Abstract
Heart failure (HF) is a common cause of hospitalization and is associated with high mortality rates, long hospital stays and high economic costs worldwide. Novel care pathways are increasingly considered to address these burdens. In France, a mixed conventional hospitalization and hospital-at-home (HaH) care pathway (named FIL-EAS-ic) has been designed to reduce hospital length of stay without impairing HF outcomes. This protocol describes the study design evaluating the non-inferiority of the FIL-EAS-ic pathway compared to conventional hospitalization in terms of six-month all-cause mortality and/or unscheduled HF-related hospitalization. A randomized, prospective, multicenter trial (NCT04878263) will be conducted involving two groups of patients in a 1:2 ratio: i) a control group following the conventional hospitalization pathway, and ii) the experimental group following the FIL-EAS-ic pathway. We aim to include 454 patients from the Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer and the Hôpital d'Instruction des Armées Sainte-Anne in France from June 2021 to June 2023. The non-inferiority of the FIL-EAS-ic pathway compared to conventional hospitalization, in terms of six-month all-cause mortality and/or unscheduled HF-related hospitalization will be tested by the Farrington-Manning method. Impact on treatment adherence, HF rehospitalizations and cumulative time spent in the hospital will also be compared between the two groups. This clinical trial will provide evidence on a novel HF care pathway in France as well as its potential to improve follow-up care, quality of life and patient satisfaction as well as its potential to reduce costs.
Published Version
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