Medicolegal Issues

Cardiac Resynchronization Added to Medical Therapy, Patient Handoffs Critical, Home-Hospital Care for Seniors


 

Benefits of Cardiac Resynchronization

By A. Rudmann, MD

Cleland J, Daubert J, Erdmann E, et al. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. 2005;352:1539-1549.

A quarter to a third of patients with CHF have left or right bundle branch block, in which one side of the heart depolarizes and contracts before the other. Such electro-mechanical dyssynchrony is associated with decreased ejection fraction (EF), decreased cardiac output, and worse symptoms. A new pacemaker technology—called cardiac resynchronization therapy (CRT)—is a technically difficult procedure that involves placing a lead through the coronary sinus to the left side of the heart, re-establishing electro-mechanical synchrony. CRT improves EF and CHF symptoms, but its effect on mortality has been unknown.

In this unblinded trial funded and aided by Medtronic (a CRT device manufacturer) patients with class III-IV CHF despite standard medical therapy, ejection fraction <35%, and QRS >120 msec were randomized to CRT plus medical therapy or medical therapy alone. Patients with a major cardiovascular event in the preceding six weeks, conventional indication for pacemaker or defibrillator, continuous intravenous therapy for CHF, or atrial arrhythmia were excluded.

Eight-hundred-thirteen patients were followed for a mean of 2.5 years. The primary endpoint (a composite of death from any cause and first unplanned hospitalization for a major cardiovascular event) was reached by 39% of patients in the CRT arm versus 55% in the control arm. Death was also lower in the CRT group (20% versus 30%). Both outcomes were highly statistically significant. Other benefits of CRT included reduced hospitalization for worsening CHF (18% versus 33%), less severe symptoms, better quality of life, and higher left ventricular ejection fraction. Twelve percent of patients required more than one attempt to successfully insert the CRT device.

This study reports significant benefits for CRT added to medical therapy in patients with moderate-to-severe CHF, low EF, and cardiac dyssynchrony. The results are consistent with reported hemodynamic benefits of CRT. Limitations of the study include the unblinded methodology and close participation of the study sponsor in conducting the trial. Both raise questions about potential bias. Until other studies are available, clinicians should decide whether CRT is appropriate for individual patients. The cost effectiveness of CRT is not known.

This study reports significant benefits for CRT added to medical therapy in patients with moderate-to-severe CHF low EF and cardiac dyssynchrony.

Handoffs Finally Get Attention

By A. Rudmann, MD

Solet D, Norvell J, Rutan G, et al. Lost in translation: challenges and opportunities in physician-to-physician communication during patient handoffs. Acad Med. 2005;80(12):1094-1099.

Handoffs involve the transfer of patient care responsibility from one clinician to another. In non-medical industries, analogous situations are known to be error-prone and have received substantial attention. However, despite the six-year-old Institute of Medicine study implicating poor communication as a major contributor to preventable deaths in U.S. hospitals, surprisingly little attention has been paid to handoffs by the medical community. A notable exception is AHRQ’s (the Agency for Healthcare Research and Quality) Web Morbidity and Mortality Rounds, which has highlighted the significance of poor communication among clinicians.

This article evaluates current handoff practices of the Indiana University School of Medicine (Indianapolis) internal medicine residency program. Major findings include significant variability in preparation, content, and method of handoffs across their four-hospital system. Barriers to effective handoff communication include lack of privacy, social hierarchy, language issues, lack of direct communication, inefficiency, and lack of formal education.

The authors propose Essential Elements for Successful Handoffs, including the following content items: complete team information, complete patient identification, brief history of present illness, active problems and past medical history, active medications, allergies, venous access status and contingencies, code status, pertinent lab data, concerns for the next 18-24 hours, long-term plans, and psychosocial concerns. Regarding process, the authors recommend both verbal and written communication routinely and bedside handoffs for high-risk patients. Additionally, they advise a formal handoff curriculum for residents, including both didactic instruction and attending role modeling.

While this may seem a tall order, the new 2006 National Patient Safety Goals now address handoff quality. As of January 1, JCAHO (Joint Commission on Accreditation of Healthcare Organizations) requires all accredited institutions to perform handoffs that are both interactive (at least offering the opportunity to interact) and appropriately informative with up-to-date clinical information about diagnoses and treatments, stability, and recent or anticipated changes. All clinicians should evaluate the quality of handoffs in their own practices and make improvements as necessary. This article offers good suggestions on where to start.

The Use of Systemic Steroids for COPD

By A. Rudmann, MD

Niewoehner D, Erbland M, Deupree R, et al. Effect of systemic glucocorticoids on exacerbations of chronic obstructive pulmonary disease. N Engl J Med. 1999;340:1941-1947.

Systemic steroids are commonly prescribed for COPD exacerbation, despite adverse side effects including hyperglycemia, infections and osteoporosis. This randomized, double-blind, controlled trial conducted by the U.S. Department of Veterans Affairs (VA) compared two- and eight-week steroid regimens to placebo in patients also receiving broad spectrum antibiotics for seven days, inhaled beta-agonists, inhaled ipratropium bromide, and inhaled Triamcinolone Acetonide starting day four.

The steroid arms received methylprednisolone 125 mg every six hours for three days, then oral prednisone was tapered gradually from 60 mg over two or eight weeks. Inclusion criteria were clinical diagnosis of COPD exacerbation, age >50 years, >30 pack years of smoking, and either an FEV1 <1.5 or inability to undergo spirometry because of severe dyspnea. Patients with asthma, systemic steroid use in the preceding 30 days, and prognosis of less than one year were excluded.

In all, 1,870 patients were screened to enroll 271 patients who were followed for 182 days. Fifty percent of screened patients were ineligible due to recent steroid use. Systemic steroid treatment significantly reduced treatment failure at 30 days (23% versus 33%) and 90 days (37% versus 48%), but not at 182 days (51% versus 54%). Treatment failure was defined as death from any cause, mechanical ventilation, readmission for COPD, or intensification of pharmacologic therapy—which accounted for 70% of treatment failures at 30 days, 62% at 90 days, and 58% at 182 days. Seventy-five percent of the time this involved initiation of open-label systemic steroids. Two- and eight-week steroid regimens were equally efficacious. Steroid therapy reduced LOS from 9.7 to 8.5 days and improved FEV1 by a maximum of 0.1 L after one day. Mortality was not affected. Hyperglycemia was more common in the steroid groups (15% vs. 4%). Subgroup analysis showed that patients previously hospitalized benefited most from steroid therapy.

This study helps define the benefits and risks of systemic steroid therapy in COPD exacerbation. It reduces treatment failure rates at one and three months and reduces LOS, but increases hyperglycemia in patients receiving inhaled corticosteroids and other COPD treatments. About half of patients in the placebo arm required intensification of treatment, usually initiation of systemic steroid therapy; the other half averted systemic steroid therapy over six months of follow-up. Overall, this study suggests a rationale for deferring or limiting systemic steroid therapy in those patients without prior hospitalization for COPD and those at high risk for hyperglycemia.

Antibiotics for Atypical Coverage in Pneumonia Patients

By Valerie J. Lang, MD

Shefet D, Robenshtok E, Paul M, et al. Empirical atypical coverage for inpatients with community-acquired pneumonia: systematic review of randomized controlled trials. Arch Intern Med. 2005:165:1992-2000.

Most guidelines recommend that inpatients with community-acquired pneumonia receive antibiotics that cover atypical organisms, though it is rare that an atypical organism causes pneumonia severe enough to require hospitalization. This review of 24 trials compared antibiotic regimens with and without atypical coverage in a total of 5,015 inpatients with community-acquired pneumonia. Atypical coverage was provided by quinolones or macrolides, and arms without atypical coverage included a wide variety of beta-lactam regimens. There was no difference in overall 30-day mortality with or without atypical coverage (RR 1.13 [95% CI, 0.82-1.54]).

For the outcome of clinical failure, there was a trend toward advantage in the quinolone monotherapy arms (RR, 0.89[95% CI, 0.77-1.02]), with a disadvantage in the macrolide monotherapy arms (RR, 1.17 [95% CI, 0.77-1.77]). However, when the studies with unclear or inadequate allocation concealment or allocation generation were excluded, the trend virtually resolved (RR, 0.99 [95%CI, 0.82-1.19]).

For the patients with documented atypical pathogens, there was a trend in favor of atypical coverage (RR, 0.52 [95% CI, 0.24-1.10]). This was significant for the subset of 43 patients with documented Legionella species, (RR, 0.17 [95% CI, 0.05-0.63]). Notably, there was no significant difference in results for different age groups overall.

Although these results support the authors’ conclusion that using antibiotics with or without atypical coverage achieve similar outcomes (except in the rare cases of Legionella species infections), most of the studies used treatment arms that are not in line with current guidelines for the treatment of community-acquired pneumonia in inpatients. Other outcomes of interest to hospitalists (duration of intravenous therapy and length of stay) were not addressed. None of the studies compared a drug without atypical coverage (e.g., ceftriaxone) with the same drug plus another with atypical coverage (e.g., ceftriaxone plus azithromycin).

While guidelines still call for atypical coverage, the results of this review may provide support for hospitalists when treating patients with multiple drug allergies or intolerances who cannot be provided atypical coverage without significant side effects.

In-Home Hospital Care for Seniors

By Valerie J. Lang, MD

Leff B, Burton L, Mader SL, et al. Hospital at home: feasibility and outcomes of a program to provide hospital-level care at home for acutely ill older patients. Ann Intern Med. 2005:143(11):798-808.

Hospitalists are acutely aware of the hazards of hospitalization for older patients, and several models of providing hospital-level care in patients’ homes have been explored in other countries. This study evaluated a hospital-at-home program which provided acute, hospital-level care to patients ≥65-year-old in three U.S. cities. All patients required hospitalization and had one of the following diagnoses: community acquired pneumonia, CHF exacerbation, COPD exacerbation, or cellulitis. Most of the patients were admitted directly from the emergency department and were never admitted to the hospital.

The hospital-at-home program provided the following services: 1) at least eight-24 hours of continuous, one-on-one nursing; 2) intermittent nursing visits at least daily after continuous nursing was no longer required; 3) at least daily home visits and 24-hour availability by a hospital-at-home physician; 4) durable medical equipment; 5) skilled therapies and pharmacy support; 6) home radiology and ECG; and 7) intravenous fluids, antibiotics, other medications, oxygen, and other respiratory therapies. Patients were referred back to their primary care physicians after discharge from the hospital-at-home stay.

The study consisted of an observation phase followed by an intervention phase for comparison. The results show that the process of providing hospital-level care at home was feasible. Nurses arrived at patients’ homes within a mean of 20 minutes and provided a mean of 16.9 hours (range 0-71 hours) of continuous care, with a mean of 1.4 visits per day (range 0-5.3) after that. Physicians evaluated patients in the homes within a mean of 1.8 hours (range 0-4.5 hours) and provided a mean of 1.5 visits per day (range 0-5.3). There was variability among the sites for some measures. For example, oxygen was delivered to the home within an average of 0.6 or 0.7 hours at two sites, but within an average of 3.3 hours at the third site.

The intervention group had significantly less incident delirium (OR 0.26 [95% CI, 0.12-0.57]), less sedative medication use (OR 0.49 [95%CI, 0.30-0.81]), less use of chemical restraints (2% versus 7%; p=0.014), fewer critical complications (0% versus 6%; p≤0.001), and fewer deaths (0% versus 3%; p=0.050). Mean length of stay in the intervention group was 3.2 days vs. 4.9 days in the observation group (p=0.004). Mean costs were lower in the hospital-at-home group than the hospitalized group ($5,081 versus $7,480; p≤0.001).

There were important limitations to the study. Follow-up data was missing on a substantial number of patients (37% of observation group and 28% of intervention group). The 85 patients who were eligible but did not receive hospital-at-home care (either because they declined or the program wasn’t open for admissions from 10 p.m. to 6 a.m.) were combined with the 84 patients who did receive it under intention-to-treat, so the effects of the intervention may be underestimated.

Despite the limitations of the data, the findings of less delirium, sedative use, and chemical restraint use in the hospital-at-home group ring true, as patients were not subjected to the 24-hour noise, 4 a.m. blood draws, and unfamiliar surroundings that promote delirium, insomnia, and agitation in the hospital. Because delirium is common, difficult to prevent, and associated with longer lengths of stay, increased complications, and lower levels of functioning on discharge, the hospital-at-home model is worth studying further. If further evidence can be obtained to support this model, it may be worth pursuing in communities where there are adequate home care resources. Additionally, it may provide a new niche for hospitalists: the “Home Hospitalist.” TH

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