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Evaluation and Support Care Process Within the Care Pathway of Heart Failure Patients (FIL-EAS)

I

Intermunicipal Hospital Center Toulon

Status

Completed

Conditions

Heart Failure Acute

Treatments

Other: Conventional hospitalization
Other: FIL-EAS ic care pathway

Study type

Interventional

Funder types

Other

Identifiers

NCT04878263
2020-A02939-30 (Other Identifier)
2019-CHITS-04

Details and patient eligibility

About

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.

Full 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.

Enrollment

361 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

361 participants in 2 patient groups

Control group
Active Comparator group
Treatment:
Other: Conventional hospitalization
FIL-EAS ic group
Experimental group
Treatment:
Other: FIL-EAS ic care pathway

Trial contacts and locations

2

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Central trial contact

Asmaa Jobic; Fanny Cucchietti

Data sourced from clinicaltrials.gov

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