CONNECT-HF

Project By-line:  Care OptimizatioN through patieNt and hospital Engagement Clinical Trial for heart failure

 Introduction Paragraph: Hospitalization for acute HF identifies patients at increased risk of re-hospitalization and death following discharge. This increased risk justifies novel interventions to improve post-discharge outcomes. At the same time, the delivery of evidence-based HF care varies significantly across hospitals, as do HF patient outcomes.3–5 Improving the quality of care for patients with HF is an essential goal, but there are limited data available to understand best practices for hospital-based QI initiatives.

Primary Aim: There are 2 co-primary endpoints, 1) time to first HF rehospitalization or death within 12-months after discharge; 2) improvement in an opportunity-based composite score for adherence to quality metrics for HF.

Design: Multi-center cluster randomized clinical trial with a 2×2 factorial design. Unit of randomization is hospital level.

Metrics: The process metrics (secondary endpoints) are: 1) an opportunity-based composite score for adherence to site level HF discharge quality measures and 2) participant-level healthcare expenditures at 6 months and 1 year post-discharge.

The opportunity-based composite score will be created to grade the quality of care provided. The numerator will be the number of times that care is provided; the denominator will be the number of opportunities available.

The per-opportunity adherence rate will consist of the following quality metrics assessed at the time of hospital discharge:

• ACE-I, ARB, or sacubitril/valsartan prescription at discharge
• Evidence-based ß-blocker prescription at discharge
• Discharge instructions addressing activity level, diet, discharge medications, follow-up appointment, weight monitoring, and how to respond to a change in symptoms
• LVEF assessment performed during the hospitalization or planned for after discharge
• Current or recent smokers who received smoking cessation advice or counseling during a hospital stay

 Timeline: Trial enrollment and hospital (site) assessments begin during the index hospitalization and are carried out over the subsequent 12 months of participant follow-up. Stratified randomization will be used to ensure that selected hospital characteristics are balanced within each stratum.

Project Leads: Tracy Dewald (tracy.dewald@duke.edu) and Monica Reed (monica.reed@duke.edu)