Research Into Factors Determining Participation in Two Interventions Modifying the Care Pathways of Patients With Heart Failure in Eastern Occitanie: PRADO-IC and Telemedicine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Percentage of patients participating in heart failure programs at 6 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Group with PRADO
All patients seen in hospital and for whom the doctor will choose whether or not to offer one of the 2 solutions, alone or in combination, will be considered as included in the study, and their non-objection will be collected.
Subsequently, patients will benefit from follow-up for 6 months: V0 inclusion visit- V1 telephone contact at 1 month only for patients participating in one of the 2 programs and V2 consultation at 6 months. The 0 and 6M (6 months) visits are part of the usual follow-up of patients hospitalized for heart failure.
Administration of questionnaires:
- Girerd's questionnaire : The objective is to measure the medication compliance of patients during treatment
- SSQ6 (Social Support Questionnaire 6) : which measures two dimensions of social support (satisfaction and availability). SSQ6 is an abbreviated form of SSQ (Social Support Questionnaire). A high SSQ score indicates more optimism about life than a low score.
干预措施: PRADO-IC (Other)
Group with PRADO + remote monitoring
All patients seen in hospital and for whom the doctor will choose whether or not to offer one of the 2 solutions, alone or in combination, will be considered as included in the study, and their non-objection will be collected.
Subsequently, patients will benefit from follow-up for 6 months: V0 inclusion visit- V1 telephone contact at 1 month optional only for patients participating in one of the 2 programs and V2 consultation at 6 months. The 0 and 6M visits are part of the usual follow-up of patients hospitalized for heart failure.
Administration of questionnaires:
- Girerd's questionnaire
- SUTAQ (Service User Technology Acceptability Questionnaire) : only for patients with remote monitoring.
the questionnaire has 22 items, measured on a Likert scale from 1 to 6, reflecting respectively more or less agreement with the statements of the items. The questionnaire has 5 subscales, each containing between 3 and 9 items.
- SSQ6
干预措施: PRADO-IC (Other)
Group with PRADO + remote monitoring
All patients seen in hospital and for whom the doctor will choose whether or not to offer one of the 2 solutions, alone or in combination, will be considered as included in the study, and their non-objection will be collected.
Subsequently, patients will benefit from follow-up for 6 months: V0 inclusion visit- V1 telephone contact at 1 month optional only for patients participating in one of the 2 programs and V2 consultation at 6 months. The 0 and 6M visits are part of the usual follow-up of patients hospitalized for heart failure.
Administration of questionnaires:
- Girerd's questionnaire
- SUTAQ (Service User Technology Acceptability Questionnaire) : only for patients with remote monitoring.
the questionnaire has 22 items, measured on a Likert scale from 1 to 6, reflecting respectively more or less agreement with the statements of the items. The questionnaire has 5 subscales, each containing between 3 and 9 items.
- SSQ6
干预措施: Remote monitoring (Device)
Group with remote monitoring
All patients seen in hospital and for whom the doctor will choose whether or not to offer one of the 2 solutions, alone or in combination, will be considered as included in the study, and their non-objection will be collected.
Subsequently, patients will benefit from follow-up for 6 months: V0 inclusion visit- V1 telephone contact at 1 month optional only for patients participating in one of the 2 programs and V2 consultation at 6 months. The 0 and 6M visits are part of the usual follow-up of patients hospitalized for heart failure.
Administration of questionnaires:
- Girerd's questionnaire on therapeutic compliance
- SUTAQ inspired digital tools acceptability questionnaire: only for patients with remote monitoring
- SSQ6 social support questionnaire
干预措施: Remote monitoring (Device)
Group without intervention
All patients seen in hospital and for whom the doctor will choose whether or not to offer one of the 2 solutions, alone or in combination, will be considered as included in the study, and their non-objection will be collected.
Subsequently, patients will benefit from follow-up for 6 months: V0 inclusion visit- V1 telephone contact at 1 month optional only for patients participating in one of the 2 programs and V2 consultation at 6 months. The 0 and 6M visits are part of the usual follow-up of patients hospitalized for heart failure.
Administration of questionnaires:
- Girerd's questionnaire on therapeutic compliance
- SSQ6 social support questionnaire
结局指标
主要结局
Percentage of patients participating in heart failure programs at 6 months
时间窗: At 6 months
Participation corresponds to: * for the PRADO group: visits to the attending physician and home nurses, and appointments made with the cardiologist * for the remote monitoring group: completion of at least 80% of the weighings * for the group without intervention: completion of the visit at 6 months
Percentage of patients participating in heart failure programs at 1 month
时间窗: At 1 month
Participation corresponds to: * for the PRADO group: visits to the attending physician and home nurses, and appointments made with the cardiologist * for the remote monitoring group: completion of at least 80% of the weighings
次要结局
- Percentage effectiveness of pathology programs at 6 months(between inclusion and 6 months)
- percentage of medical appointments made(between inclusion and 6 months)
- Number of non-participation of patients(through study completion, an average of 6 months)
- Percentage effectiveness of pathology programs at 1 month(between inclusion and 1 month)
- Average number of treatment days taken per patient per month(between inclusion and 6 months)
- percentage of days with at least one nursing contact(between inclusion and 6 months)
- Number of emergency medical contacts(between inclusion and 6 months)
- percentage of efficiency on the cost of the care pathway at 6 months(between inclusion and 6 months)
- percentage of physicians offering heart failure programs(between inclusion and 6 months)
- percentage of effectiveness on the course of care at 6 months(between inclusion and 6 months)
- Number of non-participation of patients(At inclusion)