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

Heart Failure Acute Clinical Trial

— FIL-EAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04878263
• Other study ID #: 2019-CHITS-04
• Secondary ID: 2020-A02939-30
• Status: Completed
• Phase: N/A
• Start date: June 28, 2021
• Est. completion date: December 14, 2023

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 361
• Est. completion date: December 14, 2023
• Est. primary completion date: December 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure Acute

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal Toulon La Seyne sur Mer	Toulon	Var
France	Hôpital Sainte Anne	Toulon	Var

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer	French Cardiology Society

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FIL-EAS ic care pathway safety non inferiority	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.	6 months
Secondary	FIL-EAS ic care pathway safety superiority	Safety superiority 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.	6 months
Secondary	Quality of life assessed by EQ-5D questionnaire	Scores obtained after EQ-5D questionnaire completion will be collected during inclusion and research end visit. Evolution between these two scores will be compared between FIL-EAS ic care pathway and conventional hospitalization. EQ-5D questionnaire assess through 5 questions patient mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels : no problems, slight, moderate, severe and finally extreme problems. The patient is asked to tick the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The questionnaire records also patient's self-rated health on a vertical visual analogue scale going from 0 to 100. 0 corresponds to 'The worst health you can imagine' and 100 to 'The best health you can imagine'.	6 months
Secondary	Satisfaction assessed by QSH-37 questionnaire	Scores obtained after QSH-37 questionnaire completion will be collected during the visit performed at the end of initial hospitalization and compared between FIL-EAS ic care pathway and conventional hospitalization. The QSH-37 is composed of 37 questions about care management throughout patient hospitalization from the admission until patient's discharge and concerns following elements : relation with professionals (doctors, nurses, housekeepers), response delays, cleanliness, food and room equipment. For each item, possible answers go from "better than desired" to "extremely less than desired".	At the moment of patient initial discharge, up to 3 weeks
Secondary	Cumulative number of days spent in hospital	The cumulative number of days spent in hospital within the 6 months following randomization will be compared between FIL-EAS ic care pathway and conventional hospitalization. In this calculation will be taken into account hospitalizations for acute care, hospitalizations for serious illnesses during their acute phases, mental health activities and non-ambulatory follow-up care and rehabilitation unit stays.	6 months
Secondary	Impact on medical recommendation compliance	Rate of prescription with percentage of recommended dose of heart failure treatments will be collected and compared between the two groups at initial hospitalization discharge and 6 months after. Rate of influenza, pneumococcal and Covid-19 vaccination, percentage of home therapeutic education use, percentage of ambulatory cardiovascular re-education use and rate of acute renal insufficiency occurrence during initial hospitalization will also be assessed.	6 months
Secondary	Geriatric evolution throughout care pathway	Scores obtained at 5 questionnaires will be collected during inclusion visit and research end visit. The evolution of these scores between these two time points will be compared between FIL-EAS ic care pathway and conventional hospitalization. These 5 questionnaires are : ADL (Activities of Daily Leaving), IADL(Instrumental Activities of Daily Leaving)-LAWTON, MNA (Mini Nutritional Assessment), mini GDS (Geriatric Depression Scale) and Dubois 5 words test. The two first asses the ability to perform daily activities. The third one aims at detecting malnutrition cases and is composed of 18 questions. Mini GDS, composed of 4 questions, detects depression cases and finally Dubois 5 words test is a tool evaluating patient cognitive functions. Besides these questionnaires, percentage of geriatric consultation occurrence throughout study participation will be compared between the two care pathways.	6 months
Secondary	Predictive value of biological analyses	Biological analyses results performed throughout study participation will be compared between FIL-EAS ic care pathway and conventional hospitalization and their predictive value with respect to the occurrence of unplanned re-hospitalizations for heart failure or deaths will be evaluated.	6 months