Abstract 10658: Patients Receive Better Care in a Traditional Randomized Trial Setting Than in a Pragmatic Quality Improvement Study: Potential Implications for Improvements in Care

Abstract

Introduction: Use of guideline-directed medical therapy (GDMT) is suboptimal in practice and often better in patients enrolled in clinical trials. We sought to investigate whether care differed for patients with heart failure with reduced ejection fraction (HFrEF) recently enrolled in a pharmaceutical trial versus those in a pragmatic implementation study. Methods: DAPA-HF was a randomized trial of dapagliflozin versus placebo that included patients with HFrEF, and standard background GDMT was required unless contraindicated or not tolerated. CONNECT-HF was a site-level cluster randomized pragmatic trial that included patients discharged after admission for decompensated HFrEF, with the goal of improving GDMT at one year. Each study required patient informed consent. Medication use data includes the total population at the time of enrollment in DAPA-HF and at one year in CONNECT-HF. Results: CONNECT-HF enrolled U.S. patients who were younger, more likely female, and more often Black (Table 1). Patients in DAPA-HF had significantly higher use of all classes of GDMT at any dose and at ≥ 50% target dose (Figure 1). Unadjusted mortality was lower in DAPA-HF (Table 1). Conclusions: Use of GDMT was substantially better and mortality was lower in a traditional randomized trial than in a pragmatic implementation trial. Whether this is due to differences in the populations, site care teams, or intensity of care and monitoring is unknown. The protocol-driven aspects of traditional trials are worthy of further study to improve care provided in standard practice. These observations also support inclusion of patients in randomized trials given the excellent care and outcomes in that setting.