (Writing Committee to Develop Heart Failure Clinical Performance Measures). Endorsed by the Heart Failure Society of America.J Am Coll Cardiol.2005;46(6):1144–1178.
- , , , et al.ACC/AHA guidelines for the management of patients with ST‐elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines for the Management of Patients with Acute Myocardial Infarction).Circulation.2004;110(9):e82–e292.
- , , , et al.ACC/AHA clinical performance measures for adults with ST‐elevation and non‐ST elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures (Writing Committee to Develop Performance Measures on ST‐Elevation and Non‐ST‐Elevation Myocardial Infarction).J Am Coll Cardiol.2006;47(1):236–265.
- Treating Tobacco Use and Dependence‐Clinicians Packet. A How‐To Guide For Implementing the Public Health Service Clinical Practice Guideline, March2003. Rockville, MD: U.S. Public Health Service, Agency for Healthcare Research and Quality. Available at: http://www.ahrq.gov/clinic/tobacco. Accessed November 2009.
- , , , .Implementing a smoke‐free medical campus: impact on inpatient and employee outcomes.J Hosp Med.2010;5(1):51–54.
- , , , et al.The future of behavior change research: what is needed to improve translation of research into health promotion practice?Ann Behav Med.2004;27:3–12.
- The New York State Smokers' Quitline. Available at: http://www.nysmokefree.com. Accessed November2009.
- Tobacco Cessation Continuing Education for Healthcare Professionals and Counselors. Available at: http://www.tobaccocme.com. Accessed November2009.
- Seton Health Cessation Center. The Butt Stops Here. Relaxation Exercises for Smoking Cessation. 2001. The Butt Stops Here Program. Available at: http://www.setonhealth.org. Accessed November2009.
- U.S. Department of Health and Human Services.Treating Tobacco Use and Dependence. Clinical Practice Guideline.Rockville, MD:Public Health Service;2000.
- , , , , .A randomized controlled trial of smoking cessation counseling after myocardial infarction.Prev Med.2000;30(4):261–268.
- , , , .Comorbidity measures for use with administrative data.Med Care.1998:36(1):8–27.
- Tobacco Use Supplement to the Current Population Survey (TUS‐CPS). Available at: http://riskfactor.cancer.gov/studies/tus‐cps/info.html. Accessed November 2009.
- , , .Comparison of National Death Index and world wide web death searches.Am J of Epidemiol.2000;152(2):107–111.
- , , , et al.Post‐myocardial infarction smoking cessation counseling: associations with immediate and late mortality in older Medicare patients.Am J Med.2005;118(3):269–275.
- , , .Inpatient smoking‐cessation counseling and all‐cause mortality in patients with acute myocardial infarction.Am Heart J.2007;154(2):213–220.
- , , , et al.Intensive smoking cessation intervention reduces mortality in high‐risk smokers with cardiovascular disease.Chest.2007;131:446–452.
- , , , , .Dissemination of an effective inpatient tobacco use cessation program.Nicotine Tob Res.2005;7(1):129–137.
- , , .Interventions for smoking cessation in hospitalized patients.Cochrane Database Syst Rev.2007;3:CD001837.
- , , .Smoking cessation interventions for hospitalized smokers.Arch Intern Med.2008;168(18):1950–1960.
- , , , et al.Predictors of smoking cessation after a myocardial infarction.Arch Int Med.2008;168(18):1961–1967.
- , , , .The effectiveness of smoking cessation interventions prior to surgery: a systematic review.Nicotine Tob Res.2008;10(3):407–412.
- , , , et al.Clinical trial comparing nicotine replacement therapy (NRT) plus brief counseling, brief counseling alone, and minimal intervention on smoking cessation in hospital inpatients.Thorax.2003;58:484–488.
- Department of Health and Human Services (DHHS). Treating Tobacco Use and Dependence: 2008 Update. Chapter 7. Available at: http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.section.28504. Accessed November2009.
- , .Implementation of evidence‐based tobacco use cessation guidelines in managed care organizations.Ann Behav Med.2004;27(1):13–21.
- .Decreasing effect sizes for effectiveness studies—implications for the transport of evidence‐based treatments: comment on Curtis, Ronan, and Borduin (2004).J Fam Psychol.2004;18(3):420–423.
- , , , , , .Efficacy of a smoking cessation program for hospital patients.Arch Intern Med.1997;157(22):2653–2660.
- , , , et al.Feasibility, acceptability, and cost of referring surgical patients for postdischarge cessation support from a quitline.Nicotine Tob Res.2008;10(6):1105–1108.
- .Efficacy and effectiveness trials (and other phases of research) in the development of health promotion programs.Prev Med.1986;15:451–474.
- , , .Psychosocial interventions for smoking cessation in patients with coronary heart disease.Cochrane Database Syst Rev.2008;23(1):CD006886.
- , , , , .The accuracy of self‐reported smoking: a systematic review of the relationship between self‐reported and cotinine‐assessed smoking status.Nicotine Tob Res2009;11(1):12–24.
- , , , , .Relations of cotinine and carbon monoxide to self‐reported smoking in a cohort of smokers and ex‐smokers followed over 5 years.Nicotine Tob Res.2002;4(3):287–294.
- , , , .Error in smoking measures: effects of intervention on relations of cotinine and carbon monoxide to self‐reported smoking. The Lung Health Study Research Group.Am J Public Health.1993;83(9):1251–1257.
Copyright © 2010 Society of Hospital Medicine
Outcomes for Inpatient Gainsharing
Hospitals are challenged to improve quality while reducing costs, yet traditional methods of cost containment have had limited success in aligning the goals of hospitals and physicians. Physicians directly control more than 80% of total medical costs.1 The current fee‐for‐service system encourages procedures and the use of hospital resources. Without the proper incentives to gain active participation and collaboration of the medical staff in improving the efficiency of care, the ability to manage medical costs and improve hospital operational and financial performance is hampered. A further challenge is to encourage physicians to improve the quality of care and maintain safe medical practice. While several examples of pay‐for‐performance (P4P) have previously been attempted to increase efficiency, gainsharing offers real opportunities to achieve these outcomes.
Previous reports regarding the results of gainsharing programs describe its use in outpatient settings and its limited ability to reduce costs for inpatient care for surgical implants such as coronary stents2 or orthopedic prostheses.3 The present study represents the largest series to date using a gainsharing model in a comprehensive program of inpatient care at a tertiary care medical center.
Patients and Methods
Beth Israel Medical Center is a 1000‐bed tertiary care university‐affiliated teaching hospital, located in New York City. The hospital serves a large and ethnically diverse community predominantly located in the lower east side of Manhattan and discharged about 50,000 patients per year during the study period of July 2006 through June 2009.
Applied Medical Software, Inc. (AMS, Collingswood, NJ) analyzed hospital data for case mix and severity. To establish best practice norms (BPNs), AMS used inpatient discharge data (UB‐92) to determine costs by APR‐DRG's4 during calendar year 2005, prior to the inception of the program to establish BPNs. Costs were allocated into specific areas listed in Table 1. A minimum of 10 cases was necessary in each DRG. Cost outliers (as defined by the mean cost of the APR DRG plus 3 standard deviations) were excluded. These data were used to establish a baseline for each physician and a BPN, which was set at the top 25th percentile for each specific APR DRG. BPNs were determined after exclusions using the following criteria:
Each eligible physician had to have at least 10 admissions within their specialty;
Each eligible DRG had to have at least 5 qualifying physicians within a medical specialty;
Each eligible APR DRG had to have at least 3 qualifying admissions;
If the above criteria are met, the BPN was set at the mean of the top 25th percentile of physicians (25% of the physicians with the lowest costs).
| |
| Per diem hospital bed cost | Pharmacy |
| Critical care (ICU and CCU) | Laboratory |
| Medical surgical supplies and implants | Cardiopulmonary care |
| Operating room costs | Blood bank |
| Radiology | Intravenous therapy |
Once BPNs were determined, patients were grouped by physician and compared to the BPN for a particular APR DRG. All patients of participating physicians with qualifying APR DRGs were included in the analysis reports summarizing these results, computed quarterly and distributed to each physician. Obstetrical and psychiatric admissions were excluded in the program. APR DRG data for each physician was compared from year to year to determine whether an individual physician demonstrated measurable improvement in performance.
The gainsharing program was implemented in 2006. Physician participation was voluntary. Payments were made to physicians without any risk or penalties from participation. Incentives were based on individual performance. Incentives for nonsurgical admissions were intended to offset the loss of physician income related to more efficient medical management and a reduced hospital length of stay (LOS). Income for surgical admissions was intended to reward physicians for efficient preoperative and postoperative care.
The methodology provides financial incentives for physicians for each hospital discharge in 2 ways:
Improvement in costs per case against their own historical performance;
Cost per case performance compared to BPN.
In the first year of the gainsharing program, two thirds of the total allowable incentive payments were allocated to physicians' improvement, with one third based on a performance metric. Payments for improvement were phased out over the first 3 years of the gainsharing program, with payments focused fully on performance in Year 3. Cases were adjusted for case‐mix and severity of illness (four levels of APR DRG). Physicians were not penalized for any cases in which costs greatly exceeded BPN. A floor was placed at the BPN and no additional financial incentives were paid for surpassing it. Baselines and BPNs were recalculated yearly.
A key aspect of the gainsharing program was the establishment of specific quality parameters (Table 2) that need to be met before any incentive payments were made. A committee regularly reviewed the quality performance data of each physician to determine eligibility for payments. Physicians were considered to be ineligible for incentive compensation until the next measurement period if there was evidence of failure to adequately meet these measures. At least 80% compliance with core measures (minimum 5 discharges in each domain) was expected. Infectious complication rates were to remain not more than 1 standard deviation above National Healthcare Safety Network rates during the same time period. In addition, payments were withheld from physicians if it was found that the standard of care was not met for any morbidity or mortality that was peer reviewed or if there were any significant patient complaints. Readmission rates were expected to remain at or below the baseline established during the previous 12 months by DRG.
| Quality Measure | Goal |
|---|---|
| |
| Readmissions within 7 days for the same or related diagnosis | Decrease, or less than 10% of discharges |
| Documentationquality and timeliness of medical record and related documentation including date, time, and sign all chart entries | No more than 20% of average monthly discharged medical records incomplete for more than 30 days |
| Consultation with social work/discharge planner within 24 hours of admission for appropriate pts | >80% of all appropriate cases |
| Timely switch from intravenous to oral antibiotics in accordance with hospital policy (%) | >80 |
| Unanticipated return to the operating room | Decrease or < 5% |
| Patient complaints | Decrease |
| Patient satisfaction (HCAHPS) | >75% physician domain |
| Ventilator associated pneumonia | Decrease or < 5% |
| Central line associated blood stream infections | Decrease or < 5 per 1000 catheter days. |
| Surgical site infections | Decrease or within 1 standard deviation of NHSN |
| Antibiotic prophylaxis (%) | >80 |
| Inpatient mortality | Decrease or <1% |
| Medication errors | Decrease or <1% |
| Delinquent medical records | <5 charts delinquent more than 30 days |
| Falls with injury | Decrease or <1% |
| AMI: aspirin on arrival and discharge (%) | >80 |
| AMI‐ACEI or ARB for LVSD (%) | >80 |
| Adult smoking cessation counseling (%) | >80 |
| AMI‐ Beta blocker prescribed at arrival and discharge (%) | >80 |
| CHF: discharge instructions (%) | >80 |
| CHF: Left ventricular function assessment (%) | >80 |
| CHF: ACEI or ARB for left ventricular systolic dysfunction (%) | >80 |
| CHF: smoking cessation counseling (%) | >80 |
| Pneumonia: O2 assessment, pneumococcal vaccine, blood culture and sensitivity before first antibiotic, smoking cessation counseling (%) | >80 |
Employed and private practice community physicians were both eligible for the gainsharing program. Physician participation in the program was voluntary. All patients admitted to the Medical Center received notification on admission about the program. The aggregate costs by DRG were calculated quarterly. Savings over the previous yearif anywere calculated. A total of 20% of the savings was used to administer the program and for incentive payments to physicians.
From July 1, 2006 through September 2008, only commercial managed care cases were eligible for this program. As a result of the approval of the gainsharing program as a demonstration project by the Centers for Medicare and Medicaid Services (CMS), Medicare cases were added to the program starting October 1, 2008.
Physician Payment Calculation Methodology
Performance Incentive
The performance incentive was intended to reward demonstrated levels of performance. Accordingly, a physician's share in hospital savings was in proportion to the relationship between their individual performance and the BPN. This computation was the same for both surgical and medical admissions. The following equation illustrates the computation of performance incentives for participating physicians:
This computation was made at the specific severity level for each hospital discharge. Payment for the performance incentive was made only to physicians at or below the 90th percentile of physicians.
Improvement Incentive
The improvement incentive was intended to encourage positive change. No payments were made from the improvement incentive unless an individual physician demonstrated measurable improvement in operational performance for either surgical or medical admissions. However, because physicians who admitted nonsurgical cases experienced reduced income as they help the hospital to improve operational performance, the methodology for calculating the improvement incentive was different for medical as opposed to surgical cases, as shown below.
For Medical DRGs:
For each severity level the following is calculated:
For Surgical DRGs:
Cost savings were calculated quarterly and defined as the cost per case before the gainsharing program began minus the actual case cost by APR DRG. Student's t‐test was used for continuous data and the categorical data trends were analyzed using Mantel‐Haenszel Chi‐Square.
At least every 6 months, all participating physicians received case‐specific and cost‐centered data about their discharges. They also received a careful explanation of opportunities for financial or quality improvement.
Results
Over the 3‐year period, 184 physicians enrolled, representing 54% of those eligible. The remainder of physicians either decided not to enroll or were not eligible due to inadequate number of index DRG cases or excluded diagnoses. Payer mix was 27% Medicare and 48% of the discharges were commercial and managed care. The remaining cases were a combination of Medicaid and self‐pay. A total of 29,535 commercial and managed care discharges were evaluated from participating physicians (58%) and 20,360 similar discharges from non‐participating physicians. This number of admissions accounted for 29% of all hospital discharges during this time period. Surgical admissions accounted for 43% and nonsurgical admissions for 57%. The distribution of patients by service is shown in Table 3. Pulmonary and cardiology diagnoses were the most frequent reasons for medical admissions. General and head and neck surgery were the most frequent surgical admissions. During the time period of the gainsharing program, the medical center saved $25.1 million for costs attributed to these cases. Participating physicians saved $6.9 million more than non‐participating physicians (P = 0.02, Figure 1), but all discharges demonstrated cost savings during the study period. Cost savings (Figure 2) resulted from savings in medical/surgical supplies and implants (35%), daily hospital costs, (28%), intensive care unit costs (16%) and coronary care unit costs (15%), and operating room costs (8%). Reduction in cost from reduced magnetic resonance imaging (MRI) use was not statistically significant. There were minimal increases in costs due to computed tomography (CT) scan use, cardiopulmonary care, laboratory use, pharmacy and blood bank, but none of these reached statistical significance.
| Admissions by Service | Number (%) |
|---|---|
| |
| Cardiology | 4512 (15.3) |
| Orthopedic surgery | 3994 (13.5) |
| Gastroenterology | 3214 (10.9) |
| General surgery | 2908 (9.8) |
| Cardiovascular surgery | 2432 (8.2) |
| Pulmonary | 2212 (7.5) |
| Neurology | 2064 (7.0) |
| Oncology | 1217 (4.1) |
| Infectious disease | 1171 (4.0) |
| Endocrinology | 906 (3.1) |
| Nephrology | 826 (2.8) |
| Open heart surgery | 656 (2.2) |
| Interventional cardiology | 624 (2.1) |
| Gynecological surgery | 450 (1.5) |
| Urological surgery | 326 (1.1) |
| ENT surgery | 289 (1.0) |
| Obstetrics without delivery | 261 (0.9) |
| Hematology | 253 (0.9) |
| Orthopedicsnonsurgical | 241 (0.8) |
| Rehabilitation | 204 (0.7) |
| Otolaryngology | 183 (0.6) |
| Rheumatology | 165 (0.6) |
| General medicine | 162 (0.5) |
| Neurological surgery | 112 (0.4) |
| Urology | 101 (0.3) |
| Dermatology | 52 (0.2) |
| Grand total | 29535 (100.0) |
Hospital LOS decreased 9.8% from baseline among participating doctors, while LOS decreased 9.0% among non‐participating physicians; this difference was not statistically significant (P = 0.6). Participating physicians reduced costs by an average of $7,871 per quarter, compared to a reduction in costs by $3,018 for admissions by non‐participating physicians (P < 0.0001). The average savings per admission for the participating physicians were $1,835, and for non‐participating physicians were $1,107, a difference of $728 per admission. Overall, cost savings during the three year period averaged $105,000 per physician who participated in the program and $67,000 per physician who did not (P < 0.05). There was not a statistical difference in savings between medical and surgical admissions (P = 0.24).
Deviations from quality thresholds were identified during this time period. Some or all of the gainsharing income was withheld from 8% of participating physicians due to quality issues, incomplete medical records, or administrative reasons. Payouts to participating physicians averaged $1,866 quarterly (range $0‐$27,631). Overall, 9.4% of the hospital savings was directly paid to the participating physicians. Compliance with core measures improved in the following domains from year 2006 to 2009; acute myocardial infarction 94% to 98%, congestive heart failure 76% to 93%, pneumonia 88% to 97%, and surgical care improvement project 90% to 97%, (P = 0.17). There was no measurable increase in 30‐day mortality or readmission by APR‐DRG. The number of incomplete medical records decreased from an average of 43% of the total number of records in the second quarter of 2006 to 30% in the second quarter of 2009 (P < 0.0001). Other quality indicators remained statistically unchanged.
Discussion
The promise of gainsharing may motivate physicians to decrease hospital costs while maintaining quality medical care, since it aligns physician and hospital incentives. Providing a reward to physicians creates positive reinforcement, which is more effective than warnings against poor performing physicians (carrot vs. stick).5, 6 This study is the first and largest of its kind to show the results of a gainsharing program for inpatient medical and surgical admissions and demonstrates that significant cost savings may be achieved. This is similar to previous studies that have shown positive outcomes for pay‐for‐performance programs.7
Participating physicians in the present study accumulated almost $7 million more in savings than non‐participating physicians. Over time this difference has increased, possibly due to a learning curve in educating participating physicians and the way in which information about their performance is given back to them. A significant portion of the hospital's cost savings was through improvements in documentation and completion of medical records. While there was an actual reduction in average length of stay (ALOS), better documentation may also have contributed to adjusting the severity level within each DRG.
Using financial incentives to positively impact on physician behavior is not new. One program in a community‐based hospitalist group reported similar improvements in medical record documentation, as well as improvements in physician meeting attendance and quality goals.8 Another study found that such hospital programs noted improved physician engagement and commitment to best practices and to improving the quality of care.9
There is significant experience in the outpatient setting using pay‐for‐performance programs to enhance quality. Millett et al.10 demonstrated a reduction in smoking among patients with diabetes in a program in the United Kingdom. Another study in Rochester, New York that used pay‐for‐performance incentives demonstrated better diabetes management.11 Mandel and Kotagal12 demonstrated improved asthma care utilizing a quality incentive program.
The use of financial motivation for physicians, as part of a hospital pay‐for‐performance program, has been shown to lead to improvements in quality performance scores when compared to non pay‐for‐performance hospitals.13 Berthiaume demonstrated decreased costs and improvements in risk‐adjusted complications and risk‐adjusted LOS in patents admitted for acute coronary intervention in a pay‐for‐performance program.14 Quality initiatives were integral for the gainsharing program, since measures such as surgical site infections may increase LOS and hospital costs. Core measures related to the care of patients with acute myocardial infarction, heart failure, pneumonia, and surgical prophylaxis steadily improved since the initiation of the gainsharing program. Gainsharing programs also enhance physician compliance with administrative responsibilities such as the completion of medical records.
One unexpected finding of our study was that there was a cost savings per admission even in the patients of physicians who did not participate in the gainsharing program. While the participating physicians showed statistically significant improvements in cost savings, savings were found in both groups. This raises the question as to whether these cost reductions could have been impacted by other factors such as new labor or vendor contracts, better documentation, improved operating room utilization and improved and timely documentation in the medical record. Another possibility is the Hawthorne effect on physicians, who altered their behavior with knowledge that process and outcome measurement were being measured. Physicians who voluntarily sign up for a gainsharing program would be expected to be more committed to the success of this program than physicians who decide to opt out. While this might appear to be a selection bias it does illustrate the point that motivated physicians are more likely to positively change their practice behaviors. However, one might suggest that financial savings directly attributed to the gainsharing program was not the $25.1 million saved during the 3 years overall, but the difference between participating and non‐participating physicians, or $6.9 million.
While the motivation to complete medical records was significant (gainsharing dollars were withheld from doctors with more than 5 incomplete charts for more than 30 days) it was not the only reason why the number of delinquent chart percentage decreased during the study period. While the improvement was significant, there are still more opportunities to reduce the number of incomplete charts. Hospital regulatory inspections and periodic physician education were also likely to have reduced the number of incomplete inpatient charts during this time period and may do so in the future.15
The program focused on the physician activities that have the greatest impact on hospital costs. While optimizing laboratory, blood bank, and pharmacy management decreased hospital costs; we found that improvements in patient LOS, days in an intensive care unit, and management of surgical implants had the greatest impact on costs. Orthopedic surgeons began to use different implants, and all surgeons refrained from opening disposable surgical supplies until needed. Patients in intensive care unit beds stable for transfer were moved to regular medical/surgical rooms earlier. Since the program helped physicians understand the importance of LOS, many physicians increased their rounding on weekends and considered LOS implications before ordering diagnostic procedures that could be performed as an outpatient. Nurses, physician extenders such as physician assistants, and social workers have played an important role in streamlining patient care and hospital discharge; however, they were not directly rewarded under this program.
There are challenges to aligning the incentives of internists compared to procedure‐based specialists. This may be that the result of surgeons receiving payment for bundled care and thus the incentives are already aligned. The incentive of the program for internists, who get paid for each per daily visit, was intended to overcome the lost income resulting from an earlier discharge. Moreover, in the present study, only the discharging physician received incentive payments for each case. Patient care is undoubtedly a team effort and many physicians (radiologists, anesthesiologists, pathologists, emergency medicine physicians, consultant specialty physicians, etc.) are clearly left out in the present gainsharing program. Aligning the incentives of these physicians might be necessary. Furthermore, the actions of other members of the medical team and consultants, by their behaviors, could limit the incentive payments for the discharging physician. The discharging physician is often unable to control the transfer of a patient from a high‐cost or severity unit, or improve the timeliness of consulting physicians. Previous authors have raised the issue as to whether a physician should be prevented from payment because of the actions of another member of the medical team.16
Ensuring a fair and transparent system is important in any pay‐for‐performance program. The present gainsharing program required sophisticated data analysis, which added to the costs of the program. To implement such a program, data must be clear and understandable, segregated by DRG and severity adjusted. But should the highest reward payments go to those who perform the best or improve the most? In the present study, some physicians were consistently unable to meet quality benchmarks. This may be related to several factors, 1 of which might be a particular physician's case mix. Some authors have raised concerns that pay‐for‐performance programs may unfairly impact physicians who care for more challenging or patients from disadvantaged socioeconomic circumstances.17 Other authors have questioned whether widespread implementation of such a program could potentially increase healthcare disparities in the community.18 It has been suggested by Greene and Nash that for a program to be successful, physicians who feel they provide good care yet but are not rewarded should be given an independent review.16 Such a process is important to prevent resentment among physicians who are unable to meet benchmarks for payment, despite hard work.19 Conversely, other studies have found that many physicians who receive payments in a pay‐for‐performance system do not necessarily consciously make improvement to enhance financial performance.20 Only 54% of eligible physicians participated in the present gainsharing program. This is likely due to lack of understanding about the program, misperceptions about the ethics of such programs, perceived possible negative patient outcome, conflict of interest and mistrust.21, 22 This underscores the importance of providing understandable performance results, education, and a physician champion to help facilitate communication and enhanced outcomes. What is clear is that the perception by participating physicians is that this program is worthwhile as the number of participating physicians has steadily increased and it has become an incentive for new providers to choose this medical center over others.
In conclusion, the results of the present study show that physicians can help hospitals reduce inpatients costs while maintaining or improving hospital quality. Improvements in patient LOS, implant costs, overall costs per admission, and medical record completion were noted. Further work is needed to improve physician education and better understand the impact of uneven physician case mix. Further efforts are necessary to allow other members of the health care team to participate and benefit from gainsharing.
- ,,, et al.Guided care and the cost of complex healthcare: a preliminary report.Am J Manag Care.2009;15(8):555–559.
- ,.Hospital‐physician gainsharing in cardiology.Health Aff (Millwood).2008;27(3):803–812.
- ,,,.AOA Symposium. Gainsharing in orthopaedics: passing fancy or wave of the future?J Bone Joint Surg Am.2007;89(9):2075–2083.
- All Patient Defined Diagnosis Related Groups™ ‐ 3M Health Information Systems,St Paul, MN.
- ,,, et al.Guided care and the cost of complex healthcare: a preliminary report.Am J Manag Care.2009;15(8):555–559.
- .Best practices in record completion.J Med Pract Manage.2004;20(1):18–22.
- ,,, et al.Return on investment in pay for performance: a diabetes case study.J Healthc Manag.2006;51(6):365–374; discussion 375‐376.
- .Use of pay for performance in a community hospital private hospitalists group: a preliminary report.Trans Am Clin Climatol Assoc.2007;188:263–272.
- .Making the grade with pay for performance: 7 lessons from best‐performing hospitals.Healthc Financ Manage.2006;60(12):79–85.
- ,,,,.Impact of a pay‐for‐performance incentive on support for smoking cessation and on smoking prevalence among people with diabetes.CMAJ.2007;176(12):1705–1710.
- ,,, et al,Effects of paying physicians based on their relative performance for quality.J Gen Intern Med.2007;22(6):872–876.
- ,.Pay for performance alone cannot drive quality.Arch Pediatr Adolesc Med.2007;161(7):650–655.
- .What's the return? Assessing the effect of “pay‐for‐performance” initiatives on the quality of care delivery.Med Care Res Rev.2006;63(1 suppl)( ):29S–48S.
- ,,,,.Aligning financial incentives with “Get With the Guidelines” to improve cardiovascular care.Am J Manag Care.2004;10(7 pt 2):501–504.
- .Sampling best practices. Managing delinquent records.J AHIMA.1997;68(8):28,30.
- ,.Pay for performance: an overview of the literature.Am J Med Qual.2009;24;140–163.
- ,,.Physician‐level P4P:DOA? Can quality‐based payments be resuscitated?Am J Manag Care.2007;13(5):233–236.
- ,,, et al.Will pay for performance and quality reporting affect health care disparities?Health Aff (Millwood).2007;26(3):w405–w414.
- ,,.The experience of pay for performance in English family practice: a qualitative study.Ann Fam Med.2008;8(3):228–234.
- ,,, et al.Will financial incentives stimulate quality improvement? Reactions from frontline physicians.Am J Med Qual.2006;21(6):367–374.
- ,,.Pay for performance in orthopedic surgery.Clin Orthop Relat Res.2007;457:87–95.
- ,.Pay for performance survey of diagnostic radiology faculty and trainees.J Am Coll Radiol.2007;4(6):411–415.
Hospitals are challenged to improve quality while reducing costs, yet traditional methods of cost containment have had limited success in aligning the goals of hospitals and physicians. Physicians directly control more than 80% of total medical costs.1 The current fee‐for‐service system encourages procedures and the use of hospital resources. Without the proper incentives to gain active participation and collaboration of the medical staff in improving the efficiency of care, the ability to manage medical costs and improve hospital operational and financial performance is hampered. A further challenge is to encourage physicians to improve the quality of care and maintain safe medical practice. While several examples of pay‐for‐performance (P4P) have previously been attempted to increase efficiency, gainsharing offers real opportunities to achieve these outcomes.
Previous reports regarding the results of gainsharing programs describe its use in outpatient settings and its limited ability to reduce costs for inpatient care for surgical implants such as coronary stents2 or orthopedic prostheses.3 The present study represents the largest series to date using a gainsharing model in a comprehensive program of inpatient care at a tertiary care medical center.
Patients and Methods
Beth Israel Medical Center is a 1000‐bed tertiary care university‐affiliated teaching hospital, located in New York City. The hospital serves a large and ethnically diverse community predominantly located in the lower east side of Manhattan and discharged about 50,000 patients per year during the study period of July 2006 through June 2009.
Applied Medical Software, Inc. (AMS, Collingswood, NJ) analyzed hospital data for case mix and severity. To establish best practice norms (BPNs), AMS used inpatient discharge data (UB‐92) to determine costs by APR‐DRG's4 during calendar year 2005, prior to the inception of the program to establish BPNs. Costs were allocated into specific areas listed in Table 1. A minimum of 10 cases was necessary in each DRG. Cost outliers (as defined by the mean cost of the APR DRG plus 3 standard deviations) were excluded. These data were used to establish a baseline for each physician and a BPN, which was set at the top 25th percentile for each specific APR DRG. BPNs were determined after exclusions using the following criteria:
Each eligible physician had to have at least 10 admissions within their specialty;
Each eligible DRG had to have at least 5 qualifying physicians within a medical specialty;
Each eligible APR DRG had to have at least 3 qualifying admissions;
If the above criteria are met, the BPN was set at the mean of the top 25th percentile of physicians (25% of the physicians with the lowest costs).
| |
| Per diem hospital bed cost | Pharmacy |
| Critical care (ICU and CCU) | Laboratory |
| Medical surgical supplies and implants | Cardiopulmonary care |
| Operating room costs | Blood bank |
| Radiology | Intravenous therapy |
Once BPNs were determined, patients were grouped by physician and compared to the BPN for a particular APR DRG. All patients of participating physicians with qualifying APR DRGs were included in the analysis reports summarizing these results, computed quarterly and distributed to each physician. Obstetrical and psychiatric admissions were excluded in the program. APR DRG data for each physician was compared from year to year to determine whether an individual physician demonstrated measurable improvement in performance.
The gainsharing program was implemented in 2006. Physician participation was voluntary. Payments were made to physicians without any risk or penalties from participation. Incentives were based on individual performance. Incentives for nonsurgical admissions were intended to offset the loss of physician income related to more efficient medical management and a reduced hospital length of stay (LOS). Income for surgical admissions was intended to reward physicians for efficient preoperative and postoperative care.
The methodology provides financial incentives for physicians for each hospital discharge in 2 ways:
Improvement in costs per case against their own historical performance;
Cost per case performance compared to BPN.
In the first year of the gainsharing program, two thirds of the total allowable incentive payments were allocated to physicians' improvement, with one third based on a performance metric. Payments for improvement were phased out over the first 3 years of the gainsharing program, with payments focused fully on performance in Year 3. Cases were adjusted for case‐mix and severity of illness (four levels of APR DRG). Physicians were not penalized for any cases in which costs greatly exceeded BPN. A floor was placed at the BPN and no additional financial incentives were paid for surpassing it. Baselines and BPNs were recalculated yearly.
A key aspect of the gainsharing program was the establishment of specific quality parameters (Table 2) that need to be met before any incentive payments were made. A committee regularly reviewed the quality performance data of each physician to determine eligibility for payments. Physicians were considered to be ineligible for incentive compensation until the next measurement period if there was evidence of failure to adequately meet these measures. At least 80% compliance with core measures (minimum 5 discharges in each domain) was expected. Infectious complication rates were to remain not more than 1 standard deviation above National Healthcare Safety Network rates during the same time period. In addition, payments were withheld from physicians if it was found that the standard of care was not met for any morbidity or mortality that was peer reviewed or if there were any significant patient complaints. Readmission rates were expected to remain at or below the baseline established during the previous 12 months by DRG.
| Quality Measure | Goal |
|---|---|
| |
| Readmissions within 7 days for the same or related diagnosis | Decrease, or less than 10% of discharges |
| Documentationquality and timeliness of medical record and related documentation including date, time, and sign all chart entries | No more than 20% of average monthly discharged medical records incomplete for more than 30 days |
| Consultation with social work/discharge planner within 24 hours of admission for appropriate pts | >80% of all appropriate cases |
| Timely switch from intravenous to oral antibiotics in accordance with hospital policy (%) | >80 |
| Unanticipated return to the operating room | Decrease or < 5% |
| Patient complaints | Decrease |
| Patient satisfaction (HCAHPS) | >75% physician domain |
| Ventilator associated pneumonia | Decrease or < 5% |
| Central line associated blood stream infections | Decrease or < 5 per 1000 catheter days. |
| Surgical site infections | Decrease or within 1 standard deviation of NHSN |
| Antibiotic prophylaxis (%) | >80 |
| Inpatient mortality | Decrease or <1% |
| Medication errors | Decrease or <1% |
| Delinquent medical records | <5 charts delinquent more than 30 days |
| Falls with injury | Decrease or <1% |
| AMI: aspirin on arrival and discharge (%) | >80 |
| AMI‐ACEI or ARB for LVSD (%) | >80 |
| Adult smoking cessation counseling (%) | >80 |
| AMI‐ Beta blocker prescribed at arrival and discharge (%) | >80 |
| CHF: discharge instructions (%) | >80 |
| CHF: Left ventricular function assessment (%) | >80 |
| CHF: ACEI or ARB for left ventricular systolic dysfunction (%) | >80 |
| CHF: smoking cessation counseling (%) | >80 |
| Pneumonia: O2 assessment, pneumococcal vaccine, blood culture and sensitivity before first antibiotic, smoking cessation counseling (%) | >80 |
Employed and private practice community physicians were both eligible for the gainsharing program. Physician participation in the program was voluntary. All patients admitted to the Medical Center received notification on admission about the program. The aggregate costs by DRG were calculated quarterly. Savings over the previous yearif anywere calculated. A total of 20% of the savings was used to administer the program and for incentive payments to physicians.
From July 1, 2006 through September 2008, only commercial managed care cases were eligible for this program. As a result of the approval of the gainsharing program as a demonstration project by the Centers for Medicare and Medicaid Services (CMS), Medicare cases were added to the program starting October 1, 2008.
Physician Payment Calculation Methodology
Performance Incentive
The performance incentive was intended to reward demonstrated levels of performance. Accordingly, a physician's share in hospital savings was in proportion to the relationship between their individual performance and the BPN. This computation was the same for both surgical and medical admissions. The following equation illustrates the computation of performance incentives for participating physicians:
This computation was made at the specific severity level for each hospital discharge. Payment for the performance incentive was made only to physicians at or below the 90th percentile of physicians.
Improvement Incentive
The improvement incentive was intended to encourage positive change. No payments were made from the improvement incentive unless an individual physician demonstrated measurable improvement in operational performance for either surgical or medical admissions. However, because physicians who admitted nonsurgical cases experienced reduced income as they help the hospital to improve operational performance, the methodology for calculating the improvement incentive was different for medical as opposed to surgical cases, as shown below.
For Medical DRGs:
For each severity level the following is calculated:
For Surgical DRGs:
Cost savings were calculated quarterly and defined as the cost per case before the gainsharing program began minus the actual case cost by APR DRG. Student's t‐test was used for continuous data and the categorical data trends were analyzed using Mantel‐Haenszel Chi‐Square.
At least every 6 months, all participating physicians received case‐specific and cost‐centered data about their discharges. They also received a careful explanation of opportunities for financial or quality improvement.
Results
Over the 3‐year period, 184 physicians enrolled, representing 54% of those eligible. The remainder of physicians either decided not to enroll or were not eligible due to inadequate number of index DRG cases or excluded diagnoses. Payer mix was 27% Medicare and 48% of the discharges were commercial and managed care. The remaining cases were a combination of Medicaid and self‐pay. A total of 29,535 commercial and managed care discharges were evaluated from participating physicians (58%) and 20,360 similar discharges from non‐participating physicians. This number of admissions accounted for 29% of all hospital discharges during this time period. Surgical admissions accounted for 43% and nonsurgical admissions for 57%. The distribution of patients by service is shown in Table 3. Pulmonary and cardiology diagnoses were the most frequent reasons for medical admissions. General and head and neck surgery were the most frequent surgical admissions. During the time period of the gainsharing program, the medical center saved $25.1 million for costs attributed to these cases. Participating physicians saved $6.9 million more than non‐participating physicians (P = 0.02, Figure 1), but all discharges demonstrated cost savings during the study period. Cost savings (Figure 2) resulted from savings in medical/surgical supplies and implants (35%), daily hospital costs, (28%), intensive care unit costs (16%) and coronary care unit costs (15%), and operating room costs (8%). Reduction in cost from reduced magnetic resonance imaging (MRI) use was not statistically significant. There were minimal increases in costs due to computed tomography (CT) scan use, cardiopulmonary care, laboratory use, pharmacy and blood bank, but none of these reached statistical significance.
| Admissions by Service | Number (%) |
|---|---|
| |
| Cardiology | 4512 (15.3) |
| Orthopedic surgery | 3994 (13.5) |
| Gastroenterology | 3214 (10.9) |
| General surgery | 2908 (9.8) |
| Cardiovascular surgery | 2432 (8.2) |
| Pulmonary | 2212 (7.5) |
| Neurology | 2064 (7.0) |
| Oncology | 1217 (4.1) |
| Infectious disease | 1171 (4.0) |
| Endocrinology | 906 (3.1) |
| Nephrology | 826 (2.8) |
| Open heart surgery | 656 (2.2) |
| Interventional cardiology | 624 (2.1) |
| Gynecological surgery | 450 (1.5) |
| Urological surgery | 326 (1.1) |
| ENT surgery | 289 (1.0) |
| Obstetrics without delivery | 261 (0.9) |
| Hematology | 253 (0.9) |
| Orthopedicsnonsurgical | 241 (0.8) |
| Rehabilitation | 204 (0.7) |
| Otolaryngology | 183 (0.6) |
| Rheumatology | 165 (0.6) |
| General medicine | 162 (0.5) |
| Neurological surgery | 112 (0.4) |
| Urology | 101 (0.3) |
| Dermatology | 52 (0.2) |
| Grand total | 29535 (100.0) |
Hospital LOS decreased 9.8% from baseline among participating doctors, while LOS decreased 9.0% among non‐participating physicians; this difference was not statistically significant (P = 0.6). Participating physicians reduced costs by an average of $7,871 per quarter, compared to a reduction in costs by $3,018 for admissions by non‐participating physicians (P < 0.0001). The average savings per admission for the participating physicians were $1,835, and for non‐participating physicians were $1,107, a difference of $728 per admission. Overall, cost savings during the three year period averaged $105,000 per physician who participated in the program and $67,000 per physician who did not (P < 0.05). There was not a statistical difference in savings between medical and surgical admissions (P = 0.24).
Deviations from quality thresholds were identified during this time period. Some or all of the gainsharing income was withheld from 8% of participating physicians due to quality issues, incomplete medical records, or administrative reasons. Payouts to participating physicians averaged $1,866 quarterly (range $0‐$27,631). Overall, 9.4% of the hospital savings was directly paid to the participating physicians. Compliance with core measures improved in the following domains from year 2006 to 2009; acute myocardial infarction 94% to 98%, congestive heart failure 76% to 93%, pneumonia 88% to 97%, and surgical care improvement project 90% to 97%, (P = 0.17). There was no measurable increase in 30‐day mortality or readmission by APR‐DRG. The number of incomplete medical records decreased from an average of 43% of the total number of records in the second quarter of 2006 to 30% in the second quarter of 2009 (P < 0.0001). Other quality indicators remained statistically unchanged.
Discussion
The promise of gainsharing may motivate physicians to decrease hospital costs while maintaining quality medical care, since it aligns physician and hospital incentives. Providing a reward to physicians creates positive reinforcement, which is more effective than warnings against poor performing physicians (carrot vs. stick).5, 6 This study is the first and largest of its kind to show the results of a gainsharing program for inpatient medical and surgical admissions and demonstrates that significant cost savings may be achieved. This is similar to previous studies that have shown positive outcomes for pay‐for‐performance programs.7
Participating physicians in the present study accumulated almost $7 million more in savings than non‐participating physicians. Over time this difference has increased, possibly due to a learning curve in educating participating physicians and the way in which information about their performance is given back to them. A significant portion of the hospital's cost savings was through improvements in documentation and completion of medical records. While there was an actual reduction in average length of stay (ALOS), better documentation may also have contributed to adjusting the severity level within each DRG.
Using financial incentives to positively impact on physician behavior is not new. One program in a community‐based hospitalist group reported similar improvements in medical record documentation, as well as improvements in physician meeting attendance and quality goals.8 Another study found that such hospital programs noted improved physician engagement and commitment to best practices and to improving the quality of care.9
There is significant experience in the outpatient setting using pay‐for‐performance programs to enhance quality. Millett et al.10 demonstrated a reduction in smoking among patients with diabetes in a program in the United Kingdom. Another study in Rochester, New York that used pay‐for‐performance incentives demonstrated better diabetes management.11 Mandel and Kotagal12 demonstrated improved asthma care utilizing a quality incentive program.
The use of financial motivation for physicians, as part of a hospital pay‐for‐performance program, has been shown to lead to improvements in quality performance scores when compared to non pay‐for‐performance hospitals.13 Berthiaume demonstrated decreased costs and improvements in risk‐adjusted complications and risk‐adjusted LOS in patents admitted for acute coronary intervention in a pay‐for‐performance program.14 Quality initiatives were integral for the gainsharing program, since measures such as surgical site infections may increase LOS and hospital costs. Core measures related to the care of patients with acute myocardial infarction, heart failure, pneumonia, and surgical prophylaxis steadily improved since the initiation of the gainsharing program. Gainsharing programs also enhance physician compliance with administrative responsibilities such as the completion of medical records.
One unexpected finding of our study was that there was a cost savings per admission even in the patients of physicians who did not participate in the gainsharing program. While the participating physicians showed statistically significant improvements in cost savings, savings were found in both groups. This raises the question as to whether these cost reductions could have been impacted by other factors such as new labor or vendor contracts, better documentation, improved operating room utilization and improved and timely documentation in the medical record. Another possibility is the Hawthorne effect on physicians, who altered their behavior with knowledge that process and outcome measurement were being measured. Physicians who voluntarily sign up for a gainsharing program would be expected to be more committed to the success of this program than physicians who decide to opt out. While this might appear to be a selection bias it does illustrate the point that motivated physicians are more likely to positively change their practice behaviors. However, one might suggest that financial savings directly attributed to the gainsharing program was not the $25.1 million saved during the 3 years overall, but the difference between participating and non‐participating physicians, or $6.9 million.
While the motivation to complete medical records was significant (gainsharing dollars were withheld from doctors with more than 5 incomplete charts for more than 30 days) it was not the only reason why the number of delinquent chart percentage decreased during the study period. While the improvement was significant, there are still more opportunities to reduce the number of incomplete charts. Hospital regulatory inspections and periodic physician education were also likely to have reduced the number of incomplete inpatient charts during this time period and may do so in the future.15
The program focused on the physician activities that have the greatest impact on hospital costs. While optimizing laboratory, blood bank, and pharmacy management decreased hospital costs; we found that improvements in patient LOS, days in an intensive care unit, and management of surgical implants had the greatest impact on costs. Orthopedic surgeons began to use different implants, and all surgeons refrained from opening disposable surgical supplies until needed. Patients in intensive care unit beds stable for transfer were moved to regular medical/surgical rooms earlier. Since the program helped physicians understand the importance of LOS, many physicians increased their rounding on weekends and considered LOS implications before ordering diagnostic procedures that could be performed as an outpatient. Nurses, physician extenders such as physician assistants, and social workers have played an important role in streamlining patient care and hospital discharge; however, they were not directly rewarded under this program.
There are challenges to aligning the incentives of internists compared to procedure‐based specialists. This may be that the result of surgeons receiving payment for bundled care and thus the incentives are already aligned. The incentive of the program for internists, who get paid for each per daily visit, was intended to overcome the lost income resulting from an earlier discharge. Moreover, in the present study, only the discharging physician received incentive payments for each case. Patient care is undoubtedly a team effort and many physicians (radiologists, anesthesiologists, pathologists, emergency medicine physicians, consultant specialty physicians, etc.) are clearly left out in the present gainsharing program. Aligning the incentives of these physicians might be necessary. Furthermore, the actions of other members of the medical team and consultants, by their behaviors, could limit the incentive payments for the discharging physician. The discharging physician is often unable to control the transfer of a patient from a high‐cost or severity unit, or improve the timeliness of consulting physicians. Previous authors have raised the issue as to whether a physician should be prevented from payment because of the actions of another member of the medical team.16
Ensuring a fair and transparent system is important in any pay‐for‐performance program. The present gainsharing program required sophisticated data analysis, which added to the costs of the program. To implement such a program, data must be clear and understandable, segregated by DRG and severity adjusted. But should the highest reward payments go to those who perform the best or improve the most? In the present study, some physicians were consistently unable to meet quality benchmarks. This may be related to several factors, 1 of which might be a particular physician's case mix. Some authors have raised concerns that pay‐for‐performance programs may unfairly impact physicians who care for more challenging or patients from disadvantaged socioeconomic circumstances.17 Other authors have questioned whether widespread implementation of such a program could potentially increase healthcare disparities in the community.18 It has been suggested by Greene and Nash that for a program to be successful, physicians who feel they provide good care yet but are not rewarded should be given an independent review.16 Such a process is important to prevent resentment among physicians who are unable to meet benchmarks for payment, despite hard work.19 Conversely, other studies have found that many physicians who receive payments in a pay‐for‐performance system do not necessarily consciously make improvement to enhance financial performance.20 Only 54% of eligible physicians participated in the present gainsharing program. This is likely due to lack of understanding about the program, misperceptions about the ethics of such programs, perceived possible negative patient outcome, conflict of interest and mistrust.21, 22 This underscores the importance of providing understandable performance results, education, and a physician champion to help facilitate communication and enhanced outcomes. What is clear is that the perception by participating physicians is that this program is worthwhile as the number of participating physicians has steadily increased and it has become an incentive for new providers to choose this medical center over others.
In conclusion, the results of the present study show that physicians can help hospitals reduce inpatients costs while maintaining or improving hospital quality. Improvements in patient LOS, implant costs, overall costs per admission, and medical record completion were noted. Further work is needed to improve physician education and better understand the impact of uneven physician case mix. Further efforts are necessary to allow other members of the health care team to participate and benefit from gainsharing.
Hospitals are challenged to improve quality while reducing costs, yet traditional methods of cost containment have had limited success in aligning the goals of hospitals and physicians. Physicians directly control more than 80% of total medical costs.1 The current fee‐for‐service system encourages procedures and the use of hospital resources. Without the proper incentives to gain active participation and collaboration of the medical staff in improving the efficiency of care, the ability to manage medical costs and improve hospital operational and financial performance is hampered. A further challenge is to encourage physicians to improve the quality of care and maintain safe medical practice. While several examples of pay‐for‐performance (P4P) have previously been attempted to increase efficiency, gainsharing offers real opportunities to achieve these outcomes.
Previous reports regarding the results of gainsharing programs describe its use in outpatient settings and its limited ability to reduce costs for inpatient care for surgical implants such as coronary stents2 or orthopedic prostheses.3 The present study represents the largest series to date using a gainsharing model in a comprehensive program of inpatient care at a tertiary care medical center.
Patients and Methods
Beth Israel Medical Center is a 1000‐bed tertiary care university‐affiliated teaching hospital, located in New York City. The hospital serves a large and ethnically diverse community predominantly located in the lower east side of Manhattan and discharged about 50,000 patients per year during the study period of July 2006 through June 2009.
Applied Medical Software, Inc. (AMS, Collingswood, NJ) analyzed hospital data for case mix and severity. To establish best practice norms (BPNs), AMS used inpatient discharge data (UB‐92) to determine costs by APR‐DRG's4 during calendar year 2005, prior to the inception of the program to establish BPNs. Costs were allocated into specific areas listed in Table 1. A minimum of 10 cases was necessary in each DRG. Cost outliers (as defined by the mean cost of the APR DRG plus 3 standard deviations) were excluded. These data were used to establish a baseline for each physician and a BPN, which was set at the top 25th percentile for each specific APR DRG. BPNs were determined after exclusions using the following criteria:
Each eligible physician had to have at least 10 admissions within their specialty;
Each eligible DRG had to have at least 5 qualifying physicians within a medical specialty;
Each eligible APR DRG had to have at least 3 qualifying admissions;
If the above criteria are met, the BPN was set at the mean of the top 25th percentile of physicians (25% of the physicians with the lowest costs).
| |
| Per diem hospital bed cost | Pharmacy |
| Critical care (ICU and CCU) | Laboratory |
| Medical surgical supplies and implants | Cardiopulmonary care |
| Operating room costs | Blood bank |
| Radiology | Intravenous therapy |
Once BPNs were determined, patients were grouped by physician and compared to the BPN for a particular APR DRG. All patients of participating physicians with qualifying APR DRGs were included in the analysis reports summarizing these results, computed quarterly and distributed to each physician. Obstetrical and psychiatric admissions were excluded in the program. APR DRG data for each physician was compared from year to year to determine whether an individual physician demonstrated measurable improvement in performance.
The gainsharing program was implemented in 2006. Physician participation was voluntary. Payments were made to physicians without any risk or penalties from participation. Incentives were based on individual performance. Incentives for nonsurgical admissions were intended to offset the loss of physician income related to more efficient medical management and a reduced hospital length of stay (LOS). Income for surgical admissions was intended to reward physicians for efficient preoperative and postoperative care.
The methodology provides financial incentives for physicians for each hospital discharge in 2 ways:
Improvement in costs per case against their own historical performance;
Cost per case performance compared to BPN.
In the first year of the gainsharing program, two thirds of the total allowable incentive payments were allocated to physicians' improvement, with one third based on a performance metric. Payments for improvement were phased out over the first 3 years of the gainsharing program, with payments focused fully on performance in Year 3. Cases were adjusted for case‐mix and severity of illness (four levels of APR DRG). Physicians were not penalized for any cases in which costs greatly exceeded BPN. A floor was placed at the BPN and no additional financial incentives were paid for surpassing it. Baselines and BPNs were recalculated yearly.
A key aspect of the gainsharing program was the establishment of specific quality parameters (Table 2) that need to be met before any incentive payments were made. A committee regularly reviewed the quality performance data of each physician to determine eligibility for payments. Physicians were considered to be ineligible for incentive compensation until the next measurement period if there was evidence of failure to adequately meet these measures. At least 80% compliance with core measures (minimum 5 discharges in each domain) was expected. Infectious complication rates were to remain not more than 1 standard deviation above National Healthcare Safety Network rates during the same time period. In addition, payments were withheld from physicians if it was found that the standard of care was not met for any morbidity or mortality that was peer reviewed or if there were any significant patient complaints. Readmission rates were expected to remain at or below the baseline established during the previous 12 months by DRG.
| Quality Measure | Goal |
|---|---|
| |
| Readmissions within 7 days for the same or related diagnosis | Decrease, or less than 10% of discharges |
| Documentationquality and timeliness of medical record and related documentation including date, time, and sign all chart entries | No more than 20% of average monthly discharged medical records incomplete for more than 30 days |
| Consultation with social work/discharge planner within 24 hours of admission for appropriate pts | >80% of all appropriate cases |
| Timely switch from intravenous to oral antibiotics in accordance with hospital policy (%) | >80 |
| Unanticipated return to the operating room | Decrease or < 5% |
| Patient complaints | Decrease |
| Patient satisfaction (HCAHPS) | >75% physician domain |
| Ventilator associated pneumonia | Decrease or < 5% |
| Central line associated blood stream infections | Decrease or < 5 per 1000 catheter days. |
| Surgical site infections | Decrease or within 1 standard deviation of NHSN |
| Antibiotic prophylaxis (%) | >80 |
| Inpatient mortality | Decrease or <1% |
| Medication errors | Decrease or <1% |
| Delinquent medical records | <5 charts delinquent more than 30 days |
| Falls with injury | Decrease or <1% |
| AMI: aspirin on arrival and discharge (%) | >80 |
| AMI‐ACEI or ARB for LVSD (%) | >80 |
| Adult smoking cessation counseling (%) | >80 |
| AMI‐ Beta blocker prescribed at arrival and discharge (%) | >80 |
| CHF: discharge instructions (%) | >80 |
| CHF: Left ventricular function assessment (%) | >80 |
| CHF: ACEI or ARB for left ventricular systolic dysfunction (%) | >80 |
| CHF: smoking cessation counseling (%) | >80 |
| Pneumonia: O2 assessment, pneumococcal vaccine, blood culture and sensitivity before first antibiotic, smoking cessation counseling (%) | >80 |
Employed and private practice community physicians were both eligible for the gainsharing program. Physician participation in the program was voluntary. All patients admitted to the Medical Center received notification on admission about the program. The aggregate costs by DRG were calculated quarterly. Savings over the previous yearif anywere calculated. A total of 20% of the savings was used to administer the program and for incentive payments to physicians.
From July 1, 2006 through September 2008, only commercial managed care cases were eligible for this program. As a result of the approval of the gainsharing program as a demonstration project by the Centers for Medicare and Medicaid Services (CMS), Medicare cases were added to the program starting October 1, 2008.
Physician Payment Calculation Methodology
Performance Incentive
The performance incentive was intended to reward demonstrated levels of performance. Accordingly, a physician's share in hospital savings was in proportion to the relationship between their individual performance and the BPN. This computation was the same for both surgical and medical admissions. The following equation illustrates the computation of performance incentives for participating physicians:
This computation was made at the specific severity level for each hospital discharge. Payment for the performance incentive was made only to physicians at or below the 90th percentile of physicians.
Improvement Incentive
The improvement incentive was intended to encourage positive change. No payments were made from the improvement incentive unless an individual physician demonstrated measurable improvement in operational performance for either surgical or medical admissions. However, because physicians who admitted nonsurgical cases experienced reduced income as they help the hospital to improve operational performance, the methodology for calculating the improvement incentive was different for medical as opposed to surgical cases, as shown below.
For Medical DRGs:
For each severity level the following is calculated:
For Surgical DRGs:
Cost savings were calculated quarterly and defined as the cost per case before the gainsharing program began minus the actual case cost by APR DRG. Student's t‐test was used for continuous data and the categorical data trends were analyzed using Mantel‐Haenszel Chi‐Square.
At least every 6 months, all participating physicians received case‐specific and cost‐centered data about their discharges. They also received a careful explanation of opportunities for financial or quality improvement.
Results
Over the 3‐year period, 184 physicians enrolled, representing 54% of those eligible. The remainder of physicians either decided not to enroll or were not eligible due to inadequate number of index DRG cases or excluded diagnoses. Payer mix was 27% Medicare and 48% of the discharges were commercial and managed care. The remaining cases were a combination of Medicaid and self‐pay. A total of 29,535 commercial and managed care discharges were evaluated from participating physicians (58%) and 20,360 similar discharges from non‐participating physicians. This number of admissions accounted for 29% of all hospital discharges during this time period. Surgical admissions accounted for 43% and nonsurgical admissions for 57%. The distribution of patients by service is shown in Table 3. Pulmonary and cardiology diagnoses were the most frequent reasons for medical admissions. General and head and neck surgery were the most frequent surgical admissions. During the time period of the gainsharing program, the medical center saved $25.1 million for costs attributed to these cases. Participating physicians saved $6.9 million more than non‐participating physicians (P = 0.02, Figure 1), but all discharges demonstrated cost savings during the study period. Cost savings (Figure 2) resulted from savings in medical/surgical supplies and implants (35%), daily hospital costs, (28%), intensive care unit costs (16%) and coronary care unit costs (15%), and operating room costs (8%). Reduction in cost from reduced magnetic resonance imaging (MRI) use was not statistically significant. There were minimal increases in costs due to computed tomography (CT) scan use, cardiopulmonary care, laboratory use, pharmacy and blood bank, but none of these reached statistical significance.
| Admissions by Service | Number (%) |
|---|---|
| |
| Cardiology | 4512 (15.3) |
| Orthopedic surgery | 3994 (13.5) |
| Gastroenterology | 3214 (10.9) |
| General surgery | 2908 (9.8) |
| Cardiovascular surgery | 2432 (8.2) |
| Pulmonary | 2212 (7.5) |
| Neurology | 2064 (7.0) |
| Oncology | 1217 (4.1) |
| Infectious disease | 1171 (4.0) |
| Endocrinology | 906 (3.1) |
| Nephrology | 826 (2.8) |
| Open heart surgery | 656 (2.2) |
| Interventional cardiology | 624 (2.1) |
| Gynecological surgery | 450 (1.5) |
| Urological surgery | 326 (1.1) |
| ENT surgery | 289 (1.0) |
| Obstetrics without delivery | 261 (0.9) |
| Hematology | 253 (0.9) |
| Orthopedicsnonsurgical | 241 (0.8) |
| Rehabilitation | 204 (0.7) |
| Otolaryngology | 183 (0.6) |
| Rheumatology | 165 (0.6) |
| General medicine | 162 (0.5) |
| Neurological surgery | 112 (0.4) |
| Urology | 101 (0.3) |
| Dermatology | 52 (0.2) |
| Grand total | 29535 (100.0) |
Hospital LOS decreased 9.8% from baseline among participating doctors, while LOS decreased 9.0% among non‐participating physicians; this difference was not statistically significant (P = 0.6). Participating physicians reduced costs by an average of $7,871 per quarter, compared to a reduction in costs by $3,018 for admissions by non‐participating physicians (P < 0.0001). The average savings per admission for the participating physicians were $1,835, and for non‐participating physicians were $1,107, a difference of $728 per admission. Overall, cost savings during the three year period averaged $105,000 per physician who participated in the program and $67,000 per physician who did not (P < 0.05). There was not a statistical difference in savings between medical and surgical admissions (P = 0.24).
Deviations from quality thresholds were identified during this time period. Some or all of the gainsharing income was withheld from 8% of participating physicians due to quality issues, incomplete medical records, or administrative reasons. Payouts to participating physicians averaged $1,866 quarterly (range $0‐$27,631). Overall, 9.4% of the hospital savings was directly paid to the participating physicians. Compliance with core measures improved in the following domains from year 2006 to 2009; acute myocardial infarction 94% to 98%, congestive heart failure 76% to 93%, pneumonia 88% to 97%, and surgical care improvement project 90% to 97%, (P = 0.17). There was no measurable increase in 30‐day mortality or readmission by APR‐DRG. The number of incomplete medical records decreased from an average of 43% of the total number of records in the second quarter of 2006 to 30% in the second quarter of 2009 (P < 0.0001). Other quality indicators remained statistically unchanged.
Discussion
The promise of gainsharing may motivate physicians to decrease hospital costs while maintaining quality medical care, since it aligns physician and hospital incentives. Providing a reward to physicians creates positive reinforcement, which is more effective than warnings against poor performing physicians (carrot vs. stick).5, 6 This study is the first and largest of its kind to show the results of a gainsharing program for inpatient medical and surgical admissions and demonstrates that significant cost savings may be achieved. This is similar to previous studies that have shown positive outcomes for pay‐for‐performance programs.7
Participating physicians in the present study accumulated almost $7 million more in savings than non‐participating physicians. Over time this difference has increased, possibly due to a learning curve in educating participating physicians and the way in which information about their performance is given back to them. A significant portion of the hospital's cost savings was through improvements in documentation and completion of medical records. While there was an actual reduction in average length of stay (ALOS), better documentation may also have contributed to adjusting the severity level within each DRG.
Using financial incentives to positively impact on physician behavior is not new. One program in a community‐based hospitalist group reported similar improvements in medical record documentation, as well as improvements in physician meeting attendance and quality goals.8 Another study found that such hospital programs noted improved physician engagement and commitment to best practices and to improving the quality of care.9
There is significant experience in the outpatient setting using pay‐for‐performance programs to enhance quality. Millett et al.10 demonstrated a reduction in smoking among patients with diabetes in a program in the United Kingdom. Another study in Rochester, New York that used pay‐for‐performance incentives demonstrated better diabetes management.11 Mandel and Kotagal12 demonstrated improved asthma care utilizing a quality incentive program.
The use of financial motivation for physicians, as part of a hospital pay‐for‐performance program, has been shown to lead to improvements in quality performance scores when compared to non pay‐for‐performance hospitals.13 Berthiaume demonstrated decreased costs and improvements in risk‐adjusted complications and risk‐adjusted LOS in patents admitted for acute coronary intervention in a pay‐for‐performance program.14 Quality initiatives were integral for the gainsharing program, since measures such as surgical site infections may increase LOS and hospital costs. Core measures related to the care of patients with acute myocardial infarction, heart failure, pneumonia, and surgical prophylaxis steadily improved since the initiation of the gainsharing program. Gainsharing programs also enhance physician compliance with administrative responsibilities such as the completion of medical records.
One unexpected finding of our study was that there was a cost savings per admission even in the patients of physicians who did not participate in the gainsharing program. While the participating physicians showed statistically significant improvements in cost savings, savings were found in both groups. This raises the question as to whether these cost reductions could have been impacted by other factors such as new labor or vendor contracts, better documentation, improved operating room utilization and improved and timely documentation in the medical record. Another possibility is the Hawthorne effect on physicians, who altered their behavior with knowledge that process and outcome measurement were being measured. Physicians who voluntarily sign up for a gainsharing program would be expected to be more committed to the success of this program than physicians who decide to opt out. While this might appear to be a selection bias it does illustrate the point that motivated physicians are more likely to positively change their practice behaviors. However, one might suggest that financial savings directly attributed to the gainsharing program was not the $25.1 million saved during the 3 years overall, but the difference between participating and non‐participating physicians, or $6.9 million.
While the motivation to complete medical records was significant (gainsharing dollars were withheld from doctors with more than 5 incomplete charts for more than 30 days) it was not the only reason why the number of delinquent chart percentage decreased during the study period. While the improvement was significant, there are still more opportunities to reduce the number of incomplete charts. Hospital regulatory inspections and periodic physician education were also likely to have reduced the number of incomplete inpatient charts during this time period and may do so in the future.15
The program focused on the physician activities that have the greatest impact on hospital costs. While optimizing laboratory, blood bank, and pharmacy management decreased hospital costs; we found that improvements in patient LOS, days in an intensive care unit, and management of surgical implants had the greatest impact on costs. Orthopedic surgeons began to use different implants, and all surgeons refrained from opening disposable surgical supplies until needed. Patients in intensive care unit beds stable for transfer were moved to regular medical/surgical rooms earlier. Since the program helped physicians understand the importance of LOS, many physicians increased their rounding on weekends and considered LOS implications before ordering diagnostic procedures that could be performed as an outpatient. Nurses, physician extenders such as physician assistants, and social workers have played an important role in streamlining patient care and hospital discharge; however, they were not directly rewarded under this program.
There are challenges to aligning the incentives of internists compared to procedure‐based specialists. This may be that the result of surgeons receiving payment for bundled care and thus the incentives are already aligned. The incentive of the program for internists, who get paid for each per daily visit, was intended to overcome the lost income resulting from an earlier discharge. Moreover, in the present study, only the discharging physician received incentive payments for each case. Patient care is undoubtedly a team effort and many physicians (radiologists, anesthesiologists, pathologists, emergency medicine physicians, consultant specialty physicians, etc.) are clearly left out in the present gainsharing program. Aligning the incentives of these physicians might be necessary. Furthermore, the actions of other members of the medical team and consultants, by their behaviors, could limit the incentive payments for the discharging physician. The discharging physician is often unable to control the transfer of a patient from a high‐cost or severity unit, or improve the timeliness of consulting physicians. Previous authors have raised the issue as to whether a physician should be prevented from payment because of the actions of another member of the medical team.16
Ensuring a fair and transparent system is important in any pay‐for‐performance program. The present gainsharing program required sophisticated data analysis, which added to the costs of the program. To implement such a program, data must be clear and understandable, segregated by DRG and severity adjusted. But should the highest reward payments go to those who perform the best or improve the most? In the present study, some physicians were consistently unable to meet quality benchmarks. This may be related to several factors, 1 of which might be a particular physician's case mix. Some authors have raised concerns that pay‐for‐performance programs may unfairly impact physicians who care for more challenging or patients from disadvantaged socioeconomic circumstances.17 Other authors have questioned whether widespread implementation of such a program could potentially increase healthcare disparities in the community.18 It has been suggested by Greene and Nash that for a program to be successful, physicians who feel they provide good care yet but are not rewarded should be given an independent review.16 Such a process is important to prevent resentment among physicians who are unable to meet benchmarks for payment, despite hard work.19 Conversely, other studies have found that many physicians who receive payments in a pay‐for‐performance system do not necessarily consciously make improvement to enhance financial performance.20 Only 54% of eligible physicians participated in the present gainsharing program. This is likely due to lack of understanding about the program, misperceptions about the ethics of such programs, perceived possible negative patient outcome, conflict of interest and mistrust.21, 22 This underscores the importance of providing understandable performance results, education, and a physician champion to help facilitate communication and enhanced outcomes. What is clear is that the perception by participating physicians is that this program is worthwhile as the number of participating physicians has steadily increased and it has become an incentive for new providers to choose this medical center over others.
In conclusion, the results of the present study show that physicians can help hospitals reduce inpatients costs while maintaining or improving hospital quality. Improvements in patient LOS, implant costs, overall costs per admission, and medical record completion were noted. Further work is needed to improve physician education and better understand the impact of uneven physician case mix. Further efforts are necessary to allow other members of the health care team to participate and benefit from gainsharing.
- ,,, et al.Guided care and the cost of complex healthcare: a preliminary report.Am J Manag Care.2009;15(8):555–559.
- ,.Hospital‐physician gainsharing in cardiology.Health Aff (Millwood).2008;27(3):803–812.
- ,,,.AOA Symposium. Gainsharing in orthopaedics: passing fancy or wave of the future?J Bone Joint Surg Am.2007;89(9):2075–2083.
- All Patient Defined Diagnosis Related Groups™ ‐ 3M Health Information Systems,St Paul, MN.
- ,,, et al.Guided care and the cost of complex healthcare: a preliminary report.Am J Manag Care.2009;15(8):555–559.
- .Best practices in record completion.J Med Pract Manage.2004;20(1):18–22.
- ,,, et al.Return on investment in pay for performance: a diabetes case study.J Healthc Manag.2006;51(6):365–374; discussion 375‐376.
- .Use of pay for performance in a community hospital private hospitalists group: a preliminary report.Trans Am Clin Climatol Assoc.2007;188:263–272.
- .Making the grade with pay for performance: 7 lessons from best‐performing hospitals.Healthc Financ Manage.2006;60(12):79–85.
- ,,,,.Impact of a pay‐for‐performance incentive on support for smoking cessation and on smoking prevalence among people with diabetes.CMAJ.2007;176(12):1705–1710.
- ,,, et al,Effects of paying physicians based on their relative performance for quality.J Gen Intern Med.2007;22(6):872–876.
- ,.Pay for performance alone cannot drive quality.Arch Pediatr Adolesc Med.2007;161(7):650–655.
- .What's the return? Assessing the effect of “pay‐for‐performance” initiatives on the quality of care delivery.Med Care Res Rev.2006;63(1 suppl)( ):29S–48S.
- ,,,,.Aligning financial incentives with “Get With the Guidelines” to improve cardiovascular care.Am J Manag Care.2004;10(7 pt 2):501–504.
- .Sampling best practices. Managing delinquent records.J AHIMA.1997;68(8):28,30.
- ,.Pay for performance: an overview of the literature.Am J Med Qual.2009;24;140–163.
- ,,.Physician‐level P4P:DOA? Can quality‐based payments be resuscitated?Am J Manag Care.2007;13(5):233–236.
- ,,, et al.Will pay for performance and quality reporting affect health care disparities?Health Aff (Millwood).2007;26(3):w405–w414.
- ,,.The experience of pay for performance in English family practice: a qualitative study.Ann Fam Med.2008;8(3):228–234.
- ,,, et al.Will financial incentives stimulate quality improvement? Reactions from frontline physicians.Am J Med Qual.2006;21(6):367–374.
- ,,.Pay for performance in orthopedic surgery.Clin Orthop Relat Res.2007;457:87–95.
- ,.Pay for performance survey of diagnostic radiology faculty and trainees.J Am Coll Radiol.2007;4(6):411–415.
- ,,, et al.Guided care and the cost of complex healthcare: a preliminary report.Am J Manag Care.2009;15(8):555–559.
- ,.Hospital‐physician gainsharing in cardiology.Health Aff (Millwood).2008;27(3):803–812.
- ,,,.AOA Symposium. Gainsharing in orthopaedics: passing fancy or wave of the future?J Bone Joint Surg Am.2007;89(9):2075–2083.
- All Patient Defined Diagnosis Related Groups™ ‐ 3M Health Information Systems,St Paul, MN.
- ,,, et al.Guided care and the cost of complex healthcare: a preliminary report.Am J Manag Care.2009;15(8):555–559.
- .Best practices in record completion.J Med Pract Manage.2004;20(1):18–22.
- ,,, et al.Return on investment in pay for performance: a diabetes case study.J Healthc Manag.2006;51(6):365–374; discussion 375‐376.
- .Use of pay for performance in a community hospital private hospitalists group: a preliminary report.Trans Am Clin Climatol Assoc.2007;188:263–272.
- .Making the grade with pay for performance: 7 lessons from best‐performing hospitals.Healthc Financ Manage.2006;60(12):79–85.
- ,,,,.Impact of a pay‐for‐performance incentive on support for smoking cessation and on smoking prevalence among people with diabetes.CMAJ.2007;176(12):1705–1710.
- ,,, et al,Effects of paying physicians based on their relative performance for quality.J Gen Intern Med.2007;22(6):872–876.
- ,.Pay for performance alone cannot drive quality.Arch Pediatr Adolesc Med.2007;161(7):650–655.
- .What's the return? Assessing the effect of “pay‐for‐performance” initiatives on the quality of care delivery.Med Care Res Rev.2006;63(1 suppl)( ):29S–48S.
- ,,,,.Aligning financial incentives with “Get With the Guidelines” to improve cardiovascular care.Am J Manag Care.2004;10(7 pt 2):501–504.
- .Sampling best practices. Managing delinquent records.J AHIMA.1997;68(8):28,30.
- ,.Pay for performance: an overview of the literature.Am J Med Qual.2009;24;140–163.
- ,,.Physician‐level P4P:DOA? Can quality‐based payments be resuscitated?Am J Manag Care.2007;13(5):233–236.
- ,,, et al.Will pay for performance and quality reporting affect health care disparities?Health Aff (Millwood).2007;26(3):w405–w414.
- ,,.The experience of pay for performance in English family practice: a qualitative study.Ann Fam Med.2008;8(3):228–234.
- ,,, et al.Will financial incentives stimulate quality improvement? Reactions from frontline physicians.Am J Med Qual.2006;21(6):367–374.
- ,,.Pay for performance in orthopedic surgery.Clin Orthop Relat Res.2007;457:87–95.
- ,.Pay for performance survey of diagnostic radiology faculty and trainees.J Am Coll Radiol.2007;4(6):411–415.
Copyright © 2010 Society of Hospital Medicine
Handoff Efficiency
Transfer of responsibility for patients, or handoff,1 occurs frequently in hospitalist services, requiring excellent and timely communication to ensure patient safety. Communication failure is a major contributor to medical errors.2, 3 Recognizing such findings, a growing body of literature addresses handoff techniques for learners.47
Vidyarthi described the handoff process as traditionally informal, unstructured, and idiosyncratic,4 and many believe efforts to formalize and structure this process are important for patient safety.8 Standardized handoff forms have improved accuracy of information.9 Web‐based sign‐out systems reportedly reduced the number of patients missed on rounds.10
Hospitalists also face challenges with effective communication during service change.11 The Society of Hospital Medicine identified the handoff skill as a core competency for hospitalists, and recommendations based on a systematic review of the literature were published.12 Inpatient medicine programs are increasingly using midlevel providers such as nurse practitioners (NPs) and physician assistants (PAs) along with hospitalists to accommodate workload while maintaining the scholarly enterprise in academic centers.13 To our knowledge there is no literature examining the hospitalist service handoffs involving NP/PAs.
We wished to study the effectiveness and timeliness of the morning handoff from the night coverage providers to the daytime teams consisting of one hospitalist and one NP/PA. Our objectives were to identify deficiencies and to evaluate the effectiveness of a restructured handoff process.
Methods
The Mayo Clinic Institutional Review Board reviewed and approved this study.
Setting
At the time of this study, the Division of Hospital Internal Medicine (HIM) at our institution consisted of 22 hospitalists, 11 NPs and 9 PAs (hereinafter NP/PAs), and 2 clinical assistants (CAs). The CAs assist with clerical duties not covered by Unit Secretaries:
-
Obtaining outside records
-
Clarifying referring physician contact information
-
Scheduling follow‐up outpatient appointments for tests, procedures, and visits
-
Attendance at morning handoff
Each CA can assist 3 or 4 daytime service teams.
Daytime Service Organization
Six HIM services, each managing up to 12 patients, are staffed by a partnership of 1 hospitalist and 1 NP/PA: Four services are primary general medicine services, and 2 consulting (orthopedic comanagement) services.
Night Coverage
Three of 4 primary daytime services and one consult service team transfer care to the (in‐house) night NP/PA. The night NP/PA addresses any acute‐care issues and reports at morning handoff to the 3 primary services and 1 consult service. In a designated conference room the morning handoff occurs, with at least 1 (day team) service representative present. This is usually the NP/PA, as the day team hospitalist concurrently receives a report on new admissions from the (in‐house) night hospitalist (who also covers one service and backs up the night NP/PA).
Improvement Process
An improvement team was formed within the Division of HIM consisting of 3 hospitalists, 3 NP/PAs, and 2 CAs to assess the existing handoff process at 7:45am between the Night NP/PA and daytime services. The improvement team met, reviewed evidence‐based literature on handoffs and discussed our local process. Four problems were identified by consensus:
-
Unpredictable start and finish times
-
Inefficiency (time wasted)
-
Poor environment (room noisy and distracting conversations)
-
Poor communication (overwrought and meandering narratives).
Intervention
The improvement team structured a new handoff process to address these deficiencies.
-
Environment: Moved to a smaller room (lower ceiling, less ambient noise).
-
Identification: table cards designating seats for participants (reduced queries regarding what service are you, today?).
-
Start Times: Each service team assigned a consistent start time (labeled on the table card) within a 15‐minute period, and although earlier reportage could occur, any service team present at their designated time has priority for the attention of the night NP/PA, and the opportunity to ask questions.
-
Quiet and Focus: HIM members were reminded to remain quiet in the handoff room, so the service receiving report has the floor and personal conversations must not impede the principals.
-
Visual Cue: Green Good to go sign placed on team table cards when no verbal was required.
-
Written e‐Material: The improvement team required elements of a brief written report in a specified column of our existing electronic service list (ESL). The ESL is a custom designed template importing laboratory, medication, and demographic data automatically but also capable of free text additions (Figure 1). All providers were instructed to update the ESL every 12 hours.
-
Admission and Progress Notes: After manual electronic medical record search, the CAs printed any notes generated in the preceding 12 hours and placed them by the team table card.
The improvement team provided education for the new process at a division meeting and through e‐mail. The recommended report sequence was night NP/PA reporting and day service teams asking questions and seeking clarifications. We discouraged editorial comments and chit‐chat.
A member of the improvement team monitored the new handoff process for 15 days, and 3 months later for 10 days.
Survey
An anonymous survey (Figure 2) concerning staff satisfaction with handoff was conducted immediately before and 15 days after the intervention. In the e‐mail containing the postintervention survey, providers were asked to respond only if they had been on service the preceding 15 days (and thus eligible to participate in handoff). To help insure this, the first question read, Have you been on service during the past 15 days?
Statistics
To compare the relationship of preintervention and postintervention survey responses, Fisher's exact test was used to compare categorical variables and 2 sample t‐test and Wilcoxon rank sum test were used for continuous variables. Comparisons that adjusted for the possibility of someone responding to both the preintervention and postintervention surveys were not performed since the surveys were anonymous. A P value 0.05 was considered statistically significant. For the item concerning the percentage of days morning report was attended while on service, based on a common standard deviation estimate of 35.3, we had 80% power to detect a difference of 29.1 (pre vs. post). This computation assumes a 2‐sample t‐test of = 0.05 with sample sizes of 36 and 18. We have 59% power to detect a difference of 27% (67% pre vs. 94% post) for those who at least agree that helpful information was conveyed during handoff. This computation is based on a 2‐sided Pearson 2 test with = 0.05.
Qualitative data analysis of respondents' answers to the open‐ended survey questions What would increase the likelihood of your attending handoff? and What feedback do you have regarding the changes to handoff? was performed using the constant comparative method14 associated with grounded theory approaches to identify themes and categories.15 To establish interrater reliability, three investigators (MCB, DTK, LLK) independently identified coding categories for the data set, compared results, redefined coding categories as needed, and reanalyzed the data until 80% agreement was reached.
Results
Thirty‐six of the 44 providers (82%) answered the preintervention survey, including 18 of 22 hospitalists (82%), 17 of 20 NPs/PAs (85%), and 1 of 2 CAs (50%). During the intervention based on our staffing model, 21 providers had the opportunity to participate in handoff, and 18 (86%) answered the postintervention survey, including 5 of 6 hospitalists (83%), 9 of 14 NPs/PAs (64%), and 2 of 2 CAs (100%). All respondents to the postintervention survey reported being on service during the previous 15 days.
As summarized in Table 1, compared to 60.5% of survey participants (n = 38) who thought morning handoff was performed in a timely fashion preintervention, 100% (n = 15) felt it was performed in a timely fashion postintervention (P = 0.005). The average time spent in morning report before the intervention was 11 minutes, as compared to 5 minutes after the intervention (P 0.0028). Prior to the intervention, 6.5 minutes of the handoff were viewed to be wasteful, as compared to 0.5 minutes of the handoff in the postintervention survey (P 0.0001). Attendance and quality of information perceptions did not demonstrate statistically significant change.
| Survey Question | Preintervention | Postintervention | P |
|---|---|---|---|
| What proportion of days while on service did you attend morning report? (%) | 78 | 87 | 0.4119 |
| Helpful information was conveyed in morning report, n (%) | 0.112 | ||
| Strongly agree | 9 (25) | 9 (56) | |
| Agree | 15 (42) | 6 (38) | |
| Neutral | 8 (22) | 1 (6) | |
| Disagree | 4 (11) | 0 | |
| Strongly disagree | 0 | 0 | |
| Morning report was performed in a timely manner, #yes/#no | 23/15 | 15/0 | 0.005 |
| Estimate the number of minutes each day you would spend in morning report (minute) | 11 | 5 | 0.0028 |
| Estimate the number of minutes in morning report you thought were wasteful (minute) | 6.5 | 0.5 | 0.0001 |
During the 15‐day observation period, morning handoff started by 0745 on 14 of 15 (93%) of days and finished by 0800 on 15 of 15 (100%) of days. Table cards, ESL, and progress notes were on the table by 0745 on 15 of 15 (100%) of days following the intervention. Three months after the intervention, the following were observed: morning handoff started by 0745 on 10 of 10 (100%) of days; finished by 0800 on 10 of 10 (100%) of days; and table cards, ESL, and progress notes were on the table by 0745 on 10 of 10 (100%) of days.
Qualitative Data Analysis
Three themes were identified in both preintervention and postintervention surveys: timeliness, quality of report and environment (Table 2). In the preintervention survey, timeliness complaints involved inconsistent start time, prolonged duration of handoff, and inefficiency due to time wasted while teams waited for their handoff report. Comments about report quality mentioned the nonstandardized report process that included nonpertinent information and editorializing. Environmental concerns addressed noise from multiple service team members assembled in 1 large room and chatting while awaiting report. In the postintervention survey, respondents' comments noted improved efficiency, environment, and report quality.
| Deficiency | Pre‐Intervention | Post‐Intervention |
|---|---|---|
| Timeliness | Efficiency needed | I found the changes lead to more concise and valuable time spent in report |
| Timely, scheduled and efficient reports would help increase my attendance | I personally enjoyed having the times set so you are held accountable for a certain handoff | |
| Set report times so I don't have to listen to everyone else's report | More organized and efficient | |
| Too much time wasted | Love the good to go card! Can start on rounds | |
| Environment | Not having to listen to chit chat unrelated to patient carewould improve my attendance | There is less chit chat |
| Services should receive report in a quieter room | Seems less chaotic with less people overall in the room so less distraction | |
| Need a quieter and smaller room | Because the room is quieter, I did not have to repeat information | |
| Too noisy | Quiet and respectful | |
| Quality | I would like a more organized format More information isn't needed, just the correct information in a timely manner | I felt that the amount of information shared was only what was pertinent and important |
| If I first had the opportunity to review ESL and any notes generated in the last 12 hours, this would improve report | Written information on the ESL assured that I didn't forget something important | |
| Less editorializing about events and less adrenaline | I liked having the progress notes generated overnight available for review | |
| Need only meaningful information | Excellent report with prompt dissemination of information |
Discussion
We describe an intervention that set the expectation for formal, structured written and verbal communication in a focused environment involving outgoing and incoming clinicians, resulting in improved satisfaction. Before the intervention, the improvement team identified by consensus 4 problems: unpredictable start time, inefficiency, environment, and report quality. Formal structuring of our handoff process resulted in statistically significant improvement in handoff timeliness and efficiency in the view of the HIM division members. Process improvement included precise team specific start times within a 12‐minute window to improve reliability and predictability and eliminating nonproductive waiting. Additionally, receiving teams were clearly identified with table cards so that no time was wasted locating the appropriate service for report, and minimizing role‐identification challenges. The good to go sign signaled teams that no events had occurred overnight requiring verbal report. Handoff timeliness persisted 3 months after the intervention, suggesting that the process is easily sustainable.
Postintervention survey comments noted the improved environment: a smaller, quieter room with the door closed. Before the intervention, all day team providers, CAs and night provider met in a large, loud room where multiple conversations were commonplace. Previous study of the handoff process supports creating an environment free of distraction.4
Postintervention survey responses to the open‐ended questions suggested improved provider satisfaction with the quality of the report. We believe this occurred for several reasons. First, having a precise start time for each team within a 12‐minute window led to a more focused report. Second, the ESL provided a column for providers to suggest plans of care for anticipated overnight events to improve preparedness and avoid significant omissions. Third, hospital notes generated overnight were made available which allowed daytime providers to review events before handoff, for a more informed update, or just after verbal report to reinforce the information just received, a technique used in other high‐reliability organizations.16 This measure also provided an at‐a‐glance view of each patient, decreasing the complexity of handoff.17
This study has important limitations. We address the handoff process of 1 hospitalist group at a single academic center. NP/PAs are the clinicians with first‐call responsibility for the night coverage of our patients, and the handoff process between the night NP/PA and daytime provider was studied. The handoff between physicians for patients admitted overnight was not assessed. Another limitation is that the time spent in handoff is reported as a participant estimate. There was no objective measurement of time, and respondents may have been biased. An additional limitation of our study concerns the preintervention and postintervention surveys. Both surveys were anonymous, which makes discerning the absolute impact of the intervention difficult due to the lack of paired responses. Lastly, our institution has an ESL. This option may not be available in other hospital systems.
Several deficiencies in the handoff process were addressed by providing key clinical data verbally and in written format, enhancing the physical environment, and defining each team's handoff start time. Our process improvements are consistent with the handoff recommendations endorsed by the Society of Hospital Medicine.12 Subsequent direct observation, subjective reports, and survey results demonstrated improvement in the handoff process.
Future studies might measure the effectiveness of morning handoff by end‐shift interviews of the daytime clinicians. Similarly, a study of evening handoff could measure the efficiency and effectiveness of report given by day teams to night‐coverage colleagues. Furthermore, if the handoff report skill set can be more rigorously defined and measured, a hospitalist clinical competency for hospitalists and NP/PAs could be developed in this core process‐of‐care.12
Acknowledgements
The authors thank Lisa Boucher for preparation of this manuscript.
- , , , et al.Lost in translation: challenges and opportunities in physician‐to‐physician communication during patient handoffs.Acad Med.2005;80:1094–1099.
- , , .Communication failures: an insidious contributor to medical mishaps.Acad Med.2004;79:186–194.
- , , .The human factor: the critical importance of effective teamwork and communication in providing safe care.Quality 13 Suppl 1:i85–90.
- , , , et al.Managing discontinuity in academic medical centers: strategies for a safe and effective resident sign‐out.J Hosp Med.2006;1:257–266.
- , , .Development and implementation of an oral sign‐out skills curriculum.J Gen Intern Med.2007;22:1470–1474.
- , , , et al.The top 10 list for a safe and effective sign‐out.Arch Surg2008;143(10):1008–1010.
- , , , et al.Residents' and attending physicians' handoffs: a systematic review of the literature.Acad Med.2009;84(12):1775–1787.
- , , , et al.A structured handoff program for interns.Acad Med.2009;84:347–352.
- , , , et al.Simple standardized patient handoff system that increases accuracy and completeness.J Surg.2008;65:476–485.
- , , , et al.A randomized, controlled trial evaluation the impact of a computerized rounding and sign‐out system on continuity of care and resident work hours.J Am Coll Surg.2005;200:538–545.
- , , , .Understanding communication during hospitalist service changes: A mixed methods study.J Hosp Med.2009;4(9):535–540.
- , , , , , .Hospitalist handoffs: a systematic review and task force recommendations.J of Hosp Med.2009;4(7):433–440.
- , , , et al.Implementation of a physician assistant/hospitalist service in an academic medical center: impact on efficiency and patient outcomes.J Hosp Med.2008;3:361–368.
- , .Basics of Qualitiative Research: Grounded Theory Procedures and Techniques.Sage Publications, Inc.Newbury Park, CA.1990.
- , .Naturalistic Inquiry.Sage Publications, Inc.Newbury Park, CA.1985.
- .Communication strategies from high‐reliability organizations.Ann Surg.2007;245(2):170–172.
- , , , et al.Handoff strategies in settings with high consequences for failure: lessons for health care operations.Int J Qual Health Care.2004;16(2):125.
Transfer of responsibility for patients, or handoff,1 occurs frequently in hospitalist services, requiring excellent and timely communication to ensure patient safety. Communication failure is a major contributor to medical errors.2, 3 Recognizing such findings, a growing body of literature addresses handoff techniques for learners.47
Vidyarthi described the handoff process as traditionally informal, unstructured, and idiosyncratic,4 and many believe efforts to formalize and structure this process are important for patient safety.8 Standardized handoff forms have improved accuracy of information.9 Web‐based sign‐out systems reportedly reduced the number of patients missed on rounds.10
Hospitalists also face challenges with effective communication during service change.11 The Society of Hospital Medicine identified the handoff skill as a core competency for hospitalists, and recommendations based on a systematic review of the literature were published.12 Inpatient medicine programs are increasingly using midlevel providers such as nurse practitioners (NPs) and physician assistants (PAs) along with hospitalists to accommodate workload while maintaining the scholarly enterprise in academic centers.13 To our knowledge there is no literature examining the hospitalist service handoffs involving NP/PAs.
We wished to study the effectiveness and timeliness of the morning handoff from the night coverage providers to the daytime teams consisting of one hospitalist and one NP/PA. Our objectives were to identify deficiencies and to evaluate the effectiveness of a restructured handoff process.
Methods
The Mayo Clinic Institutional Review Board reviewed and approved this study.
Setting
At the time of this study, the Division of Hospital Internal Medicine (HIM) at our institution consisted of 22 hospitalists, 11 NPs and 9 PAs (hereinafter NP/PAs), and 2 clinical assistants (CAs). The CAs assist with clerical duties not covered by Unit Secretaries:
-
Obtaining outside records
-
Clarifying referring physician contact information
-
Scheduling follow‐up outpatient appointments for tests, procedures, and visits
-
Attendance at morning handoff
Each CA can assist 3 or 4 daytime service teams.
Daytime Service Organization
Six HIM services, each managing up to 12 patients, are staffed by a partnership of 1 hospitalist and 1 NP/PA: Four services are primary general medicine services, and 2 consulting (orthopedic comanagement) services.
Night Coverage
Three of 4 primary daytime services and one consult service team transfer care to the (in‐house) night NP/PA. The night NP/PA addresses any acute‐care issues and reports at morning handoff to the 3 primary services and 1 consult service. In a designated conference room the morning handoff occurs, with at least 1 (day team) service representative present. This is usually the NP/PA, as the day team hospitalist concurrently receives a report on new admissions from the (in‐house) night hospitalist (who also covers one service and backs up the night NP/PA).
Improvement Process
An improvement team was formed within the Division of HIM consisting of 3 hospitalists, 3 NP/PAs, and 2 CAs to assess the existing handoff process at 7:45am between the Night NP/PA and daytime services. The improvement team met, reviewed evidence‐based literature on handoffs and discussed our local process. Four problems were identified by consensus:
-
Unpredictable start and finish times
-
Inefficiency (time wasted)
-
Poor environment (room noisy and distracting conversations)
-
Poor communication (overwrought and meandering narratives).
Intervention
The improvement team structured a new handoff process to address these deficiencies.
-
Environment: Moved to a smaller room (lower ceiling, less ambient noise).
-
Identification: table cards designating seats for participants (reduced queries regarding what service are you, today?).
-
Start Times: Each service team assigned a consistent start time (labeled on the table card) within a 15‐minute period, and although earlier reportage could occur, any service team present at their designated time has priority for the attention of the night NP/PA, and the opportunity to ask questions.
-
Quiet and Focus: HIM members were reminded to remain quiet in the handoff room, so the service receiving report has the floor and personal conversations must not impede the principals.
-
Visual Cue: Green Good to go sign placed on team table cards when no verbal was required.
-
Written e‐Material: The improvement team required elements of a brief written report in a specified column of our existing electronic service list (ESL). The ESL is a custom designed template importing laboratory, medication, and demographic data automatically but also capable of free text additions (Figure 1). All providers were instructed to update the ESL every 12 hours.
-
Admission and Progress Notes: After manual electronic medical record search, the CAs printed any notes generated in the preceding 12 hours and placed them by the team table card.
The improvement team provided education for the new process at a division meeting and through e‐mail. The recommended report sequence was night NP/PA reporting and day service teams asking questions and seeking clarifications. We discouraged editorial comments and chit‐chat.
A member of the improvement team monitored the new handoff process for 15 days, and 3 months later for 10 days.
Survey
An anonymous survey (Figure 2) concerning staff satisfaction with handoff was conducted immediately before and 15 days after the intervention. In the e‐mail containing the postintervention survey, providers were asked to respond only if they had been on service the preceding 15 days (and thus eligible to participate in handoff). To help insure this, the first question read, Have you been on service during the past 15 days?
Statistics
To compare the relationship of preintervention and postintervention survey responses, Fisher's exact test was used to compare categorical variables and 2 sample t‐test and Wilcoxon rank sum test were used for continuous variables. Comparisons that adjusted for the possibility of someone responding to both the preintervention and postintervention surveys were not performed since the surveys were anonymous. A P value 0.05 was considered statistically significant. For the item concerning the percentage of days morning report was attended while on service, based on a common standard deviation estimate of 35.3, we had 80% power to detect a difference of 29.1 (pre vs. post). This computation assumes a 2‐sample t‐test of = 0.05 with sample sizes of 36 and 18. We have 59% power to detect a difference of 27% (67% pre vs. 94% post) for those who at least agree that helpful information was conveyed during handoff. This computation is based on a 2‐sided Pearson 2 test with = 0.05.
Qualitative data analysis of respondents' answers to the open‐ended survey questions What would increase the likelihood of your attending handoff? and What feedback do you have regarding the changes to handoff? was performed using the constant comparative method14 associated with grounded theory approaches to identify themes and categories.15 To establish interrater reliability, three investigators (MCB, DTK, LLK) independently identified coding categories for the data set, compared results, redefined coding categories as needed, and reanalyzed the data until 80% agreement was reached.
Results
Thirty‐six of the 44 providers (82%) answered the preintervention survey, including 18 of 22 hospitalists (82%), 17 of 20 NPs/PAs (85%), and 1 of 2 CAs (50%). During the intervention based on our staffing model, 21 providers had the opportunity to participate in handoff, and 18 (86%) answered the postintervention survey, including 5 of 6 hospitalists (83%), 9 of 14 NPs/PAs (64%), and 2 of 2 CAs (100%). All respondents to the postintervention survey reported being on service during the previous 15 days.
As summarized in Table 1, compared to 60.5% of survey participants (n = 38) who thought morning handoff was performed in a timely fashion preintervention, 100% (n = 15) felt it was performed in a timely fashion postintervention (P = 0.005). The average time spent in morning report before the intervention was 11 minutes, as compared to 5 minutes after the intervention (P 0.0028). Prior to the intervention, 6.5 minutes of the handoff were viewed to be wasteful, as compared to 0.5 minutes of the handoff in the postintervention survey (P 0.0001). Attendance and quality of information perceptions did not demonstrate statistically significant change.
| Survey Question | Preintervention | Postintervention | P |
|---|---|---|---|
| What proportion of days while on service did you attend morning report? (%) | 78 | 87 | 0.4119 |
| Helpful information was conveyed in morning report, n (%) | 0.112 | ||
| Strongly agree | 9 (25) | 9 (56) | |
| Agree | 15 (42) | 6 (38) | |
| Neutral | 8 (22) | 1 (6) | |
| Disagree | 4 (11) | 0 | |
| Strongly disagree | 0 | 0 | |
| Morning report was performed in a timely manner, #yes/#no | 23/15 | 15/0 | 0.005 |
| Estimate the number of minutes each day you would spend in morning report (minute) | 11 | 5 | 0.0028 |
| Estimate the number of minutes in morning report you thought were wasteful (minute) | 6.5 | 0.5 | 0.0001 |
During the 15‐day observation period, morning handoff started by 0745 on 14 of 15 (93%) of days and finished by 0800 on 15 of 15 (100%) of days. Table cards, ESL, and progress notes were on the table by 0745 on 15 of 15 (100%) of days following the intervention. Three months after the intervention, the following were observed: morning handoff started by 0745 on 10 of 10 (100%) of days; finished by 0800 on 10 of 10 (100%) of days; and table cards, ESL, and progress notes were on the table by 0745 on 10 of 10 (100%) of days.
Qualitative Data Analysis
Three themes were identified in both preintervention and postintervention surveys: timeliness, quality of report and environment (Table 2). In the preintervention survey, timeliness complaints involved inconsistent start time, prolonged duration of handoff, and inefficiency due to time wasted while teams waited for their handoff report. Comments about report quality mentioned the nonstandardized report process that included nonpertinent information and editorializing. Environmental concerns addressed noise from multiple service team members assembled in 1 large room and chatting while awaiting report. In the postintervention survey, respondents' comments noted improved efficiency, environment, and report quality.
| Deficiency | Pre‐Intervention | Post‐Intervention |
|---|---|---|
| Timeliness | Efficiency needed | I found the changes lead to more concise and valuable time spent in report |
| Timely, scheduled and efficient reports would help increase my attendance | I personally enjoyed having the times set so you are held accountable for a certain handoff | |
| Set report times so I don't have to listen to everyone else's report | More organized and efficient | |
| Too much time wasted | Love the good to go card! Can start on rounds | |
| Environment | Not having to listen to chit chat unrelated to patient carewould improve my attendance | There is less chit chat |
| Services should receive report in a quieter room | Seems less chaotic with less people overall in the room so less distraction | |
| Need a quieter and smaller room | Because the room is quieter, I did not have to repeat information | |
| Too noisy | Quiet and respectful | |
| Quality | I would like a more organized format More information isn't needed, just the correct information in a timely manner | I felt that the amount of information shared was only what was pertinent and important |
| If I first had the opportunity to review ESL and any notes generated in the last 12 hours, this would improve report | Written information on the ESL assured that I didn't forget something important | |
| Less editorializing about events and less adrenaline | I liked having the progress notes generated overnight available for review | |
| Need only meaningful information | Excellent report with prompt dissemination of information |
Discussion
We describe an intervention that set the expectation for formal, structured written and verbal communication in a focused environment involving outgoing and incoming clinicians, resulting in improved satisfaction. Before the intervention, the improvement team identified by consensus 4 problems: unpredictable start time, inefficiency, environment, and report quality. Formal structuring of our handoff process resulted in statistically significant improvement in handoff timeliness and efficiency in the view of the HIM division members. Process improvement included precise team specific start times within a 12‐minute window to improve reliability and predictability and eliminating nonproductive waiting. Additionally, receiving teams were clearly identified with table cards so that no time was wasted locating the appropriate service for report, and minimizing role‐identification challenges. The good to go sign signaled teams that no events had occurred overnight requiring verbal report. Handoff timeliness persisted 3 months after the intervention, suggesting that the process is easily sustainable.
Postintervention survey comments noted the improved environment: a smaller, quieter room with the door closed. Before the intervention, all day team providers, CAs and night provider met in a large, loud room where multiple conversations were commonplace. Previous study of the handoff process supports creating an environment free of distraction.4
Postintervention survey responses to the open‐ended questions suggested improved provider satisfaction with the quality of the report. We believe this occurred for several reasons. First, having a precise start time for each team within a 12‐minute window led to a more focused report. Second, the ESL provided a column for providers to suggest plans of care for anticipated overnight events to improve preparedness and avoid significant omissions. Third, hospital notes generated overnight were made available which allowed daytime providers to review events before handoff, for a more informed update, or just after verbal report to reinforce the information just received, a technique used in other high‐reliability organizations.16 This measure also provided an at‐a‐glance view of each patient, decreasing the complexity of handoff.17
This study has important limitations. We address the handoff process of 1 hospitalist group at a single academic center. NP/PAs are the clinicians with first‐call responsibility for the night coverage of our patients, and the handoff process between the night NP/PA and daytime provider was studied. The handoff between physicians for patients admitted overnight was not assessed. Another limitation is that the time spent in handoff is reported as a participant estimate. There was no objective measurement of time, and respondents may have been biased. An additional limitation of our study concerns the preintervention and postintervention surveys. Both surveys were anonymous, which makes discerning the absolute impact of the intervention difficult due to the lack of paired responses. Lastly, our institution has an ESL. This option may not be available in other hospital systems.
Several deficiencies in the handoff process were addressed by providing key clinical data verbally and in written format, enhancing the physical environment, and defining each team's handoff start time. Our process improvements are consistent with the handoff recommendations endorsed by the Society of Hospital Medicine.12 Subsequent direct observation, subjective reports, and survey results demonstrated improvement in the handoff process.
Future studies might measure the effectiveness of morning handoff by end‐shift interviews of the daytime clinicians. Similarly, a study of evening handoff could measure the efficiency and effectiveness of report given by day teams to night‐coverage colleagues. Furthermore, if the handoff report skill set can be more rigorously defined and measured, a hospitalist clinical competency for hospitalists and NP/PAs could be developed in this core process‐of‐care.12
Acknowledgements
The authors thank Lisa Boucher for preparation of this manuscript.
Transfer of responsibility for patients, or handoff,1 occurs frequently in hospitalist services, requiring excellent and timely communication to ensure patient safety. Communication failure is a major contributor to medical errors.2, 3 Recognizing such findings, a growing body of literature addresses handoff techniques for learners.47
Vidyarthi described the handoff process as traditionally informal, unstructured, and idiosyncratic,4 and many believe efforts to formalize and structure this process are important for patient safety.8 Standardized handoff forms have improved accuracy of information.9 Web‐based sign‐out systems reportedly reduced the number of patients missed on rounds.10
Hospitalists also face challenges with effective communication during service change.11 The Society of Hospital Medicine identified the handoff skill as a core competency for hospitalists, and recommendations based on a systematic review of the literature were published.12 Inpatient medicine programs are increasingly using midlevel providers such as nurse practitioners (NPs) and physician assistants (PAs) along with hospitalists to accommodate workload while maintaining the scholarly enterprise in academic centers.13 To our knowledge there is no literature examining the hospitalist service handoffs involving NP/PAs.
We wished to study the effectiveness and timeliness of the morning handoff from the night coverage providers to the daytime teams consisting of one hospitalist and one NP/PA. Our objectives were to identify deficiencies and to evaluate the effectiveness of a restructured handoff process.
Methods
The Mayo Clinic Institutional Review Board reviewed and approved this study.
Setting
At the time of this study, the Division of Hospital Internal Medicine (HIM) at our institution consisted of 22 hospitalists, 11 NPs and 9 PAs (hereinafter NP/PAs), and 2 clinical assistants (CAs). The CAs assist with clerical duties not covered by Unit Secretaries:
-
Obtaining outside records
-
Clarifying referring physician contact information
-
Scheduling follow‐up outpatient appointments for tests, procedures, and visits
-
Attendance at morning handoff
Each CA can assist 3 or 4 daytime service teams.
Daytime Service Organization
Six HIM services, each managing up to 12 patients, are staffed by a partnership of 1 hospitalist and 1 NP/PA: Four services are primary general medicine services, and 2 consulting (orthopedic comanagement) services.
Night Coverage
Three of 4 primary daytime services and one consult service team transfer care to the (in‐house) night NP/PA. The night NP/PA addresses any acute‐care issues and reports at morning handoff to the 3 primary services and 1 consult service. In a designated conference room the morning handoff occurs, with at least 1 (day team) service representative present. This is usually the NP/PA, as the day team hospitalist concurrently receives a report on new admissions from the (in‐house) night hospitalist (who also covers one service and backs up the night NP/PA).
Improvement Process
An improvement team was formed within the Division of HIM consisting of 3 hospitalists, 3 NP/PAs, and 2 CAs to assess the existing handoff process at 7:45am between the Night NP/PA and daytime services. The improvement team met, reviewed evidence‐based literature on handoffs and discussed our local process. Four problems were identified by consensus:
-
Unpredictable start and finish times
-
Inefficiency (time wasted)
-
Poor environment (room noisy and distracting conversations)
-
Poor communication (overwrought and meandering narratives).
Intervention
The improvement team structured a new handoff process to address these deficiencies.
-
Environment: Moved to a smaller room (lower ceiling, less ambient noise).
-
Identification: table cards designating seats for participants (reduced queries regarding what service are you, today?).
-
Start Times: Each service team assigned a consistent start time (labeled on the table card) within a 15‐minute period, and although earlier reportage could occur, any service team present at their designated time has priority for the attention of the night NP/PA, and the opportunity to ask questions.
-
Quiet and Focus: HIM members were reminded to remain quiet in the handoff room, so the service receiving report has the floor and personal conversations must not impede the principals.
-
Visual Cue: Green Good to go sign placed on team table cards when no verbal was required.
-
Written e‐Material: The improvement team required elements of a brief written report in a specified column of our existing electronic service list (ESL). The ESL is a custom designed template importing laboratory, medication, and demographic data automatically but also capable of free text additions (Figure 1). All providers were instructed to update the ESL every 12 hours.
-
Admission and Progress Notes: After manual electronic medical record search, the CAs printed any notes generated in the preceding 12 hours and placed them by the team table card.
The improvement team provided education for the new process at a division meeting and through e‐mail. The recommended report sequence was night NP/PA reporting and day service teams asking questions and seeking clarifications. We discouraged editorial comments and chit‐chat.
A member of the improvement team monitored the new handoff process for 15 days, and 3 months later for 10 days.
Survey
An anonymous survey (Figure 2) concerning staff satisfaction with handoff was conducted immediately before and 15 days after the intervention. In the e‐mail containing the postintervention survey, providers were asked to respond only if they had been on service the preceding 15 days (and thus eligible to participate in handoff). To help insure this, the first question read, Have you been on service during the past 15 days?
Statistics
To compare the relationship of preintervention and postintervention survey responses, Fisher's exact test was used to compare categorical variables and 2 sample t‐test and Wilcoxon rank sum test were used for continuous variables. Comparisons that adjusted for the possibility of someone responding to both the preintervention and postintervention surveys were not performed since the surveys were anonymous. A P value 0.05 was considered statistically significant. For the item concerning the percentage of days morning report was attended while on service, based on a common standard deviation estimate of 35.3, we had 80% power to detect a difference of 29.1 (pre vs. post). This computation assumes a 2‐sample t‐test of = 0.05 with sample sizes of 36 and 18. We have 59% power to detect a difference of 27% (67% pre vs. 94% post) for those who at least agree that helpful information was conveyed during handoff. This computation is based on a 2‐sided Pearson 2 test with = 0.05.
Qualitative data analysis of respondents' answers to the open‐ended survey questions What would increase the likelihood of your attending handoff? and What feedback do you have regarding the changes to handoff? was performed using the constant comparative method14 associated with grounded theory approaches to identify themes and categories.15 To establish interrater reliability, three investigators (MCB, DTK, LLK) independently identified coding categories for the data set, compared results, redefined coding categories as needed, and reanalyzed the data until 80% agreement was reached.
Results
Thirty‐six of the 44 providers (82%) answered the preintervention survey, including 18 of 22 hospitalists (82%), 17 of 20 NPs/PAs (85%), and 1 of 2 CAs (50%). During the intervention based on our staffing model, 21 providers had the opportunity to participate in handoff, and 18 (86%) answered the postintervention survey, including 5 of 6 hospitalists (83%), 9 of 14 NPs/PAs (64%), and 2 of 2 CAs (100%). All respondents to the postintervention survey reported being on service during the previous 15 days.
As summarized in Table 1, compared to 60.5% of survey participants (n = 38) who thought morning handoff was performed in a timely fashion preintervention, 100% (n = 15) felt it was performed in a timely fashion postintervention (P = 0.005). The average time spent in morning report before the intervention was 11 minutes, as compared to 5 minutes after the intervention (P 0.0028). Prior to the intervention, 6.5 minutes of the handoff were viewed to be wasteful, as compared to 0.5 minutes of the handoff in the postintervention survey (P 0.0001). Attendance and quality of information perceptions did not demonstrate statistically significant change.
| Survey Question | Preintervention | Postintervention | P |
|---|---|---|---|
| What proportion of days while on service did you attend morning report? (%) | 78 | 87 | 0.4119 |
| Helpful information was conveyed in morning report, n (%) | 0.112 | ||
| Strongly agree | 9 (25) | 9 (56) | |
| Agree | 15 (42) | 6 (38) | |
| Neutral | 8 (22) | 1 (6) | |
| Disagree | 4 (11) | 0 | |
| Strongly disagree | 0 | 0 | |
| Morning report was performed in a timely manner, #yes/#no | 23/15 | 15/0 | 0.005 |
| Estimate the number of minutes each day you would spend in morning report (minute) | 11 | 5 | 0.0028 |
| Estimate the number of minutes in morning report you thought were wasteful (minute) | 6.5 | 0.5 | 0.0001 |
During the 15‐day observation period, morning handoff started by 0745 on 14 of 15 (93%) of days and finished by 0800 on 15 of 15 (100%) of days. Table cards, ESL, and progress notes were on the table by 0745 on 15 of 15 (100%) of days following the intervention. Three months after the intervention, the following were observed: morning handoff started by 0745 on 10 of 10 (100%) of days; finished by 0800 on 10 of 10 (100%) of days; and table cards, ESL, and progress notes were on the table by 0745 on 10 of 10 (100%) of days.
Qualitative Data Analysis
Three themes were identified in both preintervention and postintervention surveys: timeliness, quality of report and environment (Table 2). In the preintervention survey, timeliness complaints involved inconsistent start time, prolonged duration of handoff, and inefficiency due to time wasted while teams waited for their handoff report. Comments about report quality mentioned the nonstandardized report process that included nonpertinent information and editorializing. Environmental concerns addressed noise from multiple service team members assembled in 1 large room and chatting while awaiting report. In the postintervention survey, respondents' comments noted improved efficiency, environment, and report quality.
| Deficiency | Pre‐Intervention | Post‐Intervention |
|---|---|---|
| Timeliness | Efficiency needed | I found the changes lead to more concise and valuable time spent in report |
| Timely, scheduled and efficient reports would help increase my attendance | I personally enjoyed having the times set so you are held accountable for a certain handoff | |
| Set report times so I don't have to listen to everyone else's report | More organized and efficient | |
| Too much time wasted | Love the good to go card! Can start on rounds | |
| Environment | Not having to listen to chit chat unrelated to patient carewould improve my attendance | There is less chit chat |
| Services should receive report in a quieter room | Seems less chaotic with less people overall in the room so less distraction | |
| Need a quieter and smaller room | Because the room is quieter, I did not have to repeat information | |
| Too noisy | Quiet and respectful | |
| Quality | I would like a more organized format More information isn't needed, just the correct information in a timely manner | I felt that the amount of information shared was only what was pertinent and important |
| If I first had the opportunity to review ESL and any notes generated in the last 12 hours, this would improve report | Written information on the ESL assured that I didn't forget something important | |
| Less editorializing about events and less adrenaline | I liked having the progress notes generated overnight available for review | |
| Need only meaningful information | Excellent report with prompt dissemination of information |
Discussion
We describe an intervention that set the expectation for formal, structured written and verbal communication in a focused environment involving outgoing and incoming clinicians, resulting in improved satisfaction. Before the intervention, the improvement team identified by consensus 4 problems: unpredictable start time, inefficiency, environment, and report quality. Formal structuring of our handoff process resulted in statistically significant improvement in handoff timeliness and efficiency in the view of the HIM division members. Process improvement included precise team specific start times within a 12‐minute window to improve reliability and predictability and eliminating nonproductive waiting. Additionally, receiving teams were clearly identified with table cards so that no time was wasted locating the appropriate service for report, and minimizing role‐identification challenges. The good to go sign signaled teams that no events had occurred overnight requiring verbal report. Handoff timeliness persisted 3 months after the intervention, suggesting that the process is easily sustainable.
Postintervention survey comments noted the improved environment: a smaller, quieter room with the door closed. Before the intervention, all day team providers, CAs and night provider met in a large, loud room where multiple conversations were commonplace. Previous study of the handoff process supports creating an environment free of distraction.4
Postintervention survey responses to the open‐ended questions suggested improved provider satisfaction with the quality of the report. We believe this occurred for several reasons. First, having a precise start time for each team within a 12‐minute window led to a more focused report. Second, the ESL provided a column for providers to suggest plans of care for anticipated overnight events to improve preparedness and avoid significant omissions. Third, hospital notes generated overnight were made available which allowed daytime providers to review events before handoff, for a more informed update, or just after verbal report to reinforce the information just received, a technique used in other high‐reliability organizations.16 This measure also provided an at‐a‐glance view of each patient, decreasing the complexity of handoff.17
This study has important limitations. We address the handoff process of 1 hospitalist group at a single academic center. NP/PAs are the clinicians with first‐call responsibility for the night coverage of our patients, and the handoff process between the night NP/PA and daytime provider was studied. The handoff between physicians for patients admitted overnight was not assessed. Another limitation is that the time spent in handoff is reported as a participant estimate. There was no objective measurement of time, and respondents may have been biased. An additional limitation of our study concerns the preintervention and postintervention surveys. Both surveys were anonymous, which makes discerning the absolute impact of the intervention difficult due to the lack of paired responses. Lastly, our institution has an ESL. This option may not be available in other hospital systems.
Several deficiencies in the handoff process were addressed by providing key clinical data verbally and in written format, enhancing the physical environment, and defining each team's handoff start time. Our process improvements are consistent with the handoff recommendations endorsed by the Society of Hospital Medicine.12 Subsequent direct observation, subjective reports, and survey results demonstrated improvement in the handoff process.
Future studies might measure the effectiveness of morning handoff by end‐shift interviews of the daytime clinicians. Similarly, a study of evening handoff could measure the efficiency and effectiveness of report given by day teams to night‐coverage colleagues. Furthermore, if the handoff report skill set can be more rigorously defined and measured, a hospitalist clinical competency for hospitalists and NP/PAs could be developed in this core process‐of‐care.12
Acknowledgements
The authors thank Lisa Boucher for preparation of this manuscript.
- , , , et al.Lost in translation: challenges and opportunities in physician‐to‐physician communication during patient handoffs.Acad Med.2005;80:1094–1099.
- , , .Communication failures: an insidious contributor to medical mishaps.Acad Med.2004;79:186–194.
- , , .The human factor: the critical importance of effective teamwork and communication in providing safe care.Quality 13 Suppl 1:i85–90.
- , , , et al.Managing discontinuity in academic medical centers: strategies for a safe and effective resident sign‐out.J Hosp Med.2006;1:257–266.
- , , .Development and implementation of an oral sign‐out skills curriculum.J Gen Intern Med.2007;22:1470–1474.
- , , , et al.The top 10 list for a safe and effective sign‐out.Arch Surg2008;143(10):1008–1010.
- , , , et al.Residents' and attending physicians' handoffs: a systematic review of the literature.Acad Med.2009;84(12):1775–1787.
- , , , et al.A structured handoff program for interns.Acad Med.2009;84:347–352.
- , , , et al.Simple standardized patient handoff system that increases accuracy and completeness.J Surg.2008;65:476–485.
- , , , et al.A randomized, controlled trial evaluation the impact of a computerized rounding and sign‐out system on continuity of care and resident work hours.J Am Coll Surg.2005;200:538–545.
- , , , .Understanding communication during hospitalist service changes: A mixed methods study.J Hosp Med.2009;4(9):535–540.
- , , , , , .Hospitalist handoffs: a systematic review and task force recommendations.J of Hosp Med.2009;4(7):433–440.
- , , , et al.Implementation of a physician assistant/hospitalist service in an academic medical center: impact on efficiency and patient outcomes.J Hosp Med.2008;3:361–368.
- , .Basics of Qualitiative Research: Grounded Theory Procedures and Techniques.Sage Publications, Inc.Newbury Park, CA.1990.
- , .Naturalistic Inquiry.Sage Publications, Inc.Newbury Park, CA.1985.
- .Communication strategies from high‐reliability organizations.Ann Surg.2007;245(2):170–172.
- , , , et al.Handoff strategies in settings with high consequences for failure: lessons for health care operations.Int J Qual Health Care.2004;16(2):125.
- , , , et al.Lost in translation: challenges and opportunities in physician‐to‐physician communication during patient handoffs.Acad Med.2005;80:1094–1099.
- , , .Communication failures: an insidious contributor to medical mishaps.Acad Med.2004;79:186–194.
- , , .The human factor: the critical importance of effective teamwork and communication in providing safe care.Quality 13 Suppl 1:i85–90.
- , , , et al.Managing discontinuity in academic medical centers: strategies for a safe and effective resident sign‐out.J Hosp Med.2006;1:257–266.
- , , .Development and implementation of an oral sign‐out skills curriculum.J Gen Intern Med.2007;22:1470–1474.
- , , , et al.The top 10 list for a safe and effective sign‐out.Arch Surg2008;143(10):1008–1010.
- , , , et al.Residents' and attending physicians' handoffs: a systematic review of the literature.Acad Med.2009;84(12):1775–1787.
- , , , et al.A structured handoff program for interns.Acad Med.2009;84:347–352.
- , , , et al.Simple standardized patient handoff system that increases accuracy and completeness.J Surg.2008;65:476–485.
- , , , et al.A randomized, controlled trial evaluation the impact of a computerized rounding and sign‐out system on continuity of care and resident work hours.J Am Coll Surg.2005;200:538–545.
- , , , .Understanding communication during hospitalist service changes: A mixed methods study.J Hosp Med.2009;4(9):535–540.
- , , , , , .Hospitalist handoffs: a systematic review and task force recommendations.J of Hosp Med.2009;4(7):433–440.
- , , , et al.Implementation of a physician assistant/hospitalist service in an academic medical center: impact on efficiency and patient outcomes.J Hosp Med.2008;3:361–368.
- , .Basics of Qualitiative Research: Grounded Theory Procedures and Techniques.Sage Publications, Inc.Newbury Park, CA.1990.
- , .Naturalistic Inquiry.Sage Publications, Inc.Newbury Park, CA.1985.
- .Communication strategies from high‐reliability organizations.Ann Surg.2007;245(2):170–172.
- , , , et al.Handoff strategies in settings with high consequences for failure: lessons for health care operations.Int J Qual Health Care.2004;16(2):125.
Hospitalist‐Run Observation Unit
Hospitalists play key roles in many types of clinical services, including teaching, nonteaching, consultative, and comanagement services.14 While the impact of hospitalist programs on LOS for inpatient medicine services has been studied,58 less work has focused on the impact of hospitalists in other types of service delivery, such as in short‐stay or observation units.
While many hospitals now have short‐stay units to care for observation patients, most are adjuncts of the emergency department. A Canadian hospitalist‐run short‐stay unit that targeted patients with an expected LOS of less than 3 days has been described.9 The experience of a single, chest‐painspecific service has also been reported.10
In August 2005, we introduced a hospitalist‐run observation unit, the Clinical Decision Unit (CDU), at University Hospital, the primary teaching affiliate of the University of Texas Health Science Center at San Antonio (San Antonio, TX). The rationale was that observation‐level care in a dedicated short‐stay unit would be more efficient than in an inpatient general medicine service. Through the creation of this unit, we consolidated the care of all medical observation patients, including patients previously evaluated in a cardiology‐run chest pain unit.
In this brief report, we present a description of the unit as well as a preliminary analysis of the impact of the unit on LOS for the most common CDU diagnoses.
Methods
CDU Structure
University Hospital is the Bexar County public hospital. It contains 604 acute care beds, and averages 70,000 emergency visits annually. The CDU is a geographically separate, 10‐bed unit, staffed with dedicated nurses in 8‐hour shifts and 24/7 by hospitalists in 12‐hour shifts. Four to five hospitalists rotate through the CDU monthly. About 30% of shifts are staffed through moonlighting by hospitalist faculty or fellows.
For admissions, through examining hospital LOS data, we targeted diagnoses for which patients might be expected to stay less than 24 hours. Potentially appropriate diagnoses were discussed by the group, and general admission guidelines were created based on consensus. These diagnoses included chest pain, cellulitis, pyelonephritis, syncope, asthma exacerbation, chronic obstructive pulmonary disease exacerbation, hyperglycemia, and hepatic encephalopathy. Table 1 lists these guidelines.
| Diagnosis | Guidelines |
|---|---|
| |
| Chest pain | Patients without EKG changes or positive troponins, but for whom stress test was indicated based on history or risk factors |
| Asthma | Patients with oxygen saturation >90% and demonstrating improvement in with ED nebulizer treatment |
| Syncope | Patients without known structural heart disease based on past medical history or exam findings |
| Cellulitis | Patients without suspicion for abscess or osteomyelitis |
| Pyelonephritis | Patients without change from baseline renal function; kidney transplant recipients excluded |
If a patient's stay exceeded 23 hours, the hospitalist could transfer the patient from the CDU to a general medicine team. Formal transfer guidelines were not created, but if patients were expected to be discharged within 12 hours, they generally remained in the CDU to minimize transitions. The census of the general medicine teams could also be a factor in transfer decisions: if they were at admitting capacity, the patient remained in the CDU.
Patients admitted to the general medicine units were cared for by 5 teaching teams, staffed exclusively by hospitalists.
Assessment of CDU Implementation on LOS
To examine the impact of unit implementation on LOS, we performed a retrospective, preimplementation/postimplementation comparison of the LOS of patients discharged 12 months before and after the unit opening on August 1, 2005. To ensure a comparison of similar patients, we identified the top 5 most common CDU discharge diagnoses, and identified people discharged from general medicine with the same diagnoses. Specifically, we compared the LOS of patients discharged from the general medicine units from August 1, 2004 to July 31, 2005, vs. those with the same diagnoses discharged from either the CDU or general medicine units from August 1, 2005 to July 31, 2006.
The 5 most common CDU discharge diagnoses were identified using hospital administrative discharge data. All International Statistical Classification of Diseases and Related Health Problems, 9th edition (ICD‐9) codes associated with CDU discharges were identified and listed in order of frequency. Related ICD‐9 codes were grouped. For example, angina (413.0) and chest pain (786.50, 786.59) were considered related, and were included as chest pain. These ICD‐9 codes were then used to identify patients discharged with these diagnoses in the pre‐CDU and post‐CDU periods. Patients on general medicine units were identified using admission location and admitting attending. Only patients admitted by a hospitalist to a general medicine floor were included. Patients were analyzed according to their admission location. All patients with relevant ICD‐9 codes were included in the analysis. None were excluded. For each patient identified, all data elements were present.
The acuity of patients admitted in the preimplementation and postimplementation periods was compared using the case‐mix index calculated by 3M Incorporated's All Patient RefinedDiagnosis‐Related Group methodology (3M APR‐DRG; 3M, St. Paul, MN). This adjusts administrative data for severity of illness and mortality risk based on primary diagnoses, comorbidities, age, and procedures. Patients are assigned to mortality classes with corresponding scores of 0 or higher.
Statistical Analysis
Statistical analyses were performed using STATA 8.0. LOS and acuity differences were assessed using 2‐sample t tests with equal variances.
Results
Clinical Experience with the CDU
The 5 most common CDU discharge diagnoses accounted for 724 discharges, and included chest pain, asthma, syncope, cellulitis, and pyelonephritis. The ICD‐9 codes, as well as the numbers of patients discharged from the general medicine units and CDU with each diagnosis are listed in Table 2. The average daily census in the unit was 7.2 patients with a standard deviation of 0.8. Overall, 22% of CDU admissions were changed from observation to admission status.
| Diagnosis | ICD‐9 Codes | Pre‐CDU | Post‐CDU | Post‐CDU Admitted to CDU | Post‐CDU Admitted to Ward Team |
|---|---|---|---|---|---|
| |||||
| Top 5 diagnoses | 2240 | 2148 | 724 | 1424 | |
| Cellulitis | 681.0, 682.0‐682.9 | 1002 | 819 | 48 | 771 |
| Asthma | 493.02, 493.12 | 199 | 176 | 71 | 105 |
| Chest pain | 786.50, 786.59, 413.0 | 837 | 917 | 520 | 397 |
| Pyelonephritis | 590.1, 590.8 | 143 | 163 | 61 | 102 |
| Syncope | 780.2 | 59 | 73 | 24 | 49 |
Impact of CDU Implementation on LOS
The overall LOS for patients with the 5 most common diagnoses decreased from 2.4 to 2.2 days (P = 0.05) between the 12‐month preimplementation and postimplementation periods. A significant decrease was seen for patients with cellulitis (2.4‐1.9 days; P 0.001) and asthma (2.2‐1.2 days; P 0.001). Differences in LOS for patients with chest pain, pyelonephritis, and syncope were not statistically significant. These results are summarized in Table 3. The acuity of patients admitted in the pre‐CDU and post‐CDU implementation, shown in Table 4, was not significantly different.
| Diagnosis | Pre‐CDU | Post‐CDU | P Value |
|---|---|---|---|
| |||
| Top 5 diagnoses | 2.4 (3.8) | 2.2 (2.8) | 0.05 |
| Cellulitis | 2.4 (3.2) | 1.9 (2.6) | 0.001 |
| Asthma | 2.2 (1.9) | 1.2 (0.7) | 0.001 |
| Chest pain | 1.5 (1.3) | 1.6 (2.4) | 0.75 |
| Pyelonephritis | 3.3 (4.9) | 2.7 (2.8) | 0.27 |
| Syncope | 2.0 (2.9) | 2.2 (2.0) | 0.68 |
| Diagnosis | All Patients2005 | All Patients2006 |
|---|---|---|
| ||
| Top 5 diagnoses | 0.6987 | 0.7240 |
| Cellulitis | 0.7393 | 0.7630 |
| Asthma | 0.4382 | 0.4622 |
| Chest pain | 0.7428 | 0.7545 |
| Pyelonephritis | 0.7205 | 0.6662 |
| Syncope | 0.6769 | 0.6619 |
Discussion and Conclusions
Implementation of a hospitalist‐run observation unit was associated with an overall decreased LOS for patients with the 5 most common CDU discharge diagnoses of chest pain, cellulitis, asthma, pyelonephritis, and syncope. The lack of statistically significantly differences in patient acuity in the preimplementation and postimplementation periods suggests this result is not due to acuity differences, but rather to unit implementation. We believe this reduction resulted from the greater efficiencies of care that occur from clustering observation patients in a geographically separate unit with dedicated nursing staff and efficient workflow. The reduction of 0.2 days over 2148 patients (total number of postimplementation discharges) led to an additional 429.6 days of capacity without adding additional beds. Thus, what might appear to be a modest LOS reduction has a larger impact when patient volume is considered.
For individual diagnoses, significant differences in LOS were seen for patients with cellulitis and asthma The lack of a difference for chest pain may be related to the fact that these patients were cared for in a chest pain unit prior to CDU creation, which likely fostered similar efficiencies. This finding may suggest that hospitalists are as efficient as cardiologists in assessing patients with chest pain. The lack of a difference in LOS for syncope may have reflected a bottleneck in obtaining echocardiogram tests. Finally, the lack of a difference for pyelonephritis may indicate that it is not a diagnosis for which observation is beneficial.
While our use of administrative data over the year‐long preimplementation and postimplementation periods allows for the inclusion of a large number of discharges, the retrospective study design limits the strength of our results. A prospective study would more definitively reduce the possibility of bias and ensure the validity of our finding of reduced LOS.
The creation of a hospitalist‐run observation unit may represent an alternative to emergency departmentrun units. It allows physicians with greater expertise in inpatient medicine to make admission and discharge decisions, allowing emergency department physicians to concentrate on the care of other patients. This can be particularly critical for high‐volume emergency departments. The CDU also offers an alternative to specialist‐run chest pain units. Because patients either stay for only the observation period or are admitted and typically moved off the unit, there is little need for provider continuity, and the discontinuous shift staffing model works well.
In addition to the geographic localization, several aspects of the CDU model may be critical to the successful implementation of similar hospitalist‐run observation units. Dedicated nursing staff with expertise in caring for high‐turnover patients with a more limited spectrum of diagnoses may be a factor. Another factor may be that the lack of less‐experienced trainees in a nonteaching service leads to more efficient care.
A potential area of further exploration includes understanding the differences between CDU patients who are discharged within 23 hours and those who are later admitted. This understanding may help us better differentiate patients appropriate for CDU admission, allowing the creation of more formal admission criteria.
Acknowledgements
The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs.
- ,.The role of hospitalists in medical education.Am J Med.1999;107(4):305–309.
- ,,,,.Reorganizing an academic medical service: impact on cost, quality, patient satisfaction, and education.JAMA.1998;279:1560–1565.
- ,,, et al.,Hospitalist‐Orthopedic Team Trial Investigators. Medical and surgical comanagement after elective hip and knee arthroplasty: a randomized, controlled trial.Ann Intern Med.2004;141(1):28–38.
- ,,,,,.Implementation of a voluntary hospitalist service at a community teaching hospital: improved efficiency and patient outcomes.Ann Intern Med.2002;137:859–865.
- ,,,,,.Outcomes of care by hospitalists, general internists, and family physicians.N Engl J Med.2007;357(25):2589–2600.
- ,,,,.Hospitalist care and length of stay in patients requiring complex discharge planning and close clinical monitoring.Arch Intern Med.2007;167(17):1869–1874.
- ,,.Comparison of hospital costs and length of stay for community internists, hospitalists, and academicians.J Gen Int Med.2007;22(5):662–667.
- ,,, et al.Effects of physician experience on cost and outcomes on an academic general medicine service: results of a trial of hospitalists.Ann Intern Med.2002;37:866–875.
- ,,,.Program description: a hospitalist‐run, medical short‐stay unit in a teaching hospital.CMAJ.2000;163(11):1477–1480.
- ,,,,.Improving resource utilization in a teaching hospital: development of a nonteaching service for chest pain admissions.Acad Med.2006;81(5):432–435.
Hospitalists play key roles in many types of clinical services, including teaching, nonteaching, consultative, and comanagement services.14 While the impact of hospitalist programs on LOS for inpatient medicine services has been studied,58 less work has focused on the impact of hospitalists in other types of service delivery, such as in short‐stay or observation units.
While many hospitals now have short‐stay units to care for observation patients, most are adjuncts of the emergency department. A Canadian hospitalist‐run short‐stay unit that targeted patients with an expected LOS of less than 3 days has been described.9 The experience of a single, chest‐painspecific service has also been reported.10
In August 2005, we introduced a hospitalist‐run observation unit, the Clinical Decision Unit (CDU), at University Hospital, the primary teaching affiliate of the University of Texas Health Science Center at San Antonio (San Antonio, TX). The rationale was that observation‐level care in a dedicated short‐stay unit would be more efficient than in an inpatient general medicine service. Through the creation of this unit, we consolidated the care of all medical observation patients, including patients previously evaluated in a cardiology‐run chest pain unit.
In this brief report, we present a description of the unit as well as a preliminary analysis of the impact of the unit on LOS for the most common CDU diagnoses.
Methods
CDU Structure
University Hospital is the Bexar County public hospital. It contains 604 acute care beds, and averages 70,000 emergency visits annually. The CDU is a geographically separate, 10‐bed unit, staffed with dedicated nurses in 8‐hour shifts and 24/7 by hospitalists in 12‐hour shifts. Four to five hospitalists rotate through the CDU monthly. About 30% of shifts are staffed through moonlighting by hospitalist faculty or fellows.
For admissions, through examining hospital LOS data, we targeted diagnoses for which patients might be expected to stay less than 24 hours. Potentially appropriate diagnoses were discussed by the group, and general admission guidelines were created based on consensus. These diagnoses included chest pain, cellulitis, pyelonephritis, syncope, asthma exacerbation, chronic obstructive pulmonary disease exacerbation, hyperglycemia, and hepatic encephalopathy. Table 1 lists these guidelines.
| Diagnosis | Guidelines |
|---|---|
| |
| Chest pain | Patients without EKG changes or positive troponins, but for whom stress test was indicated based on history or risk factors |
| Asthma | Patients with oxygen saturation >90% and demonstrating improvement in with ED nebulizer treatment |
| Syncope | Patients without known structural heart disease based on past medical history or exam findings |
| Cellulitis | Patients without suspicion for abscess or osteomyelitis |
| Pyelonephritis | Patients without change from baseline renal function; kidney transplant recipients excluded |
If a patient's stay exceeded 23 hours, the hospitalist could transfer the patient from the CDU to a general medicine team. Formal transfer guidelines were not created, but if patients were expected to be discharged within 12 hours, they generally remained in the CDU to minimize transitions. The census of the general medicine teams could also be a factor in transfer decisions: if they were at admitting capacity, the patient remained in the CDU.
Patients admitted to the general medicine units were cared for by 5 teaching teams, staffed exclusively by hospitalists.
Assessment of CDU Implementation on LOS
To examine the impact of unit implementation on LOS, we performed a retrospective, preimplementation/postimplementation comparison of the LOS of patients discharged 12 months before and after the unit opening on August 1, 2005. To ensure a comparison of similar patients, we identified the top 5 most common CDU discharge diagnoses, and identified people discharged from general medicine with the same diagnoses. Specifically, we compared the LOS of patients discharged from the general medicine units from August 1, 2004 to July 31, 2005, vs. those with the same diagnoses discharged from either the CDU or general medicine units from August 1, 2005 to July 31, 2006.
The 5 most common CDU discharge diagnoses were identified using hospital administrative discharge data. All International Statistical Classification of Diseases and Related Health Problems, 9th edition (ICD‐9) codes associated with CDU discharges were identified and listed in order of frequency. Related ICD‐9 codes were grouped. For example, angina (413.0) and chest pain (786.50, 786.59) were considered related, and were included as chest pain. These ICD‐9 codes were then used to identify patients discharged with these diagnoses in the pre‐CDU and post‐CDU periods. Patients on general medicine units were identified using admission location and admitting attending. Only patients admitted by a hospitalist to a general medicine floor were included. Patients were analyzed according to their admission location. All patients with relevant ICD‐9 codes were included in the analysis. None were excluded. For each patient identified, all data elements were present.
The acuity of patients admitted in the preimplementation and postimplementation periods was compared using the case‐mix index calculated by 3M Incorporated's All Patient RefinedDiagnosis‐Related Group methodology (3M APR‐DRG; 3M, St. Paul, MN). This adjusts administrative data for severity of illness and mortality risk based on primary diagnoses, comorbidities, age, and procedures. Patients are assigned to mortality classes with corresponding scores of 0 or higher.
Statistical Analysis
Statistical analyses were performed using STATA 8.0. LOS and acuity differences were assessed using 2‐sample t tests with equal variances.
Results
Clinical Experience with the CDU
The 5 most common CDU discharge diagnoses accounted for 724 discharges, and included chest pain, asthma, syncope, cellulitis, and pyelonephritis. The ICD‐9 codes, as well as the numbers of patients discharged from the general medicine units and CDU with each diagnosis are listed in Table 2. The average daily census in the unit was 7.2 patients with a standard deviation of 0.8. Overall, 22% of CDU admissions were changed from observation to admission status.
| Diagnosis | ICD‐9 Codes | Pre‐CDU | Post‐CDU | Post‐CDU Admitted to CDU | Post‐CDU Admitted to Ward Team |
|---|---|---|---|---|---|
| |||||
| Top 5 diagnoses | 2240 | 2148 | 724 | 1424 | |
| Cellulitis | 681.0, 682.0‐682.9 | 1002 | 819 | 48 | 771 |
| Asthma | 493.02, 493.12 | 199 | 176 | 71 | 105 |
| Chest pain | 786.50, 786.59, 413.0 | 837 | 917 | 520 | 397 |
| Pyelonephritis | 590.1, 590.8 | 143 | 163 | 61 | 102 |
| Syncope | 780.2 | 59 | 73 | 24 | 49 |
Impact of CDU Implementation on LOS
The overall LOS for patients with the 5 most common diagnoses decreased from 2.4 to 2.2 days (P = 0.05) between the 12‐month preimplementation and postimplementation periods. A significant decrease was seen for patients with cellulitis (2.4‐1.9 days; P 0.001) and asthma (2.2‐1.2 days; P 0.001). Differences in LOS for patients with chest pain, pyelonephritis, and syncope were not statistically significant. These results are summarized in Table 3. The acuity of patients admitted in the pre‐CDU and post‐CDU implementation, shown in Table 4, was not significantly different.
| Diagnosis | Pre‐CDU | Post‐CDU | P Value |
|---|---|---|---|
| |||
| Top 5 diagnoses | 2.4 (3.8) | 2.2 (2.8) | 0.05 |
| Cellulitis | 2.4 (3.2) | 1.9 (2.6) | 0.001 |
| Asthma | 2.2 (1.9) | 1.2 (0.7) | 0.001 |
| Chest pain | 1.5 (1.3) | 1.6 (2.4) | 0.75 |
| Pyelonephritis | 3.3 (4.9) | 2.7 (2.8) | 0.27 |
| Syncope | 2.0 (2.9) | 2.2 (2.0) | 0.68 |
| Diagnosis | All Patients2005 | All Patients2006 |
|---|---|---|
| ||
| Top 5 diagnoses | 0.6987 | 0.7240 |
| Cellulitis | 0.7393 | 0.7630 |
| Asthma | 0.4382 | 0.4622 |
| Chest pain | 0.7428 | 0.7545 |
| Pyelonephritis | 0.7205 | 0.6662 |
| Syncope | 0.6769 | 0.6619 |
Discussion and Conclusions
Implementation of a hospitalist‐run observation unit was associated with an overall decreased LOS for patients with the 5 most common CDU discharge diagnoses of chest pain, cellulitis, asthma, pyelonephritis, and syncope. The lack of statistically significantly differences in patient acuity in the preimplementation and postimplementation periods suggests this result is not due to acuity differences, but rather to unit implementation. We believe this reduction resulted from the greater efficiencies of care that occur from clustering observation patients in a geographically separate unit with dedicated nursing staff and efficient workflow. The reduction of 0.2 days over 2148 patients (total number of postimplementation discharges) led to an additional 429.6 days of capacity without adding additional beds. Thus, what might appear to be a modest LOS reduction has a larger impact when patient volume is considered.
For individual diagnoses, significant differences in LOS were seen for patients with cellulitis and asthma The lack of a difference for chest pain may be related to the fact that these patients were cared for in a chest pain unit prior to CDU creation, which likely fostered similar efficiencies. This finding may suggest that hospitalists are as efficient as cardiologists in assessing patients with chest pain. The lack of a difference in LOS for syncope may have reflected a bottleneck in obtaining echocardiogram tests. Finally, the lack of a difference for pyelonephritis may indicate that it is not a diagnosis for which observation is beneficial.
While our use of administrative data over the year‐long preimplementation and postimplementation periods allows for the inclusion of a large number of discharges, the retrospective study design limits the strength of our results. A prospective study would more definitively reduce the possibility of bias and ensure the validity of our finding of reduced LOS.
The creation of a hospitalist‐run observation unit may represent an alternative to emergency departmentrun units. It allows physicians with greater expertise in inpatient medicine to make admission and discharge decisions, allowing emergency department physicians to concentrate on the care of other patients. This can be particularly critical for high‐volume emergency departments. The CDU also offers an alternative to specialist‐run chest pain units. Because patients either stay for only the observation period or are admitted and typically moved off the unit, there is little need for provider continuity, and the discontinuous shift staffing model works well.
In addition to the geographic localization, several aspects of the CDU model may be critical to the successful implementation of similar hospitalist‐run observation units. Dedicated nursing staff with expertise in caring for high‐turnover patients with a more limited spectrum of diagnoses may be a factor. Another factor may be that the lack of less‐experienced trainees in a nonteaching service leads to more efficient care.
A potential area of further exploration includes understanding the differences between CDU patients who are discharged within 23 hours and those who are later admitted. This understanding may help us better differentiate patients appropriate for CDU admission, allowing the creation of more formal admission criteria.
Acknowledgements
The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs.
Hospitalists play key roles in many types of clinical services, including teaching, nonteaching, consultative, and comanagement services.14 While the impact of hospitalist programs on LOS for inpatient medicine services has been studied,58 less work has focused on the impact of hospitalists in other types of service delivery, such as in short‐stay or observation units.
While many hospitals now have short‐stay units to care for observation patients, most are adjuncts of the emergency department. A Canadian hospitalist‐run short‐stay unit that targeted patients with an expected LOS of less than 3 days has been described.9 The experience of a single, chest‐painspecific service has also been reported.10
In August 2005, we introduced a hospitalist‐run observation unit, the Clinical Decision Unit (CDU), at University Hospital, the primary teaching affiliate of the University of Texas Health Science Center at San Antonio (San Antonio, TX). The rationale was that observation‐level care in a dedicated short‐stay unit would be more efficient than in an inpatient general medicine service. Through the creation of this unit, we consolidated the care of all medical observation patients, including patients previously evaluated in a cardiology‐run chest pain unit.
In this brief report, we present a description of the unit as well as a preliminary analysis of the impact of the unit on LOS for the most common CDU diagnoses.
Methods
CDU Structure
University Hospital is the Bexar County public hospital. It contains 604 acute care beds, and averages 70,000 emergency visits annually. The CDU is a geographically separate, 10‐bed unit, staffed with dedicated nurses in 8‐hour shifts and 24/7 by hospitalists in 12‐hour shifts. Four to five hospitalists rotate through the CDU monthly. About 30% of shifts are staffed through moonlighting by hospitalist faculty or fellows.
For admissions, through examining hospital LOS data, we targeted diagnoses for which patients might be expected to stay less than 24 hours. Potentially appropriate diagnoses were discussed by the group, and general admission guidelines were created based on consensus. These diagnoses included chest pain, cellulitis, pyelonephritis, syncope, asthma exacerbation, chronic obstructive pulmonary disease exacerbation, hyperglycemia, and hepatic encephalopathy. Table 1 lists these guidelines.
| Diagnosis | Guidelines |
|---|---|
| |
| Chest pain | Patients without EKG changes or positive troponins, but for whom stress test was indicated based on history or risk factors |
| Asthma | Patients with oxygen saturation >90% and demonstrating improvement in with ED nebulizer treatment |
| Syncope | Patients without known structural heart disease based on past medical history or exam findings |
| Cellulitis | Patients without suspicion for abscess or osteomyelitis |
| Pyelonephritis | Patients without change from baseline renal function; kidney transplant recipients excluded |
If a patient's stay exceeded 23 hours, the hospitalist could transfer the patient from the CDU to a general medicine team. Formal transfer guidelines were not created, but if patients were expected to be discharged within 12 hours, they generally remained in the CDU to minimize transitions. The census of the general medicine teams could also be a factor in transfer decisions: if they were at admitting capacity, the patient remained in the CDU.
Patients admitted to the general medicine units were cared for by 5 teaching teams, staffed exclusively by hospitalists.
Assessment of CDU Implementation on LOS
To examine the impact of unit implementation on LOS, we performed a retrospective, preimplementation/postimplementation comparison of the LOS of patients discharged 12 months before and after the unit opening on August 1, 2005. To ensure a comparison of similar patients, we identified the top 5 most common CDU discharge diagnoses, and identified people discharged from general medicine with the same diagnoses. Specifically, we compared the LOS of patients discharged from the general medicine units from August 1, 2004 to July 31, 2005, vs. those with the same diagnoses discharged from either the CDU or general medicine units from August 1, 2005 to July 31, 2006.
The 5 most common CDU discharge diagnoses were identified using hospital administrative discharge data. All International Statistical Classification of Diseases and Related Health Problems, 9th edition (ICD‐9) codes associated with CDU discharges were identified and listed in order of frequency. Related ICD‐9 codes were grouped. For example, angina (413.0) and chest pain (786.50, 786.59) were considered related, and were included as chest pain. These ICD‐9 codes were then used to identify patients discharged with these diagnoses in the pre‐CDU and post‐CDU periods. Patients on general medicine units were identified using admission location and admitting attending. Only patients admitted by a hospitalist to a general medicine floor were included. Patients were analyzed according to their admission location. All patients with relevant ICD‐9 codes were included in the analysis. None were excluded. For each patient identified, all data elements were present.
The acuity of patients admitted in the preimplementation and postimplementation periods was compared using the case‐mix index calculated by 3M Incorporated's All Patient RefinedDiagnosis‐Related Group methodology (3M APR‐DRG; 3M, St. Paul, MN). This adjusts administrative data for severity of illness and mortality risk based on primary diagnoses, comorbidities, age, and procedures. Patients are assigned to mortality classes with corresponding scores of 0 or higher.
Statistical Analysis
Statistical analyses were performed using STATA 8.0. LOS and acuity differences were assessed using 2‐sample t tests with equal variances.
Results
Clinical Experience with the CDU
The 5 most common CDU discharge diagnoses accounted for 724 discharges, and included chest pain, asthma, syncope, cellulitis, and pyelonephritis. The ICD‐9 codes, as well as the numbers of patients discharged from the general medicine units and CDU with each diagnosis are listed in Table 2. The average daily census in the unit was 7.2 patients with a standard deviation of 0.8. Overall, 22% of CDU admissions were changed from observation to admission status.
| Diagnosis | ICD‐9 Codes | Pre‐CDU | Post‐CDU | Post‐CDU Admitted to CDU | Post‐CDU Admitted to Ward Team |
|---|---|---|---|---|---|
| |||||
| Top 5 diagnoses | 2240 | 2148 | 724 | 1424 | |
| Cellulitis | 681.0, 682.0‐682.9 | 1002 | 819 | 48 | 771 |
| Asthma | 493.02, 493.12 | 199 | 176 | 71 | 105 |
| Chest pain | 786.50, 786.59, 413.0 | 837 | 917 | 520 | 397 |
| Pyelonephritis | 590.1, 590.8 | 143 | 163 | 61 | 102 |
| Syncope | 780.2 | 59 | 73 | 24 | 49 |
Impact of CDU Implementation on LOS
The overall LOS for patients with the 5 most common diagnoses decreased from 2.4 to 2.2 days (P = 0.05) between the 12‐month preimplementation and postimplementation periods. A significant decrease was seen for patients with cellulitis (2.4‐1.9 days; P 0.001) and asthma (2.2‐1.2 days; P 0.001). Differences in LOS for patients with chest pain, pyelonephritis, and syncope were not statistically significant. These results are summarized in Table 3. The acuity of patients admitted in the pre‐CDU and post‐CDU implementation, shown in Table 4, was not significantly different.
| Diagnosis | Pre‐CDU | Post‐CDU | P Value |
|---|---|---|---|
| |||
| Top 5 diagnoses | 2.4 (3.8) | 2.2 (2.8) | 0.05 |
| Cellulitis | 2.4 (3.2) | 1.9 (2.6) | 0.001 |
| Asthma | 2.2 (1.9) | 1.2 (0.7) | 0.001 |
| Chest pain | 1.5 (1.3) | 1.6 (2.4) | 0.75 |
| Pyelonephritis | 3.3 (4.9) | 2.7 (2.8) | 0.27 |
| Syncope | 2.0 (2.9) | 2.2 (2.0) | 0.68 |
| Diagnosis | All Patients2005 | All Patients2006 |
|---|---|---|
| ||
| Top 5 diagnoses | 0.6987 | 0.7240 |
| Cellulitis | 0.7393 | 0.7630 |
| Asthma | 0.4382 | 0.4622 |
| Chest pain | 0.7428 | 0.7545 |
| Pyelonephritis | 0.7205 | 0.6662 |
| Syncope | 0.6769 | 0.6619 |
Discussion and Conclusions
Implementation of a hospitalist‐run observation unit was associated with an overall decreased LOS for patients with the 5 most common CDU discharge diagnoses of chest pain, cellulitis, asthma, pyelonephritis, and syncope. The lack of statistically significantly differences in patient acuity in the preimplementation and postimplementation periods suggests this result is not due to acuity differences, but rather to unit implementation. We believe this reduction resulted from the greater efficiencies of care that occur from clustering observation patients in a geographically separate unit with dedicated nursing staff and efficient workflow. The reduction of 0.2 days over 2148 patients (total number of postimplementation discharges) led to an additional 429.6 days of capacity without adding additional beds. Thus, what might appear to be a modest LOS reduction has a larger impact when patient volume is considered.
For individual diagnoses, significant differences in LOS were seen for patients with cellulitis and asthma The lack of a difference for chest pain may be related to the fact that these patients were cared for in a chest pain unit prior to CDU creation, which likely fostered similar efficiencies. This finding may suggest that hospitalists are as efficient as cardiologists in assessing patients with chest pain. The lack of a difference in LOS for syncope may have reflected a bottleneck in obtaining echocardiogram tests. Finally, the lack of a difference for pyelonephritis may indicate that it is not a diagnosis for which observation is beneficial.
While our use of administrative data over the year‐long preimplementation and postimplementation periods allows for the inclusion of a large number of discharges, the retrospective study design limits the strength of our results. A prospective study would more definitively reduce the possibility of bias and ensure the validity of our finding of reduced LOS.
The creation of a hospitalist‐run observation unit may represent an alternative to emergency departmentrun units. It allows physicians with greater expertise in inpatient medicine to make admission and discharge decisions, allowing emergency department physicians to concentrate on the care of other patients. This can be particularly critical for high‐volume emergency departments. The CDU also offers an alternative to specialist‐run chest pain units. Because patients either stay for only the observation period or are admitted and typically moved off the unit, there is little need for provider continuity, and the discontinuous shift staffing model works well.
In addition to the geographic localization, several aspects of the CDU model may be critical to the successful implementation of similar hospitalist‐run observation units. Dedicated nursing staff with expertise in caring for high‐turnover patients with a more limited spectrum of diagnoses may be a factor. Another factor may be that the lack of less‐experienced trainees in a nonteaching service leads to more efficient care.
A potential area of further exploration includes understanding the differences between CDU patients who are discharged within 23 hours and those who are later admitted. This understanding may help us better differentiate patients appropriate for CDU admission, allowing the creation of more formal admission criteria.
Acknowledgements
The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs.
- ,.The role of hospitalists in medical education.Am J Med.1999;107(4):305–309.
- ,,,,.Reorganizing an academic medical service: impact on cost, quality, patient satisfaction, and education.JAMA.1998;279:1560–1565.
- ,,, et al.,Hospitalist‐Orthopedic Team Trial Investigators. Medical and surgical comanagement after elective hip and knee arthroplasty: a randomized, controlled trial.Ann Intern Med.2004;141(1):28–38.
- ,,,,,.Implementation of a voluntary hospitalist service at a community teaching hospital: improved efficiency and patient outcomes.Ann Intern Med.2002;137:859–865.
- ,,,,,.Outcomes of care by hospitalists, general internists, and family physicians.N Engl J Med.2007;357(25):2589–2600.
- ,,,,.Hospitalist care and length of stay in patients requiring complex discharge planning and close clinical monitoring.Arch Intern Med.2007;167(17):1869–1874.
- ,,.Comparison of hospital costs and length of stay for community internists, hospitalists, and academicians.J Gen Int Med.2007;22(5):662–667.
- ,,, et al.Effects of physician experience on cost and outcomes on an academic general medicine service: results of a trial of hospitalists.Ann Intern Med.2002;37:866–875.
- ,,,.Program description: a hospitalist‐run, medical short‐stay unit in a teaching hospital.CMAJ.2000;163(11):1477–1480.
- ,,,,.Improving resource utilization in a teaching hospital: development of a nonteaching service for chest pain admissions.Acad Med.2006;81(5):432–435.
- ,.The role of hospitalists in medical education.Am J Med.1999;107(4):305–309.
- ,,,,.Reorganizing an academic medical service: impact on cost, quality, patient satisfaction, and education.JAMA.1998;279:1560–1565.
- ,,, et al.,Hospitalist‐Orthopedic Team Trial Investigators. Medical and surgical comanagement after elective hip and knee arthroplasty: a randomized, controlled trial.Ann Intern Med.2004;141(1):28–38.
- ,,,,,.Implementation of a voluntary hospitalist service at a community teaching hospital: improved efficiency and patient outcomes.Ann Intern Med.2002;137:859–865.
- ,,,,,.Outcomes of care by hospitalists, general internists, and family physicians.N Engl J Med.2007;357(25):2589–2600.
- ,,,,.Hospitalist care and length of stay in patients requiring complex discharge planning and close clinical monitoring.Arch Intern Med.2007;167(17):1869–1874.
- ,,.Comparison of hospital costs and length of stay for community internists, hospitalists, and academicians.J Gen Int Med.2007;22(5):662–667.
- ,,, et al.Effects of physician experience on cost and outcomes on an academic general medicine service: results of a trial of hospitalists.Ann Intern Med.2002;37:866–875.
- ,,,.Program description: a hospitalist‐run, medical short‐stay unit in a teaching hospital.CMAJ.2000;163(11):1477–1480.
- ,,,,.Improving resource utilization in a teaching hospital: development of a nonteaching service for chest pain admissions.Acad Med.2006;81(5):432–435.
Geriatric Train‐The‐Trainer Program
Nearly half of the hospital beds in the United States are occupied by the elderly,1 whose numbers are increasing.2 The odds of a hospitalized Medicare patient being cared for by a hospitalist are increasing by nearly 30% per year.3 Hospitalists require competence in geriatrics to serve their patients and to teach trainees. Train‐the‐Trainer (TTT) programs both educate health care providers and provide educational materials, information, and skills for teaching others.4 This model has been successfully used in geriatrics to impact knowledge, attitudes, and self‐efficacy among health care workers.46
A prominent example of a geriatrics TTT program is the University of Chicago Curriculum for the Hospitalized Aging Medical Patient (CHAMP),7 which requires 48 hours of instruction over 12 sessions. To create a less time‐intensive learning format for busy hospitalists, the University of Chicago developed Mini‐CHAMP, a streamlined 2‐day workshop with web‐based components for hospitalist clinicians, but not necessarily hospitalist educators.7
We created The Donald W. Reynolds Program for Advancing Geriatrics Education (PAGE) at the University of California, San Francisco (UCSF), in light of the time intensity of CHAMP, to integrate geriatric TTT sessions within preexisting hospitalist faculty meetings. This model is consistent with current practices in faculty development.8 This paper describes the evaluation of the PAGE Model, which sought answers to 3 research questions: (1) Does PAGE increase faculty confidence in teaching geriatrics?, (2) Does PAGE increase the frequency of hospitalist teaching geriatrics topics?, and (3) Does PAGE increase residents' practice of geriatrics skills?
Methods
The PAGE Model
The PAGE Model comprises 10 hour‐long monthly seminars held at UCSF from January through December 2008 to teach specific geriatrics principles and clinical skills relevant to providing competent care to a hospitalized older adult. The aims of the PAGE are to:
Give hospitalist physicians knowledge and skills to teach geriatric topics to trainees in a time‐limited environment
Provide exportable teaching modules on geriatric topics for inpatient teaching
Increase teaching about geriatrics received by internal medicine residents
Increase resident use of 15 specific geriatric skills
Create a collaborative environment between the Geriatrics and Hospital Medicine Divisions at UCSF
The PAGE Development Group, which included 2 hospitalists, 2 geriatricians, and an analyst funded by the Donald W. Reynolds Foundation, reviewed American Geriatrics Society core competencies,9 national guidelines and mandates,10, 11 and existing published geriatric curricula.7, 1214 In late 2007, an email‐based needs assessment listing 38 possible topics, drawn from the resources above, was emailed to the 31 hospitalists at UCSF. Each hospitalist identified, in no particular order, 5 topics considered most useful to improve his/her geriatric teaching skills, with write‐in space for additional topic suggestions. The needs assessment also queried what format of teaching tools would be most useful and efficient, such as PowerPoint slides or pocket cards, and interest in session coteaching.
The topics most commonly selected by the respondents (n = 14, response rate 45%) included: home/community resources (64%), delirium/dementia (57%), minimizing medication problems (50%), using prognostic indices to make decisions (43%), and general approach to older inpatients (43%). The Development Group identified less popular topics (falls, pressure ulcers, indwelling catheters/emncontinence) that were gaining significant national attention.15 Finally, a topic suggested by many hospitalists, pain management, was added. Each topic session was mapped to 1 or more of the 15 geriatrics skills in the CHAMP model7 for residents to acquire. The requested and selected topics were then modified to create distinct sessions grouped around a theme, shown in Table 1. For example home and community resources was addressed in the session on Framework on Transitions in Care.
| Topics | Geriatric Skills Addressed for Hospitalized Older Patients |
|---|---|
| |
| 1. Approach to the vulnerable older patient; assessing function; goals of care | Conduct functional status assessmentMobilize early to prevent deconditioning |
| 2. Minimizing medication problems | Reduce polypharmacy and use of high risk/low benefit drugs |
| 3. Framework for transitions in care (including home and community resources) | Develop a safe and appropriate discharge plan, involving communication with other team members, family members and primary care physicians |
| 4. Using prognostics to guide treatment decisions | Give bad news |
| Document advance directives and DNR orders | |
| Discuss hospice care | |
| 5. Falls & immobility | Identify risk factors of hospital falls, including conventional and unconventional types of restraints |
| 6. Delirium | Assess risk and prevent delirium |
| 7. Dementia & depression | Conduct cognitive assessmentScreen for depression |
| Routinely assess pain at bedside in persons with dementia | |
| 8. Pain assessment in the elderly | Routinely assess pain at bedside in persons with dementia |
| Manage pain using the WHO 3‐step ladder and opiate conversion table and manage side effects of opiates | |
| 9. Foley catheters and incontinence | Determine appropriateness for urinary catheter use, discontinuing when inappropriate |
| 10. Pressure ulcers and wound care | Routinely perform a complete skin exam |
Most respondents (86%) wanted teaching materials in a format suitable for attending rounds; 64% preferred teaching cases, 29% PowerPoint presentations, and 29% quality improvement resources. The Development Group, with approval of the Chief of Hospital Medicine, planned 10, 1‐hour monthly sessions during weekly hospitalist meetings to optimize participation. Nine hospitalists agreed to lead sessions with geriatricians; 1 session was co‐led by a hospitalist and urologist.
The Development Group encouraged session leaders to create case‐based PowerPoint teaching modules that could be used during attending rounds, highlighting teaching triggers or teachable moments that modify or reinforce skills.1618 A Development Group hospitalist/geriatrician team cotaught the first session, which modeled the structure and style recommended. A teaching team typically met at least once to define goals and outline their teaching hour; most met repeatedly to refine their presentations. An example of a 1 PAGE session can be found online.19
Evaluation
Evaluation involved data from hospitalist faculty trainees, hospitalist and geriatrician session leaders, and internal medicine residents. The institutional review board approved this study. Self‐report rating scales were used for data collection, which were reviewed by experts in medical education at UCSF and piloted on nonparticipant faculty, or had been previously used by the CHAMP study.7
Hospitalist Trainees' Program Perceptions and Self‐Efficacy
Hospitalist trainees (n = 36) completed paper questionnaires after each session to assess perceived likelihood to use the teaching tools that were presented (1: not at all likely, 5: highly likely), whether they would recommend the program to colleagues (1: do not recommend, 5: highly recommend), and the utility of the PAGE program (Was this experience useful? and Prior to the sessions, did you think it would be useful? 1: definitely not, 5: definitely yes). Change in trainees' perceived self‐efficacy20 to teach geriatrics skills was assessed at the end of the PAGE program, using a posttest and retrospective pretest format with a 12‐items (1: low, 5: high) that was used in the CHAMP study.7 This format was used to avoid response shift bias, or the program‐produced change in a participant's understanding of the construct being measured.21
Faculty Session Leaders' Program Perceptions
After PAGE completion, all faculty session leaders (n = 15) completed an online questionnaire assessing teaching satisfaction (Likert‐type 5‐point scales), experience with coteaching, and years of faculty teaching experience.
Medical Residents
To assess change in hospitalists' teaching about geriatrics and residents' practice of geriatric clinical skills, residents (n = 56; post‐graduate year (PGY)1 = 29, PGY2 = 27) who would not complete residency before the end of PAGE received an online questionnaire, modified from the CHAMP study,7 prior to and after the completion of PAGE. Respondents received monetary gift cards as incentives. Residents gave separate ratings for their inpatient teaching attendings who were hospitalists (80% of inpatient ward attendings) and nonhospitalists (20%, mostly generalists) regarding frequency over the past year of being taught each of 15 geriatric clinical skills. A 3‐point scale was used: (1) never, (2) once, and (3) more than once. Residents also reported the frequency of practicing those skills themselves, using a questionnaire from the CHAMP study,7 with a scale of (1) never to (5) always.
Analysis
Descriptive statistics were computed for all measures. Scale means were constructed from all individual items for the retrospective pretest and posttest measures. Wilcoxon matched‐pairs signed ranks‐tests were used to compare teaching differences between hospitalist and other attendings. For the unmatched pre‐post data on frequency of teaching, Wilcoxon‐Mann‐Whitney tests were used to determine significant differences in instruction, conducting separate tests for hospitalists and nonhospitalist attendings. Effect size22 was calculated using Cohen's d23 to determine the magnitude of increase in self‐efficacy to teach geriatrics; an effect size exceeding 0.8 is considered large. Statistics were performed using PASW Statistics 17.0 (SPSS Inc., Chicago, IL, USA).
Results
The hospitalist group grew from 31 to 36 members in June of 2008. On average, 14 hospitalists (M = 14.40, standard deviation [SD] = 2.41, range 1119) attended each session, with all hospitalists (n = 36) attending 1 session (M = 3.83, SD = 2.35, range 19). At each session, an average of 72% completed a post‐session evaluation form. Overall, faculty were likely to use the PAGE teaching tools (M = 4.61, SD = 0.53) and would recommend PAGE to other hospitalists (M = 4.63, SD = 0.51).
Thirteen hospitalist trainees of 36 (36%) completed a post‐PAGE online questionnaire. Respondents taught on faculty for an average of 5 years (mean (M) = 5.08, SD = 3.52). Faculty perceived self‐efficacy at teaching residents about geriatrics improved significantly with a large effect size (pretest M = 3.05, SD = .60; posttest M = 3.96, SD = .36, d = 1.52; P < 0.001). Session attendance was positively correlated with the increase in geriatrics teaching self‐efficacy (r = .62, P < 0.05), while teaching experience was not (r = 0.05, P = 0.88). Hospitalist trainees found the PAGE model more useful after participating (M = 4.62, SD = 0.65), than they had expected (M = 3.92, SD = 0.76; P < 0.05).
All session leaders (n = 15) completed the questionnaire after PAGE (9 hospitalists, 5 geriatricians, 1 urologist). Two‐thirds had 5 years on faculty; eight had no prior experience as a faculty development trainer. Over 80% indicated that they found their coteaching experience, enjoyable, useful and collaborative. Only 1 participant did not commit to interdisciplinary teaching again. Most hospitalist session leaders reported that coteaching with a geriatrician enhanced their knowledge; they were more likely to consult a geriatrician regarding patients. All but 2 session leaders felt that the model fostered a collaborative environment between their 2 divisions.
Of the 56 residents, 41% (16 PGY1, 7 PGY2) completed a pretest; 43% (15 PGY1, 9 PGY2) completed a posttest. Residents reported receiving inpatient teaching on geriatrics skills significantly more frequently from hospitalists vs. nonhospitalist attendings both before PAGE (hospitalists M = 2.18, SD = 0.37; nonhospitalists M = 2.00, SD = 0.53, P < 0.05), and after (hospitalists M = 2.39, SD = 0.46; nonhospitalists M = 2.05, SD = 0.57, P < 0.05; see Fig. 1). Although hospitalists taught more frequently about geriatrics than nonhospitalists before PAGE, our findings suggest that they increased their teaching by a greater magnitude than nonhospitalists (P < 0.01, P > 0.05, respectively). Residents reported increased geriatric skill practice after PAGE with a medium effect size (pretest M = 2.92, SD = 0.55, posttest M = 3.28, SD = 0.66, P = 0.052, d = 0.66). There was greater mean reported practice for all skills with the exception of hospice care, which already was being performed between often and very often before PAGE. The largest increases in skill practice were (descending order, most increased first): assessing polypharmacy, performing skin exams, prognostication, performing functional assessments and examining Foley catheter use.
Discussion
Our aging population and a shortage of geriatricians necessitates new, feasible models for geriatric training. Similar to the CHAMP model,7 PAGE had a favorable impact on faculty perceived behavioral change; after the PAGE sessions, faculty reported significantly greater self‐efficacy of teaching geriatrics. However, this study also examined the impact of the PAGE Model on 2 groups not previously reported in the literature: faculty session leaders and medicine residents.
To our knowledge, this is the first study about a hospitalist TTT program codeveloped with nonhospitalists aimed at teaching geriatrics skills to residents, though smaller scale programs for medical students exist.24 We believe codevelopment was important in our model for many reasons. First, using hospitalist peers and local geriatricians likely increased trust in the educational curricula and allowed for strong communication channels between instructors.25, 26 Second, coteaching allowed for hospitalist mentorship. Hospitalists acknowledged their coleaders as mentors and several hospitalists subsequently engaged in new geriatric projects. Third, coteaching was felt to enhance patient care and increase geriatrician consultations. Coteaching may have applicability to other hospitalist faculty development such as intensive care and palliative care, and hospitalist programs may benefit from creating faculty development programs internally with their colleagues, rather than using online resources.
Another important finding of this study is that training hospitalists to teach about geriatrics seems to result in an increase in both the geriatric teaching that residents receive and residents' practice of geriatric skills. This outcome has not been previously demonstrated with geriatric TTT activities.27 This trickle‐down effect to residents likely results from both the increased teaching efficacy of hospitalists after the PAGE Model and the exportable nature of the teaching tools.
Several continuing medical education best practices were used which we believe contributed to the success of PAGE. First, we conducted a needs assessment, which improves knowledge outcomes.28, 29 Second, sessions included cases, lectures, and discussions. Use of multiple educational techniques yields greater knowledge and behavioral change as compared to a single method, such as lecture alone.24, 25, 30, 31 Finally, sessions were sequenced over a year, rather than clustered in short, intensive activity. Sequenced, or learn‐work‐learn opportunities allow education to be translated to practice and reinforced.8, 27, 30, 32
We believe that the PAGE Model is transportable to other hospitalist programs due to its cost and flexible nature. In economically‐lean times, hospitalist divisions can create a program similar to the PAGE Model essentially at no cost, except for donated faculty preparation time. In contrast, CHAMP was expensive, costing nearly $72,000 for 12 faculty to participate in the 48‐hour curriculum,7, 33 and volunteering physicians were compensated for their time. Though Mini‐CHAMP is a streamlined 2‐day workshop that offers free online lectures and slide sets, there may be some benefit to producing a faculty development program internally, as we stated above, and PAGE included additional topics (urinary catheters and decubitus ulcers/wound care) not covered in mini‐CHAMP.
There were several limitations to this study. First, some outcomes of the PAGE Model were assessed by retrospective self‐report, which may allow for recall bias. Although self‐report may or may not correlate with actual behavior,34 faculty and resident perspectives of their teaching and learning experiences are themselves important. Furthermore, a retrospective presurvey allows for content of an educational program or intervention to be explained prior to a survey, so that participants first assess their new level of understanding or skill on the post test, then reflectively assess the level of understanding or skill they had prior to the workshop. This avoids response shift bias and can improve internal validity.21, 35
Second, the small numbers of session leaders, hospitalist trainees, and residents restricted statistical power to detect small effects. The fact that we found significant improvements enhances the likelihood that the differences observed were not due to chance.
Third, the low response rates from the hospitalist trainee post‐intervention questionnaire and the residents' questionnaires may affect the validity of our results. For the resident survey, the subjects were not matched, and we cannot state that an individual's geriatric skill practice changed due to PAGE, though the results suggest the residency program as a whole improved the frequency of geriatric skill practice.
Finally, the residents were required to report the frequency of teaching on and practice of geriatric skills practice over the prior year and accuracy of recall may be an issue. However, frequencies were queried both pre and post intervention and favorable change was noted. Furthermore, because the high end of the 3‐point teaching scale was limited to more than once, the true amount of teaching may have been underestimated if more than once actually represented high frequencies.
Future studies are needed to replicate these findings at other institutions to confirm generalizability. It would be beneficial to measure patient outcomes to determine whether increased teaching and skill practice benefits patients using measures such as reduction in catheter related urinary tract infections, falls, and inadequate pain management. Further investigations of cotaught faculty development programs between hospitalists and other specialists help emphasize why internally created TTT programs are of greater value than online resources.
Conclusions
This time‐sensitive adaptation of a hospitalist geriatric TTT program was successfully implemented at an academic medical center and suggests improved hospitalist faculty self‐efficacy at teaching geriatric skills, increased frequency of inpatient geriatric teaching by hospitalists and increased resident geriatric skill practice. Confidence to care for geriatric patients and a strong skill set to assess risks and manage them appropriately will equip hospitalists and trainees to provide care that reduces geriatric patients' in‐hospital morbidity and costs of care. As hospitalists increasingly care for older adults, the need for time‐efficient methods of teaching geriatrics will continue to grow. The PAGE Model, and other new models of geriatric training for hospitalists, demonstrates that we are beginning to address this urgent need.
Acknowledgements
The authors thank Joan Abrams, MA, MPA, and Patricia O'Sullivan, EdD, whose work was key to the success of this program and this manuscript. They also thank the Donald W. Reynolds Foundation for support of this project.
- ,.2005 National Hospital Discharge Survey.Adv Data.2007;385:1–19.
- ,,,. In:U.S. Census Bureau, Current Population Reports, 65+ in the United States: 2005,Washington, D.C.:U.S. Government Printing Office;2005:23–209.
- ,,,.Growth in the care of older patients by hospitalists in the United States.N Engl J Med.2009;360(11):1102–1112.
- ,,,.Providing dementia outreach education to rural communities: lessons learned from a train‐the‐trainer program.J Appl Gerontol.2002;21:294–313.
- .Gerontologizing health care: a train‐the‐trainer program for nurses.Gerontol Geriatr Educ.1999;19:47–56.
- ,,.A statewide model detection and prevention program for geriatric alcoholism and alcohol abuse: increased knowledge among service providers.Community Ment Health J.2000;36:137–148.
- ,,, et al.The curriculum for the hospitalized aging medical patient program: a collaborative faculty development program for hospitalists, general internists, and geriatricians.J Hosp Med.2008;3(5):384–393.
- Reframing professional development through understanding authentic professional learning.Rev Educ Res.2009;79:702–739.
- The Education Committee Writing Group of the American Geriatrics Society.Core competencies for the care of older patients: recommendations of the American Geriatrics Society.Acad Med.2000;75:252–255.
- ,,, et al.American Geriatrics Society Task Force on the future of geriatric medicine.J Am Geriatr Soc.2005;53 (6 Suppl):S245–S256.
- Nadzam, Deborah. Preventing patient falls. Joint Commission Resources. Available at: http://www.jcrinc.com/Preventing‐Patient‐Falls. Accessed April2010.
- ,.Curricular recommendations for resident training in nursing home care. A collaborative effort of the Society of General Internal Medicine Task Force on Geriatric Medicine, the Society of Teachers of Family Medicine Geriatrics Task Force, the American Medical Directors Association, and the American Geriatrics Society Education Committee.J Am Geriatr Soc.1994;42:1200–1201.
- ,,,,.Curriculum recommendations for resident training in geriatrics interdisciplinary team care.J Am Geriatr Soc.1999;47:1145–1148.
- ,.ACGME requirements for geriatrics medicine curricula in medical specialties: Progress made and progress needed.Acad Med.2005;80:279–285.
- CMS Office of Public Affairs. CMS Improves Patient Safety for Medicare and Medicaid by Addressing Never Events, August 04, 2008. Available at: http://www.cms.gov/apps/media/press/factsheet.asp?Counter=322434(5):337–343.
- ,.The changing paradigm for continuing medical education: impact of information on the teachable moment.Bull Med Libr Assoc.1990;78(2):173–179.
- ,.Creating the teachable moment.J Nurs Educ.1998;37(6):278–280.
- Society of Hospital Medicine, BOOSTing Care Transitions Resource Room. Mazotti L, Johnston CB. Faculty development: Teaching triggers for transitional care. “A train‐the‐trainer model.” Available at: http://www.hospitalmedicine.org/ResourceRoomRedesign/RR_CareTransitions/PDFs/Mazotti_UCSF_Transitions.PPT. Accessed April2010.
- .Self‐efficacy: The Exercise of Control.New York:W.H. Freeman and Company;1997.
- .Internal invalidity in pretest‐posttest self‐report evaluations and a re‐evaluation of retrospective pretests.Applied Psychological Measurement.1979;3:1–23.
- ,.A visitor's guide to effect sizes.Adv Health Sci Educ Theory Pract.2004;9:241–249.
- .Statistical Power Analyses for the Behavioral Sciences.2nd ed.Hillsdale, NJ:Lawrence Erlbaum Associates;1988.
- ,,,.Hazards of hospitalization: Hospitalists and geriatricians educating medical students about delirium and falls in geriatric patients.Gerontol Geriatr Educ.2008;28(4):94–104.
- ,,, et al.Continuing medical education, continuing professional development, and knowledge translation: Improving care of older patients by practicing physicians.J Am Geriatr Soc.2006:54(10):1610–1618.
- ,,, et al.Practicing physician education in geriatrics: Lessons learned from a train‐the‐trainer model.J Am Geriatr Soc.2007:55(8):1281–1286.
- ,.CHAMP trains champions: hospitalist‐educators develop new ways to teach care for older patients.J Hosp Med.2008;3(5):357–360.
- ,,,,,.Impact of formal continuing medical education: Do conferences, workshops, rounds, and other traditional continuing education activities change physician behavior or health care outcomes?JAMA.1999;282(9):867–874.
- ,.Association for the Study of Medical Education Booklet: The effectiveness of continuing professional development.Edinburgh, Scotland:Association for the Study of Medical Education;2000.
- ,,, et al.Effectiveness of continuing medical education.Evid Rep Technol Assess (Full Rep).2007;149:1–69.
- ,,, et al.Continuing education meetings and workshops: effects on professional practice and health care outcomes.Cochrane Database Syst Rev.2009;(2):CD003030.
- ,.Continuing medical education and the physician as learner: guide to the evidence.JAMA.2002;288(9):1057–1060.
- .Care of hospitalized older patients: opportunities for hospital‐based physicians.J Hosp Med.2006;1:42–47.
- ,.What we say and what we do: self‐reported teaching behavior versus performances in written simulations among medical school faculty.Acad Med.1992;67(8):522–527.
- ,.The retrospective pretest and the role of pretest information in evaluation studies.Psychol Rep.1992;70:699–704.
Nearly half of the hospital beds in the United States are occupied by the elderly,1 whose numbers are increasing.2 The odds of a hospitalized Medicare patient being cared for by a hospitalist are increasing by nearly 30% per year.3 Hospitalists require competence in geriatrics to serve their patients and to teach trainees. Train‐the‐Trainer (TTT) programs both educate health care providers and provide educational materials, information, and skills for teaching others.4 This model has been successfully used in geriatrics to impact knowledge, attitudes, and self‐efficacy among health care workers.46
A prominent example of a geriatrics TTT program is the University of Chicago Curriculum for the Hospitalized Aging Medical Patient (CHAMP),7 which requires 48 hours of instruction over 12 sessions. To create a less time‐intensive learning format for busy hospitalists, the University of Chicago developed Mini‐CHAMP, a streamlined 2‐day workshop with web‐based components for hospitalist clinicians, but not necessarily hospitalist educators.7
We created The Donald W. Reynolds Program for Advancing Geriatrics Education (PAGE) at the University of California, San Francisco (UCSF), in light of the time intensity of CHAMP, to integrate geriatric TTT sessions within preexisting hospitalist faculty meetings. This model is consistent with current practices in faculty development.8 This paper describes the evaluation of the PAGE Model, which sought answers to 3 research questions: (1) Does PAGE increase faculty confidence in teaching geriatrics?, (2) Does PAGE increase the frequency of hospitalist teaching geriatrics topics?, and (3) Does PAGE increase residents' practice of geriatrics skills?
Methods
The PAGE Model
The PAGE Model comprises 10 hour‐long monthly seminars held at UCSF from January through December 2008 to teach specific geriatrics principles and clinical skills relevant to providing competent care to a hospitalized older adult. The aims of the PAGE are to:
Give hospitalist physicians knowledge and skills to teach geriatric topics to trainees in a time‐limited environment
Provide exportable teaching modules on geriatric topics for inpatient teaching
Increase teaching about geriatrics received by internal medicine residents
Increase resident use of 15 specific geriatric skills
Create a collaborative environment between the Geriatrics and Hospital Medicine Divisions at UCSF
The PAGE Development Group, which included 2 hospitalists, 2 geriatricians, and an analyst funded by the Donald W. Reynolds Foundation, reviewed American Geriatrics Society core competencies,9 national guidelines and mandates,10, 11 and existing published geriatric curricula.7, 1214 In late 2007, an email‐based needs assessment listing 38 possible topics, drawn from the resources above, was emailed to the 31 hospitalists at UCSF. Each hospitalist identified, in no particular order, 5 topics considered most useful to improve his/her geriatric teaching skills, with write‐in space for additional topic suggestions. The needs assessment also queried what format of teaching tools would be most useful and efficient, such as PowerPoint slides or pocket cards, and interest in session coteaching.
The topics most commonly selected by the respondents (n = 14, response rate 45%) included: home/community resources (64%), delirium/dementia (57%), minimizing medication problems (50%), using prognostic indices to make decisions (43%), and general approach to older inpatients (43%). The Development Group identified less popular topics (falls, pressure ulcers, indwelling catheters/emncontinence) that were gaining significant national attention.15 Finally, a topic suggested by many hospitalists, pain management, was added. Each topic session was mapped to 1 or more of the 15 geriatrics skills in the CHAMP model7 for residents to acquire. The requested and selected topics were then modified to create distinct sessions grouped around a theme, shown in Table 1. For example home and community resources was addressed in the session on Framework on Transitions in Care.
| Topics | Geriatric Skills Addressed for Hospitalized Older Patients |
|---|---|
| |
| 1. Approach to the vulnerable older patient; assessing function; goals of care | Conduct functional status assessmentMobilize early to prevent deconditioning |
| 2. Minimizing medication problems | Reduce polypharmacy and use of high risk/low benefit drugs |
| 3. Framework for transitions in care (including home and community resources) | Develop a safe and appropriate discharge plan, involving communication with other team members, family members and primary care physicians |
| 4. Using prognostics to guide treatment decisions | Give bad news |
| Document advance directives and DNR orders | |
| Discuss hospice care | |
| 5. Falls & immobility | Identify risk factors of hospital falls, including conventional and unconventional types of restraints |
| 6. Delirium | Assess risk and prevent delirium |
| 7. Dementia & depression | Conduct cognitive assessmentScreen for depression |
| Routinely assess pain at bedside in persons with dementia | |
| 8. Pain assessment in the elderly | Routinely assess pain at bedside in persons with dementia |
| Manage pain using the WHO 3‐step ladder and opiate conversion table and manage side effects of opiates | |
| 9. Foley catheters and incontinence | Determine appropriateness for urinary catheter use, discontinuing when inappropriate |
| 10. Pressure ulcers and wound care | Routinely perform a complete skin exam |
Most respondents (86%) wanted teaching materials in a format suitable for attending rounds; 64% preferred teaching cases, 29% PowerPoint presentations, and 29% quality improvement resources. The Development Group, with approval of the Chief of Hospital Medicine, planned 10, 1‐hour monthly sessions during weekly hospitalist meetings to optimize participation. Nine hospitalists agreed to lead sessions with geriatricians; 1 session was co‐led by a hospitalist and urologist.
The Development Group encouraged session leaders to create case‐based PowerPoint teaching modules that could be used during attending rounds, highlighting teaching triggers or teachable moments that modify or reinforce skills.1618 A Development Group hospitalist/geriatrician team cotaught the first session, which modeled the structure and style recommended. A teaching team typically met at least once to define goals and outline their teaching hour; most met repeatedly to refine their presentations. An example of a 1 PAGE session can be found online.19
Evaluation
Evaluation involved data from hospitalist faculty trainees, hospitalist and geriatrician session leaders, and internal medicine residents. The institutional review board approved this study. Self‐report rating scales were used for data collection, which were reviewed by experts in medical education at UCSF and piloted on nonparticipant faculty, or had been previously used by the CHAMP study.7
Hospitalist Trainees' Program Perceptions and Self‐Efficacy
Hospitalist trainees (n = 36) completed paper questionnaires after each session to assess perceived likelihood to use the teaching tools that were presented (1: not at all likely, 5: highly likely), whether they would recommend the program to colleagues (1: do not recommend, 5: highly recommend), and the utility of the PAGE program (Was this experience useful? and Prior to the sessions, did you think it would be useful? 1: definitely not, 5: definitely yes). Change in trainees' perceived self‐efficacy20 to teach geriatrics skills was assessed at the end of the PAGE program, using a posttest and retrospective pretest format with a 12‐items (1: low, 5: high) that was used in the CHAMP study.7 This format was used to avoid response shift bias, or the program‐produced change in a participant's understanding of the construct being measured.21
Faculty Session Leaders' Program Perceptions
After PAGE completion, all faculty session leaders (n = 15) completed an online questionnaire assessing teaching satisfaction (Likert‐type 5‐point scales), experience with coteaching, and years of faculty teaching experience.
Medical Residents
To assess change in hospitalists' teaching about geriatrics and residents' practice of geriatric clinical skills, residents (n = 56; post‐graduate year (PGY)1 = 29, PGY2 = 27) who would not complete residency before the end of PAGE received an online questionnaire, modified from the CHAMP study,7 prior to and after the completion of PAGE. Respondents received monetary gift cards as incentives. Residents gave separate ratings for their inpatient teaching attendings who were hospitalists (80% of inpatient ward attendings) and nonhospitalists (20%, mostly generalists) regarding frequency over the past year of being taught each of 15 geriatric clinical skills. A 3‐point scale was used: (1) never, (2) once, and (3) more than once. Residents also reported the frequency of practicing those skills themselves, using a questionnaire from the CHAMP study,7 with a scale of (1) never to (5) always.
Analysis
Descriptive statistics were computed for all measures. Scale means were constructed from all individual items for the retrospective pretest and posttest measures. Wilcoxon matched‐pairs signed ranks‐tests were used to compare teaching differences between hospitalist and other attendings. For the unmatched pre‐post data on frequency of teaching, Wilcoxon‐Mann‐Whitney tests were used to determine significant differences in instruction, conducting separate tests for hospitalists and nonhospitalist attendings. Effect size22 was calculated using Cohen's d23 to determine the magnitude of increase in self‐efficacy to teach geriatrics; an effect size exceeding 0.8 is considered large. Statistics were performed using PASW Statistics 17.0 (SPSS Inc., Chicago, IL, USA).
Results
The hospitalist group grew from 31 to 36 members in June of 2008. On average, 14 hospitalists (M = 14.40, standard deviation [SD] = 2.41, range 1119) attended each session, with all hospitalists (n = 36) attending 1 session (M = 3.83, SD = 2.35, range 19). At each session, an average of 72% completed a post‐session evaluation form. Overall, faculty were likely to use the PAGE teaching tools (M = 4.61, SD = 0.53) and would recommend PAGE to other hospitalists (M = 4.63, SD = 0.51).
Thirteen hospitalist trainees of 36 (36%) completed a post‐PAGE online questionnaire. Respondents taught on faculty for an average of 5 years (mean (M) = 5.08, SD = 3.52). Faculty perceived self‐efficacy at teaching residents about geriatrics improved significantly with a large effect size (pretest M = 3.05, SD = .60; posttest M = 3.96, SD = .36, d = 1.52; P < 0.001). Session attendance was positively correlated with the increase in geriatrics teaching self‐efficacy (r = .62, P < 0.05), while teaching experience was not (r = 0.05, P = 0.88). Hospitalist trainees found the PAGE model more useful after participating (M = 4.62, SD = 0.65), than they had expected (M = 3.92, SD = 0.76; P < 0.05).
All session leaders (n = 15) completed the questionnaire after PAGE (9 hospitalists, 5 geriatricians, 1 urologist). Two‐thirds had 5 years on faculty; eight had no prior experience as a faculty development trainer. Over 80% indicated that they found their coteaching experience, enjoyable, useful and collaborative. Only 1 participant did not commit to interdisciplinary teaching again. Most hospitalist session leaders reported that coteaching with a geriatrician enhanced their knowledge; they were more likely to consult a geriatrician regarding patients. All but 2 session leaders felt that the model fostered a collaborative environment between their 2 divisions.
Of the 56 residents, 41% (16 PGY1, 7 PGY2) completed a pretest; 43% (15 PGY1, 9 PGY2) completed a posttest. Residents reported receiving inpatient teaching on geriatrics skills significantly more frequently from hospitalists vs. nonhospitalist attendings both before PAGE (hospitalists M = 2.18, SD = 0.37; nonhospitalists M = 2.00, SD = 0.53, P < 0.05), and after (hospitalists M = 2.39, SD = 0.46; nonhospitalists M = 2.05, SD = 0.57, P < 0.05; see Fig. 1). Although hospitalists taught more frequently about geriatrics than nonhospitalists before PAGE, our findings suggest that they increased their teaching by a greater magnitude than nonhospitalists (P < 0.01, P > 0.05, respectively). Residents reported increased geriatric skill practice after PAGE with a medium effect size (pretest M = 2.92, SD = 0.55, posttest M = 3.28, SD = 0.66, P = 0.052, d = 0.66). There was greater mean reported practice for all skills with the exception of hospice care, which already was being performed between often and very often before PAGE. The largest increases in skill practice were (descending order, most increased first): assessing polypharmacy, performing skin exams, prognostication, performing functional assessments and examining Foley catheter use.
Discussion
Our aging population and a shortage of geriatricians necessitates new, feasible models for geriatric training. Similar to the CHAMP model,7 PAGE had a favorable impact on faculty perceived behavioral change; after the PAGE sessions, faculty reported significantly greater self‐efficacy of teaching geriatrics. However, this study also examined the impact of the PAGE Model on 2 groups not previously reported in the literature: faculty session leaders and medicine residents.
To our knowledge, this is the first study about a hospitalist TTT program codeveloped with nonhospitalists aimed at teaching geriatrics skills to residents, though smaller scale programs for medical students exist.24 We believe codevelopment was important in our model for many reasons. First, using hospitalist peers and local geriatricians likely increased trust in the educational curricula and allowed for strong communication channels between instructors.25, 26 Second, coteaching allowed for hospitalist mentorship. Hospitalists acknowledged their coleaders as mentors and several hospitalists subsequently engaged in new geriatric projects. Third, coteaching was felt to enhance patient care and increase geriatrician consultations. Coteaching may have applicability to other hospitalist faculty development such as intensive care and palliative care, and hospitalist programs may benefit from creating faculty development programs internally with their colleagues, rather than using online resources.
Another important finding of this study is that training hospitalists to teach about geriatrics seems to result in an increase in both the geriatric teaching that residents receive and residents' practice of geriatric skills. This outcome has not been previously demonstrated with geriatric TTT activities.27 This trickle‐down effect to residents likely results from both the increased teaching efficacy of hospitalists after the PAGE Model and the exportable nature of the teaching tools.
Several continuing medical education best practices were used which we believe contributed to the success of PAGE. First, we conducted a needs assessment, which improves knowledge outcomes.28, 29 Second, sessions included cases, lectures, and discussions. Use of multiple educational techniques yields greater knowledge and behavioral change as compared to a single method, such as lecture alone.24, 25, 30, 31 Finally, sessions were sequenced over a year, rather than clustered in short, intensive activity. Sequenced, or learn‐work‐learn opportunities allow education to be translated to practice and reinforced.8, 27, 30, 32
We believe that the PAGE Model is transportable to other hospitalist programs due to its cost and flexible nature. In economically‐lean times, hospitalist divisions can create a program similar to the PAGE Model essentially at no cost, except for donated faculty preparation time. In contrast, CHAMP was expensive, costing nearly $72,000 for 12 faculty to participate in the 48‐hour curriculum,7, 33 and volunteering physicians were compensated for their time. Though Mini‐CHAMP is a streamlined 2‐day workshop that offers free online lectures and slide sets, there may be some benefit to producing a faculty development program internally, as we stated above, and PAGE included additional topics (urinary catheters and decubitus ulcers/wound care) not covered in mini‐CHAMP.
There were several limitations to this study. First, some outcomes of the PAGE Model were assessed by retrospective self‐report, which may allow for recall bias. Although self‐report may or may not correlate with actual behavior,34 faculty and resident perspectives of their teaching and learning experiences are themselves important. Furthermore, a retrospective presurvey allows for content of an educational program or intervention to be explained prior to a survey, so that participants first assess their new level of understanding or skill on the post test, then reflectively assess the level of understanding or skill they had prior to the workshop. This avoids response shift bias and can improve internal validity.21, 35
Second, the small numbers of session leaders, hospitalist trainees, and residents restricted statistical power to detect small effects. The fact that we found significant improvements enhances the likelihood that the differences observed were not due to chance.
Third, the low response rates from the hospitalist trainee post‐intervention questionnaire and the residents' questionnaires may affect the validity of our results. For the resident survey, the subjects were not matched, and we cannot state that an individual's geriatric skill practice changed due to PAGE, though the results suggest the residency program as a whole improved the frequency of geriatric skill practice.
Finally, the residents were required to report the frequency of teaching on and practice of geriatric skills practice over the prior year and accuracy of recall may be an issue. However, frequencies were queried both pre and post intervention and favorable change was noted. Furthermore, because the high end of the 3‐point teaching scale was limited to more than once, the true amount of teaching may have been underestimated if more than once actually represented high frequencies.
Future studies are needed to replicate these findings at other institutions to confirm generalizability. It would be beneficial to measure patient outcomes to determine whether increased teaching and skill practice benefits patients using measures such as reduction in catheter related urinary tract infections, falls, and inadequate pain management. Further investigations of cotaught faculty development programs between hospitalists and other specialists help emphasize why internally created TTT programs are of greater value than online resources.
Conclusions
This time‐sensitive adaptation of a hospitalist geriatric TTT program was successfully implemented at an academic medical center and suggests improved hospitalist faculty self‐efficacy at teaching geriatric skills, increased frequency of inpatient geriatric teaching by hospitalists and increased resident geriatric skill practice. Confidence to care for geriatric patients and a strong skill set to assess risks and manage them appropriately will equip hospitalists and trainees to provide care that reduces geriatric patients' in‐hospital morbidity and costs of care. As hospitalists increasingly care for older adults, the need for time‐efficient methods of teaching geriatrics will continue to grow. The PAGE Model, and other new models of geriatric training for hospitalists, demonstrates that we are beginning to address this urgent need.
Acknowledgements
The authors thank Joan Abrams, MA, MPA, and Patricia O'Sullivan, EdD, whose work was key to the success of this program and this manuscript. They also thank the Donald W. Reynolds Foundation for support of this project.
Nearly half of the hospital beds in the United States are occupied by the elderly,1 whose numbers are increasing.2 The odds of a hospitalized Medicare patient being cared for by a hospitalist are increasing by nearly 30% per year.3 Hospitalists require competence in geriatrics to serve their patients and to teach trainees. Train‐the‐Trainer (TTT) programs both educate health care providers and provide educational materials, information, and skills for teaching others.4 This model has been successfully used in geriatrics to impact knowledge, attitudes, and self‐efficacy among health care workers.46
A prominent example of a geriatrics TTT program is the University of Chicago Curriculum for the Hospitalized Aging Medical Patient (CHAMP),7 which requires 48 hours of instruction over 12 sessions. To create a less time‐intensive learning format for busy hospitalists, the University of Chicago developed Mini‐CHAMP, a streamlined 2‐day workshop with web‐based components for hospitalist clinicians, but not necessarily hospitalist educators.7
We created The Donald W. Reynolds Program for Advancing Geriatrics Education (PAGE) at the University of California, San Francisco (UCSF), in light of the time intensity of CHAMP, to integrate geriatric TTT sessions within preexisting hospitalist faculty meetings. This model is consistent with current practices in faculty development.8 This paper describes the evaluation of the PAGE Model, which sought answers to 3 research questions: (1) Does PAGE increase faculty confidence in teaching geriatrics?, (2) Does PAGE increase the frequency of hospitalist teaching geriatrics topics?, and (3) Does PAGE increase residents' practice of geriatrics skills?
Methods
The PAGE Model
The PAGE Model comprises 10 hour‐long monthly seminars held at UCSF from January through December 2008 to teach specific geriatrics principles and clinical skills relevant to providing competent care to a hospitalized older adult. The aims of the PAGE are to:
Give hospitalist physicians knowledge and skills to teach geriatric topics to trainees in a time‐limited environment
Provide exportable teaching modules on geriatric topics for inpatient teaching
Increase teaching about geriatrics received by internal medicine residents
Increase resident use of 15 specific geriatric skills
Create a collaborative environment between the Geriatrics and Hospital Medicine Divisions at UCSF
The PAGE Development Group, which included 2 hospitalists, 2 geriatricians, and an analyst funded by the Donald W. Reynolds Foundation, reviewed American Geriatrics Society core competencies,9 national guidelines and mandates,10, 11 and existing published geriatric curricula.7, 1214 In late 2007, an email‐based needs assessment listing 38 possible topics, drawn from the resources above, was emailed to the 31 hospitalists at UCSF. Each hospitalist identified, in no particular order, 5 topics considered most useful to improve his/her geriatric teaching skills, with write‐in space for additional topic suggestions. The needs assessment also queried what format of teaching tools would be most useful and efficient, such as PowerPoint slides or pocket cards, and interest in session coteaching.
The topics most commonly selected by the respondents (n = 14, response rate 45%) included: home/community resources (64%), delirium/dementia (57%), minimizing medication problems (50%), using prognostic indices to make decisions (43%), and general approach to older inpatients (43%). The Development Group identified less popular topics (falls, pressure ulcers, indwelling catheters/emncontinence) that were gaining significant national attention.15 Finally, a topic suggested by many hospitalists, pain management, was added. Each topic session was mapped to 1 or more of the 15 geriatrics skills in the CHAMP model7 for residents to acquire. The requested and selected topics were then modified to create distinct sessions grouped around a theme, shown in Table 1. For example home and community resources was addressed in the session on Framework on Transitions in Care.
| Topics | Geriatric Skills Addressed for Hospitalized Older Patients |
|---|---|
| |
| 1. Approach to the vulnerable older patient; assessing function; goals of care | Conduct functional status assessmentMobilize early to prevent deconditioning |
| 2. Minimizing medication problems | Reduce polypharmacy and use of high risk/low benefit drugs |
| 3. Framework for transitions in care (including home and community resources) | Develop a safe and appropriate discharge plan, involving communication with other team members, family members and primary care physicians |
| 4. Using prognostics to guide treatment decisions | Give bad news |
| Document advance directives and DNR orders | |
| Discuss hospice care | |
| 5. Falls & immobility | Identify risk factors of hospital falls, including conventional and unconventional types of restraints |
| 6. Delirium | Assess risk and prevent delirium |
| 7. Dementia & depression | Conduct cognitive assessmentScreen for depression |
| Routinely assess pain at bedside in persons with dementia | |
| 8. Pain assessment in the elderly | Routinely assess pain at bedside in persons with dementia |
| Manage pain using the WHO 3‐step ladder and opiate conversion table and manage side effects of opiates | |
| 9. Foley catheters and incontinence | Determine appropriateness for urinary catheter use, discontinuing when inappropriate |
| 10. Pressure ulcers and wound care | Routinely perform a complete skin exam |
Most respondents (86%) wanted teaching materials in a format suitable for attending rounds; 64% preferred teaching cases, 29% PowerPoint presentations, and 29% quality improvement resources. The Development Group, with approval of the Chief of Hospital Medicine, planned 10, 1‐hour monthly sessions during weekly hospitalist meetings to optimize participation. Nine hospitalists agreed to lead sessions with geriatricians; 1 session was co‐led by a hospitalist and urologist.
The Development Group encouraged session leaders to create case‐based PowerPoint teaching modules that could be used during attending rounds, highlighting teaching triggers or teachable moments that modify or reinforce skills.1618 A Development Group hospitalist/geriatrician team cotaught the first session, which modeled the structure and style recommended. A teaching team typically met at least once to define goals and outline their teaching hour; most met repeatedly to refine their presentations. An example of a 1 PAGE session can be found online.19
Evaluation
Evaluation involved data from hospitalist faculty trainees, hospitalist and geriatrician session leaders, and internal medicine residents. The institutional review board approved this study. Self‐report rating scales were used for data collection, which were reviewed by experts in medical education at UCSF and piloted on nonparticipant faculty, or had been previously used by the CHAMP study.7
Hospitalist Trainees' Program Perceptions and Self‐Efficacy
Hospitalist trainees (n = 36) completed paper questionnaires after each session to assess perceived likelihood to use the teaching tools that were presented (1: not at all likely, 5: highly likely), whether they would recommend the program to colleagues (1: do not recommend, 5: highly recommend), and the utility of the PAGE program (Was this experience useful? and Prior to the sessions, did you think it would be useful? 1: definitely not, 5: definitely yes). Change in trainees' perceived self‐efficacy20 to teach geriatrics skills was assessed at the end of the PAGE program, using a posttest and retrospective pretest format with a 12‐items (1: low, 5: high) that was used in the CHAMP study.7 This format was used to avoid response shift bias, or the program‐produced change in a participant's understanding of the construct being measured.21
Faculty Session Leaders' Program Perceptions
After PAGE completion, all faculty session leaders (n = 15) completed an online questionnaire assessing teaching satisfaction (Likert‐type 5‐point scales), experience with coteaching, and years of faculty teaching experience.
Medical Residents
To assess change in hospitalists' teaching about geriatrics and residents' practice of geriatric clinical skills, residents (n = 56; post‐graduate year (PGY)1 = 29, PGY2 = 27) who would not complete residency before the end of PAGE received an online questionnaire, modified from the CHAMP study,7 prior to and after the completion of PAGE. Respondents received monetary gift cards as incentives. Residents gave separate ratings for their inpatient teaching attendings who were hospitalists (80% of inpatient ward attendings) and nonhospitalists (20%, mostly generalists) regarding frequency over the past year of being taught each of 15 geriatric clinical skills. A 3‐point scale was used: (1) never, (2) once, and (3) more than once. Residents also reported the frequency of practicing those skills themselves, using a questionnaire from the CHAMP study,7 with a scale of (1) never to (5) always.
Analysis
Descriptive statistics were computed for all measures. Scale means were constructed from all individual items for the retrospective pretest and posttest measures. Wilcoxon matched‐pairs signed ranks‐tests were used to compare teaching differences between hospitalist and other attendings. For the unmatched pre‐post data on frequency of teaching, Wilcoxon‐Mann‐Whitney tests were used to determine significant differences in instruction, conducting separate tests for hospitalists and nonhospitalist attendings. Effect size22 was calculated using Cohen's d23 to determine the magnitude of increase in self‐efficacy to teach geriatrics; an effect size exceeding 0.8 is considered large. Statistics were performed using PASW Statistics 17.0 (SPSS Inc., Chicago, IL, USA).
Results
The hospitalist group grew from 31 to 36 members in June of 2008. On average, 14 hospitalists (M = 14.40, standard deviation [SD] = 2.41, range 1119) attended each session, with all hospitalists (n = 36) attending 1 session (M = 3.83, SD = 2.35, range 19). At each session, an average of 72% completed a post‐session evaluation form. Overall, faculty were likely to use the PAGE teaching tools (M = 4.61, SD = 0.53) and would recommend PAGE to other hospitalists (M = 4.63, SD = 0.51).
Thirteen hospitalist trainees of 36 (36%) completed a post‐PAGE online questionnaire. Respondents taught on faculty for an average of 5 years (mean (M) = 5.08, SD = 3.52). Faculty perceived self‐efficacy at teaching residents about geriatrics improved significantly with a large effect size (pretest M = 3.05, SD = .60; posttest M = 3.96, SD = .36, d = 1.52; P < 0.001). Session attendance was positively correlated with the increase in geriatrics teaching self‐efficacy (r = .62, P < 0.05), while teaching experience was not (r = 0.05, P = 0.88). Hospitalist trainees found the PAGE model more useful after participating (M = 4.62, SD = 0.65), than they had expected (M = 3.92, SD = 0.76; P < 0.05).
All session leaders (n = 15) completed the questionnaire after PAGE (9 hospitalists, 5 geriatricians, 1 urologist). Two‐thirds had 5 years on faculty; eight had no prior experience as a faculty development trainer. Over 80% indicated that they found their coteaching experience, enjoyable, useful and collaborative. Only 1 participant did not commit to interdisciplinary teaching again. Most hospitalist session leaders reported that coteaching with a geriatrician enhanced their knowledge; they were more likely to consult a geriatrician regarding patients. All but 2 session leaders felt that the model fostered a collaborative environment between their 2 divisions.
Of the 56 residents, 41% (16 PGY1, 7 PGY2) completed a pretest; 43% (15 PGY1, 9 PGY2) completed a posttest. Residents reported receiving inpatient teaching on geriatrics skills significantly more frequently from hospitalists vs. nonhospitalist attendings both before PAGE (hospitalists M = 2.18, SD = 0.37; nonhospitalists M = 2.00, SD = 0.53, P < 0.05), and after (hospitalists M = 2.39, SD = 0.46; nonhospitalists M = 2.05, SD = 0.57, P < 0.05; see Fig. 1). Although hospitalists taught more frequently about geriatrics than nonhospitalists before PAGE, our findings suggest that they increased their teaching by a greater magnitude than nonhospitalists (P < 0.01, P > 0.05, respectively). Residents reported increased geriatric skill practice after PAGE with a medium effect size (pretest M = 2.92, SD = 0.55, posttest M = 3.28, SD = 0.66, P = 0.052, d = 0.66). There was greater mean reported practice for all skills with the exception of hospice care, which already was being performed between often and very often before PAGE. The largest increases in skill practice were (descending order, most increased first): assessing polypharmacy, performing skin exams, prognostication, performing functional assessments and examining Foley catheter use.
Discussion
Our aging population and a shortage of geriatricians necessitates new, feasible models for geriatric training. Similar to the CHAMP model,7 PAGE had a favorable impact on faculty perceived behavioral change; after the PAGE sessions, faculty reported significantly greater self‐efficacy of teaching geriatrics. However, this study also examined the impact of the PAGE Model on 2 groups not previously reported in the literature: faculty session leaders and medicine residents.
To our knowledge, this is the first study about a hospitalist TTT program codeveloped with nonhospitalists aimed at teaching geriatrics skills to residents, though smaller scale programs for medical students exist.24 We believe codevelopment was important in our model for many reasons. First, using hospitalist peers and local geriatricians likely increased trust in the educational curricula and allowed for strong communication channels between instructors.25, 26 Second, coteaching allowed for hospitalist mentorship. Hospitalists acknowledged their coleaders as mentors and several hospitalists subsequently engaged in new geriatric projects. Third, coteaching was felt to enhance patient care and increase geriatrician consultations. Coteaching may have applicability to other hospitalist faculty development such as intensive care and palliative care, and hospitalist programs may benefit from creating faculty development programs internally with their colleagues, rather than using online resources.
Another important finding of this study is that training hospitalists to teach about geriatrics seems to result in an increase in both the geriatric teaching that residents receive and residents' practice of geriatric skills. This outcome has not been previously demonstrated with geriatric TTT activities.27 This trickle‐down effect to residents likely results from both the increased teaching efficacy of hospitalists after the PAGE Model and the exportable nature of the teaching tools.
Several continuing medical education best practices were used which we believe contributed to the success of PAGE. First, we conducted a needs assessment, which improves knowledge outcomes.28, 29 Second, sessions included cases, lectures, and discussions. Use of multiple educational techniques yields greater knowledge and behavioral change as compared to a single method, such as lecture alone.24, 25, 30, 31 Finally, sessions were sequenced over a year, rather than clustered in short, intensive activity. Sequenced, or learn‐work‐learn opportunities allow education to be translated to practice and reinforced.8, 27, 30, 32
We believe that the PAGE Model is transportable to other hospitalist programs due to its cost and flexible nature. In economically‐lean times, hospitalist divisions can create a program similar to the PAGE Model essentially at no cost, except for donated faculty preparation time. In contrast, CHAMP was expensive, costing nearly $72,000 for 12 faculty to participate in the 48‐hour curriculum,7, 33 and volunteering physicians were compensated for their time. Though Mini‐CHAMP is a streamlined 2‐day workshop that offers free online lectures and slide sets, there may be some benefit to producing a faculty development program internally, as we stated above, and PAGE included additional topics (urinary catheters and decubitus ulcers/wound care) not covered in mini‐CHAMP.
There were several limitations to this study. First, some outcomes of the PAGE Model were assessed by retrospective self‐report, which may allow for recall bias. Although self‐report may or may not correlate with actual behavior,34 faculty and resident perspectives of their teaching and learning experiences are themselves important. Furthermore, a retrospective presurvey allows for content of an educational program or intervention to be explained prior to a survey, so that participants first assess their new level of understanding or skill on the post test, then reflectively assess the level of understanding or skill they had prior to the workshop. This avoids response shift bias and can improve internal validity.21, 35
Second, the small numbers of session leaders, hospitalist trainees, and residents restricted statistical power to detect small effects. The fact that we found significant improvements enhances the likelihood that the differences observed were not due to chance.
Third, the low response rates from the hospitalist trainee post‐intervention questionnaire and the residents' questionnaires may affect the validity of our results. For the resident survey, the subjects were not matched, and we cannot state that an individual's geriatric skill practice changed due to PAGE, though the results suggest the residency program as a whole improved the frequency of geriatric skill practice.
Finally, the residents were required to report the frequency of teaching on and practice of geriatric skills practice over the prior year and accuracy of recall may be an issue. However, frequencies were queried both pre and post intervention and favorable change was noted. Furthermore, because the high end of the 3‐point teaching scale was limited to more than once, the true amount of teaching may have been underestimated if more than once actually represented high frequencies.
Future studies are needed to replicate these findings at other institutions to confirm generalizability. It would be beneficial to measure patient outcomes to determine whether increased teaching and skill practice benefits patients using measures such as reduction in catheter related urinary tract infections, falls, and inadequate pain management. Further investigations of cotaught faculty development programs between hospitalists and other specialists help emphasize why internally created TTT programs are of greater value than online resources.
Conclusions
This time‐sensitive adaptation of a hospitalist geriatric TTT program was successfully implemented at an academic medical center and suggests improved hospitalist faculty self‐efficacy at teaching geriatric skills, increased frequency of inpatient geriatric teaching by hospitalists and increased resident geriatric skill practice. Confidence to care for geriatric patients and a strong skill set to assess risks and manage them appropriately will equip hospitalists and trainees to provide care that reduces geriatric patients' in‐hospital morbidity and costs of care. As hospitalists increasingly care for older adults, the need for time‐efficient methods of teaching geriatrics will continue to grow. The PAGE Model, and other new models of geriatric training for hospitalists, demonstrates that we are beginning to address this urgent need.
Acknowledgements
The authors thank Joan Abrams, MA, MPA, and Patricia O'Sullivan, EdD, whose work was key to the success of this program and this manuscript. They also thank the Donald W. Reynolds Foundation for support of this project.
- ,.2005 National Hospital Discharge Survey.Adv Data.2007;385:1–19.
- ,,,. In:U.S. Census Bureau, Current Population Reports, 65+ in the United States: 2005,Washington, D.C.:U.S. Government Printing Office;2005:23–209.
- ,,,.Growth in the care of older patients by hospitalists in the United States.N Engl J Med.2009;360(11):1102–1112.
- ,,,.Providing dementia outreach education to rural communities: lessons learned from a train‐the‐trainer program.J Appl Gerontol.2002;21:294–313.
- .Gerontologizing health care: a train‐the‐trainer program for nurses.Gerontol Geriatr Educ.1999;19:47–56.
- ,,.A statewide model detection and prevention program for geriatric alcoholism and alcohol abuse: increased knowledge among service providers.Community Ment Health J.2000;36:137–148.
- ,,, et al.The curriculum for the hospitalized aging medical patient program: a collaborative faculty development program for hospitalists, general internists, and geriatricians.J Hosp Med.2008;3(5):384–393.
- Reframing professional development through understanding authentic professional learning.Rev Educ Res.2009;79:702–739.
- The Education Committee Writing Group of the American Geriatrics Society.Core competencies for the care of older patients: recommendations of the American Geriatrics Society.Acad Med.2000;75:252–255.
- ,,, et al.American Geriatrics Society Task Force on the future of geriatric medicine.J Am Geriatr Soc.2005;53 (6 Suppl):S245–S256.
- Nadzam, Deborah. Preventing patient falls. Joint Commission Resources. Available at: http://www.jcrinc.com/Preventing‐Patient‐Falls. Accessed April2010.
- ,.Curricular recommendations for resident training in nursing home care. A collaborative effort of the Society of General Internal Medicine Task Force on Geriatric Medicine, the Society of Teachers of Family Medicine Geriatrics Task Force, the American Medical Directors Association, and the American Geriatrics Society Education Committee.J Am Geriatr Soc.1994;42:1200–1201.
- ,,,,.Curriculum recommendations for resident training in geriatrics interdisciplinary team care.J Am Geriatr Soc.1999;47:1145–1148.
- ,.ACGME requirements for geriatrics medicine curricula in medical specialties: Progress made and progress needed.Acad Med.2005;80:279–285.
- CMS Office of Public Affairs. CMS Improves Patient Safety for Medicare and Medicaid by Addressing Never Events, August 04, 2008. Available at: http://www.cms.gov/apps/media/press/factsheet.asp?Counter=322434(5):337–343.
- ,.The changing paradigm for continuing medical education: impact of information on the teachable moment.Bull Med Libr Assoc.1990;78(2):173–179.
- ,.Creating the teachable moment.J Nurs Educ.1998;37(6):278–280.
- Society of Hospital Medicine, BOOSTing Care Transitions Resource Room. Mazotti L, Johnston CB. Faculty development: Teaching triggers for transitional care. “A train‐the‐trainer model.” Available at: http://www.hospitalmedicine.org/ResourceRoomRedesign/RR_CareTransitions/PDFs/Mazotti_UCSF_Transitions.PPT. Accessed April2010.
- .Self‐efficacy: The Exercise of Control.New York:W.H. Freeman and Company;1997.
- .Internal invalidity in pretest‐posttest self‐report evaluations and a re‐evaluation of retrospective pretests.Applied Psychological Measurement.1979;3:1–23.
- ,.A visitor's guide to effect sizes.Adv Health Sci Educ Theory Pract.2004;9:241–249.
- .Statistical Power Analyses for the Behavioral Sciences.2nd ed.Hillsdale, NJ:Lawrence Erlbaum Associates;1988.
- ,,,.Hazards of hospitalization: Hospitalists and geriatricians educating medical students about delirium and falls in geriatric patients.Gerontol Geriatr Educ.2008;28(4):94–104.
- ,,, et al.Continuing medical education, continuing professional development, and knowledge translation: Improving care of older patients by practicing physicians.J Am Geriatr Soc.2006:54(10):1610–1618.
- ,,, et al.Practicing physician education in geriatrics: Lessons learned from a train‐the‐trainer model.J Am Geriatr Soc.2007:55(8):1281–1286.
- ,.CHAMP trains champions: hospitalist‐educators develop new ways to teach care for older patients.J Hosp Med.2008;3(5):357–360.
- ,,,,,.Impact of formal continuing medical education: Do conferences, workshops, rounds, and other traditional continuing education activities change physician behavior or health care outcomes?JAMA.1999;282(9):867–874.
- ,.Association for the Study of Medical Education Booklet: The effectiveness of continuing professional development.Edinburgh, Scotland:Association for the Study of Medical Education;2000.
- ,,, et al.Effectiveness of continuing medical education.Evid Rep Technol Assess (Full Rep).2007;149:1–69.
- ,,, et al.Continuing education meetings and workshops: effects on professional practice and health care outcomes.Cochrane Database Syst Rev.2009;(2):CD003030.
- ,.Continuing medical education and the physician as learner: guide to the evidence.JAMA.2002;288(9):1057–1060.
- .Care of hospitalized older patients: opportunities for hospital‐based physicians.J Hosp Med.2006;1:42–47.
- ,.What we say and what we do: self‐reported teaching behavior versus performances in written simulations among medical school faculty.Acad Med.1992;67(8):522–527.
- ,.The retrospective pretest and the role of pretest information in evaluation studies.Psychol Rep.1992;70:699–704.
- ,.2005 National Hospital Discharge Survey.Adv Data.2007;385:1–19.
- ,,,. In:U.S. Census Bureau, Current Population Reports, 65+ in the United States: 2005,Washington, D.C.:U.S. Government Printing Office;2005:23–209.
- ,,,.Growth in the care of older patients by hospitalists in the United States.N Engl J Med.2009;360(11):1102–1112.
- ,,,.Providing dementia outreach education to rural communities: lessons learned from a train‐the‐trainer program.J Appl Gerontol.2002;21:294–313.
- .Gerontologizing health care: a train‐the‐trainer program for nurses.Gerontol Geriatr Educ.1999;19:47–56.
- ,,.A statewide model detection and prevention program for geriatric alcoholism and alcohol abuse: increased knowledge among service providers.Community Ment Health J.2000;36:137–148.
- ,,, et al.The curriculum for the hospitalized aging medical patient program: a collaborative faculty development program for hospitalists, general internists, and geriatricians.J Hosp Med.2008;3(5):384–393.
- Reframing professional development through understanding authentic professional learning.Rev Educ Res.2009;79:702–739.
- The Education Committee Writing Group of the American Geriatrics Society.Core competencies for the care of older patients: recommendations of the American Geriatrics Society.Acad Med.2000;75:252–255.
- ,,, et al.American Geriatrics Society Task Force on the future of geriatric medicine.J Am Geriatr Soc.2005;53 (6 Suppl):S245–S256.
- Nadzam, Deborah. Preventing patient falls. Joint Commission Resources. Available at: http://www.jcrinc.com/Preventing‐Patient‐Falls. Accessed April2010.
- ,.Curricular recommendations for resident training in nursing home care. A collaborative effort of the Society of General Internal Medicine Task Force on Geriatric Medicine, the Society of Teachers of Family Medicine Geriatrics Task Force, the American Medical Directors Association, and the American Geriatrics Society Education Committee.J Am Geriatr Soc.1994;42:1200–1201.
- ,,,,.Curriculum recommendations for resident training in geriatrics interdisciplinary team care.J Am Geriatr Soc.1999;47:1145–1148.
- ,.ACGME requirements for geriatrics medicine curricula in medical specialties: Progress made and progress needed.Acad Med.2005;80:279–285.
- CMS Office of Public Affairs. CMS Improves Patient Safety for Medicare and Medicaid by Addressing Never Events, August 04, 2008. Available at: http://www.cms.gov/apps/media/press/factsheet.asp?Counter=322434(5):337–343.
- ,.The changing paradigm for continuing medical education: impact of information on the teachable moment.Bull Med Libr Assoc.1990;78(2):173–179.
- ,.Creating the teachable moment.J Nurs Educ.1998;37(6):278–280.
- Society of Hospital Medicine, BOOSTing Care Transitions Resource Room. Mazotti L, Johnston CB. Faculty development: Teaching triggers for transitional care. “A train‐the‐trainer model.” Available at: http://www.hospitalmedicine.org/ResourceRoomRedesign/RR_CareTransitions/PDFs/Mazotti_UCSF_Transitions.PPT. Accessed April2010.
- .Self‐efficacy: The Exercise of Control.New York:W.H. Freeman and Company;1997.
- .Internal invalidity in pretest‐posttest self‐report evaluations and a re‐evaluation of retrospective pretests.Applied Psychological Measurement.1979;3:1–23.
- ,.A visitor's guide to effect sizes.Adv Health Sci Educ Theory Pract.2004;9:241–249.
- .Statistical Power Analyses for the Behavioral Sciences.2nd ed.Hillsdale, NJ:Lawrence Erlbaum Associates;1988.
- ,,,.Hazards of hospitalization: Hospitalists and geriatricians educating medical students about delirium and falls in geriatric patients.Gerontol Geriatr Educ.2008;28(4):94–104.
- ,,, et al.Continuing medical education, continuing professional development, and knowledge translation: Improving care of older patients by practicing physicians.J Am Geriatr Soc.2006:54(10):1610–1618.
- ,,, et al.Practicing physician education in geriatrics: Lessons learned from a train‐the‐trainer model.J Am Geriatr Soc.2007:55(8):1281–1286.
- ,.CHAMP trains champions: hospitalist‐educators develop new ways to teach care for older patients.J Hosp Med.2008;3(5):357–360.
- ,,,,,.Impact of formal continuing medical education: Do conferences, workshops, rounds, and other traditional continuing education activities change physician behavior or health care outcomes?JAMA.1999;282(9):867–874.
- ,.Association for the Study of Medical Education Booklet: The effectiveness of continuing professional development.Edinburgh, Scotland:Association for the Study of Medical Education;2000.
- ,,, et al.Effectiveness of continuing medical education.Evid Rep Technol Assess (Full Rep).2007;149:1–69.
- ,,, et al.Continuing education meetings and workshops: effects on professional practice and health care outcomes.Cochrane Database Syst Rev.2009;(2):CD003030.
- ,.Continuing medical education and the physician as learner: guide to the evidence.JAMA.2002;288(9):1057–1060.
- .Care of hospitalized older patients: opportunities for hospital‐based physicians.J Hosp Med.2006;1:42–47.
- ,.What we say and what we do: self‐reported teaching behavior versus performances in written simulations among medical school faculty.Acad Med.1992;67(8):522–527.
- ,.The retrospective pretest and the role of pretest information in evaluation studies.Psychol Rep.1992;70:699–704.
Copyright © 2010 Society of Hospital Medicine
Cognitive Errors in Medical Injury
Promotion of safer healthcare by patient organizations has led to an expansion of studies aimed at understanding medical errors to minimize injury through systemic improvement. These efforts have focused on identifying patient‐related factors, reducing technology failures, and improving communication.1 In contrast, factors related to cognitive errors by healthcare providers have received relatively little attention, although such errors may be an important source of preventable harm.1, 2
Limited information is available on the types and prevalence of cognitive factors in cases of medical injury, although cognitive factors may be a major risk for medical injury. If these factors were confirmed to be important factors for medical injury, better educational strategies may be needed to reduce cognitive errors among physicians and to enhance quality improvement and patient safety. Better understanding of these cognitive factors may also help to implement educational programs aimed at the improvement of cognitive performance in medical schools or teaching hospital.35
Closed‐claim files for cases of medical injury contain valuable information for investigation of the factors involved in medical errors.3 In Japan, court claims were tried and closed orders were issued by judges without a jury system until 2009. Under this system, representatives for defense and plaintiffs can present medical experts. Courts can also appoint experts independent of either party. Court opinions in Japan are considered as neutral judgments for conflicts between plaintiffs and defendants. Usually there are 3 judges who are required to be involved with each judgment in Japanese courts.
Closed‐claim files in cases of medical injury contain information about the types and prevalence of cognitive factors suggested to be causally related to the injuries by verdicts in district courts. Thus, by analyzing these files, an unbiased description of the characteristics and epidemiology of cognitive factors can be obtained for cases of medical injury, with minimization of potentially biased claims indicated by both parties; ie, plaintiffs vs. hospitals. Therefore, in this study, by using information from closed claims files at district courts in Tokyo and Osaka, Japan, we aimed to determine the important cognitive factors associated with cases of medical injury from such factors as judgment, vigilance, memory, technical competence, or knowledge. Since we anticipated that cognitive factors would dominate among the causative factors, we also explored the association of these factors with cases in which a judgment of paid compensation was made.
Methods
Study Sample
The authors acknowledge that the methodologies are based on those from the Malpractice Insurers' Medical Errors Prevention Study.6 A claim was defined as a written demand for compensation for cases of medical injury, based on a similar approach in previous studies.7, 8 Reviews were performed for closed‐claim files for cases of medical injury involving physicians from 2001 to 2005. These files were published by the Division of the Tokyo‐Osaka Medical Malpractice Lawsuits, organized by district courts in Tokyo and Osaka. The files included all closed‐claim cases of medical injury involving physicians from 2001 to 2005 at district courts in Tokyo and Osaka. The locations of delivery of care were inpatients in this study. All patients in Japan were insured during the study period.
Data Collection
Reviews were conducted by 3 board‐certified Japanese physician‐investigators specializing in internal medicine (1 chief investigator and 2 coinvestigators). The chief investigator trained the coinvestigators in 1‐day sessions with regard to the content of claims files, data collection, and the confidentiality procedure. Reviews were first performed by 1 coinvestigator and then confirmed by the chief investigator.
Data were collected for patient demographics and characteristics of adverse events, including types, locations, clinical areas, and specialties involved in the claims. Classification of specialties was based on that of Singh et al.3 Types of adverse events included minor injury for cases with complete recovery within a year, significant injury for those with complete recovery requiring more than a year, major injury for those with incomplete recovery (any physical sequelae) after more than a year, and death. Clinical areas consisted of surgery, obstetrics, missed diagnosis, delayed diagnosis, medication, and fall. Data for litigation outcomes and the amounts of paid compensation in Japanese Yen (JY) were also collected for claims that received verdicts supporting the plaintiffs.
All factors identified in the verdicts as causally related to the medical injury were recorded for data analysis. Classification of these factors was based on that of Singh et al.3 Cognitive factors were drawn from a list of categories of physicians' tasks provided by the Occupational Information Network. This network is a database of occupational requirements and worker attributes and it describes occupations in terms of the skills and knowledge required, how the work is performed, and typical work settings. The list of cognitive factor categories of physicians' tasks included judgment, vigilance, memory, technical competence, or knowledge. Accordingly, the cognitive factor category list was considered to capture the work of clinicians across the entire range of specialties.3
An example concerning failure of judgment would be that a rapid respiratory rate in initial vital signs was missed or ignored in a patient who complained of upper abdominal pain, was sent home with a diagnosis of gastritis, and eventually died at home; and an autopsy diagnosis of myocardial infarction with congestive heart failure was later confirmed. A vigilance error example would be that, in an electronic ordering system, typing an incorrect medication that has the similar commercial name of a correct medication. An example of failure of memory as a cognitive error would be that a physician forgot a result of laboratory data (positive sputum cytology of lung cancer), and so the physician did not explain it to the patient and did not perform an appropriate subsequent treatment referral. A technical incompetence example would be an operative or procedural injury due to technical problems of physicians. An example of a knowledge error would be that a contraindicated drug combination was prescribed such as the use of both selective serotonin reuptake inhibitor and monoamine oxidase inhibitor.
For systemic factors, a teamwork problem (poor teamwork) was used to describe disruptive team behavior, based on the concept of teamwork described by the Agency for Healthcare Research and Quality and the British Medical Association.9, 10 Cases with teamwork problems were defined as those in which the original reviewer had judged that 1 or more of the following contributory factors played a role in the error: communication breakdowns, supervision problems, handoff problems, failures to establish clear lines of responsibility, and conflict among clinical staff. Technology failure indicated an error of commission or omission by devices, tools, or machines.
The Japanese courts analyze medical records but they do not open the records to the public and so we could not analyze the medical records of the cases in our study. Thus, we did not judge whether the adverse outcome could have been attributed to medical errors, while we analyzed the claims files and followed the conclusions reached by the end of the claims.
Statistical Analysis
Data are given as proportions for categorical variables and means or medians for continuous variables. Cognitive factors associated with cases receiving adjudication of a compensation payment by district courts (litigation outcomes) were analyzed using a logistic regression model including 5 types of cognitive errors. Analyses were conducted with the Stata SE 10.0 statistical software package (College Station, TX). All P values are 2‐sided and P < 0.05 was considered to be statistically significant. The study was approved by the ethics review board at the institution of the chief investigator.
Results
In a total of 274 closed cases of medical injury, the mean age of the patients was 49 years old and 45% were women (Table 1). The reviews performed by the coinvestigators were all confirmed by the chief investigator without discordance of the reviews between the coinvestigators and the chief investigator. The claims involved death of patients in 45% of cases; injuries that caused significant or major disability in 10% and 24%, respectively (a total of 34%); and minor adverse outcomes of medical care in 21% (57 cases). Closing verdicts supporting the plaintiffs (patients or family) by the district courts were given in 103 claims (38%), with compensation at a median of 8,000,000 JY (100 JY = $1 US in 2005). The compensation ranged from 20,000 JY to 222,710,251 JY. The highest compensation was ordered to be paid to a 36‐year‐old woman with an obstetrics‐related major injury and the court indicated the injury was causally related to the following 3 cognitive factors: error in judgment, failure of vigilance, and lack of technical competence.
| Characteristic | n (%) |
|---|---|
| |
| Demographic of patients | |
| Women | 121 (45) |
| Men | 153 (55) |
| Age, mean SD, year | 49 22 |
| Adverse outcome | |
| Minor | 57 (21) |
| Significant | 28 (10) |
| Major | 67 (24) |
| Death | 122 (45) |
| Operative | 36 |
| Delayed diagnosis | 35 |
| Medication | 26 |
| Missed diagnosis | 16 |
| Obstetrics | 8 |
| Clinical area | |
| Operative | 120 (44) |
| Delayed diagnosis | 54 (20) |
| Medication | 50 (18) |
| Missed diagnosis | 28 (10) |
| Obstetrics | 19 (7) |
| Fall | 3 (1) |
Operative injury was the most frequent reason for claims, followed by delayed diagnosis, medication error, and missed diagnosis. General surgery, orthopedics, internal medicine, and obstetrics/gynecology were the most frequently involved specialties, comprising 30% of all cases (Table 2). The verdicts suggested cognitive factors were the most prevalent factors associated with cases of medical injury: 73% of the injuries were judged to be the result of an error in judgment (Table 3), followed by failure of vigilance (65%), lack of technical competence (34%), and lack of knowledge (31%). Verdicts indicated systemic factors in only a few cases, including poor teamwork in 4% and technology failure in 2%. Patient‐related factors were suggested in 32% of the claims.
| Specialty | Cases, n (%) |
|---|---|
| General surgery | 27 (10) |
| Orthopedic surgery | 27 (10) |
| Internal medicine | 27 (10) |
| Obstetrics‐gynecology | 26 (9) |
| Neurosurgery | 19 (7) |
| Ear, nose, and throat | 18 (7) |
| Plastic surgery | 15 (5) |
| Psychiatry | 14 (5) |
| Cardiology | 13 (5) |
| Dental care | 13 (5) |
| Ophthalmology | 12 (4) |
| Hematology or oncology | 10 (4) |
| Adult primary care | 9 (3) |
| Pediatrics | 8 (3) |
| Urology | 8 (3) |
| Cardiothoracic surgery | 8 (3) |
| Neurology | 5 (2) |
| Anesthesiology | 4 (1) |
| Physical medicine or rehabilitation | 3 (1) |
| Emergency medicine | 2 (1) |
| Infectious disease | 2 (1) |
| Dermatology | 2 (1) |
| Radiology | 1 (<1) |
| Vascular surgery | 1 (<1) |
| Contributory Factor | n (%) |
|---|---|
| |
| Cognitive factors | |
| Error in judgment | 199 (73) |
| Failure of vigilance | 177 (65) |
| Lack of technical competence | 94 (34) |
| Lack of knowledge | 86 (31) |
| Failure of memory | 5 (2) |
| System factors | |
| Poor teamwork | 11 (4) |
| Technology failure | 5 (2) |
| Patient‐related factors | 87 (32) |
In a multivariable‐adjusted logistic regression analysis of cognitive factors with a potential association with the claims with paid compensation (Table 4), only error in judgment showed a significant association (odds ratio, 1.9; 95% confidence interval [CI], 1.01‐3.40). The other four cognitive factors in the model were not associated with these claims. The odds ratio for failure of memory was high (2.8), but this factor was identified by the courts in only 5 cases and was not significantly associated with claims with paid compensation.
| Cognitive Factor | Cases With No Compensation (n = 171), n (%) | Cases With Paid Compensation (n = 103), n (%) | Odds Ratio (95% CI)* |
|---|---|---|---|
| |||
| Error in judgment | 117 (68) | 82 (80) | 1.9 (1.03.4) |
| Failure of vigilance | 111 (65) | 66 (64) | 1.0 (0.61.7) |
| Failure of memory | 2 (1) | 3 (3) | 2.8 (0.518) |
| Lack of technical competence | 58 (34) | 36 (35) | 1.1 (0.61.8) |
| Lack of knowledge | 52 (30) | 34 (33) | 1.0 (0.61.7) |
Discussion
In this study of closed claims files, we identified 2 important cognitive factors involved in cases of medical injury. Error in judgment was the most common factor, comprising about 70% of all claims, and was significantly associated with cases with paid compensation for medical injury. The second cognitive factor was failure of vigilance, which was found in 65% of the claims. Other cognitive factors, such as lack of technical competence and knowledge or failure of memory, as well as systemic factors (poor teamwork and technology failure) were less frequently found to be causally related to cases with medical injury in the verdicts examined in the study.
Reasons for the low frequency of systemic factors involved in cases of medical injury in our study are unclear. This may be the cultural characteristics such as greater emphasis to working in teams and following rules of an organization in Japan. Another possibility is that plaintiffs might have tended to generate lawsuits in cases with suspected higher frequency of individual physicians' factors in Japan. Moreover, among cognitive factors, lack of technical competence and knowledge or failure of memory was also less frequently related to cases with medical injury in our study compared to those of the previous studies.3, 11
The study design of analyzing closed claims files of cases of medical injury is noteworthy for its methodology of error assessment and provides valuable information on errors related to medical injury.3, 7 Moreover, the system of court verdicts in Japan based on decisions by a professional judge allows elimination of potential bias from stakeholders (plaintiffs vs. hospitals) involved in cases of medical injury. Thus, probable causes related to adverse events can be determined from a neutral position. Previous studies of medical error have focused on medical record reviews, surveys, and interviews;12, 13 our study corroborates and extends the findings in these studies that cognitive errors are the most frequent source of medical injury.
Error in judgment is commonly made in the course of decision making in multiple clinical areas. This type of error is referred to recently as cognitive dispositions to respond,14 which is different from bias or heuristics, since not all heuristics are biased and not all errors in judgments come from bias. There is a well‐established value of heuristics in medical diagnosis. Moreover, the properties of this type of error are likely to be distinct from those associated with performance of procedures (lack of technical competence), such as operative injury, which are directly visible and can be prevented through rapid dissemination of information on safety procedures among a medical team. However, the consequences of error in judgment are important for patients, family, and healthcare providers, and these errors are also largely preventable by implementation of educational programs.15
Possible solutions for improving clinical judgment skills may be derived from recent education theory. The theory provides a means for minimizing errors in judgment through the process of meta‐cognition, in which cognitive forcing strategies can be developed through thinking that involves active control over the process of one's own thinking.14, 15 For example, reflective practice has been suggested to be an important instrument for improving clinical judgment and may particularly improve diagnoses in situations of uncertainty and uniqueness, thereby reducing diagnostic errors.16 The capability of critical reflection in real‐time practice (reflection‐in‐action) and on our own practice (reflection‐on‐action) appears to be a key requirement for developing and maintaining medical expertise.17, 18 For instance, case‐based discussion with clinician educators can be an opportunity for enhancing critical thinking skills of medical trainees.
Based on a context‐based approach that focuses on the nature of the clinical problem, potential systemic solutions have recently been proposed for reducing errors in judgment.1 These solutions utilize advanced technology, including symptom‐oriented diagnostic decision support, internet search engines for information on possible diagnoses, and automated reminders in electronic health records.1, 19 Previous studies have shown that long work hours and sleep deprivation can decrease cognitive function, leading to failure of vigilance and increased medical errors,20 and several systemic solutions provide models for avoidance of failure of vigilance. For instance, eliminating extended work shifts and reducing the number of work hours per week was shown to reduce serious medical errors through increased sleep and decreased failure of vigilance during night work in an intensive care unit.21, 22 Taking a brief nap during work hours has also been associated with decreased medical errors in a recent study conducted in Japan.23 Despite the well‐known importance of factors of physicians' workloads, our study did not analyze these factors and thus further studies are needed to confirm their importance in Japanese medical practice.
There were also 32% of patient‐related factors suggested as contributory factors to medical injury in verdicts of the closed claims. This finding may be also important in planning educational intervention strategies to reduce medical errors. Although our data did not include the relative frequency of components related to these factors, major components of patient‐related factors may include age, severity of illnesses, comorbidity, functional status, or mental status. Educational intervention programs may help healthcare providers to evaluate patients with these risk factors and to implement preventive strategies to avoid incidents among these patients.
General surgery, orthopedic surgery, internal medicine, and obstetrics‐gynecology were the most frequently involved specialties in our study. The reasons why these specialties were highly involved in the claims are unclear and our study could not analyze these issues. However, these specialties may be related to patients with greater clinical severity and thus they may have subsequently higher risk for receiving claims. Further, physicians in these specialties may be at higher risk for having various errors because of the complexity of care for patients.
Our study has several limitations. First, the closed claims are more likely to represent cases with severe injury.3 Therefore, it is unclear if we can generalize our findings beyond cases with severe injury.3 Second, certain contributory factors may not have been suggested by the verdicts, even though they played a role. Among these potential factors, poor teamwork and communication issues are unlikely to be identified as causative in verdicts, unless the allegation of the plaintiffs documented these issues. Moreover, the Japanese courts did not open the medical records to the public and so we could not analyze the medical records of the cases. Third, we only evaluated closed verdicts given by professional judges of district courts, who are unlikely to be medical experts. However, the closed verdicts underwent an extensive process involving testimony from medical professionals and academic societies. Fourth, we, as investigators, had few members with surgical backgrounds in this study so we might have underestimated issues related to technical competence among the claims. Finally, although a small percentage of closed‐ claim cases involving team performance were identified in our study, the plaintiffs might have indicated this point to the court claims, since it might have been difficult to describe this issue as a reason for requesting compensations from defendants. Thus, despite a low proportion of team performance involvement in the verdicts, we still believe that poor team performance is a factor related to most medical injuries.
In summary, causal factors obtained from closed claims files suggest the importance of cognitive factors in cases of medical injury. Among the cognitive factors, error in judgment and failure of vigilance were the most frequent. These findings may help leaders of medical schools and hospitals to allocate more resources for research into strategies to improve cognitive performance and thereby ensure patient safety. Further research is needed to better understand the cognitive mechanisms involved in medical errors and to translate this into educational strategies.
- ,.Diagnostic errors‐the next frontier for patient safety.JAMA.2009;301(10):1060–1062.
- ,,.Diagnostic error in internal medicine.Arch Intern Med.2005;165(13):1493–1499.
- ,,,.Medical errors involving trainees: a study of closed malpractice claims from 5 insurers.Arch Intern Med.2007;167(19):2030–2036.
- ,,.Understanding diagnostic errors in medicine: a lesson from aviation.Qual Saf Health Care.2006;15(3):159–164.
- .The importance of cognitive errors in diagnosis and strategies to minimize them.Acad Med.2003;78(8):775–780.
- ,,, et al.Claims, errors, and compensation payments in medical malpractice litigation.N Engl J Med.2006;354(19):2024–2033.
- ,,,,,.Negligent care and malpractice claiming behavior in Utah and Colorado.Med Care.2000;38(3):250–260.
- ,,, et al.Incidence and types of adverse events and negligent care in Utah and Colorado.Med Care.2000;38(3):261–271.
- ,,,,.Medical Teamwork and Patient Safety: The Evidence‐Based Relation.Rockville, MD:Agency for Healthcare Research and Quality;2005 [updated April 2005]; Available at: http://www.ahrq.gov/qual/medteam. Accessed June 2010.
- ,.Team working in Primary Health Care. Realising Shared Aims in Patient Care.London, UK:Royal Pharmaceutical Society and British Medical Association.2005.
- ,,,,.The nature and causes of unintended events reported at ten emergency departments.BMC Emerg Med.2009;9:16.
- ,,.To Err Is Human: Building a Safer Health System.Washington, USA:National Academy Press;2000.
- ,,,.Analysis of errors reported by surgeons at three teaching hospitals.Surgery.2003;133(6):614–621.
- .Achieving quality in clinical decision making: cognitive strategies and detection of bias.Acad Emerg Med.2002;9(11):1184–1204.
- .Cognitive forcing strategies in clinical decision making.Ann Emerg Med.2003;41(1):110–120.
- ,,.Effects of reflective practice on the accuracy of medical diagnoses.Med Educ.2008;42(5):468–475.
- .The Reflective Practitioner: How Professionals Think in Action.New York, NY:Basic Books;1983.
- ,,.Diagnostic errors and reflective practice in medicine.J Eval Clin Pract.2007;13(1):138–145.
- ,,,.Caught in the web: e‐diagnosis.J Hosp Med.2009;4(4):262–266.
- ,,, et al.Extended work duration and the risk of self‐reported percutaneous injuries in interns.JAMA.2006;296(9):1055–1062.
- ,,, et al.Effect of reducing interns' work hours on serious medical errors in intensive care units.N Engl J Med.2004;351(18):1838–1848.
- ,,, et al.Effect of reducing interns' weekly work hours on sleep and attentional failures.N Engl J Med.2004;351(18):1829–1837.
- ,,, et al.Influence of Residents' Workload, Mental State and Job Satisfaction on Procedural Error: a prospective daily questionnaire‐based study.General Medicine.2008;9(2):57–64.
Promotion of safer healthcare by patient organizations has led to an expansion of studies aimed at understanding medical errors to minimize injury through systemic improvement. These efforts have focused on identifying patient‐related factors, reducing technology failures, and improving communication.1 In contrast, factors related to cognitive errors by healthcare providers have received relatively little attention, although such errors may be an important source of preventable harm.1, 2
Limited information is available on the types and prevalence of cognitive factors in cases of medical injury, although cognitive factors may be a major risk for medical injury. If these factors were confirmed to be important factors for medical injury, better educational strategies may be needed to reduce cognitive errors among physicians and to enhance quality improvement and patient safety. Better understanding of these cognitive factors may also help to implement educational programs aimed at the improvement of cognitive performance in medical schools or teaching hospital.35
Closed‐claim files for cases of medical injury contain valuable information for investigation of the factors involved in medical errors.3 In Japan, court claims were tried and closed orders were issued by judges without a jury system until 2009. Under this system, representatives for defense and plaintiffs can present medical experts. Courts can also appoint experts independent of either party. Court opinions in Japan are considered as neutral judgments for conflicts between plaintiffs and defendants. Usually there are 3 judges who are required to be involved with each judgment in Japanese courts.
Closed‐claim files in cases of medical injury contain information about the types and prevalence of cognitive factors suggested to be causally related to the injuries by verdicts in district courts. Thus, by analyzing these files, an unbiased description of the characteristics and epidemiology of cognitive factors can be obtained for cases of medical injury, with minimization of potentially biased claims indicated by both parties; ie, plaintiffs vs. hospitals. Therefore, in this study, by using information from closed claims files at district courts in Tokyo and Osaka, Japan, we aimed to determine the important cognitive factors associated with cases of medical injury from such factors as judgment, vigilance, memory, technical competence, or knowledge. Since we anticipated that cognitive factors would dominate among the causative factors, we also explored the association of these factors with cases in which a judgment of paid compensation was made.
Methods
Study Sample
The authors acknowledge that the methodologies are based on those from the Malpractice Insurers' Medical Errors Prevention Study.6 A claim was defined as a written demand for compensation for cases of medical injury, based on a similar approach in previous studies.7, 8 Reviews were performed for closed‐claim files for cases of medical injury involving physicians from 2001 to 2005. These files were published by the Division of the Tokyo‐Osaka Medical Malpractice Lawsuits, organized by district courts in Tokyo and Osaka. The files included all closed‐claim cases of medical injury involving physicians from 2001 to 2005 at district courts in Tokyo and Osaka. The locations of delivery of care were inpatients in this study. All patients in Japan were insured during the study period.
Data Collection
Reviews were conducted by 3 board‐certified Japanese physician‐investigators specializing in internal medicine (1 chief investigator and 2 coinvestigators). The chief investigator trained the coinvestigators in 1‐day sessions with regard to the content of claims files, data collection, and the confidentiality procedure. Reviews were first performed by 1 coinvestigator and then confirmed by the chief investigator.
Data were collected for patient demographics and characteristics of adverse events, including types, locations, clinical areas, and specialties involved in the claims. Classification of specialties was based on that of Singh et al.3 Types of adverse events included minor injury for cases with complete recovery within a year, significant injury for those with complete recovery requiring more than a year, major injury for those with incomplete recovery (any physical sequelae) after more than a year, and death. Clinical areas consisted of surgery, obstetrics, missed diagnosis, delayed diagnosis, medication, and fall. Data for litigation outcomes and the amounts of paid compensation in Japanese Yen (JY) were also collected for claims that received verdicts supporting the plaintiffs.
All factors identified in the verdicts as causally related to the medical injury were recorded for data analysis. Classification of these factors was based on that of Singh et al.3 Cognitive factors were drawn from a list of categories of physicians' tasks provided by the Occupational Information Network. This network is a database of occupational requirements and worker attributes and it describes occupations in terms of the skills and knowledge required, how the work is performed, and typical work settings. The list of cognitive factor categories of physicians' tasks included judgment, vigilance, memory, technical competence, or knowledge. Accordingly, the cognitive factor category list was considered to capture the work of clinicians across the entire range of specialties.3
An example concerning failure of judgment would be that a rapid respiratory rate in initial vital signs was missed or ignored in a patient who complained of upper abdominal pain, was sent home with a diagnosis of gastritis, and eventually died at home; and an autopsy diagnosis of myocardial infarction with congestive heart failure was later confirmed. A vigilance error example would be that, in an electronic ordering system, typing an incorrect medication that has the similar commercial name of a correct medication. An example of failure of memory as a cognitive error would be that a physician forgot a result of laboratory data (positive sputum cytology of lung cancer), and so the physician did not explain it to the patient and did not perform an appropriate subsequent treatment referral. A technical incompetence example would be an operative or procedural injury due to technical problems of physicians. An example of a knowledge error would be that a contraindicated drug combination was prescribed such as the use of both selective serotonin reuptake inhibitor and monoamine oxidase inhibitor.
For systemic factors, a teamwork problem (poor teamwork) was used to describe disruptive team behavior, based on the concept of teamwork described by the Agency for Healthcare Research and Quality and the British Medical Association.9, 10 Cases with teamwork problems were defined as those in which the original reviewer had judged that 1 or more of the following contributory factors played a role in the error: communication breakdowns, supervision problems, handoff problems, failures to establish clear lines of responsibility, and conflict among clinical staff. Technology failure indicated an error of commission or omission by devices, tools, or machines.
The Japanese courts analyze medical records but they do not open the records to the public and so we could not analyze the medical records of the cases in our study. Thus, we did not judge whether the adverse outcome could have been attributed to medical errors, while we analyzed the claims files and followed the conclusions reached by the end of the claims.
Statistical Analysis
Data are given as proportions for categorical variables and means or medians for continuous variables. Cognitive factors associated with cases receiving adjudication of a compensation payment by district courts (litigation outcomes) were analyzed using a logistic regression model including 5 types of cognitive errors. Analyses were conducted with the Stata SE 10.0 statistical software package (College Station, TX). All P values are 2‐sided and P < 0.05 was considered to be statistically significant. The study was approved by the ethics review board at the institution of the chief investigator.
Results
In a total of 274 closed cases of medical injury, the mean age of the patients was 49 years old and 45% were women (Table 1). The reviews performed by the coinvestigators were all confirmed by the chief investigator without discordance of the reviews between the coinvestigators and the chief investigator. The claims involved death of patients in 45% of cases; injuries that caused significant or major disability in 10% and 24%, respectively (a total of 34%); and minor adverse outcomes of medical care in 21% (57 cases). Closing verdicts supporting the plaintiffs (patients or family) by the district courts were given in 103 claims (38%), with compensation at a median of 8,000,000 JY (100 JY = $1 US in 2005). The compensation ranged from 20,000 JY to 222,710,251 JY. The highest compensation was ordered to be paid to a 36‐year‐old woman with an obstetrics‐related major injury and the court indicated the injury was causally related to the following 3 cognitive factors: error in judgment, failure of vigilance, and lack of technical competence.
| Characteristic | n (%) |
|---|---|
| |
| Demographic of patients | |
| Women | 121 (45) |
| Men | 153 (55) |
| Age, mean SD, year | 49 22 |
| Adverse outcome | |
| Minor | 57 (21) |
| Significant | 28 (10) |
| Major | 67 (24) |
| Death | 122 (45) |
| Operative | 36 |
| Delayed diagnosis | 35 |
| Medication | 26 |
| Missed diagnosis | 16 |
| Obstetrics | 8 |
| Clinical area | |
| Operative | 120 (44) |
| Delayed diagnosis | 54 (20) |
| Medication | 50 (18) |
| Missed diagnosis | 28 (10) |
| Obstetrics | 19 (7) |
| Fall | 3 (1) |
Operative injury was the most frequent reason for claims, followed by delayed diagnosis, medication error, and missed diagnosis. General surgery, orthopedics, internal medicine, and obstetrics/gynecology were the most frequently involved specialties, comprising 30% of all cases (Table 2). The verdicts suggested cognitive factors were the most prevalent factors associated with cases of medical injury: 73% of the injuries were judged to be the result of an error in judgment (Table 3), followed by failure of vigilance (65%), lack of technical competence (34%), and lack of knowledge (31%). Verdicts indicated systemic factors in only a few cases, including poor teamwork in 4% and technology failure in 2%. Patient‐related factors were suggested in 32% of the claims.
| Specialty | Cases, n (%) |
|---|---|
| General surgery | 27 (10) |
| Orthopedic surgery | 27 (10) |
| Internal medicine | 27 (10) |
| Obstetrics‐gynecology | 26 (9) |
| Neurosurgery | 19 (7) |
| Ear, nose, and throat | 18 (7) |
| Plastic surgery | 15 (5) |
| Psychiatry | 14 (5) |
| Cardiology | 13 (5) |
| Dental care | 13 (5) |
| Ophthalmology | 12 (4) |
| Hematology or oncology | 10 (4) |
| Adult primary care | 9 (3) |
| Pediatrics | 8 (3) |
| Urology | 8 (3) |
| Cardiothoracic surgery | 8 (3) |
| Neurology | 5 (2) |
| Anesthesiology | 4 (1) |
| Physical medicine or rehabilitation | 3 (1) |
| Emergency medicine | 2 (1) |
| Infectious disease | 2 (1) |
| Dermatology | 2 (1) |
| Radiology | 1 (<1) |
| Vascular surgery | 1 (<1) |
| Contributory Factor | n (%) |
|---|---|
| |
| Cognitive factors | |
| Error in judgment | 199 (73) |
| Failure of vigilance | 177 (65) |
| Lack of technical competence | 94 (34) |
| Lack of knowledge | 86 (31) |
| Failure of memory | 5 (2) |
| System factors | |
| Poor teamwork | 11 (4) |
| Technology failure | 5 (2) |
| Patient‐related factors | 87 (32) |
In a multivariable‐adjusted logistic regression analysis of cognitive factors with a potential association with the claims with paid compensation (Table 4), only error in judgment showed a significant association (odds ratio, 1.9; 95% confidence interval [CI], 1.01‐3.40). The other four cognitive factors in the model were not associated with these claims. The odds ratio for failure of memory was high (2.8), but this factor was identified by the courts in only 5 cases and was not significantly associated with claims with paid compensation.
| Cognitive Factor | Cases With No Compensation (n = 171), n (%) | Cases With Paid Compensation (n = 103), n (%) | Odds Ratio (95% CI)* |
|---|---|---|---|
| |||
| Error in judgment | 117 (68) | 82 (80) | 1.9 (1.03.4) |
| Failure of vigilance | 111 (65) | 66 (64) | 1.0 (0.61.7) |
| Failure of memory | 2 (1) | 3 (3) | 2.8 (0.518) |
| Lack of technical competence | 58 (34) | 36 (35) | 1.1 (0.61.8) |
| Lack of knowledge | 52 (30) | 34 (33) | 1.0 (0.61.7) |
Discussion
In this study of closed claims files, we identified 2 important cognitive factors involved in cases of medical injury. Error in judgment was the most common factor, comprising about 70% of all claims, and was significantly associated with cases with paid compensation for medical injury. The second cognitive factor was failure of vigilance, which was found in 65% of the claims. Other cognitive factors, such as lack of technical competence and knowledge or failure of memory, as well as systemic factors (poor teamwork and technology failure) were less frequently found to be causally related to cases with medical injury in the verdicts examined in the study.
Reasons for the low frequency of systemic factors involved in cases of medical injury in our study are unclear. This may be the cultural characteristics such as greater emphasis to working in teams and following rules of an organization in Japan. Another possibility is that plaintiffs might have tended to generate lawsuits in cases with suspected higher frequency of individual physicians' factors in Japan. Moreover, among cognitive factors, lack of technical competence and knowledge or failure of memory was also less frequently related to cases with medical injury in our study compared to those of the previous studies.3, 11
The study design of analyzing closed claims files of cases of medical injury is noteworthy for its methodology of error assessment and provides valuable information on errors related to medical injury.3, 7 Moreover, the system of court verdicts in Japan based on decisions by a professional judge allows elimination of potential bias from stakeholders (plaintiffs vs. hospitals) involved in cases of medical injury. Thus, probable causes related to adverse events can be determined from a neutral position. Previous studies of medical error have focused on medical record reviews, surveys, and interviews;12, 13 our study corroborates and extends the findings in these studies that cognitive errors are the most frequent source of medical injury.
Error in judgment is commonly made in the course of decision making in multiple clinical areas. This type of error is referred to recently as cognitive dispositions to respond,14 which is different from bias or heuristics, since not all heuristics are biased and not all errors in judgments come from bias. There is a well‐established value of heuristics in medical diagnosis. Moreover, the properties of this type of error are likely to be distinct from those associated with performance of procedures (lack of technical competence), such as operative injury, which are directly visible and can be prevented through rapid dissemination of information on safety procedures among a medical team. However, the consequences of error in judgment are important for patients, family, and healthcare providers, and these errors are also largely preventable by implementation of educational programs.15
Possible solutions for improving clinical judgment skills may be derived from recent education theory. The theory provides a means for minimizing errors in judgment through the process of meta‐cognition, in which cognitive forcing strategies can be developed through thinking that involves active control over the process of one's own thinking.14, 15 For example, reflective practice has been suggested to be an important instrument for improving clinical judgment and may particularly improve diagnoses in situations of uncertainty and uniqueness, thereby reducing diagnostic errors.16 The capability of critical reflection in real‐time practice (reflection‐in‐action) and on our own practice (reflection‐on‐action) appears to be a key requirement for developing and maintaining medical expertise.17, 18 For instance, case‐based discussion with clinician educators can be an opportunity for enhancing critical thinking skills of medical trainees.
Based on a context‐based approach that focuses on the nature of the clinical problem, potential systemic solutions have recently been proposed for reducing errors in judgment.1 These solutions utilize advanced technology, including symptom‐oriented diagnostic decision support, internet search engines for information on possible diagnoses, and automated reminders in electronic health records.1, 19 Previous studies have shown that long work hours and sleep deprivation can decrease cognitive function, leading to failure of vigilance and increased medical errors,20 and several systemic solutions provide models for avoidance of failure of vigilance. For instance, eliminating extended work shifts and reducing the number of work hours per week was shown to reduce serious medical errors through increased sleep and decreased failure of vigilance during night work in an intensive care unit.21, 22 Taking a brief nap during work hours has also been associated with decreased medical errors in a recent study conducted in Japan.23 Despite the well‐known importance of factors of physicians' workloads, our study did not analyze these factors and thus further studies are needed to confirm their importance in Japanese medical practice.
There were also 32% of patient‐related factors suggested as contributory factors to medical injury in verdicts of the closed claims. This finding may be also important in planning educational intervention strategies to reduce medical errors. Although our data did not include the relative frequency of components related to these factors, major components of patient‐related factors may include age, severity of illnesses, comorbidity, functional status, or mental status. Educational intervention programs may help healthcare providers to evaluate patients with these risk factors and to implement preventive strategies to avoid incidents among these patients.
General surgery, orthopedic surgery, internal medicine, and obstetrics‐gynecology were the most frequently involved specialties in our study. The reasons why these specialties were highly involved in the claims are unclear and our study could not analyze these issues. However, these specialties may be related to patients with greater clinical severity and thus they may have subsequently higher risk for receiving claims. Further, physicians in these specialties may be at higher risk for having various errors because of the complexity of care for patients.
Our study has several limitations. First, the closed claims are more likely to represent cases with severe injury.3 Therefore, it is unclear if we can generalize our findings beyond cases with severe injury.3 Second, certain contributory factors may not have been suggested by the verdicts, even though they played a role. Among these potential factors, poor teamwork and communication issues are unlikely to be identified as causative in verdicts, unless the allegation of the plaintiffs documented these issues. Moreover, the Japanese courts did not open the medical records to the public and so we could not analyze the medical records of the cases. Third, we only evaluated closed verdicts given by professional judges of district courts, who are unlikely to be medical experts. However, the closed verdicts underwent an extensive process involving testimony from medical professionals and academic societies. Fourth, we, as investigators, had few members with surgical backgrounds in this study so we might have underestimated issues related to technical competence among the claims. Finally, although a small percentage of closed‐ claim cases involving team performance were identified in our study, the plaintiffs might have indicated this point to the court claims, since it might have been difficult to describe this issue as a reason for requesting compensations from defendants. Thus, despite a low proportion of team performance involvement in the verdicts, we still believe that poor team performance is a factor related to most medical injuries.
In summary, causal factors obtained from closed claims files suggest the importance of cognitive factors in cases of medical injury. Among the cognitive factors, error in judgment and failure of vigilance were the most frequent. These findings may help leaders of medical schools and hospitals to allocate more resources for research into strategies to improve cognitive performance and thereby ensure patient safety. Further research is needed to better understand the cognitive mechanisms involved in medical errors and to translate this into educational strategies.
Promotion of safer healthcare by patient organizations has led to an expansion of studies aimed at understanding medical errors to minimize injury through systemic improvement. These efforts have focused on identifying patient‐related factors, reducing technology failures, and improving communication.1 In contrast, factors related to cognitive errors by healthcare providers have received relatively little attention, although such errors may be an important source of preventable harm.1, 2
Limited information is available on the types and prevalence of cognitive factors in cases of medical injury, although cognitive factors may be a major risk for medical injury. If these factors were confirmed to be important factors for medical injury, better educational strategies may be needed to reduce cognitive errors among physicians and to enhance quality improvement and patient safety. Better understanding of these cognitive factors may also help to implement educational programs aimed at the improvement of cognitive performance in medical schools or teaching hospital.35
Closed‐claim files for cases of medical injury contain valuable information for investigation of the factors involved in medical errors.3 In Japan, court claims were tried and closed orders were issued by judges without a jury system until 2009. Under this system, representatives for defense and plaintiffs can present medical experts. Courts can also appoint experts independent of either party. Court opinions in Japan are considered as neutral judgments for conflicts between plaintiffs and defendants. Usually there are 3 judges who are required to be involved with each judgment in Japanese courts.
Closed‐claim files in cases of medical injury contain information about the types and prevalence of cognitive factors suggested to be causally related to the injuries by verdicts in district courts. Thus, by analyzing these files, an unbiased description of the characteristics and epidemiology of cognitive factors can be obtained for cases of medical injury, with minimization of potentially biased claims indicated by both parties; ie, plaintiffs vs. hospitals. Therefore, in this study, by using information from closed claims files at district courts in Tokyo and Osaka, Japan, we aimed to determine the important cognitive factors associated with cases of medical injury from such factors as judgment, vigilance, memory, technical competence, or knowledge. Since we anticipated that cognitive factors would dominate among the causative factors, we also explored the association of these factors with cases in which a judgment of paid compensation was made.
Methods
Study Sample
The authors acknowledge that the methodologies are based on those from the Malpractice Insurers' Medical Errors Prevention Study.6 A claim was defined as a written demand for compensation for cases of medical injury, based on a similar approach in previous studies.7, 8 Reviews were performed for closed‐claim files for cases of medical injury involving physicians from 2001 to 2005. These files were published by the Division of the Tokyo‐Osaka Medical Malpractice Lawsuits, organized by district courts in Tokyo and Osaka. The files included all closed‐claim cases of medical injury involving physicians from 2001 to 2005 at district courts in Tokyo and Osaka. The locations of delivery of care were inpatients in this study. All patients in Japan were insured during the study period.
Data Collection
Reviews were conducted by 3 board‐certified Japanese physician‐investigators specializing in internal medicine (1 chief investigator and 2 coinvestigators). The chief investigator trained the coinvestigators in 1‐day sessions with regard to the content of claims files, data collection, and the confidentiality procedure. Reviews were first performed by 1 coinvestigator and then confirmed by the chief investigator.
Data were collected for patient demographics and characteristics of adverse events, including types, locations, clinical areas, and specialties involved in the claims. Classification of specialties was based on that of Singh et al.3 Types of adverse events included minor injury for cases with complete recovery within a year, significant injury for those with complete recovery requiring more than a year, major injury for those with incomplete recovery (any physical sequelae) after more than a year, and death. Clinical areas consisted of surgery, obstetrics, missed diagnosis, delayed diagnosis, medication, and fall. Data for litigation outcomes and the amounts of paid compensation in Japanese Yen (JY) were also collected for claims that received verdicts supporting the plaintiffs.
All factors identified in the verdicts as causally related to the medical injury were recorded for data analysis. Classification of these factors was based on that of Singh et al.3 Cognitive factors were drawn from a list of categories of physicians' tasks provided by the Occupational Information Network. This network is a database of occupational requirements and worker attributes and it describes occupations in terms of the skills and knowledge required, how the work is performed, and typical work settings. The list of cognitive factor categories of physicians' tasks included judgment, vigilance, memory, technical competence, or knowledge. Accordingly, the cognitive factor category list was considered to capture the work of clinicians across the entire range of specialties.3
An example concerning failure of judgment would be that a rapid respiratory rate in initial vital signs was missed or ignored in a patient who complained of upper abdominal pain, was sent home with a diagnosis of gastritis, and eventually died at home; and an autopsy diagnosis of myocardial infarction with congestive heart failure was later confirmed. A vigilance error example would be that, in an electronic ordering system, typing an incorrect medication that has the similar commercial name of a correct medication. An example of failure of memory as a cognitive error would be that a physician forgot a result of laboratory data (positive sputum cytology of lung cancer), and so the physician did not explain it to the patient and did not perform an appropriate subsequent treatment referral. A technical incompetence example would be an operative or procedural injury due to technical problems of physicians. An example of a knowledge error would be that a contraindicated drug combination was prescribed such as the use of both selective serotonin reuptake inhibitor and monoamine oxidase inhibitor.
For systemic factors, a teamwork problem (poor teamwork) was used to describe disruptive team behavior, based on the concept of teamwork described by the Agency for Healthcare Research and Quality and the British Medical Association.9, 10 Cases with teamwork problems were defined as those in which the original reviewer had judged that 1 or more of the following contributory factors played a role in the error: communication breakdowns, supervision problems, handoff problems, failures to establish clear lines of responsibility, and conflict among clinical staff. Technology failure indicated an error of commission or omission by devices, tools, or machines.
The Japanese courts analyze medical records but they do not open the records to the public and so we could not analyze the medical records of the cases in our study. Thus, we did not judge whether the adverse outcome could have been attributed to medical errors, while we analyzed the claims files and followed the conclusions reached by the end of the claims.
Statistical Analysis
Data are given as proportions for categorical variables and means or medians for continuous variables. Cognitive factors associated with cases receiving adjudication of a compensation payment by district courts (litigation outcomes) were analyzed using a logistic regression model including 5 types of cognitive errors. Analyses were conducted with the Stata SE 10.0 statistical software package (College Station, TX). All P values are 2‐sided and P < 0.05 was considered to be statistically significant. The study was approved by the ethics review board at the institution of the chief investigator.
Results
In a total of 274 closed cases of medical injury, the mean age of the patients was 49 years old and 45% were women (Table 1). The reviews performed by the coinvestigators were all confirmed by the chief investigator without discordance of the reviews between the coinvestigators and the chief investigator. The claims involved death of patients in 45% of cases; injuries that caused significant or major disability in 10% and 24%, respectively (a total of 34%); and minor adverse outcomes of medical care in 21% (57 cases). Closing verdicts supporting the plaintiffs (patients or family) by the district courts were given in 103 claims (38%), with compensation at a median of 8,000,000 JY (100 JY = $1 US in 2005). The compensation ranged from 20,000 JY to 222,710,251 JY. The highest compensation was ordered to be paid to a 36‐year‐old woman with an obstetrics‐related major injury and the court indicated the injury was causally related to the following 3 cognitive factors: error in judgment, failure of vigilance, and lack of technical competence.
| Characteristic | n (%) |
|---|---|
| |
| Demographic of patients | |
| Women | 121 (45) |
| Men | 153 (55) |
| Age, mean SD, year | 49 22 |
| Adverse outcome | |
| Minor | 57 (21) |
| Significant | 28 (10) |
| Major | 67 (24) |
| Death | 122 (45) |
| Operative | 36 |
| Delayed diagnosis | 35 |
| Medication | 26 |
| Missed diagnosis | 16 |
| Obstetrics | 8 |
| Clinical area | |
| Operative | 120 (44) |
| Delayed diagnosis | 54 (20) |
| Medication | 50 (18) |
| Missed diagnosis | 28 (10) |
| Obstetrics | 19 (7) |
| Fall | 3 (1) |
Operative injury was the most frequent reason for claims, followed by delayed diagnosis, medication error, and missed diagnosis. General surgery, orthopedics, internal medicine, and obstetrics/gynecology were the most frequently involved specialties, comprising 30% of all cases (Table 2). The verdicts suggested cognitive factors were the most prevalent factors associated with cases of medical injury: 73% of the injuries were judged to be the result of an error in judgment (Table 3), followed by failure of vigilance (65%), lack of technical competence (34%), and lack of knowledge (31%). Verdicts indicated systemic factors in only a few cases, including poor teamwork in 4% and technology failure in 2%. Patient‐related factors were suggested in 32% of the claims.
| Specialty | Cases, n (%) |
|---|---|
| General surgery | 27 (10) |
| Orthopedic surgery | 27 (10) |
| Internal medicine | 27 (10) |
| Obstetrics‐gynecology | 26 (9) |
| Neurosurgery | 19 (7) |
| Ear, nose, and throat | 18 (7) |
| Plastic surgery | 15 (5) |
| Psychiatry | 14 (5) |
| Cardiology | 13 (5) |
| Dental care | 13 (5) |
| Ophthalmology | 12 (4) |
| Hematology or oncology | 10 (4) |
| Adult primary care | 9 (3) |
| Pediatrics | 8 (3) |
| Urology | 8 (3) |
| Cardiothoracic surgery | 8 (3) |
| Neurology | 5 (2) |
| Anesthesiology | 4 (1) |
| Physical medicine or rehabilitation | 3 (1) |
| Emergency medicine | 2 (1) |
| Infectious disease | 2 (1) |
| Dermatology | 2 (1) |
| Radiology | 1 (<1) |
| Vascular surgery | 1 (<1) |
| Contributory Factor | n (%) |
|---|---|
| |
| Cognitive factors | |
| Error in judgment | 199 (73) |
| Failure of vigilance | 177 (65) |
| Lack of technical competence | 94 (34) |
| Lack of knowledge | 86 (31) |
| Failure of memory | 5 (2) |
| System factors | |
| Poor teamwork | 11 (4) |
| Technology failure | 5 (2) |
| Patient‐related factors | 87 (32) |
In a multivariable‐adjusted logistic regression analysis of cognitive factors with a potential association with the claims with paid compensation (Table 4), only error in judgment showed a significant association (odds ratio, 1.9; 95% confidence interval [CI], 1.01‐3.40). The other four cognitive factors in the model were not associated with these claims. The odds ratio for failure of memory was high (2.8), but this factor was identified by the courts in only 5 cases and was not significantly associated with claims with paid compensation.
| Cognitive Factor | Cases With No Compensation (n = 171), n (%) | Cases With Paid Compensation (n = 103), n (%) | Odds Ratio (95% CI)* |
|---|---|---|---|
| |||
| Error in judgment | 117 (68) | 82 (80) | 1.9 (1.03.4) |
| Failure of vigilance | 111 (65) | 66 (64) | 1.0 (0.61.7) |
| Failure of memory | 2 (1) | 3 (3) | 2.8 (0.518) |
| Lack of technical competence | 58 (34) | 36 (35) | 1.1 (0.61.8) |
| Lack of knowledge | 52 (30) | 34 (33) | 1.0 (0.61.7) |
Discussion
In this study of closed claims files, we identified 2 important cognitive factors involved in cases of medical injury. Error in judgment was the most common factor, comprising about 70% of all claims, and was significantly associated with cases with paid compensation for medical injury. The second cognitive factor was failure of vigilance, which was found in 65% of the claims. Other cognitive factors, such as lack of technical competence and knowledge or failure of memory, as well as systemic factors (poor teamwork and technology failure) were less frequently found to be causally related to cases with medical injury in the verdicts examined in the study.
Reasons for the low frequency of systemic factors involved in cases of medical injury in our study are unclear. This may be the cultural characteristics such as greater emphasis to working in teams and following rules of an organization in Japan. Another possibility is that plaintiffs might have tended to generate lawsuits in cases with suspected higher frequency of individual physicians' factors in Japan. Moreover, among cognitive factors, lack of technical competence and knowledge or failure of memory was also less frequently related to cases with medical injury in our study compared to those of the previous studies.3, 11
The study design of analyzing closed claims files of cases of medical injury is noteworthy for its methodology of error assessment and provides valuable information on errors related to medical injury.3, 7 Moreover, the system of court verdicts in Japan based on decisions by a professional judge allows elimination of potential bias from stakeholders (plaintiffs vs. hospitals) involved in cases of medical injury. Thus, probable causes related to adverse events can be determined from a neutral position. Previous studies of medical error have focused on medical record reviews, surveys, and interviews;12, 13 our study corroborates and extends the findings in these studies that cognitive errors are the most frequent source of medical injury.
Error in judgment is commonly made in the course of decision making in multiple clinical areas. This type of error is referred to recently as cognitive dispositions to respond,14 which is different from bias or heuristics, since not all heuristics are biased and not all errors in judgments come from bias. There is a well‐established value of heuristics in medical diagnosis. Moreover, the properties of this type of error are likely to be distinct from those associated with performance of procedures (lack of technical competence), such as operative injury, which are directly visible and can be prevented through rapid dissemination of information on safety procedures among a medical team. However, the consequences of error in judgment are important for patients, family, and healthcare providers, and these errors are also largely preventable by implementation of educational programs.15
Possible solutions for improving clinical judgment skills may be derived from recent education theory. The theory provides a means for minimizing errors in judgment through the process of meta‐cognition, in which cognitive forcing strategies can be developed through thinking that involves active control over the process of one's own thinking.14, 15 For example, reflective practice has been suggested to be an important instrument for improving clinical judgment and may particularly improve diagnoses in situations of uncertainty and uniqueness, thereby reducing diagnostic errors.16 The capability of critical reflection in real‐time practice (reflection‐in‐action) and on our own practice (reflection‐on‐action) appears to be a key requirement for developing and maintaining medical expertise.17, 18 For instance, case‐based discussion with clinician educators can be an opportunity for enhancing critical thinking skills of medical trainees.
Based on a context‐based approach that focuses on the nature of the clinical problem, potential systemic solutions have recently been proposed for reducing errors in judgment.1 These solutions utilize advanced technology, including symptom‐oriented diagnostic decision support, internet search engines for information on possible diagnoses, and automated reminders in electronic health records.1, 19 Previous studies have shown that long work hours and sleep deprivation can decrease cognitive function, leading to failure of vigilance and increased medical errors,20 and several systemic solutions provide models for avoidance of failure of vigilance. For instance, eliminating extended work shifts and reducing the number of work hours per week was shown to reduce serious medical errors through increased sleep and decreased failure of vigilance during night work in an intensive care unit.21, 22 Taking a brief nap during work hours has also been associated with decreased medical errors in a recent study conducted in Japan.23 Despite the well‐known importance of factors of physicians' workloads, our study did not analyze these factors and thus further studies are needed to confirm their importance in Japanese medical practice.
There were also 32% of patient‐related factors suggested as contributory factors to medical injury in verdicts of the closed claims. This finding may be also important in planning educational intervention strategies to reduce medical errors. Although our data did not include the relative frequency of components related to these factors, major components of patient‐related factors may include age, severity of illnesses, comorbidity, functional status, or mental status. Educational intervention programs may help healthcare providers to evaluate patients with these risk factors and to implement preventive strategies to avoid incidents among these patients.
General surgery, orthopedic surgery, internal medicine, and obstetrics‐gynecology were the most frequently involved specialties in our study. The reasons why these specialties were highly involved in the claims are unclear and our study could not analyze these issues. However, these specialties may be related to patients with greater clinical severity and thus they may have subsequently higher risk for receiving claims. Further, physicians in these specialties may be at higher risk for having various errors because of the complexity of care for patients.
Our study has several limitations. First, the closed claims are more likely to represent cases with severe injury.3 Therefore, it is unclear if we can generalize our findings beyond cases with severe injury.3 Second, certain contributory factors may not have been suggested by the verdicts, even though they played a role. Among these potential factors, poor teamwork and communication issues are unlikely to be identified as causative in verdicts, unless the allegation of the plaintiffs documented these issues. Moreover, the Japanese courts did not open the medical records to the public and so we could not analyze the medical records of the cases. Third, we only evaluated closed verdicts given by professional judges of district courts, who are unlikely to be medical experts. However, the closed verdicts underwent an extensive process involving testimony from medical professionals and academic societies. Fourth, we, as investigators, had few members with surgical backgrounds in this study so we might have underestimated issues related to technical competence among the claims. Finally, although a small percentage of closed‐ claim cases involving team performance were identified in our study, the plaintiffs might have indicated this point to the court claims, since it might have been difficult to describe this issue as a reason for requesting compensations from defendants. Thus, despite a low proportion of team performance involvement in the verdicts, we still believe that poor team performance is a factor related to most medical injuries.
In summary, causal factors obtained from closed claims files suggest the importance of cognitive factors in cases of medical injury. Among the cognitive factors, error in judgment and failure of vigilance were the most frequent. These findings may help leaders of medical schools and hospitals to allocate more resources for research into strategies to improve cognitive performance and thereby ensure patient safety. Further research is needed to better understand the cognitive mechanisms involved in medical errors and to translate this into educational strategies.
- ,.Diagnostic errors‐the next frontier for patient safety.JAMA.2009;301(10):1060–1062.
- ,,.Diagnostic error in internal medicine.Arch Intern Med.2005;165(13):1493–1499.
- ,,,.Medical errors involving trainees: a study of closed malpractice claims from 5 insurers.Arch Intern Med.2007;167(19):2030–2036.
- ,,.Understanding diagnostic errors in medicine: a lesson from aviation.Qual Saf Health Care.2006;15(3):159–164.
- .The importance of cognitive errors in diagnosis and strategies to minimize them.Acad Med.2003;78(8):775–780.
- ,,, et al.Claims, errors, and compensation payments in medical malpractice litigation.N Engl J Med.2006;354(19):2024–2033.
- ,,,,,.Negligent care and malpractice claiming behavior in Utah and Colorado.Med Care.2000;38(3):250–260.
- ,,, et al.Incidence and types of adverse events and negligent care in Utah and Colorado.Med Care.2000;38(3):261–271.
- ,,,,.Medical Teamwork and Patient Safety: The Evidence‐Based Relation.Rockville, MD:Agency for Healthcare Research and Quality;2005 [updated April 2005]; Available at: http://www.ahrq.gov/qual/medteam. Accessed June 2010.
- ,.Team working in Primary Health Care. Realising Shared Aims in Patient Care.London, UK:Royal Pharmaceutical Society and British Medical Association.2005.
- ,,,,.The nature and causes of unintended events reported at ten emergency departments.BMC Emerg Med.2009;9:16.
- ,,.To Err Is Human: Building a Safer Health System.Washington, USA:National Academy Press;2000.
- ,,,.Analysis of errors reported by surgeons at three teaching hospitals.Surgery.2003;133(6):614–621.
- .Achieving quality in clinical decision making: cognitive strategies and detection of bias.Acad Emerg Med.2002;9(11):1184–1204.
- .Cognitive forcing strategies in clinical decision making.Ann Emerg Med.2003;41(1):110–120.
- ,,.Effects of reflective practice on the accuracy of medical diagnoses.Med Educ.2008;42(5):468–475.
- .The Reflective Practitioner: How Professionals Think in Action.New York, NY:Basic Books;1983.
- ,,.Diagnostic errors and reflective practice in medicine.J Eval Clin Pract.2007;13(1):138–145.
- ,,,.Caught in the web: e‐diagnosis.J Hosp Med.2009;4(4):262–266.
- ,,, et al.Extended work duration and the risk of self‐reported percutaneous injuries in interns.JAMA.2006;296(9):1055–1062.
- ,,, et al.Effect of reducing interns' work hours on serious medical errors in intensive care units.N Engl J Med.2004;351(18):1838–1848.
- ,,, et al.Effect of reducing interns' weekly work hours on sleep and attentional failures.N Engl J Med.2004;351(18):1829–1837.
- ,,, et al.Influence of Residents' Workload, Mental State and Job Satisfaction on Procedural Error: a prospective daily questionnaire‐based study.General Medicine.2008;9(2):57–64.
- ,.Diagnostic errors‐the next frontier for patient safety.JAMA.2009;301(10):1060–1062.
- ,,.Diagnostic error in internal medicine.Arch Intern Med.2005;165(13):1493–1499.
- ,,,.Medical errors involving trainees: a study of closed malpractice claims from 5 insurers.Arch Intern Med.2007;167(19):2030–2036.
- ,,.Understanding diagnostic errors in medicine: a lesson from aviation.Qual Saf Health Care.2006;15(3):159–164.
- .The importance of cognitive errors in diagnosis and strategies to minimize them.Acad Med.2003;78(8):775–780.
- ,,, et al.Claims, errors, and compensation payments in medical malpractice litigation.N Engl J Med.2006;354(19):2024–2033.
- ,,,,,.Negligent care and malpractice claiming behavior in Utah and Colorado.Med Care.2000;38(3):250–260.
- ,,, et al.Incidence and types of adverse events and negligent care in Utah and Colorado.Med Care.2000;38(3):261–271.
- ,,,,.Medical Teamwork and Patient Safety: The Evidence‐Based Relation.Rockville, MD:Agency for Healthcare Research and Quality;2005 [updated April 2005]; Available at: http://www.ahrq.gov/qual/medteam. Accessed June 2010.
- ,.Team working in Primary Health Care. Realising Shared Aims in Patient Care.London, UK:Royal Pharmaceutical Society and British Medical Association.2005.
- ,,,,.The nature and causes of unintended events reported at ten emergency departments.BMC Emerg Med.2009;9:16.
- ,,.To Err Is Human: Building a Safer Health System.Washington, USA:National Academy Press;2000.
- ,,,.Analysis of errors reported by surgeons at three teaching hospitals.Surgery.2003;133(6):614–621.
- .Achieving quality in clinical decision making: cognitive strategies and detection of bias.Acad Emerg Med.2002;9(11):1184–1204.
- .Cognitive forcing strategies in clinical decision making.Ann Emerg Med.2003;41(1):110–120.
- ,,.Effects of reflective practice on the accuracy of medical diagnoses.Med Educ.2008;42(5):468–475.
- .The Reflective Practitioner: How Professionals Think in Action.New York, NY:Basic Books;1983.
- ,,.Diagnostic errors and reflective practice in medicine.J Eval Clin Pract.2007;13(1):138–145.
- ,,,.Caught in the web: e‐diagnosis.J Hosp Med.2009;4(4):262–266.
- ,,, et al.Extended work duration and the risk of self‐reported percutaneous injuries in interns.JAMA.2006;296(9):1055–1062.
- ,,, et al.Effect of reducing interns' work hours on serious medical errors in intensive care units.N Engl J Med.2004;351(18):1838–1848.
- ,,, et al.Effect of reducing interns' weekly work hours on sleep and attentional failures.N Engl J Med.2004;351(18):1829–1837.
- ,,, et al.Influence of Residents' Workload, Mental State and Job Satisfaction on Procedural Error: a prospective daily questionnaire‐based study.General Medicine.2008;9(2):57–64.
Copyright © 2010 Society of Hospital Medicine
GAD Vaccine for Type 1 Diabetes Shows Continued Promise
KEYSTONE, Colo. – Right now, the Diamyd Medical’s GAD vaccine is in the sweet spot in the developmental pipeline – an interim period of enormous optimism that this novel autoantigen-based immunotherapy will safely prevent many cases of type 1 diabetes.
The results of three phase II studies are in and they look quite promising. Two large phase III clinical trials are well underway in Europe and the United States. The safety experience with the 65-kD isoform of GAD (glutamic acid decarboxylase-65) vaccine has been outstanding. The subcutaneous two-injection series is easy to administer. Acceptance of the vaccine by patients and their families is high. The vaccine targets a serious disease whose incidence is steadily climbing by 3%-5% per year in developed countries. And most patients with recently diagnosed type 1 diabetes possess GAD autoantibodies, so the Diamyd vaccine would be widely applicable.
All of that was good enough for Johnson and Johnson, which in June inked a huge development and marketing deal for the GAD vaccine with small Swedish biotech company Diamyd Medical. Under the deal, Diamyd receives $45 million upfront, milestone payments of up to $580 million, and tiered royalties after that. The Federal Trade Commission’s antitrust division has already approved the deal.
But during this blissful interlude, one key question remains: Is the Diamyd vaccine effective?
“It’s too early to say if this works. Absolutely too early. We have a phase III trial in Europe with results due next spring. And the TrialNet study [is] going on here in the U.S. So we will know in a year or 2,” Dr. Johnny L. Ludvigsson said at a conference on management of diabetes in youth sponsored by the Children’s Diabetes Foundation at Denver.
Dr. Ludvigsson, professor of pediatrics at the University of Linkoping (Sweden), led the phase III European trial evaluating whether the GAD vaccine preserves beta-cell function and residual insulin secretion in patients with type 1 diabetes diagnosed within 3 months of starting treatment. He also headed a phase II study that caused a favorable buzz within the diabetes research community (N. Engl. J. Med. 2008;359:1909-20) and for which he is now analyzing 5-year follow-up data.
And while the forthcoming phase III trial results will tell the tale as to clinical efficacy, at this time some useful interim observations can be made about the GAD vaccine, according to Dr. Ludvigsson:
• The vaccine has demonstrated excellent safety. Experience with the vaccine to date totals 850 patient-years in adults and 350 patient-years in children, with no adverse events reported. This is enormously reassuring because GAD transforms glutamate into GABA, an important neurotransmitter. Lack of GAD in the CNS leads to muscle rigidity and convulsions, while stimulation of CNS GAD results in inhibition of neurotransmission. The absence of any such adverse events indicates the vaccine is working, as designed, to affect only a very small part of the immune system: namely, the activated T cells that have targeted pancreatic beta-cells for destruction, Dr. Ludvigsson said.
• The vaccine has demonstrated prolonged immunologic effects. The immunologic response to the Diamyd vaccine lasts surprisingly long – approaching 5 years and still counting. It’s a GAD-specific, cell-mediated, and humoral immune response characterized by increased GAD autoantibodies, a Th2 shift marked by reduction in activated T cells and an increase in regulatory T cells, a sharp and sustained rise in levels of interleukins-2, -5, -10, -13, and -17, and GAD tolerance. “We see this response still after 4 years. The memory is there,” Dr. Ludvigsson observed.
• “The earlier we treat, the better the outcome.” That’s why the phase III European trial is restricted to patients diagnosed with type 1 diabetes within the past 3 months. It’s also the impetus for ongoing prevention trials in individuals at very high genetic risk for type 1 diabetes who have GAD autoantibodies but have not developed overt disease.
• The vaccine probably won’t work in diabetic patients without GAD autoantibodies. No studies have been carried out in such patients, but Dr. Ludvigsson said it’s his impression that the vaccine is more effective in individuals with higher than lower titers of GAD autoantibodies.
For the future, the GAD vaccine alone probably is not the solution to type 1 diabetes, Dr. Ludvigsson said candidly.
“I believe this opens the door to using different antigens, like in allergy. Allergists don’t use just cat antigen in patients who have cat, dog, and house dust mite allergies. I suppose we may also learn to combine autoantigens, together with possible stimulation of beta-cells in combination with drugs that promote beta-cell regeneration,” he continued.
Other autoantibodies commonly present in patients with type 1 diabetes, or at high risk for the disease, include insulin autoantibodies, islet cell autoantibodies, and antibodies to the zinc transporter. Combining the GAD vaccine with other major diabetes-specific autoantigens recognized by the immune system could provide synergistic benefits.
The likely necessity for a combined approach addressing multiple pathways was underscored in a separate presentation by Dr. Jay S. Skyler, chairman of the type 1 Diabetes TrialNet, a National Institutes of Health–funded international network of centers conducting clinical trials of diabetes therapies.
The GAD vaccine appears to have the same limitation as the other immunomodulatory therapies evaluated to date in clinical trials, including the B cell–depleting anti-CD20 agent rituximab, and the anti-CD3 biologics teplizumab and otelixizumab: namely, they preserve beta cell function for a while, but the effect is transient. Eventually fasting C-peptide levels start to fall off in parallel to the placebo group. That’s why combination therapy will probably be required in order to cure or prevent Type 1 diabetes, according to Dr. Skyler, a professor of medicine, pediatrics and psychology at the University of Miami.
Ideally, a combination therapy should be multipronged, with three goals: Stop immune destruction, preserve beta-cell mass, and replace or regenerate beta-cells. Such a regimen might start off with a potent anti-inflammatory therapy – perhaps an anti-interleukin-1beta agent or tumor necrosis factor inhibitor – to quell the metabolic stress surrounding the pancreatic islets. This might well need to be given on a continuing basis.
Next would come an immunomodulatory approach; for example, T-cell modulation with an anti-CD3 biologic or B cell depletion with rituximab. This could be followed up with an autoantigen-specific therapy such as the GAD vaccine or oral insulin. “Maybe it needs to be both,” Dr. Skyler continued.
The logical subsequent step would be to try to stimulate immunologic expansion of regulatory T cells, either with granulocyte colony–stimulating factor or by direct infusion of regulatory T cells themselves. This could be combined with beta-cell expansion via exenatide (Byetta) or the investigational HIP2B peptide.
“We could conceivably be doing some of these things even today,” Dr. Skyler said.
Dr. Ludvigsson reported receiving research grant support from Diamyd.
Dr. Skyler has served as a consultant to and/or received research grants from numerous pharmaceutical companies.
Type 1 diabetes (T1D) is an autoimmune disease caused by interplay of genetic and environmental factors. The incidence of childhood T1D has doubled worldwide over the past 20-25 years. Elimination of the environmental agent(s) responsible for this epidemic would be the most efficient approach to primary prevention; however, more work is needed to identify the environmental agents and to develop effective interventions.
Blocking progression from islet autoimmunity to clinical diabetes or secondary prevention has been attempted, so far to no avail, by a number of groups, including large randomized trials: the Diabetes Prevention Trial – Type 1, the European Nicotinamide Diabetes Intervention Trial, and the Type 1 Diabetes Prediction and Prevention Project.
Trials in patients with newly diagnosed T1D aim at tertiary prevention, such as preservation of remaining islet beta-cells to induce and prolong partial remission. Unfortunately, most islets have already been destroyed by the time diabetes is diagnosed and complete reversal of diabetes is highly unlikely. Benefits may include a simpler insulin regimen, lower HbA1c, and reduced risk of hypoglycemia and microvascular complications. The gain may be even greater if the intervention is applied as soon as the patient shows asymptomatic “dysglycemia,” detected by oral glucose tolerance test or A1c, before overt symptoms of diabetes.
While new interventions are often tested first in patients with established diabetes, and, when proven safe, applied to patients with pre-T1D, efficacy after diagnosis of diabetes is not to be a precondition to application in pre-T1D, as there may be a “point of no return” in the destruction of the islets, rendering some interventions effective only at the earlier stages of the process.
Antigen-specific vaccines
Among several approaches to prevention of T1D, “vaccination” using islet autoantigens (intact or altered peptides derived from insulin, GAD65 or other proteins) stands out as potentially inducing long-term tolerance by induction of regulatory T-cells that down-regulate immunity to autoantigens. Until recently, trials of insulin administered parenterally, orally, or intranasally have been unsuccessful. Therefore, the initial results from trials of the Diamyd vaccine, as reviewed here, were greeted with huge interest and excitement. The vaccine includes the whole recombinant human GAD65 (rhGAD65) molecule suspended in alum. The protective effect was most pronounced in patients treated within 3 months of diagnosis, and no serious side effects were observed.
Insulin-related molecules continue to attract great interest in vaccine development. Phase I studies have been completed or are nearing completion for a proinsulin peptide C19-A3, an insulin peptide with incomplete Freund adjuvant, and a plasmid encoding proinsulin.
Combination therapies may enhance efficacy while lowering risk of adverse events if utilizing therapies from different treatment pathways. While more targeted therapies are being employed, immunomodulatory agents are still relatively nonspecific and potentially toxic to some of the trial participants. Some may carry an unacceptable risk of long-term complications. This direction is important; however, multiple scientific and logistic issues remain, for example, the anticipated duration, toxicity, and complexity of immunotherapy.
In the long run, primary prevention will likely be the optimal approach to the prevention of T1D. Once more than one islet autoantibody is present, most individuals progress to diabetes in 5-10 years. The TrialNet consortium (www.diabetestrialnet.org) systematically evaluates therapies in new-onset patients as well as in pre-diabetic subjects, and invites proposals from the research community at large.
Marian Rewers, M.D., Ph.D., is professor of pediatrics and preventive medicine at the Barbara Davis Center for Childhood Diabetes, University of Colorado, Denver.
Type 1 diabetes (T1D) is an autoimmune disease caused by interplay of genetic and environmental factors. The incidence of childhood T1D has doubled worldwide over the past 20-25 years. Elimination of the environmental agent(s) responsible for this epidemic would be the most efficient approach to primary prevention; however, more work is needed to identify the environmental agents and to develop effective interventions.
Blocking progression from islet autoimmunity to clinical diabetes or secondary prevention has been attempted, so far to no avail, by a number of groups, including large randomized trials: the Diabetes Prevention Trial – Type 1, the European Nicotinamide Diabetes Intervention Trial, and the Type 1 Diabetes Prediction and Prevention Project.
Trials in patients with newly diagnosed T1D aim at tertiary prevention, such as preservation of remaining islet beta-cells to induce and prolong partial remission. Unfortunately, most islets have already been destroyed by the time diabetes is diagnosed and complete reversal of diabetes is highly unlikely. Benefits may include a simpler insulin regimen, lower HbA1c, and reduced risk of hypoglycemia and microvascular complications. The gain may be even greater if the intervention is applied as soon as the patient shows asymptomatic “dysglycemia,” detected by oral glucose tolerance test or A1c, before overt symptoms of diabetes.
While new interventions are often tested first in patients with established diabetes, and, when proven safe, applied to patients with pre-T1D, efficacy after diagnosis of diabetes is not to be a precondition to application in pre-T1D, as there may be a “point of no return” in the destruction of the islets, rendering some interventions effective only at the earlier stages of the process.
Antigen-specific vaccines
Among several approaches to prevention of T1D, “vaccination” using islet autoantigens (intact or altered peptides derived from insulin, GAD65 or other proteins) stands out as potentially inducing long-term tolerance by induction of regulatory T-cells that down-regulate immunity to autoantigens. Until recently, trials of insulin administered parenterally, orally, or intranasally have been unsuccessful. Therefore, the initial results from trials of the Diamyd vaccine, as reviewed here, were greeted with huge interest and excitement. The vaccine includes the whole recombinant human GAD65 (rhGAD65) molecule suspended in alum. The protective effect was most pronounced in patients treated within 3 months of diagnosis, and no serious side effects were observed.
Insulin-related molecules continue to attract great interest in vaccine development. Phase I studies have been completed or are nearing completion for a proinsulin peptide C19-A3, an insulin peptide with incomplete Freund adjuvant, and a plasmid encoding proinsulin.
Combination therapies may enhance efficacy while lowering risk of adverse events if utilizing therapies from different treatment pathways. While more targeted therapies are being employed, immunomodulatory agents are still relatively nonspecific and potentially toxic to some of the trial participants. Some may carry an unacceptable risk of long-term complications. This direction is important; however, multiple scientific and logistic issues remain, for example, the anticipated duration, toxicity, and complexity of immunotherapy.
In the long run, primary prevention will likely be the optimal approach to the prevention of T1D. Once more than one islet autoantibody is present, most individuals progress to diabetes in 5-10 years. The TrialNet consortium (www.diabetestrialnet.org) systematically evaluates therapies in new-onset patients as well as in pre-diabetic subjects, and invites proposals from the research community at large.
Marian Rewers, M.D., Ph.D., is professor of pediatrics and preventive medicine at the Barbara Davis Center for Childhood Diabetes, University of Colorado, Denver.
Type 1 diabetes (T1D) is an autoimmune disease caused by interplay of genetic and environmental factors. The incidence of childhood T1D has doubled worldwide over the past 20-25 years. Elimination of the environmental agent(s) responsible for this epidemic would be the most efficient approach to primary prevention; however, more work is needed to identify the environmental agents and to develop effective interventions.
Blocking progression from islet autoimmunity to clinical diabetes or secondary prevention has been attempted, so far to no avail, by a number of groups, including large randomized trials: the Diabetes Prevention Trial – Type 1, the European Nicotinamide Diabetes Intervention Trial, and the Type 1 Diabetes Prediction and Prevention Project.
Trials in patients with newly diagnosed T1D aim at tertiary prevention, such as preservation of remaining islet beta-cells to induce and prolong partial remission. Unfortunately, most islets have already been destroyed by the time diabetes is diagnosed and complete reversal of diabetes is highly unlikely. Benefits may include a simpler insulin regimen, lower HbA1c, and reduced risk of hypoglycemia and microvascular complications. The gain may be even greater if the intervention is applied as soon as the patient shows asymptomatic “dysglycemia,” detected by oral glucose tolerance test or A1c, before overt symptoms of diabetes.
While new interventions are often tested first in patients with established diabetes, and, when proven safe, applied to patients with pre-T1D, efficacy after diagnosis of diabetes is not to be a precondition to application in pre-T1D, as there may be a “point of no return” in the destruction of the islets, rendering some interventions effective only at the earlier stages of the process.
Antigen-specific vaccines
Among several approaches to prevention of T1D, “vaccination” using islet autoantigens (intact or altered peptides derived from insulin, GAD65 or other proteins) stands out as potentially inducing long-term tolerance by induction of regulatory T-cells that down-regulate immunity to autoantigens. Until recently, trials of insulin administered parenterally, orally, or intranasally have been unsuccessful. Therefore, the initial results from trials of the Diamyd vaccine, as reviewed here, were greeted with huge interest and excitement. The vaccine includes the whole recombinant human GAD65 (rhGAD65) molecule suspended in alum. The protective effect was most pronounced in patients treated within 3 months of diagnosis, and no serious side effects were observed.
Insulin-related molecules continue to attract great interest in vaccine development. Phase I studies have been completed or are nearing completion for a proinsulin peptide C19-A3, an insulin peptide with incomplete Freund adjuvant, and a plasmid encoding proinsulin.
Combination therapies may enhance efficacy while lowering risk of adverse events if utilizing therapies from different treatment pathways. While more targeted therapies are being employed, immunomodulatory agents are still relatively nonspecific and potentially toxic to some of the trial participants. Some may carry an unacceptable risk of long-term complications. This direction is important; however, multiple scientific and logistic issues remain, for example, the anticipated duration, toxicity, and complexity of immunotherapy.
In the long run, primary prevention will likely be the optimal approach to the prevention of T1D. Once more than one islet autoantibody is present, most individuals progress to diabetes in 5-10 years. The TrialNet consortium (www.diabetestrialnet.org) systematically evaluates therapies in new-onset patients as well as in pre-diabetic subjects, and invites proposals from the research community at large.
Marian Rewers, M.D., Ph.D., is professor of pediatrics and preventive medicine at the Barbara Davis Center for Childhood Diabetes, University of Colorado, Denver.
KEYSTONE, Colo. – Right now, the Diamyd Medical’s GAD vaccine is in the sweet spot in the developmental pipeline – an interim period of enormous optimism that this novel autoantigen-based immunotherapy will safely prevent many cases of type 1 diabetes.
The results of three phase II studies are in and they look quite promising. Two large phase III clinical trials are well underway in Europe and the United States. The safety experience with the 65-kD isoform of GAD (glutamic acid decarboxylase-65) vaccine has been outstanding. The subcutaneous two-injection series is easy to administer. Acceptance of the vaccine by patients and their families is high. The vaccine targets a serious disease whose incidence is steadily climbing by 3%-5% per year in developed countries. And most patients with recently diagnosed type 1 diabetes possess GAD autoantibodies, so the Diamyd vaccine would be widely applicable.
All of that was good enough for Johnson and Johnson, which in June inked a huge development and marketing deal for the GAD vaccine with small Swedish biotech company Diamyd Medical. Under the deal, Diamyd receives $45 million upfront, milestone payments of up to $580 million, and tiered royalties after that. The Federal Trade Commission’s antitrust division has already approved the deal.
But during this blissful interlude, one key question remains: Is the Diamyd vaccine effective?
“It’s too early to say if this works. Absolutely too early. We have a phase III trial in Europe with results due next spring. And the TrialNet study [is] going on here in the U.S. So we will know in a year or 2,” Dr. Johnny L. Ludvigsson said at a conference on management of diabetes in youth sponsored by the Children’s Diabetes Foundation at Denver.
Dr. Ludvigsson, professor of pediatrics at the University of Linkoping (Sweden), led the phase III European trial evaluating whether the GAD vaccine preserves beta-cell function and residual insulin secretion in patients with type 1 diabetes diagnosed within 3 months of starting treatment. He also headed a phase II study that caused a favorable buzz within the diabetes research community (N. Engl. J. Med. 2008;359:1909-20) and for which he is now analyzing 5-year follow-up data.
And while the forthcoming phase III trial results will tell the tale as to clinical efficacy, at this time some useful interim observations can be made about the GAD vaccine, according to Dr. Ludvigsson:
• The vaccine has demonstrated excellent safety. Experience with the vaccine to date totals 850 patient-years in adults and 350 patient-years in children, with no adverse events reported. This is enormously reassuring because GAD transforms glutamate into GABA, an important neurotransmitter. Lack of GAD in the CNS leads to muscle rigidity and convulsions, while stimulation of CNS GAD results in inhibition of neurotransmission. The absence of any such adverse events indicates the vaccine is working, as designed, to affect only a very small part of the immune system: namely, the activated T cells that have targeted pancreatic beta-cells for destruction, Dr. Ludvigsson said.
• The vaccine has demonstrated prolonged immunologic effects. The immunologic response to the Diamyd vaccine lasts surprisingly long – approaching 5 years and still counting. It’s a GAD-specific, cell-mediated, and humoral immune response characterized by increased GAD autoantibodies, a Th2 shift marked by reduction in activated T cells and an increase in regulatory T cells, a sharp and sustained rise in levels of interleukins-2, -5, -10, -13, and -17, and GAD tolerance. “We see this response still after 4 years. The memory is there,” Dr. Ludvigsson observed.
• “The earlier we treat, the better the outcome.” That’s why the phase III European trial is restricted to patients diagnosed with type 1 diabetes within the past 3 months. It’s also the impetus for ongoing prevention trials in individuals at very high genetic risk for type 1 diabetes who have GAD autoantibodies but have not developed overt disease.
• The vaccine probably won’t work in diabetic patients without GAD autoantibodies. No studies have been carried out in such patients, but Dr. Ludvigsson said it’s his impression that the vaccine is more effective in individuals with higher than lower titers of GAD autoantibodies.
For the future, the GAD vaccine alone probably is not the solution to type 1 diabetes, Dr. Ludvigsson said candidly.
“I believe this opens the door to using different antigens, like in allergy. Allergists don’t use just cat antigen in patients who have cat, dog, and house dust mite allergies. I suppose we may also learn to combine autoantigens, together with possible stimulation of beta-cells in combination with drugs that promote beta-cell regeneration,” he continued.
Other autoantibodies commonly present in patients with type 1 diabetes, or at high risk for the disease, include insulin autoantibodies, islet cell autoantibodies, and antibodies to the zinc transporter. Combining the GAD vaccine with other major diabetes-specific autoantigens recognized by the immune system could provide synergistic benefits.
The likely necessity for a combined approach addressing multiple pathways was underscored in a separate presentation by Dr. Jay S. Skyler, chairman of the type 1 Diabetes TrialNet, a National Institutes of Health–funded international network of centers conducting clinical trials of diabetes therapies.
The GAD vaccine appears to have the same limitation as the other immunomodulatory therapies evaluated to date in clinical trials, including the B cell–depleting anti-CD20 agent rituximab, and the anti-CD3 biologics teplizumab and otelixizumab: namely, they preserve beta cell function for a while, but the effect is transient. Eventually fasting C-peptide levels start to fall off in parallel to the placebo group. That’s why combination therapy will probably be required in order to cure or prevent Type 1 diabetes, according to Dr. Skyler, a professor of medicine, pediatrics and psychology at the University of Miami.
Ideally, a combination therapy should be multipronged, with three goals: Stop immune destruction, preserve beta-cell mass, and replace or regenerate beta-cells. Such a regimen might start off with a potent anti-inflammatory therapy – perhaps an anti-interleukin-1beta agent or tumor necrosis factor inhibitor – to quell the metabolic stress surrounding the pancreatic islets. This might well need to be given on a continuing basis.
Next would come an immunomodulatory approach; for example, T-cell modulation with an anti-CD3 biologic or B cell depletion with rituximab. This could be followed up with an autoantigen-specific therapy such as the GAD vaccine or oral insulin. “Maybe it needs to be both,” Dr. Skyler continued.
The logical subsequent step would be to try to stimulate immunologic expansion of regulatory T cells, either with granulocyte colony–stimulating factor or by direct infusion of regulatory T cells themselves. This could be combined with beta-cell expansion via exenatide (Byetta) or the investigational HIP2B peptide.
“We could conceivably be doing some of these things even today,” Dr. Skyler said.
Dr. Ludvigsson reported receiving research grant support from Diamyd.
Dr. Skyler has served as a consultant to and/or received research grants from numerous pharmaceutical companies.
KEYSTONE, Colo. – Right now, the Diamyd Medical’s GAD vaccine is in the sweet spot in the developmental pipeline – an interim period of enormous optimism that this novel autoantigen-based immunotherapy will safely prevent many cases of type 1 diabetes.
The results of three phase II studies are in and they look quite promising. Two large phase III clinical trials are well underway in Europe and the United States. The safety experience with the 65-kD isoform of GAD (glutamic acid decarboxylase-65) vaccine has been outstanding. The subcutaneous two-injection series is easy to administer. Acceptance of the vaccine by patients and their families is high. The vaccine targets a serious disease whose incidence is steadily climbing by 3%-5% per year in developed countries. And most patients with recently diagnosed type 1 diabetes possess GAD autoantibodies, so the Diamyd vaccine would be widely applicable.
All of that was good enough for Johnson and Johnson, which in June inked a huge development and marketing deal for the GAD vaccine with small Swedish biotech company Diamyd Medical. Under the deal, Diamyd receives $45 million upfront, milestone payments of up to $580 million, and tiered royalties after that. The Federal Trade Commission’s antitrust division has already approved the deal.
But during this blissful interlude, one key question remains: Is the Diamyd vaccine effective?
“It’s too early to say if this works. Absolutely too early. We have a phase III trial in Europe with results due next spring. And the TrialNet study [is] going on here in the U.S. So we will know in a year or 2,” Dr. Johnny L. Ludvigsson said at a conference on management of diabetes in youth sponsored by the Children’s Diabetes Foundation at Denver.
Dr. Ludvigsson, professor of pediatrics at the University of Linkoping (Sweden), led the phase III European trial evaluating whether the GAD vaccine preserves beta-cell function and residual insulin secretion in patients with type 1 diabetes diagnosed within 3 months of starting treatment. He also headed a phase II study that caused a favorable buzz within the diabetes research community (N. Engl. J. Med. 2008;359:1909-20) and for which he is now analyzing 5-year follow-up data.
And while the forthcoming phase III trial results will tell the tale as to clinical efficacy, at this time some useful interim observations can be made about the GAD vaccine, according to Dr. Ludvigsson:
• The vaccine has demonstrated excellent safety. Experience with the vaccine to date totals 850 patient-years in adults and 350 patient-years in children, with no adverse events reported. This is enormously reassuring because GAD transforms glutamate into GABA, an important neurotransmitter. Lack of GAD in the CNS leads to muscle rigidity and convulsions, while stimulation of CNS GAD results in inhibition of neurotransmission. The absence of any such adverse events indicates the vaccine is working, as designed, to affect only a very small part of the immune system: namely, the activated T cells that have targeted pancreatic beta-cells for destruction, Dr. Ludvigsson said.
• The vaccine has demonstrated prolonged immunologic effects. The immunologic response to the Diamyd vaccine lasts surprisingly long – approaching 5 years and still counting. It’s a GAD-specific, cell-mediated, and humoral immune response characterized by increased GAD autoantibodies, a Th2 shift marked by reduction in activated T cells and an increase in regulatory T cells, a sharp and sustained rise in levels of interleukins-2, -5, -10, -13, and -17, and GAD tolerance. “We see this response still after 4 years. The memory is there,” Dr. Ludvigsson observed.
• “The earlier we treat, the better the outcome.” That’s why the phase III European trial is restricted to patients diagnosed with type 1 diabetes within the past 3 months. It’s also the impetus for ongoing prevention trials in individuals at very high genetic risk for type 1 diabetes who have GAD autoantibodies but have not developed overt disease.
• The vaccine probably won’t work in diabetic patients without GAD autoantibodies. No studies have been carried out in such patients, but Dr. Ludvigsson said it’s his impression that the vaccine is more effective in individuals with higher than lower titers of GAD autoantibodies.
For the future, the GAD vaccine alone probably is not the solution to type 1 diabetes, Dr. Ludvigsson said candidly.
“I believe this opens the door to using different antigens, like in allergy. Allergists don’t use just cat antigen in patients who have cat, dog, and house dust mite allergies. I suppose we may also learn to combine autoantigens, together with possible stimulation of beta-cells in combination with drugs that promote beta-cell regeneration,” he continued.
Other autoantibodies commonly present in patients with type 1 diabetes, or at high risk for the disease, include insulin autoantibodies, islet cell autoantibodies, and antibodies to the zinc transporter. Combining the GAD vaccine with other major diabetes-specific autoantigens recognized by the immune system could provide synergistic benefits.
The likely necessity for a combined approach addressing multiple pathways was underscored in a separate presentation by Dr. Jay S. Skyler, chairman of the type 1 Diabetes TrialNet, a National Institutes of Health–funded international network of centers conducting clinical trials of diabetes therapies.
The GAD vaccine appears to have the same limitation as the other immunomodulatory therapies evaluated to date in clinical trials, including the B cell–depleting anti-CD20 agent rituximab, and the anti-CD3 biologics teplizumab and otelixizumab: namely, they preserve beta cell function for a while, but the effect is transient. Eventually fasting C-peptide levels start to fall off in parallel to the placebo group. That’s why combination therapy will probably be required in order to cure or prevent Type 1 diabetes, according to Dr. Skyler, a professor of medicine, pediatrics and psychology at the University of Miami.
Ideally, a combination therapy should be multipronged, with three goals: Stop immune destruction, preserve beta-cell mass, and replace or regenerate beta-cells. Such a regimen might start off with a potent anti-inflammatory therapy – perhaps an anti-interleukin-1beta agent or tumor necrosis factor inhibitor – to quell the metabolic stress surrounding the pancreatic islets. This might well need to be given on a continuing basis.
Next would come an immunomodulatory approach; for example, T-cell modulation with an anti-CD3 biologic or B cell depletion with rituximab. This could be followed up with an autoantigen-specific therapy such as the GAD vaccine or oral insulin. “Maybe it needs to be both,” Dr. Skyler continued.
The logical subsequent step would be to try to stimulate immunologic expansion of regulatory T cells, either with granulocyte colony–stimulating factor or by direct infusion of regulatory T cells themselves. This could be combined with beta-cell expansion via exenatide (Byetta) or the investigational HIP2B peptide.
“We could conceivably be doing some of these things even today,” Dr. Skyler said.
Dr. Ludvigsson reported receiving research grant support from Diamyd.
Dr. Skyler has served as a consultant to and/or received research grants from numerous pharmaceutical companies.
GAD Vaccine for Type 1 Diabetes Shows Continued Promise
KEYSTONE, Colo. – Right now, the Diamyd Medical’s GAD vaccine is in the sweet spot in the developmental pipeline – an interim period of enormous optimism that this novel autoantigen-based immunotherapy will safely prevent many cases of type 1 diabetes.
The results of three phase II studies are in and they look quite promising. Two large phase III clinical trials are well underway in Europe and the United States. The safety experience with the 65-kD isoform of GAD (glutamic acid decarboxylase-65) vaccine has been outstanding. The subcutaneous two-injection series is easy to administer. Acceptance of the vaccine by patients and their families is high. The vaccine targets a serious disease whose incidence is steadily climbing by 3%-5% per year in developed countries. And most patients with recently diagnosed type 1 diabetes possess GAD autoantibodies, so the Diamyd vaccine would be widely applicable.
All of that was good enough for Johnson and Johnson, which in June inked a huge development and marketing deal for the GAD vaccine with small Swedish biotech company Diamyd Medical. Under the deal, Diamyd receives $45 million upfront, milestone payments of up to $580 million, and tiered royalties after that. The Federal Trade Commission’s antitrust division has already approved the deal.
But during this blissful interlude, one key question remains: Is the Diamyd vaccine effective?
“It’s too early to say if this works. Absolutely too early. We have a phase III trial in Europe with results due next spring. And the TrialNet study [is] going on here in the U.S. So we will know in a year or 2,” Dr. Johnny L. Ludvigsson said at a conference on management of diabetes in youth sponsored by the Children’s Diabetes Foundation at Denver.
Dr. Ludvigsson, professor of pediatrics at the University of Linkoping (Sweden), led the phase III European trial evaluating whether the GAD vaccine preserves beta-cell function and residual insulin secretion in patients with type 1 diabetes diagnosed within 3 months of starting treatment. He also headed a phase II study that caused a favorable buzz within the diabetes research community (N. Engl. J. Med. 2008;359:1909-20) and for which he is now analyzing 5-year follow-up data.
And while the forthcoming phase III trial results will tell the tale as to clinical efficacy, at this time some useful interim observations can be made about the GAD vaccine, according to Dr. Ludvigsson:
• The vaccine has demonstrated excellent safety. Experience with the vaccine to date totals 850 patient-years in adults and 350 patient-years in children, with no adverse events reported. This is enormously reassuring because GAD transforms glutamate into GABA, an important neurotransmitter. Lack of GAD in the CNS leads to muscle rigidity and convulsions, while stimulation of CNS GAD results in inhibition of neurotransmission. The absence of any such adverse events indicates the vaccine is working, as designed, to affect only a very small part of the immune system: namely, the activated T cells that have targeted pancreatic beta-cells for destruction, Dr. Ludvigsson said.
• The vaccine has demonstrated prolonged immunologic effects. The immunologic response to the Diamyd vaccine lasts surprisingly long – approaching 5 years and still counting. It’s a GAD-specific, cell-mediated, and humoral immune response characterized by increased GAD autoantibodies, a Th2 shift marked by reduction in activated T cells and an increase in regulatory T cells, a sharp and sustained rise in levels of interleukins-2, -5, -10, -13, and -17, and GAD tolerance. “We see this response still after 4 years. The memory is there,” Dr. Ludvigsson observed.
• “The earlier we treat, the better the outcome.” That’s why the phase III European trial is restricted to patients diagnosed with type 1 diabetes within the past 3 months. It’s also the impetus for ongoing prevention trials in individuals at very high genetic risk for type 1 diabetes who have GAD autoantibodies but have not developed overt disease.
• The vaccine probably won’t work in diabetic patients without GAD autoantibodies. No studies have been carried out in such patients, but Dr. Ludvigsson said it’s his impression that the vaccine is more effective in individuals with higher than lower titers of GAD autoantibodies.
For the future, the GAD vaccine alone probably is not the solution to type 1 diabetes, Dr. Ludvigsson said candidly.
“I believe this opens the door to using different antigens, like in allergy. Allergists don’t use just cat antigen in patients who have cat, dog, and house dust mite allergies. I suppose we may also learn to combine autoantigens, together with possible stimulation of beta-cells in combination with drugs that promote beta-cell regeneration,” he continued.
Other autoantibodies commonly present in patients with type 1 diabetes, or at high risk for the disease, include insulin autoantibodies, islet cell autoantibodies, and antibodies to the zinc transporter. Combining the GAD vaccine with other major diabetes-specific autoantigens recognized by the immune system could provide synergistic benefits.
The likely necessity for a combined approach addressing multiple pathways was underscored in a separate presentation by Dr. Jay S. Skyler, chairman of the type 1 Diabetes TrialNet, a National Institutes of Health–funded international network of centers conducting clinical trials of diabetes therapies.
The GAD vaccine appears to have the same limitation as the other immunomodulatory therapies evaluated to date in clinical trials, including the B cell–depleting anti-CD20 agent rituximab, and the anti-CD3 biologics teplizumab and otelixizumab: namely, they preserve beta cell function for a while, but the effect is transient. Eventually fasting C-peptide levels start to fall off in parallel to the placebo group. That’s why combination therapy will probably be required in order to cure or prevent Type 1 diabetes, according to Dr. Skyler, a professor of medicine, pediatrics and psychology at the University of Miami.
Ideally, a combination therapy should be multipronged, with three goals: Stop immune destruction, preserve beta-cell mass, and replace or regenerate beta-cells. Such a regimen might start off with a potent anti-inflammatory therapy – perhaps an anti-interleukin-1beta agent or tumor necrosis factor inhibitor – to quell the metabolic stress surrounding the pancreatic islets. This might well need to be given on a continuing basis.
Next would come an immunomodulatory approach; for example, T-cell modulation with an anti-CD3 biologic or B cell depletion with rituximab. This could be followed up with an autoantigen-specific therapy such as the GAD vaccine or oral insulin. “Maybe it needs to be both,” Dr. Skyler continued.
The logical subsequent step would be to try to stimulate immunologic expansion of regulatory T cells, either with granulocyte colony–stimulating factor or by direct infusion of regulatory T cells themselves. This could be combined with beta-cell expansion via exenatide (Byetta) or the investigational HIP2B peptide.
“We could conceivably be doing some of these things even today,” Dr. Skyler said.
Dr. Ludvigsson reported receiving research grant support from Diamyd.
Dr. Skyler has served as a consultant to and/or received research grants from numerous pharmaceutical companies.
Type 1 diabetes (T1D) is an autoimmune disease caused by interplay of genetic and environmental factors. The incidence of childhood T1D has doubled worldwide over the past 20-25 years. Elimination of the environmental agent(s) responsible for this epidemic would be the most efficient approach to primary prevention; however, more work is needed to identify the environmental agents and to develop effective interventions.
Blocking progression from islet autoimmunity to clinical diabetes or secondary prevention has been attempted, so far to no avail, by a number of groups, including large randomized trials: the Diabetes Prevention Trial – Type 1, the European Nicotinamide Diabetes Intervention Trial, and the Type 1 Diabetes Prediction and Prevention Project.
Trials in patients with newly diagnosed T1D aim at tertiary prevention, such as preservation of remaining islet beta-cells to induce and prolong partial remission. Unfortunately, most islets have already been destroyed by the time diabetes is diagnosed and complete reversal of diabetes is highly unlikely. Benefits may include a simpler insulin regimen, lower HbA1c, and reduced risk of hypoglycemia and microvascular complications. The gain may be even greater if the intervention is applied as soon as the patient shows asymptomatic “dysglycemia,” detected by oral glucose tolerance test or A1c, before overt symptoms of diabetes.
While new interventions are often tested first in patients with established diabetes, and, when proven safe, applied to patients with pre-T1D, efficacy after diagnosis of diabetes is not to be a precondition to application in pre-T1D, as there may be a “point of no return” in the destruction of the islets, rendering some interventions effective only at the earlier stages of the process.
Antigen-specific vaccines
Among several approaches to prevention of T1D, “vaccination” using islet autoantigens (intact or altered peptides derived from insulin, GAD65 or other proteins) stands out as potentially inducing long-term tolerance by induction of regulatory T-cells that down-regulate immunity to autoantigens. Until recently, trials of insulin administered parenterally, orally, or intranasally have been unsuccessful. Therefore, the initial results from trials of the Diamyd vaccine, as reviewed here, were greeted with huge interest and excitement. The vaccine includes the whole recombinant human GAD65 (rhGAD65) molecule suspended in alum. The protective effect was most pronounced in patients treated within 3 months of diagnosis, and no serious side effects were observed.
Insulin-related molecules continue to attract great interest in vaccine development. Phase I studies have been completed or are nearing completion for a proinsulin peptide C19-A3, an insulin peptide with incomplete Freund adjuvant, and a plasmid encoding proinsulin.
Combination therapies may enhance efficacy while lowering risk of adverse events if utilizing therapies from different treatment pathways. While more targeted therapies are being employed, immunomodulatory agents are still relatively nonspecific and potentially toxic to some of the trial participants. Some may carry an unacceptable risk of long-term complications. This direction is important; however, multiple scientific and logistic issues remain, for example, the anticipated duration, toxicity, and complexity of immunotherapy.
In the long run, primary prevention will likely be the optimal approach to the prevention of T1D. Once more than one islet autoantibody is present, most individuals progress to diabetes in 5-10 years. The TrialNet consortium (www.diabetestrialnet.org) systematically evaluates therapies in new-onset patients as well as in pre-diabetic subjects, and invites proposals from the research community at large.
Marian Rewers, M.D., Ph.D., is professor of pediatrics and preventive medicine at the Barbara Davis Center for Childhood Diabetes, University of Colorado, Denver.
Type 1 diabetes (T1D) is an autoimmune disease caused by interplay of genetic and environmental factors. The incidence of childhood T1D has doubled worldwide over the past 20-25 years. Elimination of the environmental agent(s) responsible for this epidemic would be the most efficient approach to primary prevention; however, more work is needed to identify the environmental agents and to develop effective interventions.
Blocking progression from islet autoimmunity to clinical diabetes or secondary prevention has been attempted, so far to no avail, by a number of groups, including large randomized trials: the Diabetes Prevention Trial – Type 1, the European Nicotinamide Diabetes Intervention Trial, and the Type 1 Diabetes Prediction and Prevention Project.
Trials in patients with newly diagnosed T1D aim at tertiary prevention, such as preservation of remaining islet beta-cells to induce and prolong partial remission. Unfortunately, most islets have already been destroyed by the time diabetes is diagnosed and complete reversal of diabetes is highly unlikely. Benefits may include a simpler insulin regimen, lower HbA1c, and reduced risk of hypoglycemia and microvascular complications. The gain may be even greater if the intervention is applied as soon as the patient shows asymptomatic “dysglycemia,” detected by oral glucose tolerance test or A1c, before overt symptoms of diabetes.
While new interventions are often tested first in patients with established diabetes, and, when proven safe, applied to patients with pre-T1D, efficacy after diagnosis of diabetes is not to be a precondition to application in pre-T1D, as there may be a “point of no return” in the destruction of the islets, rendering some interventions effective only at the earlier stages of the process.
Antigen-specific vaccines
Among several approaches to prevention of T1D, “vaccination” using islet autoantigens (intact or altered peptides derived from insulin, GAD65 or other proteins) stands out as potentially inducing long-term tolerance by induction of regulatory T-cells that down-regulate immunity to autoantigens. Until recently, trials of insulin administered parenterally, orally, or intranasally have been unsuccessful. Therefore, the initial results from trials of the Diamyd vaccine, as reviewed here, were greeted with huge interest and excitement. The vaccine includes the whole recombinant human GAD65 (rhGAD65) molecule suspended in alum. The protective effect was most pronounced in patients treated within 3 months of diagnosis, and no serious side effects were observed.
Insulin-related molecules continue to attract great interest in vaccine development. Phase I studies have been completed or are nearing completion for a proinsulin peptide C19-A3, an insulin peptide with incomplete Freund adjuvant, and a plasmid encoding proinsulin.
Combination therapies may enhance efficacy while lowering risk of adverse events if utilizing therapies from different treatment pathways. While more targeted therapies are being employed, immunomodulatory agents are still relatively nonspecific and potentially toxic to some of the trial participants. Some may carry an unacceptable risk of long-term complications. This direction is important; however, multiple scientific and logistic issues remain, for example, the anticipated duration, toxicity, and complexity of immunotherapy.
In the long run, primary prevention will likely be the optimal approach to the prevention of T1D. Once more than one islet autoantibody is present, most individuals progress to diabetes in 5-10 years. The TrialNet consortium (www.diabetestrialnet.org) systematically evaluates therapies in new-onset patients as well as in pre-diabetic subjects, and invites proposals from the research community at large.
Marian Rewers, M.D., Ph.D., is professor of pediatrics and preventive medicine at the Barbara Davis Center for Childhood Diabetes, University of Colorado, Denver.
Type 1 diabetes (T1D) is an autoimmune disease caused by interplay of genetic and environmental factors. The incidence of childhood T1D has doubled worldwide over the past 20-25 years. Elimination of the environmental agent(s) responsible for this epidemic would be the most efficient approach to primary prevention; however, more work is needed to identify the environmental agents and to develop effective interventions.
Blocking progression from islet autoimmunity to clinical diabetes or secondary prevention has been attempted, so far to no avail, by a number of groups, including large randomized trials: the Diabetes Prevention Trial – Type 1, the European Nicotinamide Diabetes Intervention Trial, and the Type 1 Diabetes Prediction and Prevention Project.
Trials in patients with newly diagnosed T1D aim at tertiary prevention, such as preservation of remaining islet beta-cells to induce and prolong partial remission. Unfortunately, most islets have already been destroyed by the time diabetes is diagnosed and complete reversal of diabetes is highly unlikely. Benefits may include a simpler insulin regimen, lower HbA1c, and reduced risk of hypoglycemia and microvascular complications. The gain may be even greater if the intervention is applied as soon as the patient shows asymptomatic “dysglycemia,” detected by oral glucose tolerance test or A1c, before overt symptoms of diabetes.
While new interventions are often tested first in patients with established diabetes, and, when proven safe, applied to patients with pre-T1D, efficacy after diagnosis of diabetes is not to be a precondition to application in pre-T1D, as there may be a “point of no return” in the destruction of the islets, rendering some interventions effective only at the earlier stages of the process.
Antigen-specific vaccines
Among several approaches to prevention of T1D, “vaccination” using islet autoantigens (intact or altered peptides derived from insulin, GAD65 or other proteins) stands out as potentially inducing long-term tolerance by induction of regulatory T-cells that down-regulate immunity to autoantigens. Until recently, trials of insulin administered parenterally, orally, or intranasally have been unsuccessful. Therefore, the initial results from trials of the Diamyd vaccine, as reviewed here, were greeted with huge interest and excitement. The vaccine includes the whole recombinant human GAD65 (rhGAD65) molecule suspended in alum. The protective effect was most pronounced in patients treated within 3 months of diagnosis, and no serious side effects were observed.
Insulin-related molecules continue to attract great interest in vaccine development. Phase I studies have been completed or are nearing completion for a proinsulin peptide C19-A3, an insulin peptide with incomplete Freund adjuvant, and a plasmid encoding proinsulin.
Combination therapies may enhance efficacy while lowering risk of adverse events if utilizing therapies from different treatment pathways. While more targeted therapies are being employed, immunomodulatory agents are still relatively nonspecific and potentially toxic to some of the trial participants. Some may carry an unacceptable risk of long-term complications. This direction is important; however, multiple scientific and logistic issues remain, for example, the anticipated duration, toxicity, and complexity of immunotherapy.
In the long run, primary prevention will likely be the optimal approach to the prevention of T1D. Once more than one islet autoantibody is present, most individuals progress to diabetes in 5-10 years. The TrialNet consortium (www.diabetestrialnet.org) systematically evaluates therapies in new-onset patients as well as in pre-diabetic subjects, and invites proposals from the research community at large.
Marian Rewers, M.D., Ph.D., is professor of pediatrics and preventive medicine at the Barbara Davis Center for Childhood Diabetes, University of Colorado, Denver.
KEYSTONE, Colo. – Right now, the Diamyd Medical’s GAD vaccine is in the sweet spot in the developmental pipeline – an interim period of enormous optimism that this novel autoantigen-based immunotherapy will safely prevent many cases of type 1 diabetes.
The results of three phase II studies are in and they look quite promising. Two large phase III clinical trials are well underway in Europe and the United States. The safety experience with the 65-kD isoform of GAD (glutamic acid decarboxylase-65) vaccine has been outstanding. The subcutaneous two-injection series is easy to administer. Acceptance of the vaccine by patients and their families is high. The vaccine targets a serious disease whose incidence is steadily climbing by 3%-5% per year in developed countries. And most patients with recently diagnosed type 1 diabetes possess GAD autoantibodies, so the Diamyd vaccine would be widely applicable.
All of that was good enough for Johnson and Johnson, which in June inked a huge development and marketing deal for the GAD vaccine with small Swedish biotech company Diamyd Medical. Under the deal, Diamyd receives $45 million upfront, milestone payments of up to $580 million, and tiered royalties after that. The Federal Trade Commission’s antitrust division has already approved the deal.
But during this blissful interlude, one key question remains: Is the Diamyd vaccine effective?
“It’s too early to say if this works. Absolutely too early. We have a phase III trial in Europe with results due next spring. And the TrialNet study [is] going on here in the U.S. So we will know in a year or 2,” Dr. Johnny L. Ludvigsson said at a conference on management of diabetes in youth sponsored by the Children’s Diabetes Foundation at Denver.
Dr. Ludvigsson, professor of pediatrics at the University of Linkoping (Sweden), led the phase III European trial evaluating whether the GAD vaccine preserves beta-cell function and residual insulin secretion in patients with type 1 diabetes diagnosed within 3 months of starting treatment. He also headed a phase II study that caused a favorable buzz within the diabetes research community (N. Engl. J. Med. 2008;359:1909-20) and for which he is now analyzing 5-year follow-up data.
And while the forthcoming phase III trial results will tell the tale as to clinical efficacy, at this time some useful interim observations can be made about the GAD vaccine, according to Dr. Ludvigsson:
• The vaccine has demonstrated excellent safety. Experience with the vaccine to date totals 850 patient-years in adults and 350 patient-years in children, with no adverse events reported. This is enormously reassuring because GAD transforms glutamate into GABA, an important neurotransmitter. Lack of GAD in the CNS leads to muscle rigidity and convulsions, while stimulation of CNS GAD results in inhibition of neurotransmission. The absence of any such adverse events indicates the vaccine is working, as designed, to affect only a very small part of the immune system: namely, the activated T cells that have targeted pancreatic beta-cells for destruction, Dr. Ludvigsson said.
• The vaccine has demonstrated prolonged immunologic effects. The immunologic response to the Diamyd vaccine lasts surprisingly long – approaching 5 years and still counting. It’s a GAD-specific, cell-mediated, and humoral immune response characterized by increased GAD autoantibodies, a Th2 shift marked by reduction in activated T cells and an increase in regulatory T cells, a sharp and sustained rise in levels of interleukins-2, -5, -10, -13, and -17, and GAD tolerance. “We see this response still after 4 years. The memory is there,” Dr. Ludvigsson observed.
• “The earlier we treat, the better the outcome.” That’s why the phase III European trial is restricted to patients diagnosed with type 1 diabetes within the past 3 months. It’s also the impetus for ongoing prevention trials in individuals at very high genetic risk for type 1 diabetes who have GAD autoantibodies but have not developed overt disease.
• The vaccine probably won’t work in diabetic patients without GAD autoantibodies. No studies have been carried out in such patients, but Dr. Ludvigsson said it’s his impression that the vaccine is more effective in individuals with higher than lower titers of GAD autoantibodies.
For the future, the GAD vaccine alone probably is not the solution to type 1 diabetes, Dr. Ludvigsson said candidly.
“I believe this opens the door to using different antigens, like in allergy. Allergists don’t use just cat antigen in patients who have cat, dog, and house dust mite allergies. I suppose we may also learn to combine autoantigens, together with possible stimulation of beta-cells in combination with drugs that promote beta-cell regeneration,” he continued.
Other autoantibodies commonly present in patients with type 1 diabetes, or at high risk for the disease, include insulin autoantibodies, islet cell autoantibodies, and antibodies to the zinc transporter. Combining the GAD vaccine with other major diabetes-specific autoantigens recognized by the immune system could provide synergistic benefits.
The likely necessity for a combined approach addressing multiple pathways was underscored in a separate presentation by Dr. Jay S. Skyler, chairman of the type 1 Diabetes TrialNet, a National Institutes of Health–funded international network of centers conducting clinical trials of diabetes therapies.
The GAD vaccine appears to have the same limitation as the other immunomodulatory therapies evaluated to date in clinical trials, including the B cell–depleting anti-CD20 agent rituximab, and the anti-CD3 biologics teplizumab and otelixizumab: namely, they preserve beta cell function for a while, but the effect is transient. Eventually fasting C-peptide levels start to fall off in parallel to the placebo group. That’s why combination therapy will probably be required in order to cure or prevent Type 1 diabetes, according to Dr. Skyler, a professor of medicine, pediatrics and psychology at the University of Miami.
Ideally, a combination therapy should be multipronged, with three goals: Stop immune destruction, preserve beta-cell mass, and replace or regenerate beta-cells. Such a regimen might start off with a potent anti-inflammatory therapy – perhaps an anti-interleukin-1beta agent or tumor necrosis factor inhibitor – to quell the metabolic stress surrounding the pancreatic islets. This might well need to be given on a continuing basis.
Next would come an immunomodulatory approach; for example, T-cell modulation with an anti-CD3 biologic or B cell depletion with rituximab. This could be followed up with an autoantigen-specific therapy such as the GAD vaccine or oral insulin. “Maybe it needs to be both,” Dr. Skyler continued.
The logical subsequent step would be to try to stimulate immunologic expansion of regulatory T cells, either with granulocyte colony–stimulating factor or by direct infusion of regulatory T cells themselves. This could be combined with beta-cell expansion via exenatide (Byetta) or the investigational HIP2B peptide.
“We could conceivably be doing some of these things even today,” Dr. Skyler said.
Dr. Ludvigsson reported receiving research grant support from Diamyd.
Dr. Skyler has served as a consultant to and/or received research grants from numerous pharmaceutical companies.
KEYSTONE, Colo. – Right now, the Diamyd Medical’s GAD vaccine is in the sweet spot in the developmental pipeline – an interim period of enormous optimism that this novel autoantigen-based immunotherapy will safely prevent many cases of type 1 diabetes.
The results of three phase II studies are in and they look quite promising. Two large phase III clinical trials are well underway in Europe and the United States. The safety experience with the 65-kD isoform of GAD (glutamic acid decarboxylase-65) vaccine has been outstanding. The subcutaneous two-injection series is easy to administer. Acceptance of the vaccine by patients and their families is high. The vaccine targets a serious disease whose incidence is steadily climbing by 3%-5% per year in developed countries. And most patients with recently diagnosed type 1 diabetes possess GAD autoantibodies, so the Diamyd vaccine would be widely applicable.
All of that was good enough for Johnson and Johnson, which in June inked a huge development and marketing deal for the GAD vaccine with small Swedish biotech company Diamyd Medical. Under the deal, Diamyd receives $45 million upfront, milestone payments of up to $580 million, and tiered royalties after that. The Federal Trade Commission’s antitrust division has already approved the deal.
But during this blissful interlude, one key question remains: Is the Diamyd vaccine effective?
“It’s too early to say if this works. Absolutely too early. We have a phase III trial in Europe with results due next spring. And the TrialNet study [is] going on here in the U.S. So we will know in a year or 2,” Dr. Johnny L. Ludvigsson said at a conference on management of diabetes in youth sponsored by the Children’s Diabetes Foundation at Denver.
Dr. Ludvigsson, professor of pediatrics at the University of Linkoping (Sweden), led the phase III European trial evaluating whether the GAD vaccine preserves beta-cell function and residual insulin secretion in patients with type 1 diabetes diagnosed within 3 months of starting treatment. He also headed a phase II study that caused a favorable buzz within the diabetes research community (N. Engl. J. Med. 2008;359:1909-20) and for which he is now analyzing 5-year follow-up data.
And while the forthcoming phase III trial results will tell the tale as to clinical efficacy, at this time some useful interim observations can be made about the GAD vaccine, according to Dr. Ludvigsson:
• The vaccine has demonstrated excellent safety. Experience with the vaccine to date totals 850 patient-years in adults and 350 patient-years in children, with no adverse events reported. This is enormously reassuring because GAD transforms glutamate into GABA, an important neurotransmitter. Lack of GAD in the CNS leads to muscle rigidity and convulsions, while stimulation of CNS GAD results in inhibition of neurotransmission. The absence of any such adverse events indicates the vaccine is working, as designed, to affect only a very small part of the immune system: namely, the activated T cells that have targeted pancreatic beta-cells for destruction, Dr. Ludvigsson said.
• The vaccine has demonstrated prolonged immunologic effects. The immunologic response to the Diamyd vaccine lasts surprisingly long – approaching 5 years and still counting. It’s a GAD-specific, cell-mediated, and humoral immune response characterized by increased GAD autoantibodies, a Th2 shift marked by reduction in activated T cells and an increase in regulatory T cells, a sharp and sustained rise in levels of interleukins-2, -5, -10, -13, and -17, and GAD tolerance. “We see this response still after 4 years. The memory is there,” Dr. Ludvigsson observed.
• “The earlier we treat, the better the outcome.” That’s why the phase III European trial is restricted to patients diagnosed with type 1 diabetes within the past 3 months. It’s also the impetus for ongoing prevention trials in individuals at very high genetic risk for type 1 diabetes who have GAD autoantibodies but have not developed overt disease.
• The vaccine probably won’t work in diabetic patients without GAD autoantibodies. No studies have been carried out in such patients, but Dr. Ludvigsson said it’s his impression that the vaccine is more effective in individuals with higher than lower titers of GAD autoantibodies.
For the future, the GAD vaccine alone probably is not the solution to type 1 diabetes, Dr. Ludvigsson said candidly.
“I believe this opens the door to using different antigens, like in allergy. Allergists don’t use just cat antigen in patients who have cat, dog, and house dust mite allergies. I suppose we may also learn to combine autoantigens, together with possible stimulation of beta-cells in combination with drugs that promote beta-cell regeneration,” he continued.
Other autoantibodies commonly present in patients with type 1 diabetes, or at high risk for the disease, include insulin autoantibodies, islet cell autoantibodies, and antibodies to the zinc transporter. Combining the GAD vaccine with other major diabetes-specific autoantigens recognized by the immune system could provide synergistic benefits.
The likely necessity for a combined approach addressing multiple pathways was underscored in a separate presentation by Dr. Jay S. Skyler, chairman of the type 1 Diabetes TrialNet, a National Institutes of Health–funded international network of centers conducting clinical trials of diabetes therapies.
The GAD vaccine appears to have the same limitation as the other immunomodulatory therapies evaluated to date in clinical trials, including the B cell–depleting anti-CD20 agent rituximab, and the anti-CD3 biologics teplizumab and otelixizumab: namely, they preserve beta cell function for a while, but the effect is transient. Eventually fasting C-peptide levels start to fall off in parallel to the placebo group. That’s why combination therapy will probably be required in order to cure or prevent Type 1 diabetes, according to Dr. Skyler, a professor of medicine, pediatrics and psychology at the University of Miami.
Ideally, a combination therapy should be multipronged, with three goals: Stop immune destruction, preserve beta-cell mass, and replace or regenerate beta-cells. Such a regimen might start off with a potent anti-inflammatory therapy – perhaps an anti-interleukin-1beta agent or tumor necrosis factor inhibitor – to quell the metabolic stress surrounding the pancreatic islets. This might well need to be given on a continuing basis.
Next would come an immunomodulatory approach; for example, T-cell modulation with an anti-CD3 biologic or B cell depletion with rituximab. This could be followed up with an autoantigen-specific therapy such as the GAD vaccine or oral insulin. “Maybe it needs to be both,” Dr. Skyler continued.
The logical subsequent step would be to try to stimulate immunologic expansion of regulatory T cells, either with granulocyte colony–stimulating factor or by direct infusion of regulatory T cells themselves. This could be combined with beta-cell expansion via exenatide (Byetta) or the investigational HIP2B peptide.
“We could conceivably be doing some of these things even today,” Dr. Skyler said.
Dr. Ludvigsson reported receiving research grant support from Diamyd.
Dr. Skyler has served as a consultant to and/or received research grants from numerous pharmaceutical companies.
Tick, Tock, Tick, Tock
A new study in this month's Journal of Hospital Medicine that catalogues the daily routine of HM practitioners is a first step in helping streamline the hospitalist’s workflow for efficiency, say several people associated with the report.
The report, “Where Did the Day Go? A Time-Motion Study of Hospitalists,” attempted to capture the amount of time hospitalists spent on various activities, including interacting with electronic health records (EHR) (34.1%), communication with colleagues (25.9%), and direct care (7.4%) (J Hosp Med. 2010;5(6):323-328). But one of the report’s senior authors, as well as the co-author of an accompanying editorial, anticipate that the study will serve as a springboard for future research on how hospitalists can best use their time.
Hospitalists need to “lay the foundation to figure how not to just observe what the doctors are doing, but how, in the future, to what they should be doing,” says Mark Williams, MD, FHM, professor and chief of hospital medicine at Northwestern University's Feinberg School of Medicine in Chicago. “We’ve got to have a good understanding of what we’re doing every day to move forward.”
The research, which furthered a similar Northwestern study completed in 2006 found that 16% of all activities occurred simultaneously, meaning that the surveyed hospitalists spent about 9% of their average 10.3-hour shift multitasking.
“Sadly, we documented that the vast majority [of time] is away from the patient, not with the patient,” Dr. Williams says.
Dr. Williams and Amit Prachand, an administrator in the HM department at Northwestern, hope to see more research done to define the best workflow for a hospitalist. Both agree, though, that dedicated funding will have to be set aside, either by federal agencies or research institutions, to make that happen.
“We need to convince people the money is well spent in focusing on this,” says Prachand, co-author of the editorial “Hospitalists: Lean Leaders for Hospitals.” “I think the hospital is going to be the one with the most to gain by supporting these opportunities.”
A new study in this month's Journal of Hospital Medicine that catalogues the daily routine of HM practitioners is a first step in helping streamline the hospitalist’s workflow for efficiency, say several people associated with the report.
The report, “Where Did the Day Go? A Time-Motion Study of Hospitalists,” attempted to capture the amount of time hospitalists spent on various activities, including interacting with electronic health records (EHR) (34.1%), communication with colleagues (25.9%), and direct care (7.4%) (J Hosp Med. 2010;5(6):323-328). But one of the report’s senior authors, as well as the co-author of an accompanying editorial, anticipate that the study will serve as a springboard for future research on how hospitalists can best use their time.
Hospitalists need to “lay the foundation to figure how not to just observe what the doctors are doing, but how, in the future, to what they should be doing,” says Mark Williams, MD, FHM, professor and chief of hospital medicine at Northwestern University's Feinberg School of Medicine in Chicago. “We’ve got to have a good understanding of what we’re doing every day to move forward.”
The research, which furthered a similar Northwestern study completed in 2006 found that 16% of all activities occurred simultaneously, meaning that the surveyed hospitalists spent about 9% of their average 10.3-hour shift multitasking.
“Sadly, we documented that the vast majority [of time] is away from the patient, not with the patient,” Dr. Williams says.
Dr. Williams and Amit Prachand, an administrator in the HM department at Northwestern, hope to see more research done to define the best workflow for a hospitalist. Both agree, though, that dedicated funding will have to be set aside, either by federal agencies or research institutions, to make that happen.
“We need to convince people the money is well spent in focusing on this,” says Prachand, co-author of the editorial “Hospitalists: Lean Leaders for Hospitals.” “I think the hospital is going to be the one with the most to gain by supporting these opportunities.”
A new study in this month's Journal of Hospital Medicine that catalogues the daily routine of HM practitioners is a first step in helping streamline the hospitalist’s workflow for efficiency, say several people associated with the report.
The report, “Where Did the Day Go? A Time-Motion Study of Hospitalists,” attempted to capture the amount of time hospitalists spent on various activities, including interacting with electronic health records (EHR) (34.1%), communication with colleagues (25.9%), and direct care (7.4%) (J Hosp Med. 2010;5(6):323-328). But one of the report’s senior authors, as well as the co-author of an accompanying editorial, anticipate that the study will serve as a springboard for future research on how hospitalists can best use their time.
Hospitalists need to “lay the foundation to figure how not to just observe what the doctors are doing, but how, in the future, to what they should be doing,” says Mark Williams, MD, FHM, professor and chief of hospital medicine at Northwestern University's Feinberg School of Medicine in Chicago. “We’ve got to have a good understanding of what we’re doing every day to move forward.”
The research, which furthered a similar Northwestern study completed in 2006 found that 16% of all activities occurred simultaneously, meaning that the surveyed hospitalists spent about 9% of their average 10.3-hour shift multitasking.
“Sadly, we documented that the vast majority [of time] is away from the patient, not with the patient,” Dr. Williams says.
Dr. Williams and Amit Prachand, an administrator in the HM department at Northwestern, hope to see more research done to define the best workflow for a hospitalist. Both agree, though, that dedicated funding will have to be set aside, either by federal agencies or research institutions, to make that happen.
“We need to convince people the money is well spent in focusing on this,” says Prachand, co-author of the editorial “Hospitalists: Lean Leaders for Hospitals.” “I think the hospital is going to be the one with the most to gain by supporting these opportunities.”
In the Literature: Research You Need to Know
Clinical question: Do clinical outcomes differ with the use of dopamine and norepinephrine in the treatment of shock?
Background: Observational trials have suggested higher mortality among patients with shock who are treated with dopamine versus norepinephrine; however, there are limited data from randomized trials.
Study design: Randomized, double-blinded trial.
Setting: Eight ICUs in Europe.
Synopsis: The study enrolled 1,679 consecutive adult patients with shock despite intravenous fluids. Of these, 62.2% were classified as septic shock, 16.7% cardiogenic, and 15.7% hypovolemic. Clinicians titrated the blinded study drug (dopamine or norepinephrine) according to a pre-specified algorithm. If shock persisted despite titration of their study drug to a goal rate, then open-label norepinephrine was added, followed by epinephrine or vasopressin if necessary.
No difference in 28-day mortality between dopamine and norepinephrine (52% versus 48% of patients; odds ratio 1.17 (0.97-1.42); P=0.10) was detected. Patients receiving dopamine experienced more frequent (24% vs. 12%, P<0.001) and more severe arrhythmias (6.1% vs. 1.6%, P< 0.001).
In subgroup analysis, patients in cardiogenic shock had significantly increased 28-day mortality with dopamine (P=0.03).
Study limitations include the use of norepinephrine as an open-label treatment and the inclusion of patients in hypovolemic shock, who are not typically treated with vasopressors.
Bottom line: No mortality difference is detected between dopamine and norepinephrine in patients with shock. Dopamine results in increased rates of mortality in cardiogenic shock and serious arrhythmias in all patients.
Citation: De Backer D, Biston P, Devriendt J, et al. Comparison of dopamine and norepinephrine in the treatment of shock. N Engl J Med. 2010;362(9):779-789.
Reviewed for TH eWire by Robert Chang, MD, Anita Hart, MD, Hae-won Kim, MD, Robert Paretti, MD, Helena Pasieka, MD, and Matt Smitherman, MD, University of Michigan, Ann Arbor
For more physician reviews of HM-related research, visit our website.
Clinical question: Do clinical outcomes differ with the use of dopamine and norepinephrine in the treatment of shock?
Background: Observational trials have suggested higher mortality among patients with shock who are treated with dopamine versus norepinephrine; however, there are limited data from randomized trials.
Study design: Randomized, double-blinded trial.
Setting: Eight ICUs in Europe.
Synopsis: The study enrolled 1,679 consecutive adult patients with shock despite intravenous fluids. Of these, 62.2% were classified as septic shock, 16.7% cardiogenic, and 15.7% hypovolemic. Clinicians titrated the blinded study drug (dopamine or norepinephrine) according to a pre-specified algorithm. If shock persisted despite titration of their study drug to a goal rate, then open-label norepinephrine was added, followed by epinephrine or vasopressin if necessary.
No difference in 28-day mortality between dopamine and norepinephrine (52% versus 48% of patients; odds ratio 1.17 (0.97-1.42); P=0.10) was detected. Patients receiving dopamine experienced more frequent (24% vs. 12%, P<0.001) and more severe arrhythmias (6.1% vs. 1.6%, P< 0.001).
In subgroup analysis, patients in cardiogenic shock had significantly increased 28-day mortality with dopamine (P=0.03).
Study limitations include the use of norepinephrine as an open-label treatment and the inclusion of patients in hypovolemic shock, who are not typically treated with vasopressors.
Bottom line: No mortality difference is detected between dopamine and norepinephrine in patients with shock. Dopamine results in increased rates of mortality in cardiogenic shock and serious arrhythmias in all patients.
Citation: De Backer D, Biston P, Devriendt J, et al. Comparison of dopamine and norepinephrine in the treatment of shock. N Engl J Med. 2010;362(9):779-789.
Reviewed for TH eWire by Robert Chang, MD, Anita Hart, MD, Hae-won Kim, MD, Robert Paretti, MD, Helena Pasieka, MD, and Matt Smitherman, MD, University of Michigan, Ann Arbor
For more physician reviews of HM-related research, visit our website.
Clinical question: Do clinical outcomes differ with the use of dopamine and norepinephrine in the treatment of shock?
Background: Observational trials have suggested higher mortality among patients with shock who are treated with dopamine versus norepinephrine; however, there are limited data from randomized trials.
Study design: Randomized, double-blinded trial.
Setting: Eight ICUs in Europe.
Synopsis: The study enrolled 1,679 consecutive adult patients with shock despite intravenous fluids. Of these, 62.2% were classified as septic shock, 16.7% cardiogenic, and 15.7% hypovolemic. Clinicians titrated the blinded study drug (dopamine or norepinephrine) according to a pre-specified algorithm. If shock persisted despite titration of their study drug to a goal rate, then open-label norepinephrine was added, followed by epinephrine or vasopressin if necessary.
No difference in 28-day mortality between dopamine and norepinephrine (52% versus 48% of patients; odds ratio 1.17 (0.97-1.42); P=0.10) was detected. Patients receiving dopamine experienced more frequent (24% vs. 12%, P<0.001) and more severe arrhythmias (6.1% vs. 1.6%, P< 0.001).
In subgroup analysis, patients in cardiogenic shock had significantly increased 28-day mortality with dopamine (P=0.03).
Study limitations include the use of norepinephrine as an open-label treatment and the inclusion of patients in hypovolemic shock, who are not typically treated with vasopressors.
Bottom line: No mortality difference is detected between dopamine and norepinephrine in patients with shock. Dopamine results in increased rates of mortality in cardiogenic shock and serious arrhythmias in all patients.
Citation: De Backer D, Biston P, Devriendt J, et al. Comparison of dopamine and norepinephrine in the treatment of shock. N Engl J Med. 2010;362(9):779-789.
Reviewed for TH eWire by Robert Chang, MD, Anita Hart, MD, Hae-won Kim, MD, Robert Paretti, MD, Helena Pasieka, MD, and Matt Smitherman, MD, University of Michigan, Ann Arbor
For more physician reviews of HM-related research, visit our website.