RAndomized Controlled Trial of a Multiple INtervention proGram to Decrease Heart Failure Rehospitalization (RACING-HF)

The prevalence of heart failure (HF) is constantly increasing in France due to the aging of the population, better management of etiological factors and improved treatments (drug / interventional). On the other hand, re-hospitalizations for heart failure continue to increase, exceeding reception capacities and constitute a real challenge for current public health systems. The PRADO system provides administrative support (through a health insurance advisor) in the management of patient appointments with their doctors as well as home visits by a nurse trained in heart failure. Other interventional medical and educational interventions performed during an out-of-hospital consultation guided by a computer platform would help to optimize the care and continuity of care.

Study Overview

• Status: Terminated
• Conditions: Heart Decompensation
• Intervention / Treatment: Other: Multiple intervention program

Detailed Description

The aim of this study is to demonstrate the value of a multiple intervention program in reducing early readmissions for heat failure in patients hospitalized for cardiac decompensation.

This work will create an interventional assistance program to structure the exit consultation in order to optimize treatment, educate patients, ensure the continuity of hospital-city care and improve compliance (reminders) to reduce re-hospitalizations. This program will be carried out by using a computer platform allowing the systematization of output documents and the sending of messages (e-mail / SMS) for making appointments (medical consultations, biologicals sampling) and perfect therapeutic education.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Champigny-sur-Marne, France
    • Hôpital Paul d'Egine
  • Créteil, France
    • Hopital Henri Mondor
  • Eaubonne, France
    • Hôpital Simone Veil
  • Gleizé, France, 69655
    • Hôpitaux Nord-Ouest de Villefranche
  • Paris, France
    • Hôpital Européen Georges Pompidou
  • Poitiers, France, 86000
    • Polyclinique de Poitiers
  • Saint-Denis, France
    • Centre Cardiologique du Nord
  • Villeneuve-Saint-Georges, France
    • Centre Hopsitalier Lucie et Raymond Aubrac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Heart decompensation requiring hospitalization and the use of intravenous diuretic therapy
• Left Ventricular Ejection Fraction ≤ 40%.

Exclusion Criteria:

• Hospitalization for cardiac decompensation leading to an invasive procedure (valve, coronary, etc.).
• Acute reversible cause of heart failure.
• Incurable disease (other than heart failure) or estimated life expectancy of less than one year.
• Patient transferred directly to another department or cardiac rehabilitation center.
• Significant cognitive impairment.
• Patient without cell phone or email.
• Linguistic or psychic refusal or inability to sign the informed consent.
• Current participation in a clinical tria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: multi-intervention; Automatic creation of discharge prescription (personalized checklist of possible therapeutic optimizations generated from clinical data entered into the platform. This checklist will comply with the recommendations on altered left ventricular ejection fraction from European Society of Cardiology 2016.; Automatic creation of documents for patient:Reminder letter to make an appointment with his general practitioner (at 7 days) and cardiologist (1 month) and to report the prescribed blood test.Drug prescription.Prescription for blood tests (5 days and 25 days before seeing the general practitioner and cardiologist).Therapeutic education documents; Patients will receive numerous messages (SMS / e-mail) in order to 1 / not forget their medical appointments, 2 / not to forget to make and bring back their blood test for the consultation, 3 / to perfect the therapeutic education advice provided previously	Other: Multiple intervention program; Support for patient follow-up assisted by a computer program
No Intervention: Control; Discharge prescription according to the investigator's habits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with a re-hospitalization due to heart decompensation	Defined as occurence of the need for hospitalization for cardiac decompensation justifying the use of intravenous diuretic therapy.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with a re-hospitalization due to heart decompensation	Defined as occurence of the need for hospitalization for cardiac decompensation justifying the use of intravenous diuretic therapy.	12 months
Number of re-hospitalization due to heart decompensation per patient	Defined as total number of hospitalization for heart decompensation during 1 year	12 months
Delay between discharge and re-hospitalization due to heart decompensation	Defined as time to first occurrence of re-hospitalization due to heart decompensation	12 months
Number of participants with death		3 months
Number of participants with death		12 months
Rate of pacemaker implantation		12 months

Collaborators and Investigators

• Sponsor: French Cardiology Society
• Collaborators: Bayer
• Investigators: Principal Investigator: Arnaud GALAT, MD, CHU Henri Mondor, Créteil

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Actual): September 20, 2024
• Study Completion (Actual): September 20, 2024

Study Registration Dates

• First Submitted: January 7, 2021
• First Submitted That Met QC Criteria: January 8, 2021
• First Posted (Actual): January 11, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2024
• Last Update Submitted That Met QC Criteria: October 3, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: heart failure; multiple intervention program
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2016-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No