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Better outcomes for patients treated at hospitals that participate in clinical trials
Sumit R Majumdar1, Matthew T Roe, Eric D Peterson
1Department of Medicine, University of Alberta, Edmonton, Alberta, Canada. me2.majumdar@ualberta.ca
Insights
Hospitals participating in clinical trials for acute coronary syndrome demonstrated improved patient care and reduced mortality rates. This suggests that trial participation positively impacts outcomes, contrary to concerns about barriers.
Area of Science:
- Cardiology
- Clinical Trials
- Health Services Research
Background:
- Concerns about harms and costs often deter institutional participation in clinical trials.
- A hypothesis proposed that patients treated at hospitals involved in trials would experience superior outcomes.
- This was investigated using data from 494 CRUSADE hospitals involving 174,062 patients with non-ST-segment elevation acute coronary syndrome.
Purpose of the Study:
- To evaluate the association between hospital participation in clinical trials and patient outcomes.
- To determine if hospitals enrolling patients in trials provide better guideline-indicated care.
- To assess the impact of trial participation on in-hospital mortality for acute coronary syndrome patients.
Main Methods:
- Hospitals were categorized into tertiles based on the percentage of patients enrolled in non-ST-segment elevation acute coronary syndrome trials.
- Outcomes measured included composite guideline-indicated care and in-hospital mortality.
- Multivariate regression analysis was employed to examine the relationship between hospital trial participation and patient outcomes.
Main Results:
- Hospitals with higher trial participation showed increased adherence to guideline-indicated care (adjusted P = .008).
- In-hospital mortality decreased significantly with greater trial participation (adjusted P = .003).
- Patients at trial-participating hospitals had lower adjusted odds of in-hospital mortality compared to non-participating hospitals (high enrollment: 0.8 [95% CI, 0.7-0.9]).
Conclusions:
- A minority of CRUSADE hospitals enrolled patients in trials (<3%), with one-third having no trial participation.
- Hospitals engaged in clinical trials appear to deliver superior care for acute coronary syndrome.
- Trial participation is associated with reduced in-hospital mortality, suggesting a benefit beyond patient enrollment.
Background:
Barriers to institutions participating in clinical trials include concerns about harms and costs. However, we hypothesized that patients treated at hospitals participating in trials would have better outcomes than patients treated at nonparticipating hospitals. We tested this hypothesis in 494 CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the American College of Cardiology/American Heart Association Guidelines) hospitals treating 174 062 patients with non-ST-segment elevation acute coronary syndrome.
Methods:
Hospitals were classified into tertiles by percentage of patients concurrently enrolled in non-ST-segment elevation acute coronary syndrome trials. Outcomes were use of composite guideline-indicated care and in-hospital mortality. Multivariate regression was used to examine the association between hospital trial participation and outcomes.
Results:
Overall, 4590 patients (2.6%) were enrolled in trials, ranging from 0% (145 hospitals) to low-enrollment tertile (1.0%; interquartile range [IQR], 0.5%-1.4%; n=226) to high-enrollment tertile (4.9%; IQR, 3.5%-9.7%; n=123). The composite guideline adherence score increased with increasing tertiles of trial participation: 76.9% (IQR, 71.8%-81.3%) vs 78.3% (IQR, 73.2%-82.4%) vs 81.1% (IQR, 76.2%-84.1%) (adjusted P= .008). Hospitals that participated in trials had higher adjusted guideline adherence than nonparticipating hospitals (low enrollment, 0.8% greater [95% confidence interval {CI}, -0.9% to 2.6%]; and high enrollment, 2.5% greater [95% CI, 0.5%-4.5%]). In-hospital mortality decreased with increasing trial participation: 5.9% vs 4.4% vs 3.5% (adjusted P= .003). Patients treated at hospitals that participated in trials had significantly lower mortality than patients treated at nonparticipating hospitals (low enrollment adjusted odds, 0.9 [95% CI, 0.8-1.0]; and high enrollment adjusted odds, 0.8 [95% CI, 0.7-0.9]).
Conclusions:
The CRUSADE hospitals enrolled less than 3% of their patients with non-ST-segment elevation acute coronary syndrome into trials, and one-third never participated in trials. Compared with hospitals that do not participate in trials, those hospitals that do participate in trials seem to provide better care and to have lower mortality.
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