Clinical trial NCT04878263: Evaluation and Support Care Process Within the Care Pathway of Heart Failure Patients
Official title: Evaluation and Support Care Process Within the Care Pathway of Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure Acute
Keywords: Acute heart failure
At home hospitalization
Care pathway
Nurse
Geriatric assessment
Social assessment
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
Collaborators: name: French Cardiology Society
First posted: 2021-05-07
Enrollment: 361
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: FIL-EAS ic care pathway safety non inferiority
timeFrame: 6 months
Secondary outcomes:
measure: FIL-EAS ic care pathway safety superiority
timeFrame: 6 months
measure: Quality of life assessed by EQ-5D questionnaire
timeFrame: 6 months
measure: Satisfaction assessed by QSH-37 questionnaire
timeFrame: At the moment of patient initial discharge, up to 3 weeks
measure: Cumulative number of days spent in hospital
timeFrame: 6 months
measure: Impact on medical recommendation compliance
timeFrame: 6 months
measure: Geriatric evolution throughout care pathway
timeFrame: 6 months
measure: Predictive value of biological analyses
timeFrame: 6 months
Other outcomes:
Locations:
city: Toulon
country: France
facility: Hôpital Sainte Anne
state: Var
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
state: Var
Study officials:
affiliation: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
name: Jean-Michel Tartière, MD
role: STUDY_DIRECTOR
References:
citation: Tartiere JM, Candel J, Caignec ML, Jaunay L, Patin C, Kesri-Tartiere L, Esteveny M, Harel M, Derksen H, Quaino G, Lecardonnel I, Challal F, Armangaud P, Birgy C. Assessment of Noninferiority in Terms of 6-month Morbidity and Mortality Rates of a Hospital-at-home Care Pathway for Patients With Acute Heart Failure: FIL-EAS-ic Study Protocol. J Card Fail. 2024 Oct 23:S1071-9164(24)00887-X. doi: 10.1016/j.cardfail.2024.09.016. Online ahead of print.