DEED-FRAIL trial: A cluster-randomized trial of a frailty-oriented multicomponent ED discharge intervention for older adults with geriatric vulnerability and acute heart failure

OBJECTIVE To evaluate the impact of the multilevel-guided discharge plan (MGDP) on clinical outcomes in older patients with geriatric vulnerability and acute heart failure (AHF) discharged from the ED. METHODOLOGY DESIGN: Open-label, multicenter, cluster-randomized trial comparing patients with and without an intervention. Hospitals were matched by complexity for the cluster randomized procedure. MAIN INCLUSION CRITERIA Age≥70 years, geriatric vulnerability (ISAR≥2 points), NT-proBNP >1800pg/mL, discharged <96 h after ED arrival. INTERVENTION MGDP at patient discharge consisted of: 1) multidimensional checklist for clinical recommendations and activation of resources where needed; 2) early visit with the specialist scheduled; 3) information to primary care team transmitted; and 4) written instruction sheet to the patient/caregiver provided. PRIMARY OUTCOME 30-day composite of AHF-related ED visit, hospitalization, or cardiovascular-related death. RESULTS Twenty-three hospitals (intervention:11, control:12) included 472 patients (mean age:84 years; 57% women; intervention:231, control:241). Adherence to the mandatory core components of MGDP was high, although implementation of deficit-specific interventions varied across geriatric domains. The primary endpoint was observed in 30 and 41 patients in the intervention and control group, respectively (13.0%vs17.0%; OR:0.73, 95%CI:0.44-1.22). Interaction tests did not suggest heterogeneity across prespecified subgroups. The intervention was associated with higher patient/caregiver satisfaction with transition of care (67.2%vs47.3%; OR:2.28, 95%CI:1.50-3.47), although no significant differences were observed for other secondary clinical or patient-centered outcomes. Mixed-effects models yielded consistent findings. CONCLUSIONS In older patients with geriatric vulnerability and AHF discharged home from the ED or related units, MGDP did not demonstrate a statistically significant reduction in 30-day adverse outcomes.