Inappropriate Prescribing of PPIs

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Inappropriate prescribing of proton pump inhibitors in hospitalized patients

Proton pump inhibitors (PPIs) are the third most commonly prescribed class of medication in the United States, with $13.6 billion in yearly sales.1 Despite their effectiveness in treating acid reflux2 and their mortality benefit in the treatment of patients with gastrointestinal bleeding,3 recent literature has identified a number of risks associated with PPIs, including an increased incidence of Clostridium difficile infection,4 decreased effectiveness of clopidogrel in patients with acute coronary syndrome,5 increased risk of community‐ and hospital‐acquired pneumonia, and an increased risk of hip fracture.69 Additionally, in March of 2011, the US Food and Drug Administration (FDA) issued a warning regarding the potential for PPIs to cause low magnesium levels which can, in turn, cause muscle spasms, an irregular heartbeat, and convulsions.10

Inappropriate PPI prescription practice has been demonstrated in the primary care setting,11 as well as in small studies conducted in the hospital setting.1216 We hypothesized that many hospitalized patients receive these medications without having an accepted indication, and examined 2 populations of hospitalized patients, including administrative data from 6.5 million discharges from US university hospitals, to look for appropriate diagnoses justifying their use.

METHODS

We performed a retrospective review of administrative data collected between January 1, 2008 and December 31, 2009 from 2 patient populations: (a) those discharged from Denver Health (DH), a university‐affiliated public safety net hospital in Denver, CO; and (b) patients discharged from 112 academic health centers and 256 of their affiliated hospitals that participate in the University HealthSystem Consortium (UHC). The Colorado Multiple Institution Review Board reviewed and approved the conduct of this study.

Inclusion criteria for both populations were age >18 or <90 years, and hospitalization on a Medicine service. Prisoners and women known to be pregnant were excluded. In both cohorts, if patients had more than 1 admission during the 2‐year study period, only data from the first admission were used.

We recorded demographics, admitting diagnosis, and discharge diagnoses together with information pertaining to the name, route, and duration of administration of all PPIs (ie, omeprazole, lansoprazole, esomeprazole, pantoprazole, rabeprazole). We created a broadly inclusive set of valid indications for PPIs by incorporating diagnoses that could be identified by International Classification of Diseases, Ninth Revision.

(ICD‐9) codes from a number of previously published sources including the National Institute of Clinical Excellence (NICE) guidelines issued by the National Health Service (NHS) of the United Kingdom in 200012, 1721 (Table 1).

Valid Indications for Proton Pump Inhibitors
IndicationICD‐9 Code
  • NOTE: Stress ulcer prophylaxis was not included in the list due to methodological limitations.

  • Abbreviations: ICD‐9, International Classification of Diseases, Ninth Revision.

Helicobacter pylori041.86
Abnormality of secretion of gastrin251.5
Esophageal varices with bleeding456.0
Esophageal varices without mention of bleeding456.1
Esophageal varices in diseases classified elsewhere456.2
Esophagitis530.10530.19
Perforation of esophagus530.4
Gastroesophageal laceration‐hemorrhage syndrome530.7
Esophageal reflux530.81
Barrett's esophagus530.85
Gastric ulcer531.0031.91
Duodenal ulcer532.00532.91
Peptic ulcer, site unspecified533.00533.91
Gastritis and duodenitis535.00535.71
Gastroparesis536.3
Dyspepsia and other specified disorders of function of stomach536.8
Hemorrhage of gastrointestinal tract, unspecified578.9

To assess the accuracy of the administrative data from DH, we also reviewed the Emergency Department histories, admission histories, progress notes, electronic pharmacy records, endoscopy reports, and discharge summaries of 123 patients randomly selected (ie, a 5% sample) from the group of patients identified by administrative data to have received a PPI without a valid indication, looking for any accepted indication that might have been missed in the administrative data.

All analyses were performed using SAS Enterprise Guide 4.1 (SAS Institute, Cary, NC). A Student t test was used to compare continuous variables and a chi‐square test was used to compare categorical variables. Bonferroni corrections were used for multiple comparisons, such that P values less than 0.01 were considered to be significant for categorical variables.

RESULTS

Inclusion criteria were met by 9875 patients in the Denver Health database and 6,592,100 patients in the UHC database. The demographics and primary discharge diagnoses for these patients are summarized in Table 2.

Admission Characteristics of Denver Health and UHC Study Population
DH (N = 9875)UHC (N = 6,592,100)
 Received a PPINo PPI Received a PPINo PPI
  • Abbreviations: DH, Denver Health; PPI, proton pump inhibitor; UHC, University HealthSystem Consortium.

No. (%)3962 (40)5913 (60) 918,474 (14)5,673,626 (86)
Age (mean SD)53 1551 16 59 1755 18
Gender (% male)2197 (55)3438 (58) 464,552 (51)2,882,577 (51)
Race (% white)1610 (41)2425 (41) 619,571 (67)3,670,450 (65)
Top 5 primary discharge diagnoses     
Chest pain229 (6)462 (8)Coronary atherosclerosis35,470 (4)186,321 (3)
Alcohol withdrawal147 (4)174 (3)Acute myocardial infarction26,507 (3)132,159 (2)
Pneumonia, organism unspecified142 (4)262 (4)Heart failure21,143 (2)103,751 (2)
Acute pancreatitis132 (3)106 (2)Septicemia20,345 (2)64,915 (1)
Obstructive chronic bronchitis with (acute) exacerbation89 (2)154 (3)Chest pain16,936 (2)107,497 (2)

Only 39% and 27% of the patients in the DH and UHC databases, respectively, had a valid indication for PPIs on the basis of discharge diagnoses (Table 3). In the DH data, if admission ICD‐9 codes were also inspected for valid PPI indications, 1579 (40%) of patients receiving PPIs had a valid indication (admission ICD‐9 codes were not available for patients in the UHC database). Thirty‐one percent of Denver Health patients spent time in the intensive care unit (ICU) during their hospital stay and 65% of those patients received a PPI without a valid indication, as compared to 59% of patients who remained on the General Medicine ward (Table 3).

Patients Receiving PPIs With and Without a Valid Indication
 DH (N = 9875)UHC (N = 6,592,100)
  • Abbreviations: DH, Denver Health; ICU, intensive care unit; PPI, proton pump inhibitor; UHC, University HealthSystem Consortium.

  • From International Classification of Diseases, Ninth Revision (ICD‐9) codes at time of discharge.

  • P value 0.001.

Patients receiving PPIs (% of total)3962 (40)918,474 (14)
Any ICU stay, N (% of all patients)1238 (31) 
General Medicine ward only, N (% of all patients)2724 (69) 
Patients with indication for PPI (% of all patients receiving PPIs)*1540 (39)247,142 (27)
Any ICU stay, N (% of all ICU patients)434 (35) 
General Medicine ward only, N (% of all ward patients)1106 (41) 
Patients without indication for PPI (% of those receiving PPIs)*2422 (61)671,332 (73)
Any ICU stay, N (% of all ICU patients)804 (65) 
General Medicine ward only, N (% of all ward patients)1618 (59) 

Higher rates of concurrent C. difficile infections were observed in patients receiving PPIs in both databases; a higher rate of concurrent diagnosis of pneumonia was seen in patients receiving PPIs in the UHC population, with a nonsignificant trend towards the same finding in DH patients (Table 4).

Incidence of Pneumonia and Clostridium difficile Infection
 Denver HealthUHC
Concurrent diagnosis(+) PPI 3962() PPI 5913P(+) PPI 918,474() PPI 5,673,626P
  • NOTE: After Bonferroni correction, P value < 0.01 is statistically significant.

  • Abbreviations: PPI, proton pump inhibitor; UHC, University HealthSystem Consortium.

C. difficile46 (1.16)26 (0.44)<0.000112,113 (1.32)175 (0.0031)<0.0001
Pneumonia400 (10.1)517 (8.7)0.023275,274 (8.2)300,557 (5.3)<0.0001

Chart review in the DH population found valid indications for PPIs in 19% of patients who were thought not have a valid indication on the basis of the administrative data (Table 5). For 56% of those in whom no valid indication was confirmed, physicians identified prophylaxis as the justification.

Chart Review of 123 (5%) DH Patients Receiving PPI Without Valid Indication
CharacteristicN (%)
  • Abbreviations: DH, Denver Health; PPI, proton pump inhibitor.

Valid indication found on chart review only23 (19)
No valid indication after chart review100 (81)
Written indication: prophylaxis56 (56)
No written documentation of indication present in the chart33 (33)
Written indication: continue home medication9 (9)
Intubated with or without written indication of prophylaxis16 (16)

DISCUSSION

The important finding of this study was that the majority of patients in 2 large groups of Medicine patients hospitalized in university‐affiliated hospitals received PPIs without having a valid indication. To our knowledge, the more than 900,000 UHC patients who received a PPI during their hospitalization represent the largest inpatient population evaluated for appropriateness of PPI prescriptions.

Our finding that 41% of the patients admitted to the DH Medicine service received a PPI during their hospital stay is similar to what has been observed by others.9, 14, 22 The rate of PPI prescription was lower in the UHC population (14%) for unclear reasons. By our definition, 61% lacked an adequate diagnosis to justify the prescription of the PPI. After performing a chart review on a randomly selected 5% of these records, we found that the DH administrative database had failed to identify 19% of patients who had a valid indication for receiving a PPI. Adjusting the administrative data accordingly still resulted in 50% of DH patients not having a valid indication for receiving a PPI. This is consistent with the 54% recorded by Batuwitage and colleagues11 in the outpatient setting by direct chart review, as well as a range of 60%‐75% for hospitalized patients in other studies.12, 13, 15, 23, 24

Stomach acidity is believed to provide an important host defense against lower gastrointestinal tract infections including Salmonella, Campylobacter, and Clostridium difficile.25 A recent study by Howell et al26 showed a doseresponse effect between PPI use and C. difficile infection, supporting a causal connection between loss of stomach acidity and development of Clostridium difficile‐associated diarrhea (CDAD). We found that C. difficile infection was more common in both populations of patients receiving PPIs (although the relative risk was much higher in the UHC database) (Table 5). The rate of CDAD in DH patients who received PPIs was 2.6 times higher than in patients who did not receive these acid suppressive agents.

The role of acid suppression in increasing risk for community‐acquired pneumonia is not entirely clear. Theories regarding the loss of an important host defense and bacterial proliferation head the list.6, 8, 27 Gastric and duodenal bacterial overgrowth is significantly more common in patients receiving PPIs than in patients receiving histamine type‐2 (H2) blockers.28 Previous studies have identified an increased rate of hospital‐acquired pneumonia and recurrent community‐acquired pneumonia27 in patients receiving any form of acid suppression therapy, but the risk appears to be greater in patients receiving PPIs than in those receiving H2 receptor antagonists (H2RAs).9 Significantly more patients in the UHC population who were taking PPIs had a concurrent diagnosis of pneumonia, consistent with previous studies alerting to this association6, 8, 9, 27 and consistent with the nonsignificant trend observed in the DH population.

Our study has a number of limitations. Our database comes from a single university‐affiliated public hospital with residents and hospitalists writing orders for all medications. The hospitals in the UHC are also teaching hospitals. Accordingly, our results might not generalize to other settings or reflect prescribing patterns in private, nonteaching hospital environments. Because our study was retrospective, we could not confirm the decision‐making process supporting the prescription of PPIs. Similarly, we could not temporarily relate the existence of the indication with the time the PPI was prescribed. Our list of appropriate indications for prescribing PPIs was developed by reviewing a number of references, and other studies have used slightly different lists (albeit the more commonly recognized indications are the same), but it may be argued that the list either includes or misses diagnoses in error.

While there is considerable debate about the use of PPIs for stress ulcer prophylaxis,29 we specifically chose not to include this as one of our valid indications for PPIs for 4 reasons. First, the American Society of Health‐System Pharmacists (ASHP) Report does not recommend prophylaxis for non‐ICU patients, and only recommends prophylaxis for those ICU patients with a coagulopathy, those requiring mechanical ventilation for more than 48 hours, those with a history of gastrointestinal ulceration or bleeding in the year prior to admission, and those with 2 or more of the following indications: sepsis, ICU stay >1 week, occult bleeding lasting 6 or more days, receiving high‐dose corticosteroids, and selected surgical situations.30 At the time the guideline was written, the authors note that there was insufficient data on PPIs to make any recommendations on their use, but no subsequent guidelines have been issued.30 Second, a review by Mohebbi and Hesch published in 2009, and a meta‐analysis by Lin and colleagues published in 2010, summarize subsequent randomized trials that suggest that PPIs and H2 blockers are, at best, similarly effective at preventing upper gastrointestinal (GI) bleeding among critically ill patients.31, 32 Third, the NICE guidelines do not include stress ulcer prophylaxis as an appropriate indication for PPIs except in the prevention and treatment of NSAID [non‐steroidal anti‐inflammatory drug]‐associated ulcers.19 Finally, H2RAs are currently the only medications with an FDA‐approved indication for stress ulcer prophylaxis. We acknowledge that PPIs may be a reasonable and acceptable choice for stress ulcer prophylaxis in patients who meet indications, but we were unable to identify such patients in either of our administrative databases.

In our Denver Health population, only 31% of our patients spent any time in the intensive care unit, and only a fraction of these would have both an accepted indication for stress ulcer prophylaxis by the ASHP guidelines and an intolerance or contraindication to an H2RA or sulcralfate. While our administrative database lacked the detail necessary to identify this small group of patients, the number of patients who might have been misclassified as not having a valid PPI indication was likely very small. Similar to the findings of previous studies,15, 18, 23, 29 prophylaxis against gastrointestinal bleeding was the stated justification for prescribing the PPI in 56% of the DH patient charts reviewed. It is impossible for us to estimate the number of patients in our administrative database for whom stress ulcer prophylaxis was justified by existing guidelines, as it would be necessary to gather a number of specific clinical details for each patient including: 1) ICU stay; 2) presence of coagulopathy; 3) duration of mechanical ventilation; 4) presence of sepsis; 5) duration of ICU stay; 6) presence of occult bleeding for >6 days; and 7) use of high‐dose corticosteroids. This level of clinical detail would likely only be available through a prospective study design, as has been suggested by other authors.33 Further research into the use, safety, and effectiveness of PPIs specifically for stress ulcer prophylaxis is warranted.

In conclusion, we found that 73% of nearly 1 million Medicine patients discharged from academic medical centers received a PPI without a valid indication during their hospitalization. The implications of our findings are broad. PPIs are more expensive31 than H2RAs and there is increasing evidence that they have significant side effects. In both databases we examined, the rate of C. difficile infection was higher in patients receiving PPIs than others. The prescribing habits of physicians in these university hospital settings appear to be far out of line with published guidelines and evidence‐based practice. Reducing inappropriate prescribing of PPIs would be an important educational and quality assurance project in most institutions.

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References
  1. IMS Health Web site. Available at: http://www.imshealth.com/deployedfiles/ims/Global/Content/Corporate/Press%20Room/Top‐line%20Market%20Data/2009%20Top‐line%20Market%20Data/Top%20Therapy%20Classes%20by%20U.S.Sales.pdf. Accessed May 1,2011.
  2. Bate CM,Keeling PW, O'Morain C, et al.Comparison of omeprazole and cimetidine in reflux oesophagitis: symptomatic, endoscopic, and histological evaluations.Gut.1990;31(9):968972.
  3. Lau JY,Leung WK,Wu JC, et al.Omeprazole before endoscopy in patients with gastrointestinal bleeding.N Engl J Med.2007;356(16):16311640.
  4. Dial S,Delaney JA,Barkun AN,Suissa S.Use of gastric acid‐suppressive agents and the risk of community‐acquired Clostridium difficile‐associated disease.JAMA.2005;294(23):29892995.
  5. Ho PM,Maddox TM,Wang L, et al.Risk of adverse outcomes associated with concomitant use of clopidogrel and proton pump inhibitors following acute coronary syndrome.JAMA.2009;301(9):937944.
  6. Laheij RJ,Sturkenboom MC,Hassing RJ,Dieleman J,Stricker BH,Jansen JB.Risk of community‐acquired pneumonia and use of gastric acid‐suppressive drugs.JAMA.2004;292(16):19551960.
  7. Yang YX,Lewis JD,Epstein S,Metz DC.Long‐term proton pump inhibitor therapy and risk of hip fracture.JAMA2006;296(24):29472953.
  8. Gulmez SE,Holm A,Frederiksen H,Jensen TG,Pedersen C,Hallas J.Use of proton pump inhibitors and the risk of community‐acquired pneumonia: a population‐based case‐control study.Arch Intern Med.2007;167(9):950955.
  9. Herzig SJ,Howell MD,Ngo LH,Marcantonio ER.Acid‐suppressive medication use and the risk for hospital‐acquired pneumonia.JAMA.2009;301(20):21202128.
  10. US Food and Drug Administration (FDA) Website. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsfor HumanMedicalProducts/ucm245275.htm. Accessed March 2,2011.
  11. Batuwitage BT,Kingham JG,Morgan NE,Bartlett RL.Inappropriate prescribing of proton pump inhibitors in primary care.Postgrad Med J.2007;83(975):6668.
  12. Grube RR,May DB.Stress ulcer prophylaxis in hospitalized patients not in intensive care units.Am J Health Syst Pharm.2007;64(13):13961400.
  13. Afif W,Alsulaiman R,Martel M,Barkun AN.Predictors of inappropriate utilization of intravenous proton pump inhibitors.Aliment Pharmacol Ther.2007;25(5):609615.
  14. Nardino RJ,Vender RJ,Herbert PN.Overuse of acid‐suppressive therapy in hospitalized patients.Am J Gastroenterol.2000;95(11):31183122.
  15. Eid SM,Boueiz A,Paranji S,Mativo C,Landis R,Abougergi MS.Patterns and predictors of proton pump inhibitor overuse among academic and non‐academic hospitalists.Intern Med2010;49(23):25612568.
  16. Parente F,Cucino C,Gallus S, et al.Hospital use of acid‐suppressive medications and its fall‐out on prescribing in general practice: a 1‐month survey.Aliment Pharmacol Ther.2003;17(12):15031506.
  17. Choudhry MN,Soran H,Ziglam HM.Overuse and inappropriate prescribing of proton pump inhibitors in patients with Clostridium difficile‐associated disease.QJM.2008;101(6):445448.
  18. Pham CQ,Regal RE,Bostwick TR,Knauf KS.Acid suppressive therapy use on an inpatient internal medicine service.Ann Pharmacother.2006;40(7–8):12611266.
  19. National Institute of Clinical Excellence (NICE), National Health Service (NHS), Dyspepsia: Management of dyspepsia in adults in primary care. Web site. Available at: http://www.nice.org.uk/nicemedia/live/10950/29460/29460.pdf. Accessed May 1,2011.
  20. Quenot JP,Thiery N,Barbar S.When should stress ulcer prophylaxis be used in the ICU?Curr Opin Crit Care.2009;15(2):139143.
  21. Walker NM,McDonald J.An evaluation of the use of proton pump inhibitors.Pharm World Sci2001;23(3):116117.
  22. Naunton M,Peterson GM,Bleasel MD.Overuse of proton pump inhibitors.J Clin Pharm Ther.2000;25(5):333340.
  23. Alsultan MS,Mayet AY,Malhani AA,Alshaikh MK.Pattern of intravenous proton pump inhibitors use in ICU and non‐ICU setting: a prospective observational study.Saudi J Gastroenterol.2010;16(4):275279.
  24. Ramirez E,Lei SH,Borobia AM, et al.Overuse of PPIs in patients at admission, during treatment, and at discharge in a tertiary Spanish hospital.Curr Clin Pharmacol.2010;5(4):288297.
  25. Leonard J,Marshall JK,Moayyedi P.Systematic review of the risk of enteric infection in patients taking acid suppression.Am J Gastroenterol.2007;102(9):20472056.
  26. Howell MD,Novack V,Grgurich P, et al.Iatrogenic gastric acid suppression and the risk of nosocomial Clostridium difficile infection.Arch Intern Med.2010;170(9):784790.
  27. Eurich DT,Sadowski CA,Simpson SH,Marrie TJ,Majumdar SR.Recurrent community‐acquired pneumonia in patients starting acid‐suppressing drugs.Am J Med.2010;123(1):4753.
  28. Thorens J,Froehlich F,Schwizer W, et al.Bacterial overgrowth during treatment with omeprazole compared with cimetidine: a prospective randomised double blind study.Gut.1996;39(1):5459.
  29. Hussain S,Stefan M,Visintainer P,Rothberg M.Why do physicians prescribe stress ulcer prophylaxis to general medicine patients?South Med J2010;103(11):11031110.
  30. ASHP therapeutic guidelines on stress ulcer prophylaxis.ASHP Commission on Therapeutics and approved by the ASHP Board of Directors on November 14, 1998.Am J Health Syst Pharm.1999;56(4):347379.
  31. Mohebbi L,Hesch K.Stress ulcer prophylaxis in the intensive care unit.Proc (Bayl Univ Med Cent).2009;22(4):373376.
  32. Lin PC,Chang CH,Hsu PI,Tseng PL,Huang YB.The efficacy and safety of proton pump inhibitors vs histamine‐2 receptor antagonists for stress ulcer bleeding prophylaxis among critical care patients: a meta‐analysis.Crit Care Med.2010;38(4):11971205.
  33. Pongprasobchai S,Kridkratoke S,Nopmaneejumruslers C.Proton pump inhibitors for the prevention of stress‐related mucosal disease in critically‐ill patients: a meta‐analysis.J Med Assoc Thai.2009;92(5):632637.
  34. Yachimski PS,Farrell EA,Hunt DP,Reid AE.Proton pump inhibitors for prophylaxis of nosocomial upper gastrointestinal tract bleeding: effect of standardized guidelines on prescribing practice.Arch Intern Med.2010;170(9):779783.
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Proton pump inhibitors (PPIs) are the third most commonly prescribed class of medication in the United States, with $13.6 billion in yearly sales.1 Despite their effectiveness in treating acid reflux2 and their mortality benefit in the treatment of patients with gastrointestinal bleeding,3 recent literature has identified a number of risks associated with PPIs, including an increased incidence of Clostridium difficile infection,4 decreased effectiveness of clopidogrel in patients with acute coronary syndrome,5 increased risk of community‐ and hospital‐acquired pneumonia, and an increased risk of hip fracture.69 Additionally, in March of 2011, the US Food and Drug Administration (FDA) issued a warning regarding the potential for PPIs to cause low magnesium levels which can, in turn, cause muscle spasms, an irregular heartbeat, and convulsions.10

Inappropriate PPI prescription practice has been demonstrated in the primary care setting,11 as well as in small studies conducted in the hospital setting.1216 We hypothesized that many hospitalized patients receive these medications without having an accepted indication, and examined 2 populations of hospitalized patients, including administrative data from 6.5 million discharges from US university hospitals, to look for appropriate diagnoses justifying their use.

METHODS

We performed a retrospective review of administrative data collected between January 1, 2008 and December 31, 2009 from 2 patient populations: (a) those discharged from Denver Health (DH), a university‐affiliated public safety net hospital in Denver, CO; and (b) patients discharged from 112 academic health centers and 256 of their affiliated hospitals that participate in the University HealthSystem Consortium (UHC). The Colorado Multiple Institution Review Board reviewed and approved the conduct of this study.

Inclusion criteria for both populations were age >18 or <90 years, and hospitalization on a Medicine service. Prisoners and women known to be pregnant were excluded. In both cohorts, if patients had more than 1 admission during the 2‐year study period, only data from the first admission were used.

We recorded demographics, admitting diagnosis, and discharge diagnoses together with information pertaining to the name, route, and duration of administration of all PPIs (ie, omeprazole, lansoprazole, esomeprazole, pantoprazole, rabeprazole). We created a broadly inclusive set of valid indications for PPIs by incorporating diagnoses that could be identified by International Classification of Diseases, Ninth Revision.

(ICD‐9) codes from a number of previously published sources including the National Institute of Clinical Excellence (NICE) guidelines issued by the National Health Service (NHS) of the United Kingdom in 200012, 1721 (Table 1).

Valid Indications for Proton Pump Inhibitors
IndicationICD‐9 Code
  • NOTE: Stress ulcer prophylaxis was not included in the list due to methodological limitations.

  • Abbreviations: ICD‐9, International Classification of Diseases, Ninth Revision.

Helicobacter pylori041.86
Abnormality of secretion of gastrin251.5
Esophageal varices with bleeding456.0
Esophageal varices without mention of bleeding456.1
Esophageal varices in diseases classified elsewhere456.2
Esophagitis530.10530.19
Perforation of esophagus530.4
Gastroesophageal laceration‐hemorrhage syndrome530.7
Esophageal reflux530.81
Barrett's esophagus530.85
Gastric ulcer531.0031.91
Duodenal ulcer532.00532.91
Peptic ulcer, site unspecified533.00533.91
Gastritis and duodenitis535.00535.71
Gastroparesis536.3
Dyspepsia and other specified disorders of function of stomach536.8
Hemorrhage of gastrointestinal tract, unspecified578.9

To assess the accuracy of the administrative data from DH, we also reviewed the Emergency Department histories, admission histories, progress notes, electronic pharmacy records, endoscopy reports, and discharge summaries of 123 patients randomly selected (ie, a 5% sample) from the group of patients identified by administrative data to have received a PPI without a valid indication, looking for any accepted indication that might have been missed in the administrative data.

All analyses were performed using SAS Enterprise Guide 4.1 (SAS Institute, Cary, NC). A Student t test was used to compare continuous variables and a chi‐square test was used to compare categorical variables. Bonferroni corrections were used for multiple comparisons, such that P values less than 0.01 were considered to be significant for categorical variables.

RESULTS

Inclusion criteria were met by 9875 patients in the Denver Health database and 6,592,100 patients in the UHC database. The demographics and primary discharge diagnoses for these patients are summarized in Table 2.

Admission Characteristics of Denver Health and UHC Study Population
DH (N = 9875)UHC (N = 6,592,100)
 Received a PPINo PPI Received a PPINo PPI
  • Abbreviations: DH, Denver Health; PPI, proton pump inhibitor; UHC, University HealthSystem Consortium.

No. (%)3962 (40)5913 (60) 918,474 (14)5,673,626 (86)
Age (mean SD)53 1551 16 59 1755 18
Gender (% male)2197 (55)3438 (58) 464,552 (51)2,882,577 (51)
Race (% white)1610 (41)2425 (41) 619,571 (67)3,670,450 (65)
Top 5 primary discharge diagnoses     
Chest pain229 (6)462 (8)Coronary atherosclerosis35,470 (4)186,321 (3)
Alcohol withdrawal147 (4)174 (3)Acute myocardial infarction26,507 (3)132,159 (2)
Pneumonia, organism unspecified142 (4)262 (4)Heart failure21,143 (2)103,751 (2)
Acute pancreatitis132 (3)106 (2)Septicemia20,345 (2)64,915 (1)
Obstructive chronic bronchitis with (acute) exacerbation89 (2)154 (3)Chest pain16,936 (2)107,497 (2)

Only 39% and 27% of the patients in the DH and UHC databases, respectively, had a valid indication for PPIs on the basis of discharge diagnoses (Table 3). In the DH data, if admission ICD‐9 codes were also inspected for valid PPI indications, 1579 (40%) of patients receiving PPIs had a valid indication (admission ICD‐9 codes were not available for patients in the UHC database). Thirty‐one percent of Denver Health patients spent time in the intensive care unit (ICU) during their hospital stay and 65% of those patients received a PPI without a valid indication, as compared to 59% of patients who remained on the General Medicine ward (Table 3).

Patients Receiving PPIs With and Without a Valid Indication
 DH (N = 9875)UHC (N = 6,592,100)
  • Abbreviations: DH, Denver Health; ICU, intensive care unit; PPI, proton pump inhibitor; UHC, University HealthSystem Consortium.

  • From International Classification of Diseases, Ninth Revision (ICD‐9) codes at time of discharge.

  • P value 0.001.

Patients receiving PPIs (% of total)3962 (40)918,474 (14)
Any ICU stay, N (% of all patients)1238 (31) 
General Medicine ward only, N (% of all patients)2724 (69) 
Patients with indication for PPI (% of all patients receiving PPIs)*1540 (39)247,142 (27)
Any ICU stay, N (% of all ICU patients)434 (35) 
General Medicine ward only, N (% of all ward patients)1106 (41) 
Patients without indication for PPI (% of those receiving PPIs)*2422 (61)671,332 (73)
Any ICU stay, N (% of all ICU patients)804 (65) 
General Medicine ward only, N (% of all ward patients)1618 (59) 

Higher rates of concurrent C. difficile infections were observed in patients receiving PPIs in both databases; a higher rate of concurrent diagnosis of pneumonia was seen in patients receiving PPIs in the UHC population, with a nonsignificant trend towards the same finding in DH patients (Table 4).

Incidence of Pneumonia and Clostridium difficile Infection
 Denver HealthUHC
Concurrent diagnosis(+) PPI 3962() PPI 5913P(+) PPI 918,474() PPI 5,673,626P
  • NOTE: After Bonferroni correction, P value < 0.01 is statistically significant.

  • Abbreviations: PPI, proton pump inhibitor; UHC, University HealthSystem Consortium.

C. difficile46 (1.16)26 (0.44)<0.000112,113 (1.32)175 (0.0031)<0.0001
Pneumonia400 (10.1)517 (8.7)0.023275,274 (8.2)300,557 (5.3)<0.0001

Chart review in the DH population found valid indications for PPIs in 19% of patients who were thought not have a valid indication on the basis of the administrative data (Table 5). For 56% of those in whom no valid indication was confirmed, physicians identified prophylaxis as the justification.

Chart Review of 123 (5%) DH Patients Receiving PPI Without Valid Indication
CharacteristicN (%)
  • Abbreviations: DH, Denver Health; PPI, proton pump inhibitor.

Valid indication found on chart review only23 (19)
No valid indication after chart review100 (81)
Written indication: prophylaxis56 (56)
No written documentation of indication present in the chart33 (33)
Written indication: continue home medication9 (9)
Intubated with or without written indication of prophylaxis16 (16)

DISCUSSION

The important finding of this study was that the majority of patients in 2 large groups of Medicine patients hospitalized in university‐affiliated hospitals received PPIs without having a valid indication. To our knowledge, the more than 900,000 UHC patients who received a PPI during their hospitalization represent the largest inpatient population evaluated for appropriateness of PPI prescriptions.

Our finding that 41% of the patients admitted to the DH Medicine service received a PPI during their hospital stay is similar to what has been observed by others.9, 14, 22 The rate of PPI prescription was lower in the UHC population (14%) for unclear reasons. By our definition, 61% lacked an adequate diagnosis to justify the prescription of the PPI. After performing a chart review on a randomly selected 5% of these records, we found that the DH administrative database had failed to identify 19% of patients who had a valid indication for receiving a PPI. Adjusting the administrative data accordingly still resulted in 50% of DH patients not having a valid indication for receiving a PPI. This is consistent with the 54% recorded by Batuwitage and colleagues11 in the outpatient setting by direct chart review, as well as a range of 60%‐75% for hospitalized patients in other studies.12, 13, 15, 23, 24

Stomach acidity is believed to provide an important host defense against lower gastrointestinal tract infections including Salmonella, Campylobacter, and Clostridium difficile.25 A recent study by Howell et al26 showed a doseresponse effect between PPI use and C. difficile infection, supporting a causal connection between loss of stomach acidity and development of Clostridium difficile‐associated diarrhea (CDAD). We found that C. difficile infection was more common in both populations of patients receiving PPIs (although the relative risk was much higher in the UHC database) (Table 5). The rate of CDAD in DH patients who received PPIs was 2.6 times higher than in patients who did not receive these acid suppressive agents.

The role of acid suppression in increasing risk for community‐acquired pneumonia is not entirely clear. Theories regarding the loss of an important host defense and bacterial proliferation head the list.6, 8, 27 Gastric and duodenal bacterial overgrowth is significantly more common in patients receiving PPIs than in patients receiving histamine type‐2 (H2) blockers.28 Previous studies have identified an increased rate of hospital‐acquired pneumonia and recurrent community‐acquired pneumonia27 in patients receiving any form of acid suppression therapy, but the risk appears to be greater in patients receiving PPIs than in those receiving H2 receptor antagonists (H2RAs).9 Significantly more patients in the UHC population who were taking PPIs had a concurrent diagnosis of pneumonia, consistent with previous studies alerting to this association6, 8, 9, 27 and consistent with the nonsignificant trend observed in the DH population.

Our study has a number of limitations. Our database comes from a single university‐affiliated public hospital with residents and hospitalists writing orders for all medications. The hospitals in the UHC are also teaching hospitals. Accordingly, our results might not generalize to other settings or reflect prescribing patterns in private, nonteaching hospital environments. Because our study was retrospective, we could not confirm the decision‐making process supporting the prescription of PPIs. Similarly, we could not temporarily relate the existence of the indication with the time the PPI was prescribed. Our list of appropriate indications for prescribing PPIs was developed by reviewing a number of references, and other studies have used slightly different lists (albeit the more commonly recognized indications are the same), but it may be argued that the list either includes or misses diagnoses in error.

While there is considerable debate about the use of PPIs for stress ulcer prophylaxis,29 we specifically chose not to include this as one of our valid indications for PPIs for 4 reasons. First, the American Society of Health‐System Pharmacists (ASHP) Report does not recommend prophylaxis for non‐ICU patients, and only recommends prophylaxis for those ICU patients with a coagulopathy, those requiring mechanical ventilation for more than 48 hours, those with a history of gastrointestinal ulceration or bleeding in the year prior to admission, and those with 2 or more of the following indications: sepsis, ICU stay >1 week, occult bleeding lasting 6 or more days, receiving high‐dose corticosteroids, and selected surgical situations.30 At the time the guideline was written, the authors note that there was insufficient data on PPIs to make any recommendations on their use, but no subsequent guidelines have been issued.30 Second, a review by Mohebbi and Hesch published in 2009, and a meta‐analysis by Lin and colleagues published in 2010, summarize subsequent randomized trials that suggest that PPIs and H2 blockers are, at best, similarly effective at preventing upper gastrointestinal (GI) bleeding among critically ill patients.31, 32 Third, the NICE guidelines do not include stress ulcer prophylaxis as an appropriate indication for PPIs except in the prevention and treatment of NSAID [non‐steroidal anti‐inflammatory drug]‐associated ulcers.19 Finally, H2RAs are currently the only medications with an FDA‐approved indication for stress ulcer prophylaxis. We acknowledge that PPIs may be a reasonable and acceptable choice for stress ulcer prophylaxis in patients who meet indications, but we were unable to identify such patients in either of our administrative databases.

In our Denver Health population, only 31% of our patients spent any time in the intensive care unit, and only a fraction of these would have both an accepted indication for stress ulcer prophylaxis by the ASHP guidelines and an intolerance or contraindication to an H2RA or sulcralfate. While our administrative database lacked the detail necessary to identify this small group of patients, the number of patients who might have been misclassified as not having a valid PPI indication was likely very small. Similar to the findings of previous studies,15, 18, 23, 29 prophylaxis against gastrointestinal bleeding was the stated justification for prescribing the PPI in 56% of the DH patient charts reviewed. It is impossible for us to estimate the number of patients in our administrative database for whom stress ulcer prophylaxis was justified by existing guidelines, as it would be necessary to gather a number of specific clinical details for each patient including: 1) ICU stay; 2) presence of coagulopathy; 3) duration of mechanical ventilation; 4) presence of sepsis; 5) duration of ICU stay; 6) presence of occult bleeding for >6 days; and 7) use of high‐dose corticosteroids. This level of clinical detail would likely only be available through a prospective study design, as has been suggested by other authors.33 Further research into the use, safety, and effectiveness of PPIs specifically for stress ulcer prophylaxis is warranted.

In conclusion, we found that 73% of nearly 1 million Medicine patients discharged from academic medical centers received a PPI without a valid indication during their hospitalization. The implications of our findings are broad. PPIs are more expensive31 than H2RAs and there is increasing evidence that they have significant side effects. In both databases we examined, the rate of C. difficile infection was higher in patients receiving PPIs than others. The prescribing habits of physicians in these university hospital settings appear to be far out of line with published guidelines and evidence‐based practice. Reducing inappropriate prescribing of PPIs would be an important educational and quality assurance project in most institutions.

Proton pump inhibitors (PPIs) are the third most commonly prescribed class of medication in the United States, with $13.6 billion in yearly sales.1 Despite their effectiveness in treating acid reflux2 and their mortality benefit in the treatment of patients with gastrointestinal bleeding,3 recent literature has identified a number of risks associated with PPIs, including an increased incidence of Clostridium difficile infection,4 decreased effectiveness of clopidogrel in patients with acute coronary syndrome,5 increased risk of community‐ and hospital‐acquired pneumonia, and an increased risk of hip fracture.69 Additionally, in March of 2011, the US Food and Drug Administration (FDA) issued a warning regarding the potential for PPIs to cause low magnesium levels which can, in turn, cause muscle spasms, an irregular heartbeat, and convulsions.10

Inappropriate PPI prescription practice has been demonstrated in the primary care setting,11 as well as in small studies conducted in the hospital setting.1216 We hypothesized that many hospitalized patients receive these medications without having an accepted indication, and examined 2 populations of hospitalized patients, including administrative data from 6.5 million discharges from US university hospitals, to look for appropriate diagnoses justifying their use.

METHODS

We performed a retrospective review of administrative data collected between January 1, 2008 and December 31, 2009 from 2 patient populations: (a) those discharged from Denver Health (DH), a university‐affiliated public safety net hospital in Denver, CO; and (b) patients discharged from 112 academic health centers and 256 of their affiliated hospitals that participate in the University HealthSystem Consortium (UHC). The Colorado Multiple Institution Review Board reviewed and approved the conduct of this study.

Inclusion criteria for both populations were age >18 or <90 years, and hospitalization on a Medicine service. Prisoners and women known to be pregnant were excluded. In both cohorts, if patients had more than 1 admission during the 2‐year study period, only data from the first admission were used.

We recorded demographics, admitting diagnosis, and discharge diagnoses together with information pertaining to the name, route, and duration of administration of all PPIs (ie, omeprazole, lansoprazole, esomeprazole, pantoprazole, rabeprazole). We created a broadly inclusive set of valid indications for PPIs by incorporating diagnoses that could be identified by International Classification of Diseases, Ninth Revision.

(ICD‐9) codes from a number of previously published sources including the National Institute of Clinical Excellence (NICE) guidelines issued by the National Health Service (NHS) of the United Kingdom in 200012, 1721 (Table 1).

Valid Indications for Proton Pump Inhibitors
IndicationICD‐9 Code
  • NOTE: Stress ulcer prophylaxis was not included in the list due to methodological limitations.

  • Abbreviations: ICD‐9, International Classification of Diseases, Ninth Revision.

Helicobacter pylori041.86
Abnormality of secretion of gastrin251.5
Esophageal varices with bleeding456.0
Esophageal varices without mention of bleeding456.1
Esophageal varices in diseases classified elsewhere456.2
Esophagitis530.10530.19
Perforation of esophagus530.4
Gastroesophageal laceration‐hemorrhage syndrome530.7
Esophageal reflux530.81
Barrett's esophagus530.85
Gastric ulcer531.0031.91
Duodenal ulcer532.00532.91
Peptic ulcer, site unspecified533.00533.91
Gastritis and duodenitis535.00535.71
Gastroparesis536.3
Dyspepsia and other specified disorders of function of stomach536.8
Hemorrhage of gastrointestinal tract, unspecified578.9

To assess the accuracy of the administrative data from DH, we also reviewed the Emergency Department histories, admission histories, progress notes, electronic pharmacy records, endoscopy reports, and discharge summaries of 123 patients randomly selected (ie, a 5% sample) from the group of patients identified by administrative data to have received a PPI without a valid indication, looking for any accepted indication that might have been missed in the administrative data.

All analyses were performed using SAS Enterprise Guide 4.1 (SAS Institute, Cary, NC). A Student t test was used to compare continuous variables and a chi‐square test was used to compare categorical variables. Bonferroni corrections were used for multiple comparisons, such that P values less than 0.01 were considered to be significant for categorical variables.

RESULTS

Inclusion criteria were met by 9875 patients in the Denver Health database and 6,592,100 patients in the UHC database. The demographics and primary discharge diagnoses for these patients are summarized in Table 2.

Admission Characteristics of Denver Health and UHC Study Population
DH (N = 9875)UHC (N = 6,592,100)
 Received a PPINo PPI Received a PPINo PPI
  • Abbreviations: DH, Denver Health; PPI, proton pump inhibitor; UHC, University HealthSystem Consortium.

No. (%)3962 (40)5913 (60) 918,474 (14)5,673,626 (86)
Age (mean SD)53 1551 16 59 1755 18
Gender (% male)2197 (55)3438 (58) 464,552 (51)2,882,577 (51)
Race (% white)1610 (41)2425 (41) 619,571 (67)3,670,450 (65)
Top 5 primary discharge diagnoses     
Chest pain229 (6)462 (8)Coronary atherosclerosis35,470 (4)186,321 (3)
Alcohol withdrawal147 (4)174 (3)Acute myocardial infarction26,507 (3)132,159 (2)
Pneumonia, organism unspecified142 (4)262 (4)Heart failure21,143 (2)103,751 (2)
Acute pancreatitis132 (3)106 (2)Septicemia20,345 (2)64,915 (1)
Obstructive chronic bronchitis with (acute) exacerbation89 (2)154 (3)Chest pain16,936 (2)107,497 (2)

Only 39% and 27% of the patients in the DH and UHC databases, respectively, had a valid indication for PPIs on the basis of discharge diagnoses (Table 3). In the DH data, if admission ICD‐9 codes were also inspected for valid PPI indications, 1579 (40%) of patients receiving PPIs had a valid indication (admission ICD‐9 codes were not available for patients in the UHC database). Thirty‐one percent of Denver Health patients spent time in the intensive care unit (ICU) during their hospital stay and 65% of those patients received a PPI without a valid indication, as compared to 59% of patients who remained on the General Medicine ward (Table 3).

Patients Receiving PPIs With and Without a Valid Indication
 DH (N = 9875)UHC (N = 6,592,100)
  • Abbreviations: DH, Denver Health; ICU, intensive care unit; PPI, proton pump inhibitor; UHC, University HealthSystem Consortium.

  • From International Classification of Diseases, Ninth Revision (ICD‐9) codes at time of discharge.

  • P value 0.001.

Patients receiving PPIs (% of total)3962 (40)918,474 (14)
Any ICU stay, N (% of all patients)1238 (31) 
General Medicine ward only, N (% of all patients)2724 (69) 
Patients with indication for PPI (% of all patients receiving PPIs)*1540 (39)247,142 (27)
Any ICU stay, N (% of all ICU patients)434 (35) 
General Medicine ward only, N (% of all ward patients)1106 (41) 
Patients without indication for PPI (% of those receiving PPIs)*2422 (61)671,332 (73)
Any ICU stay, N (% of all ICU patients)804 (65) 
General Medicine ward only, N (% of all ward patients)1618 (59) 

Higher rates of concurrent C. difficile infections were observed in patients receiving PPIs in both databases; a higher rate of concurrent diagnosis of pneumonia was seen in patients receiving PPIs in the UHC population, with a nonsignificant trend towards the same finding in DH patients (Table 4).

Incidence of Pneumonia and Clostridium difficile Infection
 Denver HealthUHC
Concurrent diagnosis(+) PPI 3962() PPI 5913P(+) PPI 918,474() PPI 5,673,626P
  • NOTE: After Bonferroni correction, P value < 0.01 is statistically significant.

  • Abbreviations: PPI, proton pump inhibitor; UHC, University HealthSystem Consortium.

C. difficile46 (1.16)26 (0.44)<0.000112,113 (1.32)175 (0.0031)<0.0001
Pneumonia400 (10.1)517 (8.7)0.023275,274 (8.2)300,557 (5.3)<0.0001

Chart review in the DH population found valid indications for PPIs in 19% of patients who were thought not have a valid indication on the basis of the administrative data (Table 5). For 56% of those in whom no valid indication was confirmed, physicians identified prophylaxis as the justification.

Chart Review of 123 (5%) DH Patients Receiving PPI Without Valid Indication
CharacteristicN (%)
  • Abbreviations: DH, Denver Health; PPI, proton pump inhibitor.

Valid indication found on chart review only23 (19)
No valid indication after chart review100 (81)
Written indication: prophylaxis56 (56)
No written documentation of indication present in the chart33 (33)
Written indication: continue home medication9 (9)
Intubated with or without written indication of prophylaxis16 (16)

DISCUSSION

The important finding of this study was that the majority of patients in 2 large groups of Medicine patients hospitalized in university‐affiliated hospitals received PPIs without having a valid indication. To our knowledge, the more than 900,000 UHC patients who received a PPI during their hospitalization represent the largest inpatient population evaluated for appropriateness of PPI prescriptions.

Our finding that 41% of the patients admitted to the DH Medicine service received a PPI during their hospital stay is similar to what has been observed by others.9, 14, 22 The rate of PPI prescription was lower in the UHC population (14%) for unclear reasons. By our definition, 61% lacked an adequate diagnosis to justify the prescription of the PPI. After performing a chart review on a randomly selected 5% of these records, we found that the DH administrative database had failed to identify 19% of patients who had a valid indication for receiving a PPI. Adjusting the administrative data accordingly still resulted in 50% of DH patients not having a valid indication for receiving a PPI. This is consistent with the 54% recorded by Batuwitage and colleagues11 in the outpatient setting by direct chart review, as well as a range of 60%‐75% for hospitalized patients in other studies.12, 13, 15, 23, 24

Stomach acidity is believed to provide an important host defense against lower gastrointestinal tract infections including Salmonella, Campylobacter, and Clostridium difficile.25 A recent study by Howell et al26 showed a doseresponse effect between PPI use and C. difficile infection, supporting a causal connection between loss of stomach acidity and development of Clostridium difficile‐associated diarrhea (CDAD). We found that C. difficile infection was more common in both populations of patients receiving PPIs (although the relative risk was much higher in the UHC database) (Table 5). The rate of CDAD in DH patients who received PPIs was 2.6 times higher than in patients who did not receive these acid suppressive agents.

The role of acid suppression in increasing risk for community‐acquired pneumonia is not entirely clear. Theories regarding the loss of an important host defense and bacterial proliferation head the list.6, 8, 27 Gastric and duodenal bacterial overgrowth is significantly more common in patients receiving PPIs than in patients receiving histamine type‐2 (H2) blockers.28 Previous studies have identified an increased rate of hospital‐acquired pneumonia and recurrent community‐acquired pneumonia27 in patients receiving any form of acid suppression therapy, but the risk appears to be greater in patients receiving PPIs than in those receiving H2 receptor antagonists (H2RAs).9 Significantly more patients in the UHC population who were taking PPIs had a concurrent diagnosis of pneumonia, consistent with previous studies alerting to this association6, 8, 9, 27 and consistent with the nonsignificant trend observed in the DH population.

Our study has a number of limitations. Our database comes from a single university‐affiliated public hospital with residents and hospitalists writing orders for all medications. The hospitals in the UHC are also teaching hospitals. Accordingly, our results might not generalize to other settings or reflect prescribing patterns in private, nonteaching hospital environments. Because our study was retrospective, we could not confirm the decision‐making process supporting the prescription of PPIs. Similarly, we could not temporarily relate the existence of the indication with the time the PPI was prescribed. Our list of appropriate indications for prescribing PPIs was developed by reviewing a number of references, and other studies have used slightly different lists (albeit the more commonly recognized indications are the same), but it may be argued that the list either includes or misses diagnoses in error.

While there is considerable debate about the use of PPIs for stress ulcer prophylaxis,29 we specifically chose not to include this as one of our valid indications for PPIs for 4 reasons. First, the American Society of Health‐System Pharmacists (ASHP) Report does not recommend prophylaxis for non‐ICU patients, and only recommends prophylaxis for those ICU patients with a coagulopathy, those requiring mechanical ventilation for more than 48 hours, those with a history of gastrointestinal ulceration or bleeding in the year prior to admission, and those with 2 or more of the following indications: sepsis, ICU stay >1 week, occult bleeding lasting 6 or more days, receiving high‐dose corticosteroids, and selected surgical situations.30 At the time the guideline was written, the authors note that there was insufficient data on PPIs to make any recommendations on their use, but no subsequent guidelines have been issued.30 Second, a review by Mohebbi and Hesch published in 2009, and a meta‐analysis by Lin and colleagues published in 2010, summarize subsequent randomized trials that suggest that PPIs and H2 blockers are, at best, similarly effective at preventing upper gastrointestinal (GI) bleeding among critically ill patients.31, 32 Third, the NICE guidelines do not include stress ulcer prophylaxis as an appropriate indication for PPIs except in the prevention and treatment of NSAID [non‐steroidal anti‐inflammatory drug]‐associated ulcers.19 Finally, H2RAs are currently the only medications with an FDA‐approved indication for stress ulcer prophylaxis. We acknowledge that PPIs may be a reasonable and acceptable choice for stress ulcer prophylaxis in patients who meet indications, but we were unable to identify such patients in either of our administrative databases.

In our Denver Health population, only 31% of our patients spent any time in the intensive care unit, and only a fraction of these would have both an accepted indication for stress ulcer prophylaxis by the ASHP guidelines and an intolerance or contraindication to an H2RA or sulcralfate. While our administrative database lacked the detail necessary to identify this small group of patients, the number of patients who might have been misclassified as not having a valid PPI indication was likely very small. Similar to the findings of previous studies,15, 18, 23, 29 prophylaxis against gastrointestinal bleeding was the stated justification for prescribing the PPI in 56% of the DH patient charts reviewed. It is impossible for us to estimate the number of patients in our administrative database for whom stress ulcer prophylaxis was justified by existing guidelines, as it would be necessary to gather a number of specific clinical details for each patient including: 1) ICU stay; 2) presence of coagulopathy; 3) duration of mechanical ventilation; 4) presence of sepsis; 5) duration of ICU stay; 6) presence of occult bleeding for >6 days; and 7) use of high‐dose corticosteroids. This level of clinical detail would likely only be available through a prospective study design, as has been suggested by other authors.33 Further research into the use, safety, and effectiveness of PPIs specifically for stress ulcer prophylaxis is warranted.

In conclusion, we found that 73% of nearly 1 million Medicine patients discharged from academic medical centers received a PPI without a valid indication during their hospitalization. The implications of our findings are broad. PPIs are more expensive31 than H2RAs and there is increasing evidence that they have significant side effects. In both databases we examined, the rate of C. difficile infection was higher in patients receiving PPIs than others. The prescribing habits of physicians in these university hospital settings appear to be far out of line with published guidelines and evidence‐based practice. Reducing inappropriate prescribing of PPIs would be an important educational and quality assurance project in most institutions.

References
  1. IMS Health Web site. Available at: http://www.imshealth.com/deployedfiles/ims/Global/Content/Corporate/Press%20Room/Top‐line%20Market%20Data/2009%20Top‐line%20Market%20Data/Top%20Therapy%20Classes%20by%20U.S.Sales.pdf. Accessed May 1,2011.
  2. Bate CM,Keeling PW, O'Morain C, et al.Comparison of omeprazole and cimetidine in reflux oesophagitis: symptomatic, endoscopic, and histological evaluations.Gut.1990;31(9):968972.
  3. Lau JY,Leung WK,Wu JC, et al.Omeprazole before endoscopy in patients with gastrointestinal bleeding.N Engl J Med.2007;356(16):16311640.
  4. Dial S,Delaney JA,Barkun AN,Suissa S.Use of gastric acid‐suppressive agents and the risk of community‐acquired Clostridium difficile‐associated disease.JAMA.2005;294(23):29892995.
  5. Ho PM,Maddox TM,Wang L, et al.Risk of adverse outcomes associated with concomitant use of clopidogrel and proton pump inhibitors following acute coronary syndrome.JAMA.2009;301(9):937944.
  6. Laheij RJ,Sturkenboom MC,Hassing RJ,Dieleman J,Stricker BH,Jansen JB.Risk of community‐acquired pneumonia and use of gastric acid‐suppressive drugs.JAMA.2004;292(16):19551960.
  7. Yang YX,Lewis JD,Epstein S,Metz DC.Long‐term proton pump inhibitor therapy and risk of hip fracture.JAMA2006;296(24):29472953.
  8. Gulmez SE,Holm A,Frederiksen H,Jensen TG,Pedersen C,Hallas J.Use of proton pump inhibitors and the risk of community‐acquired pneumonia: a population‐based case‐control study.Arch Intern Med.2007;167(9):950955.
  9. Herzig SJ,Howell MD,Ngo LH,Marcantonio ER.Acid‐suppressive medication use and the risk for hospital‐acquired pneumonia.JAMA.2009;301(20):21202128.
  10. US Food and Drug Administration (FDA) Website. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsfor HumanMedicalProducts/ucm245275.htm. Accessed March 2,2011.
  11. Batuwitage BT,Kingham JG,Morgan NE,Bartlett RL.Inappropriate prescribing of proton pump inhibitors in primary care.Postgrad Med J.2007;83(975):6668.
  12. Grube RR,May DB.Stress ulcer prophylaxis in hospitalized patients not in intensive care units.Am J Health Syst Pharm.2007;64(13):13961400.
  13. Afif W,Alsulaiman R,Martel M,Barkun AN.Predictors of inappropriate utilization of intravenous proton pump inhibitors.Aliment Pharmacol Ther.2007;25(5):609615.
  14. Nardino RJ,Vender RJ,Herbert PN.Overuse of acid‐suppressive therapy in hospitalized patients.Am J Gastroenterol.2000;95(11):31183122.
  15. Eid SM,Boueiz A,Paranji S,Mativo C,Landis R,Abougergi MS.Patterns and predictors of proton pump inhibitor overuse among academic and non‐academic hospitalists.Intern Med2010;49(23):25612568.
  16. Parente F,Cucino C,Gallus S, et al.Hospital use of acid‐suppressive medications and its fall‐out on prescribing in general practice: a 1‐month survey.Aliment Pharmacol Ther.2003;17(12):15031506.
  17. Choudhry MN,Soran H,Ziglam HM.Overuse and inappropriate prescribing of proton pump inhibitors in patients with Clostridium difficile‐associated disease.QJM.2008;101(6):445448.
  18. Pham CQ,Regal RE,Bostwick TR,Knauf KS.Acid suppressive therapy use on an inpatient internal medicine service.Ann Pharmacother.2006;40(7–8):12611266.
  19. National Institute of Clinical Excellence (NICE), National Health Service (NHS), Dyspepsia: Management of dyspepsia in adults in primary care. Web site. Available at: http://www.nice.org.uk/nicemedia/live/10950/29460/29460.pdf. Accessed May 1,2011.
  20. Quenot JP,Thiery N,Barbar S.When should stress ulcer prophylaxis be used in the ICU?Curr Opin Crit Care.2009;15(2):139143.
  21. Walker NM,McDonald J.An evaluation of the use of proton pump inhibitors.Pharm World Sci2001;23(3):116117.
  22. Naunton M,Peterson GM,Bleasel MD.Overuse of proton pump inhibitors.J Clin Pharm Ther.2000;25(5):333340.
  23. Alsultan MS,Mayet AY,Malhani AA,Alshaikh MK.Pattern of intravenous proton pump inhibitors use in ICU and non‐ICU setting: a prospective observational study.Saudi J Gastroenterol.2010;16(4):275279.
  24. Ramirez E,Lei SH,Borobia AM, et al.Overuse of PPIs in patients at admission, during treatment, and at discharge in a tertiary Spanish hospital.Curr Clin Pharmacol.2010;5(4):288297.
  25. Leonard J,Marshall JK,Moayyedi P.Systematic review of the risk of enteric infection in patients taking acid suppression.Am J Gastroenterol.2007;102(9):20472056.
  26. Howell MD,Novack V,Grgurich P, et al.Iatrogenic gastric acid suppression and the risk of nosocomial Clostridium difficile infection.Arch Intern Med.2010;170(9):784790.
  27. Eurich DT,Sadowski CA,Simpson SH,Marrie TJ,Majumdar SR.Recurrent community‐acquired pneumonia in patients starting acid‐suppressing drugs.Am J Med.2010;123(1):4753.
  28. Thorens J,Froehlich F,Schwizer W, et al.Bacterial overgrowth during treatment with omeprazole compared with cimetidine: a prospective randomised double blind study.Gut.1996;39(1):5459.
  29. Hussain S,Stefan M,Visintainer P,Rothberg M.Why do physicians prescribe stress ulcer prophylaxis to general medicine patients?South Med J2010;103(11):11031110.
  30. ASHP therapeutic guidelines on stress ulcer prophylaxis.ASHP Commission on Therapeutics and approved by the ASHP Board of Directors on November 14, 1998.Am J Health Syst Pharm.1999;56(4):347379.
  31. Mohebbi L,Hesch K.Stress ulcer prophylaxis in the intensive care unit.Proc (Bayl Univ Med Cent).2009;22(4):373376.
  32. Lin PC,Chang CH,Hsu PI,Tseng PL,Huang YB.The efficacy and safety of proton pump inhibitors vs histamine‐2 receptor antagonists for stress ulcer bleeding prophylaxis among critical care patients: a meta‐analysis.Crit Care Med.2010;38(4):11971205.
  33. Pongprasobchai S,Kridkratoke S,Nopmaneejumruslers C.Proton pump inhibitors for the prevention of stress‐related mucosal disease in critically‐ill patients: a meta‐analysis.J Med Assoc Thai.2009;92(5):632637.
  34. Yachimski PS,Farrell EA,Hunt DP,Reid AE.Proton pump inhibitors for prophylaxis of nosocomial upper gastrointestinal tract bleeding: effect of standardized guidelines on prescribing practice.Arch Intern Med.2010;170(9):779783.
References
  1. IMS Health Web site. Available at: http://www.imshealth.com/deployedfiles/ims/Global/Content/Corporate/Press%20Room/Top‐line%20Market%20Data/2009%20Top‐line%20Market%20Data/Top%20Therapy%20Classes%20by%20U.S.Sales.pdf. Accessed May 1,2011.
  2. Bate CM,Keeling PW, O'Morain C, et al.Comparison of omeprazole and cimetidine in reflux oesophagitis: symptomatic, endoscopic, and histological evaluations.Gut.1990;31(9):968972.
  3. Lau JY,Leung WK,Wu JC, et al.Omeprazole before endoscopy in patients with gastrointestinal bleeding.N Engl J Med.2007;356(16):16311640.
  4. Dial S,Delaney JA,Barkun AN,Suissa S.Use of gastric acid‐suppressive agents and the risk of community‐acquired Clostridium difficile‐associated disease.JAMA.2005;294(23):29892995.
  5. Ho PM,Maddox TM,Wang L, et al.Risk of adverse outcomes associated with concomitant use of clopidogrel and proton pump inhibitors following acute coronary syndrome.JAMA.2009;301(9):937944.
  6. Laheij RJ,Sturkenboom MC,Hassing RJ,Dieleman J,Stricker BH,Jansen JB.Risk of community‐acquired pneumonia and use of gastric acid‐suppressive drugs.JAMA.2004;292(16):19551960.
  7. Yang YX,Lewis JD,Epstein S,Metz DC.Long‐term proton pump inhibitor therapy and risk of hip fracture.JAMA2006;296(24):29472953.
  8. Gulmez SE,Holm A,Frederiksen H,Jensen TG,Pedersen C,Hallas J.Use of proton pump inhibitors and the risk of community‐acquired pneumonia: a population‐based case‐control study.Arch Intern Med.2007;167(9):950955.
  9. Herzig SJ,Howell MD,Ngo LH,Marcantonio ER.Acid‐suppressive medication use and the risk for hospital‐acquired pneumonia.JAMA.2009;301(20):21202128.
  10. US Food and Drug Administration (FDA) Website. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsfor HumanMedicalProducts/ucm245275.htm. Accessed March 2,2011.
  11. Batuwitage BT,Kingham JG,Morgan NE,Bartlett RL.Inappropriate prescribing of proton pump inhibitors in primary care.Postgrad Med J.2007;83(975):6668.
  12. Grube RR,May DB.Stress ulcer prophylaxis in hospitalized patients not in intensive care units.Am J Health Syst Pharm.2007;64(13):13961400.
  13. Afif W,Alsulaiman R,Martel M,Barkun AN.Predictors of inappropriate utilization of intravenous proton pump inhibitors.Aliment Pharmacol Ther.2007;25(5):609615.
  14. Nardino RJ,Vender RJ,Herbert PN.Overuse of acid‐suppressive therapy in hospitalized patients.Am J Gastroenterol.2000;95(11):31183122.
  15. Eid SM,Boueiz A,Paranji S,Mativo C,Landis R,Abougergi MS.Patterns and predictors of proton pump inhibitor overuse among academic and non‐academic hospitalists.Intern Med2010;49(23):25612568.
  16. Parente F,Cucino C,Gallus S, et al.Hospital use of acid‐suppressive medications and its fall‐out on prescribing in general practice: a 1‐month survey.Aliment Pharmacol Ther.2003;17(12):15031506.
  17. Choudhry MN,Soran H,Ziglam HM.Overuse and inappropriate prescribing of proton pump inhibitors in patients with Clostridium difficile‐associated disease.QJM.2008;101(6):445448.
  18. Pham CQ,Regal RE,Bostwick TR,Knauf KS.Acid suppressive therapy use on an inpatient internal medicine service.Ann Pharmacother.2006;40(7–8):12611266.
  19. National Institute of Clinical Excellence (NICE), National Health Service (NHS), Dyspepsia: Management of dyspepsia in adults in primary care. Web site. Available at: http://www.nice.org.uk/nicemedia/live/10950/29460/29460.pdf. Accessed May 1,2011.
  20. Quenot JP,Thiery N,Barbar S.When should stress ulcer prophylaxis be used in the ICU?Curr Opin Crit Care.2009;15(2):139143.
  21. Walker NM,McDonald J.An evaluation of the use of proton pump inhibitors.Pharm World Sci2001;23(3):116117.
  22. Naunton M,Peterson GM,Bleasel MD.Overuse of proton pump inhibitors.J Clin Pharm Ther.2000;25(5):333340.
  23. Alsultan MS,Mayet AY,Malhani AA,Alshaikh MK.Pattern of intravenous proton pump inhibitors use in ICU and non‐ICU setting: a prospective observational study.Saudi J Gastroenterol.2010;16(4):275279.
  24. Ramirez E,Lei SH,Borobia AM, et al.Overuse of PPIs in patients at admission, during treatment, and at discharge in a tertiary Spanish hospital.Curr Clin Pharmacol.2010;5(4):288297.
  25. Leonard J,Marshall JK,Moayyedi P.Systematic review of the risk of enteric infection in patients taking acid suppression.Am J Gastroenterol.2007;102(9):20472056.
  26. Howell MD,Novack V,Grgurich P, et al.Iatrogenic gastric acid suppression and the risk of nosocomial Clostridium difficile infection.Arch Intern Med.2010;170(9):784790.
  27. Eurich DT,Sadowski CA,Simpson SH,Marrie TJ,Majumdar SR.Recurrent community‐acquired pneumonia in patients starting acid‐suppressing drugs.Am J Med.2010;123(1):4753.
  28. Thorens J,Froehlich F,Schwizer W, et al.Bacterial overgrowth during treatment with omeprazole compared with cimetidine: a prospective randomised double blind study.Gut.1996;39(1):5459.
  29. Hussain S,Stefan M,Visintainer P,Rothberg M.Why do physicians prescribe stress ulcer prophylaxis to general medicine patients?South Med J2010;103(11):11031110.
  30. ASHP therapeutic guidelines on stress ulcer prophylaxis.ASHP Commission on Therapeutics and approved by the ASHP Board of Directors on November 14, 1998.Am J Health Syst Pharm.1999;56(4):347379.
  31. Mohebbi L,Hesch K.Stress ulcer prophylaxis in the intensive care unit.Proc (Bayl Univ Med Cent).2009;22(4):373376.
  32. Lin PC,Chang CH,Hsu PI,Tseng PL,Huang YB.The efficacy and safety of proton pump inhibitors vs histamine‐2 receptor antagonists for stress ulcer bleeding prophylaxis among critical care patients: a meta‐analysis.Crit Care Med.2010;38(4):11971205.
  33. Pongprasobchai S,Kridkratoke S,Nopmaneejumruslers C.Proton pump inhibitors for the prevention of stress‐related mucosal disease in critically‐ill patients: a meta‐analysis.J Med Assoc Thai.2009;92(5):632637.
  34. Yachimski PS,Farrell EA,Hunt DP,Reid AE.Proton pump inhibitors for prophylaxis of nosocomial upper gastrointestinal tract bleeding: effect of standardized guidelines on prescribing practice.Arch Intern Med.2010;170(9):779783.
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Program Targets "Frequent Fliers"

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A new Michigan clinic for a hospital system's ED "frequent fliers" is a chance for HM to help streamline care delivery, a hospitalist involved in the effort says.

Doug Apple, MD, hospitalist division chief for Spectrum Health in Grand Rapids, Mich., says the Spectrum Health Medical Group Center for Integrative Medicine will help deal with patients who have used the ED at least 10 times in the past year. In the past, many of the patients would be admitted to the hospital, becoming part of a hospitalist's census. Often, they will have nonspecific conditions, such as chronic abdominal pain.

"Patients get admitted, they might not see the same hospitalist, they may not see the same surgical specialist or GI specialist," Dr. Apple says. "And so every time they get admitted, there's a different plan, there's a different diagnosis or idea. … The intent is to figure out how are these individuals able to get better care, more appropriate care, in an environment that allows them to actually have somebody that pays strict attention to what their needs are?"

Dr. Apple, who worked on the conceptual planning of the clinic, says hospitalists will have no hands-on role with its initial operation, other than referrals. But he says hospitalists who proactively identify patients best cared for via the clinic could save themselves readmissions and ensure better transitions of care.

"We're trying to figure out how we make these transitions, either into a hospital, or out of a hospital, or between an ED and back to the clinic," he adds. "We're trying to make sure these transitions do not become gaps in healthcare."

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A new Michigan clinic for a hospital system's ED "frequent fliers" is a chance for HM to help streamline care delivery, a hospitalist involved in the effort says.

Doug Apple, MD, hospitalist division chief for Spectrum Health in Grand Rapids, Mich., says the Spectrum Health Medical Group Center for Integrative Medicine will help deal with patients who have used the ED at least 10 times in the past year. In the past, many of the patients would be admitted to the hospital, becoming part of a hospitalist's census. Often, they will have nonspecific conditions, such as chronic abdominal pain.

"Patients get admitted, they might not see the same hospitalist, they may not see the same surgical specialist or GI specialist," Dr. Apple says. "And so every time they get admitted, there's a different plan, there's a different diagnosis or idea. … The intent is to figure out how are these individuals able to get better care, more appropriate care, in an environment that allows them to actually have somebody that pays strict attention to what their needs are?"

Dr. Apple, who worked on the conceptual planning of the clinic, says hospitalists will have no hands-on role with its initial operation, other than referrals. But he says hospitalists who proactively identify patients best cared for via the clinic could save themselves readmissions and ensure better transitions of care.

"We're trying to figure out how we make these transitions, either into a hospital, or out of a hospital, or between an ED and back to the clinic," he adds. "We're trying to make sure these transitions do not become gaps in healthcare."

A new Michigan clinic for a hospital system's ED "frequent fliers" is a chance for HM to help streamline care delivery, a hospitalist involved in the effort says.

Doug Apple, MD, hospitalist division chief for Spectrum Health in Grand Rapids, Mich., says the Spectrum Health Medical Group Center for Integrative Medicine will help deal with patients who have used the ED at least 10 times in the past year. In the past, many of the patients would be admitted to the hospital, becoming part of a hospitalist's census. Often, they will have nonspecific conditions, such as chronic abdominal pain.

"Patients get admitted, they might not see the same hospitalist, they may not see the same surgical specialist or GI specialist," Dr. Apple says. "And so every time they get admitted, there's a different plan, there's a different diagnosis or idea. … The intent is to figure out how are these individuals able to get better care, more appropriate care, in an environment that allows them to actually have somebody that pays strict attention to what their needs are?"

Dr. Apple, who worked on the conceptual planning of the clinic, says hospitalists will have no hands-on role with its initial operation, other than referrals. But he says hospitalists who proactively identify patients best cared for via the clinic could save themselves readmissions and ensure better transitions of care.

"We're trying to figure out how we make these transitions, either into a hospital, or out of a hospital, or between an ED and back to the clinic," he adds. "We're trying to make sure these transitions do not become gaps in healthcare."

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In the Literature: Research You Need to Know

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Clinical question: Can the aortic dissection detection (ADD) risk score be used to screen patients for acute aortic dissection at the bedside?

Background: AAD, a life-threatening condition, often is missed due to relatively low incidence, varied presentation, and need for advanced imaging studies. The American Heart Association and the American College of Cardiology have published guidelines on thoracic aortic disease from which the ADD risk score has been adapted to identify high-risk patients and to suggest additional testing based on pretest probability of disease.

Study design: Retrospective application of ADD risk score to the International Registry of Acute Aortic Dissection (IRAD) database.

Setting: Multinational medical registry compiled from 24 medical centers.

Synopsis: A total of 2,538 patients with confirmed ADD were reviewed. The number of patients presenting with one or more of 12 proposed clinical risk markers was determined. An ADD risk score of 0 to 3 was calculated based on the number of risk categories (high-risk predisposing conditions, pain features, examination features) in which patients met criteria.

Among 108 (4.3%) patients found to be low-risk (ADD score 0), 72 had a chest X-ray, 35 of which were found to have a widened mediastinum. High-risk features (ADD score 2 or 3) were found in 1,503 (59.2%) patients, and the remaining 927 (36.5%) patients had intermediate risk (ADD score 1).

The guidelines recommend further imaging for all intermediate- and high-risk patients and for low-risk patients with a wide mediastinum resulting in very good sensitivity.

Bottom line: The ADD risk score is a sensitive bedside screening tool for aortic dissection, ensuring that more than 95% patients with true dissection undergo further investigation, but it may lead to overinvestigation due to unknown specificity.

Citation: Rogers AM, Hermann LK, Booher AM, et al. Sensitivity of the aortic dissection detection risk score, a novel guideline-based tool for identification of acute aortic dissection at initial presentation: results from the international registry of acute aortic dissection. Circ. 2011;123:2213-2218.

For more physician reviews of HM-related literature, visit our website and search "Literature."

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Clinical question: Can the aortic dissection detection (ADD) risk score be used to screen patients for acute aortic dissection at the bedside?

Background: AAD, a life-threatening condition, often is missed due to relatively low incidence, varied presentation, and need for advanced imaging studies. The American Heart Association and the American College of Cardiology have published guidelines on thoracic aortic disease from which the ADD risk score has been adapted to identify high-risk patients and to suggest additional testing based on pretest probability of disease.

Study design: Retrospective application of ADD risk score to the International Registry of Acute Aortic Dissection (IRAD) database.

Setting: Multinational medical registry compiled from 24 medical centers.

Synopsis: A total of 2,538 patients with confirmed ADD were reviewed. The number of patients presenting with one or more of 12 proposed clinical risk markers was determined. An ADD risk score of 0 to 3 was calculated based on the number of risk categories (high-risk predisposing conditions, pain features, examination features) in which patients met criteria.

Among 108 (4.3%) patients found to be low-risk (ADD score 0), 72 had a chest X-ray, 35 of which were found to have a widened mediastinum. High-risk features (ADD score 2 or 3) were found in 1,503 (59.2%) patients, and the remaining 927 (36.5%) patients had intermediate risk (ADD score 1).

The guidelines recommend further imaging for all intermediate- and high-risk patients and for low-risk patients with a wide mediastinum resulting in very good sensitivity.

Bottom line: The ADD risk score is a sensitive bedside screening tool for aortic dissection, ensuring that more than 95% patients with true dissection undergo further investigation, but it may lead to overinvestigation due to unknown specificity.

Citation: Rogers AM, Hermann LK, Booher AM, et al. Sensitivity of the aortic dissection detection risk score, a novel guideline-based tool for identification of acute aortic dissection at initial presentation: results from the international registry of acute aortic dissection. Circ. 2011;123:2213-2218.

For more physician reviews of HM-related literature, visit our website and search "Literature."

Clinical question: Can the aortic dissection detection (ADD) risk score be used to screen patients for acute aortic dissection at the bedside?

Background: AAD, a life-threatening condition, often is missed due to relatively low incidence, varied presentation, and need for advanced imaging studies. The American Heart Association and the American College of Cardiology have published guidelines on thoracic aortic disease from which the ADD risk score has been adapted to identify high-risk patients and to suggest additional testing based on pretest probability of disease.

Study design: Retrospective application of ADD risk score to the International Registry of Acute Aortic Dissection (IRAD) database.

Setting: Multinational medical registry compiled from 24 medical centers.

Synopsis: A total of 2,538 patients with confirmed ADD were reviewed. The number of patients presenting with one or more of 12 proposed clinical risk markers was determined. An ADD risk score of 0 to 3 was calculated based on the number of risk categories (high-risk predisposing conditions, pain features, examination features) in which patients met criteria.

Among 108 (4.3%) patients found to be low-risk (ADD score 0), 72 had a chest X-ray, 35 of which were found to have a widened mediastinum. High-risk features (ADD score 2 or 3) were found in 1,503 (59.2%) patients, and the remaining 927 (36.5%) patients had intermediate risk (ADD score 1).

The guidelines recommend further imaging for all intermediate- and high-risk patients and for low-risk patients with a wide mediastinum resulting in very good sensitivity.

Bottom line: The ADD risk score is a sensitive bedside screening tool for aortic dissection, ensuring that more than 95% patients with true dissection undergo further investigation, but it may lead to overinvestigation due to unknown specificity.

Citation: Rogers AM, Hermann LK, Booher AM, et al. Sensitivity of the aortic dissection detection risk score, a novel guideline-based tool for identification of acute aortic dissection at initial presentation: results from the international registry of acute aortic dissection. Circ. 2011;123:2213-2218.

For more physician reviews of HM-related literature, visit our website and search "Literature."

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NPs Improve Discharges, Not Readmissions

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Adding a nurse practitioner (NP) to a resident physician team improves the efficiency of the discharge process but does nothing to decrease readmissions, according to a study in this month's Journal of Hospital Medicine.

In a randomized controlled trial at Massachusetts General Hospital (MGH) in Boston, NP use resulted in more discharge summaries completed within 24 hours when compared to a control group (67% vs 47%, P<0.001), according to the report, "Improving the Discharge Process by Embedding a Discharge Facilitator in a Resident Team." The study reported more follow-up appointments scheduled (62% vs. 36%, P<0.0001) scheduled and better attendance at those appointments within two weeks (36% vs. 23%, P<0.0002).

But for all the benefits, study author Kathleen Finn MD, MPhil, FACP, FHM, expresses disappointment in the fact that there was no significant difference between the groups in 30-day ED visits or 30-day readmissions.

"The literature suggests if we improve the discharge process, make it safer, and make sure patients have appropriate follow-ups in a timely fashion, we should be able to reduce readmissions," she says. "When we took a general medical population and did all that, we didn't get those results. However, its a single study, with one nurse, so its hard to say. But that was a little disappointing."

The study's results were enough to prompt the expansion of the program from one resident team to three. In the long term, Dr. Finn wants physician educators who are interested in limiting work hours and admissions to view the discharge process as just as important.

"We don't consider the discharge process as time-consuming, but it does take almost as much time as an admission does and yet patients are being discharged, even on admitting days,” she says. "The discharge is a very vulnerable time as the literature keeps showing. We need to rethink the discharge process."

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Adding a nurse practitioner (NP) to a resident physician team improves the efficiency of the discharge process but does nothing to decrease readmissions, according to a study in this month's Journal of Hospital Medicine.

In a randomized controlled trial at Massachusetts General Hospital (MGH) in Boston, NP use resulted in more discharge summaries completed within 24 hours when compared to a control group (67% vs 47%, P<0.001), according to the report, "Improving the Discharge Process by Embedding a Discharge Facilitator in a Resident Team." The study reported more follow-up appointments scheduled (62% vs. 36%, P<0.0001) scheduled and better attendance at those appointments within two weeks (36% vs. 23%, P<0.0002).

But for all the benefits, study author Kathleen Finn MD, MPhil, FACP, FHM, expresses disappointment in the fact that there was no significant difference between the groups in 30-day ED visits or 30-day readmissions.

"The literature suggests if we improve the discharge process, make it safer, and make sure patients have appropriate follow-ups in a timely fashion, we should be able to reduce readmissions," she says. "When we took a general medical population and did all that, we didn't get those results. However, its a single study, with one nurse, so its hard to say. But that was a little disappointing."

The study's results were enough to prompt the expansion of the program from one resident team to three. In the long term, Dr. Finn wants physician educators who are interested in limiting work hours and admissions to view the discharge process as just as important.

"We don't consider the discharge process as time-consuming, but it does take almost as much time as an admission does and yet patients are being discharged, even on admitting days,” she says. "The discharge is a very vulnerable time as the literature keeps showing. We need to rethink the discharge process."

Adding a nurse practitioner (NP) to a resident physician team improves the efficiency of the discharge process but does nothing to decrease readmissions, according to a study in this month's Journal of Hospital Medicine.

In a randomized controlled trial at Massachusetts General Hospital (MGH) in Boston, NP use resulted in more discharge summaries completed within 24 hours when compared to a control group (67% vs 47%, P<0.001), according to the report, "Improving the Discharge Process by Embedding a Discharge Facilitator in a Resident Team." The study reported more follow-up appointments scheduled (62% vs. 36%, P<0.0001) scheduled and better attendance at those appointments within two weeks (36% vs. 23%, P<0.0002).

But for all the benefits, study author Kathleen Finn MD, MPhil, FACP, FHM, expresses disappointment in the fact that there was no significant difference between the groups in 30-day ED visits or 30-day readmissions.

"The literature suggests if we improve the discharge process, make it safer, and make sure patients have appropriate follow-ups in a timely fashion, we should be able to reduce readmissions," she says. "When we took a general medical population and did all that, we didn't get those results. However, its a single study, with one nurse, so its hard to say. But that was a little disappointing."

The study's results were enough to prompt the expansion of the program from one resident team to three. In the long term, Dr. Finn wants physician educators who are interested in limiting work hours and admissions to view the discharge process as just as important.

"We don't consider the discharge process as time-consuming, but it does take almost as much time as an admission does and yet patients are being discharged, even on admitting days,” she says. "The discharge is a very vulnerable time as the literature keeps showing. We need to rethink the discharge process."

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Debunking the &quot;Holiday Blues&quot; Myth

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Around the winter holidays—for reasons as varied as weather, grieving, holiday stress, or just plain Scrooge-liness—people are more susceptible to the "holiday blues." But Timothy Lineberry, MD, psychiatric hospitalist and medical director of Mayo Psychiatric Hospital and board chair of the American Association of Suicidology, points out that depression and associated suicide risk are year-round issues.

"The holidays aren't necessarily the worst. Depression and suicide are important all year long," Dr. Lineberry says.

In fact, a 2010 Annenberg Public Policy Center study (PDF) found that the rate of suicide in the U.S. is lowest in December. Suicide actually peaks in the spring and fall, a pattern that has not changed in recent years according to the same study.

Physicians write 60% of prescriptions for anti-depressants. And because depression and other mental health issues remain a taboo topic to many Americans, many patients visit their physician instead of a mental health clinician. As such, hospitalists need to be able to accurately assess depression and suicide risk.

Dr. Lineberry suggests the following steps for hospitalists who diagnose patients with depression:

  • Consider using the holidays to renew or update systems of practice to better identify depression;
  • Use the PHQ-9 questionnaire with patients who display symptoms of depression; and
  • Ask direct and clear questions about suicidal thoughts and behaviors. Keep substance abuse as a risk factor in mind.
  •  

     

 

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Around the winter holidays—for reasons as varied as weather, grieving, holiday stress, or just plain Scrooge-liness—people are more susceptible to the "holiday blues." But Timothy Lineberry, MD, psychiatric hospitalist and medical director of Mayo Psychiatric Hospital and board chair of the American Association of Suicidology, points out that depression and associated suicide risk are year-round issues.

"The holidays aren't necessarily the worst. Depression and suicide are important all year long," Dr. Lineberry says.

In fact, a 2010 Annenberg Public Policy Center study (PDF) found that the rate of suicide in the U.S. is lowest in December. Suicide actually peaks in the spring and fall, a pattern that has not changed in recent years according to the same study.

Physicians write 60% of prescriptions for anti-depressants. And because depression and other mental health issues remain a taboo topic to many Americans, many patients visit their physician instead of a mental health clinician. As such, hospitalists need to be able to accurately assess depression and suicide risk.

Dr. Lineberry suggests the following steps for hospitalists who diagnose patients with depression:

  • Consider using the holidays to renew or update systems of practice to better identify depression;
  • Use the PHQ-9 questionnaire with patients who display symptoms of depression; and
  • Ask direct and clear questions about suicidal thoughts and behaviors. Keep substance abuse as a risk factor in mind.
  •  

     

 

Around the winter holidays—for reasons as varied as weather, grieving, holiday stress, or just plain Scrooge-liness—people are more susceptible to the "holiday blues." But Timothy Lineberry, MD, psychiatric hospitalist and medical director of Mayo Psychiatric Hospital and board chair of the American Association of Suicidology, points out that depression and associated suicide risk are year-round issues.

"The holidays aren't necessarily the worst. Depression and suicide are important all year long," Dr. Lineberry says.

In fact, a 2010 Annenberg Public Policy Center study (PDF) found that the rate of suicide in the U.S. is lowest in December. Suicide actually peaks in the spring and fall, a pattern that has not changed in recent years according to the same study.

Physicians write 60% of prescriptions for anti-depressants. And because depression and other mental health issues remain a taboo topic to many Americans, many patients visit their physician instead of a mental health clinician. As such, hospitalists need to be able to accurately assess depression and suicide risk.

Dr. Lineberry suggests the following steps for hospitalists who diagnose patients with depression:

  • Consider using the holidays to renew or update systems of practice to better identify depression;
  • Use the PHQ-9 questionnaire with patients who display symptoms of depression; and
  • Ask direct and clear questions about suicidal thoughts and behaviors. Keep substance abuse as a risk factor in mind.
  •  

     

 

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Second-Cancer Signal Affirmed After Lenalidomide for Myeloma

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SAN DIEGO – The risk of a secondary malignancy doubled in patients with newly diagnosed multiple myeloma treated with melphalan plus thalidomide or lenalidomide in a retrospective, pooled analysis of 2,283 patients.

Incidence rates per 100 persons per year of follow-up were 0.95 with high-dose melphalan (Alkeran) followed by lenalidomide (Revlimid) maintenance and 1.05 with melphalan and thalidomide. In comparison, rates were 0.40 with cyclophosphamide, lenalidomide, and dexamethasone and 0.42 with melphalan and no immunomodulatory drugs, Dr. Antonio Palumbo reported at the annual meeting of the American Society of Hematology (ASH).

Dr. Antonio Palumbo

At 4 years of follow-up, second cancers were diagnosed in 48 (2.1%) of the 2,283 patients enrolled in nine experimental trials of the European Myeloma Network. There was consistent evidence of an increase in late events over time.

"I do not want to underestimate the issue," Dr. Palumbo said. "There is a signal, but the first conclusion is caution. When you come to 48 cancers versus 2,200 patients, by chance many things may happen."

He noted that the risk of multiple myeloma progression is between 10 and 15 times higher than the diagnosis of a second cancer, and suggested that the emphasis on second cancers may be overshadowing the risk of death due to toxic effects and infections.

Of the 48 secondary cancers, 8 of the 10 hematologic malignancies and 8 of the 38 solid tumors were fatal. In contrast, there were 124 toxic deaths (8.6%) and 49 infective deaths (3.4%) among 1,435 patients given the combination of melphalan-prednisone-thalidomide or bortezomib (Velcade)-melphalan-prednisone, said Dr. Palumbo, chief of the myeloma unit at the University of Torino (Italy).

"We take it for granted that with chemo we have some toxic effects," he said in an interview. "We should increase our alert of our combinations, and not focus solely on the second cancers."

Session co-moderator Dr. Meral Beksac, with Ankara (Turkey) University, said the Italian data suggest caution and greater vigilance regarding routine cancer screenings among multiple myeloma patients, but would not change her treatment approach.

"Dr. Palumbo has shown very beautifully that the benefits you achieve in terms of the long-term myeloma effect outweigh the risk of secondary malignancies," she said in an interview. "Personally, I think we must plan to avoid alkylating agents when we now have these better agents."

Preliminary data from three trials showing a fourfold increase in secondary cancers in multiple myeloma patients treated with lenalidomide as maintenance therapy or in combination with melphalan prompted investigations into the safety of lenalidomide in the United States and Europe in 2011.

The European Medicines Agency concluded in September that the benefits of lenalidomide continue to outweigh the risks within the approved setting of relapsed multiple myeloma, but recommended that a warning be added on the risk of second cancers. The U.S. Food and Drug Administration review is ongoing, and includes the risk for thalidomide, since lenalidomide is an analogue of thalidomide.

Although the development of acute myeloid leukemia (AML) following multiple myeloma was observed decades ago, the underlying mechanisms remain unclear. Swedish researchers recently reported that the risk of AML and myelodysplastic syndromes is 11.5-fold higher in multiple myeloma patients than in the general population, even before the introduction of novel agents (Blood 2011;118:4086-92). In addition, the risk of AML/MDS was eightfold higher in patients with monoclonal gammopathy of undetermined significance (MGUS), even though none of the MGUS patients developed multiple myeloma, according to session co-moderator Dr. Sigurdur Y. Kristinsson, who was a coauthor of the Swedish study.

"Even those people that never develop the disease have an increased risk of AML and MDS, so it shows that it’s not only the treatment that we’re giving, but it’s also an inherent susceptibility," Dr. Kristinsson, with the Karolinska Hospital and Institute in Stockholm, said in an interview.

Work is ongoing to identify multiple myeloma patients at an increased risk of second cancers, thereby allowing clinicians to tailor therapy to reduce risks. A separate poster presentation at the ASH meeting reported that higher risk of second cancers was associated with older age, male sex, and radiation and/or surgery among roughly 29,250 multiple myeloma patients in the Surveillance, Epidemiology, and End Results (SEER) database.

Subgroup analysis of the pooled Italian data did not identify specific subgroups at greater risk, Dr. Palumbo said. The incidence rate was higher at 1.13 per 100 person-years for patients given melphalan-lenalidomide vs. 0.76 per 100 person-years for patients treated with autologous stem cell transplantation and lenalidomide (median age 68 years vs. 59 years, respectively).

 

 

Speaking on behalf of the investigators, Dr. Palumbo reported employment with, serving as a consultant and on the speakers bureau of, having equity ownership in, and receiving research funding, patent royalties, and honoraria from Celgene, maker of lenalidomide. Dr. Beksac reported honoraria and speakers bureau activity with Celgene and Janssen Cilag. Dr. Kristinsson reported no conflicts of interest.

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SAN DIEGO – The risk of a secondary malignancy doubled in patients with newly diagnosed multiple myeloma treated with melphalan plus thalidomide or lenalidomide in a retrospective, pooled analysis of 2,283 patients.

Incidence rates per 100 persons per year of follow-up were 0.95 with high-dose melphalan (Alkeran) followed by lenalidomide (Revlimid) maintenance and 1.05 with melphalan and thalidomide. In comparison, rates were 0.40 with cyclophosphamide, lenalidomide, and dexamethasone and 0.42 with melphalan and no immunomodulatory drugs, Dr. Antonio Palumbo reported at the annual meeting of the American Society of Hematology (ASH).

Dr. Antonio Palumbo

At 4 years of follow-up, second cancers were diagnosed in 48 (2.1%) of the 2,283 patients enrolled in nine experimental trials of the European Myeloma Network. There was consistent evidence of an increase in late events over time.

"I do not want to underestimate the issue," Dr. Palumbo said. "There is a signal, but the first conclusion is caution. When you come to 48 cancers versus 2,200 patients, by chance many things may happen."

He noted that the risk of multiple myeloma progression is between 10 and 15 times higher than the diagnosis of a second cancer, and suggested that the emphasis on second cancers may be overshadowing the risk of death due to toxic effects and infections.

Of the 48 secondary cancers, 8 of the 10 hematologic malignancies and 8 of the 38 solid tumors were fatal. In contrast, there were 124 toxic deaths (8.6%) and 49 infective deaths (3.4%) among 1,435 patients given the combination of melphalan-prednisone-thalidomide or bortezomib (Velcade)-melphalan-prednisone, said Dr. Palumbo, chief of the myeloma unit at the University of Torino (Italy).

"We take it for granted that with chemo we have some toxic effects," he said in an interview. "We should increase our alert of our combinations, and not focus solely on the second cancers."

Session co-moderator Dr. Meral Beksac, with Ankara (Turkey) University, said the Italian data suggest caution and greater vigilance regarding routine cancer screenings among multiple myeloma patients, but would not change her treatment approach.

"Dr. Palumbo has shown very beautifully that the benefits you achieve in terms of the long-term myeloma effect outweigh the risk of secondary malignancies," she said in an interview. "Personally, I think we must plan to avoid alkylating agents when we now have these better agents."

Preliminary data from three trials showing a fourfold increase in secondary cancers in multiple myeloma patients treated with lenalidomide as maintenance therapy or in combination with melphalan prompted investigations into the safety of lenalidomide in the United States and Europe in 2011.

The European Medicines Agency concluded in September that the benefits of lenalidomide continue to outweigh the risks within the approved setting of relapsed multiple myeloma, but recommended that a warning be added on the risk of second cancers. The U.S. Food and Drug Administration review is ongoing, and includes the risk for thalidomide, since lenalidomide is an analogue of thalidomide.

Although the development of acute myeloid leukemia (AML) following multiple myeloma was observed decades ago, the underlying mechanisms remain unclear. Swedish researchers recently reported that the risk of AML and myelodysplastic syndromes is 11.5-fold higher in multiple myeloma patients than in the general population, even before the introduction of novel agents (Blood 2011;118:4086-92). In addition, the risk of AML/MDS was eightfold higher in patients with monoclonal gammopathy of undetermined significance (MGUS), even though none of the MGUS patients developed multiple myeloma, according to session co-moderator Dr. Sigurdur Y. Kristinsson, who was a coauthor of the Swedish study.

"Even those people that never develop the disease have an increased risk of AML and MDS, so it shows that it’s not only the treatment that we’re giving, but it’s also an inherent susceptibility," Dr. Kristinsson, with the Karolinska Hospital and Institute in Stockholm, said in an interview.

Work is ongoing to identify multiple myeloma patients at an increased risk of second cancers, thereby allowing clinicians to tailor therapy to reduce risks. A separate poster presentation at the ASH meeting reported that higher risk of second cancers was associated with older age, male sex, and radiation and/or surgery among roughly 29,250 multiple myeloma patients in the Surveillance, Epidemiology, and End Results (SEER) database.

Subgroup analysis of the pooled Italian data did not identify specific subgroups at greater risk, Dr. Palumbo said. The incidence rate was higher at 1.13 per 100 person-years for patients given melphalan-lenalidomide vs. 0.76 per 100 person-years for patients treated with autologous stem cell transplantation and lenalidomide (median age 68 years vs. 59 years, respectively).

 

 

Speaking on behalf of the investigators, Dr. Palumbo reported employment with, serving as a consultant and on the speakers bureau of, having equity ownership in, and receiving research funding, patent royalties, and honoraria from Celgene, maker of lenalidomide. Dr. Beksac reported honoraria and speakers bureau activity with Celgene and Janssen Cilag. Dr. Kristinsson reported no conflicts of interest.

SAN DIEGO – The risk of a secondary malignancy doubled in patients with newly diagnosed multiple myeloma treated with melphalan plus thalidomide or lenalidomide in a retrospective, pooled analysis of 2,283 patients.

Incidence rates per 100 persons per year of follow-up were 0.95 with high-dose melphalan (Alkeran) followed by lenalidomide (Revlimid) maintenance and 1.05 with melphalan and thalidomide. In comparison, rates were 0.40 with cyclophosphamide, lenalidomide, and dexamethasone and 0.42 with melphalan and no immunomodulatory drugs, Dr. Antonio Palumbo reported at the annual meeting of the American Society of Hematology (ASH).

Dr. Antonio Palumbo

At 4 years of follow-up, second cancers were diagnosed in 48 (2.1%) of the 2,283 patients enrolled in nine experimental trials of the European Myeloma Network. There was consistent evidence of an increase in late events over time.

"I do not want to underestimate the issue," Dr. Palumbo said. "There is a signal, but the first conclusion is caution. When you come to 48 cancers versus 2,200 patients, by chance many things may happen."

He noted that the risk of multiple myeloma progression is between 10 and 15 times higher than the diagnosis of a second cancer, and suggested that the emphasis on second cancers may be overshadowing the risk of death due to toxic effects and infections.

Of the 48 secondary cancers, 8 of the 10 hematologic malignancies and 8 of the 38 solid tumors were fatal. In contrast, there were 124 toxic deaths (8.6%) and 49 infective deaths (3.4%) among 1,435 patients given the combination of melphalan-prednisone-thalidomide or bortezomib (Velcade)-melphalan-prednisone, said Dr. Palumbo, chief of the myeloma unit at the University of Torino (Italy).

"We take it for granted that with chemo we have some toxic effects," he said in an interview. "We should increase our alert of our combinations, and not focus solely on the second cancers."

Session co-moderator Dr. Meral Beksac, with Ankara (Turkey) University, said the Italian data suggest caution and greater vigilance regarding routine cancer screenings among multiple myeloma patients, but would not change her treatment approach.

"Dr. Palumbo has shown very beautifully that the benefits you achieve in terms of the long-term myeloma effect outweigh the risk of secondary malignancies," she said in an interview. "Personally, I think we must plan to avoid alkylating agents when we now have these better agents."

Preliminary data from three trials showing a fourfold increase in secondary cancers in multiple myeloma patients treated with lenalidomide as maintenance therapy or in combination with melphalan prompted investigations into the safety of lenalidomide in the United States and Europe in 2011.

The European Medicines Agency concluded in September that the benefits of lenalidomide continue to outweigh the risks within the approved setting of relapsed multiple myeloma, but recommended that a warning be added on the risk of second cancers. The U.S. Food and Drug Administration review is ongoing, and includes the risk for thalidomide, since lenalidomide is an analogue of thalidomide.

Although the development of acute myeloid leukemia (AML) following multiple myeloma was observed decades ago, the underlying mechanisms remain unclear. Swedish researchers recently reported that the risk of AML and myelodysplastic syndromes is 11.5-fold higher in multiple myeloma patients than in the general population, even before the introduction of novel agents (Blood 2011;118:4086-92). In addition, the risk of AML/MDS was eightfold higher in patients with monoclonal gammopathy of undetermined significance (MGUS), even though none of the MGUS patients developed multiple myeloma, according to session co-moderator Dr. Sigurdur Y. Kristinsson, who was a coauthor of the Swedish study.

"Even those people that never develop the disease have an increased risk of AML and MDS, so it shows that it’s not only the treatment that we’re giving, but it’s also an inherent susceptibility," Dr. Kristinsson, with the Karolinska Hospital and Institute in Stockholm, said in an interview.

Work is ongoing to identify multiple myeloma patients at an increased risk of second cancers, thereby allowing clinicians to tailor therapy to reduce risks. A separate poster presentation at the ASH meeting reported that higher risk of second cancers was associated with older age, male sex, and radiation and/or surgery among roughly 29,250 multiple myeloma patients in the Surveillance, Epidemiology, and End Results (SEER) database.

Subgroup analysis of the pooled Italian data did not identify specific subgroups at greater risk, Dr. Palumbo said. The incidence rate was higher at 1.13 per 100 person-years for patients given melphalan-lenalidomide vs. 0.76 per 100 person-years for patients treated with autologous stem cell transplantation and lenalidomide (median age 68 years vs. 59 years, respectively).

 

 

Speaking on behalf of the investigators, Dr. Palumbo reported employment with, serving as a consultant and on the speakers bureau of, having equity ownership in, and receiving research funding, patent royalties, and honoraria from Celgene, maker of lenalidomide. Dr. Beksac reported honoraria and speakers bureau activity with Celgene and Janssen Cilag. Dr. Kristinsson reported no conflicts of interest.

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Second-Cancer Signal Affirmed After Lenalidomide for Myeloma
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FROM THE ANNUAL MEETING OF THE AMERICAN SOCIETY OF HEMATOLOGY

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Major Finding: At 4 years of follow-up, second cancers were diagnosed in 2.1% of patients.

Data Source: Retrospective, pooled analysis of 2,283 patients who received lenalidomide for treatment of multiple myeloma in nine experimental trials.

Disclosures: Speaking on behalf of the investigators, Dr. Palumbo reported employment with, serving as a consultant and on the speakers bureau of, having equity ownership in, and receiving research funding, patent royalties, and honoraria from Celgene, maker of lenalidomide. Dr. Beksac reported honoraria and speakers bureau activity with Celgene and Janssen Cilag. Dr. Kristinsson reported no conflicts of interest.

AMA Policy Opposes Switch to ICD-10

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On Nov. 10, the American Medical Association’s House of Delegates approved a policy opposing implementation of the International Classification of Diseases and Related Health Problems, 10th Revision (ICD-10-CM) at a policy meeting in New Orleans. Following the vote, Robert M. Wah, MD, AMA board chair, stated, “The AMA will work vigorously to stop implementation of ICD-10, which will create a significant burden on the practice of medicine with no direct benefit to individual patients’ care.”

Organizations tied to hospitals, however, are fully supportive of the switch.

“We strongly support ICD-10 and the enhancements it will bring to the care that’s provided in hospitals,” says Don May, the American Hospital Association’s (AHA) vice president for policy. “The current coding system has really run its course in its ability to keep up with modern medicine.”

SHM has taken a “neutral” stance on this issue, for the time being, says SHM’s AMA delegate Bradley E. Flansbaum, DO, MPH, SFHM, director of hospitalist services at Lenox Hill Hospital in New York City. “But [SHM is] cautiously optimistic as the inpatient ecosystem evolves, hopefully, for the better.”

History of Opposition

In 2003, the AMA wrote to the National Committee on Vital and Health Statistics regarding plans to adopt ICD-10. The 55 signees of the letter (including the American College of Surgeons and other specialty societies) urged the committee to “confine your recommendation [to HHS] to the uses of ICD-10-PCS [the procedural codes portion] as a coding system for inpatient hospital services.” Another letter in 2006 to Bill Frist, then the U.S. Senate majority leader, expressed concern over a “rapid transition” from ICD-9 to ICD-10.

The AMA contends that switching to ICD-10 disproportionately burdens physicians in practice. “Depending on the size of a medical practice,” Dr. Wah says, “the total cost of impact of the ICD-10 mandate will range from $83,290 to more than $2.7 million. Physicians should not be expected to carry a disproportionate burden of the implementation costs when others in the health sector stand to reap the primary financial benefits.”

Upgrade: The Time Has Come

Organizations in support of the changeover, however, see the implementation of ICD-10 coding as a necessary step forward in improving patient care.

Physicians should not be expected to carry a disproportionate burden of the implementation costs when others in the health sector stand to reap the primary financial benefits.


—Robert M. Wah, MD, board chair, American Medical Association

“It’s not unreasonable to replace a 30-year-old, out-of-date system,” says Sue Bowman, RHIA, CCS, director of coding policy and compliance with the American Health Information Management Association (AHIMA). Bowman says she is surprised that the AMA maintains the switch will not benefit patient care. “Everything nowadays has to do with healthcare data,” she says. “Without good data, you cannot measure quality of care, patient outcomes, or effectiveness of treatments. The expectation is that ICD-10 will better mirror the terminology already used in medical records.”

May agrees. “We understand the concerns,” he says, “but if you think about how much better we’ll be able to track disease and how it affects patients, there will be a much more rich data set at our disposal. This will help us develop evidence-based medicine and quality standards in a much more robust way than we can do today.”

In addition, May says, hospitalists may be able to function as a “huge resource” to their community physician colleagues, to help them understand the benefits of making the switch, and help them find the short cuts to manage the new system.

Listen to Don May, vice president for health policy, American Hospital Association

 

 

AHIMA is aware, Bowman notes, that some physician groups “were struggling with moving forward with ICD-10, but our message to the industry is for people to continue working toward implementation. CMS has made it pretty clear that there’s not going to be a delay or a grace period.”

In response to the AMA action, a spokesperson for CMS says, “Implementation of this new coding system will mean better information to improve the quality of healthcare, and more accurate payments to providers. CMS is giving significant transition time and flexibility to providers to switch over, and we will continue to work with the healthcare community to ensure successful compliance.”

Gretchen Henkel is a freelance writer based in California.

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On Nov. 10, the American Medical Association’s House of Delegates approved a policy opposing implementation of the International Classification of Diseases and Related Health Problems, 10th Revision (ICD-10-CM) at a policy meeting in New Orleans. Following the vote, Robert M. Wah, MD, AMA board chair, stated, “The AMA will work vigorously to stop implementation of ICD-10, which will create a significant burden on the practice of medicine with no direct benefit to individual patients’ care.”

Organizations tied to hospitals, however, are fully supportive of the switch.

“We strongly support ICD-10 and the enhancements it will bring to the care that’s provided in hospitals,” says Don May, the American Hospital Association’s (AHA) vice president for policy. “The current coding system has really run its course in its ability to keep up with modern medicine.”

SHM has taken a “neutral” stance on this issue, for the time being, says SHM’s AMA delegate Bradley E. Flansbaum, DO, MPH, SFHM, director of hospitalist services at Lenox Hill Hospital in New York City. “But [SHM is] cautiously optimistic as the inpatient ecosystem evolves, hopefully, for the better.”

History of Opposition

In 2003, the AMA wrote to the National Committee on Vital and Health Statistics regarding plans to adopt ICD-10. The 55 signees of the letter (including the American College of Surgeons and other specialty societies) urged the committee to “confine your recommendation [to HHS] to the uses of ICD-10-PCS [the procedural codes portion] as a coding system for inpatient hospital services.” Another letter in 2006 to Bill Frist, then the U.S. Senate majority leader, expressed concern over a “rapid transition” from ICD-9 to ICD-10.

The AMA contends that switching to ICD-10 disproportionately burdens physicians in practice. “Depending on the size of a medical practice,” Dr. Wah says, “the total cost of impact of the ICD-10 mandate will range from $83,290 to more than $2.7 million. Physicians should not be expected to carry a disproportionate burden of the implementation costs when others in the health sector stand to reap the primary financial benefits.”

Upgrade: The Time Has Come

Organizations in support of the changeover, however, see the implementation of ICD-10 coding as a necessary step forward in improving patient care.

Physicians should not be expected to carry a disproportionate burden of the implementation costs when others in the health sector stand to reap the primary financial benefits.


—Robert M. Wah, MD, board chair, American Medical Association

“It’s not unreasonable to replace a 30-year-old, out-of-date system,” says Sue Bowman, RHIA, CCS, director of coding policy and compliance with the American Health Information Management Association (AHIMA). Bowman says she is surprised that the AMA maintains the switch will not benefit patient care. “Everything nowadays has to do with healthcare data,” she says. “Without good data, you cannot measure quality of care, patient outcomes, or effectiveness of treatments. The expectation is that ICD-10 will better mirror the terminology already used in medical records.”

May agrees. “We understand the concerns,” he says, “but if you think about how much better we’ll be able to track disease and how it affects patients, there will be a much more rich data set at our disposal. This will help us develop evidence-based medicine and quality standards in a much more robust way than we can do today.”

In addition, May says, hospitalists may be able to function as a “huge resource” to their community physician colleagues, to help them understand the benefits of making the switch, and help them find the short cuts to manage the new system.

Listen to Don May, vice president for health policy, American Hospital Association

 

 

AHIMA is aware, Bowman notes, that some physician groups “were struggling with moving forward with ICD-10, but our message to the industry is for people to continue working toward implementation. CMS has made it pretty clear that there’s not going to be a delay or a grace period.”

In response to the AMA action, a spokesperson for CMS says, “Implementation of this new coding system will mean better information to improve the quality of healthcare, and more accurate payments to providers. CMS is giving significant transition time and flexibility to providers to switch over, and we will continue to work with the healthcare community to ensure successful compliance.”

Gretchen Henkel is a freelance writer based in California.

On Nov. 10, the American Medical Association’s House of Delegates approved a policy opposing implementation of the International Classification of Diseases and Related Health Problems, 10th Revision (ICD-10-CM) at a policy meeting in New Orleans. Following the vote, Robert M. Wah, MD, AMA board chair, stated, “The AMA will work vigorously to stop implementation of ICD-10, which will create a significant burden on the practice of medicine with no direct benefit to individual patients’ care.”

Organizations tied to hospitals, however, are fully supportive of the switch.

“We strongly support ICD-10 and the enhancements it will bring to the care that’s provided in hospitals,” says Don May, the American Hospital Association’s (AHA) vice president for policy. “The current coding system has really run its course in its ability to keep up with modern medicine.”

SHM has taken a “neutral” stance on this issue, for the time being, says SHM’s AMA delegate Bradley E. Flansbaum, DO, MPH, SFHM, director of hospitalist services at Lenox Hill Hospital in New York City. “But [SHM is] cautiously optimistic as the inpatient ecosystem evolves, hopefully, for the better.”

History of Opposition

In 2003, the AMA wrote to the National Committee on Vital and Health Statistics regarding plans to adopt ICD-10. The 55 signees of the letter (including the American College of Surgeons and other specialty societies) urged the committee to “confine your recommendation [to HHS] to the uses of ICD-10-PCS [the procedural codes portion] as a coding system for inpatient hospital services.” Another letter in 2006 to Bill Frist, then the U.S. Senate majority leader, expressed concern over a “rapid transition” from ICD-9 to ICD-10.

The AMA contends that switching to ICD-10 disproportionately burdens physicians in practice. “Depending on the size of a medical practice,” Dr. Wah says, “the total cost of impact of the ICD-10 mandate will range from $83,290 to more than $2.7 million. Physicians should not be expected to carry a disproportionate burden of the implementation costs when others in the health sector stand to reap the primary financial benefits.”

Upgrade: The Time Has Come

Organizations in support of the changeover, however, see the implementation of ICD-10 coding as a necessary step forward in improving patient care.

Physicians should not be expected to carry a disproportionate burden of the implementation costs when others in the health sector stand to reap the primary financial benefits.


—Robert M. Wah, MD, board chair, American Medical Association

“It’s not unreasonable to replace a 30-year-old, out-of-date system,” says Sue Bowman, RHIA, CCS, director of coding policy and compliance with the American Health Information Management Association (AHIMA). Bowman says she is surprised that the AMA maintains the switch will not benefit patient care. “Everything nowadays has to do with healthcare data,” she says. “Without good data, you cannot measure quality of care, patient outcomes, or effectiveness of treatments. The expectation is that ICD-10 will better mirror the terminology already used in medical records.”

May agrees. “We understand the concerns,” he says, “but if you think about how much better we’ll be able to track disease and how it affects patients, there will be a much more rich data set at our disposal. This will help us develop evidence-based medicine and quality standards in a much more robust way than we can do today.”

In addition, May says, hospitalists may be able to function as a “huge resource” to their community physician colleagues, to help them understand the benefits of making the switch, and help them find the short cuts to manage the new system.

Listen to Don May, vice president for health policy, American Hospital Association

 

 

AHIMA is aware, Bowman notes, that some physician groups “were struggling with moving forward with ICD-10, but our message to the industry is for people to continue working toward implementation. CMS has made it pretty clear that there’s not going to be a delay or a grace period.”

In response to the AMA action, a spokesperson for CMS says, “Implementation of this new coding system will mean better information to improve the quality of healthcare, and more accurate payments to providers. CMS is giving significant transition time and flexibility to providers to switch over, and we will continue to work with the healthcare community to ensure successful compliance.”

Gretchen Henkel is a freelance writer based in California.

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Return ED Visits by Sickle Cell Patients Common

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SAN DIEGO – More than 40% of patients with sickle cell disease return for acute care within 14 days following an emergency department treat-and-release visit, with young adults and those with public insurance having the highest rates of return.

Those are key findings from a large analysis of data from the 2005 and 2006 State Emergency Department Databases and State Inpatient Databases managed by the Healthcare Cost and Utilization Project, a federal, state, and industry partnership sponsored by the Agency for Healthcare Research and Quality.

Dr. David C. Brousseau

"Patients with sickle cell disease who are discharged from the hospital have higher rates of rehospitalization than [patients with] almost any other chronic disease," lead study author Dr. David C. Brousseau said at the annual meeting of the American Society of Hematology. "Because of the high rate of rehospitalizations, many hospitals have been developing programs to decrease rehospitalization rates for sickle cell disease. This effort is primarily driven by two factors: the recent federal emphasis on rehospitalizations, and a desire to improve care, with the belief that rehospitalizations represent a deficiency in care quality, or at least an opportunity to improve care."

Previous studies have shown that about half of ED visits made by patients with sickle cell disease result in inpatient hospitalization, he continued, "yet little emphasis has been placed on what happens after an ED treat-and-release visit."

Dr. Brousseau and his associates conducted a retrospective cohort study of all sickle cell disease–related ED visits and hospitalizations during 2005 and 2006 in the states of Arizona, California, Florida, Massachusetts, Missouri, New York, South Carolina, and Tennessee. "One-third of patients with sickle cell disease in the United States reside in these eight states," said Dr. Brousseau, of the pediatrics department at the Medical College of Wisconsin and an emergency medicine specialist at Children’s Hospital of Wisconsin, Milwaukee.

The researchers hypothesized that patients with sickle cell disease who were treated and released from an ED would have high rates of 14-day return visits to both the ED and an inpatient unit. A 14-day window was chosen "to more accurately reflect a time period ... where a revisit would not be due to a new crisis," he said.

During the 2-year study period, 12,109 people with sickle cell disease made 39,775 index ED visits. The 14-day return visit rate was 42.1%, "meaning that 42.1% of all ED treat-and-release visits were followed within 14 days by a return visit to either the ED or the inpatient unit," Dr. Brousseau said. A higher proportion of the return visits were to the ED than to the inpatient unit (25.4% vs. 16.7%, respectively).

Analysis of data by patient age and insurance provider revealed that the highest proportion of return visits within 14 days was made by patients aged 18-30 years (49%) and by those who carried public insurance (46.5%).

The 7-day return rate was 31.6%. Of these, 18.6% were to the ED and 13% were to the inpatient unit.

The 14-day revisit rate to the same hospital was 31.2%. Children were more likely than adults to make return visits to the same hospital (84.3% vs. 72.7%, respectively).

"We conclude that an ED treat-and-release visit should serve as a trigger to focus enhanced outpatient care to prevent subsequent inpatient visits and to improve patient care," Dr. Brousseau said.

Dr. Brousseau said he had no relevant financial disclosures.

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SAN DIEGO – More than 40% of patients with sickle cell disease return for acute care within 14 days following an emergency department treat-and-release visit, with young adults and those with public insurance having the highest rates of return.

Those are key findings from a large analysis of data from the 2005 and 2006 State Emergency Department Databases and State Inpatient Databases managed by the Healthcare Cost and Utilization Project, a federal, state, and industry partnership sponsored by the Agency for Healthcare Research and Quality.

Dr. David C. Brousseau

"Patients with sickle cell disease who are discharged from the hospital have higher rates of rehospitalization than [patients with] almost any other chronic disease," lead study author Dr. David C. Brousseau said at the annual meeting of the American Society of Hematology. "Because of the high rate of rehospitalizations, many hospitals have been developing programs to decrease rehospitalization rates for sickle cell disease. This effort is primarily driven by two factors: the recent federal emphasis on rehospitalizations, and a desire to improve care, with the belief that rehospitalizations represent a deficiency in care quality, or at least an opportunity to improve care."

Previous studies have shown that about half of ED visits made by patients with sickle cell disease result in inpatient hospitalization, he continued, "yet little emphasis has been placed on what happens after an ED treat-and-release visit."

Dr. Brousseau and his associates conducted a retrospective cohort study of all sickle cell disease–related ED visits and hospitalizations during 2005 and 2006 in the states of Arizona, California, Florida, Massachusetts, Missouri, New York, South Carolina, and Tennessee. "One-third of patients with sickle cell disease in the United States reside in these eight states," said Dr. Brousseau, of the pediatrics department at the Medical College of Wisconsin and an emergency medicine specialist at Children’s Hospital of Wisconsin, Milwaukee.

The researchers hypothesized that patients with sickle cell disease who were treated and released from an ED would have high rates of 14-day return visits to both the ED and an inpatient unit. A 14-day window was chosen "to more accurately reflect a time period ... where a revisit would not be due to a new crisis," he said.

During the 2-year study period, 12,109 people with sickle cell disease made 39,775 index ED visits. The 14-day return visit rate was 42.1%, "meaning that 42.1% of all ED treat-and-release visits were followed within 14 days by a return visit to either the ED or the inpatient unit," Dr. Brousseau said. A higher proportion of the return visits were to the ED than to the inpatient unit (25.4% vs. 16.7%, respectively).

Analysis of data by patient age and insurance provider revealed that the highest proportion of return visits within 14 days was made by patients aged 18-30 years (49%) and by those who carried public insurance (46.5%).

The 7-day return rate was 31.6%. Of these, 18.6% were to the ED and 13% were to the inpatient unit.

The 14-day revisit rate to the same hospital was 31.2%. Children were more likely than adults to make return visits to the same hospital (84.3% vs. 72.7%, respectively).

"We conclude that an ED treat-and-release visit should serve as a trigger to focus enhanced outpatient care to prevent subsequent inpatient visits and to improve patient care," Dr. Brousseau said.

Dr. Brousseau said he had no relevant financial disclosures.

SAN DIEGO – More than 40% of patients with sickle cell disease return for acute care within 14 days following an emergency department treat-and-release visit, with young adults and those with public insurance having the highest rates of return.

Those are key findings from a large analysis of data from the 2005 and 2006 State Emergency Department Databases and State Inpatient Databases managed by the Healthcare Cost and Utilization Project, a federal, state, and industry partnership sponsored by the Agency for Healthcare Research and Quality.

Dr. David C. Brousseau

"Patients with sickle cell disease who are discharged from the hospital have higher rates of rehospitalization than [patients with] almost any other chronic disease," lead study author Dr. David C. Brousseau said at the annual meeting of the American Society of Hematology. "Because of the high rate of rehospitalizations, many hospitals have been developing programs to decrease rehospitalization rates for sickle cell disease. This effort is primarily driven by two factors: the recent federal emphasis on rehospitalizations, and a desire to improve care, with the belief that rehospitalizations represent a deficiency in care quality, or at least an opportunity to improve care."

Previous studies have shown that about half of ED visits made by patients with sickle cell disease result in inpatient hospitalization, he continued, "yet little emphasis has been placed on what happens after an ED treat-and-release visit."

Dr. Brousseau and his associates conducted a retrospective cohort study of all sickle cell disease–related ED visits and hospitalizations during 2005 and 2006 in the states of Arizona, California, Florida, Massachusetts, Missouri, New York, South Carolina, and Tennessee. "One-third of patients with sickle cell disease in the United States reside in these eight states," said Dr. Brousseau, of the pediatrics department at the Medical College of Wisconsin and an emergency medicine specialist at Children’s Hospital of Wisconsin, Milwaukee.

The researchers hypothesized that patients with sickle cell disease who were treated and released from an ED would have high rates of 14-day return visits to both the ED and an inpatient unit. A 14-day window was chosen "to more accurately reflect a time period ... where a revisit would not be due to a new crisis," he said.

During the 2-year study period, 12,109 people with sickle cell disease made 39,775 index ED visits. The 14-day return visit rate was 42.1%, "meaning that 42.1% of all ED treat-and-release visits were followed within 14 days by a return visit to either the ED or the inpatient unit," Dr. Brousseau said. A higher proportion of the return visits were to the ED than to the inpatient unit (25.4% vs. 16.7%, respectively).

Analysis of data by patient age and insurance provider revealed that the highest proportion of return visits within 14 days was made by patients aged 18-30 years (49%) and by those who carried public insurance (46.5%).

The 7-day return rate was 31.6%. Of these, 18.6% were to the ED and 13% were to the inpatient unit.

The 14-day revisit rate to the same hospital was 31.2%. Children were more likely than adults to make return visits to the same hospital (84.3% vs. 72.7%, respectively).

"We conclude that an ED treat-and-release visit should serve as a trigger to focus enhanced outpatient care to prevent subsequent inpatient visits and to improve patient care," Dr. Brousseau said.

Dr. Brousseau said he had no relevant financial disclosures.

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Major Finding: More than 40% of patients with sickle cell disease return for acute care following an ED treat-and-release visit.

Data Source: A study of 12,109 people with sickle cell disease in eight states who made 39,775 index ED visits in 2005 and 2006, based on Healthcare Cost and Utilization Project data.

Disclosures: Dr. Brousseau said he had no relevant financial disclosures.

Mantle Cell Lymphoma: BTK Inhibitor Scores Again

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SAN DIEGO – Even before it has earned a name, the novel targeted agent designated PCI-32765 is earning an impressive reputation, first for its mettle against chronic lymphocytic leukemia, and now for its potent action against relapsed or refractory mantle cell lymphoma in early clinical data, reported investigators at the annual meeting of the American Society of Hematology.

Preliminary results of a phase II trial of PCI-32765, an inhibitor of Bruton’s tyrosine kinase (BTK) expressed in several hematologic malignancies, show that the agent induced complete responses in 16% of 51 patients with relapsed/refractory mantle cell lymphoma (MCL) and partial responses in 53%, for a combined overall response rate of 69%, said Dr. Luhua (Michael) Wang from the division of lymphoma and myeloma at the University of Texas M.D. Anderson Cancer Center in Houston.

"We think, as a single oral agent in the relapse setting of mantle cell lymphoma, this is a high response rate so far. The efficacy is also observed in patients with bulky disease, and also in refractive disease. Most importantly, the efficacy is independent, so far, from the MIPI [MCL International Prognostic Index] score," he said.

Patients with a high-risk MIPI score had a 75% response rate, the same as that for patients with a low-risk score; intermediate-risk patients had a 65% response rate.

An additional 18% of patients overall had stable disease; only 14% experienced disease progression.

In an earlier presentation at the ASH meeting, Dr. Susan O’Brien, also from M.D. Anderson, reported that PCI-32765 was associated with an overall response rate of 70% at 10.2 months’ follow-up in patients with relapsed/refractory CLL.

In the mantle cell lymphoma study, the BTK-inhibitor induced good responses both in patients who had previously been treated with the proteasome inhibitor bortezomib (Velcade), with rates of 15% for complete responses and 50% for partial responses, and in those who were bortezomib naive, with a 16% complete response rate and 55% partial response rate.

"People are very interested in this agent," commented Dr. Mitchell R. Smith from the Fox Chase Cancer Center in Philadelphia, in an interview.

"It looks very active, but we don’t know a lot about long-term effects and how long responses will last. But when you think about hitting specific pathways, that’s our goal in treating these diseases. This hits a specific pathway, does it well, and there have been responses in many B-cell disorders," he said. Dr. Smith comoderated the session at which the data were presented, but was not involved in the study.

PCI-32765 is an oral inhibitor of BTK, an essential element of the B-cell antigen receptor-signaling pathway. It blocks receptor signaling and induces apoptosis, as well as mantle cell migration and adhesion, and has been shown in in vitro studies to block pERK, pJNK, and NF-kappaB pathways in MCL cell lines.

The trial, designated PCYC-1104-CA, is a multicenter open-label phase II study of PCI-32765 in 68 patients. Dr. Wang presented data from an efficacy analysis of 51 patients who had at least one post-baseline tumor assessment. The patients were divided into two groups: bortezomib-exposed (27 patients) and bortezomib naive (41 patients, 34 of whom had never received bortezomib, and 7 who had received less than 2 cycles).

The patients were treated with 560 mg PCI-32765 daily until disease progression.

Median time on study was 3.7 months among all patients. At the most recent follow-up, 71% of bortezomib-naive and 70% of bortezomib-exposed patients were still on study. Discontinuations were primarily for disease progression, and there was one on-study death, a patient who had previously received bortezomib.

Non-hematologic adverse events were generally mild, with the only grade 4 toxicity being abdominal pain in about 2% of patients.

Grade 3 neutropenia occurred in 2% overall of 61 patients available for a safety analysis, and grade 4 neutropenia was seen 3%. Grade 3 febrile neutropenia, anemia, and thrombocytopenias were each seen in 3% of patients (no grade 4), and grade 4 pancytopenia was seen in 2%.

The investigators saw a 57% overall response rate in patients with bulky disease, 67% in those with refractory disease, 77% among those who had received fewer than 3 prior lines of therapy, and 57% among those who had received 3 or more. In addition, the overall response rate was 71% in patients who had received high-intensity prior therapy, and 65% in those who had received standard-dose therapy.

Additional follow-up will be required before the investigators can determine duration of response and progression-free survival, and more clinical trials with PCI-32765 are in the planning stages, Dr. Wang said.

 

 

Pharmacyclics sponsored the study. Dr. Wang disclosed consulting, having equity ownership in, and receiving research funding from, Pharmacyclics. He also disclosed relationships with Celgene, Millennium, Novartis, and Onyx. Dr. Smith disclosed board membership and receiving research funding from Cephalon, and being on the speakers bureau for Celgene, Genentech, Spectrum, and Allos.

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SAN DIEGO – Even before it has earned a name, the novel targeted agent designated PCI-32765 is earning an impressive reputation, first for its mettle against chronic lymphocytic leukemia, and now for its potent action against relapsed or refractory mantle cell lymphoma in early clinical data, reported investigators at the annual meeting of the American Society of Hematology.

Preliminary results of a phase II trial of PCI-32765, an inhibitor of Bruton’s tyrosine kinase (BTK) expressed in several hematologic malignancies, show that the agent induced complete responses in 16% of 51 patients with relapsed/refractory mantle cell lymphoma (MCL) and partial responses in 53%, for a combined overall response rate of 69%, said Dr. Luhua (Michael) Wang from the division of lymphoma and myeloma at the University of Texas M.D. Anderson Cancer Center in Houston.

"We think, as a single oral agent in the relapse setting of mantle cell lymphoma, this is a high response rate so far. The efficacy is also observed in patients with bulky disease, and also in refractive disease. Most importantly, the efficacy is independent, so far, from the MIPI [MCL International Prognostic Index] score," he said.

Patients with a high-risk MIPI score had a 75% response rate, the same as that for patients with a low-risk score; intermediate-risk patients had a 65% response rate.

An additional 18% of patients overall had stable disease; only 14% experienced disease progression.

In an earlier presentation at the ASH meeting, Dr. Susan O’Brien, also from M.D. Anderson, reported that PCI-32765 was associated with an overall response rate of 70% at 10.2 months’ follow-up in patients with relapsed/refractory CLL.

In the mantle cell lymphoma study, the BTK-inhibitor induced good responses both in patients who had previously been treated with the proteasome inhibitor bortezomib (Velcade), with rates of 15% for complete responses and 50% for partial responses, and in those who were bortezomib naive, with a 16% complete response rate and 55% partial response rate.

"People are very interested in this agent," commented Dr. Mitchell R. Smith from the Fox Chase Cancer Center in Philadelphia, in an interview.

"It looks very active, but we don’t know a lot about long-term effects and how long responses will last. But when you think about hitting specific pathways, that’s our goal in treating these diseases. This hits a specific pathway, does it well, and there have been responses in many B-cell disorders," he said. Dr. Smith comoderated the session at which the data were presented, but was not involved in the study.

PCI-32765 is an oral inhibitor of BTK, an essential element of the B-cell antigen receptor-signaling pathway. It blocks receptor signaling and induces apoptosis, as well as mantle cell migration and adhesion, and has been shown in in vitro studies to block pERK, pJNK, and NF-kappaB pathways in MCL cell lines.

The trial, designated PCYC-1104-CA, is a multicenter open-label phase II study of PCI-32765 in 68 patients. Dr. Wang presented data from an efficacy analysis of 51 patients who had at least one post-baseline tumor assessment. The patients were divided into two groups: bortezomib-exposed (27 patients) and bortezomib naive (41 patients, 34 of whom had never received bortezomib, and 7 who had received less than 2 cycles).

The patients were treated with 560 mg PCI-32765 daily until disease progression.

Median time on study was 3.7 months among all patients. At the most recent follow-up, 71% of bortezomib-naive and 70% of bortezomib-exposed patients were still on study. Discontinuations were primarily for disease progression, and there was one on-study death, a patient who had previously received bortezomib.

Non-hematologic adverse events were generally mild, with the only grade 4 toxicity being abdominal pain in about 2% of patients.

Grade 3 neutropenia occurred in 2% overall of 61 patients available for a safety analysis, and grade 4 neutropenia was seen 3%. Grade 3 febrile neutropenia, anemia, and thrombocytopenias were each seen in 3% of patients (no grade 4), and grade 4 pancytopenia was seen in 2%.

The investigators saw a 57% overall response rate in patients with bulky disease, 67% in those with refractory disease, 77% among those who had received fewer than 3 prior lines of therapy, and 57% among those who had received 3 or more. In addition, the overall response rate was 71% in patients who had received high-intensity prior therapy, and 65% in those who had received standard-dose therapy.

Additional follow-up will be required before the investigators can determine duration of response and progression-free survival, and more clinical trials with PCI-32765 are in the planning stages, Dr. Wang said.

 

 

Pharmacyclics sponsored the study. Dr. Wang disclosed consulting, having equity ownership in, and receiving research funding from, Pharmacyclics. He also disclosed relationships with Celgene, Millennium, Novartis, and Onyx. Dr. Smith disclosed board membership and receiving research funding from Cephalon, and being on the speakers bureau for Celgene, Genentech, Spectrum, and Allos.

SAN DIEGO – Even before it has earned a name, the novel targeted agent designated PCI-32765 is earning an impressive reputation, first for its mettle against chronic lymphocytic leukemia, and now for its potent action against relapsed or refractory mantle cell lymphoma in early clinical data, reported investigators at the annual meeting of the American Society of Hematology.

Preliminary results of a phase II trial of PCI-32765, an inhibitor of Bruton’s tyrosine kinase (BTK) expressed in several hematologic malignancies, show that the agent induced complete responses in 16% of 51 patients with relapsed/refractory mantle cell lymphoma (MCL) and partial responses in 53%, for a combined overall response rate of 69%, said Dr. Luhua (Michael) Wang from the division of lymphoma and myeloma at the University of Texas M.D. Anderson Cancer Center in Houston.

"We think, as a single oral agent in the relapse setting of mantle cell lymphoma, this is a high response rate so far. The efficacy is also observed in patients with bulky disease, and also in refractive disease. Most importantly, the efficacy is independent, so far, from the MIPI [MCL International Prognostic Index] score," he said.

Patients with a high-risk MIPI score had a 75% response rate, the same as that for patients with a low-risk score; intermediate-risk patients had a 65% response rate.

An additional 18% of patients overall had stable disease; only 14% experienced disease progression.

In an earlier presentation at the ASH meeting, Dr. Susan O’Brien, also from M.D. Anderson, reported that PCI-32765 was associated with an overall response rate of 70% at 10.2 months’ follow-up in patients with relapsed/refractory CLL.

In the mantle cell lymphoma study, the BTK-inhibitor induced good responses both in patients who had previously been treated with the proteasome inhibitor bortezomib (Velcade), with rates of 15% for complete responses and 50% for partial responses, and in those who were bortezomib naive, with a 16% complete response rate and 55% partial response rate.

"People are very interested in this agent," commented Dr. Mitchell R. Smith from the Fox Chase Cancer Center in Philadelphia, in an interview.

"It looks very active, but we don’t know a lot about long-term effects and how long responses will last. But when you think about hitting specific pathways, that’s our goal in treating these diseases. This hits a specific pathway, does it well, and there have been responses in many B-cell disorders," he said. Dr. Smith comoderated the session at which the data were presented, but was not involved in the study.

PCI-32765 is an oral inhibitor of BTK, an essential element of the B-cell antigen receptor-signaling pathway. It blocks receptor signaling and induces apoptosis, as well as mantle cell migration and adhesion, and has been shown in in vitro studies to block pERK, pJNK, and NF-kappaB pathways in MCL cell lines.

The trial, designated PCYC-1104-CA, is a multicenter open-label phase II study of PCI-32765 in 68 patients. Dr. Wang presented data from an efficacy analysis of 51 patients who had at least one post-baseline tumor assessment. The patients were divided into two groups: bortezomib-exposed (27 patients) and bortezomib naive (41 patients, 34 of whom had never received bortezomib, and 7 who had received less than 2 cycles).

The patients were treated with 560 mg PCI-32765 daily until disease progression.

Median time on study was 3.7 months among all patients. At the most recent follow-up, 71% of bortezomib-naive and 70% of bortezomib-exposed patients were still on study. Discontinuations were primarily for disease progression, and there was one on-study death, a patient who had previously received bortezomib.

Non-hematologic adverse events were generally mild, with the only grade 4 toxicity being abdominal pain in about 2% of patients.

Grade 3 neutropenia occurred in 2% overall of 61 patients available for a safety analysis, and grade 4 neutropenia was seen 3%. Grade 3 febrile neutropenia, anemia, and thrombocytopenias were each seen in 3% of patients (no grade 4), and grade 4 pancytopenia was seen in 2%.

The investigators saw a 57% overall response rate in patients with bulky disease, 67% in those with refractory disease, 77% among those who had received fewer than 3 prior lines of therapy, and 57% among those who had received 3 or more. In addition, the overall response rate was 71% in patients who had received high-intensity prior therapy, and 65% in those who had received standard-dose therapy.

Additional follow-up will be required before the investigators can determine duration of response and progression-free survival, and more clinical trials with PCI-32765 are in the planning stages, Dr. Wang said.

 

 

Pharmacyclics sponsored the study. Dr. Wang disclosed consulting, having equity ownership in, and receiving research funding from, Pharmacyclics. He also disclosed relationships with Celgene, Millennium, Novartis, and Onyx. Dr. Smith disclosed board membership and receiving research funding from Cephalon, and being on the speakers bureau for Celgene, Genentech, Spectrum, and Allos.

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FROM THE ANNUAL MEETING OF THE AMERICAN SOCIETY OF HEMATOLOGY

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Major Finding: The Bruton’s tyrosine kinase inhibitor PCI-32765 induced a 69% overall response rate among 51 patients with relapsed/refractory mantle cell lymphoma.

Data Source: Phase II single agent trial.

Disclosures: Pharmacyclics sponsored the study. Dr. Wang disclosed consulting, having equity ownership in, and receiving research funding from, Pharmacyclics. He also disclosed relationships with Celgene, Millennium, Novartis, and Onyx. Dr. Smith disclosed board membership and receiving research funding from Cephalon, and being on the speakers bureau for Celgene, Genentech, Spectrum, and Allos.

Hospital LOS in the Homebound Population

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Nonmedical factors associated with prolonged hospital length of stay in an urban homebound population

In recent years, much attention has been paid to concerns regarding length of stay (LOS) and safety of hospital discharges.13 Yet studies conducted in a variety of populations suggest that long stays do not wholly reflect acute medical necessity, but may also be driven by nonmedical factors.46 In a study of frail elderly patients, nonmedical factors accounted for over half of patients' hospital stay days.5 Nonmedical factors may include the availability of community and outpatient resources, inadequate patient social support, disagreement with family and/or patient decision‐making, and post‐hospital placement and care needs.7

Homebound patients are at particular risk for long stays because they are typically frail, elderly, and medically complex.8 The United States homebound population numbers at least 2 million and is expected to increase to at least 3 million by the year 2020.9 This group is medically underserved, often only receiving care for medical emergencies, and represents a costly group of health care beneficiaries.10 Although homebound primary care (HBPC) programs are structured to provide coordinated medical and supportive care in the home, the clinical complexity of patients often requires hospitalization during times of acute illness.11

Navigating the discharge process for homebound patients can prove time‐consuming for inpatient physicians whose clinical obligations encompass ensuring safe care transitions between hospital and home.12 The lack of literature on the discharge needs of the homebound population provides little guidance for physicians and health systems seeking to safely transition homebound patients from the hospital to the home in a timely and efficient manner. We performed a pilot study of an urban homebound population cared for by a single academic homebound program to identify and describe nonmedical factors associated with prolonged hospitalization.

METHODS

This retrospective descriptive study included homebound patients cared for by The Mount Sinai Visiting Doctors Program (MSVD), a primary care program affiliated with The Mount Sinai Hospital. MSVD is the largest academic homebound primary care program in the United States. The structure and patient population of MSVD patients have been described previously.13 Briefly, the program employs 8 physicians, 2 nurse practitioners, and support personnel including 2 registered nurses, 4 social workers, and 4 clerical staff members to serve over 1000 homebound patients annually. To be enrolled in the program, patients must meet the Medicare definition of homebound (ie, they must be able to leave home only with great difficulty and for infrequent or short absences). Patients are referred from a variety of sources including emergency rooms, inpatient units, and local nursing and social service agencies. Physicians visit patients on average once every 2 months, but can make more frequent home visits when a clinical need arises. Thirty‐six percent of patients in the program are hospitalized at least once per year while they are under the MSVD's care.14 Patients in the MSVD are referred by their primary care physician to outpatient social work as needed for finite interventions, though not for ongoing case management; approximately one‐third of all MSVD patients have been seen by an MSVD social worker over a 1‐year period.14

All patients enrolled in MSVD discharged from The Mount Sinai Hospital in New York from January 1, 2007, to December 31, 2007, were evaluated for inclusion in this study. The MSVD clinical database was cross‐referenced with The Mount Sinai Hospital data system to maximize reliability of recorded admission and discharge dates. Discrepancies in dates were investigated and corrected by the authors. As the study focused on admissions rather than individual patients, repeat hospitalizations and factors contributing to long stays were included and considered separately. In the event of repeat hospitalizations, factors contributing to LOS were also assessed separately.

Using the University HealthSystems Consortium (UHC) Database, the selected discharges were analyzed for LOS data. The UHC Database contains data from The Mount Sinai Hospital and 106 other academic medical centers and 233 other affiliated hospitals, representing approximately 90% of the United States' nonprofit academic medical centers. UHC members submit clinical, financial, and administrative information for the purpose of facilitating comparative data analysis among institutions.15 The model assigns an expected LOS for each patient based on a 4‐step risk adjustment methodology that adjusts for variations in patient characteristics. The regression models consider a range of independent variables including patient age, sex, race, socioeconomic status, admission source, and comorbid conditions. The expected LOS value is used to produce an LOS ratio, which is the ratio of a patient's observed LOS to expected LOS. We compared LOS ratios for all patient discharges during the study period and determined the mean LOS ratio for the group. Long‐stay patients were defined using the UHC definition of an LOS ratio greater than 2 standard deviations above the mean. These patients were selected for analysis to examine factors contributing to their long stays.

The primary author conducted a chart review for the long‐stay patients. The date of medical readiness for discharge was defined as the date when no acute hospital care needs or pending procedures (eg, intravenous medication, transfusion, invasive and noninvasive testing, surgery) were documented by the attending physician, house officer, nurse practitioner, or physician assistant in the chart. Patients with a discharge immediately following determination of medical readiness were characterized as having a medical stay (eg, patient admitted for pneumonia and discharged home after 3 days once fever, leukocytosis, and symptoms improved with a prescription for remaining antibiotic course). Patients who were classified as medically ready for discharge yet remained additional days in the hospital were categorized as having a nonmedical component to their hospitalization and comprised the nonmedical stay group (eg, patient admitted for pneumonia with improved vital signs and symptoms after 3 days, but discharged home after 10 days awaiting approval of increased home health aide hours). The primary author reviewed cases (<5%) with coauthors when categorization of patient data was unclear from physician documentation in the patient's chart. Similar methodology and terminology have been used in previous studies examining the contribution of nonmedical factors to LOS.5, 7

While literature in other fields, such as social work, often characterize similar factors as social or social care factors, we use the term nonmedical to draw the distinction between factors that acutely reflect a patient's state of health and necessitate days spent in the hospital (eg, surgery, infection), in contrast to factors that are not direct contributors to the patient's current medical status (eg, post‐hospital placement). Factors contributing to nonmedical days were determined based on previous studies and categorized as follows: nursing facility bed availability, nursing facility rejection of the patient, complications with insurance coverage, lack of patient/family agreement with discharge plan, home care service delays, and other. The category other was included to identify and explore any unexpected or unique reasons for prolongation of hospitalization in this population. When multiple nonmedical factors were identified for a given hospitalization, all contributing factors were recorded.

Demographic, clinical, and discharge characteristics were extracted from the MSVD clinical database to qualitatively describe and compare the long‐stay hospitalizations to the remainder of the sample.

RESULTS

There were a total of 479 discharges of 267 unique MSVD patients from The Mount Sinai Hospital occurring from January 1, 2007, to December 31, 2007. During this 12‐month period, the average observed LOS for all admissions was 7.84 days, with a mean UHC LOS ratio of 1.23 (SD = 3.43). Seventeen admissions were identified as long‐stays, representing 3.5% of discharges. The 17 admissions represent 17 unique patients.

As shown in Table 1, the long‐stay group (n = 17) was slightly younger, more likely to be male, and had less dementia than the nonlong‐stay group (n = 462). There was a marked difference in the location of patient discharge; long‐stay patients were more than twice as likely to be discharged to a facility and less likely to be discharged home. There were no in‐hospital deaths in the long‐stay patient group during the time period studied.

Demographic, Clinical, and Discharge Characteristics for 2007 Hospitalizations According to Length of Stay
Characteristics*NonLong‐Stay Patients (n = 462)Long‐Stay Patients (n = 17)
  • NOTE: Characteristics describe all hospitalizations and include multiple discharges per patient.

  • Abbreviation: SD, standard deviation.

Mean age, years (SD)80 (15.6)74 (18.2)
Female sex69%47%
Race  
Caucasian27.1%29%
Black31.4%23.5%
Hispanic37.7%41.2%
Other2.4%5.9%
Has Medicaid68.1%70.6%
Dementia diagnosis42.9%29.4%
Depression diagnosis37.3%47.1%
Lives alone39.8%43.8%
Discharge  
Nursing/rehabilitation14.9%35.3%
Home78.3%64.7%
Death5.9%0%
Hospice0.9%0%

Of the 17 long‐stay patients, 8 (47%) remained in the hospital past the date they were determined to be medically ready for discharge and were defined as having a nonmedical component for the extension of their hospitalizations. The number of nonmedical days ranged from 6 to 34 days (mean, 17 days). Out of 428 total long‐stay patient days, 136 were nonmedical. This represented 31.8% of all long‐stay patient days, and 53% of the nonmedical group's total hospital days. The mean LOS ratio for the nonmedical cases was 6.04 (Table 2).

Medical Stay and Nonmedical Stay Length of Stay Ratios
 Medical Stay (n = 9)Nonmedical Stay (n = 8)
  • Abbreviation: LOS, length of stay.

LOS (days)19.217
LOS ratio5.076.04

Nine patients were defined as medical stay cases (ie, no nonmedical component contributing to the long hospitalization). The mean observed LOS was 19.2 days, and the mean LOS ratio for this group was 5.07 (Table 2). There were no significant differences between primary diagnosis‐related groups (DRGs) seen in the medical and nonmedical stay groups.

The most common reason for a nonmedical stay was nursing facility placement delays (Table 3), specifically related to lack of bed availability and facility rejection of the patient leading to prolonged time waiting for long‐term placement (n = 6). Other nonmedical factors contributing to LOS were lack of patient and/or family agreement with discharge plans (eg, disagreement among family members regarding caregiving responsibilities, goals of care, or patient refusal to be discharged on a particular day) (n = 4); complications with insurance coverage for facility placement or for home care (n = 3); and home care service delays, such as patient need for increased home care hours after discharge (n = 2). Of note, 5 of the 8 nonmedical stay cases had multiple factors contributing to patients' long stays. All delays were assigned to one of the a priori defined categories. There were no other or unexpected reasons identified.

Characteristics of Nonmedical Long‐Stay Patients
PatientDemographicsExpected LOS (days)Observed LOS (days)LOS RatioNo. of Nonmedical DaysNonmedical Stay Factors
  • Abbreviation: LOS, length of stay.

Patient A63‐year‐old white man4.564810.5334Nursing facility bed availability
Lack of patient/family agreement with discharge plan
Patient B53‐year‐old white man2.973110.4423Nursing facility rejection of the patient
Lack of patient/family agreement with discharge plan
Complications with insurance coverage
Home care service delays
Patient C98‐year‐old Latina woman5.51295.2623Lack of patient/family agreement with discharge plan
Home care service delays
Complications with insurance coverage
Patient D83‐year‐old white woman8.94465.1513Nursing facility bed availability
Patient E93‐year‐old white woman9.05424.6416Nursing facility bed availability
Patient F87‐year‐old Latino man2.62114.206Nursing facility bed availability
Nursing facility rejection of the patient
Complications with insurance coverage
Patient G55‐year‐old white man5.66234.067Lack of patient/family agreement with discharge plan
Patient H40‐year‐old African American man6.2325'4.0114Nursing facility rejection of the patient
Nursing facility bed availability

Of the nonmedical cases, all but 1 patient had been seen by an MSVD social worker prior to hospital admission, though the social work referral may have been years prior to or unrelated to the current admission.

DISCUSSION

Almost half of long‐stay patients identified in this homebound population remained hospitalized in an urban academic medical center due to at least one, and often multiple, nonmedical factors. Nonmedical factors identified in this group are similar to those described in previous studies, particularly family and patient decision‐making and post‐hospital placement and care needs.5, 7 Although this pilot study was limited to a single‐site population, it is to our knowledge the first study to describe these factors in a homebound population, and may be able to guide future research and discussion on this topic.

This study used a risk‐adjusted LOS measure to determine long stay cases. Using the UHC Database allowed for a more accurate understanding of the contribution of nonmedical factors to LOS by accounting for hospitalizations that were numerically lengthy but medically appropriate for their respective DRG. The use of the LOS ratio also allows for standardized application of these data across academic health centers. In our sample, 50% of the patients classified as LOS outliers by the UHC Database (cases with LOS in the top percentile for their respective DRG) had nonmedical stays. Conventional strategies often dismiss outliers in analyses of patient LOS data. However, in doing so there is a missed opportunity to identify underlying reasons for their disproportionately long hospitalizations that may also be impacting the broader set of patients with similar nonmedical factors affecting LOS.

The 8 nonmedical stay patients spent a combined 136 days longer in the hospital than medically necessary due to a variety of nonmedical factors, and represented over half of the nonmedical stay group's total hospital days. Using a conservative estimate for cost per hospital day of $1770,16 the nonmedical days cost the hospital almost a quarter of a million dollars ($240,720). Because this figure only accounts for long‐stay patients, the actual costs attributable to nonmedical days for the homebound population in general may be higher.

The longest patient stays, whether attributable to medical or nonmedical factors, were more likely to result in discharge to a facility than the rest of the sample hospitalizations. Facility placement was the most common nonmedical factor contributing to long stays in this sample. In contrast, home carerelated factors contributed the least to nonmedical days. This finding highlights the need for hospital‐based physicians and other inpatient staff members to be aware that despite patient enrollment in an HBPC, the possibility for homebound patients to be discharged to a nursing facility remains significant. A decreasing number of skilled nursing beds across the United States may magnify this factor in long‐stay cases.17 Increased awareness of this possibility among inpatient staff can allow the team to address facility placement considerations early in the hospital stay, potentially decreasing nonmedical days.18

Seven of the 8 nonmedical stay patients had been referred to and seen by MSVD social workers before hospitalization, a high percentage relative to the general MSVD population, of which fewer than half are seen by a social worker during their enrollment in MSVD. This finding may suggest that this group of patients already exhibited difficult social circumstances before their hospital admission, yet the current referral‐based social work model at MSVD did not mitigate their high LOS. This finding further suggests that patient enrollment in an HBPC does not mitigate the risk of high LOS and prolonged nonmedical stays, and that involvement of inpatient practitioners remains a critical part of advanced discharge planning.

This pilot study found that 32% of all long‐stay hospital days were due to nonmedical factors, suggesting that these factors play a greater role in the homebound population than for general medical patients. A recent study at an academic medical center examined 3574 patient‐days on a general medicine service, and noted that 11% of all days were felt to be medically unnecessary by the treating hospitalists.19 Hospitalists are well situated to participate in and lead improvement efforts given their expertise in managing complex dispositions and advancing collaborative strategies for care of patients with high overall acuity.20 These efforts will be needed to target those patients at highest risk for prolonged LOS with the greatest social care needs. Because this study did not pilot strategies to reduce LOS, we cannot offer evidence‐based suggestions for an enhanced multidisciplinary approach or other avenues for improvement. However, we believe that the study findings provide the basis for future research to test strategies to reduce excess LOS by focusing on nonmedical factors and a multidisciplinary approach. This will become especially relevant as health care systems bear increasing financial responsibility for inefficient and/or unnecessary hospitalizations and readmissions.

The involvement of social work before hospitalization for most of the homebound population with prolonged hospitalization suggests a need for greater team‐based efforts across venues. Though hospital interdisciplinary rounds aim to increase collaboration and reduce LOS, costs, and readmissions, these rounds do not typically include outpatient care providers.21 Improved communication and collaboration between social work with both inpatient and outpatient care teams to address nonmedical issues contributing to long stays are likely to improve care and transitions, though rigorous studies examining specific communication models across venues are lacking. This study found that delay in nursing facility placement was the most common reason for prolonged hospitalization for long‐stay cases. This finding emphasizes the need for communication between inpatient and outpatient staff to convey prior conversations or preparations for placement, identify patients who need post‐discharge facility placement early in hospitalization, and prompt timely discussions with patients and families.

The finding that prolonged hospitalization for the homebound population was due to nonmedical factors for almost one‐half of patients with long hospital stays has important implications for policymakers and other key stakeholders. For example, accountable care organizations are being developed to align members of the health care sector to provide higher quality care in a more efficient manner. These study data suggest that this alignment should include hospitals, nursing homes, and home health care agencies to ensure that discharge delays are minimized and unnecessary societal costs are avoided. Future research will need to confirm and build upon these findings of nonmedical reasons for excessive LOS to further inform the process of implementation of health care reform measures. Recent plans to cut Medicaid funding to nursing homes may further limit bed availability, increasing the risk of prolonged LOS and related costs to the health care system. This potential concern highlights the importance of care coordination and communication between inpatient and outpatient care providers to proactively address nursing home placement needs before hospitalization occurs, and/or to identify alternative safe discharge plans if a previously homebound patient is hospitalized.

There are several limitations to this descriptive study. Admissions included in this analysis were only captured for those admitted to The Mount Sinai Hospital. While MSVD providers report that more than 90% of hospitalizations for MSVD patients occur at The Mount Sinai Hospital, patients may also be admitted to one of many New York City metropolitan area hospitals closer to the patient's residence. It is possible that additional factors contributing to high LOS might be revealed if these admissions were included in the analysis. The urban homebound population served by MSVD may have more access to supplementary home care services (e.g. home attendants, meal services) than populations in more rural and less service‐intensive areas. Thus, it may be difficult to generalize these findings to programs serving less urban constituencies or with more restrictive policies regarding home care services. Additionally, as New York registers one of the highest nursing facility occupancy rates (in 2008, 92.2% versus the national average of 82.9%), patients in other markets may face a shorter wait time for a bed, decreasing the number of nonmedical days attributable to nursing home bed supply.17 The small total number of long‐stay patients also prevented statistical analysis comparing those patients with the rest of the sample. This pilot study may inform the design of future studies that may be able to include multiple HBPC programs or study homebound patients over a longer period to increase sample size.

Identifying the significant contribution of nonmedical days to patient stay is an important initial step to avoiding costly and medically unnecessary days for the patient and the hospital. As has been demonstrated in other interdisciplinary efforts, increased collaboration among physicians, social workers, discharge planners, and other disciplines may help address current gaps in patient care with regard to LOS.20, 21 Future studies should determine which homebound patients are at highest risk for prolonged hospitalization due to nonmedical factors to help design focused strategies and interventions for this vulnerable population.

Acknowledgements

Funding: This work was supported in part by grant funds received by Katherine Ornstein and Theresa Soriano from The Fan Fox and Leslie R. Samuels Foundation, Inc.

Files
References
  1. Chen LM,Freitag MH,Franco M,Sullivan CD,Dickson C,Brancati FL.Natural history of late discharges from a general medical ward.J Hosp Med.2009;4:226233.
  2. Rifkin WD,Holmboe E,Scherer H,Sierra H.Comparison of hospitalists and nonhospitalists in inpatient length of stay adjusting for patient and physician characteristics.J Gen Intern Med.2004;19:11271132.
  3. Kaboli PJ,Barnett MJ,Rosenthal G.Associations with reduced length of stay and costs on an academic hospitalist service.Am J Manag Care.2004;10:561568.
  4. Evans RL,Hendricks RD,Lawrence‐Umlauf KV,Bishop DS.Timing of social work intervention and medical patient's length of hospital stay.Health Soc Work.1989;14:277282.
  5. Fillit H,Howe JL,Fulop G, et al.Studies of hospital social stays in the frail elderly and their relationship to the intensity of social work intervention.Soc Work Health Care.1992;18:122.
  6. Thomas SN,McGwin G,Rue LW.The financial impact of delayed discharge at a level I trauma center.J Trauma.2005;58:121125.
  7. Semke J,VanDerWeele T,Weatherley R.Delayed discharges for medical and surgical patients in an acute care hospital.Soc Work Health Care.1989;14:1531.
  8. Qiu WQ,Dean M,Liu T, et al.Physical and mental health of homebound older adults: an overlooked population.J Am Geriatr Soc.2010;58:24232428.
  9. American Academy of Home Care Physicians. House call fact sheet. Available at: http://www.aahcp.org/displaycommon.cfm?an=156:744749.
  10. Loengard AU,Boal J.Home care of the frail elderly.Clin Geriatr Med.2004;20:795807.
  11. Kripalani S,Jackson AT,Schnipper JL,Coleman EA.Promoting effective transitions of care at hospital discharge: a review of key issues for hospitalists.J Hosp Med.2007;2:314323.
  12. Smith KL,Ornstein K,Soriano T,Muller D,Boal J.A multidisciplinary program for delivering primary care to the underserved urban homebound: looking back, moving forward.J Am Geriatr Soc.2006;54:12831289.
  13. Ornstein K,Smith KL,Foer D,Lopez‐Cantor M,Soriano T.To the hospital and back home again: a nurse practitioner‐based transitional care program for the hospitalized homebound.J Am Geriatr Soc.2011;59:544551.
  14. University HealthSystems Consortium. About UHC. Available at: https://www.uhc.edu/12443.htm. Accessed July 18,2010.
  15. US Census Bureau Statistical Abstract of the United States,2010. Health and Nutrition, Table 170: New York. Available at: http://www.census.gov/compendia/statab/cats/health_nutrition.html. Accessed February 24,year="2011"2011.
  16. National Center for Health Statistics. Health, United States, 2009: with special feature on medical technology. Table 119: nursing homes, bed, residents, and occupancy rates by state: United States, selected years 1995–2008. http://www.cdc. gov/nchs/hus.htm. Accessed July 17,2010.
  17. Hou JW,Hollenberg J,Charlson ME.Can physicians' admission evaluation of patients' status help to identify patients requiring social work interventions?Soc Work Health Care.2001;33:1729.
  18. Kim CS,Hart AL,Paretti RF, et al.Excess hospitalization days in an academic medical center: perceptions of hospitalists and discharge planners.Am J Manag Care.2011;17:e34e42.
  19. Southern WN,Berger MA,Bellin EY,Hailpern SM,Arnsten JH.Hospitalist care and length‐of‐stay in patients requiring complex discharge planning and close clinical monitoring.Arch Intern Med.2007;167:18691874.
  20. O'Leary KJ,Haviley C,Slade ME,Shah HM,Lee J,Williams MV.Improving teamwork: impact of structured interdisciplinary rounds on a hospitalist unit.J Hosp Med.2011;6:8893.
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In recent years, much attention has been paid to concerns regarding length of stay (LOS) and safety of hospital discharges.13 Yet studies conducted in a variety of populations suggest that long stays do not wholly reflect acute medical necessity, but may also be driven by nonmedical factors.46 In a study of frail elderly patients, nonmedical factors accounted for over half of patients' hospital stay days.5 Nonmedical factors may include the availability of community and outpatient resources, inadequate patient social support, disagreement with family and/or patient decision‐making, and post‐hospital placement and care needs.7

Homebound patients are at particular risk for long stays because they are typically frail, elderly, and medically complex.8 The United States homebound population numbers at least 2 million and is expected to increase to at least 3 million by the year 2020.9 This group is medically underserved, often only receiving care for medical emergencies, and represents a costly group of health care beneficiaries.10 Although homebound primary care (HBPC) programs are structured to provide coordinated medical and supportive care in the home, the clinical complexity of patients often requires hospitalization during times of acute illness.11

Navigating the discharge process for homebound patients can prove time‐consuming for inpatient physicians whose clinical obligations encompass ensuring safe care transitions between hospital and home.12 The lack of literature on the discharge needs of the homebound population provides little guidance for physicians and health systems seeking to safely transition homebound patients from the hospital to the home in a timely and efficient manner. We performed a pilot study of an urban homebound population cared for by a single academic homebound program to identify and describe nonmedical factors associated with prolonged hospitalization.

METHODS

This retrospective descriptive study included homebound patients cared for by The Mount Sinai Visiting Doctors Program (MSVD), a primary care program affiliated with The Mount Sinai Hospital. MSVD is the largest academic homebound primary care program in the United States. The structure and patient population of MSVD patients have been described previously.13 Briefly, the program employs 8 physicians, 2 nurse practitioners, and support personnel including 2 registered nurses, 4 social workers, and 4 clerical staff members to serve over 1000 homebound patients annually. To be enrolled in the program, patients must meet the Medicare definition of homebound (ie, they must be able to leave home only with great difficulty and for infrequent or short absences). Patients are referred from a variety of sources including emergency rooms, inpatient units, and local nursing and social service agencies. Physicians visit patients on average once every 2 months, but can make more frequent home visits when a clinical need arises. Thirty‐six percent of patients in the program are hospitalized at least once per year while they are under the MSVD's care.14 Patients in the MSVD are referred by their primary care physician to outpatient social work as needed for finite interventions, though not for ongoing case management; approximately one‐third of all MSVD patients have been seen by an MSVD social worker over a 1‐year period.14

All patients enrolled in MSVD discharged from The Mount Sinai Hospital in New York from January 1, 2007, to December 31, 2007, were evaluated for inclusion in this study. The MSVD clinical database was cross‐referenced with The Mount Sinai Hospital data system to maximize reliability of recorded admission and discharge dates. Discrepancies in dates were investigated and corrected by the authors. As the study focused on admissions rather than individual patients, repeat hospitalizations and factors contributing to long stays were included and considered separately. In the event of repeat hospitalizations, factors contributing to LOS were also assessed separately.

Using the University HealthSystems Consortium (UHC) Database, the selected discharges were analyzed for LOS data. The UHC Database contains data from The Mount Sinai Hospital and 106 other academic medical centers and 233 other affiliated hospitals, representing approximately 90% of the United States' nonprofit academic medical centers. UHC members submit clinical, financial, and administrative information for the purpose of facilitating comparative data analysis among institutions.15 The model assigns an expected LOS for each patient based on a 4‐step risk adjustment methodology that adjusts for variations in patient characteristics. The regression models consider a range of independent variables including patient age, sex, race, socioeconomic status, admission source, and comorbid conditions. The expected LOS value is used to produce an LOS ratio, which is the ratio of a patient's observed LOS to expected LOS. We compared LOS ratios for all patient discharges during the study period and determined the mean LOS ratio for the group. Long‐stay patients were defined using the UHC definition of an LOS ratio greater than 2 standard deviations above the mean. These patients were selected for analysis to examine factors contributing to their long stays.

The primary author conducted a chart review for the long‐stay patients. The date of medical readiness for discharge was defined as the date when no acute hospital care needs or pending procedures (eg, intravenous medication, transfusion, invasive and noninvasive testing, surgery) were documented by the attending physician, house officer, nurse practitioner, or physician assistant in the chart. Patients with a discharge immediately following determination of medical readiness were characterized as having a medical stay (eg, patient admitted for pneumonia and discharged home after 3 days once fever, leukocytosis, and symptoms improved with a prescription for remaining antibiotic course). Patients who were classified as medically ready for discharge yet remained additional days in the hospital were categorized as having a nonmedical component to their hospitalization and comprised the nonmedical stay group (eg, patient admitted for pneumonia with improved vital signs and symptoms after 3 days, but discharged home after 10 days awaiting approval of increased home health aide hours). The primary author reviewed cases (<5%) with coauthors when categorization of patient data was unclear from physician documentation in the patient's chart. Similar methodology and terminology have been used in previous studies examining the contribution of nonmedical factors to LOS.5, 7

While literature in other fields, such as social work, often characterize similar factors as social or social care factors, we use the term nonmedical to draw the distinction between factors that acutely reflect a patient's state of health and necessitate days spent in the hospital (eg, surgery, infection), in contrast to factors that are not direct contributors to the patient's current medical status (eg, post‐hospital placement). Factors contributing to nonmedical days were determined based on previous studies and categorized as follows: nursing facility bed availability, nursing facility rejection of the patient, complications with insurance coverage, lack of patient/family agreement with discharge plan, home care service delays, and other. The category other was included to identify and explore any unexpected or unique reasons for prolongation of hospitalization in this population. When multiple nonmedical factors were identified for a given hospitalization, all contributing factors were recorded.

Demographic, clinical, and discharge characteristics were extracted from the MSVD clinical database to qualitatively describe and compare the long‐stay hospitalizations to the remainder of the sample.

RESULTS

There were a total of 479 discharges of 267 unique MSVD patients from The Mount Sinai Hospital occurring from January 1, 2007, to December 31, 2007. During this 12‐month period, the average observed LOS for all admissions was 7.84 days, with a mean UHC LOS ratio of 1.23 (SD = 3.43). Seventeen admissions were identified as long‐stays, representing 3.5% of discharges. The 17 admissions represent 17 unique patients.

As shown in Table 1, the long‐stay group (n = 17) was slightly younger, more likely to be male, and had less dementia than the nonlong‐stay group (n = 462). There was a marked difference in the location of patient discharge; long‐stay patients were more than twice as likely to be discharged to a facility and less likely to be discharged home. There were no in‐hospital deaths in the long‐stay patient group during the time period studied.

Demographic, Clinical, and Discharge Characteristics for 2007 Hospitalizations According to Length of Stay
Characteristics*NonLong‐Stay Patients (n = 462)Long‐Stay Patients (n = 17)
  • NOTE: Characteristics describe all hospitalizations and include multiple discharges per patient.

  • Abbreviation: SD, standard deviation.

Mean age, years (SD)80 (15.6)74 (18.2)
Female sex69%47%
Race  
Caucasian27.1%29%
Black31.4%23.5%
Hispanic37.7%41.2%
Other2.4%5.9%
Has Medicaid68.1%70.6%
Dementia diagnosis42.9%29.4%
Depression diagnosis37.3%47.1%
Lives alone39.8%43.8%
Discharge  
Nursing/rehabilitation14.9%35.3%
Home78.3%64.7%
Death5.9%0%
Hospice0.9%0%

Of the 17 long‐stay patients, 8 (47%) remained in the hospital past the date they were determined to be medically ready for discharge and were defined as having a nonmedical component for the extension of their hospitalizations. The number of nonmedical days ranged from 6 to 34 days (mean, 17 days). Out of 428 total long‐stay patient days, 136 were nonmedical. This represented 31.8% of all long‐stay patient days, and 53% of the nonmedical group's total hospital days. The mean LOS ratio for the nonmedical cases was 6.04 (Table 2).

Medical Stay and Nonmedical Stay Length of Stay Ratios
 Medical Stay (n = 9)Nonmedical Stay (n = 8)
  • Abbreviation: LOS, length of stay.

LOS (days)19.217
LOS ratio5.076.04

Nine patients were defined as medical stay cases (ie, no nonmedical component contributing to the long hospitalization). The mean observed LOS was 19.2 days, and the mean LOS ratio for this group was 5.07 (Table 2). There were no significant differences between primary diagnosis‐related groups (DRGs) seen in the medical and nonmedical stay groups.

The most common reason for a nonmedical stay was nursing facility placement delays (Table 3), specifically related to lack of bed availability and facility rejection of the patient leading to prolonged time waiting for long‐term placement (n = 6). Other nonmedical factors contributing to LOS were lack of patient and/or family agreement with discharge plans (eg, disagreement among family members regarding caregiving responsibilities, goals of care, or patient refusal to be discharged on a particular day) (n = 4); complications with insurance coverage for facility placement or for home care (n = 3); and home care service delays, such as patient need for increased home care hours after discharge (n = 2). Of note, 5 of the 8 nonmedical stay cases had multiple factors contributing to patients' long stays. All delays were assigned to one of the a priori defined categories. There were no other or unexpected reasons identified.

Characteristics of Nonmedical Long‐Stay Patients
PatientDemographicsExpected LOS (days)Observed LOS (days)LOS RatioNo. of Nonmedical DaysNonmedical Stay Factors
  • Abbreviation: LOS, length of stay.

Patient A63‐year‐old white man4.564810.5334Nursing facility bed availability
Lack of patient/family agreement with discharge plan
Patient B53‐year‐old white man2.973110.4423Nursing facility rejection of the patient
Lack of patient/family agreement with discharge plan
Complications with insurance coverage
Home care service delays
Patient C98‐year‐old Latina woman5.51295.2623Lack of patient/family agreement with discharge plan
Home care service delays
Complications with insurance coverage
Patient D83‐year‐old white woman8.94465.1513Nursing facility bed availability
Patient E93‐year‐old white woman9.05424.6416Nursing facility bed availability
Patient F87‐year‐old Latino man2.62114.206Nursing facility bed availability
Nursing facility rejection of the patient
Complications with insurance coverage
Patient G55‐year‐old white man5.66234.067Lack of patient/family agreement with discharge plan
Patient H40‐year‐old African American man6.2325'4.0114Nursing facility rejection of the patient
Nursing facility bed availability

Of the nonmedical cases, all but 1 patient had been seen by an MSVD social worker prior to hospital admission, though the social work referral may have been years prior to or unrelated to the current admission.

DISCUSSION

Almost half of long‐stay patients identified in this homebound population remained hospitalized in an urban academic medical center due to at least one, and often multiple, nonmedical factors. Nonmedical factors identified in this group are similar to those described in previous studies, particularly family and patient decision‐making and post‐hospital placement and care needs.5, 7 Although this pilot study was limited to a single‐site population, it is to our knowledge the first study to describe these factors in a homebound population, and may be able to guide future research and discussion on this topic.

This study used a risk‐adjusted LOS measure to determine long stay cases. Using the UHC Database allowed for a more accurate understanding of the contribution of nonmedical factors to LOS by accounting for hospitalizations that were numerically lengthy but medically appropriate for their respective DRG. The use of the LOS ratio also allows for standardized application of these data across academic health centers. In our sample, 50% of the patients classified as LOS outliers by the UHC Database (cases with LOS in the top percentile for their respective DRG) had nonmedical stays. Conventional strategies often dismiss outliers in analyses of patient LOS data. However, in doing so there is a missed opportunity to identify underlying reasons for their disproportionately long hospitalizations that may also be impacting the broader set of patients with similar nonmedical factors affecting LOS.

The 8 nonmedical stay patients spent a combined 136 days longer in the hospital than medically necessary due to a variety of nonmedical factors, and represented over half of the nonmedical stay group's total hospital days. Using a conservative estimate for cost per hospital day of $1770,16 the nonmedical days cost the hospital almost a quarter of a million dollars ($240,720). Because this figure only accounts for long‐stay patients, the actual costs attributable to nonmedical days for the homebound population in general may be higher.

The longest patient stays, whether attributable to medical or nonmedical factors, were more likely to result in discharge to a facility than the rest of the sample hospitalizations. Facility placement was the most common nonmedical factor contributing to long stays in this sample. In contrast, home carerelated factors contributed the least to nonmedical days. This finding highlights the need for hospital‐based physicians and other inpatient staff members to be aware that despite patient enrollment in an HBPC, the possibility for homebound patients to be discharged to a nursing facility remains significant. A decreasing number of skilled nursing beds across the United States may magnify this factor in long‐stay cases.17 Increased awareness of this possibility among inpatient staff can allow the team to address facility placement considerations early in the hospital stay, potentially decreasing nonmedical days.18

Seven of the 8 nonmedical stay patients had been referred to and seen by MSVD social workers before hospitalization, a high percentage relative to the general MSVD population, of which fewer than half are seen by a social worker during their enrollment in MSVD. This finding may suggest that this group of patients already exhibited difficult social circumstances before their hospital admission, yet the current referral‐based social work model at MSVD did not mitigate their high LOS. This finding further suggests that patient enrollment in an HBPC does not mitigate the risk of high LOS and prolonged nonmedical stays, and that involvement of inpatient practitioners remains a critical part of advanced discharge planning.

This pilot study found that 32% of all long‐stay hospital days were due to nonmedical factors, suggesting that these factors play a greater role in the homebound population than for general medical patients. A recent study at an academic medical center examined 3574 patient‐days on a general medicine service, and noted that 11% of all days were felt to be medically unnecessary by the treating hospitalists.19 Hospitalists are well situated to participate in and lead improvement efforts given their expertise in managing complex dispositions and advancing collaborative strategies for care of patients with high overall acuity.20 These efforts will be needed to target those patients at highest risk for prolonged LOS with the greatest social care needs. Because this study did not pilot strategies to reduce LOS, we cannot offer evidence‐based suggestions for an enhanced multidisciplinary approach or other avenues for improvement. However, we believe that the study findings provide the basis for future research to test strategies to reduce excess LOS by focusing on nonmedical factors and a multidisciplinary approach. This will become especially relevant as health care systems bear increasing financial responsibility for inefficient and/or unnecessary hospitalizations and readmissions.

The involvement of social work before hospitalization for most of the homebound population with prolonged hospitalization suggests a need for greater team‐based efforts across venues. Though hospital interdisciplinary rounds aim to increase collaboration and reduce LOS, costs, and readmissions, these rounds do not typically include outpatient care providers.21 Improved communication and collaboration between social work with both inpatient and outpatient care teams to address nonmedical issues contributing to long stays are likely to improve care and transitions, though rigorous studies examining specific communication models across venues are lacking. This study found that delay in nursing facility placement was the most common reason for prolonged hospitalization for long‐stay cases. This finding emphasizes the need for communication between inpatient and outpatient staff to convey prior conversations or preparations for placement, identify patients who need post‐discharge facility placement early in hospitalization, and prompt timely discussions with patients and families.

The finding that prolonged hospitalization for the homebound population was due to nonmedical factors for almost one‐half of patients with long hospital stays has important implications for policymakers and other key stakeholders. For example, accountable care organizations are being developed to align members of the health care sector to provide higher quality care in a more efficient manner. These study data suggest that this alignment should include hospitals, nursing homes, and home health care agencies to ensure that discharge delays are minimized and unnecessary societal costs are avoided. Future research will need to confirm and build upon these findings of nonmedical reasons for excessive LOS to further inform the process of implementation of health care reform measures. Recent plans to cut Medicaid funding to nursing homes may further limit bed availability, increasing the risk of prolonged LOS and related costs to the health care system. This potential concern highlights the importance of care coordination and communication between inpatient and outpatient care providers to proactively address nursing home placement needs before hospitalization occurs, and/or to identify alternative safe discharge plans if a previously homebound patient is hospitalized.

There are several limitations to this descriptive study. Admissions included in this analysis were only captured for those admitted to The Mount Sinai Hospital. While MSVD providers report that more than 90% of hospitalizations for MSVD patients occur at The Mount Sinai Hospital, patients may also be admitted to one of many New York City metropolitan area hospitals closer to the patient's residence. It is possible that additional factors contributing to high LOS might be revealed if these admissions were included in the analysis. The urban homebound population served by MSVD may have more access to supplementary home care services (e.g. home attendants, meal services) than populations in more rural and less service‐intensive areas. Thus, it may be difficult to generalize these findings to programs serving less urban constituencies or with more restrictive policies regarding home care services. Additionally, as New York registers one of the highest nursing facility occupancy rates (in 2008, 92.2% versus the national average of 82.9%), patients in other markets may face a shorter wait time for a bed, decreasing the number of nonmedical days attributable to nursing home bed supply.17 The small total number of long‐stay patients also prevented statistical analysis comparing those patients with the rest of the sample. This pilot study may inform the design of future studies that may be able to include multiple HBPC programs or study homebound patients over a longer period to increase sample size.

Identifying the significant contribution of nonmedical days to patient stay is an important initial step to avoiding costly and medically unnecessary days for the patient and the hospital. As has been demonstrated in other interdisciplinary efforts, increased collaboration among physicians, social workers, discharge planners, and other disciplines may help address current gaps in patient care with regard to LOS.20, 21 Future studies should determine which homebound patients are at highest risk for prolonged hospitalization due to nonmedical factors to help design focused strategies and interventions for this vulnerable population.

Acknowledgements

Funding: This work was supported in part by grant funds received by Katherine Ornstein and Theresa Soriano from The Fan Fox and Leslie R. Samuels Foundation, Inc.

In recent years, much attention has been paid to concerns regarding length of stay (LOS) and safety of hospital discharges.13 Yet studies conducted in a variety of populations suggest that long stays do not wholly reflect acute medical necessity, but may also be driven by nonmedical factors.46 In a study of frail elderly patients, nonmedical factors accounted for over half of patients' hospital stay days.5 Nonmedical factors may include the availability of community and outpatient resources, inadequate patient social support, disagreement with family and/or patient decision‐making, and post‐hospital placement and care needs.7

Homebound patients are at particular risk for long stays because they are typically frail, elderly, and medically complex.8 The United States homebound population numbers at least 2 million and is expected to increase to at least 3 million by the year 2020.9 This group is medically underserved, often only receiving care for medical emergencies, and represents a costly group of health care beneficiaries.10 Although homebound primary care (HBPC) programs are structured to provide coordinated medical and supportive care in the home, the clinical complexity of patients often requires hospitalization during times of acute illness.11

Navigating the discharge process for homebound patients can prove time‐consuming for inpatient physicians whose clinical obligations encompass ensuring safe care transitions between hospital and home.12 The lack of literature on the discharge needs of the homebound population provides little guidance for physicians and health systems seeking to safely transition homebound patients from the hospital to the home in a timely and efficient manner. We performed a pilot study of an urban homebound population cared for by a single academic homebound program to identify and describe nonmedical factors associated with prolonged hospitalization.

METHODS

This retrospective descriptive study included homebound patients cared for by The Mount Sinai Visiting Doctors Program (MSVD), a primary care program affiliated with The Mount Sinai Hospital. MSVD is the largest academic homebound primary care program in the United States. The structure and patient population of MSVD patients have been described previously.13 Briefly, the program employs 8 physicians, 2 nurse practitioners, and support personnel including 2 registered nurses, 4 social workers, and 4 clerical staff members to serve over 1000 homebound patients annually. To be enrolled in the program, patients must meet the Medicare definition of homebound (ie, they must be able to leave home only with great difficulty and for infrequent or short absences). Patients are referred from a variety of sources including emergency rooms, inpatient units, and local nursing and social service agencies. Physicians visit patients on average once every 2 months, but can make more frequent home visits when a clinical need arises. Thirty‐six percent of patients in the program are hospitalized at least once per year while they are under the MSVD's care.14 Patients in the MSVD are referred by their primary care physician to outpatient social work as needed for finite interventions, though not for ongoing case management; approximately one‐third of all MSVD patients have been seen by an MSVD social worker over a 1‐year period.14

All patients enrolled in MSVD discharged from The Mount Sinai Hospital in New York from January 1, 2007, to December 31, 2007, were evaluated for inclusion in this study. The MSVD clinical database was cross‐referenced with The Mount Sinai Hospital data system to maximize reliability of recorded admission and discharge dates. Discrepancies in dates were investigated and corrected by the authors. As the study focused on admissions rather than individual patients, repeat hospitalizations and factors contributing to long stays were included and considered separately. In the event of repeat hospitalizations, factors contributing to LOS were also assessed separately.

Using the University HealthSystems Consortium (UHC) Database, the selected discharges were analyzed for LOS data. The UHC Database contains data from The Mount Sinai Hospital and 106 other academic medical centers and 233 other affiliated hospitals, representing approximately 90% of the United States' nonprofit academic medical centers. UHC members submit clinical, financial, and administrative information for the purpose of facilitating comparative data analysis among institutions.15 The model assigns an expected LOS for each patient based on a 4‐step risk adjustment methodology that adjusts for variations in patient characteristics. The regression models consider a range of independent variables including patient age, sex, race, socioeconomic status, admission source, and comorbid conditions. The expected LOS value is used to produce an LOS ratio, which is the ratio of a patient's observed LOS to expected LOS. We compared LOS ratios for all patient discharges during the study period and determined the mean LOS ratio for the group. Long‐stay patients were defined using the UHC definition of an LOS ratio greater than 2 standard deviations above the mean. These patients were selected for analysis to examine factors contributing to their long stays.

The primary author conducted a chart review for the long‐stay patients. The date of medical readiness for discharge was defined as the date when no acute hospital care needs or pending procedures (eg, intravenous medication, transfusion, invasive and noninvasive testing, surgery) were documented by the attending physician, house officer, nurse practitioner, or physician assistant in the chart. Patients with a discharge immediately following determination of medical readiness were characterized as having a medical stay (eg, patient admitted for pneumonia and discharged home after 3 days once fever, leukocytosis, and symptoms improved with a prescription for remaining antibiotic course). Patients who were classified as medically ready for discharge yet remained additional days in the hospital were categorized as having a nonmedical component to their hospitalization and comprised the nonmedical stay group (eg, patient admitted for pneumonia with improved vital signs and symptoms after 3 days, but discharged home after 10 days awaiting approval of increased home health aide hours). The primary author reviewed cases (<5%) with coauthors when categorization of patient data was unclear from physician documentation in the patient's chart. Similar methodology and terminology have been used in previous studies examining the contribution of nonmedical factors to LOS.5, 7

While literature in other fields, such as social work, often characterize similar factors as social or social care factors, we use the term nonmedical to draw the distinction between factors that acutely reflect a patient's state of health and necessitate days spent in the hospital (eg, surgery, infection), in contrast to factors that are not direct contributors to the patient's current medical status (eg, post‐hospital placement). Factors contributing to nonmedical days were determined based on previous studies and categorized as follows: nursing facility bed availability, nursing facility rejection of the patient, complications with insurance coverage, lack of patient/family agreement with discharge plan, home care service delays, and other. The category other was included to identify and explore any unexpected or unique reasons for prolongation of hospitalization in this population. When multiple nonmedical factors were identified for a given hospitalization, all contributing factors were recorded.

Demographic, clinical, and discharge characteristics were extracted from the MSVD clinical database to qualitatively describe and compare the long‐stay hospitalizations to the remainder of the sample.

RESULTS

There were a total of 479 discharges of 267 unique MSVD patients from The Mount Sinai Hospital occurring from January 1, 2007, to December 31, 2007. During this 12‐month period, the average observed LOS for all admissions was 7.84 days, with a mean UHC LOS ratio of 1.23 (SD = 3.43). Seventeen admissions were identified as long‐stays, representing 3.5% of discharges. The 17 admissions represent 17 unique patients.

As shown in Table 1, the long‐stay group (n = 17) was slightly younger, more likely to be male, and had less dementia than the nonlong‐stay group (n = 462). There was a marked difference in the location of patient discharge; long‐stay patients were more than twice as likely to be discharged to a facility and less likely to be discharged home. There were no in‐hospital deaths in the long‐stay patient group during the time period studied.

Demographic, Clinical, and Discharge Characteristics for 2007 Hospitalizations According to Length of Stay
Characteristics*NonLong‐Stay Patients (n = 462)Long‐Stay Patients (n = 17)
  • NOTE: Characteristics describe all hospitalizations and include multiple discharges per patient.

  • Abbreviation: SD, standard deviation.

Mean age, years (SD)80 (15.6)74 (18.2)
Female sex69%47%
Race  
Caucasian27.1%29%
Black31.4%23.5%
Hispanic37.7%41.2%
Other2.4%5.9%
Has Medicaid68.1%70.6%
Dementia diagnosis42.9%29.4%
Depression diagnosis37.3%47.1%
Lives alone39.8%43.8%
Discharge  
Nursing/rehabilitation14.9%35.3%
Home78.3%64.7%
Death5.9%0%
Hospice0.9%0%

Of the 17 long‐stay patients, 8 (47%) remained in the hospital past the date they were determined to be medically ready for discharge and were defined as having a nonmedical component for the extension of their hospitalizations. The number of nonmedical days ranged from 6 to 34 days (mean, 17 days). Out of 428 total long‐stay patient days, 136 were nonmedical. This represented 31.8% of all long‐stay patient days, and 53% of the nonmedical group's total hospital days. The mean LOS ratio for the nonmedical cases was 6.04 (Table 2).

Medical Stay and Nonmedical Stay Length of Stay Ratios
 Medical Stay (n = 9)Nonmedical Stay (n = 8)
  • Abbreviation: LOS, length of stay.

LOS (days)19.217
LOS ratio5.076.04

Nine patients were defined as medical stay cases (ie, no nonmedical component contributing to the long hospitalization). The mean observed LOS was 19.2 days, and the mean LOS ratio for this group was 5.07 (Table 2). There were no significant differences between primary diagnosis‐related groups (DRGs) seen in the medical and nonmedical stay groups.

The most common reason for a nonmedical stay was nursing facility placement delays (Table 3), specifically related to lack of bed availability and facility rejection of the patient leading to prolonged time waiting for long‐term placement (n = 6). Other nonmedical factors contributing to LOS were lack of patient and/or family agreement with discharge plans (eg, disagreement among family members regarding caregiving responsibilities, goals of care, or patient refusal to be discharged on a particular day) (n = 4); complications with insurance coverage for facility placement or for home care (n = 3); and home care service delays, such as patient need for increased home care hours after discharge (n = 2). Of note, 5 of the 8 nonmedical stay cases had multiple factors contributing to patients' long stays. All delays were assigned to one of the a priori defined categories. There were no other or unexpected reasons identified.

Characteristics of Nonmedical Long‐Stay Patients
PatientDemographicsExpected LOS (days)Observed LOS (days)LOS RatioNo. of Nonmedical DaysNonmedical Stay Factors
  • Abbreviation: LOS, length of stay.

Patient A63‐year‐old white man4.564810.5334Nursing facility bed availability
Lack of patient/family agreement with discharge plan
Patient B53‐year‐old white man2.973110.4423Nursing facility rejection of the patient
Lack of patient/family agreement with discharge plan
Complications with insurance coverage
Home care service delays
Patient C98‐year‐old Latina woman5.51295.2623Lack of patient/family agreement with discharge plan
Home care service delays
Complications with insurance coverage
Patient D83‐year‐old white woman8.94465.1513Nursing facility bed availability
Patient E93‐year‐old white woman9.05424.6416Nursing facility bed availability
Patient F87‐year‐old Latino man2.62114.206Nursing facility bed availability
Nursing facility rejection of the patient
Complications with insurance coverage
Patient G55‐year‐old white man5.66234.067Lack of patient/family agreement with discharge plan
Patient H40‐year‐old African American man6.2325'4.0114Nursing facility rejection of the patient
Nursing facility bed availability

Of the nonmedical cases, all but 1 patient had been seen by an MSVD social worker prior to hospital admission, though the social work referral may have been years prior to or unrelated to the current admission.

DISCUSSION

Almost half of long‐stay patients identified in this homebound population remained hospitalized in an urban academic medical center due to at least one, and often multiple, nonmedical factors. Nonmedical factors identified in this group are similar to those described in previous studies, particularly family and patient decision‐making and post‐hospital placement and care needs.5, 7 Although this pilot study was limited to a single‐site population, it is to our knowledge the first study to describe these factors in a homebound population, and may be able to guide future research and discussion on this topic.

This study used a risk‐adjusted LOS measure to determine long stay cases. Using the UHC Database allowed for a more accurate understanding of the contribution of nonmedical factors to LOS by accounting for hospitalizations that were numerically lengthy but medically appropriate for their respective DRG. The use of the LOS ratio also allows for standardized application of these data across academic health centers. In our sample, 50% of the patients classified as LOS outliers by the UHC Database (cases with LOS in the top percentile for their respective DRG) had nonmedical stays. Conventional strategies often dismiss outliers in analyses of patient LOS data. However, in doing so there is a missed opportunity to identify underlying reasons for their disproportionately long hospitalizations that may also be impacting the broader set of patients with similar nonmedical factors affecting LOS.

The 8 nonmedical stay patients spent a combined 136 days longer in the hospital than medically necessary due to a variety of nonmedical factors, and represented over half of the nonmedical stay group's total hospital days. Using a conservative estimate for cost per hospital day of $1770,16 the nonmedical days cost the hospital almost a quarter of a million dollars ($240,720). Because this figure only accounts for long‐stay patients, the actual costs attributable to nonmedical days for the homebound population in general may be higher.

The longest patient stays, whether attributable to medical or nonmedical factors, were more likely to result in discharge to a facility than the rest of the sample hospitalizations. Facility placement was the most common nonmedical factor contributing to long stays in this sample. In contrast, home carerelated factors contributed the least to nonmedical days. This finding highlights the need for hospital‐based physicians and other inpatient staff members to be aware that despite patient enrollment in an HBPC, the possibility for homebound patients to be discharged to a nursing facility remains significant. A decreasing number of skilled nursing beds across the United States may magnify this factor in long‐stay cases.17 Increased awareness of this possibility among inpatient staff can allow the team to address facility placement considerations early in the hospital stay, potentially decreasing nonmedical days.18

Seven of the 8 nonmedical stay patients had been referred to and seen by MSVD social workers before hospitalization, a high percentage relative to the general MSVD population, of which fewer than half are seen by a social worker during their enrollment in MSVD. This finding may suggest that this group of patients already exhibited difficult social circumstances before their hospital admission, yet the current referral‐based social work model at MSVD did not mitigate their high LOS. This finding further suggests that patient enrollment in an HBPC does not mitigate the risk of high LOS and prolonged nonmedical stays, and that involvement of inpatient practitioners remains a critical part of advanced discharge planning.

This pilot study found that 32% of all long‐stay hospital days were due to nonmedical factors, suggesting that these factors play a greater role in the homebound population than for general medical patients. A recent study at an academic medical center examined 3574 patient‐days on a general medicine service, and noted that 11% of all days were felt to be medically unnecessary by the treating hospitalists.19 Hospitalists are well situated to participate in and lead improvement efforts given their expertise in managing complex dispositions and advancing collaborative strategies for care of patients with high overall acuity.20 These efforts will be needed to target those patients at highest risk for prolonged LOS with the greatest social care needs. Because this study did not pilot strategies to reduce LOS, we cannot offer evidence‐based suggestions for an enhanced multidisciplinary approach or other avenues for improvement. However, we believe that the study findings provide the basis for future research to test strategies to reduce excess LOS by focusing on nonmedical factors and a multidisciplinary approach. This will become especially relevant as health care systems bear increasing financial responsibility for inefficient and/or unnecessary hospitalizations and readmissions.

The involvement of social work before hospitalization for most of the homebound population with prolonged hospitalization suggests a need for greater team‐based efforts across venues. Though hospital interdisciplinary rounds aim to increase collaboration and reduce LOS, costs, and readmissions, these rounds do not typically include outpatient care providers.21 Improved communication and collaboration between social work with both inpatient and outpatient care teams to address nonmedical issues contributing to long stays are likely to improve care and transitions, though rigorous studies examining specific communication models across venues are lacking. This study found that delay in nursing facility placement was the most common reason for prolonged hospitalization for long‐stay cases. This finding emphasizes the need for communication between inpatient and outpatient staff to convey prior conversations or preparations for placement, identify patients who need post‐discharge facility placement early in hospitalization, and prompt timely discussions with patients and families.

The finding that prolonged hospitalization for the homebound population was due to nonmedical factors for almost one‐half of patients with long hospital stays has important implications for policymakers and other key stakeholders. For example, accountable care organizations are being developed to align members of the health care sector to provide higher quality care in a more efficient manner. These study data suggest that this alignment should include hospitals, nursing homes, and home health care agencies to ensure that discharge delays are minimized and unnecessary societal costs are avoided. Future research will need to confirm and build upon these findings of nonmedical reasons for excessive LOS to further inform the process of implementation of health care reform measures. Recent plans to cut Medicaid funding to nursing homes may further limit bed availability, increasing the risk of prolonged LOS and related costs to the health care system. This potential concern highlights the importance of care coordination and communication between inpatient and outpatient care providers to proactively address nursing home placement needs before hospitalization occurs, and/or to identify alternative safe discharge plans if a previously homebound patient is hospitalized.

There are several limitations to this descriptive study. Admissions included in this analysis were only captured for those admitted to The Mount Sinai Hospital. While MSVD providers report that more than 90% of hospitalizations for MSVD patients occur at The Mount Sinai Hospital, patients may also be admitted to one of many New York City metropolitan area hospitals closer to the patient's residence. It is possible that additional factors contributing to high LOS might be revealed if these admissions were included in the analysis. The urban homebound population served by MSVD may have more access to supplementary home care services (e.g. home attendants, meal services) than populations in more rural and less service‐intensive areas. Thus, it may be difficult to generalize these findings to programs serving less urban constituencies or with more restrictive policies regarding home care services. Additionally, as New York registers one of the highest nursing facility occupancy rates (in 2008, 92.2% versus the national average of 82.9%), patients in other markets may face a shorter wait time for a bed, decreasing the number of nonmedical days attributable to nursing home bed supply.17 The small total number of long‐stay patients also prevented statistical analysis comparing those patients with the rest of the sample. This pilot study may inform the design of future studies that may be able to include multiple HBPC programs or study homebound patients over a longer period to increase sample size.

Identifying the significant contribution of nonmedical days to patient stay is an important initial step to avoiding costly and medically unnecessary days for the patient and the hospital. As has been demonstrated in other interdisciplinary efforts, increased collaboration among physicians, social workers, discharge planners, and other disciplines may help address current gaps in patient care with regard to LOS.20, 21 Future studies should determine which homebound patients are at highest risk for prolonged hospitalization due to nonmedical factors to help design focused strategies and interventions for this vulnerable population.

Acknowledgements

Funding: This work was supported in part by grant funds received by Katherine Ornstein and Theresa Soriano from The Fan Fox and Leslie R. Samuels Foundation, Inc.

References
  1. Chen LM,Freitag MH,Franco M,Sullivan CD,Dickson C,Brancati FL.Natural history of late discharges from a general medical ward.J Hosp Med.2009;4:226233.
  2. Rifkin WD,Holmboe E,Scherer H,Sierra H.Comparison of hospitalists and nonhospitalists in inpatient length of stay adjusting for patient and physician characteristics.J Gen Intern Med.2004;19:11271132.
  3. Kaboli PJ,Barnett MJ,Rosenthal G.Associations with reduced length of stay and costs on an academic hospitalist service.Am J Manag Care.2004;10:561568.
  4. Evans RL,Hendricks RD,Lawrence‐Umlauf KV,Bishop DS.Timing of social work intervention and medical patient's length of hospital stay.Health Soc Work.1989;14:277282.
  5. Fillit H,Howe JL,Fulop G, et al.Studies of hospital social stays in the frail elderly and their relationship to the intensity of social work intervention.Soc Work Health Care.1992;18:122.
  6. Thomas SN,McGwin G,Rue LW.The financial impact of delayed discharge at a level I trauma center.J Trauma.2005;58:121125.
  7. Semke J,VanDerWeele T,Weatherley R.Delayed discharges for medical and surgical patients in an acute care hospital.Soc Work Health Care.1989;14:1531.
  8. Qiu WQ,Dean M,Liu T, et al.Physical and mental health of homebound older adults: an overlooked population.J Am Geriatr Soc.2010;58:24232428.
  9. American Academy of Home Care Physicians. House call fact sheet. Available at: http://www.aahcp.org/displaycommon.cfm?an=156:744749.
  10. Loengard AU,Boal J.Home care of the frail elderly.Clin Geriatr Med.2004;20:795807.
  11. Kripalani S,Jackson AT,Schnipper JL,Coleman EA.Promoting effective transitions of care at hospital discharge: a review of key issues for hospitalists.J Hosp Med.2007;2:314323.
  12. Smith KL,Ornstein K,Soriano T,Muller D,Boal J.A multidisciplinary program for delivering primary care to the underserved urban homebound: looking back, moving forward.J Am Geriatr Soc.2006;54:12831289.
  13. Ornstein K,Smith KL,Foer D,Lopez‐Cantor M,Soriano T.To the hospital and back home again: a nurse practitioner‐based transitional care program for the hospitalized homebound.J Am Geriatr Soc.2011;59:544551.
  14. University HealthSystems Consortium. About UHC. Available at: https://www.uhc.edu/12443.htm. Accessed July 18,2010.
  15. US Census Bureau Statistical Abstract of the United States,2010. Health and Nutrition, Table 170: New York. Available at: http://www.census.gov/compendia/statab/cats/health_nutrition.html. Accessed February 24,year="2011"2011.
  16. National Center for Health Statistics. Health, United States, 2009: with special feature on medical technology. Table 119: nursing homes, bed, residents, and occupancy rates by state: United States, selected years 1995–2008. http://www.cdc. gov/nchs/hus.htm. Accessed July 17,2010.
  17. Hou JW,Hollenberg J,Charlson ME.Can physicians' admission evaluation of patients' status help to identify patients requiring social work interventions?Soc Work Health Care.2001;33:1729.
  18. Kim CS,Hart AL,Paretti RF, et al.Excess hospitalization days in an academic medical center: perceptions of hospitalists and discharge planners.Am J Manag Care.2011;17:e34e42.
  19. Southern WN,Berger MA,Bellin EY,Hailpern SM,Arnsten JH.Hospitalist care and length‐of‐stay in patients requiring complex discharge planning and close clinical monitoring.Arch Intern Med.2007;167:18691874.
  20. O'Leary KJ,Haviley C,Slade ME,Shah HM,Lee J,Williams MV.Improving teamwork: impact of structured interdisciplinary rounds on a hospitalist unit.J Hosp Med.2011;6:8893.
References
  1. Chen LM,Freitag MH,Franco M,Sullivan CD,Dickson C,Brancati FL.Natural history of late discharges from a general medical ward.J Hosp Med.2009;4:226233.
  2. Rifkin WD,Holmboe E,Scherer H,Sierra H.Comparison of hospitalists and nonhospitalists in inpatient length of stay adjusting for patient and physician characteristics.J Gen Intern Med.2004;19:11271132.
  3. Kaboli PJ,Barnett MJ,Rosenthal G.Associations with reduced length of stay and costs on an academic hospitalist service.Am J Manag Care.2004;10:561568.
  4. Evans RL,Hendricks RD,Lawrence‐Umlauf KV,Bishop DS.Timing of social work intervention and medical patient's length of hospital stay.Health Soc Work.1989;14:277282.
  5. Fillit H,Howe JL,Fulop G, et al.Studies of hospital social stays in the frail elderly and their relationship to the intensity of social work intervention.Soc Work Health Care.1992;18:122.
  6. Thomas SN,McGwin G,Rue LW.The financial impact of delayed discharge at a level I trauma center.J Trauma.2005;58:121125.
  7. Semke J,VanDerWeele T,Weatherley R.Delayed discharges for medical and surgical patients in an acute care hospital.Soc Work Health Care.1989;14:1531.
  8. Qiu WQ,Dean M,Liu T, et al.Physical and mental health of homebound older adults: an overlooked population.J Am Geriatr Soc.2010;58:24232428.
  9. American Academy of Home Care Physicians. House call fact sheet. Available at: http://www.aahcp.org/displaycommon.cfm?an=156:744749.
  10. Loengard AU,Boal J.Home care of the frail elderly.Clin Geriatr Med.2004;20:795807.
  11. Kripalani S,Jackson AT,Schnipper JL,Coleman EA.Promoting effective transitions of care at hospital discharge: a review of key issues for hospitalists.J Hosp Med.2007;2:314323.
  12. Smith KL,Ornstein K,Soriano T,Muller D,Boal J.A multidisciplinary program for delivering primary care to the underserved urban homebound: looking back, moving forward.J Am Geriatr Soc.2006;54:12831289.
  13. Ornstein K,Smith KL,Foer D,Lopez‐Cantor M,Soriano T.To the hospital and back home again: a nurse practitioner‐based transitional care program for the hospitalized homebound.J Am Geriatr Soc.2011;59:544551.
  14. University HealthSystems Consortium. About UHC. Available at: https://www.uhc.edu/12443.htm. Accessed July 18,2010.
  15. US Census Bureau Statistical Abstract of the United States,2010. Health and Nutrition, Table 170: New York. Available at: http://www.census.gov/compendia/statab/cats/health_nutrition.html. Accessed February 24,year="2011"2011.
  16. National Center for Health Statistics. Health, United States, 2009: with special feature on medical technology. Table 119: nursing homes, bed, residents, and occupancy rates by state: United States, selected years 1995–2008. http://www.cdc. gov/nchs/hus.htm. Accessed July 17,2010.
  17. Hou JW,Hollenberg J,Charlson ME.Can physicians' admission evaluation of patients' status help to identify patients requiring social work interventions?Soc Work Health Care.2001;33:1729.
  18. Kim CS,Hart AL,Paretti RF, et al.Excess hospitalization days in an academic medical center: perceptions of hospitalists and discharge planners.Am J Manag Care.2011;17:e34e42.
  19. Southern WN,Berger MA,Bellin EY,Hailpern SM,Arnsten JH.Hospitalist care and length‐of‐stay in patients requiring complex discharge planning and close clinical monitoring.Arch Intern Med.2007;167:18691874.
  20. O'Leary KJ,Haviley C,Slade ME,Shah HM,Lee J,Williams MV.Improving teamwork: impact of structured interdisciplinary rounds on a hospitalist unit.J Hosp Med.2011;6:8893.
Issue
Journal of Hospital Medicine - 7(2)
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Journal of Hospital Medicine - 7(2)
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73-78
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73-78
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Nonmedical factors associated with prolonged hospital length of stay in an urban homebound population
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Nonmedical factors associated with prolonged hospital length of stay in an urban homebound population
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