在一般实践环境中为患有慢性、生命有限疾病的患者促进预先护理计划：一项 III 期群组随机对照试验的方案和 ACP-GP 干预的过程评估。
Facilitating advance care planning in the general practice setting for patients with a chronic, life-limiting illness: protocol for a phase-III cluster-randomized controlled trial and process evaluation of the ACP-GP intervention.
机构信息
Vrije Universiteit Brussel (VUB) & Ghent University, End-of-life Care Research Group, Laarbeeklaan 103, 1090, Brussels, Belgium.
Department of Family Medicine and Chronic Care, Vrije Universiteit Brussel, Brussels, Belgium.
出版信息
BMC Palliat Care. 2021 Jun 25;20(1):97. doi: 10.1186/s12904-021-00796-1.
BACKGROUND
Advance care planning (ACP), a process of communication about patients' preferences for future medical care, should be initiated in a timely manner. Ideally situated for this initiation is the general practitioner (GP). The intervention to improve the initiation of ACP for patients with a chronic life-limiting illness in general practice (ACP-GP) includes an ACP workbook for patients, ACP communication training for GPs, planned ACP conversations, and documentation of ACP conversation outcomes in a structured template. We present the study protocol of a Phase-III randomized controlled trial (RCT) of ACP-GP that aims to evaluate its effects on outcomes at the GP, patient, and surrogate decision maker (SDM) levels; and to assess the implementation process of the intervention.
METHODS
This RCT will take place in Flanders, Belgium. Thirty-six GPs, 108 patients with a chronic, life-limiting illness, and their (potential) SDM will be recruited, then cluster-randomized to the ACP-GP intervention or the control condition. The primary outcome for GPs is ACP self-efficacy; primary outcome for patients is level of ACP engagement. Secondary outcomes for GPs are ACP practices, knowledge and attitudes; and documentation of ACP discussion outcomes. Secondary outcomes for patients are quality of life; anxiety; depression; appointment of an SDM; completion of new ACP documents; thinking about ACP; and communication with the GP. The secondary outcome for the SDM is level of engagement with ACP. A process evaluation will assess the recruitment and implementation of the intervention using the RE-AIM framework.
DISCUSSION
While the general practice setting holds promise for timely initiation of ACP, there is a lack of randomized trial studies evaluating the effectiveness of ACP interventions implemented in this setting. After this Phase-III RCT, we will be able to present valuable evidence of the effects of this ACP-GP intervention, with the potential for offering a well-tested and evaluated program to be implemented in general practice. The results of the process evaluation will provide insight into what contributes to or detracts from implementation success, as well as how the intervention can be adapted to specific contexts or needs.
TRIAL REGISTRATION
Prospectively registered at with ISRCTN ( ISRCTN12995230 ); registered 19/06/2020.
背景
预先医疗照护计划（ACP）是一个关于患者对未来医疗护理偏好的沟通过程，应及时启动。最适合启动该计划的是全科医生（GP）。改善一般实践中慢性生命终末期患者 ACP 启动的干预措施（ACP-GP）包括患者的 ACP 工作手册、GP 的 ACP 沟通培训、计划的 ACP 对话以及在结构化模板中记录 ACP 对话结果。我们介绍了 ACP-GP 的一项 III 期随机对照试验（RCT）的研究方案，旨在评估其对 GP、患者和替代决策人（SDM）水平的结果的影响；并评估干预措施的实施过程。
方法
该 RCT 将在比利时佛兰德进行。将招募 36 名全科医生、108 名患有慢性、生命终末期疾病的患者及其（潜在）SDM，并进行聚类随机分组到 ACP-GP 干预组或对照组。GP 的主要结局是 ACP 自我效能；患者的主要结局是 ACP 参与度。GP 的次要结局是 ACP 实践、知识和态度；以及 ACP 讨论结果的记录。患者的次要结局是生活质量；焦虑；抑郁；指定 SDM；完成新的 ACP 文件；思考 ACP；以及与 GP 的沟通。SDM 的次要结局是 ACP 的参与度。使用 RE-AIM 框架进行的过程评估将评估干预措施的招募和实施情况。
讨论
虽然一般实践环境有望及时启动 ACP，但缺乏评估在该环境中实施的 ACP 干预措施有效性的随机试验研究。在这项 III 期 RCT 之后，我们将能够提供有关这种 ACP-GP 干预措施效果的有价值的证据，并有潜力为一般实践提供经过充分测试和评估的计划。过程评估的结果将深入了解哪些因素有助于或阻碍实施成功，以及如何根据特定情况或需求调整干预措施。
试验注册
前瞻性注册于 ISRCTN（ISRCTN82306556）；注册于 2020 年 6 月 19 日。
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