Feasibility Study on the Implementation of a Program to Facilitate the Return Home of Patients With Heart Failure Following Hospitalization, Led by a Coordinated Multidisciplinary Team Based on the "Team-based Care" Model

NCT07849361 | Not Yet Recruiting

• 1 other identifier: AAP_ResP-Ir_2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Heart failure is a common heart condition that often leads to hospital stays and repeat readmissions. When patients leave the hospital, coordinating their care between the hospital and their local healthcare team (family doctor, nurses, cardiologist) can be difficult, and gaps in this coordination can lead to complications or unnecessary re-hospitalizations. This study, called TEAM-IC, tests a new way of organizing the return home after a hospital stay for heart failure. In this new approach, a dedicated "care coordination nurse" based in a local primary care health center works closely with the patient's usual caregivers and with the hospital team to support the patient during the first three months after discharge. This is compared to the existing standard program (PRADO-IC) currently used in France. Hypothesis: We believe that organizing the return home around a coordinating nurse embedded in a local health center, with support tailored to each patient's level of frailty, will lead to better follow-up and better care for heart failure patients than the current standard program. Before testing whether this approach actually improves health outcomes in a larger trial, this study first aims to find out whether such a program is realistic and workable in practice, for example, whether patients and healthcare professionals are willing to take part, whether the organization runs smoothly, and whether the study procedures can be followed as planned.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Overall feasibility of the TEAM-IC care pathway

  Overall feasibility of the TEAM-IC care pathway, assessed across four dimensions: 1. organizational feasibility : successful implementation of study circuits (appointment scheduling, data collection) and distribution of subjects across the flow chart; 2. acceptability : distribution of subjects across categories of potentially eligible, eligible, not contacted, refused, and included in the study; 3. protocol adherence : completeness of collected data and attrition rate (consent withdrawal, non-adherence to the program, lost to follow-up); 4. adherence to the projected study timeline : comparison of actual versus planned enrollment and study milestones. As this is a pilot feasibility study, no statistical hypothesis testing is planned for this outcome; results will be described descriptively to inform the design of a future full-scale trial.

  3 months

Study Arms (2)

Intervention Arm - TEAM-IC

EXPERIMENTAL

Patients randomized to this arm receive the TEAM-IC pathway following hospitalization for heart failure. Before discharge, a care-pathway support nurse (IAP), based in a resource primary care health center (MSP), assesses frailty (SEGA-A scale), non-adherence risk (SPUR), and quality of life (KCCQ-12), then stratifies the patient into one of three follow-up intensity levels. The patient is registered on a regional care-coordination platform (eTICSS) and offered telemonitoring of weight, blood pressure, and heart failure warning signs. The patient's GP and community nurse are informed, receive personalized recommendations and access to online training modules, and are supported by the IAP for 3 months post-discharge, including help with administrative/social care referrals and a cardiology advanced-practice nurse consultation at 1 month. The GP's role as primary caregiver is not modified; the IAP provides additional coordination support alongside standard care.

Other: Intervention Arm - TEAM-IC

Control Arm - PRADO

NO INTERVENTION

Patients randomized to this arm receive the standard PRADO-IC discharge program managed by the French national health insurance (CPAM), with no TEAM-IC coordination support. Before discharge, the IAP still assesses frailty (SEGA-A), non-adherence risk (SPUR), and quality of life (KCCQ-12), but these results do not trigger any specific follow-up actions in this arm. The patient is offered standard telemonitoring and/or advanced-practice nurse (IPA) follow-up as usually available. Home nursing visits and clinical monitoring follow the usual PRADO-IC protocol for 3 months. At month 3, the study team collects outcome data for comparison with the intervention arm: rehospitalization, non-hospitalized decompensation episodes (EPOF signs), NYHA class, BNP level, mortality, guideline-recommended drug prescriptions, KCCQ score, healthcare utilization, and satisfaction questionnaires from the patient, GP, and community nurse

Interventions

Intervention Arm - TEAM-IC OTHER

A 3-month post-discharge care pathway for heart failure patients, coordinated by a dedicated care-pathway support nurse (IAP) based in a resource primary care health center (MSP), working alongside the patient's own GP and community nurse. Before discharge, the IAP assesses frailty (SEGA-A scale) and non-adherence risk (SPUR), then stratifies patients into 3 follow-up intensity levels. The IAP registers patients on a regional hospital-community coordination platform (eTICSS), offers telemonitoring of weight, blood pressure and heart failure warning signs, and liaises with the hospital's advanced-practice nurse in cardiology. The GP and community nurse receive personalized recommendations, online training modules, and support for administrative and social care referrals. Unlike the PRADO-IC control arm, the intervention adds an upstream frailty/adherence assessment and a primary-care-based coordinating nurse linked directly to the hospital team.

Intervention Arm - TEAM-IC

Eligibility Criteria

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

You may qualify if:

• Male or female, age \> 18 years with no upper age limit;
• Hospitalized for heart failure;
• Discharge home anticipated within 7 days of enrollment;
• Signed and dated informed consent;
• Resident within the GHT Centre Franche-Comté and within a maximum of one hour by road from one of the two enrolling centers.

You may not qualify if:

• Needfor a heart transplant or ventricular assist device;
• Any severe valvular heart disease that could benefit from surgical intervention during the course of the study;
• Patients with a life expectancy of less than 3 months;
• A person subject to a legal protection measure, involuntary psychiatric care, unable to give consent, to follow instructions, or to comply with follow-up procedures;
• Any other medical condition that would put the patient at risk or could influence the study results
• Not affiliated with or not a beneficiary of a French social security scheme;
• Patient currently enrolled in an ongoing interventional clinical research study on heart failure management (risk of interference);
• Patient already benefiting from a home discharge program other than the PRADO program.

Sponsors & Collaborators

• Sant'Innovation: lead
• FeMaSCo-BFC: collaborator
• Direction Générale de l'Offre de Soin (DGOS): collaborator
• Agence Régionale de Santé - Bourgogne Franche Comté: collaborator

Study Sites (1)

MSP " Sant'Innovation " de Palente

Besançon, France

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start (Estimated): October 4, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)