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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A02457-42 | Other Identifier | ANSM |
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Heart failure affects 2.3% of the adult French population. Readmission within 30 days doubles the risk of early death within the following 30 to 60 days, as well as the risk of rehospitalization over the subsequent two years. Incorporating nurse-led discharge education can significantly reduce readmissions for heart failure as well as all-cause readmissions. Drawing on practices from English-speaking countries and Switzerland regarding patient discharge education at hospital, we propose to evaluate a discharge education program in the French hospital setting for patients with heart failure.
The objective of this multicenter before-and-after study is to evaluate the impact of a nurse-led discharge education delivered at hospital on the quality of the care pathway for patients with heart failure, assessed 30 days after hospital discharge. The primary outcome is the reduction in 30-day unplanned all-cause hospital readmissions, including emergency department visits. An informal (non-professional) caregiver may also be enrolled in the study if identified by the patient and present during the hospitalization.
Patients enrolled before implementation of the discharge education will constitute the control group (standard therapeutic patient education group). They will receive usual hospital care, including educational sessions throughout hospitalization covering the disease, treatments, and self-care, as well as a follow-up consultation with a nurse 30 days after hospital discharge. This usual care is referred to as standard therapeutic patient education and does not include a structured therapeutic patient education intervention at hospital discharge.
Patients receiving the discharge education will constitute the intervention group (standard therapeutic patient education with discharge education group). They will receive the same usual care (i.e., standard therapeutic patient education and the 30-day post-discharge nurse follow-up consultation), supplemented by the nurse-led discharge education intervention during their hospitalization.
To minimize the risk of contamination (diffusion bias), the control group will be enrolled and complete follow-up before nurses receive training in the discharge education intervention.
Patients and their informal caregivers will be informed about the study by the nursing staff within the first two days of hospitalization in the cardiology departments participating in the study. Their eligibility will then be assessed, and eligible patients and caregivers will be invited to participate. A participant information sheet describing the study will be provided and explained to both the patient and the informal caregiver.
Patients and their informal caregivers will be given a 24-hour reflection period. After this period, they will have the opportunity to discuss any remaining questions with the investigator nurse, who will provide any necessary clarification. Patients and informal caregivers who agree to participate will then sign the informed consent form and be enrolled in the study. The investigator will also sign the informed consent form.
All participants in the control group will be enrolled simultaneously across the three participating study centers. The same enrollment procedure will be followed for the intervention group.
Patients in the intervention group will receive an initial educational assessment on the day following enrollment, a participatory therapeutic education session using the teach-back method within the 24 hours preceding hospital discharge, a follow-up telephone call from a nurse 7 days after discharge, and a final educational assessment at the routine 30-day post-discharge follow-up visit. Whenever possible, the patient's informal caregiver will be asked to accompany the patient to this follow-up consultation.
A participant may be prematurely withdrawn from the study for any of the following reasons:
Patients and their informal caregivers may participate in another clinical study provided that, in the opinion of the investigator, such participation does not interfere with the conduct or objectives of the present study. Participants must therefore inform the investigator of any concurrent participation in another study, and the investigator will determine whether simultaneous participation is appropriate.
The study may be temporarily suspended or permanently terminated for any of the following reasons:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard therapeutic patient education group | No Intervention | Participants in the control group will receive usual care in the cardiology department. The multidisciplinary usual care involves both medical professionals (including cardiologists and pharmacists) and allied health professionals (including advanced practice nurses, registered nurses, dietitians, and physical activity specialists). Usual care is integrated into the heart failure care pathway, ensuring continuity between community-based and hospital care, hospitalization, and ongoing management at home. During hospitalization, participants will receive standard therapeutic patient education as well as a routine nurse-led follow-up consultation 30 days after hospital discharge. Patients will also receive the standard discharge documents, together with the usual information and advice provided at discharge. | |
| Discharge education group | Experimental | Participants will receive usual care (as described for the control group), supplemented by a structured discharge education intervention delivered by research nurses trained in therapeutic patient education. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nurse-led discharge education | Behavioral | The intervention includes :
|
| Measure | Description | Time Frame |
|---|---|---|
| Unplanned all-cause rehospitalizations, including emergency department visits. | Rehospitalization is defined as "an unplanned hospital stay of at least one overnight stay" | At 30 days after hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Unplanned rehospitalizations, including emergency department visits, for heart failure. | Rehospitalizations are assessed using the European Society of Cardiology definition of hospitalization for heart failure. Those that meet the criteria of this definition are classified as heart failure-related readmissions. | At 30 days after hospital discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise Laclautre | Contact | 0473754963 | promo_interne_drci@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Marie Sophie CHERILLAT | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34447992 | Background | McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available. | |
| 21273905 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Patients enrolled before implementation of the discharge education will constitute the control group (standard therapeutic patient education group). They will receive usual hospital care, including educational sessions throughout hospitalization covering the disease, treatments, and self-care, as well as a follow-up consultation with a nurse 30 days after hospital discharge. This usual care is referred to as standard therapeutic patient education and does not include a structured therapeutic patient education intervention at hospital discharge.
Participants in the control and intervention groups will be enrolled during two separate study periods, with training of the research nurses in discharge discharge taking place between the two enrollment periods.
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| Patient death | At 30 days after hospital discharge |
| Patient satisfaction of the hospital discharge organization | Score on the "Hospital Discharge Organization" dimension of the French National Authority for Health "e-Satis+48h MCO" questionnaire, a national patient satisfaction and experience self-administrated questionnaire for hospitalized patients | At 30 days after hospital discharge |
| Scheduled rehospitalizations that were not completed. | At 30 days after hospital discharge |
| Number of consultations with the patient's primary care physician. | At 30 days after hospital discharge |
| Scheduling of a cardiology consultation (appointment made). | At 30 days after hospital discharge |
| Daily adherence to cardiovascular medication | Measurement of cardiovascular medication adherence using the self-administered MASCARD questionnaire | At baseline |
| Daily adherence to cardiovascular medication | Measurement of cardiovascular medication adherence using the self-administered MASCARD questionnaire | At 30 days after hospital discharge |
| Number of warning signs and self-care behaviors cited by the patient. | Warning signs : Shortness of breath - Rapid weight gain - Lower limb edema - Fatigue Sel-care behaviors: Physical activity - Weighing oneself - Medication adherence - Avoiding added salt | At 30 days after hospital discharge |
| Heart failure self-care behaviors | Assessed using the European Heart Failure Self-Care Behaviour Scale-9 (EHFScB-9) self-administered questionnaire | At baseline |
| Heart failure self-care behaviors | Assessed using the European Heart Failure Self-Care Behaviour Scale-9 (EHFScB-9) self-administered questionnaire | At 30 days after hospital discharge |
| Completeness rate of remote monitoring data transmission for patients enrolled in telemonitoring | Weight, blood pressure, oxygen saturation | At 30 days after hospital discharge |
| Number of alerts and number of medically managed alerts, generated through remote monitoring for patients enrolled in telemonitoring | At 30 days after hospital discharge |
| Self-perceived patient competence in disease management | Assessed using a 0-5 "skills star" scale (management of medications, management of follow-up appointments, recognition of warning signs, and implementation of self-care behaviors). | At baseline |
| Self-perceived patient competence in disease management | Assessed using a 0-5 "skills star" scale (management of medications, management of follow-up appointments, recognition of warning signs, and implementation of self-care behaviors). | At 30 days after hospital discharge |
| Self-perceived patient competence in contacting and alerting the care team when experiencing difficulties in their care pathway | Assessed using a 0-5 "skills star" scale (communication with healthcare professionals). | At baseline |
| Self-perceived patient competence in contacting and alerting the care team when experiencing difficulties in their care pathway | Assessed using a 0-5 "skills star" scale (communication with healthcare professionals). | At 30 days after hospital discharge |
| Anxiety and depression of patients | Assessed using the self-administrated Hospital Anxiety and Depression Scale (HADS). | At baseline |
| Anxiety and depression of patients | Assessed using the self-administrated Hospital Anxiety and Depression Scale (HADS). | At 30 days after hospital discharge |
| Informal caregiver burden | Assessed using the Mini-Zarit self-administered questionnaire. | At baseline |
| Informal caregiver burden | Assessed using the Mini-Zarit self-administered questionnaire. | At 30 days after hospital discharge |
| Cost-effectiveness and budget impact medico-economic analysis of discharge education. | Incremental cost-effectiveness ratio of discharge education and the bundled payment amount compatible with the financial sustainability of discharge education. | At 30 days after hospital discharge |
| CHU Poitiers | Poitiers | France |
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| CH Vichy | Vichy | France |
|
| Background |
| Manning S. Bridging the gap between hospital and home: a new model of care for reducing readmission rates in chronic heart failure. J Cardiovasc Nurs. 2011 Sep-Oct;26(5):368-76. doi: 10.1097/JCN.0b013e318202b15c. |
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