Evaluation of the Program to Help Return Home Patients Hospitalized for Heart Failure, From Paris Saint-Joseph Hospital

NCT04613973 | Completed

• 1 other identifier: PRADO_IC2
• Study Type: observational
• Target: 633
• Locations: 1 country
• Sites: 1

Brief Summary

The prevalence of heart failure is very high worldwide is between 1 and 2% in developed countries. 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Impact of the PRADO program on re-hospitalization at 1 year

  This outcome corresponds to 1-year re-hospitalization rate for heart failure after an episode of cardiac decompensation in patients included in the PRADO program vs. patients not included in PRADO.

  Year 1

Secondary Outcomes (2)

• Mortality at 1 year

  Year 1

• First re-hospitalization

  Year 1

Study Arms (2)

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)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized for global heart failure or left ventricular failure in the Cardiology department of the GHPSJ between January 2016 and September 2018.

You may qualify if:

• Patients included in PRADO
• Patient whose age is ≥ 18 years
• Patient hospitalized for global heart failure or left ventricular failure in the Cardiology department of the GHPSJ between January 2016 and September 2018
• Patients included in the PRADO program Patients not included in PRADO
• Patient whose age is ≥ 18 years
• Patient hospitalized for global heart failure or left ventricular failure in the Cardiology department of the GHPSJ between January 2016 and September 2018
• Patients not included in the PRADO program

You may not qualify if:

• Patient under guardianship or guardianship
• Patient living in EHPAD
• Patient transferred to another establishment on discharge from hospital (surgery, follow-up care, EPHAD, etc.)
• Patient who died during hospitalization
• Patient objecting to the use of their data

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Related Publications (4)

• Tuppin P, Cuerq A, de Peretti C, Fagot-Campagna A, Danchin N, Juilliere Y, Alla F, Allemand H, Bauters C, Drici MD, Hagege A, Jondeau G, Jourdain P, Leizorovicz A, Paccaud F. First hospitalization for heart failure in France in 2009: patient characteristics and 30-day follow-up. Arch Cardiovasc Dis. 2013 Nov;106(11):570-85. doi: 10.1016/j.acvd.2013.08.002. Epub 2013 Oct 18.

  PMID: 24140417 RESULT

• Assyag P, Renaud T, Cohen-Solal A, Viaud M, Krys H, Bundalo A, Michel PL, Boukobza R, Bourgueil Y, Cohen A. RESICARD: East Paris network for the management of heart failure: absence of effect on mortality and rehospitalization in patients with severe heart failure admitted following severe decompensation. Arch Cardiovasc Dis. 2009 Jan;102(1):29-41. doi: 10.1016/j.acvd.2008.10.013. Epub 2009 Feb 10.

  PMID: 19233107 RESULT

• Desai AS. The three-phase terrain of heart failure readmissions. Circ Heart Fail. 2012 Jul 1;5(4):398-400. doi: 10.1161/CIRCHEARTFAILURE.112.968735. No abstract available.

  PMID: 22811548 RESULT

• Abassade P, Cohen L, Fels A, Chatellier G, Sacco E, Beaussier H, Fleury L, Komajda M, Cador R. [Impact of Home Return Assistance Service in Heart Failure (PRADO-IC) on the one year re-hospitalisation and mortality in a heart failure hospitalized population of patients]. Ann Cardiol Angeiol (Paris). 2022 Nov;71(5):267-275. doi: 10.1016/j.ancard.2022.07.004. Epub 2022 Aug 6. French.

  PMID: 35940973 RESULT

Related Links

• 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure - Web Addenda

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Philippe ABASSADE, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 3, 2020
• Study Start: November 28, 2020
• Primary Completion: January 31, 2022
• Study Completion: August 17, 2022
• Last Updated: August 19, 2022

Record last verified: 2022-08

Locations

FR (1)