Research on Healthcare Performance (RESHAPE), Université Claude Bernard Lyon 1, INSERM U1290, Lyon, France.
Service Recherche et Epidémiologie Cliniques, Hospices Civils de Lyon, Pôle de Sante Publique, Lyon, France.
BMC Health Serv Res. 2022 Apr 22;22(1):537. doi: 10.1186/s12913-022-07907-5.
Stroke affects many aspects of life in stroke survivors and their family, and returning home after hospital discharge is a key step for the patient and his or her relatives. Patients and caregivers report a significant need for advice and information during this transition period. Our hypothesis is that, through a comprehensive, individualised and flexible support for patients and their caregivers, a patient-centred post-stroke hospital/home transition programme, combining an Internet information platform and telephone follow-up by a case manager, could improve patients' level of participation and quality of life.
An open parallel-group randomized trial will be conducted in two centres in France. We will recruit 170 adult patients who have had a first confirmed stroke, and were directly discharged home from the stroke unit with a modified Rankin score ≤3. Intervention content will be defined using a user-centred approach involving patients, caregivers, health-care professionals and social workers. Patients randomized to the intervention group will receive telephonic support by a trained case manager and access to an interactive Internet information platform during the 12 months following their return home. Patients randomized to the control group will receive usual care. The primary outcome is patient participation, measured by the "participation" dimension score of the Stroke Impact Scale 6 months after discharge. Secondary outcomes will include, for patients, quality of life, activation, care consumption, as well as physical, mental and social outcomes; and for caregivers, quality of life and burden. Patients will be contacted within one week after discharge, at 6 and 12 months for the outcomes collection. A process evaluation alongside the study is planned.
Our patient-centred programme will empower patients and their carers, through individualised and progressive follow-up, to find their way around the range of available healthcare and social services, to better understand them and to use them more effectively. The action of a centralised case manager by telephone and the online platform will make it possible to disseminate this intervention to a large number of patients, over a wide area and even in cases of geographical isolation.
ClinicalTrials NCT03956160 , Posted: May-2019 and Update: September-2021.
中风会影响中风幸存者及其家属生活的诸多方面，而从医院出院后返回家中是患者及其亲属的关键一步。患者和护理人员在这一过渡期间报告有很大的需求，需要获得建议和信息。我们的假设是，通过为患者及其护理人员提供全面、个性化和灵活的支持，实施以患者为中心的中风后医院/家庭过渡方案，结合互联网信息平台和案例经理的电话随访，可以提高患者的参与度和生活质量。
该研究将在法国的两个中心开展一项开放性平行分组随机试验。我们将招募 170 名成年患者，这些患者首次确诊为中风，且在改良 Rankin 评分为≤3 分的情况下直接从中风病房出院回家。通过包括患者、护理人员、医疗保健专业人员和社会工作者在内的用户参与方法来确定干预内容。随机分配到干预组的患者将在出院后 12 个月内接受经过培训的案例经理的电话支持，并可访问交互式互联网信息平台。随机分配到对照组的患者将接受常规护理。主要结局是患者的参与度，通过中风影响量表的“参与”维度评分在出院后 6 个月进行评估。次要结局将包括患者的生活质量、激活、护理消耗以及身体、心理和社会结局，以及护理人员的生活质量和负担。患者将在出院后一周内、6 个月和 12 个月进行结果收集时进行联系。计划在研究的同时进行过程评估。
我们以患者为中心的方案将通过个性化和渐进式的随访，使患者及其护理人员能够了解各种医疗保健和社会服务的情况，更好地理解这些服务，并更有效地利用这些服务。通过电话和在线平台进行集中式案例经理的行动，将使该干预措施能够在很大范围内、甚至在地理隔离的情况下，广泛地传播给大量患者。
ClinicalTrials.gov 注册号：NCT03956160，[首次注册日期]：2019 年 5 月，[最新修订日期]：2021 年 9 月。
