Evaluation of a Therapeutic Patient Education Program for Discharge (ETPsh) by Nurses in a French Hospital Setting Among Patients With Heart Failure
| Registry | NCT07706543, acronym EDUSOR |
|---|
| Status | Not yet recruiting |
|---|
| Phase | Not applicable |
|---|
| Study type | Interventional; non randomized, parallel, masking: none, supportive care |
|---|
| Enrollment | 412 (Estimated) |
|---|
| Sponsor | University Hospital, Clermont-Ferrand (Other) |
|---|
| Conditions | Heart Failure |
|---|
| Interventions | Nurse-led discharge education (Behavioral) |
|---|
| Dates | start 2026-11-01 (estimated), primary completion 2028-04-01 (estimated), completion 2028-04-01 (estimated), first posted 2026-07-15, last updated 2026-10-08 |
|---|
| Locations | 3 sites in France |
|---|
Related Papers Related Patents Related Grants Related Experts
All trials for Heart Failure All trials of Nurse-led discharge education
-Summary
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.
Expand all sections · Collapse all
+Detailed description
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:
* an intercurrent disease interfering with the normal conduct of the study protocol;
* death;
* participant's decision
* a major protocol deviation;
* loss to follow-up (a participant is considered lost to follow-up if they fail to attend a scheduled study visit and no information regarding their status can be obtained despite all reasonable efforts to contact them and determine the reason for study discontinuation. The reason "lost to follow-up" will only be assigned after these efforts have been unsuccessful).
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:
* insufficient or no participant recruitment;
* inability to secure funding for the study;
* any directive issued by the competent regulatory authorities requiring the temporary suspension or permanent termination of the study;
* a decision by the sponsor and the coordinating investigator.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| 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 | Behavioral: Nurse-led discharge education | 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. |
- Nurse-led discharge education (Behavioral): The intervention includes :
1. An initial educational assessment (≈1 h) on the day after enrollment to identify individualized learning needs for discharge and assess key self-management and safety competencies ;
2. An interactive discharge education session (≈1 h) within 24 hours before discharge, using the teach-back method to reinforce warning signs, medication, self-care, follow-up, and healthcare contacts ;
3. A nurse-led follow-up telephone call 7 (±3) days after discharge (15-30 min) to assess competencies and reinforce learning if needed ;
4. A final educational assessment (≈1 h) during the routine 30-day (±7 days) follow-up consultation. Informal caregivers will be invited to participate whenever possible.
+Outcome measures
Primary outcomes
- Unplanned all-cause rehospitalizations, including emergency department visits. [At 30 days after hospital discharge]: Rehospitalization is defined as "an unplanned hospital stay of at least one overnight stay"
Secondary outcomes
- Unplanned rehospitalizations, including emergency department visits, for heart failure. [At 30 days after hospital discharge]: 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.
- Patient death [At 30 days after hospital discharge]
- Patient satisfaction of the hospital discharge organization [At 30 days after hospital discharge]: Assessed using the score for the "Discharge Organization" subscale of the French National Authority for Health (HAS) "e-Satis+48h MCO" self-administered questionnaire, which evaluates the experience of patients hospitalized for more than 48 hours in medicine, surgery, or obstetrics.
The "Discharge Organization" subscale consists of 10 items, from which a score ranging from 0 to 100 is calculated, with 0 indicating the poorest experience and 100 indicating the best possible experience.
- Number of scheduled readmissions not carried out. [At 30 days after hospital discharge]
- Number of consultations with the patient's primary care physician. [At 30 days after hospital discharge]
- Number of scheduled consultations with a cardiologist (including appointments made) [At 30 days after hospital discharge]
- Daily adherence to cardiovascular medication [At baseline]: Assessed using the score from the MASCARD self-administered questionnaire. This questionnaire consists of 5 items, from which a score ranging from 0 to 5 is calculated, with 0 indicating major difficulties with medication adherence and 5 indicating few or no difficulties with medication adherence.
- Daily adherence to cardiovascular medication [At 30 days after hospital discharge]: Assessed using the score from the MASCARD self-administered questionnaire. This questionnaire consists of 5 items, from which a score ranging from 0 to 5 is calculated, with 0 indicating major difficulties with medication adherence and 5 indicating few or no difficulties with medication adherence.
- Number of warning signs and self-care behaviors cited by the patient. [At 30 days after hospital discharge]: Warning signs : Shortness of breath - Rapid weight gain - Lower limb edema - Fatigue Sel-care behaviors: Physical activity - Weighing oneself - Medication adherence - Avoiding added salt
- Heart failure self-care behaviors [At baseline]: Assessed using the score from the self-administered European Heart Failure Self-Care Behaviour Scale-9 (EHFScBS-9) questionnaire. This questionnaire consists of 9 items, from which a score ranging from 9 to 45 is calculated, with higher scores indicating poorer self-care behaviours.
- Heart failure self-care behaviors [At 30 days after hospital discharge]: Assessed using the score from the self-administered European Heart Failure Self-Care Behaviour Scale-9 (EHFScBS-9) questionnaire. This questionnaire consists of 9 items, from which a score ranging from 9 to 45 is calculated, with higher scores indicating poorer self-care behaviours.
- Completeness rate of remote monitoring data transmission for patients enrolled in telemonitoring [At 30 days after hospital discharge]: Body weight measured in kilograms (kg) Blood pressure measured in millimetres of mercury (mmHg) Oxygen saturation measured as a percentage (%)
- 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 [At baseline]: 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).
- Self-perceived patient competence in disease management [At 30 days after hospital discharge]: 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).
- Self-perceived patient competence in contacting and alerting the care team when experiencing difficulties in their care pathway [At baseline]: Assessed using a 0-5 "skills star" scale (communication with healthcare professionals).
- Self-perceived patient competence in contacting and alerting the care team when experiencing difficulties in their care pathway [At 30 days after hospital discharge]: Assessed using a 0-5 "skills star" scale (communication with healthcare professionals).
- Anxiety and depression of patients [At baseline]: Assessed using scores from the Hospital Anxiety and Depression Scale (HADS) self-administered questionnaire, which consists of 14 items divided into 7-item "HADS Anxiety" and "HADS Depression" subscales. The total score for each subscale ranges from 0 to 21, with higher scores indicating a higher frequency of anxiety or depression symptoms.
- Anxiety and depression of patients [At 30 days after hospital discharge]: Assessed using scores from the Hospital Anxiety and Depression Scale (HADS) self-administered questionnaire, which consists of 14 items divided into 7-item "HADS Anxiety" and "HADS Depression" subscales. The total score for each subscale ranges from 0 to 21, with higher scores indicating a higher frequency of anxiety or depression symptoms.
- Informal caregiver burden [At baseline]: Assessed using the score from the Mini-Zarit Burden Interview. This self-administered questionnaire consists of 7 items, yielding a score ranging from 0 to 7, with 0 indicating absent or mild caregiver burden and 7 indicating severe caregiver burden.
- Informal caregiver burden [At 30 days after hospital discharge]: Assessed using the score from the Mini-Zarit Burden Interview. This self-administered questionnaire consists of 7 items, yielding a score ranging from 0 to 7, with 0 indicating absent or mild caregiver burden and 7 indicating severe caregiver burden.
- Cost of training nurses in discharge education [At 30 days after hospital discharge]: Cost of training nurses in discharge education (euros) to allow the economic analysis
- Cost of delivering the discharge education (euros) to allow the economic analysis [At 30 days after hospital discharge]: Cost of delivering the discharge education, calculated as the duration of the discharge education multiplied by the fully loaded hourly cost of a nurse's salary.
- Cost of the telephone follow-up call(s) 7 days after hospital discharge (euros) [At 30 days after hospital discharge]: Cost of the telephone follow-up call(s) 7 days after hospital discharge, calculated as the duration of the discharge education multiplied by the nurse's fully loaded hourly salary cost.
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
* Patient aged 18 years old or more,
* Fluent in spoken and written French,
* Willing to participate in the study,
* Hospitalized for heart failure in one of the participating centers for at least 2 days,
* Affiliated with a French social security scheme
* Discharged either to home or transferred to a Medical and Rehabilitation Care unit.
Exclusion Criteria:
* Hospitalized for a reason other than heart failure,
* Previously included in the study during a prior hospitalization,
* Presenting with identified cognitive impairment,
* In a situation deemed inappropriate by the care team (end of life),
* Living in an institutional setting,
* Pregnant women,
* Breastfeeding women,
* Under legal protective measures,
* Enrolled in another interventional research study that may interfere with the results of the present study, according to the investigator's judgment.
+Locations (3)
| Facility | City | Country | Status |
|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | France | |
| CHU Poitiers | Poitiers | France | |
| CH Vichy | Vichy | France | |
+Publications
- 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. PMID 34447992
- 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. PMID 21273905
- Paul S. Hospital discharge education for patients with heart failure: what really works and what is the evidence? Crit Care Nurse. 2008 Apr;28(2):66-82. No abstract available. PMID 18378729
- Hill CA. Acute heart failure: too sick for discharge teaching? Crit Care Nurs Q. 2009 Apr-Jun;32(2):106-11. doi: 10.1097/CNQ.0b013e3181a27ccd. PMID 19300074
- Albano MG, Gagnayre R, de Andrade V, d'Ivernois JF. L'education precedant la sortie de l'hopital : nouvelle forme d'education therapeutique. Criteres de qualite et perspectives d'application a notre contexte. Rech Soins Infirm. 2020;141(2):70-77. doi: 10.3917/rsi.141.0070. French. PMID 35724034
- Koelling TM, Johnson ML, Cody RJ, Aaronson KD. Discharge education improves clinical outcomes in patients with chronic heart failure. Circulation. 2005 Jan 18;111(2):179-85. doi: 10.1161/01.CIR.0000151811.53450.B8. Epub 2005 Jan 10. PMID 15642765
- Oh EG, Lee HJ, Yang YL, Lee S, Kim YM. Development of a discharge education program using the teach-back method for heart failure patients. BMC Nurs. 2021 Jun 24;20(1):109. doi: 10.1186/s12912-021-00622-2. PMID 34167537
- Baldewijns K, Boyne J, Rohde C, de Maesschalck L, Deville A, Brandenburg V, De Bleser L, Derickx M, Bektas S, Brunner-La Rocca HP. What kind of patient education and self-care support do patients with heart failure receive, and by whom? Implementation of the ESC guidelines for heart failure in three European regions. Heart Lung. 2023 Jan-Feb;57:25-30. doi: 10.1016/j.hrtlng.2022.07.013. Epub 2022 Aug 19. PMID 35994805
- Mattina K, Dabney BW, Linton M. The Impact of Nurse Education on Heart Failure Readmissions and Patient Education. J Dr Nurs Pract. 2021 Jan 19:JDNP-D-19-00076. doi: 10.1891/JDNP-D-19-00076. Online ahead of print. PMID 33468611
- Lambrinou E, Kalogirou F, Lamnisos D, Sourtzi P. Effectiveness of heart failure management programmes with nurse-led discharge planning in reducing re-admissions: a systematic review and meta-analysis. Int J Nurs Stud. 2012 May;49(5):610-24. doi: 10.1016/j.ijnurstu.2011.11.002. Epub 2011 Dec 22. PMID 22196054
- Boisvert S, Francoeur J, Gallani MC. Cross-Cultural Adaptation and Reliability of the French-Canadian Version of the European Heart Failure Self-Care Behaviour Scale-9. J Nurs Meas. 2019 Dec 1;27(3):458-477. doi: 10.1891/1061-3749.27.3.458. PMID 31871285
- Martin-Latry K, Latry P, Pucheu Y, Couffinhal T. [Hospital medication adherence scale development in cardiovascular disorders]. Ann Pharm Fr. 2021 Jul;79(4):457-464. doi: 10.1016/j.pharma.2020.11.008. Epub 2020 Dec 10. French. PMID 33309605
- Pellet J, Weiss M, Zuniga F, Mabire C. Improving patient activation with a tailored nursing discharge teaching intervention for multimorbid inpatients: A quasi-experimental study. Patient Educ Couns. 2024 Jan;118:108024. doi: 10.1016/j.pec.2023.108024. Epub 2023 Oct 18. PMID 37862876
- Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3. PMID 11832252
- Higginson IJ, Gao W, Jackson D, Murray J, Harding R. Short-form Zarit Caregiver Burden Interviews were valid in advanced conditions. J Clin Epidemiol. 2010 May;63(5):535-42. doi: 10.1016/j.jclinepi.2009.06.014. PMID 19836205
- Zannad F, Garcia AA, Anker SD, Armstrong PW, Calvo G, Cleland JG, Cohn JN, Dickstein K, Domanski MJ, Ekman I, Filippatos GS, Gheorghiade M, Hernandez AF, Jaarsma T, Koglin J, Konstam M, Kupfer S, Maggioni AP, Mebazaa A, Metra M, Nowack C, Pieske B, Pina IL, Pocock SJ, Ponikowski P, Rosano G, Ruilope LM, Ruschitzka F, Severin T, Solomon S, Stein K, Stockbridge NL, Stough WG, Swedberg K, Tavazzi L, Voors AA, Wasserman SM, Woehrle H, Zalewski A, McMurray JJ. Clinical outcome endpoints in heart failure trials: a European Society of Cardiology Heart Failure Association consensus document. Eur J Heart Fail. 2013 Oct;15(10):1082-94. doi: 10.1093/eurjhf/hft095. Epub 2013 Jun 19. PMID 23787718
- Oh EG, Lee HJ, Yang YL, Kim YM. Effectiveness of Discharge Education With the Teach-Back Method on 30-Day Readmission: A Systematic Review. J Patient Saf. 2021 Jun 1;17(4):305-310. doi: 10.1097/PTS.0000000000000596. PMID 30882616
- Tuppin P, Cuerq A, de Peretti C, Fagot-Campagna A, Danchin N, Juilliere Y, Alla F, Allemand H, Bauters C, Drici MD, Hagege A, Jondeau G, Jourdain P, Leizorovicz A, Paccaud F. First hospitalization for heart failure in France in 2009: patient characteristics and 30-day follow-up. Arch Cardiovasc Dis. 2013 Nov;106(11):570-85. doi: 10.1016/j.acvd.2013.08.002. Epub 2013 Oct 18. PMID 24140417
- Mowery BD, Brand E, Gisila D, Healy K, Mannaye TA, Bhuvanesh A, Babb R, Bettencourt AP, McLaughlin MK, Russell-Babin K. Improving Discharge Education and Outcomes for Patients with Heart Failure. Am J Nurs. 2025 Mar 1;125(3):40-46. doi: 10.1097/AJN.0000000000000030. Epub 2025 Feb 20. PMID 39972586
+Investigators
- Marie Sophie CHERILLAT, Principal investigator, University Hospital, Clermont-Ferrand