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 (TEAM-IC)
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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Besançon、フランス
- MSP " Sant'Innovation " de Palente
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- Subject in the exclusion period of another study or listed in the "national register of volunteers" ("fichier national des volontaires");
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Intervention Arm - TEAM-IC
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. |
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. |
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介入なし：Control Arm - PRADO
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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Organizational feasibility: proportion of study procedures completed as planned
時間枠：From discharge to 3 months after discharge
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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. |
From discharge to 3 months after discharge
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Acceptability: inclusion rate among eligible patients
時間枠：At eligibility assessment, during the index hospitalization for heart failure
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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. |
At eligibility assessment, during the index hospitalization for heart failure
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Protocol adherence: completeness of collected data
時間枠：From inclusion to 3 months after discharge
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Percentage of expected data items actually collected, among all data items planned by the protocol. Results will be reported descriptively. |
From inclusion to 3 months after discharge
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Protocol adherence: attrition rate
時間枠：From inclusion to 3 months after discharge
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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. |
From inclusion to 3 months after discharge
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Adherence to the projected study timeline: actual versus planned enrollment
時間枠：At enrollment, during the index hospitalization for heart failure
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Number of participants actually enrolled, expressed as a percentage of the number planned at the corresponding milestone of the study timeline. Results will be reported descriptively. |
At enrollment, during the index hospitalization for heart failure
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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