Patient Safety

If every system is perfectly designed to get the results it gets …

And if 15 million patients are harmed every year from medical care …

And if as many as 98,000 people die every year due to medical errors in hospitals …

Then what does that say about the system we have designed?

A System Designed to Competently Hurt Many

By now you’ve no doubt heard, read, and possibly even uttered the above facts and figures yourself. I think we all have our opinions about the veracity of these numbers, but I don’t think any of us would argue with the sentiment. The U.S. healthcare system comprises the most competent, compassionate, well-meaning, and caring professionals on this planet—who harm, maim, and kill countless people every year.

What a discomforting paradox.

Equity: The Overlooked Quality Domain

Many years back, the Institute of Medicine (IOM) published a list of six “domains” of healthcare quality. You’ve no doubt stumbled across the IOM’s Safe … Timely … Effective … Efficient … Equitable … Patient-Centered mnemonic recipe—STEEEP—for high-quality care.¹ In fact, it’s hard to read a journal, attend a medical presentation, or open a local newspaper without finding reference to these domains. It’s all the rage to talk about wrong-site surgery (safe), access to care (timely), comparative-effectiveness research (effective), lean concepts (efficient), and individualized medicine (patient-centered). However, the sixth domain often seems to get the Jan Brady treatment—minimized, marginalized, and oft-forgotten.

The IOM defines equitable care as that which “does not vary in quality because of personal characteristics such as gender, ethnicity, geographic location, and socioeconomic status.”1 To be sure, there is some hum at the national level about issues of equity, especially around healthcare coverage for all. And this is important. However, what appears lost in the rant surrounding the inherent inequities in our tiered health insurance system is that we have blantant inequalities baked into the everyday machinery of our hospitals. And they affect all, regardless of skin color, gender, or insurance status.

Think for a moment about your hospital. Are the type, level, and access to care equal at all times? Does the level of care change when the streetlights come on? How about on weekends and holidays? Do your operating rooms run on Saturdays and Sundays? Can patients get chemotherapy on the weekends? Does your hospital alter its nursing staff ratios after hours? Can you get an ultrasound at midnight? How about a urology or neurosurgery consult at 2 a.m.? How about getting interventional radiology to place an IVC filter on a holiday?

Now scratch a bit closer to home. Does your hospitalist group downstaff on weekends and holidays, even though the volumes probably warrant more coverage? Are your night providers part of your group, or are they moonlighters? Do your after-hours providers cross-cover and admit a reasonable number of patients, or are they frequently overwhelmed? Do they cover patients or admit for services that they don’t typically care for during the day (e.g. ICU, neurosurgical, subspecialty cardiology or oncology patients)? For the intensely ill patients admitted to U.S. hospitals today, should the type and availability of care differ when it’s delivered at 3 p.m. or 3 a.m., Sunday or Monday?

Disregarding the macro-inequities in our societal approach to healthcare, can we even ensure equitable care within our own hospital walls 24 hours a day, seven days a week?

The Answer: An Unfortunate “No”

For the record, I hate working nights, abhor working weekends, and resent working holidays. But the thing I’d hate even more than working nights, weekends, and holidays would be being a patient admitted during a night, weekend, or holiday. To understand why, I have to look no further than my hospital parking lot. During bankers’ hours, I can barely find a parking spot on the top floor of our multilevel parking structure.

Fast-forward to Saturday, and I have my pick of empty football fields’ worth of spots on all floors. Ditto Sundays, nights, and holidays.

Why is it that nationally, a collectively near-trillion-dollar hospital enterprise finds it acceptable to effectively shutter itself for a quarter to a third of the week? Especially when doing so seems to counter their primary mission of providing safe, timely, effective, efficient, equitable, and patient-centered care.

The Weekend Effect

There are, of course, economic and operational reasons to downshift during off hours—some hospitals don’t have the elective procedures to run operating rooms seven days a week, and very few patients want to have their elective colonoscopy at 11 p.m. or their chemotherapy during Thanksgiving dinner. However, in most cases, the reasons for doing so center on hospital staff and physician satisfaction. Most us of just don’t like working off hours. As a result, studies have shown significantly less access to such high-level care as coronary angiography and percutaneous coronary intervention on weekends.^2,3

And the effects of this “weekend effect” can be devastating.

A recent paper in the New England Journal of Medicine reported that for every 1,000 patients admitted with a myocardial infarction on a weekend, nine more would die than a comparable group admitted during the week.⁴ Their offense? Having the misfortune to get ill on a Saturday morning. The authors concluded that this higher mortality was secondary to a lower rate of invasive cardiac procedures, presumably because they were less available. And the weekend effect isn’t just limited to coronary care. Poorer outcomes, including higher mortality rates, have been reported for weekend admissions to the neonatal ICU and adult ICU, as well as admission for epiglottitis, ruptured abdominal aortic aneurysms, and pulmonary embolism.^5,6,7

So let’s connect the dots: A system designed with inequal access to lifesaving therapies and appropriate staffing results in worse outcomes, more harm, more deaths.

To be clear, 98,000 people don’t die every year because of my disdain for working nights and weekends. This is a much deeper problem that hinges on many unsatisfactory systems working unsatisfactorily in tandem (e.g. see the other five IOM domains of quality care). Furthermore, I don’t mean to suggest that hospitalists necessarily have a lot of say in cardiac catheterization schedules. Yet we do control our own systems of care—how many patients we admit and cover during a shift, how strongly we advocate for timely testing and consultation, how we staff weekends and cover patients at night.

And, more and more, we are in a position to enhance the care delivery systems of the hospital and its providers that surround us. With that comes a responsibility to ensure that these systems are highly functioning and equitable, regardless of the time of day, day of the week.

If we are going to fundamentally enhance the quality of care, then we have to design safer systems of care. It will take time and resources to alter many of our bruised systems of care, but we can begin by at least ensuring equity in how we deliver care at our own institutions. That is, unless we are comfortable with a system perfectly designed to harm. TH

Dr. Glasheen is associate professor of medicine at the University of Colorado Denver, where he serves as director of the Hospital Medicine Program and the Hospitalist Training Program, and as associate program director of the Internal Medicine Residency Program.

References

1. Institute of Medicine (IOM). Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, D.C.: National Academy Press; 2001.
2. Bell CM, Redelmeier DA. Waiting for urgent procedures on the weekend among emergently hospitalized patients. Am J Med. 2004:117(3):175-181.
3. Magid DJ, Wang Y, Herrin J, et al. Relationship between time of day, day of week, timeliness of reperfusion, and in-hospital mortality for patients with acute ST-segment elevation myocardial infarction. JAMA. 2005;294(7):803-812.
4. Kostis WJ, Demissie K, Marcella SW, Shao YH, Wilson AC, Moreyra AE. Weekend versus weekday admission and mortality from myocardial infarction. N Eng J Med. 2007;356 (11):1099-1109.
5. Hendry RA. The weekend—a dangerous time to be born? Br J Obstet Gynaecol. 1981;88(12):1200-1203.
6. Barnett MJ, Kaboli PJ, Sirio CA, Rosenthal GE. Day of the week of intensive care admission and patient outcomes: a multisite regional evaluation. Med Care. 2002;40(6):530-539.
7. Bell CM, Redelmeier DA. Mortality among patients admitted to hospitals on weekends as compared with weekdays. N Eng J Med. 2001;345(9):663-668.

If every system is perfectly designed to get the results it gets …

And if 15 million patients are harmed every year from medical care …

And if as many as 98,000 people die every year due to medical errors in hospitals …

Then what does that say about the system we have designed?

A System Designed to Competently Hurt Many

By now you’ve no doubt heard, read, and possibly even uttered the above facts and figures yourself. I think we all have our opinions about the veracity of these numbers, but I don’t think any of us would argue with the sentiment. The U.S. healthcare system comprises the most competent, compassionate, well-meaning, and caring professionals on this planet—who harm, maim, and kill countless people every year.

What a discomforting paradox.

Equity: The Overlooked Quality Domain

Many years back, the Institute of Medicine (IOM) published a list of six “domains” of healthcare quality. You’ve no doubt stumbled across the IOM’s Safe … Timely … Effective … Efficient … Equitable … Patient-Centered mnemonic recipe—STEEEP—for high-quality care.¹ In fact, it’s hard to read a journal, attend a medical presentation, or open a local newspaper without finding reference to these domains. It’s all the rage to talk about wrong-site surgery (safe), access to care (timely), comparative-effectiveness research (effective), lean concepts (efficient), and individualized medicine (patient-centered). However, the sixth domain often seems to get the Jan Brady treatment—minimized, marginalized, and oft-forgotten.

The IOM defines equitable care as that which “does not vary in quality because of personal characteristics such as gender, ethnicity, geographic location, and socioeconomic status.”1 To be sure, there is some hum at the national level about issues of equity, especially around healthcare coverage for all. And this is important. However, what appears lost in the rant surrounding the inherent inequities in our tiered health insurance system is that we have blantant inequalities baked into the everyday machinery of our hospitals. And they affect all, regardless of skin color, gender, or insurance status.

Think for a moment about your hospital. Are the type, level, and access to care equal at all times? Does the level of care change when the streetlights come on? How about on weekends and holidays? Do your operating rooms run on Saturdays and Sundays? Can patients get chemotherapy on the weekends? Does your hospital alter its nursing staff ratios after hours? Can you get an ultrasound at midnight? How about a urology or neurosurgery consult at 2 a.m.? How about getting interventional radiology to place an IVC filter on a holiday?

Now scratch a bit closer to home. Does your hospitalist group downstaff on weekends and holidays, even though the volumes probably warrant more coverage? Are your night providers part of your group, or are they moonlighters? Do your after-hours providers cross-cover and admit a reasonable number of patients, or are they frequently overwhelmed? Do they cover patients or admit for services that they don’t typically care for during the day (e.g. ICU, neurosurgical, subspecialty cardiology or oncology patients)? For the intensely ill patients admitted to U.S. hospitals today, should the type and availability of care differ when it’s delivered at 3 p.m. or 3 a.m., Sunday or Monday?

Disregarding the macro-inequities in our societal approach to healthcare, can we even ensure equitable care within our own hospital walls 24 hours a day, seven days a week?

The Answer: An Unfortunate “No”

For the record, I hate working nights, abhor working weekends, and resent working holidays. But the thing I’d hate even more than working nights, weekends, and holidays would be being a patient admitted during a night, weekend, or holiday. To understand why, I have to look no further than my hospital parking lot. During bankers’ hours, I can barely find a parking spot on the top floor of our multilevel parking structure.

Fast-forward to Saturday, and I have my pick of empty football fields’ worth of spots on all floors. Ditto Sundays, nights, and holidays.

Why is it that nationally, a collectively near-trillion-dollar hospital enterprise finds it acceptable to effectively shutter itself for a quarter to a third of the week? Especially when doing so seems to counter their primary mission of providing safe, timely, effective, efficient, equitable, and patient-centered care.

The Weekend Effect

There are, of course, economic and operational reasons to downshift during off hours—some hospitals don’t have the elective procedures to run operating rooms seven days a week, and very few patients want to have their elective colonoscopy at 11 p.m. or their chemotherapy during Thanksgiving dinner. However, in most cases, the reasons for doing so center on hospital staff and physician satisfaction. Most us of just don’t like working off hours. As a result, studies have shown significantly less access to such high-level care as coronary angiography and percutaneous coronary intervention on weekends.^2,3

And the effects of this “weekend effect” can be devastating.

A recent paper in the New England Journal of Medicine reported that for every 1,000 patients admitted with a myocardial infarction on a weekend, nine more would die than a comparable group admitted during the week.⁴ Their offense? Having the misfortune to get ill on a Saturday morning. The authors concluded that this higher mortality was secondary to a lower rate of invasive cardiac procedures, presumably because they were less available. And the weekend effect isn’t just limited to coronary care. Poorer outcomes, including higher mortality rates, have been reported for weekend admissions to the neonatal ICU and adult ICU, as well as admission for epiglottitis, ruptured abdominal aortic aneurysms, and pulmonary embolism.^5,6,7

So let’s connect the dots: A system designed with inequal access to lifesaving therapies and appropriate staffing results in worse outcomes, more harm, more deaths.

To be clear, 98,000 people don’t die every year because of my disdain for working nights and weekends. This is a much deeper problem that hinges on many unsatisfactory systems working unsatisfactorily in tandem (e.g. see the other five IOM domains of quality care). Furthermore, I don’t mean to suggest that hospitalists necessarily have a lot of say in cardiac catheterization schedules. Yet we do control our own systems of care—how many patients we admit and cover during a shift, how strongly we advocate for timely testing and consultation, how we staff weekends and cover patients at night.

And, more and more, we are in a position to enhance the care delivery systems of the hospital and its providers that surround us. With that comes a responsibility to ensure that these systems are highly functioning and equitable, regardless of the time of day, day of the week.

If we are going to fundamentally enhance the quality of care, then we have to design safer systems of care. It will take time and resources to alter many of our bruised systems of care, but we can begin by at least ensuring equity in how we deliver care at our own institutions. That is, unless we are comfortable with a system perfectly designed to harm. TH

Dr. Glasheen is associate professor of medicine at the University of Colorado Denver, where he serves as director of the Hospital Medicine Program and the Hospitalist Training Program, and as associate program director of the Internal Medicine Residency Program.

References

1. Institute of Medicine (IOM). Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, D.C.: National Academy Press; 2001.
2. Bell CM, Redelmeier DA. Waiting for urgent procedures on the weekend among emergently hospitalized patients. Am J Med. 2004:117(3):175-181.
3. Magid DJ, Wang Y, Herrin J, et al. Relationship between time of day, day of week, timeliness of reperfusion, and in-hospital mortality for patients with acute ST-segment elevation myocardial infarction. JAMA. 2005;294(7):803-812.
4. Kostis WJ, Demissie K, Marcella SW, Shao YH, Wilson AC, Moreyra AE. Weekend versus weekday admission and mortality from myocardial infarction. N Eng J Med. 2007;356 (11):1099-1109.
5. Hendry RA. The weekend—a dangerous time to be born? Br J Obstet Gynaecol. 1981;88(12):1200-1203.
6. Barnett MJ, Kaboli PJ, Sirio CA, Rosenthal GE. Day of the week of intensive care admission and patient outcomes: a multisite regional evaluation. Med Care. 2002;40(6):530-539.
7. Bell CM, Redelmeier DA. Mortality among patients admitted to hospitals on weekends as compared with weekdays. N Eng J Med. 2001;345(9):663-668.

If every system is perfectly designed to get the results it gets …

And if 15 million patients are harmed every year from medical care …

And if as many as 98,000 people die every year due to medical errors in hospitals …

Then what does that say about the system we have designed?

A System Designed to Competently Hurt Many

By now you’ve no doubt heard, read, and possibly even uttered the above facts and figures yourself. I think we all have our opinions about the veracity of these numbers, but I don’t think any of us would argue with the sentiment. The U.S. healthcare system comprises the most competent, compassionate, well-meaning, and caring professionals on this planet—who harm, maim, and kill countless people every year.

What a discomforting paradox.

Equity: The Overlooked Quality Domain

Many years back, the Institute of Medicine (IOM) published a list of six “domains” of healthcare quality. You’ve no doubt stumbled across the IOM’s Safe … Timely … Effective … Efficient … Equitable … Patient-Centered mnemonic recipe—STEEEP—for high-quality care.¹ In fact, it’s hard to read a journal, attend a medical presentation, or open a local newspaper without finding reference to these domains. It’s all the rage to talk about wrong-site surgery (safe), access to care (timely), comparative-effectiveness research (effective), lean concepts (efficient), and individualized medicine (patient-centered). However, the sixth domain often seems to get the Jan Brady treatment—minimized, marginalized, and oft-forgotten.

The IOM defines equitable care as that which “does not vary in quality because of personal characteristics such as gender, ethnicity, geographic location, and socioeconomic status.”1 To be sure, there is some hum at the national level about issues of equity, especially around healthcare coverage for all. And this is important. However, what appears lost in the rant surrounding the inherent inequities in our tiered health insurance system is that we have blantant inequalities baked into the everyday machinery of our hospitals. And they affect all, regardless of skin color, gender, or insurance status.

Think for a moment about your hospital. Are the type, level, and access to care equal at all times? Does the level of care change when the streetlights come on? How about on weekends and holidays? Do your operating rooms run on Saturdays and Sundays? Can patients get chemotherapy on the weekends? Does your hospital alter its nursing staff ratios after hours? Can you get an ultrasound at midnight? How about a urology or neurosurgery consult at 2 a.m.? How about getting interventional radiology to place an IVC filter on a holiday?

Now scratch a bit closer to home. Does your hospitalist group downstaff on weekends and holidays, even though the volumes probably warrant more coverage? Are your night providers part of your group, or are they moonlighters? Do your after-hours providers cross-cover and admit a reasonable number of patients, or are they frequently overwhelmed? Do they cover patients or admit for services that they don’t typically care for during the day (e.g. ICU, neurosurgical, subspecialty cardiology or oncology patients)? For the intensely ill patients admitted to U.S. hospitals today, should the type and availability of care differ when it’s delivered at 3 p.m. or 3 a.m., Sunday or Monday?

Disregarding the macro-inequities in our societal approach to healthcare, can we even ensure equitable care within our own hospital walls 24 hours a day, seven days a week?

The Answer: An Unfortunate “No”

For the record, I hate working nights, abhor working weekends, and resent working holidays. But the thing I’d hate even more than working nights, weekends, and holidays would be being a patient admitted during a night, weekend, or holiday. To understand why, I have to look no further than my hospital parking lot. During bankers’ hours, I can barely find a parking spot on the top floor of our multilevel parking structure.

Fast-forward to Saturday, and I have my pick of empty football fields’ worth of spots on all floors. Ditto Sundays, nights, and holidays.

Why is it that nationally, a collectively near-trillion-dollar hospital enterprise finds it acceptable to effectively shutter itself for a quarter to a third of the week? Especially when doing so seems to counter their primary mission of providing safe, timely, effective, efficient, equitable, and patient-centered care.

The Weekend Effect

There are, of course, economic and operational reasons to downshift during off hours—some hospitals don’t have the elective procedures to run operating rooms seven days a week, and very few patients want to have their elective colonoscopy at 11 p.m. or their chemotherapy during Thanksgiving dinner. However, in most cases, the reasons for doing so center on hospital staff and physician satisfaction. Most us of just don’t like working off hours. As a result, studies have shown significantly less access to such high-level care as coronary angiography and percutaneous coronary intervention on weekends.^2,3

And the effects of this “weekend effect” can be devastating.

A recent paper in the New England Journal of Medicine reported that for every 1,000 patients admitted with a myocardial infarction on a weekend, nine more would die than a comparable group admitted during the week.⁴ Their offense? Having the misfortune to get ill on a Saturday morning. The authors concluded that this higher mortality was secondary to a lower rate of invasive cardiac procedures, presumably because they were less available. And the weekend effect isn’t just limited to coronary care. Poorer outcomes, including higher mortality rates, have been reported for weekend admissions to the neonatal ICU and adult ICU, as well as admission for epiglottitis, ruptured abdominal aortic aneurysms, and pulmonary embolism.^5,6,7

So let’s connect the dots: A system designed with inequal access to lifesaving therapies and appropriate staffing results in worse outcomes, more harm, more deaths.

To be clear, 98,000 people don’t die every year because of my disdain for working nights and weekends. This is a much deeper problem that hinges on many unsatisfactory systems working unsatisfactorily in tandem (e.g. see the other five IOM domains of quality care). Furthermore, I don’t mean to suggest that hospitalists necessarily have a lot of say in cardiac catheterization schedules. Yet we do control our own systems of care—how many patients we admit and cover during a shift, how strongly we advocate for timely testing and consultation, how we staff weekends and cover patients at night.

And, more and more, we are in a position to enhance the care delivery systems of the hospital and its providers that surround us. With that comes a responsibility to ensure that these systems are highly functioning and equitable, regardless of the time of day, day of the week.

If we are going to fundamentally enhance the quality of care, then we have to design safer systems of care. It will take time and resources to alter many of our bruised systems of care, but we can begin by at least ensuring equity in how we deliver care at our own institutions. That is, unless we are comfortable with a system perfectly designed to harm. TH

Dr. Glasheen is associate professor of medicine at the University of Colorado Denver, where he serves as director of the Hospital Medicine Program and the Hospitalist Training Program, and as associate program director of the Internal Medicine Residency Program.

References

1. Institute of Medicine (IOM). Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, D.C.: National Academy Press; 2001.
2. Bell CM, Redelmeier DA. Waiting for urgent procedures on the weekend among emergently hospitalized patients. Am J Med. 2004:117(3):175-181.
3. Magid DJ, Wang Y, Herrin J, et al. Relationship between time of day, day of week, timeliness of reperfusion, and in-hospital mortality for patients with acute ST-segment elevation myocardial infarction. JAMA. 2005;294(7):803-812.
4. Kostis WJ, Demissie K, Marcella SW, Shao YH, Wilson AC, Moreyra AE. Weekend versus weekday admission and mortality from myocardial infarction. N Eng J Med. 2007;356 (11):1099-1109.
5. Hendry RA. The weekend—a dangerous time to be born? Br J Obstet Gynaecol. 1981;88(12):1200-1203.
6. Barnett MJ, Kaboli PJ, Sirio CA, Rosenthal GE. Day of the week of intensive care admission and patient outcomes: a multisite regional evaluation. Med Care. 2002;40(6):530-539.
7. Bell CM, Redelmeier DA. Mortality among patients admitted to hospitals on weekends as compared with weekdays. N Eng J Med. 2001;345(9):663-668.

New Drugs, Devices, Indications, and Approvals

• Alglucosidase alfa (Lumizyme) has been approved by the FDA for the treatment of patients older than 8 with late (noninfantile) onset Pompe disease (GAA deficiency) who do not have evidence of cardiac hypertrophy.¹
• Dutasteride and tamsulosin (Jalyn) has been approved by the FDA in a fixed-dose combination product for treating symptomatic benign prostatic hypertrophy.²
• Gatifloxacin ophthalmic solution 0.5% (Zymaxid) has been approved by the FDA to treat bacterial conjunctivitis caused by susceptible bacterial strains.³ It has the highest concentration of gatifloxacin ophthalmic on the U.S. market.
• Memantine hydrochloride (Namenda XR) has been approved by the FDA as an extended-release product to treat moderate to severe dementia of the Alzheimer's type.⁴ It is available as a 28 mg, once-daily dosage form. The immediate-release product is dosed twice daily.
• Mesenchymal stem cells for intravenous infusion (MSCs, Prochymal) formulated into Prochymal has been granted orphan drug status to treat Type 1 diabetes mellitus (T1DM).⁵ This agent is in Phase 2 clinical trials in a collaboration with the Juvenile Diabetes Research Foundation as a treatment for patients with newly diagnosed T1DM.
• Mometasone furoate/formoterol fumarate (Dulera) has been approved by the FDA as a combination treatment for asthmatics aged 12 and older.⁶
• Naproxen/esomeprazole (Vimovo) has been approved by the FDA as a fixed combination for patients with arthritis who are at risk for developing gastric ulcers.⁷
• Pioglitazone/metformin (ACTOplus met XR) has been approved by the FDA in an extended-release fixed combination for treating Type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise.⁸
• Ranibizumab (Lucentis) has received a new indication from the FDA for treating retinal vein occlusion.⁹ The original approval of ranibizumab was for wet age-related macular degeneration.
• Tramadol HCl, orally disintegrating tablets (Rybix ODT), have been approved by the FDA for treating moderate to moderately severe pain in patients 16 years of age and older.¹⁰

Pipeline

• Dronedarone (Multaq) is being investigated as to whether it can reduce major cardiovascular events in patients being treated with the agent for atrial fibrillation.¹¹ Study endpoints will include a reduction in a major cardiovascular event such as stroke or myocardial infarction, or a reduction in cardiovascular hospitalization or death.
• The combination product ibuprofen and famotidine (to be known as Duexa) has been filed as a new drug application (NDA) for reducing the risk of developing upper gastrointestinal (GI) ulcers in patients with pain and arthritis.¹² Two Phase 3 trials showed about a 50% reduction in GI ulcers in combination treatment compared with ibuprofen alone.
• Rifaximin (Xifaxan) has been submitted to the FDA at its higher dose (550 mg) for treatment of nonconstipation irritable bowel syndrome (Non-C-IBS) and IBS-related bloating.¹³ Rifaximin already has approval from the FDA for hepatic encephalopathy and diarrhea.
• TC-5214 has begun Phase 3 clinical trials.¹⁴ It is a nicotinic channel blocker for the adjunctive treatment of major depressive disorder in adults who have had an inadequate response to selective serotonin reuptake inhibitors (SSRIs) or serotonin/norepinephrine reuptake inhibitors (SNRIs). A Phase 2 study evaluating TC-5214 as a second-line (“switch”) monotherapy is planned for this year.
• An NDA for vilazodone has been filed for treating major depressive disorder.¹⁵ It is a dual-acting potent and selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist.

Safety, Warnings, and Label Changes

• Tramadol and tramadol/acetaminophen have undergone a label change related to strengthened warnings of the risk of suicide for patients who are addiction-prone, taking tranquilizers, drinking alcohol, or taking other central-nervous-system-active drugs.¹⁶ Addictive effects might occur when tramadol is combined with alcohol, other opioids, or illicit drugs that have central-nervous-system-depressive effects. Serious potential consequences of overdosage are CNS and/or respiratory depression, and death.
• Earlier this year, the FDA once again updated the warning related to severe liver injury related to the use of propylthiouracil (PTU).¹⁷ This time, PTU has garnered a boxed warning, which includes reports of severe hepatotoxicity and acute liver failure in both adults and children. Some of these reactions were fatal. Use of PTU should be reserved for patients who do not tolerate other treatments for hyperthyroidism, such as methimazole, radioactive iodine, or are not surgery candidates. PTU might be preferred over methimazole just before and/or during the first trimester of pregnancy due to the occurrence of birth defects with methimazole during this timeframe. A medication guide has been developed and is to be given to patients when they fill PTU prescriptions. The guide alerts patients to the signs and symptoms of hepatotoxicity. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. Genzyme receives FDA approval for lumizyme for Pompe disease. Business Wire website. Available at: www.businesswire.com/portal/site/home/email/alert/?ndmViewId=news_view&newsLang=en&newsId=20100525006514. Accessed June 30, 2010.
2. Dennis M. FDA approves GlaxoSmithKline’s combination BPH drug Jalyn. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=B5F703CADB0347DF970A7B7542D99982&logRowId=369156. Accessed June 30, 2010.
3. Allergan receives FDA approval for Zymaxid ophthalmic solution. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/189397.php. Accessed June 29, 2010.
4. Forest and Merz announce FDA approval of Namenda XR for the treatment of moderate to severe dementia of the Alzheimer’s type. Forest Laboratories website. Available at: http://www.frx.com/news/PressRelease.aspx?ID=1440385. Accessed June 30, 2010.
5. Osiris Therapeutics receives FDA orphan drug designation for stem cell treatment for Type 1 diabetes. Osiris Therapeutics website. Available at: http://osiris.com/pdf/2010-05-04%20T1D%20Orphan%20Drug%20Designation.pdf. Accessed June 30, 2010.
6. FDA approves Merck’s new lung drug Dulera. The Economic Times website. Available at: http://economictimes.indiatimes.com/articleshow/6087079.cms. Accessed June 30, 2010.
7. Dane L. FDA approves AstraZeneca, Pozen’s Vimovo. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=0C2915EE4D2D47D287D41D90DFE4240D. Accessed June 30, 2010.
8. ACTOplus met XR available for diabetes. Monthly Prescribing Reference website. Available at: http://www.empr.com/actoplus-met-xr-available-for-diabetes/article/172985/. Accessed June 30, 2010.
9. Dennis M. Roche’s Lucentis garners expanded FDA approval for macular oedema. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=5146664F5A4C48108209D15EA744A614&logRowId=370643. Accessed June 30, 2010.
10. Rybix ODT launched for moderate to moderately severe pain. Monthly Prescribing Reference website. Available at: http://www.empr.com/rybix-odt-launched-for-moderate-to-moderately-severe-pain/article/172743/. Accessed June 30, 3010.
11. Dennis M. Sanofi-Aventis begins late-stage study of Multaq in patients with permanent AF. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=E43104A2DB604649A812E69C58F89304&logRowId=364228. Accessed July 7, 2010.
12. FDA accepts NDA for Duexa for ulcer risk reduction in arthritis patients. Monthly Prescribing Reference website. Available at: http://www.empr.com/fda-accepts-nda-for-duexa-for-ulcer-risk-reduction-in-arthritis-patients/article/171054/. Accessed July 7, 2010.
13. Salix Pharmaceuticals announces NDA submission for Xifaxan550 for treatment of non-constipation irritable bowel syndrome. Salix Pharmaceuticals website. Available at: http://salix.com/news/stories/20100608.aspx. Accessed June 9, 2010.
14. AstraZeneca and Targacept initiate Phase 3 clinical development of TC-5214 as an adjunct treatment for major depressive disorder. Targacept website. Available at: http://www.targacept.com/wt/page/pr_1277240993. Accessed June 29, 2010.
15. Clinical Data, Inc. announces FDA acceptance of new drug application for Vilazodone for the treatment of major depressive disorder. Clinical Data Inc. website. Available at: http://clda.com/uploads/CLDA%20NDA%20acceptance%20FINAL.pdf. Accessed July 7, 2010.
16. Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label change. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm213264.htm. Accessed July 8, 2010.
17. FDA Drug Safety Communication: New boxed warning on severe liver injury with propylthiouracil. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm209023.htm. Accessed July 8, 2010.

New Drugs, Devices, Indications, and Approvals

• Alglucosidase alfa (Lumizyme) has been approved by the FDA for the treatment of patients older than 8 with late (noninfantile) onset Pompe disease (GAA deficiency) who do not have evidence of cardiac hypertrophy.¹
• Dutasteride and tamsulosin (Jalyn) has been approved by the FDA in a fixed-dose combination product for treating symptomatic benign prostatic hypertrophy.²
• Gatifloxacin ophthalmic solution 0.5% (Zymaxid) has been approved by the FDA to treat bacterial conjunctivitis caused by susceptible bacterial strains.³ It has the highest concentration of gatifloxacin ophthalmic on the U.S. market.
• Memantine hydrochloride (Namenda XR) has been approved by the FDA as an extended-release product to treat moderate to severe dementia of the Alzheimer's type.⁴ It is available as a 28 mg, once-daily dosage form. The immediate-release product is dosed twice daily.
• Mesenchymal stem cells for intravenous infusion (MSCs, Prochymal) formulated into Prochymal has been granted orphan drug status to treat Type 1 diabetes mellitus (T1DM).⁵ This agent is in Phase 2 clinical trials in a collaboration with the Juvenile Diabetes Research Foundation as a treatment for patients with newly diagnosed T1DM.
• Mometasone furoate/formoterol fumarate (Dulera) has been approved by the FDA as a combination treatment for asthmatics aged 12 and older.⁶
• Naproxen/esomeprazole (Vimovo) has been approved by the FDA as a fixed combination for patients with arthritis who are at risk for developing gastric ulcers.⁷
• Pioglitazone/metformin (ACTOplus met XR) has been approved by the FDA in an extended-release fixed combination for treating Type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise.⁸
• Ranibizumab (Lucentis) has received a new indication from the FDA for treating retinal vein occlusion.⁹ The original approval of ranibizumab was for wet age-related macular degeneration.
• Tramadol HCl, orally disintegrating tablets (Rybix ODT), have been approved by the FDA for treating moderate to moderately severe pain in patients 16 years of age and older.¹⁰

Pipeline

• Dronedarone (Multaq) is being investigated as to whether it can reduce major cardiovascular events in patients being treated with the agent for atrial fibrillation.¹¹ Study endpoints will include a reduction in a major cardiovascular event such as stroke or myocardial infarction, or a reduction in cardiovascular hospitalization or death.
• The combination product ibuprofen and famotidine (to be known as Duexa) has been filed as a new drug application (NDA) for reducing the risk of developing upper gastrointestinal (GI) ulcers in patients with pain and arthritis.¹² Two Phase 3 trials showed about a 50% reduction in GI ulcers in combination treatment compared with ibuprofen alone.
• Rifaximin (Xifaxan) has been submitted to the FDA at its higher dose (550 mg) for treatment of nonconstipation irritable bowel syndrome (Non-C-IBS) and IBS-related bloating.¹³ Rifaximin already has approval from the FDA for hepatic encephalopathy and diarrhea.
• TC-5214 has begun Phase 3 clinical trials.¹⁴ It is a nicotinic channel blocker for the adjunctive treatment of major depressive disorder in adults who have had an inadequate response to selective serotonin reuptake inhibitors (SSRIs) or serotonin/norepinephrine reuptake inhibitors (SNRIs). A Phase 2 study evaluating TC-5214 as a second-line (“switch”) monotherapy is planned for this year.
• An NDA for vilazodone has been filed for treating major depressive disorder.¹⁵ It is a dual-acting potent and selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist.

Safety, Warnings, and Label Changes

• Tramadol and tramadol/acetaminophen have undergone a label change related to strengthened warnings of the risk of suicide for patients who are addiction-prone, taking tranquilizers, drinking alcohol, or taking other central-nervous-system-active drugs.¹⁶ Addictive effects might occur when tramadol is combined with alcohol, other opioids, or illicit drugs that have central-nervous-system-depressive effects. Serious potential consequences of overdosage are CNS and/or respiratory depression, and death.
• Earlier this year, the FDA once again updated the warning related to severe liver injury related to the use of propylthiouracil (PTU).¹⁷ This time, PTU has garnered a boxed warning, which includes reports of severe hepatotoxicity and acute liver failure in both adults and children. Some of these reactions were fatal. Use of PTU should be reserved for patients who do not tolerate other treatments for hyperthyroidism, such as methimazole, radioactive iodine, or are not surgery candidates. PTU might be preferred over methimazole just before and/or during the first trimester of pregnancy due to the occurrence of birth defects with methimazole during this timeframe. A medication guide has been developed and is to be given to patients when they fill PTU prescriptions. The guide alerts patients to the signs and symptoms of hepatotoxicity. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. Genzyme receives FDA approval for lumizyme for Pompe disease. Business Wire website. Available at: www.businesswire.com/portal/site/home/email/alert/?ndmViewId=news_view&newsLang=en&newsId=20100525006514. Accessed June 30, 2010.
2. Dennis M. FDA approves GlaxoSmithKline’s combination BPH drug Jalyn. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=B5F703CADB0347DF970A7B7542D99982&logRowId=369156. Accessed June 30, 2010.
3. Allergan receives FDA approval for Zymaxid ophthalmic solution. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/189397.php. Accessed June 29, 2010.
4. Forest and Merz announce FDA approval of Namenda XR for the treatment of moderate to severe dementia of the Alzheimer’s type. Forest Laboratories website. Available at: http://www.frx.com/news/PressRelease.aspx?ID=1440385. Accessed June 30, 2010.
5. Osiris Therapeutics receives FDA orphan drug designation for stem cell treatment for Type 1 diabetes. Osiris Therapeutics website. Available at: http://osiris.com/pdf/2010-05-04%20T1D%20Orphan%20Drug%20Designation.pdf. Accessed June 30, 2010.
6. FDA approves Merck’s new lung drug Dulera. The Economic Times website. Available at: http://economictimes.indiatimes.com/articleshow/6087079.cms. Accessed June 30, 2010.
7. Dane L. FDA approves AstraZeneca, Pozen’s Vimovo. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=0C2915EE4D2D47D287D41D90DFE4240D. Accessed June 30, 2010.
8. ACTOplus met XR available for diabetes. Monthly Prescribing Reference website. Available at: http://www.empr.com/actoplus-met-xr-available-for-diabetes/article/172985/. Accessed June 30, 2010.
9. Dennis M. Roche’s Lucentis garners expanded FDA approval for macular oedema. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=5146664F5A4C48108209D15EA744A614&logRowId=370643. Accessed June 30, 2010.
10. Rybix ODT launched for moderate to moderately severe pain. Monthly Prescribing Reference website. Available at: http://www.empr.com/rybix-odt-launched-for-moderate-to-moderately-severe-pain/article/172743/. Accessed June 30, 3010.
11. Dennis M. Sanofi-Aventis begins late-stage study of Multaq in patients with permanent AF. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=E43104A2DB604649A812E69C58F89304&logRowId=364228. Accessed July 7, 2010.
12. FDA accepts NDA for Duexa for ulcer risk reduction in arthritis patients. Monthly Prescribing Reference website. Available at: http://www.empr.com/fda-accepts-nda-for-duexa-for-ulcer-risk-reduction-in-arthritis-patients/article/171054/. Accessed July 7, 2010.
13. Salix Pharmaceuticals announces NDA submission for Xifaxan550 for treatment of non-constipation irritable bowel syndrome. Salix Pharmaceuticals website. Available at: http://salix.com/news/stories/20100608.aspx. Accessed June 9, 2010.
14. AstraZeneca and Targacept initiate Phase 3 clinical development of TC-5214 as an adjunct treatment for major depressive disorder. Targacept website. Available at: http://www.targacept.com/wt/page/pr_1277240993. Accessed June 29, 2010.
15. Clinical Data, Inc. announces FDA acceptance of new drug application for Vilazodone for the treatment of major depressive disorder. Clinical Data Inc. website. Available at: http://clda.com/uploads/CLDA%20NDA%20acceptance%20FINAL.pdf. Accessed July 7, 2010.
16. Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label change. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm213264.htm. Accessed July 8, 2010.
17. FDA Drug Safety Communication: New boxed warning on severe liver injury with propylthiouracil. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm209023.htm. Accessed July 8, 2010.

New Drugs, Devices, Indications, and Approvals

• Alglucosidase alfa (Lumizyme) has been approved by the FDA for the treatment of patients older than 8 with late (noninfantile) onset Pompe disease (GAA deficiency) who do not have evidence of cardiac hypertrophy.¹
• Dutasteride and tamsulosin (Jalyn) has been approved by the FDA in a fixed-dose combination product for treating symptomatic benign prostatic hypertrophy.²
• Gatifloxacin ophthalmic solution 0.5% (Zymaxid) has been approved by the FDA to treat bacterial conjunctivitis caused by susceptible bacterial strains.³ It has the highest concentration of gatifloxacin ophthalmic on the U.S. market.
• Memantine hydrochloride (Namenda XR) has been approved by the FDA as an extended-release product to treat moderate to severe dementia of the Alzheimer's type.⁴ It is available as a 28 mg, once-daily dosage form. The immediate-release product is dosed twice daily.
• Mesenchymal stem cells for intravenous infusion (MSCs, Prochymal) formulated into Prochymal has been granted orphan drug status to treat Type 1 diabetes mellitus (T1DM).⁵ This agent is in Phase 2 clinical trials in a collaboration with the Juvenile Diabetes Research Foundation as a treatment for patients with newly diagnosed T1DM.
• Mometasone furoate/formoterol fumarate (Dulera) has been approved by the FDA as a combination treatment for asthmatics aged 12 and older.⁶
• Naproxen/esomeprazole (Vimovo) has been approved by the FDA as a fixed combination for patients with arthritis who are at risk for developing gastric ulcers.⁷
• Pioglitazone/metformin (ACTOplus met XR) has been approved by the FDA in an extended-release fixed combination for treating Type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise.⁸
• Ranibizumab (Lucentis) has received a new indication from the FDA for treating retinal vein occlusion.⁹ The original approval of ranibizumab was for wet age-related macular degeneration.
• Tramadol HCl, orally disintegrating tablets (Rybix ODT), have been approved by the FDA for treating moderate to moderately severe pain in patients 16 years of age and older.¹⁰

Pipeline

• Dronedarone (Multaq) is being investigated as to whether it can reduce major cardiovascular events in patients being treated with the agent for atrial fibrillation.¹¹ Study endpoints will include a reduction in a major cardiovascular event such as stroke or myocardial infarction, or a reduction in cardiovascular hospitalization or death.
• The combination product ibuprofen and famotidine (to be known as Duexa) has been filed as a new drug application (NDA) for reducing the risk of developing upper gastrointestinal (GI) ulcers in patients with pain and arthritis.¹² Two Phase 3 trials showed about a 50% reduction in GI ulcers in combination treatment compared with ibuprofen alone.
• Rifaximin (Xifaxan) has been submitted to the FDA at its higher dose (550 mg) for treatment of nonconstipation irritable bowel syndrome (Non-C-IBS) and IBS-related bloating.¹³ Rifaximin already has approval from the FDA for hepatic encephalopathy and diarrhea.
• TC-5214 has begun Phase 3 clinical trials.¹⁴ It is a nicotinic channel blocker for the adjunctive treatment of major depressive disorder in adults who have had an inadequate response to selective serotonin reuptake inhibitors (SSRIs) or serotonin/norepinephrine reuptake inhibitors (SNRIs). A Phase 2 study evaluating TC-5214 as a second-line (“switch”) monotherapy is planned for this year.
• An NDA for vilazodone has been filed for treating major depressive disorder.¹⁵ It is a dual-acting potent and selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist.

Safety, Warnings, and Label Changes

• Tramadol and tramadol/acetaminophen have undergone a label change related to strengthened warnings of the risk of suicide for patients who are addiction-prone, taking tranquilizers, drinking alcohol, or taking other central-nervous-system-active drugs.¹⁶ Addictive effects might occur when tramadol is combined with alcohol, other opioids, or illicit drugs that have central-nervous-system-depressive effects. Serious potential consequences of overdosage are CNS and/or respiratory depression, and death.
• Earlier this year, the FDA once again updated the warning related to severe liver injury related to the use of propylthiouracil (PTU).¹⁷ This time, PTU has garnered a boxed warning, which includes reports of severe hepatotoxicity and acute liver failure in both adults and children. Some of these reactions were fatal. Use of PTU should be reserved for patients who do not tolerate other treatments for hyperthyroidism, such as methimazole, radioactive iodine, or are not surgery candidates. PTU might be preferred over methimazole just before and/or during the first trimester of pregnancy due to the occurrence of birth defects with methimazole during this timeframe. A medication guide has been developed and is to be given to patients when they fill PTU prescriptions. The guide alerts patients to the signs and symptoms of hepatotoxicity. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. Genzyme receives FDA approval for lumizyme for Pompe disease. Business Wire website. Available at: www.businesswire.com/portal/site/home/email/alert/?ndmViewId=news_view&newsLang=en&newsId=20100525006514. Accessed June 30, 2010.
2. Dennis M. FDA approves GlaxoSmithKline’s combination BPH drug Jalyn. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=B5F703CADB0347DF970A7B7542D99982&logRowId=369156. Accessed June 30, 2010.
3. Allergan receives FDA approval for Zymaxid ophthalmic solution. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/189397.php. Accessed June 29, 2010.
4. Forest and Merz announce FDA approval of Namenda XR for the treatment of moderate to severe dementia of the Alzheimer’s type. Forest Laboratories website. Available at: http://www.frx.com/news/PressRelease.aspx?ID=1440385. Accessed June 30, 2010.
5. Osiris Therapeutics receives FDA orphan drug designation for stem cell treatment for Type 1 diabetes. Osiris Therapeutics website. Available at: http://osiris.com/pdf/2010-05-04%20T1D%20Orphan%20Drug%20Designation.pdf. Accessed June 30, 2010.
6. FDA approves Merck’s new lung drug Dulera. The Economic Times website. Available at: http://economictimes.indiatimes.com/articleshow/6087079.cms. Accessed June 30, 2010.
7. Dane L. FDA approves AstraZeneca, Pozen’s Vimovo. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=0C2915EE4D2D47D287D41D90DFE4240D. Accessed June 30, 2010.
8. ACTOplus met XR available for diabetes. Monthly Prescribing Reference website. Available at: http://www.empr.com/actoplus-met-xr-available-for-diabetes/article/172985/. Accessed June 30, 2010.
9. Dennis M. Roche’s Lucentis garners expanded FDA approval for macular oedema. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=5146664F5A4C48108209D15EA744A614&logRowId=370643. Accessed June 30, 2010.
10. Rybix ODT launched for moderate to moderately severe pain. Monthly Prescribing Reference website. Available at: http://www.empr.com/rybix-odt-launched-for-moderate-to-moderately-severe-pain/article/172743/. Accessed June 30, 3010.
11. Dennis M. Sanofi-Aventis begins late-stage study of Multaq in patients with permanent AF. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=E43104A2DB604649A812E69C58F89304&logRowId=364228. Accessed July 7, 2010.
12. FDA accepts NDA for Duexa for ulcer risk reduction in arthritis patients. Monthly Prescribing Reference website. Available at: http://www.empr.com/fda-accepts-nda-for-duexa-for-ulcer-risk-reduction-in-arthritis-patients/article/171054/. Accessed July 7, 2010.
13. Salix Pharmaceuticals announces NDA submission for Xifaxan550 for treatment of non-constipation irritable bowel syndrome. Salix Pharmaceuticals website. Available at: http://salix.com/news/stories/20100608.aspx. Accessed June 9, 2010.
14. AstraZeneca and Targacept initiate Phase 3 clinical development of TC-5214 as an adjunct treatment for major depressive disorder. Targacept website. Available at: http://www.targacept.com/wt/page/pr_1277240993. Accessed June 29, 2010.
15. Clinical Data, Inc. announces FDA acceptance of new drug application for Vilazodone for the treatment of major depressive disorder. Clinical Data Inc. website. Available at: http://clda.com/uploads/CLDA%20NDA%20acceptance%20FINAL.pdf. Accessed July 7, 2010.
16. Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label change. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm213264.htm. Accessed July 8, 2010.
17. FDA Drug Safety Communication: New boxed warning on severe liver injury with propylthiouracil. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm209023.htm. Accessed July 8, 2010.

More than 400 people attended the Pediatric Hospital Medicine annual conference July 22-25 in Minneapolis. The annual meeting is the premier networking and educational event for pediatric hospitalists and is sponsored by the American Academy of Pediatrics (AAP), SHM, and the Academic Pediatric Association (APA).

Innovation and improvement were popular topics throughout the conference. Keynote speaker George Buckley, CEO of manufacturing and technology conglomerate 3M, spoke about inspiring innovation, and a large percentage of the sessions and posters had quality-improvement (QI) themes. Experts from Cincinnati Children’s Hospital, led by Steve Muething, MD, assistant vice president of patient safety, and Shannon Phillips, MD, MPH, Cleveland Clinic’s patient safety officer, guided several popular sessions on QI.

A major innovation announced at the conference was the planned launch of a journal of pediatric hospital medicine, which will be sponsored by the AAP. (Update 09.14.2010--The journal has yet to officially announce an editor).

Research presentations have continued to increase in this young field, and the meeting was full of poster and platform presentations in the areas of clinical research, QI, educational research, and health services research. Vineeta Mittal, MD, of the University of Texas Southwestern and Children’s Medical Center in Dallas presented research on family-centered rounds, which was recently published in Pediatrics and picked up by the National Association of Children’s Hospitals (NACHRI) for dissemination.¹ Patrick Brady, MD, of Cincinnati Children’s Hospital presented his research on short- versus long-course IV therapy for pediatric urinary tract infections, also published in Pediatrics.²

Other buzzed-about sessions included Vanderbilt University pediatric hospitalist Dr. Paul Hain’s ambitious attempt to create a PHM performance dashboard, and a case of “situational” epilepsy presented by Dr. Lisa Zaoutis of CHOP.

As in years past, the hottest ticket was for the luncheon presentation of the “Top Articles in Pediatric Hospital Medicine,” paneled this year by Drs. John Pope, Kris Rehm, and Brian Alverson. Raj Srivastava, MD, of Primary Children’s Medical Center in Salt Lake City and chairperson of the Pediatric Research in Inpatient Settings network, announced that the network had been awarded major grant funding.

Dan Rauch, MD, chair of the AAP’s Section on Hospital Medicine, dropped the biggest bombshell of all: He announced that the American Board of Pediatrics will support the development of pediatric HM as a full-fledged subspecialty in the near future. TH

Dr. Ralston is associate professor of pediatrics and chief of the division of inpatient pediatrics at the University of Texas Health Science Center in San Antonio, and medical director of inpatient services at Christus Santa Rosa Children’s Hospital.

References

1. Mittal VS, Sigrest T, Ottolini MC, et al. Family-centered rounds on pediatric wards: a PRIS network survey of U.S. and Canadian hospitalists. Pediatrics. 2010;126(1):37-43.
2. Brady PW, Conway PH, Goudie A. Length of intravenous antibiotic therapy and treatment failure in infants with urinary track infections. Pediatrics. 2010;126(2):196-203.

More than 400 people attended the Pediatric Hospital Medicine annual conference July 22-25 in Minneapolis. The annual meeting is the premier networking and educational event for pediatric hospitalists and is sponsored by the American Academy of Pediatrics (AAP), SHM, and the Academic Pediatric Association (APA).

Innovation and improvement were popular topics throughout the conference. Keynote speaker George Buckley, CEO of manufacturing and technology conglomerate 3M, spoke about inspiring innovation, and a large percentage of the sessions and posters had quality-improvement (QI) themes. Experts from Cincinnati Children’s Hospital, led by Steve Muething, MD, assistant vice president of patient safety, and Shannon Phillips, MD, MPH, Cleveland Clinic’s patient safety officer, guided several popular sessions on QI.

A major innovation announced at the conference was the planned launch of a journal of pediatric hospital medicine, which will be sponsored by the AAP. (Update 09.14.2010--The journal has yet to officially announce an editor).

Research presentations have continued to increase in this young field, and the meeting was full of poster and platform presentations in the areas of clinical research, QI, educational research, and health services research. Vineeta Mittal, MD, of the University of Texas Southwestern and Children’s Medical Center in Dallas presented research on family-centered rounds, which was recently published in Pediatrics and picked up by the National Association of Children’s Hospitals (NACHRI) for dissemination.¹ Patrick Brady, MD, of Cincinnati Children’s Hospital presented his research on short- versus long-course IV therapy for pediatric urinary tract infections, also published in Pediatrics.²

Other buzzed-about sessions included Vanderbilt University pediatric hospitalist Dr. Paul Hain’s ambitious attempt to create a PHM performance dashboard, and a case of “situational” epilepsy presented by Dr. Lisa Zaoutis of CHOP.

As in years past, the hottest ticket was for the luncheon presentation of the “Top Articles in Pediatric Hospital Medicine,” paneled this year by Drs. John Pope, Kris Rehm, and Brian Alverson. Raj Srivastava, MD, of Primary Children’s Medical Center in Salt Lake City and chairperson of the Pediatric Research in Inpatient Settings network, announced that the network had been awarded major grant funding.

Dan Rauch, MD, chair of the AAP’s Section on Hospital Medicine, dropped the biggest bombshell of all: He announced that the American Board of Pediatrics will support the development of pediatric HM as a full-fledged subspecialty in the near future. TH

Dr. Ralston is associate professor of pediatrics and chief of the division of inpatient pediatrics at the University of Texas Health Science Center in San Antonio, and medical director of inpatient services at Christus Santa Rosa Children’s Hospital.

References

1. Mittal VS, Sigrest T, Ottolini MC, et al. Family-centered rounds on pediatric wards: a PRIS network survey of U.S. and Canadian hospitalists. Pediatrics. 2010;126(1):37-43.
2. Brady PW, Conway PH, Goudie A. Length of intravenous antibiotic therapy and treatment failure in infants with urinary track infections. Pediatrics. 2010;126(2):196-203.

More than 400 people attended the Pediatric Hospital Medicine annual conference July 22-25 in Minneapolis. The annual meeting is the premier networking and educational event for pediatric hospitalists and is sponsored by the American Academy of Pediatrics (AAP), SHM, and the Academic Pediatric Association (APA).

Innovation and improvement were popular topics throughout the conference. Keynote speaker George Buckley, CEO of manufacturing and technology conglomerate 3M, spoke about inspiring innovation, and a large percentage of the sessions and posters had quality-improvement (QI) themes. Experts from Cincinnati Children’s Hospital, led by Steve Muething, MD, assistant vice president of patient safety, and Shannon Phillips, MD, MPH, Cleveland Clinic’s patient safety officer, guided several popular sessions on QI.

A major innovation announced at the conference was the planned launch of a journal of pediatric hospital medicine, which will be sponsored by the AAP. (Update 09.14.2010--The journal has yet to officially announce an editor).

Research presentations have continued to increase in this young field, and the meeting was full of poster and platform presentations in the areas of clinical research, QI, educational research, and health services research. Vineeta Mittal, MD, of the University of Texas Southwestern and Children’s Medical Center in Dallas presented research on family-centered rounds, which was recently published in Pediatrics and picked up by the National Association of Children’s Hospitals (NACHRI) for dissemination.¹ Patrick Brady, MD, of Cincinnati Children’s Hospital presented his research on short- versus long-course IV therapy for pediatric urinary tract infections, also published in Pediatrics.²

Other buzzed-about sessions included Vanderbilt University pediatric hospitalist Dr. Paul Hain’s ambitious attempt to create a PHM performance dashboard, and a case of “situational” epilepsy presented by Dr. Lisa Zaoutis of CHOP.

As in years past, the hottest ticket was for the luncheon presentation of the “Top Articles in Pediatric Hospital Medicine,” paneled this year by Drs. John Pope, Kris Rehm, and Brian Alverson. Raj Srivastava, MD, of Primary Children’s Medical Center in Salt Lake City and chairperson of the Pediatric Research in Inpatient Settings network, announced that the network had been awarded major grant funding.

Dan Rauch, MD, chair of the AAP’s Section on Hospital Medicine, dropped the biggest bombshell of all: He announced that the American Board of Pediatrics will support the development of pediatric HM as a full-fledged subspecialty in the near future. TH

Dr. Ralston is associate professor of pediatrics and chief of the division of inpatient pediatrics at the University of Texas Health Science Center in San Antonio, and medical director of inpatient services at Christus Santa Rosa Children’s Hospital.

References

1. Mittal VS, Sigrest T, Ottolini MC, et al. Family-centered rounds on pediatric wards: a PRIS network survey of U.S. and Canadian hospitalists. Pediatrics. 2010;126(1):37-43.
2. Brady PW, Conway PH, Goudie A. Length of intravenous antibiotic therapy and treatment failure in infants with urinary track infections. Pediatrics. 2010;126(2):196-203.

As the field of HM continues to mature, branch out, and is called upon to lead in the care of a larger cross-section of hospitalized patients, it is only natural that this includes the critically ill patient. Hospitalists already care for—and are the attending of record for—this patient population in most U.S. hospitals. It is my position that a technically proficient hospitalist service, which is facility-exclusive and offers 24/7 coverage, is able to offer the same quality of care as an intensivist group. An important feature of this model is the inclusion and “buy in” from community pulmonologists in order to provide backup and consultative assistance when warranted.

Our program at Westside Regional Medical Center in Plantation, Fla., has made great strides as we continue to integrate this model in the hospital. We are actively tracking ICU length of stay and throughput, incidence of ventilator-associated pneumonia (VAP), central-line infection rates, and ICU mortality.

I believe that a clinically competent and aggressive HM service is able to drive down costs and generate revenue by establishing clinically beneficial quality-improvement (QI) protocols; drive down ICU length of stay; provide effective and timely procedural services; and incur a lower cost burden (i.e., hospitalists cost less than intensivists). And I believe all of these benefits are available without sacrificing quality or patient care.

Leadership from medical staff and administration is imperative to establish the appropriate vision and drive toward hospitalist/intensivist implementation. Finding the right supporting physicians who bring excitement and energy is equally as important. Establishing expectations for skill sets, as well as the opportunity and mechanism by which these skill sets might be acquired and refined, is a must. The following technical skills should be required of hospitalist/intensivists:

• Ultrasound-guided central line insertion;
• PICC line insertion;
• Endotracheal intubation;
• Advanced airway management;
• Thoracostomy tube insertion;
• Arterial-line insertion;
• Transvenous pacing wire insertion;
• Lumbar puncture;
• Thoracentesis; and
• Paracentesis.

An important starting point is the identification of skill sets for each hospitalist. Once this information is ascertained, the next step is to understand what the credentialing requirements for the individual procedures are. This usually consists of a certain number of “logged” cases, which must be put forward for review by the medical staff leadership. Most physicians completing residency are required to keep a procedural log where cases are documented. Any deficiencies within the log can be supplemented by establishing a practice log where proctored cases are documented until the recommended number of cases are completed and put forward for credentialing.

Obtaining buy-in from the medical staff is important. They can serve as allies in many areas, specifically as proctors in the credentialing process. The key to successful interface is in awakening them to the beneficial impact a service such as this can have on patients and on the lifestyle of providers.

As an example, before our group started the hybrid model at Westside, the nursing staff would call anesthesia to evaluate patients for endotracheal intubation. This system took anesthesia away from its OR cases, causing delays and frustration. After a conversation, the anesthesia director realized the benefits that would come with assisting the hospitalists in becoming more proficient with intubations. This same scenario has been true in our experience with ED physicians, cardiothoracic surgeons (chest tubes), and so on.

Other resources for hospitalists include the National Procedure Institute, which offers CME credit and certification toward “Hospitalist Procedures.” Additionally, difficult airway or advanced airway courses provide certification.

Hospitalists have long been called on to provide emergency services for unstable patients via rapid response or codes. In many facilities hospitalists serve as the lead physicians in the management of critically ill patients. Our hospitalist model serves as a great launching pad for the development and evolution of this new breed of physician.

There exists no clinical evidence to assert inferiority between the care provided by an in-house, 24/7 hospitalist group with assistance from pulmonary medicine versus an intensivist group. It is my belief that if the appropriate infrastructure, fostered skill sets, pulmonologist partnership, and QI protocols are implemented, there will be no measurable difference in scope of care or outcomes.

The inpatient management of critically ill and unstable patients continues to be a significant and important subgroup of hospital patient populations. As patients continue to live longer with debilitating chronic diseases, the fallout from decompensation can be devastating. Many facilities have hospitalists leading the charge in the care of these patients. It is undeniable that the next evolution in HM will require a more proactive inpatient physician, with both the clinical and technical acumen to manage all patients across the hospital spectrum.

Ulises A. Perez, MD,

medical director, hospitalist division,

Westside Regional Medical Center, Plantation, Fla.,

Kendall Regional Medical Center, Miami

As the field of HM continues to mature, branch out, and is called upon to lead in the care of a larger cross-section of hospitalized patients, it is only natural that this includes the critically ill patient. Hospitalists already care for—and are the attending of record for—this patient population in most U.S. hospitals. It is my position that a technically proficient hospitalist service, which is facility-exclusive and offers 24/7 coverage, is able to offer the same quality of care as an intensivist group. An important feature of this model is the inclusion and “buy in” from community pulmonologists in order to provide backup and consultative assistance when warranted.

Our program at Westside Regional Medical Center in Plantation, Fla., has made great strides as we continue to integrate this model in the hospital. We are actively tracking ICU length of stay and throughput, incidence of ventilator-associated pneumonia (VAP), central-line infection rates, and ICU mortality.

I believe that a clinically competent and aggressive HM service is able to drive down costs and generate revenue by establishing clinically beneficial quality-improvement (QI) protocols; drive down ICU length of stay; provide effective and timely procedural services; and incur a lower cost burden (i.e., hospitalists cost less than intensivists). And I believe all of these benefits are available without sacrificing quality or patient care.

Leadership from medical staff and administration is imperative to establish the appropriate vision and drive toward hospitalist/intensivist implementation. Finding the right supporting physicians who bring excitement and energy is equally as important. Establishing expectations for skill sets, as well as the opportunity and mechanism by which these skill sets might be acquired and refined, is a must. The following technical skills should be required of hospitalist/intensivists:

• Ultrasound-guided central line insertion;
• PICC line insertion;
• Endotracheal intubation;
• Advanced airway management;
• Thoracostomy tube insertion;
• Arterial-line insertion;
• Transvenous pacing wire insertion;
• Lumbar puncture;
• Thoracentesis; and
• Paracentesis.

An important starting point is the identification of skill sets for each hospitalist. Once this information is ascertained, the next step is to understand what the credentialing requirements for the individual procedures are. This usually consists of a certain number of “logged” cases, which must be put forward for review by the medical staff leadership. Most physicians completing residency are required to keep a procedural log where cases are documented. Any deficiencies within the log can be supplemented by establishing a practice log where proctored cases are documented until the recommended number of cases are completed and put forward for credentialing.

Obtaining buy-in from the medical staff is important. They can serve as allies in many areas, specifically as proctors in the credentialing process. The key to successful interface is in awakening them to the beneficial impact a service such as this can have on patients and on the lifestyle of providers.

As an example, before our group started the hybrid model at Westside, the nursing staff would call anesthesia to evaluate patients for endotracheal intubation. This system took anesthesia away from its OR cases, causing delays and frustration. After a conversation, the anesthesia director realized the benefits that would come with assisting the hospitalists in becoming more proficient with intubations. This same scenario has been true in our experience with ED physicians, cardiothoracic surgeons (chest tubes), and so on.

Other resources for hospitalists include the National Procedure Institute, which offers CME credit and certification toward “Hospitalist Procedures.” Additionally, difficult airway or advanced airway courses provide certification.

Hospitalists have long been called on to provide emergency services for unstable patients via rapid response or codes. In many facilities hospitalists serve as the lead physicians in the management of critically ill patients. Our hospitalist model serves as a great launching pad for the development and evolution of this new breed of physician.

There exists no clinical evidence to assert inferiority between the care provided by an in-house, 24/7 hospitalist group with assistance from pulmonary medicine versus an intensivist group. It is my belief that if the appropriate infrastructure, fostered skill sets, pulmonologist partnership, and QI protocols are implemented, there will be no measurable difference in scope of care or outcomes.

The inpatient management of critically ill and unstable patients continues to be a significant and important subgroup of hospital patient populations. As patients continue to live longer with debilitating chronic diseases, the fallout from decompensation can be devastating. Many facilities have hospitalists leading the charge in the care of these patients. It is undeniable that the next evolution in HM will require a more proactive inpatient physician, with both the clinical and technical acumen to manage all patients across the hospital spectrum.

Ulises A. Perez, MD,

medical director, hospitalist division,

Westside Regional Medical Center, Plantation, Fla.,

Kendall Regional Medical Center, Miami

As the field of HM continues to mature, branch out, and is called upon to lead in the care of a larger cross-section of hospitalized patients, it is only natural that this includes the critically ill patient. Hospitalists already care for—and are the attending of record for—this patient population in most U.S. hospitals. It is my position that a technically proficient hospitalist service, which is facility-exclusive and offers 24/7 coverage, is able to offer the same quality of care as an intensivist group. An important feature of this model is the inclusion and “buy in” from community pulmonologists in order to provide backup and consultative assistance when warranted.

Our program at Westside Regional Medical Center in Plantation, Fla., has made great strides as we continue to integrate this model in the hospital. We are actively tracking ICU length of stay and throughput, incidence of ventilator-associated pneumonia (VAP), central-line infection rates, and ICU mortality.

I believe that a clinically competent and aggressive HM service is able to drive down costs and generate revenue by establishing clinically beneficial quality-improvement (QI) protocols; drive down ICU length of stay; provide effective and timely procedural services; and incur a lower cost burden (i.e., hospitalists cost less than intensivists). And I believe all of these benefits are available without sacrificing quality or patient care.

Leadership from medical staff and administration is imperative to establish the appropriate vision and drive toward hospitalist/intensivist implementation. Finding the right supporting physicians who bring excitement and energy is equally as important. Establishing expectations for skill sets, as well as the opportunity and mechanism by which these skill sets might be acquired and refined, is a must. The following technical skills should be required of hospitalist/intensivists:

• Ultrasound-guided central line insertion;
• PICC line insertion;
• Endotracheal intubation;
• Advanced airway management;
• Thoracostomy tube insertion;
• Arterial-line insertion;
• Transvenous pacing wire insertion;
• Lumbar puncture;
• Thoracentesis; and
• Paracentesis.

An important starting point is the identification of skill sets for each hospitalist. Once this information is ascertained, the next step is to understand what the credentialing requirements for the individual procedures are. This usually consists of a certain number of “logged” cases, which must be put forward for review by the medical staff leadership. Most physicians completing residency are required to keep a procedural log where cases are documented. Any deficiencies within the log can be supplemented by establishing a practice log where proctored cases are documented until the recommended number of cases are completed and put forward for credentialing.

Obtaining buy-in from the medical staff is important. They can serve as allies in many areas, specifically as proctors in the credentialing process. The key to successful interface is in awakening them to the beneficial impact a service such as this can have on patients and on the lifestyle of providers.

As an example, before our group started the hybrid model at Westside, the nursing staff would call anesthesia to evaluate patients for endotracheal intubation. This system took anesthesia away from its OR cases, causing delays and frustration. After a conversation, the anesthesia director realized the benefits that would come with assisting the hospitalists in becoming more proficient with intubations. This same scenario has been true in our experience with ED physicians, cardiothoracic surgeons (chest tubes), and so on.

Other resources for hospitalists include the National Procedure Institute, which offers CME credit and certification toward “Hospitalist Procedures.” Additionally, difficult airway or advanced airway courses provide certification.

Hospitalists have long been called on to provide emergency services for unstable patients via rapid response or codes. In many facilities hospitalists serve as the lead physicians in the management of critically ill patients. Our hospitalist model serves as a great launching pad for the development and evolution of this new breed of physician.

There exists no clinical evidence to assert inferiority between the care provided by an in-house, 24/7 hospitalist group with assistance from pulmonary medicine versus an intensivist group. It is my belief that if the appropriate infrastructure, fostered skill sets, pulmonologist partnership, and QI protocols are implemented, there will be no measurable difference in scope of care or outcomes.

The inpatient management of critically ill and unstable patients continues to be a significant and important subgroup of hospital patient populations. As patients continue to live longer with debilitating chronic diseases, the fallout from decompensation can be devastating. Many facilities have hospitalists leading the charge in the care of these patients. It is undeniable that the next evolution in HM will require a more proactive inpatient physician, with both the clinical and technical acumen to manage all patients across the hospital spectrum.

Ulises A. Perez, MD,

medical director, hospitalist division,

Westside Regional Medical Center, Plantation, Fla.,

Kendall Regional Medical Center, Miami

The mark of any great society is balance—balance between the production realized today and the preservation of “production capacity” to ensure the same or greater production in the future. HM is not exempt from this fundamental tenet. What we do now in the way of advancing quality, efficiency, and patient safety will matter little if our contributions are not sustained by the generation that follows us.

It is tempting to think that the issue of how we train residents is germane only to universities, but the reality is that it affects us all. There are 126 “university” medical school programs, but there are 384 residency programs, most of which are within community-based hospitals. The result is that most hospitalists encounter resident physicians in some capacity, and all hospitalists will encounter the results of residency training when they welcome a new recruit to their ranks.

The education and socialization of our residents will define the character of the hospitalists of the future. But the “residency” in which most of us trained does not exist anymore: The duty-hours changes and additional training requirements have dramatically changed the landscape of residency training in the past 10 years, and another series of sea changes is underway. As with all things HM, we again have a choice: Be reactive, wait for the dust to clear, and then lament the results, or be proactive and see this change for what it is—an opportunity to improve healthcare quality now, and in the future.

The ACGME

HM felt the impact of the first wave of duty-hours restrictions beginning in 2003, as many training programs opted to employ hospitalists to provide the coverage that could no longer be maintained by residents working under tighter admission caps and duty-hour restrictions. In doing so, hospitalists have provided a valuable service in preserving the integrity of training environments and fidelity to the Accreditation Council for Graduate Medical Education (ACGME) regulations (more than 85% of training programs have hospitalists working in their systems). But the model of hospitalists working solely as “resident-extenders” is not sustainable.

First, hospitalists who work solely on nonteaching services are at great risk of burning out, especially if the distribution of patients has been manipulated such that the more interesting patients are funneled away from the hospitalist’s service to the teaching service. Second, there is a risk in perception: In models in which the hospitalist is solely the “overflow cap coverage” or the night-float physician (i.e., the resident-extender), residents come to see hospitalists as the “PGY-4, 5, 6 …” physicians—that is, the physician who becomes a resident for life. The result is a serious pipeline issue for us, as the most talented resident physicians are unlikely to forego subspecialty training for a career in HM if hospitalists are perceived as perpetual residents.

The solution is simple: The hospitalist’s role in training environments has to be more than merely solving admission cap or duty-hour issues. It is fine for hospitalists to operate nonteaching services, but the hospitalist also has to be a part of the fulfillment that comes with overseeing teaching services. Further, residents have to see the hospitalist career for what it actually is: Academic or not, HM is much more than merely clinical service. HM is about the value-added services of system interventions to improve quality and patient safety; it is about developing a career as a systems architect. Getting the best and brightest residents to choose HM as a career is contingent upon residents seeing hospitalists in the training environment who are happy and fulfilled in the execution of this career goal.

The hospitalist’s plight was helped substantially on June 23, when ACGME released for comment the revised Common Program Requirements (www.acgme.org). The duty-hours changes are unlikely to substantially alter hospitalists’ lives; the only significant change was a limitation on intern shift durations to fewer than 16 hours in a row (upper-level residents still operate under the 24+6 hour rule, with increased flexibility to stay longer by volition). But the interesting part of the new requirements is an augmented focus on teaching residents transitions-of-care skills, improving direct supervision of residents, and constructing educational systems that minimize handoffs.

There is no specialty that is as suited as HM for fulfilling these unique (and, as of yet, unmet) requirements. Transitions, quality, being present on the hospital wards … this is what we do. And requiring instruction in transitions and quality is an unprecedented leverage point for HM to advance the quality of future physicians. How great it would be to attend HM20 and realize that the attendees had already learned the “Quality 101” lessons (i.e., those we are currently teaching at our annual meeting) as part of their residency? Freed from the need to do basic quality sessions, the content of the annual meeting could escalate to even higher-level principles that would result in substantial and sustainable quality improvement (QI).

MedPAC and GME Funding

Simultaneous with the ACGME changes are changes at the Medicare Payment Advisory Committee (MedPAC), the advisory organization responsible for recommending changes in the distribution of Centers for Medicare and Medicaid Services (CMS) funds to support graduate medical education. CMS is the primary funding agent for residency training. Each hospital receives direct medical expenditures to cover a resident’s salary and benefits. Each hospital has a pre-set per-resident allotment, or PRA. This number varies by hospital, but the average is $100,000 per resident. CMS reimburses the hospital a percentage of this number based upon the percentage of hospital days occupied by Medicare patients (e.g., 35% Medicare days=$35,000 per resident).

The hospital also receives indirect medical expenditures, or IME. IME is not a distinct payment to the hospital, but rather an “inflator” of the clinical-care payments the hospital receives from CMS. IME is paid to the hospital under the presumption that a typical training facility incurs greater cost due to higher patient severity, a higher indigent care percentage, and has higher resource utilization due to residents’ excessive testing, etc. The final presumption is that support is needed for the educational infrastructure (i.e., supervision and teaching).

IME is not inconsequential to a hospital; depending upon the payor mix, a 200-bed hospital might have from $4 million to $8 million in annual IME payments. CMS’ total IME payments to hospitals is more than $6 billion a year. Each hospital’s IME revenue can be found at www.graham-center.org/online/graham/home/tools-resources/data-tables/dt001-gme-2007.html.

The game-changing event occurred in April, when MedPAC announced its intent to reassess the mechanisms of IME funding, with a vision of IME funding eventually being linked to a hospital’s training programs’ ability to demonstrate substantial improvement in quality and patient safety. And here is the leverage point that is a unique opportunity for hospitalists in the training environment. For many hospitalists, especially if employed directly by the hospital, there is little financial incentive to engaging on a teaching service. The ACGME caps limit the service size, and this in turn limits the possible RVUs. Up until now, asking the hospital to compensate for teaching time (i.e., EVUs) was a pipe dream. But the linking of IME funding to quality outcomes (and quality instruction to residents) could change all of that.

If you put the two together: ACGME calling for instruction in quality and transitions, plus MedPAC calling for payments linked to resident outcomes in quality and patient safety, you have one inescapable conclusion—the residency of the future will hinge upon having supervisors with the necessary expertise to ensure that residents participate in, and understand the principles of, patient safety and quality as a part of the residency curriculum. And the people who can ensure that goal are likely to be in a position to warrant compensation for doing so.

Who is better to do this than the hospitalist?

SHM’s Proactive Strategy

This is the opportune time for HM to advance its stature as a profession and to ensure its future via a pipeline of residents adequately training in quality and patient safety. But it is not enough to merely wish for this to happen. There are real barriers that have kept hospitalists from being more intimately involved in physician training, the first of which is age.

HM is a young specialty (the average hospitalist is 37; the average HM leader is 41), and its youth makes it hard to compete with older subspecialists/generalists who have more experience in education. But deficits in experience can be compensated by additional training.

The Academic Hospitalist Academy (AHA)—cosponsored by SHM, the Society of General Internal Medicine (SGIM), and the Association of Chiefs and Leaders of General Internal Medicine (ACLGIM)—is the key to the strategy of catching up quickly. The academy will convene this month outside of Atlanta, and it is very important that each training facility think about sending one of its hospitalists to receive the advanced training in education necessary to compensate for not having years of experience in medical education. Academy details are available at http://academichospitalist.org.

SHM’s initiatives on this front do not stop with the academy. Over the past three months, Kevin O’Leary, MD, and his Quality Improvement Education Committee have been furiously building a “Quality and Patient Safety” curriculum, with a target audience of new hospitalists and resident physicians. The vision is to create a Web-based, interactive curriculum that teaches resident physicians the basics of quality and patient safety, design projects with their colleagues (under the supervision of their hospitalist mentor), and track their data to see real-time results.

Unlike other curricula on the market, the SHM Quality Curriculum for residents will be dynamic, requiring participating institutions commit to SHM’s modus operandi of mentored implementation by sponsoring a hospitalist to receive the training necessary to put the curriculum in motion. To this end, SHM has collaborated with the Alliance for Internal Medicine (AIM) in co-sponsoring the Quality Academy, with a focus on how to teach quality and patient safety. Jen Meyers, MD, FHM, and Jeff Glasheen, MD, SFHM, will be leading the team responsible for the development of this Quality Training Course, which should emerge in the fall of 2011.

As this project proceeds, Paul Grant, MD, chair of the Early Career Hospitalist Committee, and Cheryl O’Malley, MD, chair of the Pipeline Committee, will provide counsel. Both of these groups will continue efforts to improve the process by which residents transition from residency to HM practice, and supporting young physicians with distance mentoring.

The SHM vision of our production capacity is simple: Bring in the best and brightest hospitalists who are interested in teaching quality and patient safety, train them in the fundamentals of medical education, provide them with an “off the net” curriculum for how to teach quality, then return them to their respective training environments to coach residents on the principles of quality.

Training programs that invest in this vision will reap the rewards of fidelity to the new ACGME requirements. Hospitals that support such a vision will receive assurances, should MedPAC’s recommendation come to fruition, that DME and IME funding is secure. Hospitalists investing in this vision will find a fulfilling career in quality education.

And all of us will find assurances that, for as good as things are right now for HM, the future will be even better. TH

Dr. Wiese is president of SHM.

The mark of any great society is balance—balance between the production realized today and the preservation of “production capacity” to ensure the same or greater production in the future. HM is not exempt from this fundamental tenet. What we do now in the way of advancing quality, efficiency, and patient safety will matter little if our contributions are not sustained by the generation that follows us.

It is tempting to think that the issue of how we train residents is germane only to universities, but the reality is that it affects us all. There are 126 “university” medical school programs, but there are 384 residency programs, most of which are within community-based hospitals. The result is that most hospitalists encounter resident physicians in some capacity, and all hospitalists will encounter the results of residency training when they welcome a new recruit to their ranks.

The education and socialization of our residents will define the character of the hospitalists of the future. But the “residency” in which most of us trained does not exist anymore: The duty-hours changes and additional training requirements have dramatically changed the landscape of residency training in the past 10 years, and another series of sea changes is underway. As with all things HM, we again have a choice: Be reactive, wait for the dust to clear, and then lament the results, or be proactive and see this change for what it is—an opportunity to improve healthcare quality now, and in the future.

The ACGME

HM felt the impact of the first wave of duty-hours restrictions beginning in 2003, as many training programs opted to employ hospitalists to provide the coverage that could no longer be maintained by residents working under tighter admission caps and duty-hour restrictions. In doing so, hospitalists have provided a valuable service in preserving the integrity of training environments and fidelity to the Accreditation Council for Graduate Medical Education (ACGME) regulations (more than 85% of training programs have hospitalists working in their systems). But the model of hospitalists working solely as “resident-extenders” is not sustainable.

First, hospitalists who work solely on nonteaching services are at great risk of burning out, especially if the distribution of patients has been manipulated such that the more interesting patients are funneled away from the hospitalist’s service to the teaching service. Second, there is a risk in perception: In models in which the hospitalist is solely the “overflow cap coverage” or the night-float physician (i.e., the resident-extender), residents come to see hospitalists as the “PGY-4, 5, 6 …” physicians—that is, the physician who becomes a resident for life. The result is a serious pipeline issue for us, as the most talented resident physicians are unlikely to forego subspecialty training for a career in HM if hospitalists are perceived as perpetual residents.

The solution is simple: The hospitalist’s role in training environments has to be more than merely solving admission cap or duty-hour issues. It is fine for hospitalists to operate nonteaching services, but the hospitalist also has to be a part of the fulfillment that comes with overseeing teaching services. Further, residents have to see the hospitalist career for what it actually is: Academic or not, HM is much more than merely clinical service. HM is about the value-added services of system interventions to improve quality and patient safety; it is about developing a career as a systems architect. Getting the best and brightest residents to choose HM as a career is contingent upon residents seeing hospitalists in the training environment who are happy and fulfilled in the execution of this career goal.

The hospitalist’s plight was helped substantially on June 23, when ACGME released for comment the revised Common Program Requirements (www.acgme.org). The duty-hours changes are unlikely to substantially alter hospitalists’ lives; the only significant change was a limitation on intern shift durations to fewer than 16 hours in a row (upper-level residents still operate under the 24+6 hour rule, with increased flexibility to stay longer by volition). But the interesting part of the new requirements is an augmented focus on teaching residents transitions-of-care skills, improving direct supervision of residents, and constructing educational systems that minimize handoffs.

There is no specialty that is as suited as HM for fulfilling these unique (and, as of yet, unmet) requirements. Transitions, quality, being present on the hospital wards … this is what we do. And requiring instruction in transitions and quality is an unprecedented leverage point for HM to advance the quality of future physicians. How great it would be to attend HM20 and realize that the attendees had already learned the “Quality 101” lessons (i.e., those we are currently teaching at our annual meeting) as part of their residency? Freed from the need to do basic quality sessions, the content of the annual meeting could escalate to even higher-level principles that would result in substantial and sustainable quality improvement (QI).

MedPAC and GME Funding

Simultaneous with the ACGME changes are changes at the Medicare Payment Advisory Committee (MedPAC), the advisory organization responsible for recommending changes in the distribution of Centers for Medicare and Medicaid Services (CMS) funds to support graduate medical education. CMS is the primary funding agent for residency training. Each hospital receives direct medical expenditures to cover a resident’s salary and benefits. Each hospital has a pre-set per-resident allotment, or PRA. This number varies by hospital, but the average is $100,000 per resident. CMS reimburses the hospital a percentage of this number based upon the percentage of hospital days occupied by Medicare patients (e.g., 35% Medicare days=$35,000 per resident).

The hospital also receives indirect medical expenditures, or IME. IME is not a distinct payment to the hospital, but rather an “inflator” of the clinical-care payments the hospital receives from CMS. IME is paid to the hospital under the presumption that a typical training facility incurs greater cost due to higher patient severity, a higher indigent care percentage, and has higher resource utilization due to residents’ excessive testing, etc. The final presumption is that support is needed for the educational infrastructure (i.e., supervision and teaching).

IME is not inconsequential to a hospital; depending upon the payor mix, a 200-bed hospital might have from $4 million to $8 million in annual IME payments. CMS’ total IME payments to hospitals is more than $6 billion a year. Each hospital’s IME revenue can be found at www.graham-center.org/online/graham/home/tools-resources/data-tables/dt001-gme-2007.html.

The game-changing event occurred in April, when MedPAC announced its intent to reassess the mechanisms of IME funding, with a vision of IME funding eventually being linked to a hospital’s training programs’ ability to demonstrate substantial improvement in quality and patient safety. And here is the leverage point that is a unique opportunity for hospitalists in the training environment. For many hospitalists, especially if employed directly by the hospital, there is little financial incentive to engaging on a teaching service. The ACGME caps limit the service size, and this in turn limits the possible RVUs. Up until now, asking the hospital to compensate for teaching time (i.e., EVUs) was a pipe dream. But the linking of IME funding to quality outcomes (and quality instruction to residents) could change all of that.

If you put the two together: ACGME calling for instruction in quality and transitions, plus MedPAC calling for payments linked to resident outcomes in quality and patient safety, you have one inescapable conclusion—the residency of the future will hinge upon having supervisors with the necessary expertise to ensure that residents participate in, and understand the principles of, patient safety and quality as a part of the residency curriculum. And the people who can ensure that goal are likely to be in a position to warrant compensation for doing so.

Who is better to do this than the hospitalist?

SHM’s Proactive Strategy

This is the opportune time for HM to advance its stature as a profession and to ensure its future via a pipeline of residents adequately training in quality and patient safety. But it is not enough to merely wish for this to happen. There are real barriers that have kept hospitalists from being more intimately involved in physician training, the first of which is age.

HM is a young specialty (the average hospitalist is 37; the average HM leader is 41), and its youth makes it hard to compete with older subspecialists/generalists who have more experience in education. But deficits in experience can be compensated by additional training.

The Academic Hospitalist Academy (AHA)—cosponsored by SHM, the Society of General Internal Medicine (SGIM), and the Association of Chiefs and Leaders of General Internal Medicine (ACLGIM)—is the key to the strategy of catching up quickly. The academy will convene this month outside of Atlanta, and it is very important that each training facility think about sending one of its hospitalists to receive the advanced training in education necessary to compensate for not having years of experience in medical education. Academy details are available at http://academichospitalist.org.

SHM’s initiatives on this front do not stop with the academy. Over the past three months, Kevin O’Leary, MD, and his Quality Improvement Education Committee have been furiously building a “Quality and Patient Safety” curriculum, with a target audience of new hospitalists and resident physicians. The vision is to create a Web-based, interactive curriculum that teaches resident physicians the basics of quality and patient safety, design projects with their colleagues (under the supervision of their hospitalist mentor), and track their data to see real-time results.

Unlike other curricula on the market, the SHM Quality Curriculum for residents will be dynamic, requiring participating institutions commit to SHM’s modus operandi of mentored implementation by sponsoring a hospitalist to receive the training necessary to put the curriculum in motion. To this end, SHM has collaborated with the Alliance for Internal Medicine (AIM) in co-sponsoring the Quality Academy, with a focus on how to teach quality and patient safety. Jen Meyers, MD, FHM, and Jeff Glasheen, MD, SFHM, will be leading the team responsible for the development of this Quality Training Course, which should emerge in the fall of 2011.

As this project proceeds, Paul Grant, MD, chair of the Early Career Hospitalist Committee, and Cheryl O’Malley, MD, chair of the Pipeline Committee, will provide counsel. Both of these groups will continue efforts to improve the process by which residents transition from residency to HM practice, and supporting young physicians with distance mentoring.

The SHM vision of our production capacity is simple: Bring in the best and brightest hospitalists who are interested in teaching quality and patient safety, train them in the fundamentals of medical education, provide them with an “off the net” curriculum for how to teach quality, then return them to their respective training environments to coach residents on the principles of quality.

Training programs that invest in this vision will reap the rewards of fidelity to the new ACGME requirements. Hospitals that support such a vision will receive assurances, should MedPAC’s recommendation come to fruition, that DME and IME funding is secure. Hospitalists investing in this vision will find a fulfilling career in quality education.

And all of us will find assurances that, for as good as things are right now for HM, the future will be even better. TH

Dr. Wiese is president of SHM.

The mark of any great society is balance—balance between the production realized today and the preservation of “production capacity” to ensure the same or greater production in the future. HM is not exempt from this fundamental tenet. What we do now in the way of advancing quality, efficiency, and patient safety will matter little if our contributions are not sustained by the generation that follows us.

It is tempting to think that the issue of how we train residents is germane only to universities, but the reality is that it affects us all. There are 126 “university” medical school programs, but there are 384 residency programs, most of which are within community-based hospitals. The result is that most hospitalists encounter resident physicians in some capacity, and all hospitalists will encounter the results of residency training when they welcome a new recruit to their ranks.

The education and socialization of our residents will define the character of the hospitalists of the future. But the “residency” in which most of us trained does not exist anymore: The duty-hours changes and additional training requirements have dramatically changed the landscape of residency training in the past 10 years, and another series of sea changes is underway. As with all things HM, we again have a choice: Be reactive, wait for the dust to clear, and then lament the results, or be proactive and see this change for what it is—an opportunity to improve healthcare quality now, and in the future.

The ACGME

HM felt the impact of the first wave of duty-hours restrictions beginning in 2003, as many training programs opted to employ hospitalists to provide the coverage that could no longer be maintained by residents working under tighter admission caps and duty-hour restrictions. In doing so, hospitalists have provided a valuable service in preserving the integrity of training environments and fidelity to the Accreditation Council for Graduate Medical Education (ACGME) regulations (more than 85% of training programs have hospitalists working in their systems). But the model of hospitalists working solely as “resident-extenders” is not sustainable.

First, hospitalists who work solely on nonteaching services are at great risk of burning out, especially if the distribution of patients has been manipulated such that the more interesting patients are funneled away from the hospitalist’s service to the teaching service. Second, there is a risk in perception: In models in which the hospitalist is solely the “overflow cap coverage” or the night-float physician (i.e., the resident-extender), residents come to see hospitalists as the “PGY-4, 5, 6 …” physicians—that is, the physician who becomes a resident for life. The result is a serious pipeline issue for us, as the most talented resident physicians are unlikely to forego subspecialty training for a career in HM if hospitalists are perceived as perpetual residents.

The solution is simple: The hospitalist’s role in training environments has to be more than merely solving admission cap or duty-hour issues. It is fine for hospitalists to operate nonteaching services, but the hospitalist also has to be a part of the fulfillment that comes with overseeing teaching services. Further, residents have to see the hospitalist career for what it actually is: Academic or not, HM is much more than merely clinical service. HM is about the value-added services of system interventions to improve quality and patient safety; it is about developing a career as a systems architect. Getting the best and brightest residents to choose HM as a career is contingent upon residents seeing hospitalists in the training environment who are happy and fulfilled in the execution of this career goal.

The hospitalist’s plight was helped substantially on June 23, when ACGME released for comment the revised Common Program Requirements (www.acgme.org). The duty-hours changes are unlikely to substantially alter hospitalists’ lives; the only significant change was a limitation on intern shift durations to fewer than 16 hours in a row (upper-level residents still operate under the 24+6 hour rule, with increased flexibility to stay longer by volition). But the interesting part of the new requirements is an augmented focus on teaching residents transitions-of-care skills, improving direct supervision of residents, and constructing educational systems that minimize handoffs.

There is no specialty that is as suited as HM for fulfilling these unique (and, as of yet, unmet) requirements. Transitions, quality, being present on the hospital wards … this is what we do. And requiring instruction in transitions and quality is an unprecedented leverage point for HM to advance the quality of future physicians. How great it would be to attend HM20 and realize that the attendees had already learned the “Quality 101” lessons (i.e., those we are currently teaching at our annual meeting) as part of their residency? Freed from the need to do basic quality sessions, the content of the annual meeting could escalate to even higher-level principles that would result in substantial and sustainable quality improvement (QI).

MedPAC and GME Funding

Simultaneous with the ACGME changes are changes at the Medicare Payment Advisory Committee (MedPAC), the advisory organization responsible for recommending changes in the distribution of Centers for Medicare and Medicaid Services (CMS) funds to support graduate medical education. CMS is the primary funding agent for residency training. Each hospital receives direct medical expenditures to cover a resident’s salary and benefits. Each hospital has a pre-set per-resident allotment, or PRA. This number varies by hospital, but the average is $100,000 per resident. CMS reimburses the hospital a percentage of this number based upon the percentage of hospital days occupied by Medicare patients (e.g., 35% Medicare days=$35,000 per resident).

The hospital also receives indirect medical expenditures, or IME. IME is not a distinct payment to the hospital, but rather an “inflator” of the clinical-care payments the hospital receives from CMS. IME is paid to the hospital under the presumption that a typical training facility incurs greater cost due to higher patient severity, a higher indigent care percentage, and has higher resource utilization due to residents’ excessive testing, etc. The final presumption is that support is needed for the educational infrastructure (i.e., supervision and teaching).

IME is not inconsequential to a hospital; depending upon the payor mix, a 200-bed hospital might have from $4 million to $8 million in annual IME payments. CMS’ total IME payments to hospitals is more than $6 billion a year. Each hospital’s IME revenue can be found at www.graham-center.org/online/graham/home/tools-resources/data-tables/dt001-gme-2007.html.

The game-changing event occurred in April, when MedPAC announced its intent to reassess the mechanisms of IME funding, with a vision of IME funding eventually being linked to a hospital’s training programs’ ability to demonstrate substantial improvement in quality and patient safety. And here is the leverage point that is a unique opportunity for hospitalists in the training environment. For many hospitalists, especially if employed directly by the hospital, there is little financial incentive to engaging on a teaching service. The ACGME caps limit the service size, and this in turn limits the possible RVUs. Up until now, asking the hospital to compensate for teaching time (i.e., EVUs) was a pipe dream. But the linking of IME funding to quality outcomes (and quality instruction to residents) could change all of that.

If you put the two together: ACGME calling for instruction in quality and transitions, plus MedPAC calling for payments linked to resident outcomes in quality and patient safety, you have one inescapable conclusion—the residency of the future will hinge upon having supervisors with the necessary expertise to ensure that residents participate in, and understand the principles of, patient safety and quality as a part of the residency curriculum. And the people who can ensure that goal are likely to be in a position to warrant compensation for doing so.

Who is better to do this than the hospitalist?

SHM’s Proactive Strategy

This is the opportune time for HM to advance its stature as a profession and to ensure its future via a pipeline of residents adequately training in quality and patient safety. But it is not enough to merely wish for this to happen. There are real barriers that have kept hospitalists from being more intimately involved in physician training, the first of which is age.

HM is a young specialty (the average hospitalist is 37; the average HM leader is 41), and its youth makes it hard to compete with older subspecialists/generalists who have more experience in education. But deficits in experience can be compensated by additional training.

The Academic Hospitalist Academy (AHA)—cosponsored by SHM, the Society of General Internal Medicine (SGIM), and the Association of Chiefs and Leaders of General Internal Medicine (ACLGIM)—is the key to the strategy of catching up quickly. The academy will convene this month outside of Atlanta, and it is very important that each training facility think about sending one of its hospitalists to receive the advanced training in education necessary to compensate for not having years of experience in medical education. Academy details are available at http://academichospitalist.org.

SHM’s initiatives on this front do not stop with the academy. Over the past three months, Kevin O’Leary, MD, and his Quality Improvement Education Committee have been furiously building a “Quality and Patient Safety” curriculum, with a target audience of new hospitalists and resident physicians. The vision is to create a Web-based, interactive curriculum that teaches resident physicians the basics of quality and patient safety, design projects with their colleagues (under the supervision of their hospitalist mentor), and track their data to see real-time results.

Unlike other curricula on the market, the SHM Quality Curriculum for residents will be dynamic, requiring participating institutions commit to SHM’s modus operandi of mentored implementation by sponsoring a hospitalist to receive the training necessary to put the curriculum in motion. To this end, SHM has collaborated with the Alliance for Internal Medicine (AIM) in co-sponsoring the Quality Academy, with a focus on how to teach quality and patient safety. Jen Meyers, MD, FHM, and Jeff Glasheen, MD, SFHM, will be leading the team responsible for the development of this Quality Training Course, which should emerge in the fall of 2011.

As this project proceeds, Paul Grant, MD, chair of the Early Career Hospitalist Committee, and Cheryl O’Malley, MD, chair of the Pipeline Committee, will provide counsel. Both of these groups will continue efforts to improve the process by which residents transition from residency to HM practice, and supporting young physicians with distance mentoring.

The SHM vision of our production capacity is simple: Bring in the best and brightest hospitalists who are interested in teaching quality and patient safety, train them in the fundamentals of medical education, provide them with an “off the net” curriculum for how to teach quality, then return them to their respective training environments to coach residents on the principles of quality.

Training programs that invest in this vision will reap the rewards of fidelity to the new ACGME requirements. Hospitals that support such a vision will receive assurances, should MedPAC’s recommendation come to fruition, that DME and IME funding is secure. Hospitalists investing in this vision will find a fulfilling career in quality education.

And all of us will find assurances that, for as good as things are right now for HM, the future will be even better. TH

Dr. Wiese is president of SHM.

Christina Payne, MD, is a third-year resident at Emory University Hospital in Atlanta who will begin her first hospitalist job, with Emory in September. In spite of her dearth of practical experience, she already has experience researching one of the most vexing problems confronting HM: how to improve transitions of care.

Dr. Payne has been studying the benefits of a structured electronic tool that generates a standardized sign-out list of a hospital team’s full census at the time of shift change, compared with the usual, highly variable sign-out practices of medical residents. At a poster presentation at Internal Medicine 2010 in April in Toronto, Dr. Payne and colleagues reported that residents using the tool were twice as confident at performing handoffs, had lower rates of perceived near-miss events, and were happier.¹

“Hospitalists everywhere are starting to realize the importance of trying to reduce opportunities for human error that occur during care transitions,” Dr. Payne says. “The biggest thing I learned from this research is the importance of standardizing the handoff process [with information communicated consistently].

“It is essential to keep communication lines open,” Dr. Payne adds. “No tool can replace the importance of communication between doctors and the need to sit down and talk. The ideal signout happens in a quiet room where the two of you can talk about active patients and achieve rapport. But, realistically, how often does that happen?”

Standardization is one of a handful of strategies hospitalists, researchers, and policymakers are using to tackle transitions—both in-hospital handoffs and post-discharge transitions—with outpatient care. Some hospitalists are using practice simulations and training strategies; others have implemented medication reconciliation checks at every discharge, checklists and other communication strategies, team-based quality-improvement (QI) initiatives, and new technologies to enhance and streamline communication. Some interventions follow the patient from the hospital to the community physician with a phone call, follow-up clinic, or other contact; others aim to empower the patient to be a better self-advocate. But for hospitalists, the challenge is to communicate the right amount of transfer information to the right receiver at the right time.

No matter the technique, the goal is the same: Improve the handoff and discharge process in a way that promotes efficiency and patient safety. And hospitalists are at the forefront of the changing landscape of care transitions.

Under the Microscope

Care transitions of all kinds are under the magnifying glass of national healthcare reform, with growing recognition of the need to make care safer and reduce the preventable, costly hospital readmissions caused by incomplete handoffs. Care transitions for hospitalists include internal handoffs, both at daily shift changes and at service changes when an outgoing provider is leaving after a period of consecutive daily shifts. These typically involve a sign-out process and face-to-face encounter, with some kind of written backup. One teaching institution reported that such handoffs take place 4,000 times per day in the hospital, or 1.6 million times per year.²

This is a complex problem and it needs a multifaceted solution. But this lies squarely within the hospitalist arena. We’re part of everything that happens in the hospital.

—Arpana Vidyarthi, MD, University of California at San Francisco

Geographical transitions can be from one floor or department to another, or out the hospital door to another facility or home. Transitions typically involve a discharge process and a written discharge summary. Care transitions also include hospital admissions, which put the hospitalist in the role of handoff receiver rather than initiator, plus a variety of other transitions involving nurses, physician extenders, and other practitioners.

Each transition is a major decision point in the course of a patient’s hospitalization; each transition also presents a time of heightened vulnerability (e.g., potential communication breakdowns, medication errors, patient anxiety or confusion, etc.). In fact, according to a Transitions of Care Consensus Policy Statement published in 2009 by SHM and five other medical societies, handoffs are ubiquitous in HM, with significant patient safety and quality deficiencies in handoffs existing in the current system.³

Poor communication at the time of handoff has been implicated in near-misses and adverse events in a variety of healthcare contexts, including 70% of hospital sentinel events studied by The Joint Commission, which named standardized handoffs (with an opportunity for interactive communication) as a National Patient Safety Goal in 2006.⁴ The federal government is studying care transitions, supporting demonstration projects for Medicare enrollees, and including readmission rates in national hospital report card data.

Dr. Arora

“Transitions of care and handoffs are a huge focus right now because of the increased fragmentation of care in the United States. Hospitalists are in charge of a greater percentage of hospitalized patients, which means more coordination of care is needed,” says Vineet Arora, MD, MA, FHM, assistant professor of medicine and associate director of the internal-medicine residency at the University of Chicago, and chair of the SHM task force on handoffs.

Inadequate communication and poor care transitions can undermine hospitalists’ best care-planning efforts, erode patients’ and families’ confidence and satisfaction with hospital care, and leave primary-care physicians (PCPs) feeling unsatisfied with the relationship. As many as 1 in 5 Medicare beneficiary hospitalizations result in a readmission within 30 days, and while not all of these are preventable, far too many are.⁵ Another prospective cohort study found that 1 in 5 patients discharged from the hospital to the home experienced an adverse event within three weeks of discharge.⁶ Complex comorbidities, advanced age, unknown PCP, and limited healthcare literacy present hospitalists with extremely difficult transitions.

Patient safety and cost control are the linchpins to national efforts to improve transitions of care. Dr. Arora recently coauthored an original research paper, which will be published in the Journal of Hospital Medicine in September, showing older hospitalized patients are twice as likely to report problems after discharge if their PCPs were not aware they were hospitalized.

“With escalating healthcare costs, people are looking at ways to save money and reduce redundant care,” Dr. Arora explains, pointing out, as an example, repeated tests resulting from inadequate communication between healthcare providers.

The System Must Change

“All of the effort we put into saving someone’s life—the years of experience, training, medical school, and residency—all of it comes to bear on that hospitalized patient. And it can all be unraveled at the time of discharge if it’s not handled properly,” says Arpana Vidyarthi, MD, a hospitalist and director of quality at the University of California at San Francisco.

Dr. Vidyarthi views in-hospital and discharge transitions as integrally related. “The analysis is similar, even if different techniques may be needed,” she says, adding that, fundamentally, it involves having a system that allows people—or forces them—to do the “right thing.”

That’s why achieving effective care transitions will require more than just a standardized tool or process, Dr. Vidyarthi says. “This is about understanding the ways people communicate and finding ways to train them to communicate better,” she says. “The problem we have is not a lack of information, but how to communicate what, to whom, and when.”

What’s really needed, Dr. Vidyarthi says, is a hospital’s commitment to more effective transitions and its hospitalists’ leadership in driving a comprehensive, multidisciplinary, team- and evidence-based QI process. The new process should be a QI-based solution to a hospital’s care-transitions issues. “Before you can standardize your process, you need to understand it,” she says. “This is a complex problem, and it needs a multifaceted solution. But this lies squarely within the hospitalist arena. We’re part of everything that happens in the hospital.

We created an intervention that automatically triggers an e-mail with the finalized test results to the responsible providers. The intervention creates a loop of communication between the inpatient attending and the PCP. What we hope to show in our research over the next year or two is whether the intervention actually increases awareness of test results by providers.

—Anuj Dalal, MD, Brigham and Women’s Hospital, Boston

Hospital administrators are looking to HM to solve transition and readmission problems now, says Tina Budnitz, MPH, BOOST Project Director (Better Outcomes for Older Adults through Safe Transitions). She expects the scrutiny from the C-suite, legislators, and watchdog groups to increase as the spotlight continues to shine on the healthcare system.

“Any hospitalist can act as a leader in their institution,” Budnitz says. “Be a change agent, pull a group together, and start asking questions: Do we have safe care-transitions practices and processes in place? Just by asking the right question, you can be a catalyst for the system.”

Budnitz also emphasizes the importance of teamwork in the hospital setting. “How can I help my teammates? What am I communicating to the nurses on rounds?” she says. “Can you initiate dialogue with your outpatient medical groups: ‘These faxes we’re sending you—is that information getting to you in ways and times that are helpful? And, by the way, when your patient is admitted, this information would really help me.’ ”

Dr. Arora

Innovative Strategies

One of the most important initiatives responding to concerns about care transitions is Project BOOST (www.hos pitalmedicine.org/BOOST), a comprehensive toolkit for improving a hospital’s transitions of care. The project aims to build a national consensus for best practices in transitions; collaborate with representatives from the Agency for Healthcare Research and Quality (AHRQ), the Centers for Medicare and Medicaid Services (CMS), and the Joint Commission; and develop a national resource library, Budnitz says.

“Project BOOST not only puts forth best practices for admitting patients, planning for discharge, and then doing the discharge, it also helps show facilities how to change their systems, with resources and tools for analyzing and re-engineering the system,” she says. “Sites get one-to-one assistance from a mentor.”

Six hospitals signed on to the pilot program in 2008; 24 more joined last year. In January, SHM announced a collaborative with the University of Michigan and Blue Cross Blue Shield of Michigan for 15 Michigan hospitals to receive training and mentorship starting in May. And last month, SHM and the California HealthCare Foundation announced a Project BOOST initiative for 20 of the health system’s hospitals (see “California Dreamin’”, p. 6). Other free resources offered on the BOOST Web portal include clinical, data collection, and project management tools. SHM also has a DVD that explains how to use the “teachback” method to improve communication with patients.

Jennifer Myers, MD, FHM, assistant professor of clinical medicine and patient-safety officer at the Hospital of the University of Pennsylvania in Philadelphia, is a Project BOOST participant who spearheaded a process change to improve the quality of her facility’s discharge summary, along with accompanying resident education.⁷ The discharge summary recently was integrated with the hospital’s electronic health record (EHR) system.

“We’ve gone from dictating the discharge summary to an electronic version completed by the hospitalist, with prompts for key components of the summary, which allows us to create summaries more efficiently—ideally on the day of discharge, but usually within 48 hours,” Dr. Myers says. “We previously researched whether teaching made a difference in the quality of discharges; we found that it did. So we look forward to standardizing our teaching approach around this important topic for all residents.”

Another care-transitions innovation receiving a lot of attention from the government and the private sector is Project RED (Re-Engineered Discharge), led by Brian Jack, MD, vice chair of the department of family medicine at Boston Medical Center. The Project RED research group develops and tests strategies to improve the hospital discharge process to promote patient safety and reduce rehospitalization rates.

“We used re-engineering tools borrowed from other fields, brought together experts from all over the hospital, divided up the whole discharge process, and identified key principles,” Dr. Jack explains. The resulting discharge strategy is reflected in an 11-item checklist of discrete, mutually reinforcing components, which have been shown to reduce rehospitalization rates by 32% while raising patient satisfaction.⁸ It includes comprehensive discharge and after-hospital plans, a nurse discharge advocate, and a medication reconciliation phone call to the patient. A virtual “patient advocate,” a computerized avatar named Louise, is now being tested. If successful, it will allow patients to interact with a touch-screen teacher of the after-care plan who has time to work at the patient’s pace.

Technology and Transitions

Dr. Chopra

Informatics can be a key player in facilitating care transitions, says Anuj Dalal, MD, a hospitalist and instructor in medicine at Brigham and Women’s Hospital in Boston. He is using one of his hospital’s technological strengths—a well-established, firewall-protected e-mail system—to help improve the discharge process.

“We decided to try to improve awareness of test results pending at the time of discharge,” Dr. Dalal explains. “We created an intervention that automatically triggers an e-mail with the finalized test results to the responsible providers. The intervention creates a loop of communication between the inpatient attending and the PCP. What we hope to show in our research over the next year or two is whether the intervention actually increases awareness of test results by providers.”

One thing to remember is that “all kinds of things can go wrong with care transitions,” no matter the size of the institution, the experience of the staff, or technological limitations, says Vineet Chopra, MD, FACP, a hospitalist at the University of Michigan Health System in Ann Arbor. “The problems of transitions vary from place to place, day to day, time of day, shift changes; and let’s not forget physician extenders and the other members of the healthcare team,” he says. “The more complicated the team, the more complicated the information needing to be handed off becomes.”

Who Else Is Looking at Transitions of Care?

Dr. Zadzam

SHM convened the Handoffs Task Force in 2006. The team systematically reviewed the literature and published recommendations in the September 2009 Journal of Hospital Medicine.⁹ The recommendations are aimed at both community and academic hospitals, as well as hospitalists and other healthcare providers. A new collaborative designed to supplement Project BOOST for hospitalist group handoffs and help put the guidelines into practice is in the works, says Dr. Arora, the task force’s chair.

SHM and five medical groups, including the American College of Physicians, issued a Transitions of Care Consensus Statement, published in the July 2009 issue of the Journal of Hospital Medicine.⁵ Guiding principles relate to education, measurement, accountability, timely interchange of information, inclusion of patient and family, respect for the medical home, and the need for national standards.

The Joint Commission’s Center for Transforming Health Care, established in 2009 to solve healthcare’s most critical safety and quality problems, has made handoff communications its second major target, and is now working with 10 healthcare systems. Standardized handoff processes and communications were the subject of the Joint Commission’s 2006 National Patient Safety Goal, while the Comprehensive Accreditation Manual for Hospitals also specifies that before a hospital discharges or transfers a patient, it should inform and educate the patient about his or her follow-up care and services.

“We now have a safety goal under review dealing with medication reconciliation, and there are relevant standards related to culturally sensitive communication and low-literacy-level communication,” says Deborah Zadzam, PhD, RN, FAAN, director of international quality and performance measures for Joint Commission Resources. “The essential message the Joint Commission has for hospitalists is to communicate clearly, effectively and thoroughly; don’t assume you are understood or that you understand.”—LB

Before he joined the group at the university, Dr. Chopra worked at a community hospital, St. Joseph’s Mercy Hospital in Hot Springs, Ark. “It’s hard to come up with a one-size-fits-all solution when there are so many variables,” he says. At the community hospital, “we mandated that the hospitalist call the PCP at the time of discharge. At the academic medical center, we share an EHR with the PCPs and can reach them electronically. We are required to have the discharge summary in the computer before the patient leaves the hospital, and we mandate that hospitalists are reachable by e-mail or phone when they are off.

“I’m not a believer in throwing more technology at problems and just adding more layers of information tools,” Dr. Chopra adds. “Hospitalists who used to carry stethoscopes now also have a clipboard, phone, pager, PDA, and nine different signouts in their pockets. What we want to do is make their life easier. Here, we are looking at technology as a means to do that.”

Dr. Chopra and hospitalist colleague Prasanth Gosineni, MD, have been working with an Ann Arbor tech company called Synaptin to develop a lightweight, mobile client application designed to work on smartphones. Still in pilot testing, it would allow for task-oriented and priority-based messaging in real time and the systematic transfer of important information for the next hospitalist shift.

“You need to be able to share information in a systematic way, but that’s only half of the answer. The other half is the ability to ask specific questions,” Dr. Chopra says. “Technology doesn’t take away from the face-to-face encounter that needs to happen. Nothing will replace face time, but part of the solution is to provide data efficiently and in a way that is easily accessible.”

Dr. Chopra admits that EHR presents both positives and negatives to improved transitions and patient care, “depending on how well it works and what smart features it offers,” he says, “but also recognizing that EHR and other technologies have also taken us farther away from face-to-face exchanges. Some would say that’s part of the problem.”

Handoffs, discharges, and other transitions are ubiquitous in HM—and fraught with the potential for costly and harmful errors. The ideal of an interactive, face-to-face handoff simply is not available for many care transitions. However, hospitalists are challenged to find solutions that will work in their hospitals, with their teams, and their types of patients. Patients and policymakers expect nothing less. TH

Larry Beresford is a freelance writer based in Oakland, Calif.

References

1. Payne C, Stein J, Dressler D. Implementation of a structured electronic tool to improve patient handoffs and resident satisfaction. Poster abstract: Internal Medicine 2010, April 21-24, 2010, Toronto.
2. Vidyarthi AR. Triple Handoff. AHRQ WebM&M website. Available at: webmm.ahrq.gov/case.aspx? caseID=134. Published May 2006. Accessed May 29, 2010.
3. Snow V, Beck D, Budnitz T, et al. Transitions of Care Consensus Policy Statement: American College of Physicians, Society of General Internal Medicine, Society of Hospital Medicine, American Geriatrics Society, American College of Emergency Physicians, and Society for Academic Emergency Medicine. J Hosp Med. 2009;4(6):364-370.
4. 2006 National Patient Safety Goals. The Joint Commission website. Available at: www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/06_npsgs.htm. Accessed June 8, 2010.
5. Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009; 2:360:1418-1428.
6. Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003;138(3):161-167.
7. Myers JS, Jaipaul CK, Kogan JR, Krekun S, Bellini LM, Shea JA. Are discharge summaries teachable? The effects of a discharge summary curriculum on the quality of discharge summaries in an internal medicine residency program. Acad Med. 2006; 81(10):S5-S8.
8. Jack BW, Chetty VK, Anthony D, et al. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial. Ann Intern Med. 2009;150(3):178-187.
9. Arora VM, Manjarrez E, Dressler DD, Basaviah P, Halasyamani L, Kripalani S. Hospitalist handoffs: a systematic review and task force recommendations. J Hosp Med. 2009;4(7): 433-440.
10. Halasyamani L, Kripalani S, Coleman E, et al. Transition of care for hospitalized elderly patients—development of a discharge checklist for hospitalists. J Hosp Med. 2006;1(6):354-360.
11. Schnipper JL, Kirwin JL, Cotugno MC, et al. Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Int Med. 2006;166(5):565-571.
12. Dudas V, Bookwalter T, Kerr KM, Pantilat SZ. The impact of follow-up telephone calls to patients after hospitalization. Am J Med. 2001;111(9B): 26S-30S.

Care Transition Tips for Hospitalists and Groups

Dr. Arora

One recognized key to effective internal handoffs is the face-to-face verbal update, with opportunities to ask questions, priority given to sicker patients, and a written backup filling in the blanks with information that might become important as the patient’s condition changes. But if that is not practical for your HM group, what tools and processes will come closest to the ideal?

A key to effective discharge from the hospital is connection with the PCP, although face-to-face encounters with PCPs are highly unlikely. Hospitalists say there are levels of connection with PCPs, from the urgent (“I need to talk to someone right now”) to the routine (“It’s OK if they get this information tomorrow”). Many often wonder if there should be two levels of discharge communication with PCPs: an immediate message relaying crucial information and a formal discharge summary coming later.

For HM groups, the following is a list of suggestions from transitions-of-care researchers:

• Keep accurate and up-to-date contact information, including preferred communication medium, on referring physicians; survey them on their satisfaction with the discharge communications they receive from hospitalists.
• Partner with hospital administrators and with patient-safety and quality officers to address handoff issues.
• Partner with IT staff to help bridge the divide between clinicians and information technology.
• Track such outcomes as rehospitalization rates.
• Offer formal training on handoffs, discharges, and effective communication to physicians and other providers.
• Standardize the signout process, with computerized tools when appropriate, and create automated systems for following up on tests and lab results that come back after discharge.
• Structure shifts and their overlaps to help facilitate signouts.
• Consider implementing a discharge checklist.¹⁰
• Develop a strategy for medication reconciliation, with someone assigned to the process, be that a hospitalist, pharmacist or nurse.¹¹
• Advocate for a post-discharge call-back policy by assigned staff at defined intervals, either for every patient discharged or for those targeted as higher-risk.¹²
• Consider creating a post-discharge clinic and/or a phone number that discharged patients can call to clarify post-discharge questions and concerns.

For individual hospitalists:

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• Understand the transition process, where it fails, and why.
• Be open to changing the way you do things. Be accountable for transitions, and a role model for others.
• Focus on the present—today’s baseline, current to-do items, and what to expect next in the patient’s care.
• Track patients and their future discharge needs from the day of admission. What’s the likely date for going home? What does the patient need to learn in the meantime? Help nurses focus on achieving those needs and, if possible, schedule the initial outpatient clinic appointment before the patient leaves the hospital.
• Take time to talk your patients, listen to their concerns and confirm their understanding of what lies ahead.

For hospitalists on the receiving end of transition messages:

• Actively listen—stay focused, limit interruptions, take notes.
• Ask questions to ensure your understanding and read back what you understand to be the communication.
• Have a system for keeping track of to-do items requiring follow-up.—LB

Christina Payne, MD, is a third-year resident at Emory University Hospital in Atlanta who will begin her first hospitalist job, with Emory in September. In spite of her dearth of practical experience, she already has experience researching one of the most vexing problems confronting HM: how to improve transitions of care.

Dr. Payne has been studying the benefits of a structured electronic tool that generates a standardized sign-out list of a hospital team’s full census at the time of shift change, compared with the usual, highly variable sign-out practices of medical residents. At a poster presentation at Internal Medicine 2010 in April in Toronto, Dr. Payne and colleagues reported that residents using the tool were twice as confident at performing handoffs, had lower rates of perceived near-miss events, and were happier.¹

“Hospitalists everywhere are starting to realize the importance of trying to reduce opportunities for human error that occur during care transitions,” Dr. Payne says. “The biggest thing I learned from this research is the importance of standardizing the handoff process [with information communicated consistently].

“It is essential to keep communication lines open,” Dr. Payne adds. “No tool can replace the importance of communication between doctors and the need to sit down and talk. The ideal signout happens in a quiet room where the two of you can talk about active patients and achieve rapport. But, realistically, how often does that happen?”

Standardization is one of a handful of strategies hospitalists, researchers, and policymakers are using to tackle transitions—both in-hospital handoffs and post-discharge transitions—with outpatient care. Some hospitalists are using practice simulations and training strategies; others have implemented medication reconciliation checks at every discharge, checklists and other communication strategies, team-based quality-improvement (QI) initiatives, and new technologies to enhance and streamline communication. Some interventions follow the patient from the hospital to the community physician with a phone call, follow-up clinic, or other contact; others aim to empower the patient to be a better self-advocate. But for hospitalists, the challenge is to communicate the right amount of transfer information to the right receiver at the right time.

No matter the technique, the goal is the same: Improve the handoff and discharge process in a way that promotes efficiency and patient safety. And hospitalists are at the forefront of the changing landscape of care transitions.

Under the Microscope

Care transitions of all kinds are under the magnifying glass of national healthcare reform, with growing recognition of the need to make care safer and reduce the preventable, costly hospital readmissions caused by incomplete handoffs. Care transitions for hospitalists include internal handoffs, both at daily shift changes and at service changes when an outgoing provider is leaving after a period of consecutive daily shifts. These typically involve a sign-out process and face-to-face encounter, with some kind of written backup. One teaching institution reported that such handoffs take place 4,000 times per day in the hospital, or 1.6 million times per year.²

This is a complex problem and it needs a multifaceted solution. But this lies squarely within the hospitalist arena. We’re part of everything that happens in the hospital.

—Arpana Vidyarthi, MD, University of California at San Francisco

Geographical transitions can be from one floor or department to another, or out the hospital door to another facility or home. Transitions typically involve a discharge process and a written discharge summary. Care transitions also include hospital admissions, which put the hospitalist in the role of handoff receiver rather than initiator, plus a variety of other transitions involving nurses, physician extenders, and other practitioners.

Each transition is a major decision point in the course of a patient’s hospitalization; each transition also presents a time of heightened vulnerability (e.g., potential communication breakdowns, medication errors, patient anxiety or confusion, etc.). In fact, according to a Transitions of Care Consensus Policy Statement published in 2009 by SHM and five other medical societies, handoffs are ubiquitous in HM, with significant patient safety and quality deficiencies in handoffs existing in the current system.³

Poor communication at the time of handoff has been implicated in near-misses and adverse events in a variety of healthcare contexts, including 70% of hospital sentinel events studied by The Joint Commission, which named standardized handoffs (with an opportunity for interactive communication) as a National Patient Safety Goal in 2006.⁴ The federal government is studying care transitions, supporting demonstration projects for Medicare enrollees, and including readmission rates in national hospital report card data.

Dr. Arora

“Transitions of care and handoffs are a huge focus right now because of the increased fragmentation of care in the United States. Hospitalists are in charge of a greater percentage of hospitalized patients, which means more coordination of care is needed,” says Vineet Arora, MD, MA, FHM, assistant professor of medicine and associate director of the internal-medicine residency at the University of Chicago, and chair of the SHM task force on handoffs.

Inadequate communication and poor care transitions can undermine hospitalists’ best care-planning efforts, erode patients’ and families’ confidence and satisfaction with hospital care, and leave primary-care physicians (PCPs) feeling unsatisfied with the relationship. As many as 1 in 5 Medicare beneficiary hospitalizations result in a readmission within 30 days, and while not all of these are preventable, far too many are.⁵ Another prospective cohort study found that 1 in 5 patients discharged from the hospital to the home experienced an adverse event within three weeks of discharge.⁶ Complex comorbidities, advanced age, unknown PCP, and limited healthcare literacy present hospitalists with extremely difficult transitions.

Patient safety and cost control are the linchpins to national efforts to improve transitions of care. Dr. Arora recently coauthored an original research paper, which will be published in the Journal of Hospital Medicine in September, showing older hospitalized patients are twice as likely to report problems after discharge if their PCPs were not aware they were hospitalized.

“With escalating healthcare costs, people are looking at ways to save money and reduce redundant care,” Dr. Arora explains, pointing out, as an example, repeated tests resulting from inadequate communication between healthcare providers.

The System Must Change

“All of the effort we put into saving someone’s life—the years of experience, training, medical school, and residency—all of it comes to bear on that hospitalized patient. And it can all be unraveled at the time of discharge if it’s not handled properly,” says Arpana Vidyarthi, MD, a hospitalist and director of quality at the University of California at San Francisco.

Dr. Vidyarthi views in-hospital and discharge transitions as integrally related. “The analysis is similar, even if different techniques may be needed,” she says, adding that, fundamentally, it involves having a system that allows people—or forces them—to do the “right thing.”

That’s why achieving effective care transitions will require more than just a standardized tool or process, Dr. Vidyarthi says. “This is about understanding the ways people communicate and finding ways to train them to communicate better,” she says. “The problem we have is not a lack of information, but how to communicate what, to whom, and when.”

What’s really needed, Dr. Vidyarthi says, is a hospital’s commitment to more effective transitions and its hospitalists’ leadership in driving a comprehensive, multidisciplinary, team- and evidence-based QI process. The new process should be a QI-based solution to a hospital’s care-transitions issues. “Before you can standardize your process, you need to understand it,” she says. “This is a complex problem, and it needs a multifaceted solution. But this lies squarely within the hospitalist arena. We’re part of everything that happens in the hospital.

We created an intervention that automatically triggers an e-mail with the finalized test results to the responsible providers. The intervention creates a loop of communication between the inpatient attending and the PCP. What we hope to show in our research over the next year or two is whether the intervention actually increases awareness of test results by providers.

—Anuj Dalal, MD, Brigham and Women’s Hospital, Boston

Hospital administrators are looking to HM to solve transition and readmission problems now, says Tina Budnitz, MPH, BOOST Project Director (Better Outcomes for Older Adults through Safe Transitions). She expects the scrutiny from the C-suite, legislators, and watchdog groups to increase as the spotlight continues to shine on the healthcare system.

“Any hospitalist can act as a leader in their institution,” Budnitz says. “Be a change agent, pull a group together, and start asking questions: Do we have safe care-transitions practices and processes in place? Just by asking the right question, you can be a catalyst for the system.”

Budnitz also emphasizes the importance of teamwork in the hospital setting. “How can I help my teammates? What am I communicating to the nurses on rounds?” she says. “Can you initiate dialogue with your outpatient medical groups: ‘These faxes we’re sending you—is that information getting to you in ways and times that are helpful? And, by the way, when your patient is admitted, this information would really help me.’ ”

Dr. Arora

Innovative Strategies

One of the most important initiatives responding to concerns about care transitions is Project BOOST (www.hos pitalmedicine.org/BOOST), a comprehensive toolkit for improving a hospital’s transitions of care. The project aims to build a national consensus for best practices in transitions; collaborate with representatives from the Agency for Healthcare Research and Quality (AHRQ), the Centers for Medicare and Medicaid Services (CMS), and the Joint Commission; and develop a national resource library, Budnitz says.

“Project BOOST not only puts forth best practices for admitting patients, planning for discharge, and then doing the discharge, it also helps show facilities how to change their systems, with resources and tools for analyzing and re-engineering the system,” she says. “Sites get one-to-one assistance from a mentor.”

Six hospitals signed on to the pilot program in 2008; 24 more joined last year. In January, SHM announced a collaborative with the University of Michigan and Blue Cross Blue Shield of Michigan for 15 Michigan hospitals to receive training and mentorship starting in May. And last month, SHM and the California HealthCare Foundation announced a Project BOOST initiative for 20 of the health system’s hospitals (see “California Dreamin’”, p. 6). Other free resources offered on the BOOST Web portal include clinical, data collection, and project management tools. SHM also has a DVD that explains how to use the “teachback” method to improve communication with patients.

Jennifer Myers, MD, FHM, assistant professor of clinical medicine and patient-safety officer at the Hospital of the University of Pennsylvania in Philadelphia, is a Project BOOST participant who spearheaded a process change to improve the quality of her facility’s discharge summary, along with accompanying resident education.⁷ The discharge summary recently was integrated with the hospital’s electronic health record (EHR) system.

“We’ve gone from dictating the discharge summary to an electronic version completed by the hospitalist, with prompts for key components of the summary, which allows us to create summaries more efficiently—ideally on the day of discharge, but usually within 48 hours,” Dr. Myers says. “We previously researched whether teaching made a difference in the quality of discharges; we found that it did. So we look forward to standardizing our teaching approach around this important topic for all residents.”

Another care-transitions innovation receiving a lot of attention from the government and the private sector is Project RED (Re-Engineered Discharge), led by Brian Jack, MD, vice chair of the department of family medicine at Boston Medical Center. The Project RED research group develops and tests strategies to improve the hospital discharge process to promote patient safety and reduce rehospitalization rates.

“We used re-engineering tools borrowed from other fields, brought together experts from all over the hospital, divided up the whole discharge process, and identified key principles,” Dr. Jack explains. The resulting discharge strategy is reflected in an 11-item checklist of discrete, mutually reinforcing components, which have been shown to reduce rehospitalization rates by 32% while raising patient satisfaction.⁸ It includes comprehensive discharge and after-hospital plans, a nurse discharge advocate, and a medication reconciliation phone call to the patient. A virtual “patient advocate,” a computerized avatar named Louise, is now being tested. If successful, it will allow patients to interact with a touch-screen teacher of the after-care plan who has time to work at the patient’s pace.

Technology and Transitions

Dr. Chopra

Informatics can be a key player in facilitating care transitions, says Anuj Dalal, MD, a hospitalist and instructor in medicine at Brigham and Women’s Hospital in Boston. He is using one of his hospital’s technological strengths—a well-established, firewall-protected e-mail system—to help improve the discharge process.

“We decided to try to improve awareness of test results pending at the time of discharge,” Dr. Dalal explains. “We created an intervention that automatically triggers an e-mail with the finalized test results to the responsible providers. The intervention creates a loop of communication between the inpatient attending and the PCP. What we hope to show in our research over the next year or two is whether the intervention actually increases awareness of test results by providers.”

One thing to remember is that “all kinds of things can go wrong with care transitions,” no matter the size of the institution, the experience of the staff, or technological limitations, says Vineet Chopra, MD, FACP, a hospitalist at the University of Michigan Health System in Ann Arbor. “The problems of transitions vary from place to place, day to day, time of day, shift changes; and let’s not forget physician extenders and the other members of the healthcare team,” he says. “The more complicated the team, the more complicated the information needing to be handed off becomes.”

Who Else Is Looking at Transitions of Care?

Dr. Zadzam

SHM convened the Handoffs Task Force in 2006. The team systematically reviewed the literature and published recommendations in the September 2009 Journal of Hospital Medicine.⁹ The recommendations are aimed at both community and academic hospitals, as well as hospitalists and other healthcare providers. A new collaborative designed to supplement Project BOOST for hospitalist group handoffs and help put the guidelines into practice is in the works, says Dr. Arora, the task force’s chair.

SHM and five medical groups, including the American College of Physicians, issued a Transitions of Care Consensus Statement, published in the July 2009 issue of the Journal of Hospital Medicine.⁵ Guiding principles relate to education, measurement, accountability, timely interchange of information, inclusion of patient and family, respect for the medical home, and the need for national standards.

The Joint Commission’s Center for Transforming Health Care, established in 2009 to solve healthcare’s most critical safety and quality problems, has made handoff communications its second major target, and is now working with 10 healthcare systems. Standardized handoff processes and communications were the subject of the Joint Commission’s 2006 National Patient Safety Goal, while the Comprehensive Accreditation Manual for Hospitals also specifies that before a hospital discharges or transfers a patient, it should inform and educate the patient about his or her follow-up care and services.

“We now have a safety goal under review dealing with medication reconciliation, and there are relevant standards related to culturally sensitive communication and low-literacy-level communication,” says Deborah Zadzam, PhD, RN, FAAN, director of international quality and performance measures for Joint Commission Resources. “The essential message the Joint Commission has for hospitalists is to communicate clearly, effectively and thoroughly; don’t assume you are understood or that you understand.”—LB

Before he joined the group at the university, Dr. Chopra worked at a community hospital, St. Joseph’s Mercy Hospital in Hot Springs, Ark. “It’s hard to come up with a one-size-fits-all solution when there are so many variables,” he says. At the community hospital, “we mandated that the hospitalist call the PCP at the time of discharge. At the academic medical center, we share an EHR with the PCPs and can reach them electronically. We are required to have the discharge summary in the computer before the patient leaves the hospital, and we mandate that hospitalists are reachable by e-mail or phone when they are off.

“I’m not a believer in throwing more technology at problems and just adding more layers of information tools,” Dr. Chopra adds. “Hospitalists who used to carry stethoscopes now also have a clipboard, phone, pager, PDA, and nine different signouts in their pockets. What we want to do is make their life easier. Here, we are looking at technology as a means to do that.”

Dr. Chopra and hospitalist colleague Prasanth Gosineni, MD, have been working with an Ann Arbor tech company called Synaptin to develop a lightweight, mobile client application designed to work on smartphones. Still in pilot testing, it would allow for task-oriented and priority-based messaging in real time and the systematic transfer of important information for the next hospitalist shift.

“You need to be able to share information in a systematic way, but that’s only half of the answer. The other half is the ability to ask specific questions,” Dr. Chopra says. “Technology doesn’t take away from the face-to-face encounter that needs to happen. Nothing will replace face time, but part of the solution is to provide data efficiently and in a way that is easily accessible.”

Dr. Chopra admits that EHR presents both positives and negatives to improved transitions and patient care, “depending on how well it works and what smart features it offers,” he says, “but also recognizing that EHR and other technologies have also taken us farther away from face-to-face exchanges. Some would say that’s part of the problem.”

Handoffs, discharges, and other transitions are ubiquitous in HM—and fraught with the potential for costly and harmful errors. The ideal of an interactive, face-to-face handoff simply is not available for many care transitions. However, hospitalists are challenged to find solutions that will work in their hospitals, with their teams, and their types of patients. Patients and policymakers expect nothing less. TH

Larry Beresford is a freelance writer based in Oakland, Calif.

References

1. Payne C, Stein J, Dressler D. Implementation of a structured electronic tool to improve patient handoffs and resident satisfaction. Poster abstract: Internal Medicine 2010, April 21-24, 2010, Toronto.
2. Vidyarthi AR. Triple Handoff. AHRQ WebM&M website. Available at: webmm.ahrq.gov/case.aspx? caseID=134. Published May 2006. Accessed May 29, 2010.
3. Snow V, Beck D, Budnitz T, et al. Transitions of Care Consensus Policy Statement: American College of Physicians, Society of General Internal Medicine, Society of Hospital Medicine, American Geriatrics Society, American College of Emergency Physicians, and Society for Academic Emergency Medicine. J Hosp Med. 2009;4(6):364-370.
4. 2006 National Patient Safety Goals. The Joint Commission website. Available at: www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/06_npsgs.htm. Accessed June 8, 2010.
5. Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009; 2:360:1418-1428.
6. Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003;138(3):161-167.
7. Myers JS, Jaipaul CK, Kogan JR, Krekun S, Bellini LM, Shea JA. Are discharge summaries teachable? The effects of a discharge summary curriculum on the quality of discharge summaries in an internal medicine residency program. Acad Med. 2006; 81(10):S5-S8.
8. Jack BW, Chetty VK, Anthony D, et al. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial. Ann Intern Med. 2009;150(3):178-187.
9. Arora VM, Manjarrez E, Dressler DD, Basaviah P, Halasyamani L, Kripalani S. Hospitalist handoffs: a systematic review and task force recommendations. J Hosp Med. 2009;4(7): 433-440.
10. Halasyamani L, Kripalani S, Coleman E, et al. Transition of care for hospitalized elderly patients—development of a discharge checklist for hospitalists. J Hosp Med. 2006;1(6):354-360.
11. Schnipper JL, Kirwin JL, Cotugno MC, et al. Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Int Med. 2006;166(5):565-571.
12. Dudas V, Bookwalter T, Kerr KM, Pantilat SZ. The impact of follow-up telephone calls to patients after hospitalization. Am J Med. 2001;111(9B): 26S-30S.

Care Transition Tips for Hospitalists and Groups

Dr. Arora

One recognized key to effective internal handoffs is the face-to-face verbal update, with opportunities to ask questions, priority given to sicker patients, and a written backup filling in the blanks with information that might become important as the patient’s condition changes. But if that is not practical for your HM group, what tools and processes will come closest to the ideal?

A key to effective discharge from the hospital is connection with the PCP, although face-to-face encounters with PCPs are highly unlikely. Hospitalists say there are levels of connection with PCPs, from the urgent (“I need to talk to someone right now”) to the routine (“It’s OK if they get this information tomorrow”). Many often wonder if there should be two levels of discharge communication with PCPs: an immediate message relaying crucial information and a formal discharge summary coming later.

For HM groups, the following is a list of suggestions from transitions-of-care researchers:

• Keep accurate and up-to-date contact information, including preferred communication medium, on referring physicians; survey them on their satisfaction with the discharge communications they receive from hospitalists.
• Partner with hospital administrators and with patient-safety and quality officers to address handoff issues.
• Partner with IT staff to help bridge the divide between clinicians and information technology.
• Track such outcomes as rehospitalization rates.
• Offer formal training on handoffs, discharges, and effective communication to physicians and other providers.
• Standardize the signout process, with computerized tools when appropriate, and create automated systems for following up on tests and lab results that come back after discharge.
• Structure shifts and their overlaps to help facilitate signouts.
• Consider implementing a discharge checklist.¹⁰
• Develop a strategy for medication reconciliation, with someone assigned to the process, be that a hospitalist, pharmacist or nurse.¹¹
• Advocate for a post-discharge call-back policy by assigned staff at defined intervals, either for every patient discharged or for those targeted as higher-risk.¹²
• Consider creating a post-discharge clinic and/or a phone number that discharged patients can call to clarify post-discharge questions and concerns.

For individual hospitalists:

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• Understand the transition process, where it fails, and why.
• Be open to changing the way you do things. Be accountable for transitions, and a role model for others.
• Focus on the present—today’s baseline, current to-do items, and what to expect next in the patient’s care.
• Track patients and their future discharge needs from the day of admission. What’s the likely date for going home? What does the patient need to learn in the meantime? Help nurses focus on achieving those needs and, if possible, schedule the initial outpatient clinic appointment before the patient leaves the hospital.
• Take time to talk your patients, listen to their concerns and confirm their understanding of what lies ahead.

For hospitalists on the receiving end of transition messages:

• Actively listen—stay focused, limit interruptions, take notes.
• Ask questions to ensure your understanding and read back what you understand to be the communication.
• Have a system for keeping track of to-do items requiring follow-up.—LB

Christina Payne, MD, is a third-year resident at Emory University Hospital in Atlanta who will begin her first hospitalist job, with Emory in September. In spite of her dearth of practical experience, she already has experience researching one of the most vexing problems confronting HM: how to improve transitions of care.

Dr. Payne has been studying the benefits of a structured electronic tool that generates a standardized sign-out list of a hospital team’s full census at the time of shift change, compared with the usual, highly variable sign-out practices of medical residents. At a poster presentation at Internal Medicine 2010 in April in Toronto, Dr. Payne and colleagues reported that residents using the tool were twice as confident at performing handoffs, had lower rates of perceived near-miss events, and were happier.¹

“Hospitalists everywhere are starting to realize the importance of trying to reduce opportunities for human error that occur during care transitions,” Dr. Payne says. “The biggest thing I learned from this research is the importance of standardizing the handoff process [with information communicated consistently].

“It is essential to keep communication lines open,” Dr. Payne adds. “No tool can replace the importance of communication between doctors and the need to sit down and talk. The ideal signout happens in a quiet room where the two of you can talk about active patients and achieve rapport. But, realistically, how often does that happen?”

Standardization is one of a handful of strategies hospitalists, researchers, and policymakers are using to tackle transitions—both in-hospital handoffs and post-discharge transitions—with outpatient care. Some hospitalists are using practice simulations and training strategies; others have implemented medication reconciliation checks at every discharge, checklists and other communication strategies, team-based quality-improvement (QI) initiatives, and new technologies to enhance and streamline communication. Some interventions follow the patient from the hospital to the community physician with a phone call, follow-up clinic, or other contact; others aim to empower the patient to be a better self-advocate. But for hospitalists, the challenge is to communicate the right amount of transfer information to the right receiver at the right time.

No matter the technique, the goal is the same: Improve the handoff and discharge process in a way that promotes efficiency and patient safety. And hospitalists are at the forefront of the changing landscape of care transitions.

Under the Microscope

Care transitions of all kinds are under the magnifying glass of national healthcare reform, with growing recognition of the need to make care safer and reduce the preventable, costly hospital readmissions caused by incomplete handoffs. Care transitions for hospitalists include internal handoffs, both at daily shift changes and at service changes when an outgoing provider is leaving after a period of consecutive daily shifts. These typically involve a sign-out process and face-to-face encounter, with some kind of written backup. One teaching institution reported that such handoffs take place 4,000 times per day in the hospital, or 1.6 million times per year.²

This is a complex problem and it needs a multifaceted solution. But this lies squarely within the hospitalist arena. We’re part of everything that happens in the hospital.

—Arpana Vidyarthi, MD, University of California at San Francisco

Geographical transitions can be from one floor or department to another, or out the hospital door to another facility or home. Transitions typically involve a discharge process and a written discharge summary. Care transitions also include hospital admissions, which put the hospitalist in the role of handoff receiver rather than initiator, plus a variety of other transitions involving nurses, physician extenders, and other practitioners.

Each transition is a major decision point in the course of a patient’s hospitalization; each transition also presents a time of heightened vulnerability (e.g., potential communication breakdowns, medication errors, patient anxiety or confusion, etc.). In fact, according to a Transitions of Care Consensus Policy Statement published in 2009 by SHM and five other medical societies, handoffs are ubiquitous in HM, with significant patient safety and quality deficiencies in handoffs existing in the current system.³

Poor communication at the time of handoff has been implicated in near-misses and adverse events in a variety of healthcare contexts, including 70% of hospital sentinel events studied by The Joint Commission, which named standardized handoffs (with an opportunity for interactive communication) as a National Patient Safety Goal in 2006.⁴ The federal government is studying care transitions, supporting demonstration projects for Medicare enrollees, and including readmission rates in national hospital report card data.

Dr. Arora

“Transitions of care and handoffs are a huge focus right now because of the increased fragmentation of care in the United States. Hospitalists are in charge of a greater percentage of hospitalized patients, which means more coordination of care is needed,” says Vineet Arora, MD, MA, FHM, assistant professor of medicine and associate director of the internal-medicine residency at the University of Chicago, and chair of the SHM task force on handoffs.

Inadequate communication and poor care transitions can undermine hospitalists’ best care-planning efforts, erode patients’ and families’ confidence and satisfaction with hospital care, and leave primary-care physicians (PCPs) feeling unsatisfied with the relationship. As many as 1 in 5 Medicare beneficiary hospitalizations result in a readmission within 30 days, and while not all of these are preventable, far too many are.⁵ Another prospective cohort study found that 1 in 5 patients discharged from the hospital to the home experienced an adverse event within three weeks of discharge.⁶ Complex comorbidities, advanced age, unknown PCP, and limited healthcare literacy present hospitalists with extremely difficult transitions.

Patient safety and cost control are the linchpins to national efforts to improve transitions of care. Dr. Arora recently coauthored an original research paper, which will be published in the Journal of Hospital Medicine in September, showing older hospitalized patients are twice as likely to report problems after discharge if their PCPs were not aware they were hospitalized.

“With escalating healthcare costs, people are looking at ways to save money and reduce redundant care,” Dr. Arora explains, pointing out, as an example, repeated tests resulting from inadequate communication between healthcare providers.

The System Must Change

“All of the effort we put into saving someone’s life—the years of experience, training, medical school, and residency—all of it comes to bear on that hospitalized patient. And it can all be unraveled at the time of discharge if it’s not handled properly,” says Arpana Vidyarthi, MD, a hospitalist and director of quality at the University of California at San Francisco.

Dr. Vidyarthi views in-hospital and discharge transitions as integrally related. “The analysis is similar, even if different techniques may be needed,” she says, adding that, fundamentally, it involves having a system that allows people—or forces them—to do the “right thing.”

That’s why achieving effective care transitions will require more than just a standardized tool or process, Dr. Vidyarthi says. “This is about understanding the ways people communicate and finding ways to train them to communicate better,” she says. “The problem we have is not a lack of information, but how to communicate what, to whom, and when.”

What’s really needed, Dr. Vidyarthi says, is a hospital’s commitment to more effective transitions and its hospitalists’ leadership in driving a comprehensive, multidisciplinary, team- and evidence-based QI process. The new process should be a QI-based solution to a hospital’s care-transitions issues. “Before you can standardize your process, you need to understand it,” she says. “This is a complex problem, and it needs a multifaceted solution. But this lies squarely within the hospitalist arena. We’re part of everything that happens in the hospital.

We created an intervention that automatically triggers an e-mail with the finalized test results to the responsible providers. The intervention creates a loop of communication between the inpatient attending and the PCP. What we hope to show in our research over the next year or two is whether the intervention actually increases awareness of test results by providers.

—Anuj Dalal, MD, Brigham and Women’s Hospital, Boston

Hospital administrators are looking to HM to solve transition and readmission problems now, says Tina Budnitz, MPH, BOOST Project Director (Better Outcomes for Older Adults through Safe Transitions). She expects the scrutiny from the C-suite, legislators, and watchdog groups to increase as the spotlight continues to shine on the healthcare system.

“Any hospitalist can act as a leader in their institution,” Budnitz says. “Be a change agent, pull a group together, and start asking questions: Do we have safe care-transitions practices and processes in place? Just by asking the right question, you can be a catalyst for the system.”

Budnitz also emphasizes the importance of teamwork in the hospital setting. “How can I help my teammates? What am I communicating to the nurses on rounds?” she says. “Can you initiate dialogue with your outpatient medical groups: ‘These faxes we’re sending you—is that information getting to you in ways and times that are helpful? And, by the way, when your patient is admitted, this information would really help me.’ ”

Dr. Arora

Innovative Strategies

One of the most important initiatives responding to concerns about care transitions is Project BOOST (www.hos pitalmedicine.org/BOOST), a comprehensive toolkit for improving a hospital’s transitions of care. The project aims to build a national consensus for best practices in transitions; collaborate with representatives from the Agency for Healthcare Research and Quality (AHRQ), the Centers for Medicare and Medicaid Services (CMS), and the Joint Commission; and develop a national resource library, Budnitz says.

“Project BOOST not only puts forth best practices for admitting patients, planning for discharge, and then doing the discharge, it also helps show facilities how to change their systems, with resources and tools for analyzing and re-engineering the system,” she says. “Sites get one-to-one assistance from a mentor.”

Six hospitals signed on to the pilot program in 2008; 24 more joined last year. In January, SHM announced a collaborative with the University of Michigan and Blue Cross Blue Shield of Michigan for 15 Michigan hospitals to receive training and mentorship starting in May. And last month, SHM and the California HealthCare Foundation announced a Project BOOST initiative for 20 of the health system’s hospitals (see “California Dreamin’”, p. 6). Other free resources offered on the BOOST Web portal include clinical, data collection, and project management tools. SHM also has a DVD that explains how to use the “teachback” method to improve communication with patients.

Jennifer Myers, MD, FHM, assistant professor of clinical medicine and patient-safety officer at the Hospital of the University of Pennsylvania in Philadelphia, is a Project BOOST participant who spearheaded a process change to improve the quality of her facility’s discharge summary, along with accompanying resident education.⁷ The discharge summary recently was integrated with the hospital’s electronic health record (EHR) system.

“We’ve gone from dictating the discharge summary to an electronic version completed by the hospitalist, with prompts for key components of the summary, which allows us to create summaries more efficiently—ideally on the day of discharge, but usually within 48 hours,” Dr. Myers says. “We previously researched whether teaching made a difference in the quality of discharges; we found that it did. So we look forward to standardizing our teaching approach around this important topic for all residents.”

Another care-transitions innovation receiving a lot of attention from the government and the private sector is Project RED (Re-Engineered Discharge), led by Brian Jack, MD, vice chair of the department of family medicine at Boston Medical Center. The Project RED research group develops and tests strategies to improve the hospital discharge process to promote patient safety and reduce rehospitalization rates.

“We used re-engineering tools borrowed from other fields, brought together experts from all over the hospital, divided up the whole discharge process, and identified key principles,” Dr. Jack explains. The resulting discharge strategy is reflected in an 11-item checklist of discrete, mutually reinforcing components, which have been shown to reduce rehospitalization rates by 32% while raising patient satisfaction.⁸ It includes comprehensive discharge and after-hospital plans, a nurse discharge advocate, and a medication reconciliation phone call to the patient. A virtual “patient advocate,” a computerized avatar named Louise, is now being tested. If successful, it will allow patients to interact with a touch-screen teacher of the after-care plan who has time to work at the patient’s pace.

Technology and Transitions

Dr. Chopra

Informatics can be a key player in facilitating care transitions, says Anuj Dalal, MD, a hospitalist and instructor in medicine at Brigham and Women’s Hospital in Boston. He is using one of his hospital’s technological strengths—a well-established, firewall-protected e-mail system—to help improve the discharge process.

“We decided to try to improve awareness of test results pending at the time of discharge,” Dr. Dalal explains. “We created an intervention that automatically triggers an e-mail with the finalized test results to the responsible providers. The intervention creates a loop of communication between the inpatient attending and the PCP. What we hope to show in our research over the next year or two is whether the intervention actually increases awareness of test results by providers.”

One thing to remember is that “all kinds of things can go wrong with care transitions,” no matter the size of the institution, the experience of the staff, or technological limitations, says Vineet Chopra, MD, FACP, a hospitalist at the University of Michigan Health System in Ann Arbor. “The problems of transitions vary from place to place, day to day, time of day, shift changes; and let’s not forget physician extenders and the other members of the healthcare team,” he says. “The more complicated the team, the more complicated the information needing to be handed off becomes.”

Who Else Is Looking at Transitions of Care?

Dr. Zadzam

SHM convened the Handoffs Task Force in 2006. The team systematically reviewed the literature and published recommendations in the September 2009 Journal of Hospital Medicine.⁹ The recommendations are aimed at both community and academic hospitals, as well as hospitalists and other healthcare providers. A new collaborative designed to supplement Project BOOST for hospitalist group handoffs and help put the guidelines into practice is in the works, says Dr. Arora, the task force’s chair.

SHM and five medical groups, including the American College of Physicians, issued a Transitions of Care Consensus Statement, published in the July 2009 issue of the Journal of Hospital Medicine.⁵ Guiding principles relate to education, measurement, accountability, timely interchange of information, inclusion of patient and family, respect for the medical home, and the need for national standards.

The Joint Commission’s Center for Transforming Health Care, established in 2009 to solve healthcare’s most critical safety and quality problems, has made handoff communications its second major target, and is now working with 10 healthcare systems. Standardized handoff processes and communications were the subject of the Joint Commission’s 2006 National Patient Safety Goal, while the Comprehensive Accreditation Manual for Hospitals also specifies that before a hospital discharges or transfers a patient, it should inform and educate the patient about his or her follow-up care and services.

“We now have a safety goal under review dealing with medication reconciliation, and there are relevant standards related to culturally sensitive communication and low-literacy-level communication,” says Deborah Zadzam, PhD, RN, FAAN, director of international quality and performance measures for Joint Commission Resources. “The essential message the Joint Commission has for hospitalists is to communicate clearly, effectively and thoroughly; don’t assume you are understood or that you understand.”—LB

Before he joined the group at the university, Dr. Chopra worked at a community hospital, St. Joseph’s Mercy Hospital in Hot Springs, Ark. “It’s hard to come up with a one-size-fits-all solution when there are so many variables,” he says. At the community hospital, “we mandated that the hospitalist call the PCP at the time of discharge. At the academic medical center, we share an EHR with the PCPs and can reach them electronically. We are required to have the discharge summary in the computer before the patient leaves the hospital, and we mandate that hospitalists are reachable by e-mail or phone when they are off.

“I’m not a believer in throwing more technology at problems and just adding more layers of information tools,” Dr. Chopra adds. “Hospitalists who used to carry stethoscopes now also have a clipboard, phone, pager, PDA, and nine different signouts in their pockets. What we want to do is make their life easier. Here, we are looking at technology as a means to do that.”

Dr. Chopra and hospitalist colleague Prasanth Gosineni, MD, have been working with an Ann Arbor tech company called Synaptin to develop a lightweight, mobile client application designed to work on smartphones. Still in pilot testing, it would allow for task-oriented and priority-based messaging in real time and the systematic transfer of important information for the next hospitalist shift.

“You need to be able to share information in a systematic way, but that’s only half of the answer. The other half is the ability to ask specific questions,” Dr. Chopra says. “Technology doesn’t take away from the face-to-face encounter that needs to happen. Nothing will replace face time, but part of the solution is to provide data efficiently and in a way that is easily accessible.”

Dr. Chopra admits that EHR presents both positives and negatives to improved transitions and patient care, “depending on how well it works and what smart features it offers,” he says, “but also recognizing that EHR and other technologies have also taken us farther away from face-to-face exchanges. Some would say that’s part of the problem.”

Handoffs, discharges, and other transitions are ubiquitous in HM—and fraught with the potential for costly and harmful errors. The ideal of an interactive, face-to-face handoff simply is not available for many care transitions. However, hospitalists are challenged to find solutions that will work in their hospitals, with their teams, and their types of patients. Patients and policymakers expect nothing less. TH

Larry Beresford is a freelance writer based in Oakland, Calif.

References

1. Payne C, Stein J, Dressler D. Implementation of a structured electronic tool to improve patient handoffs and resident satisfaction. Poster abstract: Internal Medicine 2010, April 21-24, 2010, Toronto.
2. Vidyarthi AR. Triple Handoff. AHRQ WebM&M website. Available at: webmm.ahrq.gov/case.aspx? caseID=134. Published May 2006. Accessed May 29, 2010.
3. Snow V, Beck D, Budnitz T, et al. Transitions of Care Consensus Policy Statement: American College of Physicians, Society of General Internal Medicine, Society of Hospital Medicine, American Geriatrics Society, American College of Emergency Physicians, and Society for Academic Emergency Medicine. J Hosp Med. 2009;4(6):364-370.
4. 2006 National Patient Safety Goals. The Joint Commission website. Available at: www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/06_npsgs.htm. Accessed June 8, 2010.
5. Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009; 2:360:1418-1428.
6. Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003;138(3):161-167.
7. Myers JS, Jaipaul CK, Kogan JR, Krekun S, Bellini LM, Shea JA. Are discharge summaries teachable? The effects of a discharge summary curriculum on the quality of discharge summaries in an internal medicine residency program. Acad Med. 2006; 81(10):S5-S8.
8. Jack BW, Chetty VK, Anthony D, et al. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial. Ann Intern Med. 2009;150(3):178-187.
9. Arora VM, Manjarrez E, Dressler DD, Basaviah P, Halasyamani L, Kripalani S. Hospitalist handoffs: a systematic review and task force recommendations. J Hosp Med. 2009;4(7): 433-440.
10. Halasyamani L, Kripalani S, Coleman E, et al. Transition of care for hospitalized elderly patients—development of a discharge checklist for hospitalists. J Hosp Med. 2006;1(6):354-360.
11. Schnipper JL, Kirwin JL, Cotugno MC, et al. Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Int Med. 2006;166(5):565-571.
12. Dudas V, Bookwalter T, Kerr KM, Pantilat SZ. The impact of follow-up telephone calls to patients after hospitalization. Am J Med. 2001;111(9B): 26S-30S.

Care Transition Tips for Hospitalists and Groups

Dr. Arora

One recognized key to effective internal handoffs is the face-to-face verbal update, with opportunities to ask questions, priority given to sicker patients, and a written backup filling in the blanks with information that might become important as the patient’s condition changes. But if that is not practical for your HM group, what tools and processes will come closest to the ideal?

A key to effective discharge from the hospital is connection with the PCP, although face-to-face encounters with PCPs are highly unlikely. Hospitalists say there are levels of connection with PCPs, from the urgent (“I need to talk to someone right now”) to the routine (“It’s OK if they get this information tomorrow”). Many often wonder if there should be two levels of discharge communication with PCPs: an immediate message relaying crucial information and a formal discharge summary coming later.

For HM groups, the following is a list of suggestions from transitions-of-care researchers:

• Keep accurate and up-to-date contact information, including preferred communication medium, on referring physicians; survey them on their satisfaction with the discharge communications they receive from hospitalists.
• Partner with hospital administrators and with patient-safety and quality officers to address handoff issues.
• Partner with IT staff to help bridge the divide between clinicians and information technology.
• Track such outcomes as rehospitalization rates.
• Offer formal training on handoffs, discharges, and effective communication to physicians and other providers.
• Standardize the signout process, with computerized tools when appropriate, and create automated systems for following up on tests and lab results that come back after discharge.
• Structure shifts and their overlaps to help facilitate signouts.
• Consider implementing a discharge checklist.¹⁰
• Develop a strategy for medication reconciliation, with someone assigned to the process, be that a hospitalist, pharmacist or nurse.¹¹
• Advocate for a post-discharge call-back policy by assigned staff at defined intervals, either for every patient discharged or for those targeted as higher-risk.¹²
• Consider creating a post-discharge clinic and/or a phone number that discharged patients can call to clarify post-discharge questions and concerns.

For individual hospitalists:

Contribute to The Hospitalist

Have a story idea or a clinical question you’d like answered? We’d like to hear about it. Send your questions and story ideas to Editor Jason Carris, [email protected], or to Physician Editor Jeff Glasheen, MD, SFHM, [email protected].

• Understand the transition process, where it fails, and why.
• Be open to changing the way you do things. Be accountable for transitions, and a role model for others.
• Focus on the present—today’s baseline, current to-do items, and what to expect next in the patient’s care.
• Track patients and their future discharge needs from the day of admission. What’s the likely date for going home? What does the patient need to learn in the meantime? Help nurses focus on achieving those needs and, if possible, schedule the initial outpatient clinic appointment before the patient leaves the hospital.
• Take time to talk your patients, listen to their concerns and confirm their understanding of what lies ahead.

For hospitalists on the receiving end of transition messages:

• Actively listen—stay focused, limit interruptions, take notes.
• Ask questions to ensure your understanding and read back what you understand to be the communication.
• Have a system for keeping track of to-do items requiring follow-up.—LB

You’re a what?” he asked over the noise of the passing Mardi Gras parade.

“I’m a hospitalist,” I replied.

“Oh.” There was an extended pause. I could tell he was searching his mental database to determine if he had a family member who was a hospitalist. Nope, nothing there. Then it came: “What is that exactly?” I followed with a general description of “what a hospitalist does,” but his response made it apparent that my description hadn’t stuck: “So you’re like a generalist, but you work in the hospital?”

I let it go. Mardi Gras wasn’t the time to launch into all that a hospitalist truly embodies: quality improvement, systems redesign, patient safety, effective transitions of care. And he probably wouldn’t remember it tomorrow anyway. But my reveler friend’s summary statement stayed with me through the night, for it returned me to a core philosophical tenet: Esse est percipi. We are who we appear to be.

There are 30,000 of us now, all facing the same problem: How do we match who we are perceived to be with who we are? The hospitalist is much more than a “generalist who works in a hospital,” but what is perceived to be is equally as important as what is. At the root of the problem is a question of accountability: How do we hold ourselves out to the public as a specialty that possesses the knowledge and skills necessary to advance quality and safety for the hospitalized patient?

This question of public accountability is not new to the profession. The heterogeneity of physicians in the early 1900s, from the authentic to the snake-oil salesmen, prompted the need for independent validation of physicians’ qualifications. Dr. Derrick Vail introduced the concept of a board certification in 1908, with the goal of “issuing credentials that would assure the public of the specialist’s qualifications.” The American Board of Medical Specialties was formed in 1933, and continues to this day to be the entity responsible for ensuring this accountability.

While there are no “snake-oil salesmen” in HM, there is heterogeneity. There are many of us answering the call to advance quality and patient safety, but there are many more of us who are not yet there. And there are some (i.e., those practicing medicine in the hospital while awaiting a subspecialty fellowship) who, while referred to as “hospitalists,” do not embrace the central tenets of the career hospitalist. Thirty-thousand hospitalists is a spectacular achievement, but with that growth comes the new problem of dilution: Without some measure of distinguishing those who are authentic in the value-added services of quality and patient safety from those who have not embraced these tenets, the perception of us all will be merely “physicians who practice in the hospital.”

To my mind, the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) Focused Practice in Hospital Medicine (FPHM) program answers this question of public accountability. This new MOC process provides an objective way of establishing that hospitalists who claim to be competent in their field have, in fact, demonstrated this competence. Paradoxically, it is even more compelling than a board certification following a residency or fellowship; skills and knowledge fade over time, and new knowledge consistently is added. The MOC certification assures the public that despite these challenges, the certified hospitalist has continued to maintain competence in the field.

Further, the components of the FPHM (www.abim.org/specialty/fphm.aspx) provide assurance that the certified hospitalist has the expertise to practice HM, and has the knowledge and skills necessary to offer the value-added services of quality, patient safety, and performance improvement.

Why Is It Important to Recertify?

Registration for the MOC in FPHM opened March 15, and more than 100 hospitalists enrolled in the program in the first two weeks. While exciting, this number is not enough; here I share with you my reflections on why this MOC is so important to our field.

As with all things SHM, the rationale begins with, “What is the best thing for the patient?” I completed my first recertification in 2008, and I can honestly say that this was the first “test” in my career that actually made me a better physician for my patients. I was skeptical at first, seeing the MOC as another bureaucratic hurdle for which I would have the opportunity to pay $1,000. But the reality was that it was much more than that; it made me a better physician. It alerted me to blind spots in my clinical repertoire: some topics I had never learned, some I had forgotten, and some that were new knowledge.

Preparing for the examination isn’t onerous, perhaps a couple extra hours a week of reading. Since the examination focused on the practical aspects of diagnosis and management, and not the basic- science minutiae that had characterized the earlier examinations in my career, I found that the preparation for the MOC exam improved my practice of medicine. The only downside was that I did not have the luxury of an HM-focused exam in 2008, and there were content areas on the standard internal medicine (IM) MOC that were not a part of my inpatient practice.

But it was the Practice Improvement Module (PIM) component of the MOC process, a shared feature of both the FPHM and the IM MOC processes, that most benefited my patients. As a hospitalist, this too was not onerous, as practice improvement is what I do on a daily basis. Moreover, it was the external discipline of completing the PIM that made it truly valuable: collecting data, reflecting on methods of improvement, enacting an intervention, and then reassessing the results. The process forced me to reflect on my practice, and it heightened my sensitivity to other parts of my practice, and the hospital system, that needed to be improved.

Further benefit came through collaboration with other physicians in my group, as encouraged by the ABIM, to complete the PIM. This teamwork fostered a heightened spirit of QI within our team, further augmenting quality of care and sensitivity to needed systems improvements. True, at the end of the process, I was $1,000 lighter … but my conscience was richer. I had improved as a physician, and I think it has translated into a benefit for my patients.

What Recertification Means to HM

Although the virtue of improving patient care is sufficient to justify participation in the MOC in FPHM, the passage of healthcare reform legislation raises the stakes for hospitalists. The Physician Quality Reporting Initiative (PQRI) is an ongoing reality, further voicing the public’s need for accountability.

The final impact will hinge on the Center for Medicare & Medicaid Services’ (CMS) interpretation and execution of the language in the final bill, but it is clear that physicians who participate in the PQRI (through claims-based or registry reporting) have the opportunity to receive an additional 0.5% bonus on their total allowable Medicare charges in 2011 through 2014, if they also meet MOC program requirements. (The health reform bill provides a 1.0% bonus in 2011 for PQRI participation and a 0.5% bonus through 2014.)

Subsequently, physicians who do not participate in the PQRI will face a 1.5% payment penalty in 2015, and a 2% payment penalty in 2016 and thereafter. With these incentives, it appears the day-to-day finances of practice will offset the cost of MOC participation.

The importance of FPHM extends to the remainder of the PQRI as well. Currently, HM is not recognized by CMS as its own specialty, which means that it does not have its own CMS specialty code. In turn, this means that the core measures CMS will apply to the hospitalist in fulfilling the PQRI standards will be those of the general internist, and these might or might not apply to HM practice. For those to whom the standards do not apply, PQRI becomes a practical impossibility, though the financial penalty remains an unfortunate reality.

The extent to which the core measures for general medicine do not apply to the inpatient environment is the extent to which PQRI will be less effective in incentivizing the advancement of inpatient healthcare quality. This is an opportunity missed. Preventing this systematic exclusion begins with recognizing HM as a specialty. In convincing CMS that HM is its own specialty, deserving of its own code and its own PQRI indices, I can think of no argument as compelling as pointing to 10,000 hospitalists certified in the MOC in FPHM program.

Financial incentives aside, the ultimate success of HM will be in our ability to change the healthcare system such that it provides safe, timely, equitable, efficient, and patient-centered care. We’ve spent more than 10 years trying to get into the conversation, and now we have a seat at the table. But to be effective in this audacious goal, we must speak with a stentorian voice—a timbre that comes only from the chords of the sincere. Society must know of our sincerity—not by our words, but by our actions.

As president of SHM, I am calling on you to join me in meeting this standard of public accountability. Let us prove to the world that our talk of quality and patient safety is much more than talk. Let us establish that we are willing to engage in the ongoing self-improvement necessary to reach this wished-for goal.

Esse est percipi. We are as we are perceived. Now is our time to make one with the other—fulfilling a covenant that promises that we will, eventually, close this quality chasm. TH

Dr. Wiese is president of SHM.

You’re a what?” he asked over the noise of the passing Mardi Gras parade.

“I’m a hospitalist,” I replied.

“Oh.” There was an extended pause. I could tell he was searching his mental database to determine if he had a family member who was a hospitalist. Nope, nothing there. Then it came: “What is that exactly?” I followed with a general description of “what a hospitalist does,” but his response made it apparent that my description hadn’t stuck: “So you’re like a generalist, but you work in the hospital?”

I let it go. Mardi Gras wasn’t the time to launch into all that a hospitalist truly embodies: quality improvement, systems redesign, patient safety, effective transitions of care. And he probably wouldn’t remember it tomorrow anyway. But my reveler friend’s summary statement stayed with me through the night, for it returned me to a core philosophical tenet: Esse est percipi. We are who we appear to be.

There are 30,000 of us now, all facing the same problem: How do we match who we are perceived to be with who we are? The hospitalist is much more than a “generalist who works in a hospital,” but what is perceived to be is equally as important as what is. At the root of the problem is a question of accountability: How do we hold ourselves out to the public as a specialty that possesses the knowledge and skills necessary to advance quality and safety for the hospitalized patient?

This question of public accountability is not new to the profession. The heterogeneity of physicians in the early 1900s, from the authentic to the snake-oil salesmen, prompted the need for independent validation of physicians’ qualifications. Dr. Derrick Vail introduced the concept of a board certification in 1908, with the goal of “issuing credentials that would assure the public of the specialist’s qualifications.” The American Board of Medical Specialties was formed in 1933, and continues to this day to be the entity responsible for ensuring this accountability.

While there are no “snake-oil salesmen” in HM, there is heterogeneity. There are many of us answering the call to advance quality and patient safety, but there are many more of us who are not yet there. And there are some (i.e., those practicing medicine in the hospital while awaiting a subspecialty fellowship) who, while referred to as “hospitalists,” do not embrace the central tenets of the career hospitalist. Thirty-thousand hospitalists is a spectacular achievement, but with that growth comes the new problem of dilution: Without some measure of distinguishing those who are authentic in the value-added services of quality and patient safety from those who have not embraced these tenets, the perception of us all will be merely “physicians who practice in the hospital.”

To my mind, the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) Focused Practice in Hospital Medicine (FPHM) program answers this question of public accountability. This new MOC process provides an objective way of establishing that hospitalists who claim to be competent in their field have, in fact, demonstrated this competence. Paradoxically, it is even more compelling than a board certification following a residency or fellowship; skills and knowledge fade over time, and new knowledge consistently is added. The MOC certification assures the public that despite these challenges, the certified hospitalist has continued to maintain competence in the field.

Further, the components of the FPHM (www.abim.org/specialty/fphm.aspx) provide assurance that the certified hospitalist has the expertise to practice HM, and has the knowledge and skills necessary to offer the value-added services of quality, patient safety, and performance improvement.

Why Is It Important to Recertify?

Registration for the MOC in FPHM opened March 15, and more than 100 hospitalists enrolled in the program in the first two weeks. While exciting, this number is not enough; here I share with you my reflections on why this MOC is so important to our field.

As with all things SHM, the rationale begins with, “What is the best thing for the patient?” I completed my first recertification in 2008, and I can honestly say that this was the first “test” in my career that actually made me a better physician for my patients. I was skeptical at first, seeing the MOC as another bureaucratic hurdle for which I would have the opportunity to pay $1,000. But the reality was that it was much more than that; it made me a better physician. It alerted me to blind spots in my clinical repertoire: some topics I had never learned, some I had forgotten, and some that were new knowledge.

Preparing for the examination isn’t onerous, perhaps a couple extra hours a week of reading. Since the examination focused on the practical aspects of diagnosis and management, and not the basic- science minutiae that had characterized the earlier examinations in my career, I found that the preparation for the MOC exam improved my practice of medicine. The only downside was that I did not have the luxury of an HM-focused exam in 2008, and there were content areas on the standard internal medicine (IM) MOC that were not a part of my inpatient practice.

But it was the Practice Improvement Module (PIM) component of the MOC process, a shared feature of both the FPHM and the IM MOC processes, that most benefited my patients. As a hospitalist, this too was not onerous, as practice improvement is what I do on a daily basis. Moreover, it was the external discipline of completing the PIM that made it truly valuable: collecting data, reflecting on methods of improvement, enacting an intervention, and then reassessing the results. The process forced me to reflect on my practice, and it heightened my sensitivity to other parts of my practice, and the hospital system, that needed to be improved.

Further benefit came through collaboration with other physicians in my group, as encouraged by the ABIM, to complete the PIM. This teamwork fostered a heightened spirit of QI within our team, further augmenting quality of care and sensitivity to needed systems improvements. True, at the end of the process, I was $1,000 lighter … but my conscience was richer. I had improved as a physician, and I think it has translated into a benefit for my patients.

What Recertification Means to HM

Although the virtue of improving patient care is sufficient to justify participation in the MOC in FPHM, the passage of healthcare reform legislation raises the stakes for hospitalists. The Physician Quality Reporting Initiative (PQRI) is an ongoing reality, further voicing the public’s need for accountability.

The final impact will hinge on the Center for Medicare & Medicaid Services’ (CMS) interpretation and execution of the language in the final bill, but it is clear that physicians who participate in the PQRI (through claims-based or registry reporting) have the opportunity to receive an additional 0.5% bonus on their total allowable Medicare charges in 2011 through 2014, if they also meet MOC program requirements. (The health reform bill provides a 1.0% bonus in 2011 for PQRI participation and a 0.5% bonus through 2014.)

Subsequently, physicians who do not participate in the PQRI will face a 1.5% payment penalty in 2015, and a 2% payment penalty in 2016 and thereafter. With these incentives, it appears the day-to-day finances of practice will offset the cost of MOC participation.

The importance of FPHM extends to the remainder of the PQRI as well. Currently, HM is not recognized by CMS as its own specialty, which means that it does not have its own CMS specialty code. In turn, this means that the core measures CMS will apply to the hospitalist in fulfilling the PQRI standards will be those of the general internist, and these might or might not apply to HM practice. For those to whom the standards do not apply, PQRI becomes a practical impossibility, though the financial penalty remains an unfortunate reality.

The extent to which the core measures for general medicine do not apply to the inpatient environment is the extent to which PQRI will be less effective in incentivizing the advancement of inpatient healthcare quality. This is an opportunity missed. Preventing this systematic exclusion begins with recognizing HM as a specialty. In convincing CMS that HM is its own specialty, deserving of its own code and its own PQRI indices, I can think of no argument as compelling as pointing to 10,000 hospitalists certified in the MOC in FPHM program.

Financial incentives aside, the ultimate success of HM will be in our ability to change the healthcare system such that it provides safe, timely, equitable, efficient, and patient-centered care. We’ve spent more than 10 years trying to get into the conversation, and now we have a seat at the table. But to be effective in this audacious goal, we must speak with a stentorian voice—a timbre that comes only from the chords of the sincere. Society must know of our sincerity—not by our words, but by our actions.

As president of SHM, I am calling on you to join me in meeting this standard of public accountability. Let us prove to the world that our talk of quality and patient safety is much more than talk. Let us establish that we are willing to engage in the ongoing self-improvement necessary to reach this wished-for goal.

Esse est percipi. We are as we are perceived. Now is our time to make one with the other—fulfilling a covenant that promises that we will, eventually, close this quality chasm. TH

Dr. Wiese is president of SHM.

You’re a what?” he asked over the noise of the passing Mardi Gras parade.

“I’m a hospitalist,” I replied.

“Oh.” There was an extended pause. I could tell he was searching his mental database to determine if he had a family member who was a hospitalist. Nope, nothing there. Then it came: “What is that exactly?” I followed with a general description of “what a hospitalist does,” but his response made it apparent that my description hadn’t stuck: “So you’re like a generalist, but you work in the hospital?”

I let it go. Mardi Gras wasn’t the time to launch into all that a hospitalist truly embodies: quality improvement, systems redesign, patient safety, effective transitions of care. And he probably wouldn’t remember it tomorrow anyway. But my reveler friend’s summary statement stayed with me through the night, for it returned me to a core philosophical tenet: Esse est percipi. We are who we appear to be.

There are 30,000 of us now, all facing the same problem: How do we match who we are perceived to be with who we are? The hospitalist is much more than a “generalist who works in a hospital,” but what is perceived to be is equally as important as what is. At the root of the problem is a question of accountability: How do we hold ourselves out to the public as a specialty that possesses the knowledge and skills necessary to advance quality and safety for the hospitalized patient?

This question of public accountability is not new to the profession. The heterogeneity of physicians in the early 1900s, from the authentic to the snake-oil salesmen, prompted the need for independent validation of physicians’ qualifications. Dr. Derrick Vail introduced the concept of a board certification in 1908, with the goal of “issuing credentials that would assure the public of the specialist’s qualifications.” The American Board of Medical Specialties was formed in 1933, and continues to this day to be the entity responsible for ensuring this accountability.

While there are no “snake-oil salesmen” in HM, there is heterogeneity. There are many of us answering the call to advance quality and patient safety, but there are many more of us who are not yet there. And there are some (i.e., those practicing medicine in the hospital while awaiting a subspecialty fellowship) who, while referred to as “hospitalists,” do not embrace the central tenets of the career hospitalist. Thirty-thousand hospitalists is a spectacular achievement, but with that growth comes the new problem of dilution: Without some measure of distinguishing those who are authentic in the value-added services of quality and patient safety from those who have not embraced these tenets, the perception of us all will be merely “physicians who practice in the hospital.”

To my mind, the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) Focused Practice in Hospital Medicine (FPHM) program answers this question of public accountability. This new MOC process provides an objective way of establishing that hospitalists who claim to be competent in their field have, in fact, demonstrated this competence. Paradoxically, it is even more compelling than a board certification following a residency or fellowship; skills and knowledge fade over time, and new knowledge consistently is added. The MOC certification assures the public that despite these challenges, the certified hospitalist has continued to maintain competence in the field.

Further, the components of the FPHM (www.abim.org/specialty/fphm.aspx) provide assurance that the certified hospitalist has the expertise to practice HM, and has the knowledge and skills necessary to offer the value-added services of quality, patient safety, and performance improvement.

Why Is It Important to Recertify?

Registration for the MOC in FPHM opened March 15, and more than 100 hospitalists enrolled in the program in the first two weeks. While exciting, this number is not enough; here I share with you my reflections on why this MOC is so important to our field.

As with all things SHM, the rationale begins with, “What is the best thing for the patient?” I completed my first recertification in 2008, and I can honestly say that this was the first “test” in my career that actually made me a better physician for my patients. I was skeptical at first, seeing the MOC as another bureaucratic hurdle for which I would have the opportunity to pay $1,000. But the reality was that it was much more than that; it made me a better physician. It alerted me to blind spots in my clinical repertoire: some topics I had never learned, some I had forgotten, and some that were new knowledge.

Preparing for the examination isn’t onerous, perhaps a couple extra hours a week of reading. Since the examination focused on the practical aspects of diagnosis and management, and not the basic- science minutiae that had characterized the earlier examinations in my career, I found that the preparation for the MOC exam improved my practice of medicine. The only downside was that I did not have the luxury of an HM-focused exam in 2008, and there were content areas on the standard internal medicine (IM) MOC that were not a part of my inpatient practice.

But it was the Practice Improvement Module (PIM) component of the MOC process, a shared feature of both the FPHM and the IM MOC processes, that most benefited my patients. As a hospitalist, this too was not onerous, as practice improvement is what I do on a daily basis. Moreover, it was the external discipline of completing the PIM that made it truly valuable: collecting data, reflecting on methods of improvement, enacting an intervention, and then reassessing the results. The process forced me to reflect on my practice, and it heightened my sensitivity to other parts of my practice, and the hospital system, that needed to be improved.

Further benefit came through collaboration with other physicians in my group, as encouraged by the ABIM, to complete the PIM. This teamwork fostered a heightened spirit of QI within our team, further augmenting quality of care and sensitivity to needed systems improvements. True, at the end of the process, I was $1,000 lighter … but my conscience was richer. I had improved as a physician, and I think it has translated into a benefit for my patients.

What Recertification Means to HM

Although the virtue of improving patient care is sufficient to justify participation in the MOC in FPHM, the passage of healthcare reform legislation raises the stakes for hospitalists. The Physician Quality Reporting Initiative (PQRI) is an ongoing reality, further voicing the public’s need for accountability.

The final impact will hinge on the Center for Medicare & Medicaid Services’ (CMS) interpretation and execution of the language in the final bill, but it is clear that physicians who participate in the PQRI (through claims-based or registry reporting) have the opportunity to receive an additional 0.5% bonus on their total allowable Medicare charges in 2011 through 2014, if they also meet MOC program requirements. (The health reform bill provides a 1.0% bonus in 2011 for PQRI participation and a 0.5% bonus through 2014.)

Subsequently, physicians who do not participate in the PQRI will face a 1.5% payment penalty in 2015, and a 2% payment penalty in 2016 and thereafter. With these incentives, it appears the day-to-day finances of practice will offset the cost of MOC participation.

The importance of FPHM extends to the remainder of the PQRI as well. Currently, HM is not recognized by CMS as its own specialty, which means that it does not have its own CMS specialty code. In turn, this means that the core measures CMS will apply to the hospitalist in fulfilling the PQRI standards will be those of the general internist, and these might or might not apply to HM practice. For those to whom the standards do not apply, PQRI becomes a practical impossibility, though the financial penalty remains an unfortunate reality.

The extent to which the core measures for general medicine do not apply to the inpatient environment is the extent to which PQRI will be less effective in incentivizing the advancement of inpatient healthcare quality. This is an opportunity missed. Preventing this systematic exclusion begins with recognizing HM as a specialty. In convincing CMS that HM is its own specialty, deserving of its own code and its own PQRI indices, I can think of no argument as compelling as pointing to 10,000 hospitalists certified in the MOC in FPHM program.

Financial incentives aside, the ultimate success of HM will be in our ability to change the healthcare system such that it provides safe, timely, equitable, efficient, and patient-centered care. We’ve spent more than 10 years trying to get into the conversation, and now we have a seat at the table. But to be effective in this audacious goal, we must speak with a stentorian voice—a timbre that comes only from the chords of the sincere. Society must know of our sincerity—not by our words, but by our actions.

As president of SHM, I am calling on you to join me in meeting this standard of public accountability. Let us prove to the world that our talk of quality and patient safety is much more than talk. Let us establish that we are willing to engage in the ongoing self-improvement necessary to reach this wished-for goal.

Esse est percipi. We are as we are perceived. Now is our time to make one with the other—fulfilling a covenant that promises that we will, eventually, close this quality chasm. TH

Dr. Wiese is president of SHM.

Pipeline Drugs

• Phentermine/topiramate (Qnexa) is an investigational drug for the treatment of obesity. This includes weight loss and weight-loss maintenance in patients who are obese or overweight with such comorbidities as hypertension, Type 2 diabetes, dyslipidemia, or central adiposity. A new drug application (NDA) was filed with the FDA for this agent late in 2009.1 Qnexa is a once-daily, oral, controlled-release formulation comprised of low-dose phentermine and topiramate, which works on both patient satiety and appetite. Clinical trials show the drug has led to significant weight loss, glycemic control, and improved cardiovascular risk factors. Common side effects in clinical trials were dry mouth, tingling, and constipation.
• Pirfenidone, a potential treatment for idiopathic pulmonary fibrosis (IPF), has been granted a priority review by the FDA.2 Idiopathic pulmonary fibrosis is a disabling and fatal disease characterized by lung inflammation and scarring. The median survival time from diagnosis is two to five years, with an approximate five-year survival rate of 20%. Patients usually are diagnosed between the ages of 20 and 70, with a median of 63 years. It affects slightly more men than women. There are no medications approved to treat this fatal disease. Pirfenidone has been shown to have both antifibrotic and anti-inflammatory properties. The most common side effects are photosensitivity rash and gastrointestinal symptoms.3 The FDA’s action date is expected to be May 4.
• FDA approval was requested for retigabine, a potential new adjunctive epilepsy treatment, on Dec. 30, 2009.4 Retigabine is a neuronal potassium channel opener for use in adults with partial-onset seizures. In Phase 3 clinical trials, common adverse effects (occurring in more than 5% of patients) were dizziness, fatigue, confused state, vertigo, tremor, abnormal coordination, diplopia, attention disturbance, asthenia, and visual blurring.

Safety Information

• Desipramine (Norpramin), a tricyclic antidepressant approved by the FDA for treating major depression in adults, has undergone a label change to reflect new safety information. The “Warnings” and “Overdosage” sections of the product label now include information stating that extreme caution needs to be used when desipramine is administered to patients with a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances. The information also states that seizures might precede cardiac dysrhythmias and death in some patients.5 In a related “Dear Healthcare Professional” letter, information related to this warning was included with regard to identifying patients who present with a desipramine overdose, managing gastrointestinal decontamination with activated charcoal, managing cardiovascular effects, and deletion of measuring plasma-concentration desipramine as a guide to patient monitoring.5
• Diclofenac gel (Voltaren gel), a topical NSAID indicated for the relief of osteoarthritis pain of joints amenable to topical treatment (e.g., knees and hands), has undergone a label change related to its hepatic effects section. The label has revised warnings and precautions about the potential for liver function test elevations while receiving treatment with all diclofenac-containing products.6 There have been post-marketing reports of drug-induced hepatotoxicity within the first month of treatment with this topical agent. However, this reaction can occur at any time during diclofenac treatment. Severe hepatic reactions have been reported, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these cases resulted in fatalities or liver transplantation. Oral diclofenac also is hepatotoxic; it’s one of the most hepatotoxic NSAIDs available. To monitor patients receiving topical diclofenac, you should, after obtaining baseline transaminases, periodically measure transaminases in patients receiving long-term therapy. The optimum times for measurement are unknown. Based on available data from clinical trials and other cases, transaminases should be monitored within four to eight weeks after initiating diclofenac treatment.
• Fosamprenavir (Lexiva) has undergone a label change in the “Warnings” and “Precautions” sections, which is related to a potential association between the agent and the occurrence of myocardial infarction and dyslipidemia in adults with HIV.7 The updated label notes that patient cholesterol levels might increase if treated with fosamprenavir, and that lipid monitoring prior to and after initiating the agent should occur.
• Valproate sodium, valproic acid, and divalproex sodium have been associated with an increased risk of neural tube defects and other major birth defects (e.g., craniofacial defects and cardiovascular malformations) in babies exposed to these agents during pregnancy.8 Healthcare providers need to inform women of childbearing potential about these risks and consider alternative therapies, especially if the use of valproate is considered to treat migraines or other conditions that are not considered life-threatening. Women who are not actively planning a pregnancy and require use of valproate for medical conditions should use contraception, as birth-defect risks are high during the first trimester of pregnancy. Pregnant women using valproate should be encouraged to enroll in the North American Antiepileptic Drug Pregnancy Registry (888-233-2334 or www.aedpregnancyregistry.org). A medication guide explaining the risk and benefits of such treatment is required to be distributed with each dispensed valproate prescription.9 TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. NDA submitted for Qnexa. Drugs.com Web site. Available at: http://www.drugs.com/nda/qnexa_091229.html. Accessed Jan. 7, 2010.
2. Todoruk M. InterMune’s pulmonary drug pirfenidone granted priority review by FDA. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=5C01296C0574469B9A67F3574353FB1E&logRowId=343385. Accessed Jan. 7, 2010.
3. FDA grants priority review of pirfenidone NDA for the treatment of patients with IPF. InterMune Web site. Available at: http://phx.corporate-ir.net/phoenix.zhtml?c=100067&p=irol-newsArticle&ID=1370133&highlight=. Accessed Jan. 7, 2010.
4. FDA accepts NDA filing for retigabine. Drugs.com Web site. Available at: http://www.drugs.com/nda/retigabine_091230.html. Accessed Jan. 7, 2010.
5. Norpramin (desipramine hydrochloride)—Dear Healthcare Professional letter. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192655.htm. Accessed Jan. 7, 2010.
6. Voltaren gel (diclofenac sodium topical gel) 1%—hepatic effects labeling changes. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm193047.htm. Accessed Jan. 7, 2009.
7. Lexiva (fosamprenavir calcium)—Dear Healthcare Professional letter. Food and Drug Administration Web site. Available at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192699.htm. Accessed Jan. 7, 2010.
8. FDA warns of birth defects with valproate sodium, valproic acid, and divalproex sodium. Monthly Prescribing Reference Web site. Available at: http://www.empr.com/fda-warns-of-birth-defects-with-valproate-sodium-valproic-acid-and-divalproex-sodium/article/159034/. Accessed Jan. 7, 2010.
9. Valproate sodium and related products (valproic acid and divalproex sodium): risk of birth defects. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192788.htm. Accessed Jan. 7, 2009.

Pipeline Drugs

• Phentermine/topiramate (Qnexa) is an investigational drug for the treatment of obesity. This includes weight loss and weight-loss maintenance in patients who are obese or overweight with such comorbidities as hypertension, Type 2 diabetes, dyslipidemia, or central adiposity. A new drug application (NDA) was filed with the FDA for this agent late in 2009.1 Qnexa is a once-daily, oral, controlled-release formulation comprised of low-dose phentermine and topiramate, which works on both patient satiety and appetite. Clinical trials show the drug has led to significant weight loss, glycemic control, and improved cardiovascular risk factors. Common side effects in clinical trials were dry mouth, tingling, and constipation.
• Pirfenidone, a potential treatment for idiopathic pulmonary fibrosis (IPF), has been granted a priority review by the FDA.2 Idiopathic pulmonary fibrosis is a disabling and fatal disease characterized by lung inflammation and scarring. The median survival time from diagnosis is two to five years, with an approximate five-year survival rate of 20%. Patients usually are diagnosed between the ages of 20 and 70, with a median of 63 years. It affects slightly more men than women. There are no medications approved to treat this fatal disease. Pirfenidone has been shown to have both antifibrotic and anti-inflammatory properties. The most common side effects are photosensitivity rash and gastrointestinal symptoms.3 The FDA’s action date is expected to be May 4.
• FDA approval was requested for retigabine, a potential new adjunctive epilepsy treatment, on Dec. 30, 2009.4 Retigabine is a neuronal potassium channel opener for use in adults with partial-onset seizures. In Phase 3 clinical trials, common adverse effects (occurring in more than 5% of patients) were dizziness, fatigue, confused state, vertigo, tremor, abnormal coordination, diplopia, attention disturbance, asthenia, and visual blurring.

Safety Information

• Desipramine (Norpramin), a tricyclic antidepressant approved by the FDA for treating major depression in adults, has undergone a label change to reflect new safety information. The “Warnings” and “Overdosage” sections of the product label now include information stating that extreme caution needs to be used when desipramine is administered to patients with a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances. The information also states that seizures might precede cardiac dysrhythmias and death in some patients.5 In a related “Dear Healthcare Professional” letter, information related to this warning was included with regard to identifying patients who present with a desipramine overdose, managing gastrointestinal decontamination with activated charcoal, managing cardiovascular effects, and deletion of measuring plasma-concentration desipramine as a guide to patient monitoring.5
• Diclofenac gel (Voltaren gel), a topical NSAID indicated for the relief of osteoarthritis pain of joints amenable to topical treatment (e.g., knees and hands), has undergone a label change related to its hepatic effects section. The label has revised warnings and precautions about the potential for liver function test elevations while receiving treatment with all diclofenac-containing products.6 There have been post-marketing reports of drug-induced hepatotoxicity within the first month of treatment with this topical agent. However, this reaction can occur at any time during diclofenac treatment. Severe hepatic reactions have been reported, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these cases resulted in fatalities or liver transplantation. Oral diclofenac also is hepatotoxic; it’s one of the most hepatotoxic NSAIDs available. To monitor patients receiving topical diclofenac, you should, after obtaining baseline transaminases, periodically measure transaminases in patients receiving long-term therapy. The optimum times for measurement are unknown. Based on available data from clinical trials and other cases, transaminases should be monitored within four to eight weeks after initiating diclofenac treatment.
• Fosamprenavir (Lexiva) has undergone a label change in the “Warnings” and “Precautions” sections, which is related to a potential association between the agent and the occurrence of myocardial infarction and dyslipidemia in adults with HIV.7 The updated label notes that patient cholesterol levels might increase if treated with fosamprenavir, and that lipid monitoring prior to and after initiating the agent should occur.
• Valproate sodium, valproic acid, and divalproex sodium have been associated with an increased risk of neural tube defects and other major birth defects (e.g., craniofacial defects and cardiovascular malformations) in babies exposed to these agents during pregnancy.8 Healthcare providers need to inform women of childbearing potential about these risks and consider alternative therapies, especially if the use of valproate is considered to treat migraines or other conditions that are not considered life-threatening. Women who are not actively planning a pregnancy and require use of valproate for medical conditions should use contraception, as birth-defect risks are high during the first trimester of pregnancy. Pregnant women using valproate should be encouraged to enroll in the North American Antiepileptic Drug Pregnancy Registry (888-233-2334 or www.aedpregnancyregistry.org). A medication guide explaining the risk and benefits of such treatment is required to be distributed with each dispensed valproate prescription.9 TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. NDA submitted for Qnexa. Drugs.com Web site. Available at: http://www.drugs.com/nda/qnexa_091229.html. Accessed Jan. 7, 2010.
2. Todoruk M. InterMune’s pulmonary drug pirfenidone granted priority review by FDA. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=5C01296C0574469B9A67F3574353FB1E&logRowId=343385. Accessed Jan. 7, 2010.
3. FDA grants priority review of pirfenidone NDA for the treatment of patients with IPF. InterMune Web site. Available at: http://phx.corporate-ir.net/phoenix.zhtml?c=100067&p=irol-newsArticle&ID=1370133&highlight=. Accessed Jan. 7, 2010.
4. FDA accepts NDA filing for retigabine. Drugs.com Web site. Available at: http://www.drugs.com/nda/retigabine_091230.html. Accessed Jan. 7, 2010.
5. Norpramin (desipramine hydrochloride)—Dear Healthcare Professional letter. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192655.htm. Accessed Jan. 7, 2010.
6. Voltaren gel (diclofenac sodium topical gel) 1%—hepatic effects labeling changes. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm193047.htm. Accessed Jan. 7, 2009.
7. Lexiva (fosamprenavir calcium)—Dear Healthcare Professional letter. Food and Drug Administration Web site. Available at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192699.htm. Accessed Jan. 7, 2010.
8. FDA warns of birth defects with valproate sodium, valproic acid, and divalproex sodium. Monthly Prescribing Reference Web site. Available at: http://www.empr.com/fda-warns-of-birth-defects-with-valproate-sodium-valproic-acid-and-divalproex-sodium/article/159034/. Accessed Jan. 7, 2010.
9. Valproate sodium and related products (valproic acid and divalproex sodium): risk of birth defects. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192788.htm. Accessed Jan. 7, 2009.

Pipeline Drugs

• Phentermine/topiramate (Qnexa) is an investigational drug for the treatment of obesity. This includes weight loss and weight-loss maintenance in patients who are obese or overweight with such comorbidities as hypertension, Type 2 diabetes, dyslipidemia, or central adiposity. A new drug application (NDA) was filed with the FDA for this agent late in 2009.1 Qnexa is a once-daily, oral, controlled-release formulation comprised of low-dose phentermine and topiramate, which works on both patient satiety and appetite. Clinical trials show the drug has led to significant weight loss, glycemic control, and improved cardiovascular risk factors. Common side effects in clinical trials were dry mouth, tingling, and constipation.
• Pirfenidone, a potential treatment for idiopathic pulmonary fibrosis (IPF), has been granted a priority review by the FDA.2 Idiopathic pulmonary fibrosis is a disabling and fatal disease characterized by lung inflammation and scarring. The median survival time from diagnosis is two to five years, with an approximate five-year survival rate of 20%. Patients usually are diagnosed between the ages of 20 and 70, with a median of 63 years. It affects slightly more men than women. There are no medications approved to treat this fatal disease. Pirfenidone has been shown to have both antifibrotic and anti-inflammatory properties. The most common side effects are photosensitivity rash and gastrointestinal symptoms.3 The FDA’s action date is expected to be May 4.
• FDA approval was requested for retigabine, a potential new adjunctive epilepsy treatment, on Dec. 30, 2009.4 Retigabine is a neuronal potassium channel opener for use in adults with partial-onset seizures. In Phase 3 clinical trials, common adverse effects (occurring in more than 5% of patients) were dizziness, fatigue, confused state, vertigo, tremor, abnormal coordination, diplopia, attention disturbance, asthenia, and visual blurring.

Safety Information

• Desipramine (Norpramin), a tricyclic antidepressant approved by the FDA for treating major depression in adults, has undergone a label change to reflect new safety information. The “Warnings” and “Overdosage” sections of the product label now include information stating that extreme caution needs to be used when desipramine is administered to patients with a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances. The information also states that seizures might precede cardiac dysrhythmias and death in some patients.5 In a related “Dear Healthcare Professional” letter, information related to this warning was included with regard to identifying patients who present with a desipramine overdose, managing gastrointestinal decontamination with activated charcoal, managing cardiovascular effects, and deletion of measuring plasma-concentration desipramine as a guide to patient monitoring.5
• Diclofenac gel (Voltaren gel), a topical NSAID indicated for the relief of osteoarthritis pain of joints amenable to topical treatment (e.g., knees and hands), has undergone a label change related to its hepatic effects section. The label has revised warnings and precautions about the potential for liver function test elevations while receiving treatment with all diclofenac-containing products.6 There have been post-marketing reports of drug-induced hepatotoxicity within the first month of treatment with this topical agent. However, this reaction can occur at any time during diclofenac treatment. Severe hepatic reactions have been reported, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these cases resulted in fatalities or liver transplantation. Oral diclofenac also is hepatotoxic; it’s one of the most hepatotoxic NSAIDs available. To monitor patients receiving topical diclofenac, you should, after obtaining baseline transaminases, periodically measure transaminases in patients receiving long-term therapy. The optimum times for measurement are unknown. Based on available data from clinical trials and other cases, transaminases should be monitored within four to eight weeks after initiating diclofenac treatment.
• Fosamprenavir (Lexiva) has undergone a label change in the “Warnings” and “Precautions” sections, which is related to a potential association between the agent and the occurrence of myocardial infarction and dyslipidemia in adults with HIV.7 The updated label notes that patient cholesterol levels might increase if treated with fosamprenavir, and that lipid monitoring prior to and after initiating the agent should occur.
• Valproate sodium, valproic acid, and divalproex sodium have been associated with an increased risk of neural tube defects and other major birth defects (e.g., craniofacial defects and cardiovascular malformations) in babies exposed to these agents during pregnancy.8 Healthcare providers need to inform women of childbearing potential about these risks and consider alternative therapies, especially if the use of valproate is considered to treat migraines or other conditions that are not considered life-threatening. Women who are not actively planning a pregnancy and require use of valproate for medical conditions should use contraception, as birth-defect risks are high during the first trimester of pregnancy. Pregnant women using valproate should be encouraged to enroll in the North American Antiepileptic Drug Pregnancy Registry (888-233-2334 or www.aedpregnancyregistry.org). A medication guide explaining the risk and benefits of such treatment is required to be distributed with each dispensed valproate prescription.9 TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. NDA submitted for Qnexa. Drugs.com Web site. Available at: http://www.drugs.com/nda/qnexa_091229.html. Accessed Jan. 7, 2010.
2. Todoruk M. InterMune’s pulmonary drug pirfenidone granted priority review by FDA. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=5C01296C0574469B9A67F3574353FB1E&logRowId=343385. Accessed Jan. 7, 2010.
3. FDA grants priority review of pirfenidone NDA for the treatment of patients with IPF. InterMune Web site. Available at: http://phx.corporate-ir.net/phoenix.zhtml?c=100067&p=irol-newsArticle&ID=1370133&highlight=. Accessed Jan. 7, 2010.
4. FDA accepts NDA filing for retigabine. Drugs.com Web site. Available at: http://www.drugs.com/nda/retigabine_091230.html. Accessed Jan. 7, 2010.
5. Norpramin (desipramine hydrochloride)—Dear Healthcare Professional letter. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192655.htm. Accessed Jan. 7, 2010.
6. Voltaren gel (diclofenac sodium topical gel) 1%—hepatic effects labeling changes. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm193047.htm. Accessed Jan. 7, 2009.
7. Lexiva (fosamprenavir calcium)—Dear Healthcare Professional letter. Food and Drug Administration Web site. Available at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192699.htm. Accessed Jan. 7, 2010.
8. FDA warns of birth defects with valproate sodium, valproic acid, and divalproex sodium. Monthly Prescribing Reference Web site. Available at: http://www.empr.com/fda-warns-of-birth-defects-with-valproate-sodium-valproic-acid-and-divalproex-sodium/article/159034/. Accessed Jan. 7, 2010.
9. Valproate sodium and related products (valproic acid and divalproex sodium): risk of birth defects. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192788.htm. Accessed Jan. 7, 2009.

Thousands of Michigan residents will have a better chance of avoiding readmission to the hospital thanks to a groundbreaking new collaboration between three of the state’s healthcare leaders.

Based on SHM’s Project BOOST (Better Outcomes for Older Adults through Safe Transitions) model, the collaborative program will be managed by the University of Michigan in collaboration with Blue Cross Blue Shield of Michigan. The Michigan Blues provide and administer health benefits to 4.7 million Michigan residents.

Project BOOST helps hospitals reduce readmission rates by providing them with proven resources and expert mentoring to optimize the discharge transition process, enhance patient and family education practices, and improve the flow of information between inpatient and outpatient providers. Project BOOST was developed through a grant from the John A. Hartford Foundation. Earlier in the year, the program recruited 15 Michigan sites to participate. Training begins in May.

Each improvement team will be assigned a mentor to coach them through the process of planning, implementing, and evaluating Project BOOST at their site. Program participants will receive face-to-face training, monthly coaching sessions with their mentors, and a comprehensive toolkit to implement Project BOOST. Sites also participate in an online peer learning and collaboration network.

“This kind of innovative, targeted program benefits both the patient and the healthcare provider by establishing better communication between all parties,” says Scott Flanders, MD, FHM, associate professor and director of hospital medicine at the University of Michigan in Ann Arbor, and SHM president.

To Flanders, it’s no coincidence that hospitalists are taking the lead in improving hospital discharges. “Readmissions are a pervasive but preventable problem,” he says. “Hospitalists are uniquely positioned to provide leadership within the hospital, to promote positive, system-based changes that improve patient satisfaction, and promote collaboration between hospitalists and primary-care physicians.”

In addition to being preventable, readmissions are costly, draining the resources, time, and energy of the patient, PCPs, and hospitals. Research in the April 2009 New England Journal of Medicine indicates that 20% of hospitalized patients are readmitted to the hospital within a month of their discharge.1 Nationally, readmissions cost Medicare $17.4 billion each year.1

Collaborative Partnerships

Prior to the program’s launch in Michigan, SHM recruited and mentored Project BOOST sites independently. However, like many productive relationships in a hospital, Project BOOST in Michigan depends on collaboration between experts.

“Blue Cross Blue Shield of Michigan is confident that this project, like our other Value Partnership programs that focus on robust, statewide, data-driven quality-improvement (QI) partnerships, will have a positive impact on thousands of Michigan lives,” says David Share, MD, MPH, BCBS Michigan’s senior associate medical director of Healthcare Quality. “We look forward to helping hospitals, physicians, and patients work together to assure smooth transitions between inpatient and outpatient care, and to reduce readmissions and improve the patient experience.”

For University of Michigan hospitalist Christopher Kim, MD, MBA, FHM, Project BOOST is a chance to work with a diverse set of groups. “We are grateful for the opportunity to work with not just Blue Cross Blue Shield of Michigan, but also with the other physician organizations across our state to implement and share best-practice ideas in transitions of care,” says Kim, director of the statewide collaborative program on transitions of care.

Results and Reports

Having launched six pilot sites just two years ago, adding 24 additional sites in 2009, Project BOOST is still a relatively young QI program, which makes reliable quantitative data about its effectiveness tough to come by. The expansion into Michigan gives SHM and others the prospect of programwide measurement of how Project BOOST affects discharge and reduces readmissions.

“This is a tremendous opportunity to improve patient safety, reduce readmissions, and study the impact of Project BOOST interventions through patient-level data,” says Mark Williams, MD, FHM, Journal of Hospital Medicine editor, principal investigator for Project BOOST, and former SHM president. “We’re thrilled to be working with the state’s healthcare leaders to implement this critical program.”

Nonetheless, in the absence of comprehensive data, the early reports from Project BOOST sites are promising. At Piedmont Hospital in the Atlanta area, the rate of readmission among patients under the age of 70 participating in BOOST is 8.5%, compared with 25.5% among nonparticipants. The readmission rate among BOOST participants at Piedmont over the age of 70 was 22%, compared with 26% of nonparticipants. When SSM St. Mary’s Medical Center in St. Louis implemented BOOST at its 33-bed hospitalist unit, 30-day readmissions dropped to 7% from 12% within three months.

Patient satisfaction rates also increased markedly, to 68% from 52%. And in 2009, the University of Pennsylvania Health System awarded its annual Operational Quality and Safety Award to the Project BOOST implementation team at the hospital.

BOOST’s Reach Expands

Project BOOST leaders are planning an aggressive expansion in the near future. In addition to the potential for new program sites, SHM has made materials available to hospitalists through the Project BOOST Resource Room at SHM’s newly redesigned Web site (see “The New Face of HospitalMedicine.org,” p. 12), www.hospitalmedicine.org/boost.

In addition to free resources, new BOOST materials are for sale through SHM’s online store. The Project BOOST Implementation Guide—available electronically for free through the resource room—is now available for sale as a hard copy. The online store also features a new Project BOOST instructional DVD for hospitalists, “Using Teach Back to Improve Communication with Patients.” TH

Brendon Shank is a freelance writer based in Philadelphia.

Reference

1. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009;360(14): 1418-1428.

Chapter Updates

The Historic Main Street Trolley in Memphis, Tenn.

Memphis

The Memphis chapter held its quarterly meeting Feb. 4 at Erling Jensen in Memphis, Tenn. Dr. William Edmonson of the North Mississippi Medical Center in Tupelo, Miss., discussed “Updates on COPD.” Boehringer Engelheim sponsored the dinner meeting, which was attended by hospitalists and physicians in the area as well as hospital nurses and administration.

Milwaukee/Southeast Wisconsin

The Milwaukee/Southeast Wisconsin chapter’s Feb. 27 meeting in the Columbia Hospital Auditorium brought together hospitalists, nurse practitioners, pharmacists, and others from the Milwaukee area. Attendees were able to obtain CME credit on topics including acute coronary syndrome, hyponatremia, and sepsis. The meeting highlight was a presentation from Dr. Alpesh Amin, interim chair of the Department of Medicine at the University of California at Irvine. Dr. Amin discussed how to start up a local SHM chapter. Sponsorship from CME University helped make the chapter’s first HM symposium a success.

Nebraska Area

Lincoln HM group Bryan LGH hosted the Nebraska Area chapter quarterly meeting Feb. 23. Dr. Tamer Mahrous gave an overview of coding issues for hospitalists. A copy of the presentation will be sent to all of the chapter members.

The chapter elected officers to serve terms through 2012. They include: Dr. Eric Rice, president; Russ Cowles, vice president; Alissa Clough, secretary; and Jay Snow, officer at large.

Several additional items were discussed, including topics for upcoming meetings, how the chapter can best take advantage of opportunities at HM10, the possibility of launching a chapter newsletter, and organizational issues.

Thousands of Michigan residents will have a better chance of avoiding readmission to the hospital thanks to a groundbreaking new collaboration between three of the state’s healthcare leaders.

Based on SHM’s Project BOOST (Better Outcomes for Older Adults through Safe Transitions) model, the collaborative program will be managed by the University of Michigan in collaboration with Blue Cross Blue Shield of Michigan. The Michigan Blues provide and administer health benefits to 4.7 million Michigan residents.

Project BOOST helps hospitals reduce readmission rates by providing them with proven resources and expert mentoring to optimize the discharge transition process, enhance patient and family education practices, and improve the flow of information between inpatient and outpatient providers. Project BOOST was developed through a grant from the John A. Hartford Foundation. Earlier in the year, the program recruited 15 Michigan sites to participate. Training begins in May.

Each improvement team will be assigned a mentor to coach them through the process of planning, implementing, and evaluating Project BOOST at their site. Program participants will receive face-to-face training, monthly coaching sessions with their mentors, and a comprehensive toolkit to implement Project BOOST. Sites also participate in an online peer learning and collaboration network.

“This kind of innovative, targeted program benefits both the patient and the healthcare provider by establishing better communication between all parties,” says Scott Flanders, MD, FHM, associate professor and director of hospital medicine at the University of Michigan in Ann Arbor, and SHM president.

To Flanders, it’s no coincidence that hospitalists are taking the lead in improving hospital discharges. “Readmissions are a pervasive but preventable problem,” he says. “Hospitalists are uniquely positioned to provide leadership within the hospital, to promote positive, system-based changes that improve patient satisfaction, and promote collaboration between hospitalists and primary-care physicians.”

In addition to being preventable, readmissions are costly, draining the resources, time, and energy of the patient, PCPs, and hospitals. Research in the April 2009 New England Journal of Medicine indicates that 20% of hospitalized patients are readmitted to the hospital within a month of their discharge.1 Nationally, readmissions cost Medicare $17.4 billion each year.1

Collaborative Partnerships

Prior to the program’s launch in Michigan, SHM recruited and mentored Project BOOST sites independently. However, like many productive relationships in a hospital, Project BOOST in Michigan depends on collaboration between experts.

“Blue Cross Blue Shield of Michigan is confident that this project, like our other Value Partnership programs that focus on robust, statewide, data-driven quality-improvement (QI) partnerships, will have a positive impact on thousands of Michigan lives,” says David Share, MD, MPH, BCBS Michigan’s senior associate medical director of Healthcare Quality. “We look forward to helping hospitals, physicians, and patients work together to assure smooth transitions between inpatient and outpatient care, and to reduce readmissions and improve the patient experience.”

For University of Michigan hospitalist Christopher Kim, MD, MBA, FHM, Project BOOST is a chance to work with a diverse set of groups. “We are grateful for the opportunity to work with not just Blue Cross Blue Shield of Michigan, but also with the other physician organizations across our state to implement and share best-practice ideas in transitions of care,” says Kim, director of the statewide collaborative program on transitions of care.

Results and Reports

Having launched six pilot sites just two years ago, adding 24 additional sites in 2009, Project BOOST is still a relatively young QI program, which makes reliable quantitative data about its effectiveness tough to come by. The expansion into Michigan gives SHM and others the prospect of programwide measurement of how Project BOOST affects discharge and reduces readmissions.

“This is a tremendous opportunity to improve patient safety, reduce readmissions, and study the impact of Project BOOST interventions through patient-level data,” says Mark Williams, MD, FHM, Journal of Hospital Medicine editor, principal investigator for Project BOOST, and former SHM president. “We’re thrilled to be working with the state’s healthcare leaders to implement this critical program.”

Nonetheless, in the absence of comprehensive data, the early reports from Project BOOST sites are promising. At Piedmont Hospital in the Atlanta area, the rate of readmission among patients under the age of 70 participating in BOOST is 8.5%, compared with 25.5% among nonparticipants. The readmission rate among BOOST participants at Piedmont over the age of 70 was 22%, compared with 26% of nonparticipants. When SSM St. Mary’s Medical Center in St. Louis implemented BOOST at its 33-bed hospitalist unit, 30-day readmissions dropped to 7% from 12% within three months.

Patient satisfaction rates also increased markedly, to 68% from 52%. And in 2009, the University of Pennsylvania Health System awarded its annual Operational Quality and Safety Award to the Project BOOST implementation team at the hospital.

BOOST’s Reach Expands

Project BOOST leaders are planning an aggressive expansion in the near future. In addition to the potential for new program sites, SHM has made materials available to hospitalists through the Project BOOST Resource Room at SHM’s newly redesigned Web site (see “The New Face of HospitalMedicine.org,” p. 12), www.hospitalmedicine.org/boost.

In addition to free resources, new BOOST materials are for sale through SHM’s online store. The Project BOOST Implementation Guide—available electronically for free through the resource room—is now available for sale as a hard copy. The online store also features a new Project BOOST instructional DVD for hospitalists, “Using Teach Back to Improve Communication with Patients.” TH

Brendon Shank is a freelance writer based in Philadelphia.

Reference

1. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009;360(14): 1418-1428.

Chapter Updates

The Historic Main Street Trolley in Memphis, Tenn.

Memphis

The Memphis chapter held its quarterly meeting Feb. 4 at Erling Jensen in Memphis, Tenn. Dr. William Edmonson of the North Mississippi Medical Center in Tupelo, Miss., discussed “Updates on COPD.” Boehringer Engelheim sponsored the dinner meeting, which was attended by hospitalists and physicians in the area as well as hospital nurses and administration.

Milwaukee/Southeast Wisconsin

The Milwaukee/Southeast Wisconsin chapter’s Feb. 27 meeting in the Columbia Hospital Auditorium brought together hospitalists, nurse practitioners, pharmacists, and others from the Milwaukee area. Attendees were able to obtain CME credit on topics including acute coronary syndrome, hyponatremia, and sepsis. The meeting highlight was a presentation from Dr. Alpesh Amin, interim chair of the Department of Medicine at the University of California at Irvine. Dr. Amin discussed how to start up a local SHM chapter. Sponsorship from CME University helped make the chapter’s first HM symposium a success.

Nebraska Area

Lincoln HM group Bryan LGH hosted the Nebraska Area chapter quarterly meeting Feb. 23. Dr. Tamer Mahrous gave an overview of coding issues for hospitalists. A copy of the presentation will be sent to all of the chapter members.

The chapter elected officers to serve terms through 2012. They include: Dr. Eric Rice, president; Russ Cowles, vice president; Alissa Clough, secretary; and Jay Snow, officer at large.

Several additional items were discussed, including topics for upcoming meetings, how the chapter can best take advantage of opportunities at HM10, the possibility of launching a chapter newsletter, and organizational issues.

Thousands of Michigan residents will have a better chance of avoiding readmission to the hospital thanks to a groundbreaking new collaboration between three of the state’s healthcare leaders.

Based on SHM’s Project BOOST (Better Outcomes for Older Adults through Safe Transitions) model, the collaborative program will be managed by the University of Michigan in collaboration with Blue Cross Blue Shield of Michigan. The Michigan Blues provide and administer health benefits to 4.7 million Michigan residents.

Project BOOST helps hospitals reduce readmission rates by providing them with proven resources and expert mentoring to optimize the discharge transition process, enhance patient and family education practices, and improve the flow of information between inpatient and outpatient providers. Project BOOST was developed through a grant from the John A. Hartford Foundation. Earlier in the year, the program recruited 15 Michigan sites to participate. Training begins in May.

Each improvement team will be assigned a mentor to coach them through the process of planning, implementing, and evaluating Project BOOST at their site. Program participants will receive face-to-face training, monthly coaching sessions with their mentors, and a comprehensive toolkit to implement Project BOOST. Sites also participate in an online peer learning and collaboration network.

“This kind of innovative, targeted program benefits both the patient and the healthcare provider by establishing better communication between all parties,” says Scott Flanders, MD, FHM, associate professor and director of hospital medicine at the University of Michigan in Ann Arbor, and SHM president.

To Flanders, it’s no coincidence that hospitalists are taking the lead in improving hospital discharges. “Readmissions are a pervasive but preventable problem,” he says. “Hospitalists are uniquely positioned to provide leadership within the hospital, to promote positive, system-based changes that improve patient satisfaction, and promote collaboration between hospitalists and primary-care physicians.”

In addition to being preventable, readmissions are costly, draining the resources, time, and energy of the patient, PCPs, and hospitals. Research in the April 2009 New England Journal of Medicine indicates that 20% of hospitalized patients are readmitted to the hospital within a month of their discharge.1 Nationally, readmissions cost Medicare $17.4 billion each year.1

Collaborative Partnerships

Prior to the program’s launch in Michigan, SHM recruited and mentored Project BOOST sites independently. However, like many productive relationships in a hospital, Project BOOST in Michigan depends on collaboration between experts.

“Blue Cross Blue Shield of Michigan is confident that this project, like our other Value Partnership programs that focus on robust, statewide, data-driven quality-improvement (QI) partnerships, will have a positive impact on thousands of Michigan lives,” says David Share, MD, MPH, BCBS Michigan’s senior associate medical director of Healthcare Quality. “We look forward to helping hospitals, physicians, and patients work together to assure smooth transitions between inpatient and outpatient care, and to reduce readmissions and improve the patient experience.”

For University of Michigan hospitalist Christopher Kim, MD, MBA, FHM, Project BOOST is a chance to work with a diverse set of groups. “We are grateful for the opportunity to work with not just Blue Cross Blue Shield of Michigan, but also with the other physician organizations across our state to implement and share best-practice ideas in transitions of care,” says Kim, director of the statewide collaborative program on transitions of care.

Results and Reports

Having launched six pilot sites just two years ago, adding 24 additional sites in 2009, Project BOOST is still a relatively young QI program, which makes reliable quantitative data about its effectiveness tough to come by. The expansion into Michigan gives SHM and others the prospect of programwide measurement of how Project BOOST affects discharge and reduces readmissions.

“This is a tremendous opportunity to improve patient safety, reduce readmissions, and study the impact of Project BOOST interventions through patient-level data,” says Mark Williams, MD, FHM, Journal of Hospital Medicine editor, principal investigator for Project BOOST, and former SHM president. “We’re thrilled to be working with the state’s healthcare leaders to implement this critical program.”

Nonetheless, in the absence of comprehensive data, the early reports from Project BOOST sites are promising. At Piedmont Hospital in the Atlanta area, the rate of readmission among patients under the age of 70 participating in BOOST is 8.5%, compared with 25.5% among nonparticipants. The readmission rate among BOOST participants at Piedmont over the age of 70 was 22%, compared with 26% of nonparticipants. When SSM St. Mary’s Medical Center in St. Louis implemented BOOST at its 33-bed hospitalist unit, 30-day readmissions dropped to 7% from 12% within three months.

Patient satisfaction rates also increased markedly, to 68% from 52%. And in 2009, the University of Pennsylvania Health System awarded its annual Operational Quality and Safety Award to the Project BOOST implementation team at the hospital.

BOOST’s Reach Expands

Project BOOST leaders are planning an aggressive expansion in the near future. In addition to the potential for new program sites, SHM has made materials available to hospitalists through the Project BOOST Resource Room at SHM’s newly redesigned Web site (see “The New Face of HospitalMedicine.org,” p. 12), www.hospitalmedicine.org/boost.

In addition to free resources, new BOOST materials are for sale through SHM’s online store. The Project BOOST Implementation Guide—available electronically for free through the resource room—is now available for sale as a hard copy. The online store also features a new Project BOOST instructional DVD for hospitalists, “Using Teach Back to Improve Communication with Patients.” TH

Brendon Shank is a freelance writer based in Philadelphia.

Reference

1. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009;360(14): 1418-1428.

Chapter Updates

The Historic Main Street Trolley in Memphis, Tenn.

Memphis

The Memphis chapter held its quarterly meeting Feb. 4 at Erling Jensen in Memphis, Tenn. Dr. William Edmonson of the North Mississippi Medical Center in Tupelo, Miss., discussed “Updates on COPD.” Boehringer Engelheim sponsored the dinner meeting, which was attended by hospitalists and physicians in the area as well as hospital nurses and administration.

Milwaukee/Southeast Wisconsin

The Milwaukee/Southeast Wisconsin chapter’s Feb. 27 meeting in the Columbia Hospital Auditorium brought together hospitalists, nurse practitioners, pharmacists, and others from the Milwaukee area. Attendees were able to obtain CME credit on topics including acute coronary syndrome, hyponatremia, and sepsis. The meeting highlight was a presentation from Dr. Alpesh Amin, interim chair of the Department of Medicine at the University of California at Irvine. Dr. Amin discussed how to start up a local SHM chapter. Sponsorship from CME University helped make the chapter’s first HM symposium a success.

Nebraska Area

Lincoln HM group Bryan LGH hosted the Nebraska Area chapter quarterly meeting Feb. 23. Dr. Tamer Mahrous gave an overview of coding issues for hospitalists. A copy of the presentation will be sent to all of the chapter members.

The chapter elected officers to serve terms through 2012. They include: Dr. Eric Rice, president; Russ Cowles, vice president; Alissa Clough, secretary; and Jay Snow, officer at large.

Several additional items were discussed, including topics for upcoming meetings, how the chapter can best take advantage of opportunities at HM10, the possibility of launching a chapter newsletter, and organizational issues.

Case

A 67-year-old man with a history of hypertension presents with a swollen right lower extremity. An ultrasound reveals a DVT, and he is commenced on low-molecular-weight heparin and warfarin. Two days later, he develops slurred speech and right-sided weakness. A head CT reveals an intracranial hemorrhage. When should an inferior vena cava (IVC) filter be utilized for treatment of DVT?

Overview

It is estimated that 350,000 to 600,000 Americans develop a VTE each year.1 Patients with a DVT are at high risk of developing a pulmonary embolism (PE). In a multicenter study, nearly 40% of patients admitted with a DVT had evidence of a PE on ventilation perfusion scan.2 Treatment of a DVT is aimed at preventing the extension of the DVT and embolization.3 The American College of Chest Physicians (ACCP) recommends anticoagulation as the primary DVT treatment (Grade 1A).4 However, IVC filters might be considered when anticoagulation is contraindicated.

In 1868, Trousseau created the conceptual model of surgical interruption of the IVC to prevent PE. However, it wasn’t until 1959 by Bottini that the surgical interruption was successfully performed.5 The Mobin-Uddin filter was introduced in 1967 as the first mechanical IVC filter.6 IVC filters mechanically trap the DVT, preventing emboli from traveling into the pulmonary vasculature.7

There are two classes of IVC filters: permanent filters and removable filters. Removable filters include both temporary filters and retrievable filters. Temporary filters are attached to a catheter that exits the skin and therefore must be removed due to the risk of infection and embolization.7 Retrievable filters are similar in design to permanent filters but are designed to be removed. However, this must be done with caution, as neointimal hyperplasia can prevent removal or cause vessel wall damage upon removal.8

IVC filters are inserted into the vena cava percutaneously via the femoral or jugular approach under fluoroscopy or ultrasound guidance (see Figure 1, p. 16). The filters typically are placed infrarenally, unless there is an indication for a suprarenal filter (e.g., renal vein thrombosis or IVC thrombus extending above the renal veins).7 Complete IVC thrombosis is an absolute contraindication to IVC filter placement, and the relative contraindications include significant coagulopathy and bacteremia.9

The incidence of complications related to IVC filter placement is 4% to 11%. Complications include:

• Insertion-site thrombosis;
• IVC thrombosis;
• Recurrent DVT postphlebitic syndrome;
• Filter migration;
• Erosion of the filter through the vessel wall; and
• Vena caval obstruction.10

A review of the National Hospital Discharge Survey database for trends in IVC filter use in the U.S. found a dramatic increase in the use of IVC filters from 1979 to 1999—to 49,000 patients from 2,000 patients with IVC filters in place. The indications for IVC filter use vary such that it is imperative there are well-designed trials and guidelines to guide appropriate use.11

MEDICAL-ON-LINE/ALAMY

The Evidence

The 2008 ACCP guidelines on VTE management follow a grading system that classifies recommendations as Grade 1 (strong) or Grade 2 (weak), and classifies the quality of evidence as A (high), B (moderate), or C (low).12 The ACCP guidelines’ recommended first-line treatment for a confirmed DVT is anticoagulation with subcutaneous low-molecular-weight heparin, intravenous unfractionated heparin, monitored subcutaneous heparin, fixed-dose subcutaneous unfractionated heparin, or subcutaneous fondaparinux (all Grade 1A recommendations). The ACCP recommends against the routine use of an IVC filter in addition to anticoagulants (Grade 1A). However, for patients with acute proximal DVT, if anticoagulant therapy is not possible because of the risk of bleeding, IVC filter placement is recommended (Grade 1C). If a patient requires an IVC filter for treatment of an acute DVT as an alternative to anticoagulation, it is recommended to start anticoagulant therapy once the risk of bleeding resolves (Grade 1C).4

click for large version

The 2008 ACCP guidelines for IVC filter use have a few important changes from the 2004 version. First, the IVC filter placement recommendation for patients with contraindications to anticoagulation was strengthened from Grade 2C to Grade 1C. Second, the 2008 guidelines omitted the early recommendation of IVC filter use for recurrent VTE, despite adequate anticoagulation (Grade 2C).13

Only one randomized study has evaluated the efficacy of IVC filters. All other studies of IVC filters are retrospective or prospective case series.

The PREPIC study randomized 400 patients with proximal DVT considered to be at high risk for PE to receive either an IVC filter or no IVC filter. Additionally, patients were randomized to receive enoxaparin or unfractionated heparin as a bridge to warfarin therapy, which was continued for at least three months. The primary endpoints were recurrent DVT, PE, major bleeding, or death. The patients were followed up at day 12, two years, and then annually up to eight years following randomization.14 At day 12, there were fewer PEs in the group that received filters (OR 0.22, 95% CI, 0.05-0.90). However, at year two, there was no significant difference in PE development in the filter group compared with the no-filter group (OR 0.50, 95% CI, 0.19-1.33).

click for large version

Additionally, at year two, the filter group was more likely to develop recurrent DVT (OR 1.87, 95% CI, 1.10-3.20). At year eight, there was a significant reduction in the number of PEs in the filter group versus the no-filter group (6.2% vs.15.1%, P=0.008). However, at eight-year followup, IVC filter use was associated with increased DVT (35.7% vs. 27.5%, P=0.042). There was no difference in mortality between the two groups.

In summary, the use of IVC filters was associated with decreased incidence of PE at eight years, offset by higher rates of recurrent DVT and no overall mortality benefit.14,15 Importantly, the indications for IVC filter use in this study differ from the current ACCP guidelines; all patients were given concomitant anticoagulation for at least three months, which might not be possible in patients for whom the ACCP recommends IVC filters.

There are no randomized studies to compare the efficacy of permanent IVC filters and retrievable filters for PE prevention. A retrospective study comparing the clinical effectiveness of the two filter types reported no difference in the rates of symptomatic PE (permanent filter 4% vs. retrievable filter 4.7%, P=0.67) or DVT (11.3% vs. 12.6%, P=0.59). In addition, the frequency of symptomatic IVC thrombosis was similar (1.1% vs. 0.5%, p=0.39).16 A paper reviewing the efficacy of IVC filters reported that permanent filters were associated with a 0%-6.2% rate of PE versus a 0%-1.9% rate with retrievable filters.7 Notably, these studies were not randomized controlled trials—rather, case series—and the indications for IVC filters were not necessarily those currently recommended by the ACCP.

Due to the long-term complications of permanent IVC filters, it is suggested that a retrievable IVC filter be used for patients with temporary contraindications to anticoagulation.17 Comerata et al created a clinical decision-making tool for picking the type of filter to employ. If the duration of contraindication to anticoagulation is short or uncertain, a retrievable filter is recommended.18 Table 1 (p. 15) outlines the recommendations for IVC filter placement.

click for large version

There are no randomized controlled trials to guide the use of concomitant anticoagulation after filter insertion, although this intervention may be beneficial to prevent DVT propagation, recurrence, or IVC filter thrombosis.5 A meta-analysis of 14 studies evaluating the rates of VTE after IVC filter placement demonstrated a non-statistically significant trend toward fewer VTE events in the patients with an IVC filter and concomitant anticoagulation in comparison with those who solely had an IVC filter (OR 0.64, 95% CI, 0.35-1.2). The duration and degree of anticoagulation was not presented in all of the studies in the meta-analysis, therefore limiting the analysis.19

In addition to the ACCP guidelines, there have been other proposed indications for IVC filter use, including recurrent VTE despite anticoagulation, chronic recurrent PE with pulmonary hypertension, extensive free-floating iliofemoral thrombus, and thrombolysis of ilio-caval thrombus.20 The ACCP guidelines do not specifically address these individual indications, and at this time there are no randomized controlled trials to guide IVC filter use in these cases.

Back to the Case

Our patient developed a significant complication from anticoagulation. Current ACCP guidelines recommend an IVC filter if anticoagulant therapy is contraindicated (Grade 1C). The anticoagulation was discontinued and a retrievable IVC filter was placed. Once a patient no longer has a contraindication for anticoagulation, the ACCP recommends restarting a conventional course of anticoagulation. Thus, once the patient can tolerate anticoagulation, consideration will be given to removal of the retrievable filter.

Bottom Line

An IVC filter should be considered in patients with a DVT who have a contraindication to anticoagulation. Other indications for IVC filter use are not supported by the current literature. TH

Drs. Bhogal and Eid are hospitalist fellows and instructors at Johns Hopkins Bayview Medical Center in Baltimore. Dr. Kantsiper is a hospitalist and assistant professor at Bayview Medical Center.

References

1. The Surgeon General’s Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism. U.S. Department of Health & Human Services Web site. Available at: www.surgeongeneral.gov/topics/deepvein/. Accessed Jan. 25, 2010.
2. Moser KM, Fedullo PR, LitteJohn JK, Crawford R. Frequent asymptomatic pulmonary embolism in patients with deep venous thrombosis. JAMA. 1994;271(3):223-225.
3. Bates SM, Ginsberg JS. Treatment of deep vein thrombosis. N Engl J Med. 2004;351:268-277.
4. Kearon C, Kahn SR, Agnelli G, Goldhaber S, Raskob GE, Comerota AJ, American College of Chest Physicians. Antithrombotic therapy for venous theomboembolic disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133(6 Suppl):454S-545S.
5. Becker DM, Philbrick JT, Selby JB. Inferior vena cava filters. Indications, safety, effectiveness. Arch Intern Med. 1992;152(10):1985-1994.
6. Streiff MB. Vena caval filters: a comprehensive review. Blood. 2000;95(12):3669-3677.
7. Chung J, Owen RJ. Using inferior vena cava filters to prevent pulmonary embolism. Can Fam Physician. 2008;54(1):49-55.
8. Ku GH. Billett HH. Long lives, short indications. The case for removable inferior cava filters. Thromb Haemost. 2005;93(1):17-22.
9. Stavropoulos WS. Inferior vena cava filters. Tech Vasc Interv Radiol. 2004;7(2):91-95.
10. Crowther MA. Inferior vena cava filters in the management of venous thromboembolism. Am J Med. 2007;120(10 Suppl 2):S13–S17.
11. Stein PD, Kayali F, Olson RE. Twenty-one-year trends in the use of inferior vena cava filters. Arch Intern Med. 2004;164(14):1541-1545.
12. Guyatt G, Gutterman D, Baumann MH, et al. Grading strength of recommendations and quality of evidence in clinical guidelines: report from an American College of Chest Physicians task force. Chest. 2006;129(1):174-181.
13. Büller HR, Agnelli G, Hull RD, Hyers TM, Prins MH, Raskob GE. Antithrombotic therapy for venous thromboembolic disease: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004;126(3 Suppl):401S-428S.
14. Decousus H, Leizorovicz A, Parent F, et al. A clinical trial of vena caval filters in the prevention of pulmonary embolism in patients with proximal deep-vein thrombosis. Prévention du Risque d’Embolie Pulmonaire par Interruption Cave Study Group. N Engl J Med. 1998;338(7):409-415.
15. Decousus H, Barral F, Buchmuller-Cordier A, et al. Participating centers eight-year follow-up of patients with permanent vena cava filters in the prevention of pulmonary embolism: the PREPIC randomization croup. Circulation. 2005;112:416-422.
16. Kim HS, Young MJ, Narayan AK, Liddell RP, Streiff MB. A comparison of clinical outcomes with retrievable and permanent inferior vena cava filters. J Vasc Interv Radiol. 2008:19(3):393-399.
17. Houman Fekrazad M, Lopes RD, Stashenko GJ, Alexander JH, Garcia D. Treatment of venous thromboembolism: guidelines translated for the clinician. J Thromb Thrombolysis. 2009; 28(3):270–275.
18. Comerota AJ. Retrievable IVC filters: a decision matrix for appropriate utilization. Perspect Vasc Surg Endovasc Ther. 2006;18(1):11-17.
19. Ray CE Jr, Prochazka A. The need for anticoagulation following inferior vena cava filter placement: systematic review. Cardiovasc Intervent Radiol. 2008; 31(2):316-324.
20. Hajduk B, Tomkowski WZ, Malek G, Davidson BL. Vena cava filter occlusion and venous thromboembolism risk in persistently anticoagulated patients: A prospective, observational cohort study. Chest. 2009.

Case

A 67-year-old man with a history of hypertension presents with a swollen right lower extremity. An ultrasound reveals a DVT, and he is commenced on low-molecular-weight heparin and warfarin. Two days later, he develops slurred speech and right-sided weakness. A head CT reveals an intracranial hemorrhage. When should an inferior vena cava (IVC) filter be utilized for treatment of DVT?

Overview

It is estimated that 350,000 to 600,000 Americans develop a VTE each year.1 Patients with a DVT are at high risk of developing a pulmonary embolism (PE). In a multicenter study, nearly 40% of patients admitted with a DVT had evidence of a PE on ventilation perfusion scan.2 Treatment of a DVT is aimed at preventing the extension of the DVT and embolization.3 The American College of Chest Physicians (ACCP) recommends anticoagulation as the primary DVT treatment (Grade 1A).4 However, IVC filters might be considered when anticoagulation is contraindicated.

In 1868, Trousseau created the conceptual model of surgical interruption of the IVC to prevent PE. However, it wasn’t until 1959 by Bottini that the surgical interruption was successfully performed.5 The Mobin-Uddin filter was introduced in 1967 as the first mechanical IVC filter.6 IVC filters mechanically trap the DVT, preventing emboli from traveling into the pulmonary vasculature.7

There are two classes of IVC filters: permanent filters and removable filters. Removable filters include both temporary filters and retrievable filters. Temporary filters are attached to a catheter that exits the skin and therefore must be removed due to the risk of infection and embolization.7 Retrievable filters are similar in design to permanent filters but are designed to be removed. However, this must be done with caution, as neointimal hyperplasia can prevent removal or cause vessel wall damage upon removal.8

IVC filters are inserted into the vena cava percutaneously via the femoral or jugular approach under fluoroscopy or ultrasound guidance (see Figure 1, p. 16). The filters typically are placed infrarenally, unless there is an indication for a suprarenal filter (e.g., renal vein thrombosis or IVC thrombus extending above the renal veins).7 Complete IVC thrombosis is an absolute contraindication to IVC filter placement, and the relative contraindications include significant coagulopathy and bacteremia.9

The incidence of complications related to IVC filter placement is 4% to 11%. Complications include:

• Insertion-site thrombosis;
• IVC thrombosis;
• Recurrent DVT postphlebitic syndrome;
• Filter migration;
• Erosion of the filter through the vessel wall; and
• Vena caval obstruction.10

A review of the National Hospital Discharge Survey database for trends in IVC filter use in the U.S. found a dramatic increase in the use of IVC filters from 1979 to 1999—to 49,000 patients from 2,000 patients with IVC filters in place. The indications for IVC filter use vary such that it is imperative there are well-designed trials and guidelines to guide appropriate use.11

MEDICAL-ON-LINE/ALAMY

The Evidence

The 2008 ACCP guidelines on VTE management follow a grading system that classifies recommendations as Grade 1 (strong) or Grade 2 (weak), and classifies the quality of evidence as A (high), B (moderate), or C (low).12 The ACCP guidelines’ recommended first-line treatment for a confirmed DVT is anticoagulation with subcutaneous low-molecular-weight heparin, intravenous unfractionated heparin, monitored subcutaneous heparin, fixed-dose subcutaneous unfractionated heparin, or subcutaneous fondaparinux (all Grade 1A recommendations). The ACCP recommends against the routine use of an IVC filter in addition to anticoagulants (Grade 1A). However, for patients with acute proximal DVT, if anticoagulant therapy is not possible because of the risk of bleeding, IVC filter placement is recommended (Grade 1C). If a patient requires an IVC filter for treatment of an acute DVT as an alternative to anticoagulation, it is recommended to start anticoagulant therapy once the risk of bleeding resolves (Grade 1C).4

click for large version

The 2008 ACCP guidelines for IVC filter use have a few important changes from the 2004 version. First, the IVC filter placement recommendation for patients with contraindications to anticoagulation was strengthened from Grade 2C to Grade 1C. Second, the 2008 guidelines omitted the early recommendation of IVC filter use for recurrent VTE, despite adequate anticoagulation (Grade 2C).13

Only one randomized study has evaluated the efficacy of IVC filters. All other studies of IVC filters are retrospective or prospective case series.

The PREPIC study randomized 400 patients with proximal DVT considered to be at high risk for PE to receive either an IVC filter or no IVC filter. Additionally, patients were randomized to receive enoxaparin or unfractionated heparin as a bridge to warfarin therapy, which was continued for at least three months. The primary endpoints were recurrent DVT, PE, major bleeding, or death. The patients were followed up at day 12, two years, and then annually up to eight years following randomization.14 At day 12, there were fewer PEs in the group that received filters (OR 0.22, 95% CI, 0.05-0.90). However, at year two, there was no significant difference in PE development in the filter group compared with the no-filter group (OR 0.50, 95% CI, 0.19-1.33).

click for large version

Additionally, at year two, the filter group was more likely to develop recurrent DVT (OR 1.87, 95% CI, 1.10-3.20). At year eight, there was a significant reduction in the number of PEs in the filter group versus the no-filter group (6.2% vs.15.1%, P=0.008). However, at eight-year followup, IVC filter use was associated with increased DVT (35.7% vs. 27.5%, P=0.042). There was no difference in mortality between the two groups.

In summary, the use of IVC filters was associated with decreased incidence of PE at eight years, offset by higher rates of recurrent DVT and no overall mortality benefit.14,15 Importantly, the indications for IVC filter use in this study differ from the current ACCP guidelines; all patients were given concomitant anticoagulation for at least three months, which might not be possible in patients for whom the ACCP recommends IVC filters.

There are no randomized studies to compare the efficacy of permanent IVC filters and retrievable filters for PE prevention. A retrospective study comparing the clinical effectiveness of the two filter types reported no difference in the rates of symptomatic PE (permanent filter 4% vs. retrievable filter 4.7%, P=0.67) or DVT (11.3% vs. 12.6%, P=0.59). In addition, the frequency of symptomatic IVC thrombosis was similar (1.1% vs. 0.5%, p=0.39).16 A paper reviewing the efficacy of IVC filters reported that permanent filters were associated with a 0%-6.2% rate of PE versus a 0%-1.9% rate with retrievable filters.7 Notably, these studies were not randomized controlled trials—rather, case series—and the indications for IVC filters were not necessarily those currently recommended by the ACCP.

Due to the long-term complications of permanent IVC filters, it is suggested that a retrievable IVC filter be used for patients with temporary contraindications to anticoagulation.17 Comerata et al created a clinical decision-making tool for picking the type of filter to employ. If the duration of contraindication to anticoagulation is short or uncertain, a retrievable filter is recommended.18 Table 1 (p. 15) outlines the recommendations for IVC filter placement.

click for large version

There are no randomized controlled trials to guide the use of concomitant anticoagulation after filter insertion, although this intervention may be beneficial to prevent DVT propagation, recurrence, or IVC filter thrombosis.5 A meta-analysis of 14 studies evaluating the rates of VTE after IVC filter placement demonstrated a non-statistically significant trend toward fewer VTE events in the patients with an IVC filter and concomitant anticoagulation in comparison with those who solely had an IVC filter (OR 0.64, 95% CI, 0.35-1.2). The duration and degree of anticoagulation was not presented in all of the studies in the meta-analysis, therefore limiting the analysis.19

In addition to the ACCP guidelines, there have been other proposed indications for IVC filter use, including recurrent VTE despite anticoagulation, chronic recurrent PE with pulmonary hypertension, extensive free-floating iliofemoral thrombus, and thrombolysis of ilio-caval thrombus.20 The ACCP guidelines do not specifically address these individual indications, and at this time there are no randomized controlled trials to guide IVC filter use in these cases.

Back to the Case

Our patient developed a significant complication from anticoagulation. Current ACCP guidelines recommend an IVC filter if anticoagulant therapy is contraindicated (Grade 1C). The anticoagulation was discontinued and a retrievable IVC filter was placed. Once a patient no longer has a contraindication for anticoagulation, the ACCP recommends restarting a conventional course of anticoagulation. Thus, once the patient can tolerate anticoagulation, consideration will be given to removal of the retrievable filter.

Bottom Line

An IVC filter should be considered in patients with a DVT who have a contraindication to anticoagulation. Other indications for IVC filter use are not supported by the current literature. TH

Drs. Bhogal and Eid are hospitalist fellows and instructors at Johns Hopkins Bayview Medical Center in Baltimore. Dr. Kantsiper is a hospitalist and assistant professor at Bayview Medical Center.

References

1. The Surgeon General’s Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism. U.S. Department of Health & Human Services Web site. Available at: www.surgeongeneral.gov/topics/deepvein/. Accessed Jan. 25, 2010.
2. Moser KM, Fedullo PR, LitteJohn JK, Crawford R. Frequent asymptomatic pulmonary embolism in patients with deep venous thrombosis. JAMA. 1994;271(3):223-225.
3. Bates SM, Ginsberg JS. Treatment of deep vein thrombosis. N Engl J Med. 2004;351:268-277.
4. Kearon C, Kahn SR, Agnelli G, Goldhaber S, Raskob GE, Comerota AJ, American College of Chest Physicians. Antithrombotic therapy for venous theomboembolic disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133(6 Suppl):454S-545S.
5. Becker DM, Philbrick JT, Selby JB. Inferior vena cava filters. Indications, safety, effectiveness. Arch Intern Med. 1992;152(10):1985-1994.
6. Streiff MB. Vena caval filters: a comprehensive review. Blood. 2000;95(12):3669-3677.
7. Chung J, Owen RJ. Using inferior vena cava filters to prevent pulmonary embolism. Can Fam Physician. 2008;54(1):49-55.
8. Ku GH. Billett HH. Long lives, short indications. The case for removable inferior cava filters. Thromb Haemost. 2005;93(1):17-22.
9. Stavropoulos WS. Inferior vena cava filters. Tech Vasc Interv Radiol. 2004;7(2):91-95.
10. Crowther MA. Inferior vena cava filters in the management of venous thromboembolism. Am J Med. 2007;120(10 Suppl 2):S13–S17.
11. Stein PD, Kayali F, Olson RE. Twenty-one-year trends in the use of inferior vena cava filters. Arch Intern Med. 2004;164(14):1541-1545.
12. Guyatt G, Gutterman D, Baumann MH, et al. Grading strength of recommendations and quality of evidence in clinical guidelines: report from an American College of Chest Physicians task force. Chest. 2006;129(1):174-181.
13. Büller HR, Agnelli G, Hull RD, Hyers TM, Prins MH, Raskob GE. Antithrombotic therapy for venous thromboembolic disease: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004;126(3 Suppl):401S-428S.
14. Decousus H, Leizorovicz A, Parent F, et al. A clinical trial of vena caval filters in the prevention of pulmonary embolism in patients with proximal deep-vein thrombosis. Prévention du Risque d’Embolie Pulmonaire par Interruption Cave Study Group. N Engl J Med. 1998;338(7):409-415.
15. Decousus H, Barral F, Buchmuller-Cordier A, et al. Participating centers eight-year follow-up of patients with permanent vena cava filters in the prevention of pulmonary embolism: the PREPIC randomization croup. Circulation. 2005;112:416-422.
16. Kim HS, Young MJ, Narayan AK, Liddell RP, Streiff MB. A comparison of clinical outcomes with retrievable and permanent inferior vena cava filters. J Vasc Interv Radiol. 2008:19(3):393-399.
17. Houman Fekrazad M, Lopes RD, Stashenko GJ, Alexander JH, Garcia D. Treatment of venous thromboembolism: guidelines translated for the clinician. J Thromb Thrombolysis. 2009; 28(3):270–275.
18. Comerota AJ. Retrievable IVC filters: a decision matrix for appropriate utilization. Perspect Vasc Surg Endovasc Ther. 2006;18(1):11-17.
19. Ray CE Jr, Prochazka A. The need for anticoagulation following inferior vena cava filter placement: systematic review. Cardiovasc Intervent Radiol. 2008; 31(2):316-324.
20. Hajduk B, Tomkowski WZ, Malek G, Davidson BL. Vena cava filter occlusion and venous thromboembolism risk in persistently anticoagulated patients: A prospective, observational cohort study. Chest. 2009.

Case

A 67-year-old man with a history of hypertension presents with a swollen right lower extremity. An ultrasound reveals a DVT, and he is commenced on low-molecular-weight heparin and warfarin. Two days later, he develops slurred speech and right-sided weakness. A head CT reveals an intracranial hemorrhage. When should an inferior vena cava (IVC) filter be utilized for treatment of DVT?

Overview

It is estimated that 350,000 to 600,000 Americans develop a VTE each year.1 Patients with a DVT are at high risk of developing a pulmonary embolism (PE). In a multicenter study, nearly 40% of patients admitted with a DVT had evidence of a PE on ventilation perfusion scan.2 Treatment of a DVT is aimed at preventing the extension of the DVT and embolization.3 The American College of Chest Physicians (ACCP) recommends anticoagulation as the primary DVT treatment (Grade 1A).4 However, IVC filters might be considered when anticoagulation is contraindicated.

In 1868, Trousseau created the conceptual model of surgical interruption of the IVC to prevent PE. However, it wasn’t until 1959 by Bottini that the surgical interruption was successfully performed.5 The Mobin-Uddin filter was introduced in 1967 as the first mechanical IVC filter.6 IVC filters mechanically trap the DVT, preventing emboli from traveling into the pulmonary vasculature.7

There are two classes of IVC filters: permanent filters and removable filters. Removable filters include both temporary filters and retrievable filters. Temporary filters are attached to a catheter that exits the skin and therefore must be removed due to the risk of infection and embolization.7 Retrievable filters are similar in design to permanent filters but are designed to be removed. However, this must be done with caution, as neointimal hyperplasia can prevent removal or cause vessel wall damage upon removal.8

IVC filters are inserted into the vena cava percutaneously via the femoral or jugular approach under fluoroscopy or ultrasound guidance (see Figure 1, p. 16). The filters typically are placed infrarenally, unless there is an indication for a suprarenal filter (e.g., renal vein thrombosis or IVC thrombus extending above the renal veins).7 Complete IVC thrombosis is an absolute contraindication to IVC filter placement, and the relative contraindications include significant coagulopathy and bacteremia.9

The incidence of complications related to IVC filter placement is 4% to 11%. Complications include:

• Insertion-site thrombosis;
• IVC thrombosis;
• Recurrent DVT postphlebitic syndrome;
• Filter migration;
• Erosion of the filter through the vessel wall; and
• Vena caval obstruction.10

A review of the National Hospital Discharge Survey database for trends in IVC filter use in the U.S. found a dramatic increase in the use of IVC filters from 1979 to 1999—to 49,000 patients from 2,000 patients with IVC filters in place. The indications for IVC filter use vary such that it is imperative there are well-designed trials and guidelines to guide appropriate use.11

MEDICAL-ON-LINE/ALAMY

The Evidence

The 2008 ACCP guidelines on VTE management follow a grading system that classifies recommendations as Grade 1 (strong) or Grade 2 (weak), and classifies the quality of evidence as A (high), B (moderate), or C (low).12 The ACCP guidelines’ recommended first-line treatment for a confirmed DVT is anticoagulation with subcutaneous low-molecular-weight heparin, intravenous unfractionated heparin, monitored subcutaneous heparin, fixed-dose subcutaneous unfractionated heparin, or subcutaneous fondaparinux (all Grade 1A recommendations). The ACCP recommends against the routine use of an IVC filter in addition to anticoagulants (Grade 1A). However, for patients with acute proximal DVT, if anticoagulant therapy is not possible because of the risk of bleeding, IVC filter placement is recommended (Grade 1C). If a patient requires an IVC filter for treatment of an acute DVT as an alternative to anticoagulation, it is recommended to start anticoagulant therapy once the risk of bleeding resolves (Grade 1C).4

click for large version

The 2008 ACCP guidelines for IVC filter use have a few important changes from the 2004 version. First, the IVC filter placement recommendation for patients with contraindications to anticoagulation was strengthened from Grade 2C to Grade 1C. Second, the 2008 guidelines omitted the early recommendation of IVC filter use for recurrent VTE, despite adequate anticoagulation (Grade 2C).13

Only one randomized study has evaluated the efficacy of IVC filters. All other studies of IVC filters are retrospective or prospective case series.

The PREPIC study randomized 400 patients with proximal DVT considered to be at high risk for PE to receive either an IVC filter or no IVC filter. Additionally, patients were randomized to receive enoxaparin or unfractionated heparin as a bridge to warfarin therapy, which was continued for at least three months. The primary endpoints were recurrent DVT, PE, major bleeding, or death. The patients were followed up at day 12, two years, and then annually up to eight years following randomization.14 At day 12, there were fewer PEs in the group that received filters (OR 0.22, 95% CI, 0.05-0.90). However, at year two, there was no significant difference in PE development in the filter group compared with the no-filter group (OR 0.50, 95% CI, 0.19-1.33).

click for large version

Additionally, at year two, the filter group was more likely to develop recurrent DVT (OR 1.87, 95% CI, 1.10-3.20). At year eight, there was a significant reduction in the number of PEs in the filter group versus the no-filter group (6.2% vs.15.1%, P=0.008). However, at eight-year followup, IVC filter use was associated with increased DVT (35.7% vs. 27.5%, P=0.042). There was no difference in mortality between the two groups.

In summary, the use of IVC filters was associated with decreased incidence of PE at eight years, offset by higher rates of recurrent DVT and no overall mortality benefit.14,15 Importantly, the indications for IVC filter use in this study differ from the current ACCP guidelines; all patients were given concomitant anticoagulation for at least three months, which might not be possible in patients for whom the ACCP recommends IVC filters.

There are no randomized studies to compare the efficacy of permanent IVC filters and retrievable filters for PE prevention. A retrospective study comparing the clinical effectiveness of the two filter types reported no difference in the rates of symptomatic PE (permanent filter 4% vs. retrievable filter 4.7%, P=0.67) or DVT (11.3% vs. 12.6%, P=0.59). In addition, the frequency of symptomatic IVC thrombosis was similar (1.1% vs. 0.5%, p=0.39).16 A paper reviewing the efficacy of IVC filters reported that permanent filters were associated with a 0%-6.2% rate of PE versus a 0%-1.9% rate with retrievable filters.7 Notably, these studies were not randomized controlled trials—rather, case series—and the indications for IVC filters were not necessarily those currently recommended by the ACCP.

Due to the long-term complications of permanent IVC filters, it is suggested that a retrievable IVC filter be used for patients with temporary contraindications to anticoagulation.17 Comerata et al created a clinical decision-making tool for picking the type of filter to employ. If the duration of contraindication to anticoagulation is short or uncertain, a retrievable filter is recommended.18 Table 1 (p. 15) outlines the recommendations for IVC filter placement.

click for large version

There are no randomized controlled trials to guide the use of concomitant anticoagulation after filter insertion, although this intervention may be beneficial to prevent DVT propagation, recurrence, or IVC filter thrombosis.5 A meta-analysis of 14 studies evaluating the rates of VTE after IVC filter placement demonstrated a non-statistically significant trend toward fewer VTE events in the patients with an IVC filter and concomitant anticoagulation in comparison with those who solely had an IVC filter (OR 0.64, 95% CI, 0.35-1.2). The duration and degree of anticoagulation was not presented in all of the studies in the meta-analysis, therefore limiting the analysis.19

In addition to the ACCP guidelines, there have been other proposed indications for IVC filter use, including recurrent VTE despite anticoagulation, chronic recurrent PE with pulmonary hypertension, extensive free-floating iliofemoral thrombus, and thrombolysis of ilio-caval thrombus.20 The ACCP guidelines do not specifically address these individual indications, and at this time there are no randomized controlled trials to guide IVC filter use in these cases.

Back to the Case

Our patient developed a significant complication from anticoagulation. Current ACCP guidelines recommend an IVC filter if anticoagulant therapy is contraindicated (Grade 1C). The anticoagulation was discontinued and a retrievable IVC filter was placed. Once a patient no longer has a contraindication for anticoagulation, the ACCP recommends restarting a conventional course of anticoagulation. Thus, once the patient can tolerate anticoagulation, consideration will be given to removal of the retrievable filter.

Bottom Line

An IVC filter should be considered in patients with a DVT who have a contraindication to anticoagulation. Other indications for IVC filter use are not supported by the current literature. TH

Drs. Bhogal and Eid are hospitalist fellows and instructors at Johns Hopkins Bayview Medical Center in Baltimore. Dr. Kantsiper is a hospitalist and assistant professor at Bayview Medical Center.

References

1. The Surgeon General’s Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism. U.S. Department of Health & Human Services Web site. Available at: www.surgeongeneral.gov/topics/deepvein/. Accessed Jan. 25, 2010.
2. Moser KM, Fedullo PR, LitteJohn JK, Crawford R. Frequent asymptomatic pulmonary embolism in patients with deep venous thrombosis. JAMA. 1994;271(3):223-225.
3. Bates SM, Ginsberg JS. Treatment of deep vein thrombosis. N Engl J Med. 2004;351:268-277.
4. Kearon C, Kahn SR, Agnelli G, Goldhaber S, Raskob GE, Comerota AJ, American College of Chest Physicians. Antithrombotic therapy for venous theomboembolic disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133(6 Suppl):454S-545S.
5. Becker DM, Philbrick JT, Selby JB. Inferior vena cava filters. Indications, safety, effectiveness. Arch Intern Med. 1992;152(10):1985-1994.
6. Streiff MB. Vena caval filters: a comprehensive review. Blood. 2000;95(12):3669-3677.
7. Chung J, Owen RJ. Using inferior vena cava filters to prevent pulmonary embolism. Can Fam Physician. 2008;54(1):49-55.
8. Ku GH. Billett HH. Long lives, short indications. The case for removable inferior cava filters. Thromb Haemost. 2005;93(1):17-22.
9. Stavropoulos WS. Inferior vena cava filters. Tech Vasc Interv Radiol. 2004;7(2):91-95.
10. Crowther MA. Inferior vena cava filters in the management of venous thromboembolism. Am J Med. 2007;120(10 Suppl 2):S13–S17.
11. Stein PD, Kayali F, Olson RE. Twenty-one-year trends in the use of inferior vena cava filters. Arch Intern Med. 2004;164(14):1541-1545.
12. Guyatt G, Gutterman D, Baumann MH, et al. Grading strength of recommendations and quality of evidence in clinical guidelines: report from an American College of Chest Physicians task force. Chest. 2006;129(1):174-181.
13. Büller HR, Agnelli G, Hull RD, Hyers TM, Prins MH, Raskob GE. Antithrombotic therapy for venous thromboembolic disease: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004;126(3 Suppl):401S-428S.
14. Decousus H, Leizorovicz A, Parent F, et al. A clinical trial of vena caval filters in the prevention of pulmonary embolism in patients with proximal deep-vein thrombosis. Prévention du Risque d’Embolie Pulmonaire par Interruption Cave Study Group. N Engl J Med. 1998;338(7):409-415.
15. Decousus H, Barral F, Buchmuller-Cordier A, et al. Participating centers eight-year follow-up of patients with permanent vena cava filters in the prevention of pulmonary embolism: the PREPIC randomization croup. Circulation. 2005;112:416-422.
16. Kim HS, Young MJ, Narayan AK, Liddell RP, Streiff MB. A comparison of clinical outcomes with retrievable and permanent inferior vena cava filters. J Vasc Interv Radiol. 2008:19(3):393-399.
17. Houman Fekrazad M, Lopes RD, Stashenko GJ, Alexander JH, Garcia D. Treatment of venous thromboembolism: guidelines translated for the clinician. J Thromb Thrombolysis. 2009; 28(3):270–275.
18. Comerota AJ. Retrievable IVC filters: a decision matrix for appropriate utilization. Perspect Vasc Surg Endovasc Ther. 2006;18(1):11-17.
19. Ray CE Jr, Prochazka A. The need for anticoagulation following inferior vena cava filter placement: systematic review. Cardiovasc Intervent Radiol. 2008; 31(2):316-324.
20. Hajduk B, Tomkowski WZ, Malek G, Davidson BL. Vena cava filter occlusion and venous thromboembolism risk in persistently anticoagulated patients: A prospective, observational cohort study. Chest. 2009.