Evaluation of a Therapeutic Patient Education Program for Discharge (ETPsh) by Nurses in a French Hospital Setting Among Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 412
- 试验地点
- 3
- 主要终点
- Unplanned all-cause rehospitalizations, including emergency department visits.
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Unplanned all-cause rehospitalizations, including emergency department visits.
时间窗: At 30 days after hospital discharge
Rehospitalization is defined as "an unplanned hospital stay of at least one overnight stay"
次要结局
- 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)
- Unplanned rehospitalizations, including emergency department visits, for heart failure.(At 30 days after hospital discharge)
- Patient death(At 30 days after hospital discharge)
- Patient satisfaction of the hospital discharge organization(At 30 days after hospital discharge)
- Scheduled rehospitalizations that were not completed.(At 30 days after hospital discharge)
- Daily adherence to cardiovascular medication(At baseline)
- Daily adherence to cardiovascular medication(At 30 days after hospital discharge)
- Number of warning signs and self-care behaviors cited by the patient.(At 30 days after hospital discharge)
- Heart failure self-care behaviors(At baseline)
- Heart failure self-care behaviors(At 30 days after hospital discharge)
- Completeness rate of remote monitoring data transmission for patients enrolled in telemonitoring(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(At baseline)
- Self-perceived patient competence in disease management(At 30 days after hospital discharge)
- Self-perceived patient competence in contacting and alerting the care team when experiencing difficulties in their care pathway(At baseline)
- Self-perceived patient competence in contacting and alerting the care team when experiencing difficulties in their care pathway(At 30 days after hospital discharge)
- Anxiety and depression of patients(At baseline)
- Anxiety and depression of patients(At 30 days after hospital discharge)
- Informal caregiver burden(At baseline)
- Informal caregiver burden(At 30 days after hospital discharge)
- Cost-effectiveness and budget impact medico-economic analysis of discharge education.(At 30 days after hospital discharge)