Planning to reduce 30-day adverse events after discharge of frail elderly patients with acute heart failure: design and rationale for the DEED FRAIL-AHF trial.

OBJETIVO: Demostrar la eficacia de una intervencion integral en la transicion de cuidados (Plan de Alta Guiado Multinivel, PAGM) para disminuir eventos adversos a 30 dias en ancianos fragiles con insuficiencia cardiaca aguda (ICA) dados de alta desde servicios de urgencias (SU) y validar los resultados de dicha intervencion en condiciones reales. MATERIAL AND METHODS: We will enroll frail patients over the age of 70 years discharged home from the ED with a main diagnosis of AHF. The MGDP includes the following components: 1) a checklist of clinical recommendations and resource activations, 2) scheduling of an early follow-up visit, 3) transfer of information to the primary care doctor, and 4) written instructions for the patient. Phase 1 of the study will be a matched-pair cluster-randomized controlled trial. Ten EDs will be randomly assigned to the intervention group and 10 to the control group. Each group will enroll 480 patients, and the outcomes will be compared between groups. Phase 2 will be a quasi-experimental study of the intervention in 300 new patients enrolled by the same 20 EDs. The outcomes will be compared to those for each Phase-1 group. The main endpoint at 30 days will be a composite of 2 outcomes: revisits to an ED and/for hospitalization for AHF or cardiovascular death. CONCLUSIONES: El estudio valorara la eficacia y factibilidad de una intervencion integral en la transicion de cuidados para reducir resultados adversos a 30 dias en ancianos fragiles con ICA dados de alta desde los SU.