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

10 de julho de 2026 atualizado por: University Hospital, Clermont-Ferrand

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

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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

412

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • França
      • Clermont-Ferrand, França
        • CHU clermont-ferrand
        • Contato:
        • Investigador principal:
          • Sarah LAROCHE
      • Poitiers, França
      • Vichy, França
        • CH VICHY
        • Contato:
        • Investigador principal:
          • Claude LAGRANGE

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: Standard therapeutic patient education group

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.
Experimental: Discharge education group
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.
Comportamental: 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 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Unplanned all-cause rehospitalizations, including emergency department visits.
Prazo: At 30 days after hospital discharge
Rehospitalization is defined as "an unplanned hospital stay of at least one overnight stay"
At 30 days after hospital discharge

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Unplanned rehospitalizations, including emergency department visits, for heart failure.
Prazo: 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.
At 30 days after hospital discharge
Patient death
Prazo: At 30 days after hospital discharge
At 30 days after hospital discharge
Patient satisfaction of the hospital discharge organization
Prazo: At 30 days after hospital discharge
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.
Prazo: At 30 days after hospital discharge
At 30 days after hospital discharge
Number of consultations with the patient's primary care physician.
Prazo: At 30 days after hospital discharge
At 30 days after hospital discharge
Scheduling of a cardiology consultation (appointment made).
Prazo: At 30 days after hospital discharge
At 30 days after hospital discharge
Daily adherence to cardiovascular medication
Prazo: At baseline
Measurement of cardiovascular medication adherence using the self-administered MASCARD questionnaire
At baseline
Daily adherence to cardiovascular medication
Prazo: At 30 days after hospital discharge
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.
Prazo: 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
At 30 days after hospital discharge
Heart failure self-care behaviors
Prazo: At baseline
Assessed using the European Heart Failure Self-Care Behaviour Scale-9 (EHFScB-9) self-administered questionnaire
At baseline
Heart failure self-care behaviors
Prazo: At 30 days after hospital discharge
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
Prazo: At 30 days after hospital discharge
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
Prazo: At 30 days after hospital discharge
At 30 days after hospital discharge
Self-perceived patient competence in disease management
Prazo: 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).
At baseline
Self-perceived patient competence in disease management
Prazo: 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).
At 30 days after hospital discharge
Self-perceived patient competence in contacting and alerting the care team when experiencing difficulties in their care pathway
Prazo: At baseline
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
Prazo: At 30 days after hospital discharge
Assessed using a 0-5 "skills star" scale (communication with healthcare professionals).
At 30 days after hospital discharge
Anxiety and depression of patients
Prazo: At baseline
Assessed using the self-administrated Hospital Anxiety and Depression Scale (HADS).
At baseline
Anxiety and depression of patients
Prazo: At 30 days after hospital discharge
Assessed using the self-administrated Hospital Anxiety and Depression Scale (HADS).
At 30 days after hospital discharge
Informal caregiver burden
Prazo: At baseline
Assessed using the Mini-Zarit self-administered questionnaire.
At baseline
Informal caregiver burden
Prazo: At 30 days after hospital discharge
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.
Prazo: At 30 days after hospital discharge
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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University Hospital, Clermont-Ferrand

Investigadores

  • Investigador principal: Marie Sophie CHERILLAT, University Hospital, Clermont-Ferrand

Publicações e links úteis

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Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

1 de abril de 2028

Conclusão do estudo (Estimado)

1 de abril de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

10 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de julho de 2026

Primeira postagem (Real)

15 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

15 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de julho de 2026

Última verificação

1 de março de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • PHRIP 2024 CHERILLAT
  • 2025-A02457-42 (Outro identificador: ANSM)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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