Effect of a Hospital and Postdischarge Quality Improvement Intervention on Clinical Outcomes and Quality of Care for Patients With Heart Failure With Reduced Ejection Fraction: The CONNECT-HF Randomized Clinical Trial

Abstract

Importance: Adoption of guideline-directed medical therapy for patients with heart failure is variable. Interventions to improve guideline-directed medical therapy have failed to consistently achieve target metrics, and limited data exist to inform efforts to improve heart failure quality of care.

Objective: To evaluate the effect of a hospital and postdischarge quality improvement intervention compared with usual care on heart failure outcomes and care.

Design, setting, and participants: This cluster randomized clinical trial was conducted at 161 US hospitals and included 5647 patients (2675 intervention vs 2972 usual care) followed up after a hospital discharge for acute heart failure with reduced ejection fraction (HFrEF). The trial was performed from 2017 to 2020, and the date of final follow-up was August 31, 2020.

Interventions: Hospitals (n = 82) randomized to a hospital and postdischarge quality improvement intervention received regular education of clinicians by a trained group of heart failure and quality improvement experts and audit and feedback on heart failure process measures (eg, use of guideline-directed medical therapy for HFrEF) and outcomes. Hospitals (n = 79) randomized to usual care received access to a generalized heart failure education website.

Main outcomes and measures: The coprimary outcomes were a composite of first heart failure rehospitalization or all-cause mortality and change in an opportunity-based composite score for heart failure quality (percentage of recommendations followed).

Results: Among 5647 patients (mean age, 63 years; 33% women; 38% Black; 87% chronic heart failure; 49% recent heart failure hospitalization), vital status was known for 5636 (99.8%). Heart failure rehospitalization or all-cause mortality occurred in 38.6% in the intervention group vs 39.2% in usual care (adjusted hazard ratio, 0.92 [95% CI, 0.81 to 1.05). The baseline quality-of-care score was 42.1% vs 45.5%, respectively, and the change from baseline to follow-up was 2.3% vs -1.0% (difference, 3.3% [95% CI, -0.8% to 7.3%]), with no significant difference between the 2 groups in the odds of achieving a higher composite quality score at last follow-up (adjusted odds ratio, 1.06 [95% CI, 0.93 to 1.21]).

Conclusions and relevance: Among patients with HFrEF in hospitals randomized to a hospital and postdischarge quality improvement intervention vs usual care, there was no significant difference in time to first heart failure rehospitalization or death, or in change in a composite heart failure quality-of-care score.

Trial registration: ClinicalTrials.gov Identifier: NCT03035474.

Figure 1.. Site and Patient Recruitment, Randomization, and Follow-up in the CONNECT-HF Cluster Randomized Trial

Randomization occurred at the hospital level, and the effect of the intervention was measured in consented patients. AMA indicates against medical advice; HF, heart failure; LVAD, left ventricular assist device.

Figure 2.. Survival Curves for All-Cause Mortality or Heart Failure Rehospitalizations

Cumulative incidence of heart failure rehospitalization or death by study group. The median observation time was 299 days (range, 128-365) in the intervention group and 287 (range, 116-365) in the usual care group. HR indicates hazard ratio. ^aP value for the comparison was derived from an unadjusted Cox proportional hazards model with shared frailty to account for clustering effect.

Figure 3.. Change in Individual Components of the Heart Failure Process of Care Score Over Time

Change in components of the heart failure (HF) quality score. The score was based on guideline-based recommendations for quality of care provided at the time of hospital discharge and during outpatient follow-up and consisted of the following: (1) use of evidence-based β-blockers at 50% or greater of the target dose; (2) use of angiotensin-converting enzyme (ACE) inhibitor/angiotensin receptor blocker (ARB)/angiotensin receptor neprilysin inhibitor (ARNI) at 50% or greater of the target dose; (3) use of a mineralcorticoid receptor antagonist (MRA) at any dose; (4) use of anticoagulation for patients with atrial fibrillation (AF); (5) use of an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT); and (6) attendance at a multidisciplinary HF disease management program, a cardiac rehabilitation program, or HF group educational classes.