Evaluation and Support Care Process Within the Care Pathway of Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 361
- 试验地点
- 2
- 主要终点
- FIL-EAS ic care pathway safety non inferiority
研究概览
简要总结
Acute heart failure current management turns out to be a relative failure considering its elevated economical and human costs and the poor results obtained in terms of disease outcome. Indeed this disease remains associated with a high rate of early re-hospitalizations and low adherence to therapeutic recommended settings and doses. Moreover, extra cardiological follow-up such as in social, geriatric or vaccination fields remain low compared to real needs.
Current recommendations incite health professionals to better define care pathways and to rationalize resources. Guidelines toward creation of hospitalization alternatives or limitation of time spent in hospital are given. In the same time, lack of cardiologic care management within heart failure patient care pathway is associated to poor prognosis and medical desertification as well as resource concentration on important health centers exacerbate this phenomenon. Innovative projects are then needed to improve patient care pathways, to open up areas without specialized health professionals and to rationalize care management by encouraging communication and skill exchange between hospitals and private practices.
FIL-EAS ic projet aims to compare a conventional care pathway in hospital with a follow up defined according to High Authority of Health recommendations to an organized care pathway favoring a short hospitalization (maximum of 4 working days) with early transition, when possible, to a medical and paramedical home care management with an approximately 10 day long combined follow up between hospital and private practices. This second care pathway should help to optimize therapeutics in home living conditions.
详细描述
Acute heart failure current management turns out to be a relative failure considering its elevated economical and human costs and the poor results obtained in terms of disease outcome. Indeed this disease remains associated with a high rate of early re-hospitalizations and low adherence to therapeutic recommended settings and doses. Current recommendations incite health professionals to better define care pathways and to rationalize resources.
FIL-EAS ic projet aims to compare a conventional care pathway in hospital with a follow up defined according to High Authority of Health recommendations to an organized care pathway favoring a short hospitalization (maximum of 4 working days) with early transition, when possible, to a medical and paramedical home care management with an approximately 10 day long combined follow up between hospital and private practices.
Patients included in the study will be followed up for 6 months with one phone contact one month after hospital discharge, a second one two months later and one consultation 6 months after inclusion in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Patient over 18 years old hospitalized for acute heart failure
- •Patient able to express his consent before participating in the study, certified by the caregiver if a written consent is not possible
- •Patient able to follow protocol procedures, alone or with a caregiver help
- •Caregiver consent to participate in the study and assist the patient during its own participation, if caregiver involvement is necessary
- •Patient requiring an hospitalisation of at least 24 hours
- •Patient covered by social security or equivalent regimen
- •Patient having access to a mobile of fixed phone line
排除标准
- •Admission in intensive care or resuscitation unit AND need for inotropic support, vasodilator, or invasive/non-invasive ventilation for the last 24h
- •Renal insufficiency with CKD-EPI clearance inferior to 15 ml/min/1.73m2 since admission or dialysis
- •Patient planned transfer to a rehabilitation and recuperative care facility (hospital or nursing home)
- •Associated disease requiring frequent re-hospitalizations (cancer, dialysis, repeated sessions during planned hospitalizations)
- •Associated disease with a high risk of death for the next 6 months
- •Chronical respiratory insufficiency requiring daily invasive ventilation or a more than 3L/min permanent oxygen therapy
- •Patient suffering from severe dementia defined by a MMSE score ≤ 9
- •Person participating in another research testing another care pathway
- •Every other reason which, according to investigator, might interfere with study objective assessment
- •Person under judicial protection measure (guardianship, curatorship)
- •Person deprived of liberty by a judicial or administrative decision
研究组 & 干预措施
Control group
干预措施: Conventional hospitalization (Other)
FIL-EAS ic group
干预措施: FIL-EAS ic care pathway (Other)
结局指标
主要结局
FIL-EAS ic care pathway safety non inferiority
时间窗: 6 months
Safety non inferiority will be assessed by comparing the proportion of patients deceased or with unplanned re-hospitalizations for heart failure within the 6 months following randomization between FIL-EAS ic care pathway and conventional hospitalization.
次要结局
- FIL-EAS ic care pathway safety superiority(6 months)
- Quality of life assessed by EQ-5D questionnaire(6 months)
- Satisfaction assessed by QSH-37 questionnaire(At the moment of patient initial discharge, up to 3 weeks)
- Cumulative number of days spent in hospital(6 months)
- Impact on medical recommendation compliance(6 months)
- Geriatric evolution throughout care pathway(6 months)
- Predictive value of biological analyses(6 months)