Clinical trial NCT05417490: Research Into Factors Determining Participation in 2 Interventions Modifying the Care Pathways of Patients With Heart Failure: PRADO and Telemedicine
Official title: Research Into Factors Determining Participation in Two Interventions Modifying the Care Pathways of Patients With Heart Failure in Eastern Occitanie: PRADO-IC and Telemedicine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Keywords: heart failure
transitional care
PRADO
remote monitoring
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population consists of adult patients, suffering from heart failure, hospitalized for cardiac decompensation.

The source population consists of patients hospitalized for heart failure in cardiology departments of UH of Montpellier, Nîmes, Bassin de Thau and Béziers.

Brief summary: Patients with heart failure (HF), after hospitalization, present a marked fragility. Interventions improving the coordination of care actors at the time of discharge from hospitalization have been tested and have shown, in preliminary studies, a reduction in rehospitalizations for heart failure and all-cause mortality.

Among these promising devices, two have recently been deployed nationwide.

* The return home program for IC patients (PRADO IC), set up by the Health Insurance, aims to facilitate the return and stay at home after hospitalization. It offers assistance with the initiation of outpatient medical follow-up, nursing follow-up for 2 to 6 months depending on the severity of the patient, and a follow-up log facilitating the exchange of information.
* At the same time, as part of the ETAPES (Telemedicine experiments for the improvement of healthcare pathways) program of the Health Insurance, the deployment of telemedicine for remote monitoring of heart failure pursues a comparable objective of reducing rehospitalizations.

These two systems are widely deployed on a national scale, and are intended to be universal.

Our hypothesis is that adherence to care transition and telemedicine programs, and therefore their effectiveness, may depend on their association, as well as socio-demographic, cultural, and geographical factors.

Detailed description: Patients with heart failure (HF), after hospitalization, present a marked fragility: in France, in the first year, 29% die and 45% are rehospitalized for HF. Interventions improving the coordination of care actors at the time of discharge from hospitalization have been tested and have shown in preliminary studies a reduction in rehospitalizations for HF (relative risk (RR) from 0.51 to 0.74) and all-cause mortality (RR 0.75 to 0.87).

Among these promising devices, two have recently been deployed nationwide.

* The return home program for IC patients (PRADO IC), set up by the Health Insurance, aims to facilitate the return and stay at home after hospitalization. It offers assistance with the initiation of outpatient medical follow-up, nursing follow-up for 2 to 6 months depending on the severity of the patient, and a follow-up log facilitating the exchange of information. It is based on the assumption that these actions will improve the coordination of care between the hospital and the city, and between home nurses and doctors. In addition, nurses reinforce therapeutic patient education (TPE), whether or not it is initiated in a setting dedicated to TPE.
* At the same time, as part of the ETAPES program of the Health Insurance, the deployment of telemedicine for remote monitoring of heart failure pursues a comparable objective of reducing rehospitalizations. It is based on the hypothesis that the early signs of cardiac decompensation can be diagnosed by telemonitoring and trigger earlier and therefore less aggressive management for similar effectiveness.

These two systems are widely deployed on a national scale, and are intended to be universal.

However, three points can call into question the effectiveness of this deployment: their evaluation is often difficult, the extrapolability of randomized studies to health systems and different populations is low, and the complementarity of two independently constructed programs has never been been studied so far.

1. The preliminary data concerning the PRADO were epidemiological, historical, comparative before-elsewhere, on the SNIIRAM (National health insurance inter-scheme information system) databases, without optimal consideration of clinical and cultural confounding factors.
2. The acceptability of these programs by all health professionals (and therefore how they choose to deploy such and such a system for a given patient) and patients in the French context is not known.
3. The PRADO system and telemedicine solutions, acting differently, could be synergistic and therefore multiply the benefits obtained. However, in practice, some patients experience these programs as intrusive, and it is possible that their adherence is in fact all the worse when two programs are implemented. Similarly, from the prescriber's point of view, the way in which the various possible combinations are chosen is unknown.

The answer to these three questions is necessary to guide the most effective deployment of these programs nationwide.

Our hypothesis is that adherence to care transition and telemedicine programs, and therefore their effectiveness, may depend on their association, as well as socio-demographic, cultural, and geographical factors.

Eligibility criteria: Inclusion Criteria:

* Adult patient
* Patient hospitalized at the time of inclusion for cardiac decompensation, or cause of admission for which heart failure plays a decisive or aggravating role (co-infection, etc.) recognized by the clinician.
* Patient agreeing to take part in this research (absence of non-objection)

Exclusion Criteria:

* Refusal to participate
* Pregnant or breastfeeding women, patients unable to give protected adult consent, vulnerable people (art.L.1121-6, L.1121-7, L.1211-8, L.1211-9)
* Subject deprived of liberty by judicial or administrative decision

Primary outcomes:
measure: Percentage of patients participating in heart failure programs at 1 month
timeFrame: At 1 month
measure: Percentage of patients participating in heart failure programs at 6 months
timeFrame: At 6 months
Secondary outcomes:
measure: Number of non-participation of patients
timeFrame: At inclusion
measure: Number of non-participation of patients
timeFrame: through study completion, an average of 6 months
measure: Percentage effectiveness of pathology programs at 1 month
timeFrame: between inclusion and 1 month
measure: Percentage effectiveness of pathology programs at 1 month
timeFrame: between inclusion and 1 month
measure: Percentage effectiveness of pathology programs at 1 month
timeFrame: between inclusion and 1 month
measure: Percentage effectiveness of pathology programs at 1 month
timeFrame: between inclusion and 1 month
measure: Percentage effectiveness of pathology programs at 6 months
timeFrame: between inclusion and 6 months
measure: Percentage effectiveness of pathology programs at 6 months
timeFrame: between inclusion and 6 months
measure: Percentage effectiveness of pathology programs at 6 months
timeFrame: between inclusion and 6 months
measure: Percentage effectiveness of pathology programs at 6 months
timeFrame: between inclusion and 6 months
measure: percentage of effectiveness on the course of care at 6 months
timeFrame: between inclusion and 6 months
measure: percentage of effectiveness on the course of care at 6 months
timeFrame: between inclusion and 6 months
measure: percentage of effectiveness on the course of care at 6 months
timeFrame: between inclusion and 6 months
measure: percentage of effectiveness on the course of care at 6 months
timeFrame: between inclusion and 6 months
measure: percentage of days with at least one nursing contact
timeFrame: between inclusion and 6 months
measure: Number of emergency medical contacts
timeFrame: between inclusion and 6 months
measure: percentage of medical appointments made
timeFrame: between inclusion and 6 months
measure: Average number of treatment days taken per patient per month
timeFrame: between inclusion and 6 months
measure: Average number of treatment days taken per patient per month
timeFrame: between inclusion and 6 months
measure: Average number of treatment days taken per patient per month
timeFrame: between inclusion and 6 months
measure: percentage of efficiency on the cost of the care pathway at 6 months
timeFrame: between inclusion and 6 months
measure: percentage of physicians offering heart failure programs
timeFrame: between inclusion and 6 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital, Montpellier
Study officials:
affiliation: UH of Montpellier
name: François ROUBILLE, PUPH
role: PRINCIPAL_INVESTIGATOR
References: