Evaluation and Support Care Process Within the Care Pathway of Heart Failure Patients (FIL-EAS)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04878263 |
|
Recruitment Status :
Recruiting
First Posted : May 7, 2021
Last Update Posted : February 2, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Heart Failure Acute | Other: Conventional hospitalization Other: FIL-EAS ic care pathway | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 454 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Health Services Research |
| Official Title: | Evaluation and Support Care Process Within the Care Pathway of Heart Failure Patients |
| Actual Study Start Date : | June 28, 2021 |
| Estimated Primary Completion Date : | December 27, 2023 |
| Estimated Study Completion Date : | December 27, 2023 |
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Control group |
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. |
| Experimental: FIL-EAS ic group |
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. |
- FIL-EAS ic care pathway safety non inferiority [ Time Frame: 6 months ]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.
- FIL-EAS ic care pathway safety superiority [ Time Frame: 6 months ]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 [ Time Frame: 6 months ]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 [ Time Frame: At the moment of patient initial discharge, up to 3 weeks ]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 [ Time Frame: 6 months ]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 [ Time Frame: 6 months ]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 [ Time Frame: 6 months ]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 [ Time Frame: 6 months ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 MDRD clearance inferior to 15 ml/min/1.73m2 the day of inclusion 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04878263
| Contact: Asmaa Jobic | 04 94 14 55 19 ext +33 | Asmaa.jobic@ch-toulon.fr | |
| Contact: Fanny Cucchietti | 04 94 14 55 29 ext +33 | Fanny.cucchietti@ch-toulon.fr |
| France | |
| Hôpital Sainte Anne | Not yet recruiting |
| Toulon, Var, France, 83000 | |
| Contact: Christophe Jego, MD 0483162485 ext +33 christophejego@aol.com | |
| Centre Hospitalier Intercommunal Toulon La Seyne sur Mer | Recruiting |
| Toulon, Var, France, 83100 | |
| Contact: Jean-Michel Tartière, MD 04 94 14 59 31 ext +33 jean-michel.tartiere@ch-toulon.fr | |
| Study Director: | Jean-Michel Tartière, MD | Centre Hospitalier Intercommunal Toulon La Seyne sur Mer |
| Responsible Party: | Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer |
| ClinicalTrials.gov Identifier: | NCT04878263 |
| Other Study ID Numbers: |
2019-CHITS-04 2020-A02939-30 ( Other Identifier: Id-RCB ) |
| First Posted: | May 7, 2021 Key Record Dates |
| Last Update Posted: | February 2, 2022 |
| Last Verified: | February 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Acute heart failure At home hospitalization Care pathway |
Nurse Geriatric assessment Social assessment |
|
Heart Failure Heart Diseases Cardiovascular Diseases |