PRADOC: A Multicenter Randomized Controlled Trial to Assess the Efficiency of PRADO‐IC, a Nationwide Pragmatic Transition Care Management Plan for Hospitalized Patients With Heart Failure in France

Author:

Roubille François1ORCID,Labarre Jean‐Philippe2,Georger Frédéric3ORCID,Galinier Michel4ORCID,Herman Fanchon5,Berdague Philippe3,Nogue Erika5ORCID,Petroni Thibaut2,Delbaere Quentin6ORCID,Malak Alexandre6,Robin Marie6,Prunet Elvira7ORCID,Leclercq Florence6ORCID,Pasquie Jean‐Luc8ORCID,Papinaud Laurence9ORCID,Mercier Grégoire1011ORCID,Ricci Jean‐Etienne7ORCID,Cayla Guillaume7ORCID,Duflos Claire1011ORCID

Affiliation:

1. PhyMedExp Université de Montpellier INSERM CNRS Cardiology Department INI‐CRT CHU de Montpellier Montpellier France

2. Cardiology Clinique du Pont de Chaume ELSAN Montauban France

3. Cardiology Unit Beziers Hospital Béziers France

4. Fédération des Services de Cardiologie CHU Toulouse‐Rangueil Toulouse France

5. Epidemiology and Clinical Research Department University Hospital University of Montpellier Montpellier France

6. Department of Cardiology Montpellier University Hospital Montpellier France

7. Department of Cardiology Nimes University Hospital Montpellier University Nimes France

8. PhyMedExp Université de Montpellier INSERM CNRS Cardiology Department CHU de Montpellier Montpellier France

9. Direction Régionale du Service Médical Occitanie CNAM Montpellier France

10. Public Health Department Montpellier University Hospital Montpellier France

11. UMR IDESP INSERM Montpellier University Montpellier France

Abstract

Background The PRADO‐IC (Programme de Retour à Domicile après une Insuffisance Cardiaque) is a transition care program designed to improve the coordination of care between hospital and home that was generalized in France in 2014. The PRADO‐IC consists of an administrative assistant who visits patients during hospitalization to schedule follow‐up visits. The aim of the present study was to evaluate the PRADO‐IC program based on the hypotheses provided by health authorities. Methods and Results The PRADOC study is a multicenter, controlled, randomized, open‐label, mixed‐method trial of the transition program PRADO‐IC versus usual management in patients hospitalized with heart failure (standard of care group; NCT03396081). A total of 404 patients were recruited between April 2018 and May 2021. The mean patient age was 75 years (±12 years) in both groups. The 2 groups were well balanced regarding severity indices. At discharge, patients homogeneously received the recommended drugs. There was no difference between groups regarding hospitalizations for acute heart failure at 1 year, with 24.60% in the standard of care group and 25.40% in the PRADO‐IC group during the year following the index hospitalization (hazard ratio, 1.04 [95% CI, 0.69–1.56]; P =0.85) or cardiovascular mortality (hazard ratio, 0.67 [95% CI, 0.34–1.31]; P =0.24). Conclusions The PRADO‐IC has not significantly improved clinical outcomes, though a trend toward reduced cardiovascular mortality is evident. These results will help in understanding how transitional care programs remain to be integrated in pathways of current patients, including telemonitoring, and to better tailor individualized approaches. REGISTRATION URL: https://www.clinicaltrials.gov ; Unique Identifier: NCT03396081.

Publisher

Ovid Technologies (Wolters Kluwer Health)

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