Evaluation of a Back-to-home Support Program for Hospitalized Patients for Heart Failure
NCT ID: NCT05566145
Last Updated: 2022-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
616 participants
OBSERVATIONAL
2020-12-15
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The French Federation of Cardiology estimates that a million people are affected in France. Each year in France, there are nearly 70,000 deaths linked to heart failure, and more than 150,000 hospitalizations with an average cumulative duration per year of 12.7 days, figures which show the extent of the phenomenon. Heart failure is therefore a common pathology, which constitutes an important public health issue. It requires rigorous monitoring and early adaptation of treatments to avoid repeated hospitalizations. Studies show that following hospitalization for heart failure, all-cause re-hospitalization rates rise to 18% within 30 days. In 2019, the rate of re-hospitalization at 1 year is 30%, half of which in the following 3 months. The prognosis is grim with 20 to 30% of deaths within the year.
The European Society of Cardiology recommends that the patient be integrated into a care path coordinated by the general practitioner; and a consultation with his general practitioner in the week after hospitalization and his cardiologist within two weeks. The CPAM (Caisse Primaire d'Assurance Maladie) has set up since 2013 the PRADO-IC program (Program for Return to Home Hospital for Heart Failure). This program must be in place before discharge from hospital. A health insurance advisor comes to meet the patient, declared eligible for PRADO by the hospital medical team, to present the offer and collect his approval before discharge. He then contacts the attending physician and organizes his return home. A follow-up book is given to the patient to allow better transmission of information between town and hospital.
A specially trained nurse visits the patient's home every week. The duration of PRADO support varies according to the NYHA stage of severity. It provides therapeutic education with reinforcement of hygieno-dietetic rules, warning signs, checks compliance with treatments and the necessary biological monitoring and must alert the attending physician in the event of aggravation.
The objectives of this program are: to preserve the quality of life and the autonomy of patients, to support the reduction of the length of stay in hospital, to strengthen the quality of care in town around the attending physician, improve the efficiency of recourse to hospitalization by reserving the heaviest structures for the patients who need them most.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of the Program to Help Return Home Patients Hospitalized for Heart Failure, From Paris Saint-Joseph Hospital
NCT04613973
Development of a Predictive Algorithm for the Risk of Rehospitalization of Patients With Heart Failure
NCT03905226
Consultation at 8 Days to Reduce Hospitalisations in Heart Failure Patient
NCT01834833
SAFEty and Efficacy of HOME-based Hospitalization Versus Inpatient Care for Patients With Acute Heart Failure in Chronic Heart Failure.
NCT03156686
Readmission in the Case of Patients With Heart Failure
NCT02808221
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The French Federation of Cardiology estimates that a million people are affected in France. This prevalence increases sharply with age, reaching 15% of people aged 85 and over.
Each year in France, there are nearly 70,000 deaths linked to heart failure, and more than 150,000 hospitalizations with an average cumulative duration per year of 12.7 days, figures which show the extent of the phenomenon. In addition, the aging of the population and the explosion of cardiovascular risk factors suggest that the impact of heart failure will be greater in the future.
Heart failure is therefore a common pathology, which constitutes an important public health issue. It requires rigorous monitoring and early adaptation of treatments to avoid repeated hospitalizations. Studies show that following hospitalization for heart failure, all-cause re-hospitalization rates rise to 18% within 30 days. According to a report from the Caisse Primaire d'Assurance Maladie (CPAM) in 2019, the rate of re-hospitalization at 1 year is 30%, half of which in the following 3 months. The prognosis is grim with 20 to 30% of deaths within the year.
The European Society of Cardiology recommends that the patient be integrated into a care path coordinated by the general practitioner; and a consultation with his general practitioner in the week after hospitalization and his cardiologist within two weeks. But general practitioners deplore a lack of coordination between city and hospital with difficulties in taking care of their patient following hospitalization. According to the CPAM report, only 30% of re-hospitalized patients had contact with a cardiologist before their readmission, and 15% of patients had no contact with the health care system within 2 months of followed their hospitalization.
It is in this need to improve monitoring that the CPAM has set up since 2013 the PRADO-IC program (Support Program for Return to Home Hospital for Heart Failure). This program must be in place before discharge from hospital. A health insurance advisor comes to meet the patient, declared eligible for PRADO by the hospital medical team, to present the offer and collect his approval before discharge. He then contacts the attending physician and organizes his return home. A follow-up book is given to the patient to allow better transmission of information between town and hospital.
A specially trained nurse (internet training) visits the patient's home every week. The duration of PRADO support varies according to the NYHA stage of severity: a patient in NYHA stage I or II benefits from home support for a period of 2 months, and 6 months for NYHA stages III and IV. It should make it possible to monitor the constants: blood pressure, pulse, and weight. It provides therapeutic education with reinforcement of hygieno-dietetic rules (low sodium diet), warning signs (orthopnea, cough, dyspnea), checks compliance with treatments and the necessary biological monitoring and must alert the attending physician in the event of aggravation.
The objectives of this program are: to preserve the quality of life and the autonomy of patients, to support the reduction of the length of stay in hospital, to strengthen the quality of care in town around the attending physician, improve the efficiency of recourse to hospitalization by reserving the heaviest structures for the patients who need them most.
The main objective of this study is to evaluate the impact of the PRADO program on morbidity and mortality in a retrospective cohort of heart failure patients.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients included in the PRADO program
Patients hospitalized for global heart failure or left ventricular insufficiency in the Cardiology department of the GHPSJ between January 2016 and September 2018, included in the support program for Return To Home for Heart Failure (PRADO)
No interventions assigned to this group
Patients not included in the PRADO program
Patients hospitalized for global heart failure or left ventricular insufficiency in the Cardiology department of the GHPSJ between January 2016 and September 2018, not included in the Return A DOmicile support program for Heart Failure (PRADO)
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Male or female whose age is ≥ 18 years
* Patient hospitalized for heart failure in the GHPSJ Cardiology Department between September 2016 and December 2018 included in the PRADO program
* Patient affiliated to a CNAM IDF social security scheme (general scheme a priori)
* Patient understanding the research issues
For the control cohort
* Male or female whose age is ≥ 18 years
* Patient hospitalized for congestive heart failure (ICD 10 code I500) or left ventricular failure (ICD 10 code I501) in the GHPSJ Cardiology department between September 2016 and December 2018
* Patient affiliated to a social security scheme CNAM IDF
* Patient discharged to home
* Not included in the PRADO program
* Patient who understands the research issues
Exclusion Criteria
* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient at the end of life whose vital status is engaged
* Patient who objects to the use of his data
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fondation Hôpital Saint-Joseph
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Philippe ABASSADE, MD
Role: PRINCIPAL_INVESTIGATOR
Fondation Hôpital Saint-Joseph
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Groupe Hospitalier Paris Saint-Joseph
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.
Gheorghiade M, Vaduganathan M, Fonarow GC, Bonow RO. Rehospitalization for heart failure: problems and perspectives. J Am Coll Cardiol. 2013 Jan 29;61(4):391-403. doi: 10.1016/j.jacc.2012.09.038. Epub 2012 Dec 5.
Albert NM, Barnason S, Deswal A, Hernandez A, Kociol R, Lee E, Paul S, Ryan CJ, White-Williams C; American Heart Association Complex Cardiovascular Patient and Family Care Committee of the Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Transitions of care in heart failure: a scientific statement from the American Heart Association. Circ Heart Fail. 2015 Mar;8(2):384-409. doi: 10.1161/HHF.0000000000000006. Epub 2015 Jan 20.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRADO St Jo
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.