Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)

Official title

Evaluation of a Therapeutic Patient Education Program for Discharge (ETPsh) by Nurses in a French Hospital Setting Among Patients With Heart Failure

Overview

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.

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.

Interventions

• Behavioral Nurse-led discharge education
  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

Primary outcome measures

• Unplanned all-cause rehospitalizations, including emergency department visits. [Time frame: At 30 days after hospital discharge]

Secondary outcome measures (12)

• Unplanned rehospitalizations, including emergency department visits, for heart failure. [Time frame: At 30 days after hospital discharge]
• Patient death [Time frame: At 30 days after hospital discharge]
• Patient satisfaction of the hospital discharge organization [Time frame: At 30 days after hospital discharge]
• Scheduled rehospitalizations that were not completed. [Time frame: At 30 days after hospital discharge]
• Number of consultations with the patient's primary care physician. [Time frame: At 30 days after hospital discharge]
• Scheduling of a cardiology consultation (appointment made). [Time frame: At 30 days after hospital discharge]
• Daily adherence to cardiovascular medication [Time frame: At baseline]
• Daily adherence to cardiovascular medication [Time frame: At 30 days after hospital discharge]
• Number of warning signs and self-care behaviors cited by the patient. [Time frame: At 30 days after hospital discharge]
• Heart failure self-care behaviors [Time frame: At baseline]
• Heart failure self-care behaviors [Time frame: At 30 days after hospital discharge]
• Completeness rate of remote monitoring data transmission for patients enrolled in telemonitoring [Time frame: At 30 days after hospital discharge]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 3 centers

• CHU Clermont-Ferrand — Clermont-Ferrand
• CHU Poitiers — Poitiers
• CH Vichy — Vichy

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 Gro 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 A PMID 35994805

Identifiers

NCT: NCT07706543 · PHRIP 2024 CHERILLAT · 2025-A02457-42

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗