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

描述（由申请人提供）：家庭照顾者的代理决策是高度紧张和情感负担，部分原因是照顾者经常感到没有准备好做出代理决定。目前尚不清楚哪种预先护理计划（ACP）过程最适合护理人员担任这一角色。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准备得更好，并且在替代决策方面有更好的经验：1）当他们与患者一起参与结构化ACP过程时（与患者单独参与ACP时相比）; 2）当他们使用ACP在线决策辅助工具时（与使用标准ACP相比）。在此过程中，我们还将研究：3）这些因素之间的相互作用。 采用2 x 2析因设计，将200例患者/家庭护理者配对入组随机对照试验，并分配至4组之一：第1组：单独使用标准ACP，其中患者（但不是家庭护理人员）使用标准ACP材料进行ACP;第2组：仅辅助决策，患者第三组：标准ACP，其中患者和家庭护理人员一起使用标准ACP材料;第四组：决策辅助，其中患者和家庭护理人员一起使用决策辅助。 将有3次研究访视：访视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;访视2，患者和家庭护理人员独立完成假设的小插图，然后对护理人员进行访谈;第三次访问，家庭护理人员（但不是病人）采访他们的经验，和准备的感觉，代理决策。 我们假设一起参与ACP（患者+家庭护理者）将上级单独参与ACP的患者，并且使用在线决策辅助将上级使用标准ACP。我们进一步预测，使用决策辅助工具一起参与ACP（第4组）在家庭照顾者方面上级其他3组：1）自我效能; 2）知识; 3）关于ACP的沟通深度; 4）他们对插图的决定与患者决定之间的一致性; 5）对如何做出替代决定的理解;（6）对机场核心计划的程序感到满意。我们还预计，与第1-3组相比，第4组的家庭照顾者将报告：7）更少的痛苦; 8）更少的决策冲突; 9）对决策更满意; 10）更好的代理决策经验。 实现我们的研究目标将决定使用在线决策辅助工具参与ACP的家庭护理人员是否与患有危及生命的疾病的患者一起做好了更好的准备，并在代理决策方面有更好的经验。如果答案是肯定的，正如我们所预期的那样，这项研究有可能通过建立一个易于获得，可靠和具有成本效益的机制，让家庭护理人员和患者参与有效的预先护理计划，来解决一个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.