Factors Influencing Participation in PRADO and Telemedicine Interventions in Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PRADO-IC, Remote monitoring.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Other PRADO-IC
The CAM (Health Insurance Advisor) are part of the staff of the Primary Health Insurance Funds (CPAM). They are physically present in the establishments participating in the PRADO. They are facilitators between city health professionals and the patient for their return home. They assist the patient in making appointments with their general practitioner, their cardiologist, and the IDE (general care nurses) trained at PRADO-IC who will make the home visits. After returning home, the CAM verifi - Device Remote monitoring
Chronic Care Connect is intended for remote medical monitoring of patients suffering from chronic heart failure. It consists of a web application (named NOMHADChronic™) and non-medical remote human assistance performed by qualified personnel. Non-medical human assistance allows the following steps to be carried out: * characterization of alerts * structured follow-up of remote patients. This non-medical human assistance is provided by: * nurses trained in therapeutic education and cardiolog
Primary outcome measures
- Percentage of patients participating in heart failure programs at 1 month [Time frame: At 1 month]
- Percentage of patients participating in heart failure programs at 6 months [Time frame: At 6 months]
Secondary outcome measures (12)
- Number of non-participation of patients [Time frame: At inclusion]
- Number of non-participation of patients [Time frame: through study completion, an average of 6 months]
- Percentage effectiveness of pathology programs at 1 month [Time frame: between inclusion and 1 month]
- Percentage effectiveness of pathology programs at 1 month [Time frame: between inclusion and 1 month]
- Percentage effectiveness of pathology programs at 1 month [Time frame: between inclusion and 1 month]
- Percentage effectiveness of pathology programs at 1 month [Time frame: between inclusion and 1 month]
- Percentage effectiveness of pathology programs at 6 months [Time frame: between inclusion and 6 months]
- Percentage effectiveness of pathology programs at 6 months [Time frame: between inclusion and 6 months]
- Percentage effectiveness of pathology programs at 6 months [Time frame: between inclusion and 6 months]
- Percentage effectiveness of pathology programs at 6 months [Time frame: between inclusion and 6 months]
- percentage of effectiveness on the course of care at 6 months [Time frame: between inclusion and 6 months]
- percentage of effectiveness on the course of care at 6 months [Time frame: between inclusion and 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- University Hospital, Montpellier — Montpellier
Identifiers
NCT: NCT05417490 · RECHMPL20_0018