Evaluation and Support Care Process Within the Care Pathway of Heart Failure Patients

NCT ID: NCT04878263

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 361 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-28
• Study Completion Date: 2023-12-14

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.

Conditions

Heart Failure Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Control group

Group Type: ACTIVE_COMPARATOR

Conventional hospitalization

Intervention Type: OTHER

Conventional care pathway : patients will be hospitalized as long as necessary and then followed according to High Health Authorities recommendations and usual practices.

FIL-EAS ic group

Group Type: EXPERIMENTAL

FIL-EAS ic care pathway

Intervention Type: OTHER

Organized care pathway with a maximum 4 working day long conventional hospitalization followed by hospitalization at home with a follow up combining hospital and private practice competences.

Interventions

Conventional hospitalization

Conventional care pathway : patients will be hospitalized as long as necessary and then followed according to High Health Authorities recommendations and usual practices.

Intervention Type: OTHER

FIL-EAS ic care pathway

Organized care pathway with a maximum 4 working day long conventional hospitalization followed by hospitalization at home with a follow up combining hospital and private practice competences.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

French Cardiology Society

OTHER

Sponsor Role: collaborator

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Michel Tartière, MD

Role: STUDY_DIRECTOR

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Locations

Hôpital Sainte Anne

Toulon, Var, France

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Toulon, Var, France

Countries

France

References

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. 2025 Jun;31(6):928-938. doi: 10.1016/j.cardfail.2024.09.016. Epub 2024 Oct 23.

Reference Type: BACKGROUND

PMID: 39454939 (View on PubMed)

Other Identifiers

2020-A02939-30

Identifier Type: OTHER

Identifier Source: secondary_id

2019-CHITS-04

Identifier Type: -

Identifier Source: org_study_id