多 sclerosis 中的 advance care planning 研究方案 (ConCure-SM)：干预构建和多中心可行性试验。
Study protocol on advance care planning in multiple sclerosis (ConCure-SM): intervention construction and multicentre feasibility trial.
机构信息
Bioethics Unit, Azienda USL - IRCCS di Reggio Emilia, Reggio Emilia, Italy.
Fondazione FARO, Turin, Italy.
出版信息
BMJ Open. 2021 Aug 13;11(8):e052012. doi: 10.1136/bmjopen-2021-052012.
INTRODUCTION
Multiple sclerosis (MS) is the most common cause of progressive neurological disability in young adults. The use of advance care planning (ACP) for people with progressive MS (pwPMS) remains limited. The ConCure-SM project aims to assess the effectiveness of a structured ACP intervention for pwPMS. The intervention consists of a training programme on ACP for healthcare professionals caring for pwPMS, and a booklet to be used during the ACP conversation. Herein, we describe the first two project phases.
METHODS
In phase 1 we translated and adapted, to the Italian legislation and MS context, the ACP booklet of the National ACP Programme for New Zealand. Acceptability, comprehensibility and usefulness of the booklet were assessed via 13 personal cognitive interviews with pwPMS and significant others (SOs), and one health professional focus group. Based on these findings, we will revise the booklet. In phase 2 we will conduct a single-arm pilot/feasibility trial with nested qualitative study. Participants will be 40 pwPMS, their SOs, health professionals from six MS and rehabilitation centres in Italy. In the 6 months following the ACP conversation, we will assess completion of an advance care plan document (primary outcome), as well as safety of the intervention. Secondary outcomes will be a range of measures to capture the full process of ACP; patient-carer congruence in treatment preferences; quality of patient-clinician communication and caregiver burden. A qualitative process evaluation will help understand the factors likely to influence future implementation and scalability of the intervention.
ETHICS AND DISSEMINATION
The project is coleaded by a neurologist and a bioethicist. Phase 1 has received ethical approvals from each participating centre, while phase 2 will be submitted to the centres in May 2021. Findings from both phases will be disseminated widely through peer-reviewed publications, conferences and workshops.
TRIAL REGISTRATION NUMBER
ISRCTN48527663; Pre-results.
简介
多发性硬化症（MS）是导致年轻人进行性神经功能障碍的最常见原因。在进行性多发性硬化症患者（pwPMS）中使用预先护理计划（ACP）仍然有限。ConCure-SM 项目旨在评估针对 pwPMS 的结构化 ACP 干预措施的有效性。该干预措施包括针对照顾 pwPMS 的医疗保健专业人员的 ACP 培训计划，以及在 ACP 对话中使用的手册。在此，我们描述了前两个项目阶段。
方法
在第 1 阶段，我们根据意大利立法和 MS 背景，对新西兰国家 ACP 计划的 ACP 手册进行了翻译和改编。通过对 13 名 pwPMS 和重要他人（SO）进行 13 次个人认知访谈，并进行一次医疗保健专业人员焦点小组，评估了手册的可接受性、理解性和有用性。根据这些发现，我们将修改手册。在第 2 阶段，我们将在意大利六个 MS 和康复中心的 40 名 pwPMS、他们的 SO、卫生专业人员中进行一项单臂试验/可行性试验，并嵌套一项定性研究。在 ACP 对话后的 6 个月内，我们将评估预先护理计划文件的完成情况（主要结果），以及干预措施的安全性。次要结果将包括一系列衡量指标，以全面评估 ACP 过程；患者-护理人员在治疗偏好方面的一致性；医患沟通质量和护理人员负担。定性过程评估将有助于了解可能影响干预措施未来实施和可扩展性的因素。
伦理和传播
该项目由一名神经科医生和一名生物伦理学家共同领导。第 1 阶段已获得每个参与中心的伦理批准，而第 2 阶段将于 2021 年 5 月提交给各中心。两个阶段的研究结果将通过同行评议的出版物、会议和研讨会广泛传播。
注册号
ISRCTN48527663；预结果。
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