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Effect of a Hospital and Post-discharge Quality Improvement Intervention on Clinical Outcomes and Quality of Care for Patients with Heart Failure with Reduced Ejection Fraction

Presenter: Adam DeVore, MD, MHS

Heart failure with reduced ejection fraction (HFrEF) affects over 3 million adults in the United States. Currently outcomes for these patients remain suboptimal with high rates of rehospitalization and death as well as a high burden of symptoms. This is due in part to insufficient use of guideline-directed medical therapy (GDMT) for HFrEF, according to Adam DeVore, MD, MHS, who presented on behalf of the CONNECT-HF Investigators and Committees.

Dr. DeVore said, “I would submit that this is not just a problem. It’s a major public health issue that requires immediate attention.”

Currently there are limited data available to inform best practices for hospital and post-discharge quality improvement initiatives. The CONNECT-HF study was designed as a pragmatic, prospective, cluster-randomized trial to assess the effect of a hospital and post-discharge quality improvement intervention compared with usual care.

The intervention used local quality improvement teams that already exist in hospitals. It focused on audit and feedback to hospitals on heart failure processes of care and outcomes as well as education and mentorship to hospitals by the CONNECT-HF Academy, a team of quality improvement and heart failure experts.

The primary hypothesis of the study was that the intervention would improve clinical outcomes and measure by rates of HF rehospitalization or death, and quality-of-care delivery over 12 months of follow-up compared with usual care.

The study was a cluster-randomized trial conducted only in the U.S., and the unit of randomization was the hospital. The study had co-primary endpoints, composite of heart failure rehospitalization or death, and change in an opportunity-based composite score for HF quality. It was designed to detect a 15% difference between intervention and usual care.

The primary outcomes of the trial showed in the cumulative incidence of first heart failure rehospitalization or all-cause death, there was not a statistical significance between the usual care and intervention groups. In the opportunity-based composite quality scores (the number of quality successes divided by the number of opportunities for guideline-directed care), at both baseline and 12-month follow-up there again was no significant statistical difference between the two groups.

Dr. DeVore summarized by saying, “In this cluster-randomized trial of hospitals treating patients after a hospitalization for heart failure with reduced ejection fraction, a hospital and post-discharge quality improvement intervention that focused on clinician education and audit and feedback of heart failure quality of care did not meaningfully improve heart failure outcomes or care above the current quality improvement efforts.

He continued, saying he thinks there are some important clinical implications. First, the data again highlight the low rates of use of GDMT for HFrEF, including ace inhibitors, ARBs, ARNIs, evidence-based beta-blockers and MRAs. Dr. DeVore said he also thinks the study suggests new approaches are needed to improve care, not just in the hospital or clinic, but across the entire heart failure patient journey.

Adam DeVore, MD, MHS, reports research funding through his institution from Novartis and has provided consulting services for Novartis. CONNECT-HF was funded by Novartis through an investigator-initiated trial program.

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