Factors Influencing Participation in PRADO and Telemedicine Interventions in Heart Failure
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: PRADO-IC, Remote monitoring.
- Кому может быть актуально
- Состояния в реестре: Heart Failure. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
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Официальное название
Research Into Factors Determining Participation in Two Interventions Modifying the Care Pathways of Patients With Heart Failure in Eastern Occitanie: PRADO-IC and Telemedicine
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое 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 - Устройство 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
Первичные конечные точки
- Percentage of patients participating in heart failure programs at 1 month [Срок оценки: At 1 month]
- Percentage of patients participating in heart failure programs at 6 months [Срок оценки: At 6 months]
Вторичные конечные точки (12)
- Number of non-participation of patients [Срок оценки: At inclusion]
- Number of non-participation of patients [Срок оценки: through study completion, an average of 6 months]
- Percentage effectiveness of pathology programs at 1 month [Срок оценки: between inclusion and 1 month]
- Percentage effectiveness of pathology programs at 1 month [Срок оценки: between inclusion and 1 month]
- Percentage effectiveness of pathology programs at 1 month [Срок оценки: between inclusion and 1 month]
- Percentage effectiveness of pathology programs at 1 month [Срок оценки: between inclusion and 1 month]
- Percentage effectiveness of pathology programs at 6 months [Срок оценки: between inclusion and 6 months]
- Percentage effectiveness of pathology programs at 6 months [Срок оценки: between inclusion and 6 months]
- Percentage effectiveness of pathology programs at 6 months [Срок оценки: between inclusion and 6 months]
- Percentage effectiveness of pathology programs at 6 months [Срок оценки: between inclusion and 6 months]
- percentage of effectiveness on the course of care at 6 months [Срок оценки: between inclusion and 6 months]
- percentage of effectiveness on the course of care at 6 months [Срок оценки: between inclusion and 6 months]
Критерии участия
Критерии включения
- 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)
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 1 центр
- University Hospital, Montpellier — Montpellier
Идентификаторы
NCT: NCT05417490 · RECHMPL20_0018