Heart failure is a common heart condition that often leads to hospital stays and repeat readmissions. When patients leave the hospital, coordinating patient care between the hospital and the 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: The investigators 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.
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;
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;
Parallel
Intervention Arm - TEAM-IC
Other interventionA 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.
Organizational feasibility: proportion of study procedures completed as planned
Percentage of scheduled study procedures (appointments and data collection visits) carried out as planned in the TEAM-IC care pathway, among all scheduled procedures. As this is a pilot feasibility study, no statistical hypothesis testing is planned; results will be reported descriptively to inform the design of a future full-scale trial.
Acceptability: inclusion rate among eligible patients
Percentage of eligible patients who are included in the study (number of included participants divided by number of eligible patients). The numbers of potentially eligible, eligible, not contacted, refusing, and included patients will be reported in the participant flow chart. Results will be reported descriptively.
Protocol adherence: completeness of collected data
Percentage of expected data items actually collected, among all data items planned by the protocol. Results will be reported descriptively.
Protocol adherence: attrition rate
Percentage of included participants who leave the study before the end of follow-up, whether through consent withdrawal, non-adherence to the program, or loss to follow-up. Results will be reported descriptively.
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Sant'Innovation
Lead sponsor
Direction Générale de l'Offre de Soin (DGOS)
Collaborator
FeMaSCo-BFC
Collaborator
Agence Régionale de Santé - Bourgogne Franche Comté
Collaborator
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