Intensive therapeutic education strategy for patients with acute heart failure (EduStra-HF): Design of a randomized controlled trial

Abstract

Background: Heart failure is associated with reduced quality of life, hospitalizations, death and high healthcare costs. Despite care improvements, the rehospitalization rate after an acute heart failure episode, especially for acute heart failure, remains high.Methods: The Education Strategy for patients with acute Heart Failure (EduStra-HF; ClinicalTrials.gov Identifier NCT03035123) study will randomize patients admitted for acute heart failure in six French hospitals to usual care (control) or therapeutic education (intervention). All patients will be evaluated at baseline and will meet with a therapeutic education nurse before discharge. Those in the usual care arm will have standard appointments with their cardiologist and general practitioner. Those in the intervention arm will have an intensive follow-up schedule of phone calls, home visits and text messages from the therapeutic education nurses, plus cardiologist visits. Patients will be stratified by discharge location (home or cardiac rehabilitation centre) before randomization, and will be followed up for 1 year. The primary outcome will be the readmission rates for acute heart failure during 1 year in the two groups. Secondary outcomes will include: quality of life; time from inclusion to first readmission for acute heart failure; non-heart failure cardiovascular rehospitalization rates; length of stay for heart failure; cardiovascular and all-cause death; rates of patients receiving optimal medical therapies; evolution of knowledge about heart failure; and cost-effectiveness.Conclusions: This study will assess the efficacy and feasibility of a standardized management strategy for the care and follow-up of patients discharged after hospitalization for acute heart failure. The EduStra-HF strategy will combine various nurse care methods to help prevent rehospitalization.