Hospitals that participate in clinical trials appear to provide better care for patients with heart attacks or other acute heart events and have lower death rates than hospitals that do not participate in clinical trials, according to a report in the March 24 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

Quality of care for common conditions such as acute coronary syndromes has slowly improved after the implementation of clinical guidelines, performance measurement, and quality improvement efforts. Recent studies suggest that physician leadership, presence of shared goals, administrative support, and credible feedback are associated with better hospital performance. Three of these characteristics are also believed to be important in successfully conducting hospital-based clinical trials.

“We hypothesized that these same elements required for hospitals to participate in trials could induce beneficial changes in the hospital environment, thereby leading to better processes and outcomes of care for patients treated outside the trial setting,” the authors write.

Sumit R. Majumdar, MD, MPH, of the University of Alberta, Canada, and colleagues analyzed data from 174,062 patients with two specific types of heart conditions, high-risk non–ST-segment elevation acute coronary syndrome with unstable angina and non–ST-segment elevation myocardial infarction. The patients were admitted to 494 hospitals participating in Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the American College of Cardiology/American Heart Association Guidelines (CRUSADE)—an ongoing, voluntary, observational data collection and quality improvement initiative—from Jan. 1, 2001 to June 30, 2006. Process-of-care and in-hospital outcome data were collected. Patients were split into three groups: those treated at hospitals with no trial participation (29,984 patients), low trial participation (93,705 patients), and high trial participation (50,373 patients).

In total, 4,590 patients (2.6 percent) were enrolled in clinical trials, with 145 hospitals having no enrollment, 226 hospitals having a midpoint of 1 percent enrollment, and 123 hospitals having a midpoint of 4.9 percent enrollment.

The overall (composite) median (midpoint) guideline adherence scores increased with increasing levels of trial participation, from 76.9 percent among hospitals with no trial enrollment, 78.3 percent for hospitals with low trial enrollment, and 81.1 percent among hospitals with high trial enrollment.

“In-hospital mortality decreased with increasing trial participation: 5.9 percent vs. 4.4 percent vs. 3.5 percent,” the authors write. “Patients treated at hospitals that participated in trials had significantly lower mortality than patients treated at nonparticipating hospitals.”

“In conclusion, patients treated at hospitals that participate in clinical trials seem to receive better quality of care and seem to have significantly better outcomes than patients treated at hospitals that do not participate in trials—at least in the setting of acute coronary syndrome,” the authors conclude. “For policy makers and physicians, our findings should assuage some of the concerns related to the possible opportunity costs and potential downsides of participating in the clinical research enterprise.”

This study was supported by CRUSADE, a National Quality Improvement Initiative of the Duke Clinical Research Institute, which was funded by Schering Plough Corporation, Bristol Myers Squibb/Sanofi Aventis Pharmaceuticals Partnership, and Millenium Pharmaceuticals. Dr. Majumdar receives salary support awards from the Alberta Heritage Foundation for Medical Research (Health Scholar) and the Canadian Institutes of Health Research (New Investigator).

Source: EurekAlert! 3/24/08

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