Effectiveness of an Intervention to Improve Guideline-Directed Medications for Patients With Acute Heart Failure: A Randomized Clinical Trial.

BACKGROUND

Guideline-directed medical therapy during the transitional period is crucial for improving outcomes in heart failure with reduced ejection fraction. We investigated whether a simplified transitional care intervention could increase guideline-directed medical therapy adherence in patients with acute heart failure (HF).

METHODS

This multicenter, open-label randomized trial enrolled 982 patients with acute HF. The transitional care intervention included a discharge checklist, HF education, and telephone monitoring. The primary outcome was achievement of high guideline adherence indicator, defined as the prescription of all 3 guideline-directed medical therapy drugs (renin-angiotensin system blockades, beta blockers, and mineralocorticoid receptor antagonists) at 6 months. Both modified intention-to-treat and per-intervention analyses were conducted to evaluate the effectiveness of intervention components.

RESULTS

Among 982 participants (mean age, 62.4±15.5 years; 64.5% male), there was no statistical difference in the proportion achieving a high guideline adherence indicator between the intervention and control groups (49.6% versus 44.6%; OR, 1.12; 95% CI, 0.86-1.45; P=0.37). No significant differences were observed in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score or clinical outcomes. In the per-intervention analysis, patients who received all components showed significantly higher guideline adherence indicator achievement compared with those who received no components (adjusted odds ratio [OR], 1.56 [95% CI, 1.07-2.27], P=0.02).

CONCLUSIONS

In this randomized trial of patients with acute HF, although the simplified transitional care intervention did not increase high guideline adherence indicator achievement, implementation of all intervention components was associated with improved guideline adherence. Our findings emphasize that implementation fidelity is the key challenge in optimizing transitional care for HF management.

REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04900584.