Hospital, post-discharge quality improvement intervention failed to improve HFrEF outcomes
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A hospital and post-discharge quality improvement intervention did not improve rehospitalization or survival in patients with HF with reduced ejection fraction beyond existing quality improvement programs, researchers reported.
“In this cluster randomized trial of hospitals treating patients after a hospitalization for HF with reduced ejection fraction, a hospital and post-discharge quality improvement intervention that focused on clinician education and audit and feedback on HF quality of care did not meaningfully improve heart failure outcomes or care above the current quality improvement efforts,” Adam DeVore, MD, MHS, cardiologist at Duke University Medical Center, said during a presentation of the CONNECT-HF trial results at the American College of Cardiology Scientific Session.
The trial was designed as a pragmatic, prospective, cluster randomized trial to investigate the effects of the CONNECT-HF hospital and post-discharge quality improvement intervention compared with usual care. The intervention was focused on audit and feedback to hospitals on HF processes of care and outcomes, and education and mentorship to hospitals by the CONNECT-HF Academy, DeVore said during the presentation.
Over 3 years, the trial enrolled 5,647 patients (mean age, 62 years; 33% women; 56% white) treated for HFrEF at 161 U.S. hospitals. Nearly half of the hospitals were located in the southern U.S. Participating hospitals treated at least 50 patients with HFrEF annually and already had an onsite quality improvement program designed to ensure compliance with guideline-based practices for HF treatment and reduce negative outcomes such as rehospitalization and death.
Participating hospitals were randomly assigned to receive the quality improvement intervention or usual HF care. For those in the intervention group, researchers worked with the in-house quality improvement team at the hospitals to review and improve existing programs to reinforce evidence-based practices. Then, the researchers independently tracked hospital discharges and post-discharge follow-up care and provided feedback to hospital care teams on performance metrics, a strategy of audits and feedback that had worked for other quality improvement initiatives in previous studies, according to a press release.
After 12 months, the researchers reported no difference in the primary endpoint of HF rehospitalization or death between the intervention and usual care groups (adjusted HR = 0.92; 95% CI, 0.81-1.05; P = .21). There was also no difference in the co-primary endpoint of change in opportunity based composite score for HF quality (adjusted OR = 1.06; 95% CI, 0.93-1.21; P = .35).
Moreover, researchers reported low rates at 12-month follow-up of achieving 50% or more of the target dose of guideline-recommended HF therapies including ACE inhibitors, angiotensin receptor blockers and angiotensin receptor-neprilysin inhibitors (25.1% vs. 25.4%, respectively), beta-blockers (31.3% vs. 32.4%, respectively) and mineralocorticoid receptor antagonists (36% vs. 36.4%) in the intervention and usual care groups.
“Our data, again, highlight low rates of use of guideline-directed medical therapy for HF with reduced ejection fraction,” DeVore said during the presentation. “This study suggests that new approaches are necessary to improve care, not just in the hospital or in the clinic, but across the entire HF patient journey. We observed very high clinical event rates of HF rehospitalization or death over 12 months of follow-up. We had a lot of difficulty connecting hospitals with their outpatient clinicians, in part, due to the fragmented nature of HF care in the current U.S. health care system.”
A patient panel helped inform the CONNECT-HF trial design, according to DeVore. The trial was stopped early as a result of the COVID-19 pandemic and did not enroll as many patients as planned, but the researchers said it was still adequately powered to detect differences between the intervention and usual care groups.
“Based on our findings, I don’t think we’re going to move the needle if we continue focusing our attention on the hospital if there is already a quality improvement program there,” Devore said in the release.
Perspective
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Mary Norine Walsh, MD, MACC
This was an important trial because it tested a strategy for care, rather than a particular therapy, in a pragmatic, rigorous and randomized controlled trial. Quality improvement initiatives are often assumed to improve care, but the intervention here — clinician education, auditing and feedback — did not improve outcomes. Hospitals and clinicians would do well to examine similar strategies of care that they have in place and make sure that they focus on efforts that have been demonstrated to impact patient outcomes.
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Devore A, et al. Late Breaking Clinical Trials IV. Presented at: American College of Cardiology Scientific Session; May 15-17, 2021 (virtual meeting).
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