Case

A 79-year-old male with coronary artery disease, hypertension, non-insulin-dependent mellitus, moderate dementia, and chronic renal insufficiency is admitted after a fall evaluation. He is widowed and lives in an assisted living facility. He’s accompanied by his niece, is alert, and oriented to person. He thinks he is in a clinic and is unable to state the year, but the remainder of the examination is unremarkable. His labs are notable for potassium of 6.3 mmol/L, BUN of 78 mg/dL, and Cr of 3.7 mg/dL. The niece reports that the patient is not fond of medical care, thus the most recent labs are from two years ago (and indicate a BUN of 39 and Cr of 2.8, with an upward trend over the past decade). You discuss possible long-term need for dialysis with the patient and niece, and the patient clearly states "no." However, he also states that it is 1988. How do you determine if he has the capacity to make decisions?

Overview

Hospitalists are familiar with the doctrine of informed consent—describing a disease, treatment options, associated risks and benefits, potential for complications, and alternatives, including no treatment. Not only must the patient be informed, and the decision free from any coercion, but the patient also must have capacity to make the decision.

Hospitalists often care for patients in whom decision-making capacity comes into question. This includes populations with depression, psychosis, dementia, stroke, severe personality disorders, developmental delay, comatose patients, as well as those with impaired attentional capacity (e.g. acute pain) or general debility (e.g. metastatic cancer).^1,2

ave for the comatose patient, whether the patient has capacity might not be obvious. However, addressing the components of capacity (communication, understanding, appreciation, and rationalization) by using a validated clinical tool, such as the MacCAT-T, or more simply by systematically applying those four components to the clinical scenario under consideration, hospitalists can make this determination.

Review of the Literature

It is important to differentiate capacity from competency. Competency is a global assessment and a legal determination made by a judge in court. Capacity, on the other hand, is a functional assessment regarding a particular decision. Capacity is not static, and it can be performed by any clinician familiar with the patient. A hospitalist often is well positioned to make a capacity determination given established rapport with the patient and familiarity with the details of the case.

To make this determination, a hospitalist needs to know how to assess capacity. Although capacity usually is defined by state law and varies by jurisdiction, clinicians generally can assume it includes one or more of the four key components:

• Communication. The patient needs to be able to express a treatment choice, and this decision needs to be stable enough for the treatment to be implemented. Changing one’s decision in itself would not bring a patient’s capacity into question, so long as the patient was able to explain the rationale behind the switch. Frequent changes back and forth in the decision-making, however, could be indicative of an underlying psychiatric disorder or extreme indecision, which could bring capacity into question.
• Understanding. The patient needs to recall conversations about treatment, to make the link between causal relationships, and to process probabilities for outcomes. Problems with memory, attention span, and intelligence can affect one’s understanding.
• Appreciation. The patient should be able to identify the illness, treatment options, and likely outcomes as things that will affect him or her directly. A lack of appreciation usually stems from a denial based on intelligence (lack of a capability to understand) or emotion, or a delusion that the patient is not affected by this situation the same way and will have a different outcome.
• Rationalization or reasoning. The patient needs to be able to weigh the risks and benefits of the treatment options presented to come to a conclusion in keeping with their goals and best interests, as defined by their personal set of values. This often is affected in psychosis, depression, anxiety, phobias, delirium, and dementia.³

Several clinical capacity tools have been developed to assess these components:

Clinical tools.

The Mini-Mental Status Examination (MMSE) is a bedside test of a patient’s cognitive function, with scores ranging from 0 to 30.⁴ Although it wasn’t developed for assessing decision-making capacity, it has been compared with expert evaluation for assessment of capacity; the test performs reasonably well, particularly with high and low scores. Specifically, a MMSE >24 has a negative likelihood ratio (LR) of 0.05 for lack of capacity, while a MMSE <16 has a positive LR of 15.⁵ Scores from 17 to 23 do not correlate well with capacity, and further testing would be necessary. It is easy to administer, requires no formal training, and is familiar to most hospitalists. However, it does not address any specific aspects of informed consent, such as understanding or choice, and has not been validated in patients with mental illness.

The MacArthur Competence Assessment Tools for Treatment (MacCAT-T) is regarded as the gold standard for capacity assessment aids. It utilizes hospital chart review followed by a semi-structured interview to address clinical issues relevant to the patient being assessed; it takes 15 to 20 minutes to complete.⁶ The test provides scores in each of the four domains (choice, understanding, appreciation, and reasoning) of capacity. It has been validated in patients with dementia, schizophrenia, and depression. Limiting its clinical applicability is the fact that the MacCAT-T requires training to administer and interpret the results, though this is a relatively brief process.

The Capacity to Consent to Treatment Instrument (CCTI) uses hypothetical clinical vignettes in a structured interview to assess capacity across all four domains. The tool was developed and validated in patients with dementia and Parkinson’s disease, and takes 20 to 25 minutes to complete.⁷ A potential limitation is the CCTI’s use of vignettes as opposed to a patient-specific discussion, which could lead to different patient answers and a false assessment of the patient’s capacity.

The Hopemont Capacity Assessment Interview (HCAI) utilizes hypothetical vignettes in a semi-structured interview format to assess understanding, appreciation, choice, and likely reasoning.^8,9 Similar to CCTI, HCAI is not modified for individual patients. Rather, it uses clinical vignettes to gauge a patient’s ability to make decisions. The test takes 30 to 60 minutes to administer and performs less well in assessing appreciation and reasoning than the MacCAT-T and CCTI.¹⁰

It is not necessary to perform a formal assessment of capacity on every inpatient. For most, there is no reasonable concern for impaired capacity, obviating the need for formal testing. Likewise, in patients who clearly lack capacity, such as those with end-stage dementia or established guardians, formal reassessment usually is not required. Formal testing is most useful in situations in which capacity is unclear, disagreement amongst surrogate decision-makers exists, or judicial involvement is anticipated.

The MacCAT-T has been validated in the broadest population and is probably the most clinically useful tool currently available. The MMSE is an attractive alternative because of its widespread use and familiarity; however, it is imprecise with scores from 17 to 23, limiting its applicability.

click for large version

At a minimum, familiarity with the core legal standards of capacity (communication of choice, understanding, appreciation, and reasoning) will improve a hospitalist’s ability to identify patients who lack capacity. Understanding and applying the defined markers most often provides a sufficient capacity evaluation in itself. As capacity is not static, the decision usually requires more than one assessment.

Equally, deciding that a patient lacks capacity is not an end in itself, and the underlying cause should be addressed. Certain factors, such as infection, medication, time of day, and relationship with the clinician doing the assessment, can affect a patient’s capacity. These should be addressed through treatment, education, and social support whenever possible in order to optimize a patient’s performance during the capacity evaluation. If the decision can be delayed until a time when the patient can regain capacity, this should be done in order to maximize the patient’s autonomy.¹¹

Risk-related standards of capacity.

Although some question the notion, given our desire to facilitate management beneficial to the patient, the general consensus is that we have a lower threshold for capacity for consent to treatments that are low-risk and high-benefit.^12,13 We would then have a somewhat higher threshold for capacity to refuse that same treatment. Stemming from a desire to protect patients from harm, we have a relatively higher threshold for capacity to make decisions regarding high-risk, low-benefit treatments. For the remainder of cases (low risk/low benefit; high risk/high benefit), as well as treatments that significantly impact a patient’s lifestyle (e.g. dialysis, amputation), we have a low capacity to let patients decide for themselves.^11,14

Other considerations.

Clinicians should be thorough in documenting details in coming to a capacity determination, both as a means to formalize the thought process running through the four determinants of capacity, and in order to document for future reference. Cases in which it could be reasonable to call a consultant for those familiar with the assessment basics include:

• Cases in which a determination of lack of capacity could adversely affect the hospitalist’s relationship with the patient;
• Cases in which the hospitalist lacks the time to properly perform the evaluation;
• Particularly difficult or high-stakes cases (e.g. cases that might involve legal proceedings); and
• Cases in which significant mental illness affects a patient’s capacity.¹¹

Early involvement of potential surrogate decision-makers is wise for patients in whom capacity is questioned, both for obtaining collateral history as well as initiating dialogue as to the patient’s wishes. When a patient is found to lack capacity, resources to utilize to help make a treatment decision include existing advance directives and substitute decision-makers, such as durable power of attorneys (DPOAs) and family members. In those rare cases in which clinicians are unable to reach a consensus about a patient’s capacity, an ethics consult should be considered.

click for large version

Back to the Case.

Following the patient’s declaration that dialysis is not something he is interested in, his niece reports that he is a minimalist when it comes to interventions, and that he had similarly refused a cardiac catheterization in the 1990s. You review with the patient and niece that dialysis would be a procedure to replace his failing kidney function, and that failure to pursue this would ultimately be life-threatening and likely result in death, especially in regard to electrolyte abnormalities and his lack of any other terminal illness.

The consulting nephrologist reviews their recommendations with the patient and niece as well, and the patient consistently refuses. Having clearly communicated his choice, you ask the patient if he understands the situation. He says, "My kidneys are failing. That’s how I got the high potassium." You ask him what that means. "They aren’t going to function on their own much longer," he says. "I could die from it."

You confirm his ideas, and ask him why he doesn’t want dialysis. "I don’t want dialysis because I don’t want to spend my life hooked up to machines three times a week," the patient explains. "I just want to let things run their natural course." The niece says her uncle wouldn’t have wanted dialysis even if it were 10 years ago, so she’s not surprised he is refusing now.

Following this discussion, you feel comfortable that the patient has capacity to make this decision. Having documented this discussion, you discharge him to a subacute rehabilitation facility.

Bottom Line.

In cases in which capacity is in question, a hospitalist’s case-by-case review of the four components of capacity—communicating a choice, understanding, appreciation, and rationalization and reasoning—is warranted to help determine whether a patient has capacity. In cases in which a second opinion is warranted, psychiatry, geriatrics, or ethics consults could be utilized.

Drs. Dastidar and Odden are hospitalists at the University of Michigan in Ann Arbor.

References

1. Buchanan A, Brock DW. Deciding for others. Milbank Q. 1986;64(Suppl. 2):17-94.
2. Guidelines for assessing the decision-making capacities of potential research subjects with cognitive impairment. American Psychiatric Association. Am J Psychiatry. 1998;155(11):1649-50.
3. Appelbaum PS, Grisso T. Assessing patients’ capacities to consent to treatment. N Engl J Med. 1988;319(25):1635-1638.
4. Folstein MF, Folstein SE, McHugh PR. “Mini-mental state”. A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975;12:189-198.
5. Etchells E, Darzins P, Silberfeld M, et al. Assessment of patient capacity to consent to treatment. J Gen Intern Med. 1999;14:27-34.
6. Grisso T, Appelbaum PS, Hill-Fotouhi C. The MacCAT-T: a clinical tool to assess patients’ capacities to make treatment decisions. Psychiatr Serv. 1997;48:1415- 1419.
7. Marson DC, Ingram KK, Cody HA, Harrell LE. Assessing the competency of patients with Alzheimer’s disease under different legal standards. A prototype instrument. Arch Neurol. 1995;52:949-954.
8. Edelstein B. Hopemont Capacity Assessment Interview Manual and Scoring Guide. 1999: Morgantown, W.V.: West Virginia University.
9. Pruchno RA, Smyer MA, Rose MS, Hartman-Stein PE, Henderson-Laribee DL. Competence of long-term care residents to participate in decisions about their medical care: a brief, objective assessment. Gerontologist. 1995;35:622-629.
10. Moye J, Karel M, Azar AR, Gurrera R. Capacity to consent to treatment: empirical comparison of three instruments in older adults with and without dementia. Gerontologist. 2004;44:166-175.
11. Grisso T, Appelbaum PS. Assessing competence to consent to treatment: a guide for physicians and other health professionals. 1998; New York: Oxford University Press, 211.
12. Cale GS. Risk-related standards of competence: continuing the debate over risk-related standards of competence. Bioethics. 1999;13(2):131-148.
13. Checkland D. On risk and decisional capacity. J Med Philos. 2001;26(1):35-59.
14. Wilks I. The debate over risk-related standards of competence. Bioethics. 1997;11(5):413-426.
15. Ganzini L, Volicer L, Nelson WA, Fox E, Derse AR. Ten myths about decision-making capacity. J Am Med Dir Assoc. 2004;5(4):263-267.

Acknowledgements:The authors would like to thank Dr. Jeff Rohde for reviewing a copy of the manuscript, and Dr. Amy Rosinski for providing direction from the psychiatry standpoint

Case

A 79-year-old male with coronary artery disease, hypertension, non-insulin-dependent mellitus, moderate dementia, and chronic renal insufficiency is admitted after a fall evaluation. He is widowed and lives in an assisted living facility. He’s accompanied by his niece, is alert, and oriented to person. He thinks he is in a clinic and is unable to state the year, but the remainder of the examination is unremarkable. His labs are notable for potassium of 6.3 mmol/L, BUN of 78 mg/dL, and Cr of 3.7 mg/dL. The niece reports that the patient is not fond of medical care, thus the most recent labs are from two years ago (and indicate a BUN of 39 and Cr of 2.8, with an upward trend over the past decade). You discuss possible long-term need for dialysis with the patient and niece, and the patient clearly states "no." However, he also states that it is 1988. How do you determine if he has the capacity to make decisions?

Overview

Hospitalists are familiar with the doctrine of informed consent—describing a disease, treatment options, associated risks and benefits, potential for complications, and alternatives, including no treatment. Not only must the patient be informed, and the decision free from any coercion, but the patient also must have capacity to make the decision.

Hospitalists often care for patients in whom decision-making capacity comes into question. This includes populations with depression, psychosis, dementia, stroke, severe personality disorders, developmental delay, comatose patients, as well as those with impaired attentional capacity (e.g. acute pain) or general debility (e.g. metastatic cancer).^1,2

ave for the comatose patient, whether the patient has capacity might not be obvious. However, addressing the components of capacity (communication, understanding, appreciation, and rationalization) by using a validated clinical tool, such as the MacCAT-T, or more simply by systematically applying those four components to the clinical scenario under consideration, hospitalists can make this determination.

Review of the Literature

It is important to differentiate capacity from competency. Competency is a global assessment and a legal determination made by a judge in court. Capacity, on the other hand, is a functional assessment regarding a particular decision. Capacity is not static, and it can be performed by any clinician familiar with the patient. A hospitalist often is well positioned to make a capacity determination given established rapport with the patient and familiarity with the details of the case.

To make this determination, a hospitalist needs to know how to assess capacity. Although capacity usually is defined by state law and varies by jurisdiction, clinicians generally can assume it includes one or more of the four key components:

• Communication. The patient needs to be able to express a treatment choice, and this decision needs to be stable enough for the treatment to be implemented. Changing one’s decision in itself would not bring a patient’s capacity into question, so long as the patient was able to explain the rationale behind the switch. Frequent changes back and forth in the decision-making, however, could be indicative of an underlying psychiatric disorder or extreme indecision, which could bring capacity into question.
• Understanding. The patient needs to recall conversations about treatment, to make the link between causal relationships, and to process probabilities for outcomes. Problems with memory, attention span, and intelligence can affect one’s understanding.
• Appreciation. The patient should be able to identify the illness, treatment options, and likely outcomes as things that will affect him or her directly. A lack of appreciation usually stems from a denial based on intelligence (lack of a capability to understand) or emotion, or a delusion that the patient is not affected by this situation the same way and will have a different outcome.
• Rationalization or reasoning. The patient needs to be able to weigh the risks and benefits of the treatment options presented to come to a conclusion in keeping with their goals and best interests, as defined by their personal set of values. This often is affected in psychosis, depression, anxiety, phobias, delirium, and dementia.³

Several clinical capacity tools have been developed to assess these components:

Clinical tools.

The Mini-Mental Status Examination (MMSE) is a bedside test of a patient’s cognitive function, with scores ranging from 0 to 30.⁴ Although it wasn’t developed for assessing decision-making capacity, it has been compared with expert evaluation for assessment of capacity; the test performs reasonably well, particularly with high and low scores. Specifically, a MMSE >24 has a negative likelihood ratio (LR) of 0.05 for lack of capacity, while a MMSE <16 has a positive LR of 15.⁵ Scores from 17 to 23 do not correlate well with capacity, and further testing would be necessary. It is easy to administer, requires no formal training, and is familiar to most hospitalists. However, it does not address any specific aspects of informed consent, such as understanding or choice, and has not been validated in patients with mental illness.

The MacArthur Competence Assessment Tools for Treatment (MacCAT-T) is regarded as the gold standard for capacity assessment aids. It utilizes hospital chart review followed by a semi-structured interview to address clinical issues relevant to the patient being assessed; it takes 15 to 20 minutes to complete.⁶ The test provides scores in each of the four domains (choice, understanding, appreciation, and reasoning) of capacity. It has been validated in patients with dementia, schizophrenia, and depression. Limiting its clinical applicability is the fact that the MacCAT-T requires training to administer and interpret the results, though this is a relatively brief process.

The Capacity to Consent to Treatment Instrument (CCTI) uses hypothetical clinical vignettes in a structured interview to assess capacity across all four domains. The tool was developed and validated in patients with dementia and Parkinson’s disease, and takes 20 to 25 minutes to complete.⁷ A potential limitation is the CCTI’s use of vignettes as opposed to a patient-specific discussion, which could lead to different patient answers and a false assessment of the patient’s capacity.

The Hopemont Capacity Assessment Interview (HCAI) utilizes hypothetical vignettes in a semi-structured interview format to assess understanding, appreciation, choice, and likely reasoning.^8,9 Similar to CCTI, HCAI is not modified for individual patients. Rather, it uses clinical vignettes to gauge a patient’s ability to make decisions. The test takes 30 to 60 minutes to administer and performs less well in assessing appreciation and reasoning than the MacCAT-T and CCTI.¹⁰

It is not necessary to perform a formal assessment of capacity on every inpatient. For most, there is no reasonable concern for impaired capacity, obviating the need for formal testing. Likewise, in patients who clearly lack capacity, such as those with end-stage dementia or established guardians, formal reassessment usually is not required. Formal testing is most useful in situations in which capacity is unclear, disagreement amongst surrogate decision-makers exists, or judicial involvement is anticipated.

The MacCAT-T has been validated in the broadest population and is probably the most clinically useful tool currently available. The MMSE is an attractive alternative because of its widespread use and familiarity; however, it is imprecise with scores from 17 to 23, limiting its applicability.

click for large version

At a minimum, familiarity with the core legal standards of capacity (communication of choice, understanding, appreciation, and reasoning) will improve a hospitalist’s ability to identify patients who lack capacity. Understanding and applying the defined markers most often provides a sufficient capacity evaluation in itself. As capacity is not static, the decision usually requires more than one assessment.

Equally, deciding that a patient lacks capacity is not an end in itself, and the underlying cause should be addressed. Certain factors, such as infection, medication, time of day, and relationship with the clinician doing the assessment, can affect a patient’s capacity. These should be addressed through treatment, education, and social support whenever possible in order to optimize a patient’s performance during the capacity evaluation. If the decision can be delayed until a time when the patient can regain capacity, this should be done in order to maximize the patient’s autonomy.¹¹

Risk-related standards of capacity.

Although some question the notion, given our desire to facilitate management beneficial to the patient, the general consensus is that we have a lower threshold for capacity for consent to treatments that are low-risk and high-benefit.^12,13 We would then have a somewhat higher threshold for capacity to refuse that same treatment. Stemming from a desire to protect patients from harm, we have a relatively higher threshold for capacity to make decisions regarding high-risk, low-benefit treatments. For the remainder of cases (low risk/low benefit; high risk/high benefit), as well as treatments that significantly impact a patient’s lifestyle (e.g. dialysis, amputation), we have a low capacity to let patients decide for themselves.^11,14

Other considerations.

Clinicians should be thorough in documenting details in coming to a capacity determination, both as a means to formalize the thought process running through the four determinants of capacity, and in order to document for future reference. Cases in which it could be reasonable to call a consultant for those familiar with the assessment basics include:

• Cases in which a determination of lack of capacity could adversely affect the hospitalist’s relationship with the patient;
• Cases in which the hospitalist lacks the time to properly perform the evaluation;
• Particularly difficult or high-stakes cases (e.g. cases that might involve legal proceedings); and
• Cases in which significant mental illness affects a patient’s capacity.¹¹

Early involvement of potential surrogate decision-makers is wise for patients in whom capacity is questioned, both for obtaining collateral history as well as initiating dialogue as to the patient’s wishes. When a patient is found to lack capacity, resources to utilize to help make a treatment decision include existing advance directives and substitute decision-makers, such as durable power of attorneys (DPOAs) and family members. In those rare cases in which clinicians are unable to reach a consensus about a patient’s capacity, an ethics consult should be considered.

click for large version

Back to the Case.

Following the patient’s declaration that dialysis is not something he is interested in, his niece reports that he is a minimalist when it comes to interventions, and that he had similarly refused a cardiac catheterization in the 1990s. You review with the patient and niece that dialysis would be a procedure to replace his failing kidney function, and that failure to pursue this would ultimately be life-threatening and likely result in death, especially in regard to electrolyte abnormalities and his lack of any other terminal illness.

The consulting nephrologist reviews their recommendations with the patient and niece as well, and the patient consistently refuses. Having clearly communicated his choice, you ask the patient if he understands the situation. He says, "My kidneys are failing. That’s how I got the high potassium." You ask him what that means. "They aren’t going to function on their own much longer," he says. "I could die from it."

You confirm his ideas, and ask him why he doesn’t want dialysis. "I don’t want dialysis because I don’t want to spend my life hooked up to machines three times a week," the patient explains. "I just want to let things run their natural course." The niece says her uncle wouldn’t have wanted dialysis even if it were 10 years ago, so she’s not surprised he is refusing now.

Following this discussion, you feel comfortable that the patient has capacity to make this decision. Having documented this discussion, you discharge him to a subacute rehabilitation facility.

Bottom Line.

In cases in which capacity is in question, a hospitalist’s case-by-case review of the four components of capacity—communicating a choice, understanding, appreciation, and rationalization and reasoning—is warranted to help determine whether a patient has capacity. In cases in which a second opinion is warranted, psychiatry, geriatrics, or ethics consults could be utilized.

Drs. Dastidar and Odden are hospitalists at the University of Michigan in Ann Arbor.

References

1. Buchanan A, Brock DW. Deciding for others. Milbank Q. 1986;64(Suppl. 2):17-94.
2. Guidelines for assessing the decision-making capacities of potential research subjects with cognitive impairment. American Psychiatric Association. Am J Psychiatry. 1998;155(11):1649-50.
3. Appelbaum PS, Grisso T. Assessing patients’ capacities to consent to treatment. N Engl J Med. 1988;319(25):1635-1638.
4. Folstein MF, Folstein SE, McHugh PR. “Mini-mental state”. A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975;12:189-198.
5. Etchells E, Darzins P, Silberfeld M, et al. Assessment of patient capacity to consent to treatment. J Gen Intern Med. 1999;14:27-34.
6. Grisso T, Appelbaum PS, Hill-Fotouhi C. The MacCAT-T: a clinical tool to assess patients’ capacities to make treatment decisions. Psychiatr Serv. 1997;48:1415- 1419.
7. Marson DC, Ingram KK, Cody HA, Harrell LE. Assessing the competency of patients with Alzheimer’s disease under different legal standards. A prototype instrument. Arch Neurol. 1995;52:949-954.
8. Edelstein B. Hopemont Capacity Assessment Interview Manual and Scoring Guide. 1999: Morgantown, W.V.: West Virginia University.
9. Pruchno RA, Smyer MA, Rose MS, Hartman-Stein PE, Henderson-Laribee DL. Competence of long-term care residents to participate in decisions about their medical care: a brief, objective assessment. Gerontologist. 1995;35:622-629.
10. Moye J, Karel M, Azar AR, Gurrera R. Capacity to consent to treatment: empirical comparison of three instruments in older adults with and without dementia. Gerontologist. 2004;44:166-175.
11. Grisso T, Appelbaum PS. Assessing competence to consent to treatment: a guide for physicians and other health professionals. 1998; New York: Oxford University Press, 211.
12. Cale GS. Risk-related standards of competence: continuing the debate over risk-related standards of competence. Bioethics. 1999;13(2):131-148.
13. Checkland D. On risk and decisional capacity. J Med Philos. 2001;26(1):35-59.
14. Wilks I. The debate over risk-related standards of competence. Bioethics. 1997;11(5):413-426.
15. Ganzini L, Volicer L, Nelson WA, Fox E, Derse AR. Ten myths about decision-making capacity. J Am Med Dir Assoc. 2004;5(4):263-267.

Acknowledgements:The authors would like to thank Dr. Jeff Rohde for reviewing a copy of the manuscript, and Dr. Amy Rosinski for providing direction from the psychiatry standpoint

Case

A 79-year-old male with coronary artery disease, hypertension, non-insulin-dependent mellitus, moderate dementia, and chronic renal insufficiency is admitted after a fall evaluation. He is widowed and lives in an assisted living facility. He’s accompanied by his niece, is alert, and oriented to person. He thinks he is in a clinic and is unable to state the year, but the remainder of the examination is unremarkable. His labs are notable for potassium of 6.3 mmol/L, BUN of 78 mg/dL, and Cr of 3.7 mg/dL. The niece reports that the patient is not fond of medical care, thus the most recent labs are from two years ago (and indicate a BUN of 39 and Cr of 2.8, with an upward trend over the past decade). You discuss possible long-term need for dialysis with the patient and niece, and the patient clearly states "no." However, he also states that it is 1988. How do you determine if he has the capacity to make decisions?

Overview

Hospitalists are familiar with the doctrine of informed consent—describing a disease, treatment options, associated risks and benefits, potential for complications, and alternatives, including no treatment. Not only must the patient be informed, and the decision free from any coercion, but the patient also must have capacity to make the decision.

Hospitalists often care for patients in whom decision-making capacity comes into question. This includes populations with depression, psychosis, dementia, stroke, severe personality disorders, developmental delay, comatose patients, as well as those with impaired attentional capacity (e.g. acute pain) or general debility (e.g. metastatic cancer).^1,2

ave for the comatose patient, whether the patient has capacity might not be obvious. However, addressing the components of capacity (communication, understanding, appreciation, and rationalization) by using a validated clinical tool, such as the MacCAT-T, or more simply by systematically applying those four components to the clinical scenario under consideration, hospitalists can make this determination.

Review of the Literature

It is important to differentiate capacity from competency. Competency is a global assessment and a legal determination made by a judge in court. Capacity, on the other hand, is a functional assessment regarding a particular decision. Capacity is not static, and it can be performed by any clinician familiar with the patient. A hospitalist often is well positioned to make a capacity determination given established rapport with the patient and familiarity with the details of the case.

To make this determination, a hospitalist needs to know how to assess capacity. Although capacity usually is defined by state law and varies by jurisdiction, clinicians generally can assume it includes one or more of the four key components:

• Communication. The patient needs to be able to express a treatment choice, and this decision needs to be stable enough for the treatment to be implemented. Changing one’s decision in itself would not bring a patient’s capacity into question, so long as the patient was able to explain the rationale behind the switch. Frequent changes back and forth in the decision-making, however, could be indicative of an underlying psychiatric disorder or extreme indecision, which could bring capacity into question.
• Understanding. The patient needs to recall conversations about treatment, to make the link between causal relationships, and to process probabilities for outcomes. Problems with memory, attention span, and intelligence can affect one’s understanding.
• Appreciation. The patient should be able to identify the illness, treatment options, and likely outcomes as things that will affect him or her directly. A lack of appreciation usually stems from a denial based on intelligence (lack of a capability to understand) or emotion, or a delusion that the patient is not affected by this situation the same way and will have a different outcome.
• Rationalization or reasoning. The patient needs to be able to weigh the risks and benefits of the treatment options presented to come to a conclusion in keeping with their goals and best interests, as defined by their personal set of values. This often is affected in psychosis, depression, anxiety, phobias, delirium, and dementia.³

Several clinical capacity tools have been developed to assess these components:

Clinical tools.

The Mini-Mental Status Examination (MMSE) is a bedside test of a patient’s cognitive function, with scores ranging from 0 to 30.⁴ Although it wasn’t developed for assessing decision-making capacity, it has been compared with expert evaluation for assessment of capacity; the test performs reasonably well, particularly with high and low scores. Specifically, a MMSE >24 has a negative likelihood ratio (LR) of 0.05 for lack of capacity, while a MMSE <16 has a positive LR of 15.⁵ Scores from 17 to 23 do not correlate well with capacity, and further testing would be necessary. It is easy to administer, requires no formal training, and is familiar to most hospitalists. However, it does not address any specific aspects of informed consent, such as understanding or choice, and has not been validated in patients with mental illness.

The MacArthur Competence Assessment Tools for Treatment (MacCAT-T) is regarded as the gold standard for capacity assessment aids. It utilizes hospital chart review followed by a semi-structured interview to address clinical issues relevant to the patient being assessed; it takes 15 to 20 minutes to complete.⁶ The test provides scores in each of the four domains (choice, understanding, appreciation, and reasoning) of capacity. It has been validated in patients with dementia, schizophrenia, and depression. Limiting its clinical applicability is the fact that the MacCAT-T requires training to administer and interpret the results, though this is a relatively brief process.

The Capacity to Consent to Treatment Instrument (CCTI) uses hypothetical clinical vignettes in a structured interview to assess capacity across all four domains. The tool was developed and validated in patients with dementia and Parkinson’s disease, and takes 20 to 25 minutes to complete.⁷ A potential limitation is the CCTI’s use of vignettes as opposed to a patient-specific discussion, which could lead to different patient answers and a false assessment of the patient’s capacity.

The Hopemont Capacity Assessment Interview (HCAI) utilizes hypothetical vignettes in a semi-structured interview format to assess understanding, appreciation, choice, and likely reasoning.^8,9 Similar to CCTI, HCAI is not modified for individual patients. Rather, it uses clinical vignettes to gauge a patient’s ability to make decisions. The test takes 30 to 60 minutes to administer and performs less well in assessing appreciation and reasoning than the MacCAT-T and CCTI.¹⁰

It is not necessary to perform a formal assessment of capacity on every inpatient. For most, there is no reasonable concern for impaired capacity, obviating the need for formal testing. Likewise, in patients who clearly lack capacity, such as those with end-stage dementia or established guardians, formal reassessment usually is not required. Formal testing is most useful in situations in which capacity is unclear, disagreement amongst surrogate decision-makers exists, or judicial involvement is anticipated.

The MacCAT-T has been validated in the broadest population and is probably the most clinically useful tool currently available. The MMSE is an attractive alternative because of its widespread use and familiarity; however, it is imprecise with scores from 17 to 23, limiting its applicability.

click for large version

At a minimum, familiarity with the core legal standards of capacity (communication of choice, understanding, appreciation, and reasoning) will improve a hospitalist’s ability to identify patients who lack capacity. Understanding and applying the defined markers most often provides a sufficient capacity evaluation in itself. As capacity is not static, the decision usually requires more than one assessment.

Equally, deciding that a patient lacks capacity is not an end in itself, and the underlying cause should be addressed. Certain factors, such as infection, medication, time of day, and relationship with the clinician doing the assessment, can affect a patient’s capacity. These should be addressed through treatment, education, and social support whenever possible in order to optimize a patient’s performance during the capacity evaluation. If the decision can be delayed until a time when the patient can regain capacity, this should be done in order to maximize the patient’s autonomy.¹¹

Risk-related standards of capacity.

Although some question the notion, given our desire to facilitate management beneficial to the patient, the general consensus is that we have a lower threshold for capacity for consent to treatments that are low-risk and high-benefit.^12,13 We would then have a somewhat higher threshold for capacity to refuse that same treatment. Stemming from a desire to protect patients from harm, we have a relatively higher threshold for capacity to make decisions regarding high-risk, low-benefit treatments. For the remainder of cases (low risk/low benefit; high risk/high benefit), as well as treatments that significantly impact a patient’s lifestyle (e.g. dialysis, amputation), we have a low capacity to let patients decide for themselves.^11,14

Other considerations.

Clinicians should be thorough in documenting details in coming to a capacity determination, both as a means to formalize the thought process running through the four determinants of capacity, and in order to document for future reference. Cases in which it could be reasonable to call a consultant for those familiar with the assessment basics include:

• Cases in which a determination of lack of capacity could adversely affect the hospitalist’s relationship with the patient;
• Cases in which the hospitalist lacks the time to properly perform the evaluation;
• Particularly difficult or high-stakes cases (e.g. cases that might involve legal proceedings); and
• Cases in which significant mental illness affects a patient’s capacity.¹¹

Early involvement of potential surrogate decision-makers is wise for patients in whom capacity is questioned, both for obtaining collateral history as well as initiating dialogue as to the patient’s wishes. When a patient is found to lack capacity, resources to utilize to help make a treatment decision include existing advance directives and substitute decision-makers, such as durable power of attorneys (DPOAs) and family members. In those rare cases in which clinicians are unable to reach a consensus about a patient’s capacity, an ethics consult should be considered.

click for large version

Back to the Case.

Following the patient’s declaration that dialysis is not something he is interested in, his niece reports that he is a minimalist when it comes to interventions, and that he had similarly refused a cardiac catheterization in the 1990s. You review with the patient and niece that dialysis would be a procedure to replace his failing kidney function, and that failure to pursue this would ultimately be life-threatening and likely result in death, especially in regard to electrolyte abnormalities and his lack of any other terminal illness.

The consulting nephrologist reviews their recommendations with the patient and niece as well, and the patient consistently refuses. Having clearly communicated his choice, you ask the patient if he understands the situation. He says, "My kidneys are failing. That’s how I got the high potassium." You ask him what that means. "They aren’t going to function on their own much longer," he says. "I could die from it."

You confirm his ideas, and ask him why he doesn’t want dialysis. "I don’t want dialysis because I don’t want to spend my life hooked up to machines three times a week," the patient explains. "I just want to let things run their natural course." The niece says her uncle wouldn’t have wanted dialysis even if it were 10 years ago, so she’s not surprised he is refusing now.

Following this discussion, you feel comfortable that the patient has capacity to make this decision. Having documented this discussion, you discharge him to a subacute rehabilitation facility.

Bottom Line.

In cases in which capacity is in question, a hospitalist’s case-by-case review of the four components of capacity—communicating a choice, understanding, appreciation, and rationalization and reasoning—is warranted to help determine whether a patient has capacity. In cases in which a second opinion is warranted, psychiatry, geriatrics, or ethics consults could be utilized.

Drs. Dastidar and Odden are hospitalists at the University of Michigan in Ann Arbor.

References

1. Buchanan A, Brock DW. Deciding for others. Milbank Q. 1986;64(Suppl. 2):17-94.
2. Guidelines for assessing the decision-making capacities of potential research subjects with cognitive impairment. American Psychiatric Association. Am J Psychiatry. 1998;155(11):1649-50.
3. Appelbaum PS, Grisso T. Assessing patients’ capacities to consent to treatment. N Engl J Med. 1988;319(25):1635-1638.
4. Folstein MF, Folstein SE, McHugh PR. “Mini-mental state”. A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975;12:189-198.
5. Etchells E, Darzins P, Silberfeld M, et al. Assessment of patient capacity to consent to treatment. J Gen Intern Med. 1999;14:27-34.
6. Grisso T, Appelbaum PS, Hill-Fotouhi C. The MacCAT-T: a clinical tool to assess patients’ capacities to make treatment decisions. Psychiatr Serv. 1997;48:1415- 1419.
7. Marson DC, Ingram KK, Cody HA, Harrell LE. Assessing the competency of patients with Alzheimer’s disease under different legal standards. A prototype instrument. Arch Neurol. 1995;52:949-954.
8. Edelstein B. Hopemont Capacity Assessment Interview Manual and Scoring Guide. 1999: Morgantown, W.V.: West Virginia University.
9. Pruchno RA, Smyer MA, Rose MS, Hartman-Stein PE, Henderson-Laribee DL. Competence of long-term care residents to participate in decisions about their medical care: a brief, objective assessment. Gerontologist. 1995;35:622-629.
10. Moye J, Karel M, Azar AR, Gurrera R. Capacity to consent to treatment: empirical comparison of three instruments in older adults with and without dementia. Gerontologist. 2004;44:166-175.
11. Grisso T, Appelbaum PS. Assessing competence to consent to treatment: a guide for physicians and other health professionals. 1998; New York: Oxford University Press, 211.
12. Cale GS. Risk-related standards of competence: continuing the debate over risk-related standards of competence. Bioethics. 1999;13(2):131-148.
13. Checkland D. On risk and decisional capacity. J Med Philos. 2001;26(1):35-59.
14. Wilks I. The debate over risk-related standards of competence. Bioethics. 1997;11(5):413-426.
15. Ganzini L, Volicer L, Nelson WA, Fox E, Derse AR. Ten myths about decision-making capacity. J Am Med Dir Assoc. 2004;5(4):263-267.

Acknowledgements:The authors would like to thank Dr. Jeff Rohde for reviewing a copy of the manuscript, and Dr. Amy Rosinski for providing direction from the psychiatry standpoint

The reviews are in, and most healthcare provider groups are finding little to their liking in the proposed rules for the Centers for Medicare & Medicaid Services’ (CMS) voluntary Accountable Care Organization (ACO) program. Organizations like SHM have publically supported the concept of an ACO, but details in the 128 pages of proposed rules released March 31 apparently were not what they had in mind. The problem, as many provider groups detailed in a flurry of letters sent before the June 6 deadline for comments, is too much stick and not enough carrot.

The Patient Protection and Affordable Care Act of 2010, which authorized the program, stipulates that any Medicare savings deriving from ACOs must be divided between CMS and participating organizations. Organizations can choose between two financial models: One track allows participants to retain 60% of overall savings but also requires them to assume financial risk from the start; a second track delays any risk until the third year and offers 50% savings. In exchange, ACOs must achieve an average savings of 2% per patient, as well as meet or beat thresholds for 65 measures of quality.

Organizational Uproar

Critics contend that the recommended rules are so onerous and bureaucratic that the program is likely to attract few takers. In its comment letter, SHM expressed an opinion shared by many: "Although the ACO concept holds much promise, the proposed rule as written presents many barriers to successful ACO development and operations. Establishing an ACO will require an enormous upfront investment from participating providers, but the proposed rule does not allow for enough flexibility to ensure a reasonable return on investment." (Read SHM’s response letter at www.hospital medicine.org/advocacy.)

The American College of Physicians similarly warned that the proposed rules set the bar too high for many would-be participants. "The required administrative, infrastructure, service delivery, and financial resources and the need to accept risk will effectively limit participation to those few large entities already organized under an ACO-like structure; that already have ready access to capital, substantial infrastructure development, and experience operating under an integrative service/payment model (e.g. Medicare Advantage)," the ACP wrote in its response letter (www.acponline.org/run ning_practice/aco/acp_comments.pdf).

The tone was markedly different in letters from consumer and advocacy groups, including one by the Campaign for Better Care, signed by more than 40 organizations (www.national­partnership.org). "Overall we believe you are moving in the right direction with the proposed rule, and we applaud your commitment to ensuring ACOs deliver truly patient-centered care," the letter stated. Acknowledging the negative feedback, the letter continued, "While some are concerned about asking too much of ACOs, we cannot expect genuine transformation to be easy, and we know that these new models must be held to standards that ensure they deliver on the promise of better care, better health, and lower cost."

Accountability Gap

Michael W. Painter, JD, MD, senior program officer at the Robert Wood Johnson Foundation in Princeton, N.J., helped research and write the foundation’s own comment letter, which he says tried to bridge the divide between provider and patient groups.

"We did get behind the notion of ratcheting up the accountability for quality and cost, including the risk, as soon as it makes sense to do it," he says. "Not dragging our feet, recognizing that we have to do it rapidly, but it has to be balanced by being reasonable to help move from where we are."

Given the mandate for change, Dr. Painter says, the negative tone of many letters from provider organizations shouldn’t be surprising. "What we’re asking the hospital, the health professionals, to do is to change fairly radically and embrace this accountability. So as you just walk through the door of this conversation, it’s not surprising that they would balk," he says. "Nobody wants to take on all of this new responsibility. It’s no fault of theirs; they’ve just been following the rules of the road of the current system and the payment schemes to try to be successful in that environment."

Success, of course, depends on financial stability, and Dr. Painter says the worry that participating ACOs could open themselves up to financial risk too soon is "absolutely a legitimate concern." CMS, he says, should give providers clear guidance and assistance, as well as assurance that the regulations won’t change on them once they’ve enrolled.

So far, at least, CMS has not swayed some of the very institutions that government officials have lauded as examples of how ACOs should be run. In June, the Mayo Clinic in Rochester, Minn., announced that it would not participate. As reported by the Minneapolis Star Tribune, clinic officials said the proposed regulations clashed with Mayo’s existing Medicare operations. One of the clinic’s chief complaints is the proposed requirement that patients be added to oversight boards charged with assessing performance, something that Mayo argues is unnecessary to deliver patient-centered care. Antitrust rules represent another major concern for Mayo and others that argue their dominant position as healthcare providers in rural communities could run afoul of the regulations.

Cleveland Clinic likewise blasted the proposed ACO rules in a letter. "Rather than providing a broad framework that focuses on results as the key criteria of success, the Proposed Rule is replete with (1) prescriptive requirements that have little to do with outcomes, and (2) many detailed governance and reporting requirements that create significant administrative burdens," stated Delos Cosgrove, MD, the clinic’s CEO and president.

Furthermore, Cosgrove’s letter concluded that the shared-savings component "is structured in such a way that creates real uncertainty about whether applicants will be able to achieve success."

The American Medical Group Association went so far as to include in its letter the results of a member survey, which showed 93% would not enroll under the current ACO rules.

No Turning Back

Dr. Painter says the pushback is to be expected. Although the country has no choice but to move toward more accountability, he says, it’s impossible for the first attempt at a proposed rule to be the "magic bullet" that gets it exactly right. "One, this is a radical departure, and two, when you get into the nitty-gritty of the proposed rule and people crunch the numbers, if it’s not going to work for them or it’s simply not enticing enough for them, they [CMS] need to go back to the table and make it that way," he says.

Organizations like the American Medical Association have been particularly vocal about asking CMS to delay issuing its final rule, slated for January. So far, Dr. Painter says, CMS officials have indicated that the timeline will proceed according to schedule, though he notes that providers have raised plenty of valid concerns that should be addressed.

"Would I be surprised if there’s a delay? No. This is a big deal," he says.

Along with some expected rule changes, he says the newly formed Center for Medicare and Medicaid Innovation could play a key role in offering assistance and developing alternative ACO models and pilot programs.

Regardless of whether the voluntary CMS program ultimately pleases both providers and patients, though, one thing seems certain: The accountable-care concept is here to stay.

Bryn Nelson is a freelance medical writer based in Seattle

The reviews are in, and most healthcare provider groups are finding little to their liking in the proposed rules for the Centers for Medicare & Medicaid Services’ (CMS) voluntary Accountable Care Organization (ACO) program. Organizations like SHM have publically supported the concept of an ACO, but details in the 128 pages of proposed rules released March 31 apparently were not what they had in mind. The problem, as many provider groups detailed in a flurry of letters sent before the June 6 deadline for comments, is too much stick and not enough carrot.

The Patient Protection and Affordable Care Act of 2010, which authorized the program, stipulates that any Medicare savings deriving from ACOs must be divided between CMS and participating organizations. Organizations can choose between two financial models: One track allows participants to retain 60% of overall savings but also requires them to assume financial risk from the start; a second track delays any risk until the third year and offers 50% savings. In exchange, ACOs must achieve an average savings of 2% per patient, as well as meet or beat thresholds for 65 measures of quality.

Organizational Uproar

Critics contend that the recommended rules are so onerous and bureaucratic that the program is likely to attract few takers. In its comment letter, SHM expressed an opinion shared by many: "Although the ACO concept holds much promise, the proposed rule as written presents many barriers to successful ACO development and operations. Establishing an ACO will require an enormous upfront investment from participating providers, but the proposed rule does not allow for enough flexibility to ensure a reasonable return on investment." (Read SHM’s response letter at www.hospital medicine.org/advocacy.)

The American College of Physicians similarly warned that the proposed rules set the bar too high for many would-be participants. "The required administrative, infrastructure, service delivery, and financial resources and the need to accept risk will effectively limit participation to those few large entities already organized under an ACO-like structure; that already have ready access to capital, substantial infrastructure development, and experience operating under an integrative service/payment model (e.g. Medicare Advantage)," the ACP wrote in its response letter (www.acponline.org/run ning_practice/aco/acp_comments.pdf).

The tone was markedly different in letters from consumer and advocacy groups, including one by the Campaign for Better Care, signed by more than 40 organizations (www.national­partnership.org). "Overall we believe you are moving in the right direction with the proposed rule, and we applaud your commitment to ensuring ACOs deliver truly patient-centered care," the letter stated. Acknowledging the negative feedback, the letter continued, "While some are concerned about asking too much of ACOs, we cannot expect genuine transformation to be easy, and we know that these new models must be held to standards that ensure they deliver on the promise of better care, better health, and lower cost."

Accountability Gap

Michael W. Painter, JD, MD, senior program officer at the Robert Wood Johnson Foundation in Princeton, N.J., helped research and write the foundation’s own comment letter, which he says tried to bridge the divide between provider and patient groups.

"We did get behind the notion of ratcheting up the accountability for quality and cost, including the risk, as soon as it makes sense to do it," he says. "Not dragging our feet, recognizing that we have to do it rapidly, but it has to be balanced by being reasonable to help move from where we are."

Given the mandate for change, Dr. Painter says, the negative tone of many letters from provider organizations shouldn’t be surprising. "What we’re asking the hospital, the health professionals, to do is to change fairly radically and embrace this accountability. So as you just walk through the door of this conversation, it’s not surprising that they would balk," he says. "Nobody wants to take on all of this new responsibility. It’s no fault of theirs; they’ve just been following the rules of the road of the current system and the payment schemes to try to be successful in that environment."

Success, of course, depends on financial stability, and Dr. Painter says the worry that participating ACOs could open themselves up to financial risk too soon is "absolutely a legitimate concern." CMS, he says, should give providers clear guidance and assistance, as well as assurance that the regulations won’t change on them once they’ve enrolled.

So far, at least, CMS has not swayed some of the very institutions that government officials have lauded as examples of how ACOs should be run. In June, the Mayo Clinic in Rochester, Minn., announced that it would not participate. As reported by the Minneapolis Star Tribune, clinic officials said the proposed regulations clashed with Mayo’s existing Medicare operations. One of the clinic’s chief complaints is the proposed requirement that patients be added to oversight boards charged with assessing performance, something that Mayo argues is unnecessary to deliver patient-centered care. Antitrust rules represent another major concern for Mayo and others that argue their dominant position as healthcare providers in rural communities could run afoul of the regulations.

Cleveland Clinic likewise blasted the proposed ACO rules in a letter. "Rather than providing a broad framework that focuses on results as the key criteria of success, the Proposed Rule is replete with (1) prescriptive requirements that have little to do with outcomes, and (2) many detailed governance and reporting requirements that create significant administrative burdens," stated Delos Cosgrove, MD, the clinic’s CEO and president.

Furthermore, Cosgrove’s letter concluded that the shared-savings component "is structured in such a way that creates real uncertainty about whether applicants will be able to achieve success."

The American Medical Group Association went so far as to include in its letter the results of a member survey, which showed 93% would not enroll under the current ACO rules.

No Turning Back

Dr. Painter says the pushback is to be expected. Although the country has no choice but to move toward more accountability, he says, it’s impossible for the first attempt at a proposed rule to be the "magic bullet" that gets it exactly right. "One, this is a radical departure, and two, when you get into the nitty-gritty of the proposed rule and people crunch the numbers, if it’s not going to work for them or it’s simply not enticing enough for them, they [CMS] need to go back to the table and make it that way," he says.

Organizations like the American Medical Association have been particularly vocal about asking CMS to delay issuing its final rule, slated for January. So far, Dr. Painter says, CMS officials have indicated that the timeline will proceed according to schedule, though he notes that providers have raised plenty of valid concerns that should be addressed.

"Would I be surprised if there’s a delay? No. This is a big deal," he says.

Along with some expected rule changes, he says the newly formed Center for Medicare and Medicaid Innovation could play a key role in offering assistance and developing alternative ACO models and pilot programs.

Regardless of whether the voluntary CMS program ultimately pleases both providers and patients, though, one thing seems certain: The accountable-care concept is here to stay.

Bryn Nelson is a freelance medical writer based in Seattle

The reviews are in, and most healthcare provider groups are finding little to their liking in the proposed rules for the Centers for Medicare & Medicaid Services’ (CMS) voluntary Accountable Care Organization (ACO) program. Organizations like SHM have publically supported the concept of an ACO, but details in the 128 pages of proposed rules released March 31 apparently were not what they had in mind. The problem, as many provider groups detailed in a flurry of letters sent before the June 6 deadline for comments, is too much stick and not enough carrot.

The Patient Protection and Affordable Care Act of 2010, which authorized the program, stipulates that any Medicare savings deriving from ACOs must be divided between CMS and participating organizations. Organizations can choose between two financial models: One track allows participants to retain 60% of overall savings but also requires them to assume financial risk from the start; a second track delays any risk until the third year and offers 50% savings. In exchange, ACOs must achieve an average savings of 2% per patient, as well as meet or beat thresholds for 65 measures of quality.

Organizational Uproar

Critics contend that the recommended rules are so onerous and bureaucratic that the program is likely to attract few takers. In its comment letter, SHM expressed an opinion shared by many: "Although the ACO concept holds much promise, the proposed rule as written presents many barriers to successful ACO development and operations. Establishing an ACO will require an enormous upfront investment from participating providers, but the proposed rule does not allow for enough flexibility to ensure a reasonable return on investment." (Read SHM’s response letter at www.hospital medicine.org/advocacy.)

The American College of Physicians similarly warned that the proposed rules set the bar too high for many would-be participants. "The required administrative, infrastructure, service delivery, and financial resources and the need to accept risk will effectively limit participation to those few large entities already organized under an ACO-like structure; that already have ready access to capital, substantial infrastructure development, and experience operating under an integrative service/payment model (e.g. Medicare Advantage)," the ACP wrote in its response letter (www.acponline.org/run ning_practice/aco/acp_comments.pdf).

The tone was markedly different in letters from consumer and advocacy groups, including one by the Campaign for Better Care, signed by more than 40 organizations (www.national­partnership.org). "Overall we believe you are moving in the right direction with the proposed rule, and we applaud your commitment to ensuring ACOs deliver truly patient-centered care," the letter stated. Acknowledging the negative feedback, the letter continued, "While some are concerned about asking too much of ACOs, we cannot expect genuine transformation to be easy, and we know that these new models must be held to standards that ensure they deliver on the promise of better care, better health, and lower cost."

Accountability Gap

Michael W. Painter, JD, MD, senior program officer at the Robert Wood Johnson Foundation in Princeton, N.J., helped research and write the foundation’s own comment letter, which he says tried to bridge the divide between provider and patient groups.

"We did get behind the notion of ratcheting up the accountability for quality and cost, including the risk, as soon as it makes sense to do it," he says. "Not dragging our feet, recognizing that we have to do it rapidly, but it has to be balanced by being reasonable to help move from where we are."

Given the mandate for change, Dr. Painter says, the negative tone of many letters from provider organizations shouldn’t be surprising. "What we’re asking the hospital, the health professionals, to do is to change fairly radically and embrace this accountability. So as you just walk through the door of this conversation, it’s not surprising that they would balk," he says. "Nobody wants to take on all of this new responsibility. It’s no fault of theirs; they’ve just been following the rules of the road of the current system and the payment schemes to try to be successful in that environment."

Success, of course, depends on financial stability, and Dr. Painter says the worry that participating ACOs could open themselves up to financial risk too soon is "absolutely a legitimate concern." CMS, he says, should give providers clear guidance and assistance, as well as assurance that the regulations won’t change on them once they’ve enrolled.

So far, at least, CMS has not swayed some of the very institutions that government officials have lauded as examples of how ACOs should be run. In June, the Mayo Clinic in Rochester, Minn., announced that it would not participate. As reported by the Minneapolis Star Tribune, clinic officials said the proposed regulations clashed with Mayo’s existing Medicare operations. One of the clinic’s chief complaints is the proposed requirement that patients be added to oversight boards charged with assessing performance, something that Mayo argues is unnecessary to deliver patient-centered care. Antitrust rules represent another major concern for Mayo and others that argue their dominant position as healthcare providers in rural communities could run afoul of the regulations.

Cleveland Clinic likewise blasted the proposed ACO rules in a letter. "Rather than providing a broad framework that focuses on results as the key criteria of success, the Proposed Rule is replete with (1) prescriptive requirements that have little to do with outcomes, and (2) many detailed governance and reporting requirements that create significant administrative burdens," stated Delos Cosgrove, MD, the clinic’s CEO and president.

Furthermore, Cosgrove’s letter concluded that the shared-savings component "is structured in such a way that creates real uncertainty about whether applicants will be able to achieve success."

The American Medical Group Association went so far as to include in its letter the results of a member survey, which showed 93% would not enroll under the current ACO rules.

No Turning Back

Dr. Painter says the pushback is to be expected. Although the country has no choice but to move toward more accountability, he says, it’s impossible for the first attempt at a proposed rule to be the "magic bullet" that gets it exactly right. "One, this is a radical departure, and two, when you get into the nitty-gritty of the proposed rule and people crunch the numbers, if it’s not going to work for them or it’s simply not enticing enough for them, they [CMS] need to go back to the table and make it that way," he says.

Organizations like the American Medical Association have been particularly vocal about asking CMS to delay issuing its final rule, slated for January. So far, Dr. Painter says, CMS officials have indicated that the timeline will proceed according to schedule, though he notes that providers have raised plenty of valid concerns that should be addressed.

"Would I be surprised if there’s a delay? No. This is a big deal," he says.

Along with some expected rule changes, he says the newly formed Center for Medicare and Medicaid Innovation could play a key role in offering assistance and developing alternative ACO models and pilot programs.

Regardless of whether the voluntary CMS program ultimately pleases both providers and patients, though, one thing seems certain: The accountable-care concept is here to stay.

Bryn Nelson is a freelance medical writer based in Seattle

In This Edition

Literature At A Glance

A guide to this month’s studies

1. Screening for AAA
2. Adverse events in atrial fibrillation
3. Biological treatment of inflammatory bowel diseases
4. Steroid treatment of inflammatory bowel diseases
5. Levofloxacin for H. pylori
6. Natural history of tako-tsubo cardiomyopathy
7. Predicting postoperative pulmonary complications
8. Code status and goals of care in the ICU

New Screening Strategy To Identify Large Abdominal Aortic Aneurysms

Clinical question: Can an effective scoring system be developed to better identify patients at risk for large abdominal aortic aneurysms (AAA)?

Background: Screening reduces AAA-related mortality by about half in men aged >65. The United States Preventive Services Task Force (USPSTF) has recommended screening for AAA in men aged 65 to 75 with a history of smoking. However, more than 50% of AAA ruptures occur in individuals outside this patient cohort, and only some AAAs detected are large enough to warrant surgery.

Study design: Retrospective, observational cohort study.

Setting: More than 20,000 screening sites across the U.S.

Synopsis: Researchers collected demographics and risk factors from 3.1 million people undergoing ultrasound screening for AAA by Life Line Screening Inc. At the screening visit, subjects completed a questionnaire about their health status and medical history. Screening data also included diameter of the infrarenal abdominal aorta. To construct and test a risk model, the screened individuals were randomly allocated into two equal groups: a data set used for model development and one for validation.

Most of the AAAs greater than 5 cm in diameter discovered were in males (84.4%) and among subjects with a smoking history (83%). Other risk factors for large AAAs included advanced age, peripheral arterial disease, and obesity. The authors estimate that there are about 121,000 people with >5.0 cm aneurysms in the general population. Current guidelines would detect only 33.7% of the existing large AAAs. Study limitations include possible selection bias, as a majority of patients were self-referred. Also, the database did not include all comorbidities that could affect the risk of AAA. The self-reported nature of health data might cause misclassification of a patient’s true health status.

Bottom line: A screening strategy based on a newly developed scoring system is an effective way to identify patients at risk of large abdominal aortic aneurysms.

Citation: Greco G, Egorova NN, Gelijns AC, et al. Development of a novel scoring tool for the identification of large >5 cm abdominal aortic aneurysms. Ann Surg. 2010;252(4):675-682.

Risk Factors for Adverse Events in Patients with Symptomatic Atrial Fibrillation

Clinical question: What are the predictors of 30-day adverse events in ED patients evaluated for symptomatic atrial fibrillation?

Background: Atrial fibrillation (AF) affects more than 2 million people in the U.S. and accounts for nearly 1% of ED visits. Physicians have little information to guide risk stratification, and they admit more than 65% of patients. A strategy to better define the ED management of patients presenting with atrial fibrillation is required.

Study design: Retrospective, observational cohort study.

Setting: Urban academic tertiary-care referral center with an adult ED.

Synopsis: A systematic review of the electronic medical records of all ED patients presenting with symptomatic atrial fibrillation over a three-year period was performed. Predefined adverse outcomes included 30-day ED return visits, unscheduled hospitalizations, cardiovascular complications, or death.

Of 832 eligible patients, 216 (25.9%) experienced at least one of the 30-day adverse events. Adverse events occurred in 181 of the 638 (28.4%) admitted patients and 35 of the 192 (18.2%) patients discharged from the ED. Increasing age, complaint of dyspnea, smoking history, inadequate ventricular rate control, and patients receiving beta-blockers were factors independently associated with higher risk for adverse events.

Study results were limited by a number of factors. This was a single-center, retrospective, observational study, with all of its inherent limitations. The predictor model did not include laboratory data, such as BNP or troponin. Patients might have experienced additional events within the 30 days that were treated at other hospitals and not recorded in the database. Patient disposition might have affected the results, as patients initially admitted from the ED had a higher rate of 30-day adverse events than patients who were discharged from the ED.

Bottom line: Patients with increased age, smoking history, complaints of dyspnea, inadequate ventricular rate control in the ED, and home beta-blocker therapy are more likely to experience an atrial-fibrillation-related adverse event within 30 days.

Citation: Barrett TW, Martin AR, Storrow AB, et al. A clinical prediction model to estimate risk for 30-day adverse events in emergency department patients with symptomatic atrial fibrillation. Ann Emerg Med. 2011;57 (1):1-12.

Biological Therapies Are Effective in Inducing Remission in Inflammatory Bowel Disease

Clinical question: Are biological therapies useful in the treatment of ulcerative colitis (UC) and Crohn’s disease (CD)?

Background: Patients with CD and UC often experience flares of disease activity, despite maintenance therapy with 5-aminosalicylic acid compounds. These flares are usually treated with corticosteroids, which carry numerous adverse side effects. The role of biological therapies in inducing remission is uncertain.

Study design: Systematic review and meta-analysis.

Setting: Twenty-seven randomized controlled trials involving 7,416 patients.

Synopsis: Anti-TNF α antibodies and natalizumab were both superior to placebo in inducing remission of luminal CD (RR of no remission 0.87 and 0.88, respectively). Anti-TNF antibodies also were superior to placebo in preventing relapse of luminal CD (RR of relapse=0.71). Infliximab was superior to placebo in inducing remission of moderate to severely active UC (RR=0.72; 95% CI, 0.57-0.91). There were no significantly increased adverse drug effects with anti-TNF α antibodies or with infliximab compared with placebo. Natalizumab caused significantly higher rates of headache.

Limitations include risk of publication bias inherent in meta-analyses. There also was evidence of moderate heterogeneity in the studies analyzed. Finally, not every study was consistent in reporting adverse drug effects.

Bottom line: Biological therapies are superior to placebo in inducing remission of active UC and CD, as well as preventing relapse of quiescent CD.

Citation: Ford AC, Sandborn WJ, Khan KJ, Hanauer SB, Talley NJ, Moayyedi P. Efficacy of biological therapies in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol. 2011; 106(4):644-659.

Glucocortico­steroids Probably Effective in Treatment of Inflammatory Bowel Disease, Primarily in Active Ulcerative Colitis

Clinical question: Is glucocorticosteroid therapy effective in the treatment of active IBD and in preventing relapses?

Background: Crohn’s disease (CD) and ulcerative colitis (UC) are chronic inflammatory bowel diseases of unclear etiology. Use of standard glucocorticosteroids and budesonide is widespread in inflammatory bowel disease (IBD) treatment. To date, there has been no large-scale meta-analysis to examine the effectiveness of both treatments in CD and UC.

Study design: Systematic review and meta-analysis.

Setting: Twenty randomized controlled trials totaling 2,398 patients.

Synopsis: Standard glucocorticosteroids were superior to placebo for UC remission (RR of no remission=0.65; 95% CI, 0.45-0.93). Both trials of standard glucocorticosteroids in CD remission reported a statistically significant effect, but the overall effect was not significant due to heterogeneity of the studies. Budesonide was superior to placebo for CD remission (RR=0.73; 95% CI, 0.63-0.84) but not in preventing CD relapse (RR=0.93; 95% CI, 0.83-1.04). Standard glucocorticosteroids were superior to budesonide for CD remission (RR=0.82; 95% CI, 0.68-0.98) but with more adverse effects (RR=1.64; 95% CI, 1.34-2.00).

The limitations of the study include the poor overall quality of the studies included in the meta-analysis, with only one study judged as low risk of bias. There was intermediate to high heterogeneity between study results.

Bottom line: Standard glucocorticosteroids are likely effective in inducing remission in UC and, possibly, in CD. Budesonide probably is effective at inducing remission in active CD. Neither therapy was recommended in preventing relapse of UC and CD.

Citation: Ford AC, Bernstein CN, Khan KJ, et al. Glucocorticosteroid therapy in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol. 2011;106(4):590-599.

Levofloxacin Effective in Treatment of H. Pylori in Settings of High Clarithromycin Resistance

Clinical question: In areas with high H. pylori clarithromycin resistance rates, is levofloxacin more effective in eradicating H. pylori than standard clarithromycin, based treatment regimens?

Background: The rise in antimicrobial drug resistance is a major cause for the decreasing rate of H. pylori eradication. In areas with higher than 15% H. pyloriclarithromycin-resistant strains, quadruple therapy has been suggested as first-line therapy. The efficacy of a levofloxacin-based sequential therapy in eradicating H. pylori is undetermined.

Study design: Prospective, randomized, controlled multicenter study with a parallel-group design.

Setting: Five gastroenterology clinics in Italy.

Synopsis: Researchers randomly assigned 375 patients who were infected with H. pylori and naive to treatment to one of three groups. All three treatment groups received an initial five days of omeprazole 20 mg BID and amoxicillin 1 gm BID, then five days of omeprazole 20 mg BID and tinidazole 500 mg BID. The groups also received either clarithromycin 500 mg BID, levofloxacin 250 mg BID, or levofloxacin 500 mg BID, respectively, during the second five days of treatment.

Eradication rates were 80.8% (95% CI, 72.8% to 87.3%) with clarithromycin sequential therapy, 96.0% (95% CI, 90.9% to 98.7%) with levofloxacin-250 sequential therapy, and 96.8% (95% CI, 92.0% to 99.1%) with levofloxacin-500 sequential therapy.

The clarithromycin-group eradication rate was significantly lower than both levofloxacin groups. No significant difference was observed between the levofloxacin-250 and levofloxacin-500 groups. No differences in prevalence of antimicrobial resistance or incidence of adverse events were observed between the groups. Levofloxacin-250 therapy does offer cost savings when compared with clarithromycin sequential therapy.

A potential limitation to the study is referral bias, as each of the patients first were sent by their primary physicians to a specialized GI clinic.

Bottom line: In areas with a high prevalence of clarithromycin-resistant strains of H. pylori levofloxacin-containing sequential therapy should be considered for a first-line eradication regimen.

Citation: Romano M, Cuomo A, Gravina AG, et al. Empirical levofloxacin-containing versus clarithromycin-containing sequential therapy for Helicobacter pylori eradication: a randomised trial. Gut. 2010;59(11):1465-1470.

Tako-Tsubo Cardiomyopathy Is Associated with Higher Hospital Readmission Rates and Long-Term Mortality

Clinical question: What is the natural history of patients who develop tako-tsubo cardiomyopathy?

Background: Stress-induced or tako-tsubo cardiomyopathy (TTC) is a rare acute cardiac syndrome, characterized by chest pain or dyspnea, ischemic electrocardiographic changes, transient left ventricular (LV) dysfunction, and limited release of cardiac injury markers, in the absence of epicardial coronary artery disease (CAD). The long-term outcome of this condition is unknown.

Study design: Prospective, case-control study.

Setting: Five urban-based hospitals in Italy.

Synopsis: One hundred-sixteen patients with TTC were included in the five-year study period. Patients were followed up at one and six months, then annually thereafter. Primary endpoints were death, TTC recurrence, and rehospitalization for any cause.

Mean initial LV ejection fraction (LVEF) was 36%. Two patients died of refractory heart failure during hospitalization. Of the patients who were discharged alive, all except one showed complete LV functional recovery.

At follow-up (mean two years), only 64 (55%) patients were asymptomatic. Rehospitalization rate was high (25%), with chest pain and dyspnea the most common causes. Only two patients had a recurrence of TTC. Eleven patients died (seven from cardiovascular causes). There was no significant difference in mortality or in other clinical events between patients with and without severe LV dysfunction at presentation. The standardized mortality ratio was 3.40 (95% CI, 1.83-6.34) in the TTC population, compared with the age- and sex-specific mortality of the general population.

The study is limited by a lack of patients with subclinical TTC disease and those who might have suffered from sudden cardiac death prior to enrollment, leading to a possible sampling bias, as well as the nonrandomized use of beta-blockers.

Bottom line: Tako-tsubo disease is associated with rare recurrence of the disease, common recurrence of chest pain and dyspnea, and three times the mortality rate of the general population.

Citation: Parodi G, Bellandi B, Del Pace S, et al. Natural history of tako-tsubo cardiomyopathy. Chest. 2011;139(4):887-892.

Seven Independent Risk Factors Predict Postoperative Pulmonary Complications

Clinical question: What are the clinical risk factors that predict higher rates of postoperative pulmonary complications?

Background: Postoperative pulmonary complications (PPCs) are a major cause of postoperative morbidity, mortality, and prolonged hospital stays. Previous studies looking at risk factors for PPCs were limited by sampling bias and small sample sizes.

Study design: Prospective, randomized-sample cohort study.

Setting: Fifty-nine participating Spanish hospitals (community, intermediate referral, or major tertiary-care facilities).

Synopsis: Patients undergoing surgical procedures with general, neuraxial, or regional anesthesia were selected randomly. The main outcome was the development of at least one of the following: respiratory infection, respiratory failure, bronchospasm, atelectasis, pleural effusion, pneumothorax, or aspiration pneumonitis. Of 2,464 patients enrolled, 252 events were observed in 123 patients (5%). The 30-day mortality rate was significantly higher in patients suffering a PPC than those who did not (19.5% vs. 0.5%). Additionally, regression modeling identified seven independent risk factors: low preoperative arterial oxygen saturation, acute respiratory infection within one month of surgery, advanced age, preoperative anemia, upper abdominal or intrathoracic surgery, surgical duration more than two hours, and emergency surgery.

The study was underpowered to assess the significance of all potential risk factors for PPCs. Also, given the number of centers involved in the study, variation in assessing development of PPCs is likely.

Bottom line: Postoperative pulmonary complications are a major cause of morbidity and mortality. Seven independent risk factors were identified for the development of PPCs, which could be useful in preoperative risk stratification.

Citation: Canet J, Gallart L, Gomar C, et al. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010;113(6):1338-1350.

Code Status Orders and Goals of Medical ICU Care

Clinical question: How familiar are patients in the medical ICU (MICU) or their surrogates regarding code-status orders and goals of care, what are their preferences, and to what extent do they and their physicians differ?

Background: Discussions about code-status orders and goals of care carry great import in the MICU. However, little data exist on patients’ code-status preferences and goals of care. More knowledge of these issues can help physicians deliver more patient-centered care.

Study design: Prospective interviews.

Setting: Twenty-six-bed MICU at a large Midwestern academic medical center.

Synopsis: Data were collected from December 2008 to December 2009 on a random sample of patients—or their surrogates—admitted to the MICU. Of 135 eligible patients/surrogates, 100 completed interviews. Patients primarily were white (95%) and from the ages of 41 to 80 (79%).

Only 28% of participants recalled having a discussion about CPR and one goal of care, while 27% recalled no discussion at all; 83% preferred full code status but had limited knowledge of CPR and its outcomes in the hospital setting. Only 4% were able to identify all components of CPR, and they estimated the mean probability of survival following in-hospital arrest with CPR to be 71.8%, although data suggest survival is closer to 18%. There was a correlation between a higher estimation of survival following CPR and preference for it. After learning about the evidence-based likelihood of a good neurologic outcome following CPR, 8% of the participants became less interested.

Discrepancies between patients’ stated code status and that in the medical record was identified 16% of the time. Additionally, 67.7% of participants differed with their physicians regarding the most important goal of care.

Bottom line: Discussions about code status and goals of care in the MICU occur less frequently than recommended, leading to widespread discrepancies between patients/surrogates and their physicians regarding the most important goal of care. This is compounded by the fact that patients and their surrogates have limited knowledge about in-hospital CPR and its likelihood of success.

Citation: Gehlbach TG, Shinkunas LA, Forman-Hoffman VL, Thomas KW, Schmidt GA, Kaldjian LC. Code status orders and goals of care in the medical ICU. Chest. 2011;139:802-809. TH

In This Edition

Literature At A Glance

A guide to this month’s studies

1. Screening for AAA
2. Adverse events in atrial fibrillation
3. Biological treatment of inflammatory bowel diseases
4. Steroid treatment of inflammatory bowel diseases
5. Levofloxacin for H. pylori
6. Natural history of tako-tsubo cardiomyopathy
7. Predicting postoperative pulmonary complications
8. Code status and goals of care in the ICU

New Screening Strategy To Identify Large Abdominal Aortic Aneurysms

Clinical question: Can an effective scoring system be developed to better identify patients at risk for large abdominal aortic aneurysms (AAA)?

Background: Screening reduces AAA-related mortality by about half in men aged >65. The United States Preventive Services Task Force (USPSTF) has recommended screening for AAA in men aged 65 to 75 with a history of smoking. However, more than 50% of AAA ruptures occur in individuals outside this patient cohort, and only some AAAs detected are large enough to warrant surgery.

Study design: Retrospective, observational cohort study.

Setting: More than 20,000 screening sites across the U.S.

Synopsis: Researchers collected demographics and risk factors from 3.1 million people undergoing ultrasound screening for AAA by Life Line Screening Inc. At the screening visit, subjects completed a questionnaire about their health status and medical history. Screening data also included diameter of the infrarenal abdominal aorta. To construct and test a risk model, the screened individuals were randomly allocated into two equal groups: a data set used for model development and one for validation.

Most of the AAAs greater than 5 cm in diameter discovered were in males (84.4%) and among subjects with a smoking history (83%). Other risk factors for large AAAs included advanced age, peripheral arterial disease, and obesity. The authors estimate that there are about 121,000 people with >5.0 cm aneurysms in the general population. Current guidelines would detect only 33.7% of the existing large AAAs. Study limitations include possible selection bias, as a majority of patients were self-referred. Also, the database did not include all comorbidities that could affect the risk of AAA. The self-reported nature of health data might cause misclassification of a patient’s true health status.

Bottom line: A screening strategy based on a newly developed scoring system is an effective way to identify patients at risk of large abdominal aortic aneurysms.

Citation: Greco G, Egorova NN, Gelijns AC, et al. Development of a novel scoring tool for the identification of large >5 cm abdominal aortic aneurysms. Ann Surg. 2010;252(4):675-682.

Risk Factors for Adverse Events in Patients with Symptomatic Atrial Fibrillation

Clinical question: What are the predictors of 30-day adverse events in ED patients evaluated for symptomatic atrial fibrillation?

Background: Atrial fibrillation (AF) affects more than 2 million people in the U.S. and accounts for nearly 1% of ED visits. Physicians have little information to guide risk stratification, and they admit more than 65% of patients. A strategy to better define the ED management of patients presenting with atrial fibrillation is required.

Study design: Retrospective, observational cohort study.

Setting: Urban academic tertiary-care referral center with an adult ED.

Synopsis: A systematic review of the electronic medical records of all ED patients presenting with symptomatic atrial fibrillation over a three-year period was performed. Predefined adverse outcomes included 30-day ED return visits, unscheduled hospitalizations, cardiovascular complications, or death.

Of 832 eligible patients, 216 (25.9%) experienced at least one of the 30-day adverse events. Adverse events occurred in 181 of the 638 (28.4%) admitted patients and 35 of the 192 (18.2%) patients discharged from the ED. Increasing age, complaint of dyspnea, smoking history, inadequate ventricular rate control, and patients receiving beta-blockers were factors independently associated with higher risk for adverse events.

Study results were limited by a number of factors. This was a single-center, retrospective, observational study, with all of its inherent limitations. The predictor model did not include laboratory data, such as BNP or troponin. Patients might have experienced additional events within the 30 days that were treated at other hospitals and not recorded in the database. Patient disposition might have affected the results, as patients initially admitted from the ED had a higher rate of 30-day adverse events than patients who were discharged from the ED.

Bottom line: Patients with increased age, smoking history, complaints of dyspnea, inadequate ventricular rate control in the ED, and home beta-blocker therapy are more likely to experience an atrial-fibrillation-related adverse event within 30 days.

Citation: Barrett TW, Martin AR, Storrow AB, et al. A clinical prediction model to estimate risk for 30-day adverse events in emergency department patients with symptomatic atrial fibrillation. Ann Emerg Med. 2011;57 (1):1-12.

Biological Therapies Are Effective in Inducing Remission in Inflammatory Bowel Disease

Clinical question: Are biological therapies useful in the treatment of ulcerative colitis (UC) and Crohn’s disease (CD)?

Background: Patients with CD and UC often experience flares of disease activity, despite maintenance therapy with 5-aminosalicylic acid compounds. These flares are usually treated with corticosteroids, which carry numerous adverse side effects. The role of biological therapies in inducing remission is uncertain.

Study design: Systematic review and meta-analysis.

Setting: Twenty-seven randomized controlled trials involving 7,416 patients.

Synopsis: Anti-TNF α antibodies and natalizumab were both superior to placebo in inducing remission of luminal CD (RR of no remission 0.87 and 0.88, respectively). Anti-TNF antibodies also were superior to placebo in preventing relapse of luminal CD (RR of relapse=0.71). Infliximab was superior to placebo in inducing remission of moderate to severely active UC (RR=0.72; 95% CI, 0.57-0.91). There were no significantly increased adverse drug effects with anti-TNF α antibodies or with infliximab compared with placebo. Natalizumab caused significantly higher rates of headache.

Limitations include risk of publication bias inherent in meta-analyses. There also was evidence of moderate heterogeneity in the studies analyzed. Finally, not every study was consistent in reporting adverse drug effects.

Bottom line: Biological therapies are superior to placebo in inducing remission of active UC and CD, as well as preventing relapse of quiescent CD.

Citation: Ford AC, Sandborn WJ, Khan KJ, Hanauer SB, Talley NJ, Moayyedi P. Efficacy of biological therapies in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol. 2011; 106(4):644-659.

Glucocortico­steroids Probably Effective in Treatment of Inflammatory Bowel Disease, Primarily in Active Ulcerative Colitis

Clinical question: Is glucocorticosteroid therapy effective in the treatment of active IBD and in preventing relapses?

Background: Crohn’s disease (CD) and ulcerative colitis (UC) are chronic inflammatory bowel diseases of unclear etiology. Use of standard glucocorticosteroids and budesonide is widespread in inflammatory bowel disease (IBD) treatment. To date, there has been no large-scale meta-analysis to examine the effectiveness of both treatments in CD and UC.

Study design: Systematic review and meta-analysis.

Setting: Twenty randomized controlled trials totaling 2,398 patients.

Synopsis: Standard glucocorticosteroids were superior to placebo for UC remission (RR of no remission=0.65; 95% CI, 0.45-0.93). Both trials of standard glucocorticosteroids in CD remission reported a statistically significant effect, but the overall effect was not significant due to heterogeneity of the studies. Budesonide was superior to placebo for CD remission (RR=0.73; 95% CI, 0.63-0.84) but not in preventing CD relapse (RR=0.93; 95% CI, 0.83-1.04). Standard glucocorticosteroids were superior to budesonide for CD remission (RR=0.82; 95% CI, 0.68-0.98) but with more adverse effects (RR=1.64; 95% CI, 1.34-2.00).

The limitations of the study include the poor overall quality of the studies included in the meta-analysis, with only one study judged as low risk of bias. There was intermediate to high heterogeneity between study results.

Bottom line: Standard glucocorticosteroids are likely effective in inducing remission in UC and, possibly, in CD. Budesonide probably is effective at inducing remission in active CD. Neither therapy was recommended in preventing relapse of UC and CD.

Citation: Ford AC, Bernstein CN, Khan KJ, et al. Glucocorticosteroid therapy in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol. 2011;106(4):590-599.

Levofloxacin Effective in Treatment of H. Pylori in Settings of High Clarithromycin Resistance

Clinical question: In areas with high H. pylori clarithromycin resistance rates, is levofloxacin more effective in eradicating H. pylori than standard clarithromycin, based treatment regimens?

Background: The rise in antimicrobial drug resistance is a major cause for the decreasing rate of H. pylori eradication. In areas with higher than 15% H. pyloriclarithromycin-resistant strains, quadruple therapy has been suggested as first-line therapy. The efficacy of a levofloxacin-based sequential therapy in eradicating H. pylori is undetermined.

Study design: Prospective, randomized, controlled multicenter study with a parallel-group design.

Setting: Five gastroenterology clinics in Italy.

Synopsis: Researchers randomly assigned 375 patients who were infected with H. pylori and naive to treatment to one of three groups. All three treatment groups received an initial five days of omeprazole 20 mg BID and amoxicillin 1 gm BID, then five days of omeprazole 20 mg BID and tinidazole 500 mg BID. The groups also received either clarithromycin 500 mg BID, levofloxacin 250 mg BID, or levofloxacin 500 mg BID, respectively, during the second five days of treatment.

Eradication rates were 80.8% (95% CI, 72.8% to 87.3%) with clarithromycin sequential therapy, 96.0% (95% CI, 90.9% to 98.7%) with levofloxacin-250 sequential therapy, and 96.8% (95% CI, 92.0% to 99.1%) with levofloxacin-500 sequential therapy.

The clarithromycin-group eradication rate was significantly lower than both levofloxacin groups. No significant difference was observed between the levofloxacin-250 and levofloxacin-500 groups. No differences in prevalence of antimicrobial resistance or incidence of adverse events were observed between the groups. Levofloxacin-250 therapy does offer cost savings when compared with clarithromycin sequential therapy.

A potential limitation to the study is referral bias, as each of the patients first were sent by their primary physicians to a specialized GI clinic.

Bottom line: In areas with a high prevalence of clarithromycin-resistant strains of H. pylori levofloxacin-containing sequential therapy should be considered for a first-line eradication regimen.

Citation: Romano M, Cuomo A, Gravina AG, et al. Empirical levofloxacin-containing versus clarithromycin-containing sequential therapy for Helicobacter pylori eradication: a randomised trial. Gut. 2010;59(11):1465-1470.

Tako-Tsubo Cardiomyopathy Is Associated with Higher Hospital Readmission Rates and Long-Term Mortality

Clinical question: What is the natural history of patients who develop tako-tsubo cardiomyopathy?

Background: Stress-induced or tako-tsubo cardiomyopathy (TTC) is a rare acute cardiac syndrome, characterized by chest pain or dyspnea, ischemic electrocardiographic changes, transient left ventricular (LV) dysfunction, and limited release of cardiac injury markers, in the absence of epicardial coronary artery disease (CAD). The long-term outcome of this condition is unknown.

Study design: Prospective, case-control study.

Setting: Five urban-based hospitals in Italy.

Synopsis: One hundred-sixteen patients with TTC were included in the five-year study period. Patients were followed up at one and six months, then annually thereafter. Primary endpoints were death, TTC recurrence, and rehospitalization for any cause.

Mean initial LV ejection fraction (LVEF) was 36%. Two patients died of refractory heart failure during hospitalization. Of the patients who were discharged alive, all except one showed complete LV functional recovery.

At follow-up (mean two years), only 64 (55%) patients were asymptomatic. Rehospitalization rate was high (25%), with chest pain and dyspnea the most common causes. Only two patients had a recurrence of TTC. Eleven patients died (seven from cardiovascular causes). There was no significant difference in mortality or in other clinical events between patients with and without severe LV dysfunction at presentation. The standardized mortality ratio was 3.40 (95% CI, 1.83-6.34) in the TTC population, compared with the age- and sex-specific mortality of the general population.

The study is limited by a lack of patients with subclinical TTC disease and those who might have suffered from sudden cardiac death prior to enrollment, leading to a possible sampling bias, as well as the nonrandomized use of beta-blockers.

Bottom line: Tako-tsubo disease is associated with rare recurrence of the disease, common recurrence of chest pain and dyspnea, and three times the mortality rate of the general population.

Citation: Parodi G, Bellandi B, Del Pace S, et al. Natural history of tako-tsubo cardiomyopathy. Chest. 2011;139(4):887-892.

Seven Independent Risk Factors Predict Postoperative Pulmonary Complications

Clinical question: What are the clinical risk factors that predict higher rates of postoperative pulmonary complications?

Background: Postoperative pulmonary complications (PPCs) are a major cause of postoperative morbidity, mortality, and prolonged hospital stays. Previous studies looking at risk factors for PPCs were limited by sampling bias and small sample sizes.

Study design: Prospective, randomized-sample cohort study.

Setting: Fifty-nine participating Spanish hospitals (community, intermediate referral, or major tertiary-care facilities).

Synopsis: Patients undergoing surgical procedures with general, neuraxial, or regional anesthesia were selected randomly. The main outcome was the development of at least one of the following: respiratory infection, respiratory failure, bronchospasm, atelectasis, pleural effusion, pneumothorax, or aspiration pneumonitis. Of 2,464 patients enrolled, 252 events were observed in 123 patients (5%). The 30-day mortality rate was significantly higher in patients suffering a PPC than those who did not (19.5% vs. 0.5%). Additionally, regression modeling identified seven independent risk factors: low preoperative arterial oxygen saturation, acute respiratory infection within one month of surgery, advanced age, preoperative anemia, upper abdominal or intrathoracic surgery, surgical duration more than two hours, and emergency surgery.

The study was underpowered to assess the significance of all potential risk factors for PPCs. Also, given the number of centers involved in the study, variation in assessing development of PPCs is likely.

Bottom line: Postoperative pulmonary complications are a major cause of morbidity and mortality. Seven independent risk factors were identified for the development of PPCs, which could be useful in preoperative risk stratification.

Citation: Canet J, Gallart L, Gomar C, et al. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010;113(6):1338-1350.

Code Status Orders and Goals of Medical ICU Care

Clinical question: How familiar are patients in the medical ICU (MICU) or their surrogates regarding code-status orders and goals of care, what are their preferences, and to what extent do they and their physicians differ?

Background: Discussions about code-status orders and goals of care carry great import in the MICU. However, little data exist on patients’ code-status preferences and goals of care. More knowledge of these issues can help physicians deliver more patient-centered care.

Study design: Prospective interviews.

Setting: Twenty-six-bed MICU at a large Midwestern academic medical center.

Synopsis: Data were collected from December 2008 to December 2009 on a random sample of patients—or their surrogates—admitted to the MICU. Of 135 eligible patients/surrogates, 100 completed interviews. Patients primarily were white (95%) and from the ages of 41 to 80 (79%).

Only 28% of participants recalled having a discussion about CPR and one goal of care, while 27% recalled no discussion at all; 83% preferred full code status but had limited knowledge of CPR and its outcomes in the hospital setting. Only 4% were able to identify all components of CPR, and they estimated the mean probability of survival following in-hospital arrest with CPR to be 71.8%, although data suggest survival is closer to 18%. There was a correlation between a higher estimation of survival following CPR and preference for it. After learning about the evidence-based likelihood of a good neurologic outcome following CPR, 8% of the participants became less interested.

Discrepancies between patients’ stated code status and that in the medical record was identified 16% of the time. Additionally, 67.7% of participants differed with their physicians regarding the most important goal of care.

Bottom line: Discussions about code status and goals of care in the MICU occur less frequently than recommended, leading to widespread discrepancies between patients/surrogates and their physicians regarding the most important goal of care. This is compounded by the fact that patients and their surrogates have limited knowledge about in-hospital CPR and its likelihood of success.

Citation: Gehlbach TG, Shinkunas LA, Forman-Hoffman VL, Thomas KW, Schmidt GA, Kaldjian LC. Code status orders and goals of care in the medical ICU. Chest. 2011;139:802-809. TH

In This Edition

Literature At A Glance

A guide to this month’s studies

1. Screening for AAA
2. Adverse events in atrial fibrillation
3. Biological treatment of inflammatory bowel diseases
4. Steroid treatment of inflammatory bowel diseases
5. Levofloxacin for H. pylori
6. Natural history of tako-tsubo cardiomyopathy
7. Predicting postoperative pulmonary complications
8. Code status and goals of care in the ICU

New Screening Strategy To Identify Large Abdominal Aortic Aneurysms

Clinical question: Can an effective scoring system be developed to better identify patients at risk for large abdominal aortic aneurysms (AAA)?

Background: Screening reduces AAA-related mortality by about half in men aged >65. The United States Preventive Services Task Force (USPSTF) has recommended screening for AAA in men aged 65 to 75 with a history of smoking. However, more than 50% of AAA ruptures occur in individuals outside this patient cohort, and only some AAAs detected are large enough to warrant surgery.

Study design: Retrospective, observational cohort study.

Setting: More than 20,000 screening sites across the U.S.

Synopsis: Researchers collected demographics and risk factors from 3.1 million people undergoing ultrasound screening for AAA by Life Line Screening Inc. At the screening visit, subjects completed a questionnaire about their health status and medical history. Screening data also included diameter of the infrarenal abdominal aorta. To construct and test a risk model, the screened individuals were randomly allocated into two equal groups: a data set used for model development and one for validation.

Most of the AAAs greater than 5 cm in diameter discovered were in males (84.4%) and among subjects with a smoking history (83%). Other risk factors for large AAAs included advanced age, peripheral arterial disease, and obesity. The authors estimate that there are about 121,000 people with >5.0 cm aneurysms in the general population. Current guidelines would detect only 33.7% of the existing large AAAs. Study limitations include possible selection bias, as a majority of patients were self-referred. Also, the database did not include all comorbidities that could affect the risk of AAA. The self-reported nature of health data might cause misclassification of a patient’s true health status.

Bottom line: A screening strategy based on a newly developed scoring system is an effective way to identify patients at risk of large abdominal aortic aneurysms.

Citation: Greco G, Egorova NN, Gelijns AC, et al. Development of a novel scoring tool for the identification of large >5 cm abdominal aortic aneurysms. Ann Surg. 2010;252(4):675-682.

Risk Factors for Adverse Events in Patients with Symptomatic Atrial Fibrillation

Clinical question: What are the predictors of 30-day adverse events in ED patients evaluated for symptomatic atrial fibrillation?

Background: Atrial fibrillation (AF) affects more than 2 million people in the U.S. and accounts for nearly 1% of ED visits. Physicians have little information to guide risk stratification, and they admit more than 65% of patients. A strategy to better define the ED management of patients presenting with atrial fibrillation is required.

Study design: Retrospective, observational cohort study.

Setting: Urban academic tertiary-care referral center with an adult ED.

Synopsis: A systematic review of the electronic medical records of all ED patients presenting with symptomatic atrial fibrillation over a three-year period was performed. Predefined adverse outcomes included 30-day ED return visits, unscheduled hospitalizations, cardiovascular complications, or death.

Of 832 eligible patients, 216 (25.9%) experienced at least one of the 30-day adverse events. Adverse events occurred in 181 of the 638 (28.4%) admitted patients and 35 of the 192 (18.2%) patients discharged from the ED. Increasing age, complaint of dyspnea, smoking history, inadequate ventricular rate control, and patients receiving beta-blockers were factors independently associated with higher risk for adverse events.

Study results were limited by a number of factors. This was a single-center, retrospective, observational study, with all of its inherent limitations. The predictor model did not include laboratory data, such as BNP or troponin. Patients might have experienced additional events within the 30 days that were treated at other hospitals and not recorded in the database. Patient disposition might have affected the results, as patients initially admitted from the ED had a higher rate of 30-day adverse events than patients who were discharged from the ED.

Bottom line: Patients with increased age, smoking history, complaints of dyspnea, inadequate ventricular rate control in the ED, and home beta-blocker therapy are more likely to experience an atrial-fibrillation-related adverse event within 30 days.

Citation: Barrett TW, Martin AR, Storrow AB, et al. A clinical prediction model to estimate risk for 30-day adverse events in emergency department patients with symptomatic atrial fibrillation. Ann Emerg Med. 2011;57 (1):1-12.

Biological Therapies Are Effective in Inducing Remission in Inflammatory Bowel Disease

Clinical question: Are biological therapies useful in the treatment of ulcerative colitis (UC) and Crohn’s disease (CD)?

Background: Patients with CD and UC often experience flares of disease activity, despite maintenance therapy with 5-aminosalicylic acid compounds. These flares are usually treated with corticosteroids, which carry numerous adverse side effects. The role of biological therapies in inducing remission is uncertain.

Study design: Systematic review and meta-analysis.

Setting: Twenty-seven randomized controlled trials involving 7,416 patients.

Synopsis: Anti-TNF α antibodies and natalizumab were both superior to placebo in inducing remission of luminal CD (RR of no remission 0.87 and 0.88, respectively). Anti-TNF antibodies also were superior to placebo in preventing relapse of luminal CD (RR of relapse=0.71). Infliximab was superior to placebo in inducing remission of moderate to severely active UC (RR=0.72; 95% CI, 0.57-0.91). There were no significantly increased adverse drug effects with anti-TNF α antibodies or with infliximab compared with placebo. Natalizumab caused significantly higher rates of headache.

Limitations include risk of publication bias inherent in meta-analyses. There also was evidence of moderate heterogeneity in the studies analyzed. Finally, not every study was consistent in reporting adverse drug effects.

Bottom line: Biological therapies are superior to placebo in inducing remission of active UC and CD, as well as preventing relapse of quiescent CD.

Citation: Ford AC, Sandborn WJ, Khan KJ, Hanauer SB, Talley NJ, Moayyedi P. Efficacy of biological therapies in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol. 2011; 106(4):644-659.

Glucocortico­steroids Probably Effective in Treatment of Inflammatory Bowel Disease, Primarily in Active Ulcerative Colitis

Clinical question: Is glucocorticosteroid therapy effective in the treatment of active IBD and in preventing relapses?

Background: Crohn’s disease (CD) and ulcerative colitis (UC) are chronic inflammatory bowel diseases of unclear etiology. Use of standard glucocorticosteroids and budesonide is widespread in inflammatory bowel disease (IBD) treatment. To date, there has been no large-scale meta-analysis to examine the effectiveness of both treatments in CD and UC.

Study design: Systematic review and meta-analysis.

Setting: Twenty randomized controlled trials totaling 2,398 patients.

Synopsis: Standard glucocorticosteroids were superior to placebo for UC remission (RR of no remission=0.65; 95% CI, 0.45-0.93). Both trials of standard glucocorticosteroids in CD remission reported a statistically significant effect, but the overall effect was not significant due to heterogeneity of the studies. Budesonide was superior to placebo for CD remission (RR=0.73; 95% CI, 0.63-0.84) but not in preventing CD relapse (RR=0.93; 95% CI, 0.83-1.04). Standard glucocorticosteroids were superior to budesonide for CD remission (RR=0.82; 95% CI, 0.68-0.98) but with more adverse effects (RR=1.64; 95% CI, 1.34-2.00).

The limitations of the study include the poor overall quality of the studies included in the meta-analysis, with only one study judged as low risk of bias. There was intermediate to high heterogeneity between study results.

Bottom line: Standard glucocorticosteroids are likely effective in inducing remission in UC and, possibly, in CD. Budesonide probably is effective at inducing remission in active CD. Neither therapy was recommended in preventing relapse of UC and CD.

Citation: Ford AC, Bernstein CN, Khan KJ, et al. Glucocorticosteroid therapy in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol. 2011;106(4):590-599.

Levofloxacin Effective in Treatment of H. Pylori in Settings of High Clarithromycin Resistance

Clinical question: In areas with high H. pylori clarithromycin resistance rates, is levofloxacin more effective in eradicating H. pylori than standard clarithromycin, based treatment regimens?

Background: The rise in antimicrobial drug resistance is a major cause for the decreasing rate of H. pylori eradication. In areas with higher than 15% H. pyloriclarithromycin-resistant strains, quadruple therapy has been suggested as first-line therapy. The efficacy of a levofloxacin-based sequential therapy in eradicating H. pylori is undetermined.

Study design: Prospective, randomized, controlled multicenter study with a parallel-group design.

Setting: Five gastroenterology clinics in Italy.

Synopsis: Researchers randomly assigned 375 patients who were infected with H. pylori and naive to treatment to one of three groups. All three treatment groups received an initial five days of omeprazole 20 mg BID and amoxicillin 1 gm BID, then five days of omeprazole 20 mg BID and tinidazole 500 mg BID. The groups also received either clarithromycin 500 mg BID, levofloxacin 250 mg BID, or levofloxacin 500 mg BID, respectively, during the second five days of treatment.

Eradication rates were 80.8% (95% CI, 72.8% to 87.3%) with clarithromycin sequential therapy, 96.0% (95% CI, 90.9% to 98.7%) with levofloxacin-250 sequential therapy, and 96.8% (95% CI, 92.0% to 99.1%) with levofloxacin-500 sequential therapy.

The clarithromycin-group eradication rate was significantly lower than both levofloxacin groups. No significant difference was observed between the levofloxacin-250 and levofloxacin-500 groups. No differences in prevalence of antimicrobial resistance or incidence of adverse events were observed between the groups. Levofloxacin-250 therapy does offer cost savings when compared with clarithromycin sequential therapy.

A potential limitation to the study is referral bias, as each of the patients first were sent by their primary physicians to a specialized GI clinic.

Bottom line: In areas with a high prevalence of clarithromycin-resistant strains of H. pylori levofloxacin-containing sequential therapy should be considered for a first-line eradication regimen.

Citation: Romano M, Cuomo A, Gravina AG, et al. Empirical levofloxacin-containing versus clarithromycin-containing sequential therapy for Helicobacter pylori eradication: a randomised trial. Gut. 2010;59(11):1465-1470.

Tako-Tsubo Cardiomyopathy Is Associated with Higher Hospital Readmission Rates and Long-Term Mortality

Clinical question: What is the natural history of patients who develop tako-tsubo cardiomyopathy?

Background: Stress-induced or tako-tsubo cardiomyopathy (TTC) is a rare acute cardiac syndrome, characterized by chest pain or dyspnea, ischemic electrocardiographic changes, transient left ventricular (LV) dysfunction, and limited release of cardiac injury markers, in the absence of epicardial coronary artery disease (CAD). The long-term outcome of this condition is unknown.

Study design: Prospective, case-control study.

Setting: Five urban-based hospitals in Italy.

Synopsis: One hundred-sixteen patients with TTC were included in the five-year study period. Patients were followed up at one and six months, then annually thereafter. Primary endpoints were death, TTC recurrence, and rehospitalization for any cause.

Mean initial LV ejection fraction (LVEF) was 36%. Two patients died of refractory heart failure during hospitalization. Of the patients who were discharged alive, all except one showed complete LV functional recovery.

At follow-up (mean two years), only 64 (55%) patients were asymptomatic. Rehospitalization rate was high (25%), with chest pain and dyspnea the most common causes. Only two patients had a recurrence of TTC. Eleven patients died (seven from cardiovascular causes). There was no significant difference in mortality or in other clinical events between patients with and without severe LV dysfunction at presentation. The standardized mortality ratio was 3.40 (95% CI, 1.83-6.34) in the TTC population, compared with the age- and sex-specific mortality of the general population.

The study is limited by a lack of patients with subclinical TTC disease and those who might have suffered from sudden cardiac death prior to enrollment, leading to a possible sampling bias, as well as the nonrandomized use of beta-blockers.

Bottom line: Tako-tsubo disease is associated with rare recurrence of the disease, common recurrence of chest pain and dyspnea, and three times the mortality rate of the general population.

Citation: Parodi G, Bellandi B, Del Pace S, et al. Natural history of tako-tsubo cardiomyopathy. Chest. 2011;139(4):887-892.

Seven Independent Risk Factors Predict Postoperative Pulmonary Complications

Clinical question: What are the clinical risk factors that predict higher rates of postoperative pulmonary complications?

Background: Postoperative pulmonary complications (PPCs) are a major cause of postoperative morbidity, mortality, and prolonged hospital stays. Previous studies looking at risk factors for PPCs were limited by sampling bias and small sample sizes.

Study design: Prospective, randomized-sample cohort study.

Setting: Fifty-nine participating Spanish hospitals (community, intermediate referral, or major tertiary-care facilities).

Synopsis: Patients undergoing surgical procedures with general, neuraxial, or regional anesthesia were selected randomly. The main outcome was the development of at least one of the following: respiratory infection, respiratory failure, bronchospasm, atelectasis, pleural effusion, pneumothorax, or aspiration pneumonitis. Of 2,464 patients enrolled, 252 events were observed in 123 patients (5%). The 30-day mortality rate was significantly higher in patients suffering a PPC than those who did not (19.5% vs. 0.5%). Additionally, regression modeling identified seven independent risk factors: low preoperative arterial oxygen saturation, acute respiratory infection within one month of surgery, advanced age, preoperative anemia, upper abdominal or intrathoracic surgery, surgical duration more than two hours, and emergency surgery.

The study was underpowered to assess the significance of all potential risk factors for PPCs. Also, given the number of centers involved in the study, variation in assessing development of PPCs is likely.

Bottom line: Postoperative pulmonary complications are a major cause of morbidity and mortality. Seven independent risk factors were identified for the development of PPCs, which could be useful in preoperative risk stratification.

Citation: Canet J, Gallart L, Gomar C, et al. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010;113(6):1338-1350.

Code Status Orders and Goals of Medical ICU Care

Clinical question: How familiar are patients in the medical ICU (MICU) or their surrogates regarding code-status orders and goals of care, what are their preferences, and to what extent do they and their physicians differ?

Background: Discussions about code-status orders and goals of care carry great import in the MICU. However, little data exist on patients’ code-status preferences and goals of care. More knowledge of these issues can help physicians deliver more patient-centered care.

Study design: Prospective interviews.

Setting: Twenty-six-bed MICU at a large Midwestern academic medical center.

Synopsis: Data were collected from December 2008 to December 2009 on a random sample of patients—or their surrogates—admitted to the MICU. Of 135 eligible patients/surrogates, 100 completed interviews. Patients primarily were white (95%) and from the ages of 41 to 80 (79%).

Only 28% of participants recalled having a discussion about CPR and one goal of care, while 27% recalled no discussion at all; 83% preferred full code status but had limited knowledge of CPR and its outcomes in the hospital setting. Only 4% were able to identify all components of CPR, and they estimated the mean probability of survival following in-hospital arrest with CPR to be 71.8%, although data suggest survival is closer to 18%. There was a correlation between a higher estimation of survival following CPR and preference for it. After learning about the evidence-based likelihood of a good neurologic outcome following CPR, 8% of the participants became less interested.

Discrepancies between patients’ stated code status and that in the medical record was identified 16% of the time. Additionally, 67.7% of participants differed with their physicians regarding the most important goal of care.

Bottom line: Discussions about code status and goals of care in the MICU occur less frequently than recommended, leading to widespread discrepancies between patients/surrogates and their physicians regarding the most important goal of care. This is compounded by the fact that patients and their surrogates have limited knowledge about in-hospital CPR and its likelihood of success.

Citation: Gehlbach TG, Shinkunas LA, Forman-Hoffman VL, Thomas KW, Schmidt GA, Kaldjian LC. Code status orders and goals of care in the medical ICU. Chest. 2011;139:802-809. TH

As HM programs mature, seasoned leaders begin to evaluate the leadership potential of their staff, both clinical and administrative. Although the skills that brought each staff member to their current position often are well above average, the personal tools necessary to lead teams will ultimately come to the fore.

The need to develop and enhance leadership skills within hospitalist programs has attracted nearly 1,800 participants to SHM’s Leadership Academy courses.

Hundreds more are expected to attend the next academy, Sept. 12-15 at the historic Fontainebleau Miami Beach resort. Registration is available at www.hospitalmedicine.org/leadership.

To encourage HM programs to strengthen entire teams, SHM offers a $100 discount per person for groups of three or more hospitalists. Group leaders who bring their administrators receive a 10% discount.

First-time Leadership Academy participants will participate in the "Foundations for Effective Leadership" course. Those who already have completed "Foundations" will take their leadership skills to the next level with "Advanced Leadership: Personal Leadership Excellence."

Another advanced leadership course, "Strengthening Your Organization," will be presented in February 2012 in New Orleans.

"I send every hospitalist to Leadership Academy because I believe it makes them better team members," said Eric Howell, section chief of hospital medicine and deputy director of hospital operations for the Department of Medicine at Johns Hopkins Bayview Medical Center, in a video presented at HM11. Dr. Howell, an academy faculty member, says the training makes hospitalists "better problem-solvers. I believe it makes them better doctors." TH

As HM programs mature, seasoned leaders begin to evaluate the leadership potential of their staff, both clinical and administrative. Although the skills that brought each staff member to their current position often are well above average, the personal tools necessary to lead teams will ultimately come to the fore.

The need to develop and enhance leadership skills within hospitalist programs has attracted nearly 1,800 participants to SHM’s Leadership Academy courses.

Hundreds more are expected to attend the next academy, Sept. 12-15 at the historic Fontainebleau Miami Beach resort. Registration is available at www.hospitalmedicine.org/leadership.

To encourage HM programs to strengthen entire teams, SHM offers a $100 discount per person for groups of three or more hospitalists. Group leaders who bring their administrators receive a 10% discount.

First-time Leadership Academy participants will participate in the "Foundations for Effective Leadership" course. Those who already have completed "Foundations" will take their leadership skills to the next level with "Advanced Leadership: Personal Leadership Excellence."

Another advanced leadership course, "Strengthening Your Organization," will be presented in February 2012 in New Orleans.

"I send every hospitalist to Leadership Academy because I believe it makes them better team members," said Eric Howell, section chief of hospital medicine and deputy director of hospital operations for the Department of Medicine at Johns Hopkins Bayview Medical Center, in a video presented at HM11. Dr. Howell, an academy faculty member, says the training makes hospitalists "better problem-solvers. I believe it makes them better doctors." TH

As HM programs mature, seasoned leaders begin to evaluate the leadership potential of their staff, both clinical and administrative. Although the skills that brought each staff member to their current position often are well above average, the personal tools necessary to lead teams will ultimately come to the fore.

The need to develop and enhance leadership skills within hospitalist programs has attracted nearly 1,800 participants to SHM’s Leadership Academy courses.

Hundreds more are expected to attend the next academy, Sept. 12-15 at the historic Fontainebleau Miami Beach resort. Registration is available at www.hospitalmedicine.org/leadership.

To encourage HM programs to strengthen entire teams, SHM offers a $100 discount per person for groups of three or more hospitalists. Group leaders who bring their administrators receive a 10% discount.

First-time Leadership Academy participants will participate in the "Foundations for Effective Leadership" course. Those who already have completed "Foundations" will take their leadership skills to the next level with "Advanced Leadership: Personal Leadership Excellence."

Another advanced leadership course, "Strengthening Your Organization," will be presented in February 2012 in New Orleans.

"I send every hospitalist to Leadership Academy because I believe it makes them better team members," said Eric Howell, section chief of hospital medicine and deputy director of hospital operations for the Department of Medicine at Johns Hopkins Bayview Medical Center, in a video presented at HM11. Dr. Howell, an academy faculty member, says the training makes hospitalists "better problem-solvers. I believe it makes them better doctors." TH

The federal government is taking a hard look at many of its regulations, and hospitalists might have the chance to help identify those that no longer make sense.

On Jan. 18, President Obama issued Executive Order 13563, which calls, in part, for a comprehensive retrospective review of existing government regulations. The stated goal of this review is to improve or remove those rules that are out of date, unnecessary, excessively burdensome, or in conflict with other rules.

The Office of Information and Regulatory Affairs (OIRA), the executive-level department charged with overseeing the execution of this order, asked federal agencies to submit preliminary plans for how they will conduct their internal reviews. The agencies responded, and on May 26, the White House released 30 agency preliminary plans to the public, including those prepared by the Department of Commerce, the Department of Energy, and the Department of Health and Human Services (HHS).

When reviewing some of these publicly available preliminary plans, the easy answer for some observers is to say that most rules should be eliminated. Rules requiring the use of such technologies as film X-rays instead of digital images are obvious culprits in the out-of date category; rules defining milk as "oil" (subjecting it to the same costly environmental safeguards as real oil) are just as absurd. Both of these regulations are being lifted as a result of the review.

In contrast, many rules actually do protect public health and safety and will not be subject to review. For example, as a result of federal rulemaking, highway deaths are at the lowest level in 60 years and the risk of contracting salmonella from eggs is relatively low.

As part of HHS, the Center for Medicare & Medicaid Services (CMS) specifically stated that "the goal of the retrospective review will be to identify opportunities to improve patient care and outcomes and reduce system costs by removing obsolete or burdensome requirements." A major CMS concern will be to prevent the elimination or revision of a regulation only to find that the problem it sought to solve resurfaces, or that its removal or revision results in unanticipated and more serious outcomes.

This review could significantly impact HM in areas of quality measurement and reporting requirements:

• What quality measurements might not accomplish their intent?
• What measures might result in more harm than good?
• What reporting or process requirements could be changed to make for less duplication?
• If requirements cannot be eliminated, how can they be improved?

Due to hospitalist expertise in quality-improvement (QI) efforts and cost containment, these stated goals and the concerns that come with them are areas where hospitalists are likely to have some good answers. Hospitalists should not hesitate to provide their input to SHM Government Relations staff so that your ideas can be shared with CMS.

A complete list of agency proposals is available at www.whitehouse.gov/21stcentury gov/actions/21st-century-regulatory-system.

The federal government is taking a hard look at many of its regulations, and hospitalists might have the chance to help identify those that no longer make sense.

On Jan. 18, President Obama issued Executive Order 13563, which calls, in part, for a comprehensive retrospective review of existing government regulations. The stated goal of this review is to improve or remove those rules that are out of date, unnecessary, excessively burdensome, or in conflict with other rules.

The Office of Information and Regulatory Affairs (OIRA), the executive-level department charged with overseeing the execution of this order, asked federal agencies to submit preliminary plans for how they will conduct their internal reviews. The agencies responded, and on May 26, the White House released 30 agency preliminary plans to the public, including those prepared by the Department of Commerce, the Department of Energy, and the Department of Health and Human Services (HHS).

When reviewing some of these publicly available preliminary plans, the easy answer for some observers is to say that most rules should be eliminated. Rules requiring the use of such technologies as film X-rays instead of digital images are obvious culprits in the out-of date category; rules defining milk as "oil" (subjecting it to the same costly environmental safeguards as real oil) are just as absurd. Both of these regulations are being lifted as a result of the review.

In contrast, many rules actually do protect public health and safety and will not be subject to review. For example, as a result of federal rulemaking, highway deaths are at the lowest level in 60 years and the risk of contracting salmonella from eggs is relatively low.

As part of HHS, the Center for Medicare & Medicaid Services (CMS) specifically stated that "the goal of the retrospective review will be to identify opportunities to improve patient care and outcomes and reduce system costs by removing obsolete or burdensome requirements." A major CMS concern will be to prevent the elimination or revision of a regulation only to find that the problem it sought to solve resurfaces, or that its removal or revision results in unanticipated and more serious outcomes.

This review could significantly impact HM in areas of quality measurement and reporting requirements:

• What quality measurements might not accomplish their intent?
• What measures might result in more harm than good?
• What reporting or process requirements could be changed to make for less duplication?
• If requirements cannot be eliminated, how can they be improved?

Due to hospitalist expertise in quality-improvement (QI) efforts and cost containment, these stated goals and the concerns that come with them are areas where hospitalists are likely to have some good answers. Hospitalists should not hesitate to provide their input to SHM Government Relations staff so that your ideas can be shared with CMS.

A complete list of agency proposals is available at www.whitehouse.gov/21stcentury gov/actions/21st-century-regulatory-system.

The federal government is taking a hard look at many of its regulations, and hospitalists might have the chance to help identify those that no longer make sense.

On Jan. 18, President Obama issued Executive Order 13563, which calls, in part, for a comprehensive retrospective review of existing government regulations. The stated goal of this review is to improve or remove those rules that are out of date, unnecessary, excessively burdensome, or in conflict with other rules.

The Office of Information and Regulatory Affairs (OIRA), the executive-level department charged with overseeing the execution of this order, asked federal agencies to submit preliminary plans for how they will conduct their internal reviews. The agencies responded, and on May 26, the White House released 30 agency preliminary plans to the public, including those prepared by the Department of Commerce, the Department of Energy, and the Department of Health and Human Services (HHS).

When reviewing some of these publicly available preliminary plans, the easy answer for some observers is to say that most rules should be eliminated. Rules requiring the use of such technologies as film X-rays instead of digital images are obvious culprits in the out-of date category; rules defining milk as "oil" (subjecting it to the same costly environmental safeguards as real oil) are just as absurd. Both of these regulations are being lifted as a result of the review.

In contrast, many rules actually do protect public health and safety and will not be subject to review. For example, as a result of federal rulemaking, highway deaths are at the lowest level in 60 years and the risk of contracting salmonella from eggs is relatively low.

As part of HHS, the Center for Medicare & Medicaid Services (CMS) specifically stated that "the goal of the retrospective review will be to identify opportunities to improve patient care and outcomes and reduce system costs by removing obsolete or burdensome requirements." A major CMS concern will be to prevent the elimination or revision of a regulation only to find that the problem it sought to solve resurfaces, or that its removal or revision results in unanticipated and more serious outcomes.

This review could significantly impact HM in areas of quality measurement and reporting requirements:

• What quality measurements might not accomplish their intent?
• What measures might result in more harm than good?
• What reporting or process requirements could be changed to make for less duplication?
• If requirements cannot be eliminated, how can they be improved?

Due to hospitalist expertise in quality-improvement (QI) efforts and cost containment, these stated goals and the concerns that come with them are areas where hospitalists are likely to have some good answers. Hospitalists should not hesitate to provide their input to SHM Government Relations staff so that your ideas can be shared with CMS.

A complete list of agency proposals is available at www.whitehouse.gov/21stcentury gov/actions/21st-century-regulatory-system.

Fifteen years ago, Bob Wachter, MD, MHM, and Lee Goldman, MD, introduced hospital medicine and the term "hospitalist" to modern medicine in an article in the New England Journal of Medicine. In it, they wrote, "we anticipate the rapid growth of a new breed of physicians we call ‘hospitalists’—specialists in inpatient medicine—who will be responsible for managing the care of hospitalized patients in the same way that primary care physicians are responsible for managing the care of outpatients."

Since that introduction in 1996, the term "hospitalist" has gone from concept to cutting edge, and now to a title that describes more than 30,000 caregivers in hospitals around the world.

The evolution and growth of the hospitalist specialty owes much to Dr. Wachter. In addition to coining the term, he wrote the specialty’s first textbook, led SHM as president in 2000, and in 2010 was one of three HM pioneers honored by SHM as the first group of Masters in Hospital Medicine.

For each of the past three years, Modern Healthcare has listed him as one of healthcare’s most influential physician-executives.

Dr. Wachter used his recent presentation at HM11 to reflect on the growth of hospital medicine, where he showed how the specialty’s early focus on quality and safety puts hospitalists in positions of authority among physicians and hospitals.

Today, he is professor and associate chairman of the Department of Medicine at the University of California at San Francisco and chief of the division of hospital medicine, and chief of the medical service at UCSF Medical Center.

In July, Dr. Wachter was named chair-elect of the American Board of Internal Medicine’s (ABIM) board of directors.

Fifteen years ago, Bob Wachter, MD, MHM, and Lee Goldman, MD, introduced hospital medicine and the term "hospitalist" to modern medicine in an article in the New England Journal of Medicine. In it, they wrote, "we anticipate the rapid growth of a new breed of physicians we call ‘hospitalists’—specialists in inpatient medicine—who will be responsible for managing the care of hospitalized patients in the same way that primary care physicians are responsible for managing the care of outpatients."

Since that introduction in 1996, the term "hospitalist" has gone from concept to cutting edge, and now to a title that describes more than 30,000 caregivers in hospitals around the world.

The evolution and growth of the hospitalist specialty owes much to Dr. Wachter. In addition to coining the term, he wrote the specialty’s first textbook, led SHM as president in 2000, and in 2010 was one of three HM pioneers honored by SHM as the first group of Masters in Hospital Medicine.

For each of the past three years, Modern Healthcare has listed him as one of healthcare’s most influential physician-executives.

Dr. Wachter used his recent presentation at HM11 to reflect on the growth of hospital medicine, where he showed how the specialty’s early focus on quality and safety puts hospitalists in positions of authority among physicians and hospitals.

Today, he is professor and associate chairman of the Department of Medicine at the University of California at San Francisco and chief of the division of hospital medicine, and chief of the medical service at UCSF Medical Center.

In July, Dr. Wachter was named chair-elect of the American Board of Internal Medicine’s (ABIM) board of directors.

Fifteen years ago, Bob Wachter, MD, MHM, and Lee Goldman, MD, introduced hospital medicine and the term "hospitalist" to modern medicine in an article in the New England Journal of Medicine. In it, they wrote, "we anticipate the rapid growth of a new breed of physicians we call ‘hospitalists’—specialists in inpatient medicine—who will be responsible for managing the care of hospitalized patients in the same way that primary care physicians are responsible for managing the care of outpatients."

Since that introduction in 1996, the term "hospitalist" has gone from concept to cutting edge, and now to a title that describes more than 30,000 caregivers in hospitals around the world.

The evolution and growth of the hospitalist specialty owes much to Dr. Wachter. In addition to coining the term, he wrote the specialty’s first textbook, led SHM as president in 2000, and in 2010 was one of three HM pioneers honored by SHM as the first group of Masters in Hospital Medicine.

For each of the past three years, Modern Healthcare has listed him as one of healthcare’s most influential physician-executives.

Dr. Wachter used his recent presentation at HM11 to reflect on the growth of hospital medicine, where he showed how the specialty’s early focus on quality and safety puts hospitalists in positions of authority among physicians and hospitals.

Today, he is professor and associate chairman of the Department of Medicine at the University of California at San Francisco and chief of the division of hospital medicine, and chief of the medical service at UCSF Medical Center.

In July, Dr. Wachter was named chair-elect of the American Board of Internal Medicine’s (ABIM) board of directors.

Dr. Greeno

Cogent HMG has announced its new executive team and outside directors following the merger of Cogent Healthcare and Hospitalists Management Group (HMG). Gene Fleming, formerly president and CEO of Cogent Healthcare, will serve as executive chairman, assisting CEO Stephen Houff, MD, founder and CEO of Hospitalists Management Group. Ron Greeno, MD, a founder of Cogent Healthcare, will serve as chief medical officer of Cogent HMG and will steer the consulting business and serve as an advisor to the board. Antoine Agassi will serve as president and oversee day-to-day business operations. Linda Ellis will serve as COO, directing all regional and site operations.

Dr. Holman

Other key executives: Rusty Holman, MD, chief clinical officer; Susan Brownie, chief financial officer; Doug Mefford, chief legal officer; Anna-Gene O’Neal, senior vice president of quality; and Cheryl Slack, senior vice president of human resources. In addition to Fleming and Houff, Cogent HMG board members include Gary Chartrand, executive chairman of Acosta Sales and Marketing; Mike Leavitt, founder and chairman of Leavitt Partners and former U.S. Secretary of Health and Human Services; and Mark Neaman, president and CEO of NorthShore University HealthSystem.

Dr. Ellinger

The St. Anthony’s Hospital Foundation in St. Petersburg, Fla., has announced five new members of its board of directors: Emery Ellinger, CEO of the brokerage firm Aberdeen Advisors; Vitalis Unaeze, MD; Brian McNulty of USI Insurance Services; Angela Rouson, a St. Petersburg resident with a history of community service; and Dan Masi of Bright House Networks, a telecommunications company. Karim Godamunne, MD, has been promoted from medical director to vice president of clinical systems integration at Eagle Hospital Physicians in Atlanta.

Dr. Foxley

Dr. Godamunne won primary stroke center designation within eight months of adding a teleneurology program to an existing Eagle hospitalist program at South Fulton Medical Center in East Point, Ga. Caitlin B. Foxley, MD, has been elected hospital medicine service chief for the Nebraska Medical Center in Omaha. Dr. Foxley is a member of Team Hospitalist.

Cynthia Roldan, MD, director of Westminster, Md.-based Carroll Hospital Center’s pediatric hospitalist program, has been selected as the hospital’s June Physician of the Month. A physician affiliated with Carroll Hospital Center for four years, Roldan was nominated for exceptional patient care and education of new and expecting mothers.

Dr. Appenheimer

Dixon, Ill.-based Kath­erine Shaw Bethea Hospital has announced that hospitalist Tim Appenheimer, MD, has been promoted to vice president and CMO. The move is meant to address the growing focus on improving quality and patient safety across the country.

Dr. Greeno

Cogent HMG has announced its new executive team and outside directors following the merger of Cogent Healthcare and Hospitalists Management Group (HMG). Gene Fleming, formerly president and CEO of Cogent Healthcare, will serve as executive chairman, assisting CEO Stephen Houff, MD, founder and CEO of Hospitalists Management Group. Ron Greeno, MD, a founder of Cogent Healthcare, will serve as chief medical officer of Cogent HMG and will steer the consulting business and serve as an advisor to the board. Antoine Agassi will serve as president and oversee day-to-day business operations. Linda Ellis will serve as COO, directing all regional and site operations.

Dr. Holman

Other key executives: Rusty Holman, MD, chief clinical officer; Susan Brownie, chief financial officer; Doug Mefford, chief legal officer; Anna-Gene O’Neal, senior vice president of quality; and Cheryl Slack, senior vice president of human resources. In addition to Fleming and Houff, Cogent HMG board members include Gary Chartrand, executive chairman of Acosta Sales and Marketing; Mike Leavitt, founder and chairman of Leavitt Partners and former U.S. Secretary of Health and Human Services; and Mark Neaman, president and CEO of NorthShore University HealthSystem.

Dr. Ellinger

The St. Anthony’s Hospital Foundation in St. Petersburg, Fla., has announced five new members of its board of directors: Emery Ellinger, CEO of the brokerage firm Aberdeen Advisors; Vitalis Unaeze, MD; Brian McNulty of USI Insurance Services; Angela Rouson, a St. Petersburg resident with a history of community service; and Dan Masi of Bright House Networks, a telecommunications company. Karim Godamunne, MD, has been promoted from medical director to vice president of clinical systems integration at Eagle Hospital Physicians in Atlanta.

Dr. Foxley

Dr. Godamunne won primary stroke center designation within eight months of adding a teleneurology program to an existing Eagle hospitalist program at South Fulton Medical Center in East Point, Ga. Caitlin B. Foxley, MD, has been elected hospital medicine service chief for the Nebraska Medical Center in Omaha. Dr. Foxley is a member of Team Hospitalist.

Cynthia Roldan, MD, director of Westminster, Md.-based Carroll Hospital Center’s pediatric hospitalist program, has been selected as the hospital’s June Physician of the Month. A physician affiliated with Carroll Hospital Center for four years, Roldan was nominated for exceptional patient care and education of new and expecting mothers.

Dr. Appenheimer

Dixon, Ill.-based Kath­erine Shaw Bethea Hospital has announced that hospitalist Tim Appenheimer, MD, has been promoted to vice president and CMO. The move is meant to address the growing focus on improving quality and patient safety across the country.

Dr. Greeno

Cogent HMG has announced its new executive team and outside directors following the merger of Cogent Healthcare and Hospitalists Management Group (HMG). Gene Fleming, formerly president and CEO of Cogent Healthcare, will serve as executive chairman, assisting CEO Stephen Houff, MD, founder and CEO of Hospitalists Management Group. Ron Greeno, MD, a founder of Cogent Healthcare, will serve as chief medical officer of Cogent HMG and will steer the consulting business and serve as an advisor to the board. Antoine Agassi will serve as president and oversee day-to-day business operations. Linda Ellis will serve as COO, directing all regional and site operations.

Dr. Holman

Other key executives: Rusty Holman, MD, chief clinical officer; Susan Brownie, chief financial officer; Doug Mefford, chief legal officer; Anna-Gene O’Neal, senior vice president of quality; and Cheryl Slack, senior vice president of human resources. In addition to Fleming and Houff, Cogent HMG board members include Gary Chartrand, executive chairman of Acosta Sales and Marketing; Mike Leavitt, founder and chairman of Leavitt Partners and former U.S. Secretary of Health and Human Services; and Mark Neaman, president and CEO of NorthShore University HealthSystem.

Dr. Ellinger

The St. Anthony’s Hospital Foundation in St. Petersburg, Fla., has announced five new members of its board of directors: Emery Ellinger, CEO of the brokerage firm Aberdeen Advisors; Vitalis Unaeze, MD; Brian McNulty of USI Insurance Services; Angela Rouson, a St. Petersburg resident with a history of community service; and Dan Masi of Bright House Networks, a telecommunications company. Karim Godamunne, MD, has been promoted from medical director to vice president of clinical systems integration at Eagle Hospital Physicians in Atlanta.

Dr. Foxley

Dr. Godamunne won primary stroke center designation within eight months of adding a teleneurology program to an existing Eagle hospitalist program at South Fulton Medical Center in East Point, Ga. Caitlin B. Foxley, MD, has been elected hospital medicine service chief for the Nebraska Medical Center in Omaha. Dr. Foxley is a member of Team Hospitalist.

Cynthia Roldan, MD, director of Westminster, Md.-based Carroll Hospital Center’s pediatric hospitalist program, has been selected as the hospital’s June Physician of the Month. A physician affiliated with Carroll Hospital Center for four years, Roldan was nominated for exceptional patient care and education of new and expecting mothers.

Dr. Appenheimer

Dixon, Ill.-based Kath­erine Shaw Bethea Hospital has announced that hospitalist Tim Appenheimer, MD, has been promoted to vice president and CMO. The move is meant to address the growing focus on improving quality and patient safety across the country.

Starting a new, hospital-based quality-improvement (QI) program can be a lonely task for hospitalists. What can begin with a rush of enthusiasm to solve a critical problem on your hospital floor quickly can lead to a single hospitalist in front of a computer screen wondering, "Has anyone else ever done this before?"

Unlike clinical knowledge, most of which comes from years of specialized formal training and volumes of peer-reviewed evidence on procedures, starting QI programs often presents a special challenge: a blank page and limited access to those who’ve taken on similar projects.

Those challenges, and the need to better understand what other hospitalists have already tried, motivated SHM’s Center for Hospital Innovation & Improvement, also known as The Center, to develop SQUINT, a new user-generated online repository of hospital-based QI programs.

"Being asked to lead a quality-improvement project is a daunting and difficult task," says Andrew Dunn, MD, FACP, professor of medicine and acting chief for Mount Sinai School of Medicine’s hospital medicine division in New York City. "Getting ideas on methods that have worked elsewhere is a great way to start. SQUINT is an easy way for hospitalists to get a head start on a project rather than start from scratch."

Access to SQUINT (SHM’s QUality Improve-ment NeTwork) is free to SHM members. Log in and gain access to summaries of QI programs from around the country. Because the summaries are searchable based on type, size, location, and specific kinds of topics, hospitalists can quickly find out whether projects similar to theirs are available through SQUINT.

For instance, a user could search for projects specifically related to transitions of care during discharge at community hospitals with 200-299 beds; a user in Oklahoma could search for all QI projects that have been uploaded from hospitals in the Sooner State. SQUINT also affords users keyword searches and browsing options.

For Hasan F. Shabbir, MD, SFHM, chief quality officer at Emory Johns Creek Hospital and assistant professor of medicine for Emory University School of Medicine’s division of hospital medicine in Atlanta, the ability to search user-generated, user-posted project files is especially important. Dr. Shabbir is no stranger to starting a QI project cold, or poring through literature and searching the Internet, worried that the materials don’t always explain the outcomes of a QI project that can be found through Google.

"You may just find a PDF on the Web and not know if it was a success," he says. "What’s unique about SQUINT is that it gives you a product, describes how it was utilized, and describes how it was—or wasn’t—effective. A lot of the work that needs to be done doesn’t always achieve the intended result."

Understanding the pitfalls and challenges of QI programs can save time and effort, he explains. "It’s equally important," he says. "Typically, only the successful stuff gets published in journals."

One of the first projects shared via SQUINT is a case study in using local resources to improve transitions of care for diabetic patients, submitted by medical director Jordan Messler, MD, SFHM, and his colleagues at Morton Plant Hospital in Clearwater, Fla.

"This was a project that we have done that we were probably not going to publish, but came up with some neat process things that we can share," says Dr. Messler, who hopes his team’s progress could help others get started. "If just one other program finds it and it saves them some time, that would be great."

Uploading descriptions of the QI programs can take as little as 15 minutes. Once project details and supporting documents are loaded into SQUINT, submissions are reviewed by members of SHM’s Health Quality and Patient Safety committee for clarity, the involvement of multidisciplinary team members, presentation of details, and the description of impacts and barriers to success.

Dr. Messler found the process of uploading simple and easy to use. He plans to add more.

"We have a variety of programs that we’ll probably upload," he says, including other recent QI programs addressing diabetes and DVT. "There’s no harm in putting them up there."

Like other online user-submitted forums, submitting accepted content has added benefits: increased visibility among a community dedicated to improving the care of hospitalized patients and career advancement.

"This is a portal for you to spread what you’ve learned," Dr. Messler says. "Then, over time, this could be something that could be added to a resume or get to the point that folks will be proud of having a list of submissions to SQUINT."

For Dr. Shabbir, the utility of SQUINT extends beyond his own use.

"I have a junior colleague who is working on a new quality-improvement program. I’m going to tell her to look into SQUINT to see if others have worked on similar programs," he says. "If they have, that will put you two or three steps forward. For the novice, it also teaches the language and structure of how quality improvement happens."

Teaching and changing patient safety is a big part of SQUINT’s goal, according to Dr. Dunn.

"Hospitals should not need to start at ground zero, take months to get started and re-create every mistake made at other institutions," he says. "By sharing successful projects and learning from our errors, we can move patient safety initiatives along faster and better. … And that will, hopefully, improve outcomes across the country."

Brendon Shank is associate vice president of communications at SHM.

Starting a new, hospital-based quality-improvement (QI) program can be a lonely task for hospitalists. What can begin with a rush of enthusiasm to solve a critical problem on your hospital floor quickly can lead to a single hospitalist in front of a computer screen wondering, "Has anyone else ever done this before?"

Unlike clinical knowledge, most of which comes from years of specialized formal training and volumes of peer-reviewed evidence on procedures, starting QI programs often presents a special challenge: a blank page and limited access to those who’ve taken on similar projects.

Those challenges, and the need to better understand what other hospitalists have already tried, motivated SHM’s Center for Hospital Innovation & Improvement, also known as The Center, to develop SQUINT, a new user-generated online repository of hospital-based QI programs.

"Being asked to lead a quality-improvement project is a daunting and difficult task," says Andrew Dunn, MD, FACP, professor of medicine and acting chief for Mount Sinai School of Medicine’s hospital medicine division in New York City. "Getting ideas on methods that have worked elsewhere is a great way to start. SQUINT is an easy way for hospitalists to get a head start on a project rather than start from scratch."

Access to SQUINT (SHM’s QUality Improve-ment NeTwork) is free to SHM members. Log in and gain access to summaries of QI programs from around the country. Because the summaries are searchable based on type, size, location, and specific kinds of topics, hospitalists can quickly find out whether projects similar to theirs are available through SQUINT.

For instance, a user could search for projects specifically related to transitions of care during discharge at community hospitals with 200-299 beds; a user in Oklahoma could search for all QI projects that have been uploaded from hospitals in the Sooner State. SQUINT also affords users keyword searches and browsing options.

For Hasan F. Shabbir, MD, SFHM, chief quality officer at Emory Johns Creek Hospital and assistant professor of medicine for Emory University School of Medicine’s division of hospital medicine in Atlanta, the ability to search user-generated, user-posted project files is especially important. Dr. Shabbir is no stranger to starting a QI project cold, or poring through literature and searching the Internet, worried that the materials don’t always explain the outcomes of a QI project that can be found through Google.

"You may just find a PDF on the Web and not know if it was a success," he says. "What’s unique about SQUINT is that it gives you a product, describes how it was utilized, and describes how it was—or wasn’t—effective. A lot of the work that needs to be done doesn’t always achieve the intended result."

Understanding the pitfalls and challenges of QI programs can save time and effort, he explains. "It’s equally important," he says. "Typically, only the successful stuff gets published in journals."

One of the first projects shared via SQUINT is a case study in using local resources to improve transitions of care for diabetic patients, submitted by medical director Jordan Messler, MD, SFHM, and his colleagues at Morton Plant Hospital in Clearwater, Fla.

"This was a project that we have done that we were probably not going to publish, but came up with some neat process things that we can share," says Dr. Messler, who hopes his team’s progress could help others get started. "If just one other program finds it and it saves them some time, that would be great."

Uploading descriptions of the QI programs can take as little as 15 minutes. Once project details and supporting documents are loaded into SQUINT, submissions are reviewed by members of SHM’s Health Quality and Patient Safety committee for clarity, the involvement of multidisciplinary team members, presentation of details, and the description of impacts and barriers to success.

Dr. Messler found the process of uploading simple and easy to use. He plans to add more.

"We have a variety of programs that we’ll probably upload," he says, including other recent QI programs addressing diabetes and DVT. "There’s no harm in putting them up there."

Like other online user-submitted forums, submitting accepted content has added benefits: increased visibility among a community dedicated to improving the care of hospitalized patients and career advancement.

"This is a portal for you to spread what you’ve learned," Dr. Messler says. "Then, over time, this could be something that could be added to a resume or get to the point that folks will be proud of having a list of submissions to SQUINT."

For Dr. Shabbir, the utility of SQUINT extends beyond his own use.

"I have a junior colleague who is working on a new quality-improvement program. I’m going to tell her to look into SQUINT to see if others have worked on similar programs," he says. "If they have, that will put you two or three steps forward. For the novice, it also teaches the language and structure of how quality improvement happens."

Teaching and changing patient safety is a big part of SQUINT’s goal, according to Dr. Dunn.

"Hospitals should not need to start at ground zero, take months to get started and re-create every mistake made at other institutions," he says. "By sharing successful projects and learning from our errors, we can move patient safety initiatives along faster and better. … And that will, hopefully, improve outcomes across the country."

Brendon Shank is associate vice president of communications at SHM.

Starting a new, hospital-based quality-improvement (QI) program can be a lonely task for hospitalists. What can begin with a rush of enthusiasm to solve a critical problem on your hospital floor quickly can lead to a single hospitalist in front of a computer screen wondering, "Has anyone else ever done this before?"

Unlike clinical knowledge, most of which comes from years of specialized formal training and volumes of peer-reviewed evidence on procedures, starting QI programs often presents a special challenge: a blank page and limited access to those who’ve taken on similar projects.

Those challenges, and the need to better understand what other hospitalists have already tried, motivated SHM’s Center for Hospital Innovation & Improvement, also known as The Center, to develop SQUINT, a new user-generated online repository of hospital-based QI programs.

"Being asked to lead a quality-improvement project is a daunting and difficult task," says Andrew Dunn, MD, FACP, professor of medicine and acting chief for Mount Sinai School of Medicine’s hospital medicine division in New York City. "Getting ideas on methods that have worked elsewhere is a great way to start. SQUINT is an easy way for hospitalists to get a head start on a project rather than start from scratch."

Access to SQUINT (SHM’s QUality Improve-ment NeTwork) is free to SHM members. Log in and gain access to summaries of QI programs from around the country. Because the summaries are searchable based on type, size, location, and specific kinds of topics, hospitalists can quickly find out whether projects similar to theirs are available through SQUINT.

For instance, a user could search for projects specifically related to transitions of care during discharge at community hospitals with 200-299 beds; a user in Oklahoma could search for all QI projects that have been uploaded from hospitals in the Sooner State. SQUINT also affords users keyword searches and browsing options.

For Hasan F. Shabbir, MD, SFHM, chief quality officer at Emory Johns Creek Hospital and assistant professor of medicine for Emory University School of Medicine’s division of hospital medicine in Atlanta, the ability to search user-generated, user-posted project files is especially important. Dr. Shabbir is no stranger to starting a QI project cold, or poring through literature and searching the Internet, worried that the materials don’t always explain the outcomes of a QI project that can be found through Google.

"You may just find a PDF on the Web and not know if it was a success," he says. "What’s unique about SQUINT is that it gives you a product, describes how it was utilized, and describes how it was—or wasn’t—effective. A lot of the work that needs to be done doesn’t always achieve the intended result."

Understanding the pitfalls and challenges of QI programs can save time and effort, he explains. "It’s equally important," he says. "Typically, only the successful stuff gets published in journals."

One of the first projects shared via SQUINT is a case study in using local resources to improve transitions of care for diabetic patients, submitted by medical director Jordan Messler, MD, SFHM, and his colleagues at Morton Plant Hospital in Clearwater, Fla.

"This was a project that we have done that we were probably not going to publish, but came up with some neat process things that we can share," says Dr. Messler, who hopes his team’s progress could help others get started. "If just one other program finds it and it saves them some time, that would be great."

Uploading descriptions of the QI programs can take as little as 15 minutes. Once project details and supporting documents are loaded into SQUINT, submissions are reviewed by members of SHM’s Health Quality and Patient Safety committee for clarity, the involvement of multidisciplinary team members, presentation of details, and the description of impacts and barriers to success.

Dr. Messler found the process of uploading simple and easy to use. He plans to add more.

"We have a variety of programs that we’ll probably upload," he says, including other recent QI programs addressing diabetes and DVT. "There’s no harm in putting them up there."

Like other online user-submitted forums, submitting accepted content has added benefits: increased visibility among a community dedicated to improving the care of hospitalized patients and career advancement.

"This is a portal for you to spread what you’ve learned," Dr. Messler says. "Then, over time, this could be something that could be added to a resume or get to the point that folks will be proud of having a list of submissions to SQUINT."

For Dr. Shabbir, the utility of SQUINT extends beyond his own use.

"I have a junior colleague who is working on a new quality-improvement program. I’m going to tell her to look into SQUINT to see if others have worked on similar programs," he says. "If they have, that will put you two or three steps forward. For the novice, it also teaches the language and structure of how quality improvement happens."

Teaching and changing patient safety is a big part of SQUINT’s goal, according to Dr. Dunn.

"Hospitals should not need to start at ground zero, take months to get started and re-create every mistake made at other institutions," he says. "By sharing successful projects and learning from our errors, we can move patient safety initiatives along faster and better. … And that will, hopefully, improve outcomes across the country."

Brendon Shank is associate vice president of communications at SHM.

Your article "NPPs to the Rescue" (May 2011, p. 24) contained one statement that is at strong variance with our experience: All your interviewees are said to agree that a 1:1 ratio of physicians to NPPs is optimally efficient and that "having one NPP work with more than one physician is not sustainable."

My group has used nonphysician providers (NPPs) for 13 years with great success and excellent retention, physician and patient satisfaction, and quality of care. We have presented nationally on the subject. We have always resisted the formation of separate "teams," and our system involves all 15 NPPs in our largest program working serially with all 35 physicians. This maximizes flexibility and helps to standardize and make uniform our practice styles and clinical methods. Also, it promotes a maximally flexible schedule, which we have found is a key to provider satisfaction.

Important to our system is a strong training program for new NPP hires, which allows them to function eventually with a good deal of autonomy. Also embedded in our culture is the notion that physicians and NPPs are both valued team members, and that NPPs are not asked to do work that physicians are unwilling to do. In fact, we tell providers that what physicians find satisfying and gratifying in practice are the same as those that NPPs look for, and that a strong collaborative relationship helps everyone benefit the patient. While it is clear that physicians are the clinical supervisors, NPPs and physicians are on an equal footing in many nonclinical areas of group management.

Another important piece of our system is that all billing is done by the attending physician. Thus, physicians are highly incented to work with NPPs, to seek cases on which they can collaborate, and to maintain cordial relations with their nonphysician associates.

This approach has resulted in an enormously capable clinical team and a high rate of provider retention and satisfaction.

As I heard a number of times at HM11 in Dallas in May, "If you’ve seen one hospitalist program, you’ve seen one hospitalist program." The same applies to optimal utilization of hospitalist NPPs.

Your article "NPPs to the Rescue" (May 2011, p. 24) contained one statement that is at strong variance with our experience: All your interviewees are said to agree that a 1:1 ratio of physicians to NPPs is optimally efficient and that "having one NPP work with more than one physician is not sustainable."

My group has used nonphysician providers (NPPs) for 13 years with great success and excellent retention, physician and patient satisfaction, and quality of care. We have presented nationally on the subject. We have always resisted the formation of separate "teams," and our system involves all 15 NPPs in our largest program working serially with all 35 physicians. This maximizes flexibility and helps to standardize and make uniform our practice styles and clinical methods. Also, it promotes a maximally flexible schedule, which we have found is a key to provider satisfaction.

Important to our system is a strong training program for new NPP hires, which allows them to function eventually with a good deal of autonomy. Also embedded in our culture is the notion that physicians and NPPs are both valued team members, and that NPPs are not asked to do work that physicians are unwilling to do. In fact, we tell providers that what physicians find satisfying and gratifying in practice are the same as those that NPPs look for, and that a strong collaborative relationship helps everyone benefit the patient. While it is clear that physicians are the clinical supervisors, NPPs and physicians are on an equal footing in many nonclinical areas of group management.

Another important piece of our system is that all billing is done by the attending physician. Thus, physicians are highly incented to work with NPPs, to seek cases on which they can collaborate, and to maintain cordial relations with their nonphysician associates.

This approach has resulted in an enormously capable clinical team and a high rate of provider retention and satisfaction.

As I heard a number of times at HM11 in Dallas in May, "If you’ve seen one hospitalist program, you’ve seen one hospitalist program." The same applies to optimal utilization of hospitalist NPPs.

Your article "NPPs to the Rescue" (May 2011, p. 24) contained one statement that is at strong variance with our experience: All your interviewees are said to agree that a 1:1 ratio of physicians to NPPs is optimally efficient and that "having one NPP work with more than one physician is not sustainable."

My group has used nonphysician providers (NPPs) for 13 years with great success and excellent retention, physician and patient satisfaction, and quality of care. We have presented nationally on the subject. We have always resisted the formation of separate "teams," and our system involves all 15 NPPs in our largest program working serially with all 35 physicians. This maximizes flexibility and helps to standardize and make uniform our practice styles and clinical methods. Also, it promotes a maximally flexible schedule, which we have found is a key to provider satisfaction.

Important to our system is a strong training program for new NPP hires, which allows them to function eventually with a good deal of autonomy. Also embedded in our culture is the notion that physicians and NPPs are both valued team members, and that NPPs are not asked to do work that physicians are unwilling to do. In fact, we tell providers that what physicians find satisfying and gratifying in practice are the same as those that NPPs look for, and that a strong collaborative relationship helps everyone benefit the patient. While it is clear that physicians are the clinical supervisors, NPPs and physicians are on an equal footing in many nonclinical areas of group management.

Another important piece of our system is that all billing is done by the attending physician. Thus, physicians are highly incented to work with NPPs, to seek cases on which they can collaborate, and to maintain cordial relations with their nonphysician associates.

This approach has resulted in an enormously capable clinical team and a high rate of provider retention and satisfaction.

As I heard a number of times at HM11 in Dallas in May, "If you’ve seen one hospitalist program, you’ve seen one hospitalist program." The same applies to optimal utilization of hospitalist NPPs.

One hospitalist-led pilot project produced a 61% decrease in heart failure readmission rates. Another resulted in a 33% drop in all-cause readmissions. The numbers might be impressive, but what do they really say about how hospitalists have influenced healthcare quality?

When HM emerged 15 years ago, advocates pitched the fledgling physician specialty as a model of efficient inpatient care, and subsequent findings that the concept led to reductions in length of stay encouraged more hospitals to bolster their staff with the newcomers. With a rising emphasis on quality and patient safety over the past decade, and the new era of pay-for-performance, the hospitalist model of care has expanded to embrace improved quality of care as a chief selling point.

Measuring quality is no easy task, however, and researchers still debate the relative merits of metrics like 30-day readmission rates and inpatient mortality. "Without question, quality measurement is an imperfect science, and all measures will contain some level of imprecision and bias," concluded a recent commentary in Health Affairs.¹

Against that backdrop, relatively few studies have looked broadly at the contributions of hospital medicine. Most interventions have been individually tailored to a hospital or instituted at only a few sites, precluding large-scale, head-to-head comparisons.

And so the question remains: Has hospital medicine lived up to its promise on quality?

The Evidence

In one of the few national surveys of HM’s impact on patient care, a yearlong comparison of more than 3,600 hospitals found that the roughly 40% that employed hospitalists scored better on multiple Hospital Quality Alliance indicators. The 2009 Archives of Internal Medicine study suggested that hospitals with hospitalists outperformed their counterparts in quality metrics for acute myocardial infarction, pneumonia, overall disease treatment and diagnosis, and counseling and prevention. Congestive heart failure was the only category of the five reviewed that lacked a statistically significant difference.²

A separate editorial, however, argued that the study’s data were not persuasive enough to support the conclusion that hospitalists bring a higher quality of care to the table.³ And even less can be said about the national impact of HM on newly elevated metrics, such as readmission rates. The obligation to gather evidence, in fact, is largely falling upon hospitalists themselves, and the multitude of research abstracts from SHM’s annual meeting in May suggests that plenty of physician scientists are taking the responsibility seriously. Among the presentations, a study led by David Boyte, MD, assistant professor of medicine at Duke University and a hospitalist at Durham Regional Hospital, found that a multidisciplinary approach greatly improved one hospital unit’s 30-day readmission rates for heart failure patients. After a three-month pilot in the cardiac nursing unit, readmission rates fell to 10.7% from 27.6%.⁴

Although the multidisciplinary effort has included doctors, nurses, nutritionists, pharmacists, unit managers, and other personnel, Dr. Boyte says the involvement of hospitalists has been key to the project’s success. "We feel like we were the main participants who could see the whole picture from a patient-centered perspective," he says. "We were the glue; we were the center node of all the healthcare providers." Based on that dramatic improvement, Dr. Boyte says, the same interventional protocol has been rolled out in three other medical surgical units, and the hospital is using a similar approach to address AMI readmission rates.

Listen to Dr. Vaidyan

SHM’s Project BOOST (Better Outcomes for Older Adults through Safe Transitions; www.hospitalmedicine.org/boost )—by far the largest study of how HM is impacting readmission rates—has amassed data from more than 20 hospitals, with more expected from a growing roster of participants. So far, however, the project has only released data from six pilot sites describing the six-month periods before and after the project’s start. Among those sites, initial results suggest that readmission rates fell by an average of more than 20%, to 11.2% from 14.2%.⁵

Though the early numbers are encouraging, experts say rates from a larger group of participants at the one-year mark will be more telling, as will direct comparisons between BOOST units and nonparticipating counterparts at the same hospitals. Principal investigator Mark Williams, MD, FHM, professor and chief of the division of hospital medicine at the Northwestern University Feinberg School of Medicine in Chicago, says researchers still need to clean up that data before they’re ready to share it publicly.

In the meantime, some individual BOOST case studies are suggesting that hospitalist-led changes could pay big dividends. To help create cohesiveness and a sense of ownership within its HM program, St. Mary’s Health Center in St. Louis started a 20-bed hospitalist unit in 2008. Philip Vaidyan, MD, FACP, head of the hospitalist program and practice group leader for IPC: The Hospitalist Company at St. Mary’s, says one unit, 3 West, has since functioned as a lab for testing new ideas that are then introduced hospitalwide.

One early change was to bring all of the unit’s care providers together, from doctors and nurses to the unit-based case manager and social worker, for 9 a.m. handoff meetings. "We have this collective brain to find unique solutions," Dr. Vaidyan says. After seeing positive trends on length of stay, 30-day readmission rates, and patient satisfaction scores, St. Mary’s upgraded to a 32-bed hospitalist unit in early 2009. That same year, the 525-bed community teaching hospital was accepted into the BOOST program.

Listen to Dr. Vaidyan

The hospitalist unit’s improved quality scores continued under BOOST, leading to a 33% reduction in readmission rates from 2008 to 2010 (to 10.5% from 15.7%). Rates for a nonhospitalist unit, by contrast, hovered around 17%. "For reducing readmissions, people may think that you have to have a higher length of stay," Dr. Vaidyan says. But the unit trended toward a lower length of stay, in addition to its reduced 30-day readmissions and improved patient satisfaction scores.

Dr. Singh

Flush with success, the 10 physicians and four nurse practitioners in the hospitalist program have since begun spreading their best practices to the rest of the hospital units. "Hospitalists are in the best ‘sweet spot,’ " Dr. Vaidyan says, "partnering with all of the disciplines, bringing them together, and keeping everybody on the same page."

Ironically, pinpointing the contribution of hospitalists is harder when their changes produce an ecological effect throughout an entire institution, says Siddhartha Singh, MD, MS, associate chief medical officer of Medical College Physicians, the adult practice for Medical College of Wisconsin in Milwaukee. Even so, he stresses that the impact of the two dozen hospitalists at Medical College Physicians has been felt.

Listen to Dr. Vaidyan

"Coinciding with and following the introduction of our hospitalist program in 2004, we have noticed dramatic decreases in our length of stay throughout medicine services," he says. The same has held true for inpatient mortality. "And that, we feel, is attributable to the standardization of processes introduced by the hospitalist group." Multidisciplinary rounds; whiteboards in patient rooms; and standardized admission orders, prophylactic treatments, and discharge processes—"all of this would’ve been impossible, absolutely impossible, without the hospitalist," he says.

Over the past decade, Dr. Singh’s assessment has been echoed by several studies suggesting that individual hospitalist programs have brought significant improvements in quality measures, such as complication rates and inpatient mortality. In 2002, for example, Andrew Auerbach, MD, MPH, at the University of California San Francisco Medical Center, led a study that compared HM care with that of community physicians in a community-based teaching hospital. Patients cared for by hospitalists, the study found, had a lower risk of death during the hospitalization, as well as at 30 days and 60 days after discharge.⁶

Dr. Kripalani

A separate report by David Meltzer, MD, PhD, and colleagues at the University of Chicago found that an HM program in an academic general medicine service led to a 30% reduction in 30-day mortality rates during its second year of operation.⁷ And a 2004 study led by Jeanne Huddleston, MD, at the Mayo Clinic College of Medicine in Rochester, Minn., found that a hospitalist-orthopedic co-management model (versus care by orthopedic surgeons with medical consultation) led to more patients being discharged with no complications after elective hip or knee surgery.⁸ Hospitalist co-management also reduced the rate of minor complications, but had no effect on actual length of stay or cost.

A subsequent study by the same group, however, documented improved efficiency of care through the HM model, but no effect on the mortality of hip fracture patients up to one year after discharge.⁹ Multiple studies of hospitalist programs, in fact, have seen increased efficiency but little or no impact on inpatient mortality, leading researchers to broadly conclude that such programs can decrease resource use without compromising quality.

In 2007, a retrospective study of nearly 77,000 patients admitted to 45 hospitals with one of seven common diagnoses compared the care delivered by hospitalists, general internists, and family physicians.¹⁰ Although the study authors found that hospitalist care yielded a small drop in length of stay, they saw no difference in the inpatient mortality rates or 14-day readmission rates. More recently, mortality has become ensnared in controversy over its reliability as an accurate indicator of quality.

When we sit on committees, people often look to us for answers and directions because they know we’re on the front lines and we’ve interfaced with all of the services in the hospital. You have a good view of the whole hospital operation from A to Z, and I think that’s pretty unique to hospitalists.

-Shai Gavi, DO, MPH, chief, section of hospital medicine, assistant professor, Stony Brook University School of Medicine, Brookhaven, N.Y.

Half of the Equation

Despite a lack of ideal metrics, another promising sign for HM might be the model’s exportability. Lee Kheng Hock, MMed, senior consultant and head of the Department of Family Medicine and Continuing Care at Singapore General Hospital, says the 1,600-bed hospital began experimenting with the hospitalist model when officials realized the existing care system wasn’t sustainable. Amid an aging population and increasingly complex and fragmented care, Hock views the hospitalist movement as a natural evolution of the healthcare system to meet the needs of a changing environment.

In a recent study, Hock and his colleagues used the hospital’s administrative database to examine the resource use and outcomes of patients cared for in 2008 by family medicine hospitalists or by specialists.¹¹ The comparison, based on several standard metrics, found no significant improvements in quality, with similar inpatient mortality rates and 30-day, all-cause, unscheduled readmission rates regardless of the care delivery method. The study, though, revealed a significantly shorter hospital stay (4.4 days vs. 5.3 days) and lower costs per patient for those cared for by hospitalists ($2,250 vs. $2,500).¹¹

Hock points out that, like his study, most analyses of hospitalist programs have shown an improvement in length of stay and cost of care without any increase in mortality and morbidity. If value equals quality divided by cost, he says, it stands to reason that quality must increase as overall value remains the same but costs decrease.

"The main difference is that the patients received undivided attention from a well-rounded generalist physician who is focused on providing holistic general medical care," Hock says, adding that "it is really a no-brainer that the outcome would be different."

Listen to Dr. Vaidyan

Patients Rule

Other measures like the effectiveness of communication and seamlessness of handoffs often are assessed through their impacts on patient outcomes. But Sunil Kripalani, MD, MSc, SFHM, chief of the section of hospital medicine and an associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn., says communication is now a primary focal point in Medicare’s new hospital value-based purchasing program (VBP). Within VBP’s Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) component, worth 30% of a hospital’s sum score, four of the 10 survey-based measures deal directly with communication. Patients’ overall rating and recommendation of hospitals likely will reflect their satisfaction with communication as well. Dr. Kripalani says it’s inevitable that hospitals—and hospitalists—will pay more attention to communication ratings as patients become judges of quality.

The expertise of hospitalists in handling challenging patients also leads to improved quality over time, says Shai Gavi, DO, MPH, chief of the section of hospital medicine and assistant professor of clinical medicine at Stony Brook University School of Medicine in Brookhaven, N.Y. Hospitalists, he says, excel in handling such high-stakes medical issues as gastrointestinal bleeding, pancreatitis, sepsis, and pain management that can quickly impact patient outcomes if not addressed properly and proficiently. "I think there’s significant value to having people who do this on a pretty frequent basis," he says.

And because of their broad day-to-day interactions, Dr. Gavi says, hospitalists are natural choices for committees focused on improving quality. "When we sit on committees, people often look to us for answers and directions because they know we’re on the front lines and we’ve interfaced with all of the services in the hospital," he says. "You have a good view of the whole hospital operation from A to Z, and I think that’s pretty unique to hospitalists."

The Verdict

In a recent issue brief by Lisa Sprague, principal policy analyst at the National Health Policy Forum, she asserts, "Hospitalists have the undeniable advantage of being there when a crisis occurs, when a patient is ready for discharge, and so on."¹²

So is "being there" the defining concept of hospital medicine, as she subsequently suggests?

Based on both scientific and anecdotal evidence, the contribution of hospitalists to healthcare quality might be better summarized as "being involved." Whether as innovators, navigators, physician champions, the "sweet spot" of interdepartmental partnerships, the "glue" of multidisciplinary teams, or the nuclei of performance committees, hospitalists are increasingly described as being in the middle of efforts to improve quality. On this basis, the discipline appears to be living up to expectations, though experts say more research is needed to better assess the impacts of HM on quality.

Dr. Vaidyan says hospitalists are particularly well positioned to understand what constitutes ideal care from the perspective of patients. "They want to be treated well: That’s patient satisfaction," he says. "They want to have their chief complaint—why they came to the hospital—properly addressed, so you need a coordinated care team. They want to go home early and don’t want come back: That’s low length of stay and a reduction in 30-day readmissions. And they don’t want any hospital-acquired complications."

Treating patients better, then, should be reflected by improved quality, even if the participation of hospitalists cannot be precisely quantified. "Being involved is something that may be difficult to measure," Dr. Gavi says, "but nonetheless, it has an important impact." TH

Bryn Nelson is a medical writer based in Seattle.

References

1. Pronovost PJ, Lilford R. Analysis & commentary: A roadmap for improving the performance of performance measures. Health Aff (Millwood). 2011;30(4):569-73.
2. López L, Hicks LS, Cohen AP, McKean S, Weissman JS. Hospitalists and the quality of care in hospitals. Arch Intern Med. 2009;169(15):1389-1394.
3. Centor RM, Taylor BB. Do hospitalists improve quality? Arch Intern Med. 2009;169(15):1351-1352.
4. Boyte D, Verma L, Wightman M. A multidisciplinary approach to reducing heart failure readmissions. J Hosp Med. 2011;6(4)Supp 2:S14.
5. Williams MV, Hansen L, Greenwald J, Howell E, et al. BOOST: impact of a quality improvement project to reduce rehospitalizations. J Hosp Med. 2011;6(4) Supp 2:S88. BOOST: impact of a quality improvement project to reduce rehospitalizations.
6. Auerbach AD, Wachter RM, Katz P, Showstack J, Baron RB, Goldman L. Implementation of a voluntary hospitalist service at a community teaching hospital: improved clinical efficiency and patient outcomes. Ann Intern Med. 2002;137(11):859-865.
7. Meltzer D, Manning WG, Morrison J, et al. Effects of physician experience on costs and outcomes on an academic general medicine service: results of a trial of hospitalists. Ann Intern Med. 2002;137(1):866-874.
8. Huddleston JM, Hall K, Naessens JM, et al. Medical and surgical comanagement after elective hip and knee arthroplasty. Ann Intern Med. 2004;141(1):28-38.
9. Batsis JA, Phy MP, Melton LJ, et al. Effects of a hospitalist care model on mortality of elderly patients with hip fractures. J Hosp Med. 2007;2(4): 219–225.
10. Lindenauer PK, Rothberg MB, Pekow PS, et al. Outcomes of care by hospitalists, general internists, and family physicians. N Eng J Med. 2007;357:2589-2600.
11. Hock Lee K, Yang Y, Soong Yang K, Chi Ong B, Seong Ng H. Bringing generalists into the hospital: outcomes of a family medicine hospitalist model in Singapore. J Hosp Med. 2011;6(3):115-121.
12. Sprague L. The hospitalist: better value in inpatient care? National Health Policy Forum website. Available at: www.nhpf.org/library/issue-briefs/IB842_Hospitalist_03-30-11.pdf. Accessed June 28, 2011.

One hospitalist-led pilot project produced a 61% decrease in heart failure readmission rates. Another resulted in a 33% drop in all-cause readmissions. The numbers might be impressive, but what do they really say about how hospitalists have influenced healthcare quality?

When HM emerged 15 years ago, advocates pitched the fledgling physician specialty as a model of efficient inpatient care, and subsequent findings that the concept led to reductions in length of stay encouraged more hospitals to bolster their staff with the newcomers. With a rising emphasis on quality and patient safety over the past decade, and the new era of pay-for-performance, the hospitalist model of care has expanded to embrace improved quality of care as a chief selling point.

Measuring quality is no easy task, however, and researchers still debate the relative merits of metrics like 30-day readmission rates and inpatient mortality. "Without question, quality measurement is an imperfect science, and all measures will contain some level of imprecision and bias," concluded a recent commentary in Health Affairs.¹

Against that backdrop, relatively few studies have looked broadly at the contributions of hospital medicine. Most interventions have been individually tailored to a hospital or instituted at only a few sites, precluding large-scale, head-to-head comparisons.

And so the question remains: Has hospital medicine lived up to its promise on quality?

The Evidence

In one of the few national surveys of HM’s impact on patient care, a yearlong comparison of more than 3,600 hospitals found that the roughly 40% that employed hospitalists scored better on multiple Hospital Quality Alliance indicators. The 2009 Archives of Internal Medicine study suggested that hospitals with hospitalists outperformed their counterparts in quality metrics for acute myocardial infarction, pneumonia, overall disease treatment and diagnosis, and counseling and prevention. Congestive heart failure was the only category of the five reviewed that lacked a statistically significant difference.²

A separate editorial, however, argued that the study’s data were not persuasive enough to support the conclusion that hospitalists bring a higher quality of care to the table.³ And even less can be said about the national impact of HM on newly elevated metrics, such as readmission rates. The obligation to gather evidence, in fact, is largely falling upon hospitalists themselves, and the multitude of research abstracts from SHM’s annual meeting in May suggests that plenty of physician scientists are taking the responsibility seriously. Among the presentations, a study led by David Boyte, MD, assistant professor of medicine at Duke University and a hospitalist at Durham Regional Hospital, found that a multidisciplinary approach greatly improved one hospital unit’s 30-day readmission rates for heart failure patients. After a three-month pilot in the cardiac nursing unit, readmission rates fell to 10.7% from 27.6%.⁴

Although the multidisciplinary effort has included doctors, nurses, nutritionists, pharmacists, unit managers, and other personnel, Dr. Boyte says the involvement of hospitalists has been key to the project’s success. "We feel like we were the main participants who could see the whole picture from a patient-centered perspective," he says. "We were the glue; we were the center node of all the healthcare providers." Based on that dramatic improvement, Dr. Boyte says, the same interventional protocol has been rolled out in three other medical surgical units, and the hospital is using a similar approach to address AMI readmission rates.

Listen to Dr. Vaidyan

SHM’s Project BOOST (Better Outcomes for Older Adults through Safe Transitions; www.hospitalmedicine.org/boost )—by far the largest study of how HM is impacting readmission rates—has amassed data from more than 20 hospitals, with more expected from a growing roster of participants. So far, however, the project has only released data from six pilot sites describing the six-month periods before and after the project’s start. Among those sites, initial results suggest that readmission rates fell by an average of more than 20%, to 11.2% from 14.2%.⁵

Though the early numbers are encouraging, experts say rates from a larger group of participants at the one-year mark will be more telling, as will direct comparisons between BOOST units and nonparticipating counterparts at the same hospitals. Principal investigator Mark Williams, MD, FHM, professor and chief of the division of hospital medicine at the Northwestern University Feinberg School of Medicine in Chicago, says researchers still need to clean up that data before they’re ready to share it publicly.

In the meantime, some individual BOOST case studies are suggesting that hospitalist-led changes could pay big dividends. To help create cohesiveness and a sense of ownership within its HM program, St. Mary’s Health Center in St. Louis started a 20-bed hospitalist unit in 2008. Philip Vaidyan, MD, FACP, head of the hospitalist program and practice group leader for IPC: The Hospitalist Company at St. Mary’s, says one unit, 3 West, has since functioned as a lab for testing new ideas that are then introduced hospitalwide.

One early change was to bring all of the unit’s care providers together, from doctors and nurses to the unit-based case manager and social worker, for 9 a.m. handoff meetings. "We have this collective brain to find unique solutions," Dr. Vaidyan says. After seeing positive trends on length of stay, 30-day readmission rates, and patient satisfaction scores, St. Mary’s upgraded to a 32-bed hospitalist unit in early 2009. That same year, the 525-bed community teaching hospital was accepted into the BOOST program.

Listen to Dr. Vaidyan

The hospitalist unit’s improved quality scores continued under BOOST, leading to a 33% reduction in readmission rates from 2008 to 2010 (to 10.5% from 15.7%). Rates for a nonhospitalist unit, by contrast, hovered around 17%. "For reducing readmissions, people may think that you have to have a higher length of stay," Dr. Vaidyan says. But the unit trended toward a lower length of stay, in addition to its reduced 30-day readmissions and improved patient satisfaction scores.

Dr. Singh

Flush with success, the 10 physicians and four nurse practitioners in the hospitalist program have since begun spreading their best practices to the rest of the hospital units. "Hospitalists are in the best ‘sweet spot,’ " Dr. Vaidyan says, "partnering with all of the disciplines, bringing them together, and keeping everybody on the same page."

Ironically, pinpointing the contribution of hospitalists is harder when their changes produce an ecological effect throughout an entire institution, says Siddhartha Singh, MD, MS, associate chief medical officer of Medical College Physicians, the adult practice for Medical College of Wisconsin in Milwaukee. Even so, he stresses that the impact of the two dozen hospitalists at Medical College Physicians has been felt.

Listen to Dr. Vaidyan

"Coinciding with and following the introduction of our hospitalist program in 2004, we have noticed dramatic decreases in our length of stay throughout medicine services," he says. The same has held true for inpatient mortality. "And that, we feel, is attributable to the standardization of processes introduced by the hospitalist group." Multidisciplinary rounds; whiteboards in patient rooms; and standardized admission orders, prophylactic treatments, and discharge processes—"all of this would’ve been impossible, absolutely impossible, without the hospitalist," he says.

Over the past decade, Dr. Singh’s assessment has been echoed by several studies suggesting that individual hospitalist programs have brought significant improvements in quality measures, such as complication rates and inpatient mortality. In 2002, for example, Andrew Auerbach, MD, MPH, at the University of California San Francisco Medical Center, led a study that compared HM care with that of community physicians in a community-based teaching hospital. Patients cared for by hospitalists, the study found, had a lower risk of death during the hospitalization, as well as at 30 days and 60 days after discharge.⁶

Dr. Kripalani

A separate report by David Meltzer, MD, PhD, and colleagues at the University of Chicago found that an HM program in an academic general medicine service led to a 30% reduction in 30-day mortality rates during its second year of operation.⁷ And a 2004 study led by Jeanne Huddleston, MD, at the Mayo Clinic College of Medicine in Rochester, Minn., found that a hospitalist-orthopedic co-management model (versus care by orthopedic surgeons with medical consultation) led to more patients being discharged with no complications after elective hip or knee surgery.⁸ Hospitalist co-management also reduced the rate of minor complications, but had no effect on actual length of stay or cost.

A subsequent study by the same group, however, documented improved efficiency of care through the HM model, but no effect on the mortality of hip fracture patients up to one year after discharge.⁹ Multiple studies of hospitalist programs, in fact, have seen increased efficiency but little or no impact on inpatient mortality, leading researchers to broadly conclude that such programs can decrease resource use without compromising quality.

In 2007, a retrospective study of nearly 77,000 patients admitted to 45 hospitals with one of seven common diagnoses compared the care delivered by hospitalists, general internists, and family physicians.¹⁰ Although the study authors found that hospitalist care yielded a small drop in length of stay, they saw no difference in the inpatient mortality rates or 14-day readmission rates. More recently, mortality has become ensnared in controversy over its reliability as an accurate indicator of quality.

When we sit on committees, people often look to us for answers and directions because they know we’re on the front lines and we’ve interfaced with all of the services in the hospital. You have a good view of the whole hospital operation from A to Z, and I think that’s pretty unique to hospitalists.

-Shai Gavi, DO, MPH, chief, section of hospital medicine, assistant professor, Stony Brook University School of Medicine, Brookhaven, N.Y.

Half of the Equation

Despite a lack of ideal metrics, another promising sign for HM might be the model’s exportability. Lee Kheng Hock, MMed, senior consultant and head of the Department of Family Medicine and Continuing Care at Singapore General Hospital, says the 1,600-bed hospital began experimenting with the hospitalist model when officials realized the existing care system wasn’t sustainable. Amid an aging population and increasingly complex and fragmented care, Hock views the hospitalist movement as a natural evolution of the healthcare system to meet the needs of a changing environment.

In a recent study, Hock and his colleagues used the hospital’s administrative database to examine the resource use and outcomes of patients cared for in 2008 by family medicine hospitalists or by specialists.¹¹ The comparison, based on several standard metrics, found no significant improvements in quality, with similar inpatient mortality rates and 30-day, all-cause, unscheduled readmission rates regardless of the care delivery method. The study, though, revealed a significantly shorter hospital stay (4.4 days vs. 5.3 days) and lower costs per patient for those cared for by hospitalists ($2,250 vs. $2,500).¹¹

Hock points out that, like his study, most analyses of hospitalist programs have shown an improvement in length of stay and cost of care without any increase in mortality and morbidity. If value equals quality divided by cost, he says, it stands to reason that quality must increase as overall value remains the same but costs decrease.

"The main difference is that the patients received undivided attention from a well-rounded generalist physician who is focused on providing holistic general medical care," Hock says, adding that "it is really a no-brainer that the outcome would be different."

Listen to Dr. Vaidyan

Patients Rule

Other measures like the effectiveness of communication and seamlessness of handoffs often are assessed through their impacts on patient outcomes. But Sunil Kripalani, MD, MSc, SFHM, chief of the section of hospital medicine and an associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn., says communication is now a primary focal point in Medicare’s new hospital value-based purchasing program (VBP). Within VBP’s Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) component, worth 30% of a hospital’s sum score, four of the 10 survey-based measures deal directly with communication. Patients’ overall rating and recommendation of hospitals likely will reflect their satisfaction with communication as well. Dr. Kripalani says it’s inevitable that hospitals—and hospitalists—will pay more attention to communication ratings as patients become judges of quality.

The expertise of hospitalists in handling challenging patients also leads to improved quality over time, says Shai Gavi, DO, MPH, chief of the section of hospital medicine and assistant professor of clinical medicine at Stony Brook University School of Medicine in Brookhaven, N.Y. Hospitalists, he says, excel in handling such high-stakes medical issues as gastrointestinal bleeding, pancreatitis, sepsis, and pain management that can quickly impact patient outcomes if not addressed properly and proficiently. "I think there’s significant value to having people who do this on a pretty frequent basis," he says.

And because of their broad day-to-day interactions, Dr. Gavi says, hospitalists are natural choices for committees focused on improving quality. "When we sit on committees, people often look to us for answers and directions because they know we’re on the front lines and we’ve interfaced with all of the services in the hospital," he says. "You have a good view of the whole hospital operation from A to Z, and I think that’s pretty unique to hospitalists."

The Verdict

In a recent issue brief by Lisa Sprague, principal policy analyst at the National Health Policy Forum, she asserts, "Hospitalists have the undeniable advantage of being there when a crisis occurs, when a patient is ready for discharge, and so on."¹²

So is "being there" the defining concept of hospital medicine, as she subsequently suggests?

Based on both scientific and anecdotal evidence, the contribution of hospitalists to healthcare quality might be better summarized as "being involved." Whether as innovators, navigators, physician champions, the "sweet spot" of interdepartmental partnerships, the "glue" of multidisciplinary teams, or the nuclei of performance committees, hospitalists are increasingly described as being in the middle of efforts to improve quality. On this basis, the discipline appears to be living up to expectations, though experts say more research is needed to better assess the impacts of HM on quality.

Dr. Vaidyan says hospitalists are particularly well positioned to understand what constitutes ideal care from the perspective of patients. "They want to be treated well: That’s patient satisfaction," he says. "They want to have their chief complaint—why they came to the hospital—properly addressed, so you need a coordinated care team. They want to go home early and don’t want come back: That’s low length of stay and a reduction in 30-day readmissions. And they don’t want any hospital-acquired complications."

Treating patients better, then, should be reflected by improved quality, even if the participation of hospitalists cannot be precisely quantified. "Being involved is something that may be difficult to measure," Dr. Gavi says, "but nonetheless, it has an important impact." TH

Bryn Nelson is a medical writer based in Seattle.

References

1. Pronovost PJ, Lilford R. Analysis & commentary: A roadmap for improving the performance of performance measures. Health Aff (Millwood). 2011;30(4):569-73.
2. López L, Hicks LS, Cohen AP, McKean S, Weissman JS. Hospitalists and the quality of care in hospitals. Arch Intern Med. 2009;169(15):1389-1394.
3. Centor RM, Taylor BB. Do hospitalists improve quality? Arch Intern Med. 2009;169(15):1351-1352.
4. Boyte D, Verma L, Wightman M. A multidisciplinary approach to reducing heart failure readmissions. J Hosp Med. 2011;6(4)Supp 2:S14.
5. Williams MV, Hansen L, Greenwald J, Howell E, et al. BOOST: impact of a quality improvement project to reduce rehospitalizations. J Hosp Med. 2011;6(4) Supp 2:S88. BOOST: impact of a quality improvement project to reduce rehospitalizations.
6. Auerbach AD, Wachter RM, Katz P, Showstack J, Baron RB, Goldman L. Implementation of a voluntary hospitalist service at a community teaching hospital: improved clinical efficiency and patient outcomes. Ann Intern Med. 2002;137(11):859-865.
7. Meltzer D, Manning WG, Morrison J, et al. Effects of physician experience on costs and outcomes on an academic general medicine service: results of a trial of hospitalists. Ann Intern Med. 2002;137(1):866-874.
8. Huddleston JM, Hall K, Naessens JM, et al. Medical and surgical comanagement after elective hip and knee arthroplasty. Ann Intern Med. 2004;141(1):28-38.
9. Batsis JA, Phy MP, Melton LJ, et al. Effects of a hospitalist care model on mortality of elderly patients with hip fractures. J Hosp Med. 2007;2(4): 219–225.
10. Lindenauer PK, Rothberg MB, Pekow PS, et al. Outcomes of care by hospitalists, general internists, and family physicians. N Eng J Med. 2007;357:2589-2600.
11. Hock Lee K, Yang Y, Soong Yang K, Chi Ong B, Seong Ng H. Bringing generalists into the hospital: outcomes of a family medicine hospitalist model in Singapore. J Hosp Med. 2011;6(3):115-121.
12. Sprague L. The hospitalist: better value in inpatient care? National Health Policy Forum website. Available at: www.nhpf.org/library/issue-briefs/IB842_Hospitalist_03-30-11.pdf. Accessed June 28, 2011.

One hospitalist-led pilot project produced a 61% decrease in heart failure readmission rates. Another resulted in a 33% drop in all-cause readmissions. The numbers might be impressive, but what do they really say about how hospitalists have influenced healthcare quality?

When HM emerged 15 years ago, advocates pitched the fledgling physician specialty as a model of efficient inpatient care, and subsequent findings that the concept led to reductions in length of stay encouraged more hospitals to bolster their staff with the newcomers. With a rising emphasis on quality and patient safety over the past decade, and the new era of pay-for-performance, the hospitalist model of care has expanded to embrace improved quality of care as a chief selling point.

Measuring quality is no easy task, however, and researchers still debate the relative merits of metrics like 30-day readmission rates and inpatient mortality. "Without question, quality measurement is an imperfect science, and all measures will contain some level of imprecision and bias," concluded a recent commentary in Health Affairs.¹

Against that backdrop, relatively few studies have looked broadly at the contributions of hospital medicine. Most interventions have been individually tailored to a hospital or instituted at only a few sites, precluding large-scale, head-to-head comparisons.

And so the question remains: Has hospital medicine lived up to its promise on quality?

The Evidence

In one of the few national surveys of HM’s impact on patient care, a yearlong comparison of more than 3,600 hospitals found that the roughly 40% that employed hospitalists scored better on multiple Hospital Quality Alliance indicators. The 2009 Archives of Internal Medicine study suggested that hospitals with hospitalists outperformed their counterparts in quality metrics for acute myocardial infarction, pneumonia, overall disease treatment and diagnosis, and counseling and prevention. Congestive heart failure was the only category of the five reviewed that lacked a statistically significant difference.²

A separate editorial, however, argued that the study’s data were not persuasive enough to support the conclusion that hospitalists bring a higher quality of care to the table.³ And even less can be said about the national impact of HM on newly elevated metrics, such as readmission rates. The obligation to gather evidence, in fact, is largely falling upon hospitalists themselves, and the multitude of research abstracts from SHM’s annual meeting in May suggests that plenty of physician scientists are taking the responsibility seriously. Among the presentations, a study led by David Boyte, MD, assistant professor of medicine at Duke University and a hospitalist at Durham Regional Hospital, found that a multidisciplinary approach greatly improved one hospital unit’s 30-day readmission rates for heart failure patients. After a three-month pilot in the cardiac nursing unit, readmission rates fell to 10.7% from 27.6%.⁴

Although the multidisciplinary effort has included doctors, nurses, nutritionists, pharmacists, unit managers, and other personnel, Dr. Boyte says the involvement of hospitalists has been key to the project’s success. "We feel like we were the main participants who could see the whole picture from a patient-centered perspective," he says. "We were the glue; we were the center node of all the healthcare providers." Based on that dramatic improvement, Dr. Boyte says, the same interventional protocol has been rolled out in three other medical surgical units, and the hospital is using a similar approach to address AMI readmission rates.

Listen to Dr. Vaidyan

SHM’s Project BOOST (Better Outcomes for Older Adults through Safe Transitions; www.hospitalmedicine.org/boost )—by far the largest study of how HM is impacting readmission rates—has amassed data from more than 20 hospitals, with more expected from a growing roster of participants. So far, however, the project has only released data from six pilot sites describing the six-month periods before and after the project’s start. Among those sites, initial results suggest that readmission rates fell by an average of more than 20%, to 11.2% from 14.2%.⁵

Though the early numbers are encouraging, experts say rates from a larger group of participants at the one-year mark will be more telling, as will direct comparisons between BOOST units and nonparticipating counterparts at the same hospitals. Principal investigator Mark Williams, MD, FHM, professor and chief of the division of hospital medicine at the Northwestern University Feinberg School of Medicine in Chicago, says researchers still need to clean up that data before they’re ready to share it publicly.

In the meantime, some individual BOOST case studies are suggesting that hospitalist-led changes could pay big dividends. To help create cohesiveness and a sense of ownership within its HM program, St. Mary’s Health Center in St. Louis started a 20-bed hospitalist unit in 2008. Philip Vaidyan, MD, FACP, head of the hospitalist program and practice group leader for IPC: The Hospitalist Company at St. Mary’s, says one unit, 3 West, has since functioned as a lab for testing new ideas that are then introduced hospitalwide.

One early change was to bring all of the unit’s care providers together, from doctors and nurses to the unit-based case manager and social worker, for 9 a.m. handoff meetings. "We have this collective brain to find unique solutions," Dr. Vaidyan says. After seeing positive trends on length of stay, 30-day readmission rates, and patient satisfaction scores, St. Mary’s upgraded to a 32-bed hospitalist unit in early 2009. That same year, the 525-bed community teaching hospital was accepted into the BOOST program.

Listen to Dr. Vaidyan

The hospitalist unit’s improved quality scores continued under BOOST, leading to a 33% reduction in readmission rates from 2008 to 2010 (to 10.5% from 15.7%). Rates for a nonhospitalist unit, by contrast, hovered around 17%. "For reducing readmissions, people may think that you have to have a higher length of stay," Dr. Vaidyan says. But the unit trended toward a lower length of stay, in addition to its reduced 30-day readmissions and improved patient satisfaction scores.

Dr. Singh

Flush with success, the 10 physicians and four nurse practitioners in the hospitalist program have since begun spreading their best practices to the rest of the hospital units. "Hospitalists are in the best ‘sweet spot,’ " Dr. Vaidyan says, "partnering with all of the disciplines, bringing them together, and keeping everybody on the same page."

Ironically, pinpointing the contribution of hospitalists is harder when their changes produce an ecological effect throughout an entire institution, says Siddhartha Singh, MD, MS, associate chief medical officer of Medical College Physicians, the adult practice for Medical College of Wisconsin in Milwaukee. Even so, he stresses that the impact of the two dozen hospitalists at Medical College Physicians has been felt.

Listen to Dr. Vaidyan

"Coinciding with and following the introduction of our hospitalist program in 2004, we have noticed dramatic decreases in our length of stay throughout medicine services," he says. The same has held true for inpatient mortality. "And that, we feel, is attributable to the standardization of processes introduced by the hospitalist group." Multidisciplinary rounds; whiteboards in patient rooms; and standardized admission orders, prophylactic treatments, and discharge processes—"all of this would’ve been impossible, absolutely impossible, without the hospitalist," he says.

Over the past decade, Dr. Singh’s assessment has been echoed by several studies suggesting that individual hospitalist programs have brought significant improvements in quality measures, such as complication rates and inpatient mortality. In 2002, for example, Andrew Auerbach, MD, MPH, at the University of California San Francisco Medical Center, led a study that compared HM care with that of community physicians in a community-based teaching hospital. Patients cared for by hospitalists, the study found, had a lower risk of death during the hospitalization, as well as at 30 days and 60 days after discharge.⁶

Dr. Kripalani

A separate report by David Meltzer, MD, PhD, and colleagues at the University of Chicago found that an HM program in an academic general medicine service led to a 30% reduction in 30-day mortality rates during its second year of operation.⁷ And a 2004 study led by Jeanne Huddleston, MD, at the Mayo Clinic College of Medicine in Rochester, Minn., found that a hospitalist-orthopedic co-management model (versus care by orthopedic surgeons with medical consultation) led to more patients being discharged with no complications after elective hip or knee surgery.⁸ Hospitalist co-management also reduced the rate of minor complications, but had no effect on actual length of stay or cost.

A subsequent study by the same group, however, documented improved efficiency of care through the HM model, but no effect on the mortality of hip fracture patients up to one year after discharge.⁹ Multiple studies of hospitalist programs, in fact, have seen increased efficiency but little or no impact on inpatient mortality, leading researchers to broadly conclude that such programs can decrease resource use without compromising quality.

In 2007, a retrospective study of nearly 77,000 patients admitted to 45 hospitals with one of seven common diagnoses compared the care delivered by hospitalists, general internists, and family physicians.¹⁰ Although the study authors found that hospitalist care yielded a small drop in length of stay, they saw no difference in the inpatient mortality rates or 14-day readmission rates. More recently, mortality has become ensnared in controversy over its reliability as an accurate indicator of quality.

When we sit on committees, people often look to us for answers and directions because they know we’re on the front lines and we’ve interfaced with all of the services in the hospital. You have a good view of the whole hospital operation from A to Z, and I think that’s pretty unique to hospitalists.

-Shai Gavi, DO, MPH, chief, section of hospital medicine, assistant professor, Stony Brook University School of Medicine, Brookhaven, N.Y.

Half of the Equation

Despite a lack of ideal metrics, another promising sign for HM might be the model’s exportability. Lee Kheng Hock, MMed, senior consultant and head of the Department of Family Medicine and Continuing Care at Singapore General Hospital, says the 1,600-bed hospital began experimenting with the hospitalist model when officials realized the existing care system wasn’t sustainable. Amid an aging population and increasingly complex and fragmented care, Hock views the hospitalist movement as a natural evolution of the healthcare system to meet the needs of a changing environment.

In a recent study, Hock and his colleagues used the hospital’s administrative database to examine the resource use and outcomes of patients cared for in 2008 by family medicine hospitalists or by specialists.¹¹ The comparison, based on several standard metrics, found no significant improvements in quality, with similar inpatient mortality rates and 30-day, all-cause, unscheduled readmission rates regardless of the care delivery method. The study, though, revealed a significantly shorter hospital stay (4.4 days vs. 5.3 days) and lower costs per patient for those cared for by hospitalists ($2,250 vs. $2,500).¹¹

Hock points out that, like his study, most analyses of hospitalist programs have shown an improvement in length of stay and cost of care without any increase in mortality and morbidity. If value equals quality divided by cost, he says, it stands to reason that quality must increase as overall value remains the same but costs decrease.

"The main difference is that the patients received undivided attention from a well-rounded generalist physician who is focused on providing holistic general medical care," Hock says, adding that "it is really a no-brainer that the outcome would be different."

Listen to Dr. Vaidyan

Patients Rule

Other measures like the effectiveness of communication and seamlessness of handoffs often are assessed through their impacts on patient outcomes. But Sunil Kripalani, MD, MSc, SFHM, chief of the section of hospital medicine and an associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn., says communication is now a primary focal point in Medicare’s new hospital value-based purchasing program (VBP). Within VBP’s Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) component, worth 30% of a hospital’s sum score, four of the 10 survey-based measures deal directly with communication. Patients’ overall rating and recommendation of hospitals likely will reflect their satisfaction with communication as well. Dr. Kripalani says it’s inevitable that hospitals—and hospitalists—will pay more attention to communication ratings as patients become judges of quality.

The expertise of hospitalists in handling challenging patients also leads to improved quality over time, says Shai Gavi, DO, MPH, chief of the section of hospital medicine and assistant professor of clinical medicine at Stony Brook University School of Medicine in Brookhaven, N.Y. Hospitalists, he says, excel in handling such high-stakes medical issues as gastrointestinal bleeding, pancreatitis, sepsis, and pain management that can quickly impact patient outcomes if not addressed properly and proficiently. "I think there’s significant value to having people who do this on a pretty frequent basis," he says.

And because of their broad day-to-day interactions, Dr. Gavi says, hospitalists are natural choices for committees focused on improving quality. "When we sit on committees, people often look to us for answers and directions because they know we’re on the front lines and we’ve interfaced with all of the services in the hospital," he says. "You have a good view of the whole hospital operation from A to Z, and I think that’s pretty unique to hospitalists."

The Verdict

In a recent issue brief by Lisa Sprague, principal policy analyst at the National Health Policy Forum, she asserts, "Hospitalists have the undeniable advantage of being there when a crisis occurs, when a patient is ready for discharge, and so on."¹²

So is "being there" the defining concept of hospital medicine, as she subsequently suggests?

Based on both scientific and anecdotal evidence, the contribution of hospitalists to healthcare quality might be better summarized as "being involved." Whether as innovators, navigators, physician champions, the "sweet spot" of interdepartmental partnerships, the "glue" of multidisciplinary teams, or the nuclei of performance committees, hospitalists are increasingly described as being in the middle of efforts to improve quality. On this basis, the discipline appears to be living up to expectations, though experts say more research is needed to better assess the impacts of HM on quality.

Dr. Vaidyan says hospitalists are particularly well positioned to understand what constitutes ideal care from the perspective of patients. "They want to be treated well: That’s patient satisfaction," he says. "They want to have their chief complaint—why they came to the hospital—properly addressed, so you need a coordinated care team. They want to go home early and don’t want come back: That’s low length of stay and a reduction in 30-day readmissions. And they don’t want any hospital-acquired complications."

Treating patients better, then, should be reflected by improved quality, even if the participation of hospitalists cannot be precisely quantified. "Being involved is something that may be difficult to measure," Dr. Gavi says, "but nonetheless, it has an important impact." TH

Bryn Nelson is a medical writer based in Seattle.

References

1. Pronovost PJ, Lilford R. Analysis & commentary: A roadmap for improving the performance of performance measures. Health Aff (Millwood). 2011;30(4):569-73.
2. López L, Hicks LS, Cohen AP, McKean S, Weissman JS. Hospitalists and the quality of care in hospitals. Arch Intern Med. 2009;169(15):1389-1394.
3. Centor RM, Taylor BB. Do hospitalists improve quality? Arch Intern Med. 2009;169(15):1351-1352.
4. Boyte D, Verma L, Wightman M. A multidisciplinary approach to reducing heart failure readmissions. J Hosp Med. 2011;6(4)Supp 2:S14.
5. Williams MV, Hansen L, Greenwald J, Howell E, et al. BOOST: impact of a quality improvement project to reduce rehospitalizations. J Hosp Med. 2011;6(4) Supp 2:S88. BOOST: impact of a quality improvement project to reduce rehospitalizations.
6. Auerbach AD, Wachter RM, Katz P, Showstack J, Baron RB, Goldman L. Implementation of a voluntary hospitalist service at a community teaching hospital: improved clinical efficiency and patient outcomes. Ann Intern Med. 2002;137(11):859-865.
7. Meltzer D, Manning WG, Morrison J, et al. Effects of physician experience on costs and outcomes on an academic general medicine service: results of a trial of hospitalists. Ann Intern Med. 2002;137(1):866-874.
8. Huddleston JM, Hall K, Naessens JM, et al. Medical and surgical comanagement after elective hip and knee arthroplasty. Ann Intern Med. 2004;141(1):28-38.
9. Batsis JA, Phy MP, Melton LJ, et al. Effects of a hospitalist care model on mortality of elderly patients with hip fractures. J Hosp Med. 2007;2(4): 219–225.
10. Lindenauer PK, Rothberg MB, Pekow PS, et al. Outcomes of care by hospitalists, general internists, and family physicians. N Eng J Med. 2007;357:2589-2600.
11. Hock Lee K, Yang Y, Soong Yang K, Chi Ong B, Seong Ng H. Bringing generalists into the hospital: outcomes of a family medicine hospitalist model in Singapore. J Hosp Med. 2011;6(3):115-121.
12. Sprague L. The hospitalist: better value in inpatient care? National Health Policy Forum website. Available at: www.nhpf.org/library/issue-briefs/IB842_Hospitalist_03-30-11.pdf. Accessed June 28, 2011.