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Randomized Controlled Trial
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.
- Francisco Javier Martín-Sánchez, Guillermo Llopis García, Pere Llorens, Javier Jacob, Pablo Herrero, Víctor Gil, Antoni Juan Pastor, Amanda López-Picado, Manuel Fuentes Ferrer, Xavier Rosselló, Pedro Gil, Pablo Díez Villanueva, Elpidio Calvo, Manuel Méndez Bailón, Federico Cuesta-Triana, Juan Jorge González Armengol, Juan González Del Castillo, Isabelle Runtkle, Mª Teresa Vidán, Josep Comín-Colet, Alfonso Cruz Jentoft, Héctor Bueno, Òscar Miró, and Cristina Fernández Pérez.
- Servicio de Urgencias, Hospital Clínico San Carlos; Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC); Facultad de Medicina, Universidad Complutense, Madrid, España. Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, España.
- Emergencias. 2019 Feb 1; 31 (1): 27-35.
ObjectivesTo demonstrate the efficacy of a system for comprehensive care transfer (Multilevel Guided Discharge Plan [MGDP]) for frail older patients diagnosed with acute heart failure (AHF) and to validate the results of MGDP implementation under real clinical conditions. The MGDP seeks to reduce the number of adverse outcomes within 30 days of emergency department (ED) discharge.Material And MethodsWe 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.ConclusionThe study will assess the efficacy and feasibility of comprehensive MGDP transfer of care for frail older AHF patients discharged home.
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