Assessment of Noninferiority in Terms of 6-month Morbidity and Mortality Rates of a Hospital-at-home Care Pathway for Patients With Acute Heart Failure: FIL-EAS-ic Study Protocol.

Background: 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 being 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 lengths of stay without impairing HF outcomes. This protocol describes the study design, which evaluate the noninferiority of the FIL-EAS-ic pathway compared to conventional hospitalization in terms of 6-month all-cause mortality and/or unscheduled HF-related hospitalization.

Methods and results: A randomized, prospective multicenter trial (NCT04878263) will be conducted involving 2 groups of patients in a 1:2 ratio: (1) a control group following the conventional hospitalization pathway; and (2) 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-June 2023. The noninferiority of the FIL-EAS-ic pathway compared to conventional hospitalization, in terms of 6-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 2 groups.

Conclusions: This clinical trial will provide evidence concerning a novel HF care pathway in France as well as its potential to improve follow-up care, quality of life, and patient satisfaction and its potential to reduce costs.