University Hospital, Montpellier
Montpellier, France
Location status: Recruiting
NCT Number: NCT05417490
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.
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Request Info18 year and older
All sexes
Observational
Montpellier, France
Location status: Recruiting
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.
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.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 verifies, by two telephone calls at 1 week and 2 months, that the patient has initiated his outpatient follow-up.
IDE, trained in the therapeutic education of the IC patient according to the PRADO-IC device, carry out:
The doctor carries out a long consultation at 2 months.
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:
This non-medical human assistance is provided by:
Weight and symptoms (listed in an 8-question questionnaire) are collected respectively using a connected scale and the mobile application.
It allows, via a web browser:
Time frame: At 1 month
Participation corresponds to:
Time frame: At 6 months
Participation corresponds to:
Time frame: At inclusion
Describe the causes of non-participation, primary (when the intervention was proposed)
Time frame: through study completion, an average of 6 months
Describe the causes of non-participation secondary (after initial acceptance)
Time frame: between inclusion and 1 month
Evaluate the effectiveness at 1 month of the PRADO and telemedicine programs, as well as their interaction, on hospitalizations for all causes combined
Time frame: between inclusion and 1 month
Evaluate the effectiveness at 1 month of the PRADO and telemedicine programs, as well as their interaction, on hospitalizations for heart failure
Time frame: between inclusion and 1 month
Evaluate the effectiveness at 1 month of the PRADO and telemedicine programs, as well as their interaction, on deaths from all causes combined
Time frame: between inclusion and 1 month
Evaluate the effectiveness at 1 month of the PRADO and telemedicine programs, as well as their interaction, on deaths due to heart failure
Time frame: between inclusion and 6 months
Evaluate the effectiveness at 1 month of the PRADO and telemedicine programs, as well as their interaction, on hospitalizations for all causes combined
Time frame: between inclusion and 6 months
Evaluate the effectiveness at 1 month of the PRADO and telemedicine programs, as well as their interaction, on hospitalizations for heart failure
Time frame: between inclusion and 6 months
Evaluate the effectiveness at 1 month of the PRADO and telemedicine programs, as well as their interaction, on deaths from all causes combined
Time frame: between inclusion and 6 months
Evaluate the effectiveness at 1 month of the PRADO and telemedicine programs, as well as their interaction, on deaths due to heart failure
Time frame: between inclusion and 6 months
Average number of consultations per month with the general practitioner
Time frame: between inclusion and 6 months
Time between the first consultation with the general practitioner and discharge from hospital
Time frame: between inclusion and 6 months
Average number of consultations per month with the cardiologist
Time frame: between inclusion and 6 months
Time between the first consultation with the cardiologist and discharge from hospital
Time frame: between inclusion and 6 months
number of days with at least one nursing contact
Time frame: between inclusion and 6 months
are considered as emergency contacts: consultations with emergency increase, or increase for Night, Weekend or Public Holiday; consultations in emergencies; hospitalizations with emergency entry mode
Time frame: between inclusion and 6 months
according to the continuity of care index, corresponding to the percentage of appointments made by patients with a doctor
Time frame: between inclusion and 6 months
For taking sartans treatments
Time frame: between inclusion and 6 months
For taking beta-blocker treatments
Time frame: between inclusion and 6 months
Coefficient of variation of the daily dose of loop diuretics, calculated as the average dose between two deliveries
Time frame: between inclusion and 6 months
Cost of care pathways: made up of production costs over 6 months after initial hospitalization, and includes all direct costs, whether medical or non-medical.
Time frame: between inclusion and 6 months
Beliefs of physicians on the facilitating elements and on the obstacles of these programs
Contact information is provided by the study sponsor or research team.
University Hospital, Montpellier
Other
Research Into Factors Determining Participation in Two Interventions Modifying the Care Pathways of Patients With Heart Failure in Eastern Occitanie: PRADO-IC and Telemedicine
Acronym: PARTI-PARC
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