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Randomized Controlled Trial
. 2024 Aug 6;13(15):e032931.
doi: 10.1161/JAHA.123.032931. Epub 2024 Jul 18.

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

François Roubille  1 , Jean-Philippe Labarre  2 , Frédéric Georger  3 , Michel Galinier  4 , Fanchon Herman  5 , Philippe Berdague  3 , Erika Nogue  5 , Thibaut Petroni  2 , Quentin Delbaere  6 , Alexandre Malak  6 , Marie Robin  6 , Elvira Prunet  7 , Florence Leclercq  6 , Jean-Luc Pasquie  8 , Laurence Papinaud  9 , Grégoire Mercier  10   11 , Jean-Etienne Ricci  7 , Guillaume Cayla  7 , Claire Duflos  10   11
Affiliations
Randomized Controlled Trial

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

François Roubille et al. J Am Heart Assoc. .

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.

Keywords: heart failure; mixed‐methods study; readmission; transition program.

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Figures

Figure 1
Figure 1. Study flowchart.
PRADO‐IC indicates Programme de Retour à Domicile après une Insuffisance Cardiaque; and SOC, standard of care.
Figure 2
Figure 2. Comparison of outcomes in both study groups.
A, First hospitalization for acute heart failure; B, First hospitalization for any cause; C, Cardiovascular death; D, Death from any cause. Time is in days. P values of log‐rank tests are given. PRADO‐IC indicates Programme de Retour à Domicile après une Insuffisance Cardiaque.
Figure 3
Figure 3. Study summary.
GP indicates general practitioner; HF, heart failure; HR, hazard ratio; PRADO‐IC, Programme de Retour à Domicile après une Insuffisance Cardiaque; and SOC, standard of care.
See this image and copyright information in PMC

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