Back to resultsEvaluation and Support Care Process Within the Care Pathway of Heart Failure Patients (FIL-EAS)
Primary Purpose
Heart Failure Acute
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Conventional hospitalization
FIL-EAS ic care pathway
Sponsored by
About this trial
This is an interventional health services research trial for Heart Failure Acute focused on measuring Acute heart failure, At home hospitalization, Care pathway, Nurse, Geriatric assessment, Social assessment
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
Sites / Locations
- Hôpital Sainte Anne
- Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
FIL-EAS ic group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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'.
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".
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.
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.
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.
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.
Full Information
NCT ID
NCT04878263
First Posted
May 4, 2021
Last Updated
October 23, 2023
Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Collaborators
French Cardiology Society
1. Study Identification
Unique Protocol Identification Number
NCT04878263
Brief Title
Evaluation and Support Care Process Within the Care Pathway of Heart Failure Patients
Acronym
FIL-EAS
Official Title
Evaluation and Support Care Process Within the Care Pathway of Heart Failure Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 28, 2021 (Actual)
Primary Completion Date
December 27, 2023 (Anticipated)
Study Completion Date
December 27, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Collaborators
French Cardiology Society
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure Acute
Keywords
Acute heart failure, At home hospitalization, Care pathway, Nurse, Geriatric assessment, Social assessment
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
361 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Title
FIL-EAS ic group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Conventional hospitalization
Intervention Description
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
Intervention Name(s)
FIL-EAS ic care pathway
Intervention Description
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.
Primary Outcome Measure Information:
Title
FIL-EAS ic care pathway safety non inferiority
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
FIL-EAS ic care pathway safety superiority
Description
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.
Time Frame
6 months
Title
Quality of life assessed by EQ-5D questionnaire
Description
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'.
Time Frame
6 months
Title
Satisfaction assessed by QSH-37 questionnaire
Description
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".
Time Frame
At the moment of patient initial discharge, up to 3 weeks
Title
Cumulative number of days spent in hospital
Description
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.
Time Frame
6 months
Title
Impact on medical recommendation compliance
Description
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.
Time Frame
6 months
Title
Geriatric evolution throughout care pathway
Description
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.
Time Frame
6 months
Title
Predictive value of biological analyses
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Michel Tartière, MD
Organizational Affiliation
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Sainte Anne
City
Toulon
State/Province
Var
ZIP/Postal Code
83000
Country
France
Facility Name
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
City
Toulon
State/Province
Var
ZIP/Postal Code
83100
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation and Support Care Process Within the Care Pathway of Heart Failure Patients
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