Preparing Family Caregivers of Very Ill Patients for End-of-Life Decision Making

描述（由申请人提供）：家庭看护者做出的代孕决策压力很大且情绪沉重，部分原因是看护者常常感觉没有准备好做出代孕决定。目前尚不清楚哪种预先护理计划 (ACP) 流程最适合护理人员胜任这一角色。本研究的主要目的是评估患有危及生命的疾病的患者的家庭护理人员是否在代理决策方面做好了更好的准备并拥有更好的经验：1）当他们与患者一起参与结构化 ACP 流程时（相对于患者单独参与 ACP 时）； 2) 当他们使用 ACP 在线决策辅助时（相对于使用标准 ACP）。在此过程中，我们还将检查：3）这些因素之间的相互作用。 使用 2 x 2 析因设计，200 名患者/家庭护理人员将被纳入一项随机对照试验，并被分配到 4 组中的一组： 第 1 组：单独标准 ACP，其中患者（但不是家庭护理人员）使用标准 ACP 材料来参与 ACP；第 2 组：仅决策辅助，患者（但不是家庭护理人员）使用决策辅助来参与 ACP；第 3 组：Standard ACP Together，患者和家庭护理人员一起使用标准 ACP 材料；第 4 组：共同决策辅助，患者和家庭护理人员一起使用决策辅助。 将进行 3 次研究访问： 访问 1，患者（/- 家庭护理人员）使用标准材料或决策辅助工具参与 ACP；访问 2，患者和家庭护理人员独立完成假设的小插曲，然后对护理人员进行访谈；访问 3，对家庭护理人员（但不包括患者）进行访谈，了解他们在代理决策方面的经验和准备情况。 我们假设一起参与 ACP（患者家庭护理人员）将优于患者单独参与 ACP，并且使用在线决策辅助将优于使用标准 ACP。我们进一步预计，在家庭照顾者方面，使用决策辅助工具（第 4 组）参与 ACP Together 将优于其他 3 组：1) 自我效能； 2）知识； 3）关于ACP的深度沟通； 4) 他们对小插图的决定与患者的决定达成一致； 5）了解应如何做出代理决定； 6) 对 ACP 流程的满意度。我们还预计，与第 1-3 组相比，第 4 组的家庭护理人员将报告： 7) 更少的痛苦； 8）减少决策冲突； 9）对决策更加满意； 10) 更好的代理决策体验。 实现我们的研究目标将决定使用在线决策辅助与患有危及生命的疾病的患者一起参与 ACP 的家庭护理人员是否能做好更好的准备并在代理决策方面拥有更好的经验。如果答案是肯定的，正如我们预期的那样，这项研究有可能通过为家庭护理人员和患者建立一个易于使用、可靠且具有成本效益的机制来参与有效的预先护理计划，从而解决关键的公共卫生问题。

DESCRIPTION (provided by applicant): Surrogate decision-making by family caregivers is highly stressful and emotionally burdensome, in part because caregivers often feel unprepared to make surrogate decisions. It is not known which advance care planning (ACP) process best prepares caregivers for this role. The main purpose of this study is to evaluate whether family caregivers of patients with life-threatening illnesses are better prepared and have better experiences with surrogate decision-making: 1) when they engage in a structured ACP process together with patients (versus when patients engage in ACP alone); and 2) when they use an online decision aid for ACP (versus using standard ACP). In doing so, we will also examine: 3) interactions between these factors. Using a 2 x 2 factorial design, 200 patient/family-caregiver dyads will be enrolled in a randomized, controlled trial, and assigned to 1 of 4 groups: Group 1: Standard ACP Alone, where the patient (but not family caregiver) uses standard ACP materials to engage in ACP; Group 2: Decision Aid Alone, where the patient (but not family caregiver) uses the decision aid to engage in ACP; Group 3: Standard ACP Together, where the patient and family caregiver use standard ACP materials together; and Group 4: Decision Aid Together, where the patient and family caregiver use the decision aid together. There will be 3 study visits: Visit 1, where patients (+/- family caregivers) engage in ACP using either standard materials or the decision aid; Visit 2, where patients and family caregivers independently complete hypothetical vignettes and then caregivers are interviewed; and Visit 3, where family caregivers (but not patients) are interviewed about their experience with, and sense of preparation for, surrogate decision-making. We hypothesize that engaging in ACP Together (patient + family caregiver) will be superior to patients engaging in ACP Alone, and that using the online Decision Aid will be superior to using Standard ACP. We further anticipate that engaging in ACP Together using the Decision Aid (Group 4) will be superior to the other 3 groups with regard to family caregiver: 1) self-efficacy; 2) knowledge; 3) depth of communication about ACP; 4) agreement between their decisions on the vignettes and patients' decisions; 5) understanding of how surrogate decisions should be made; and 6) satisfaction with the ACP process. We also expect that compared to Groups 1-3, family caregivers in Group 4 will report: 7) less distress; 8) less decisional conflict; 9) greater satisfaction with decisions; and 10) better experiences with surrogate decision-making. Achieving our study aims will determine whether family caregivers who use an online decision aid to engage in ACP Together with patients who have life-threatening illnesses are better prepared and have better experiences with surrogate decision-making. If the answer is yes, as we anticipate, this research has the potential to address a critical public health concern by establishing a readily accessible, reliable, and cost- effective mechanism for family caregivers and patients to engage in advance care planning that works.