PRADOC: A multicentre 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

Abstract

Introduction

The PRADO-IC is a transition care programme 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.

Objective

The aim of the present study was to evaluate the PRADO-IC programme based on the hypotheses provided by health authorities.

Method

The PRADOC study is a multicentre controlled randomized open-label mixed-method trial of the transition programme PRADO-IC vs. usual management in patients hospitalized with heart failure (SOC group; NCT03396081).

Results

A total of 404 patients were recruited between April 2018 and May 2021 (Fig. 1).

The mean patient age was 75 years (±12 years) in both groups. The two 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 SOC group and 25.40% in the PRADO-IC group during the year following the index hospitalization [hazard ratio (HR) = 1.04, 95% confidence interval (CI) = 0.69–1.56; P = 0.85] or cardio-vascular mortality (HR = 0.67, 95% CI = 0.34–1.31; P = 0.24).

Conclusion

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 programmes remain to be integrated in current patients’ pathways, including telemonitoring, and to better tailor individualized approaches.