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

描述(申请人提供)：家庭照顾者的代孕决定压力很大，情感负担很大，部分原因是照顾者经常感觉没有准备好做出代孕决定。目前尚不清楚哪种高级护理计划(ACP)流程最适合护理人员担任这一角色。这项研究的主要目的是评估危及生命的疾病患者的家庭照顾者是否有更好的准备和更好的代理决策经验：1)当他们与患者一起参与结构化的ACP过程时(而不是当患者单独参与ACP时)；以及2)当他们使用ACP的在线决策辅助时(与使用标准的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2×2析因设计，200名患者/家庭照顾者双方将被纳入随机对照试验，并被分配到4组中的一组：第1组：单独使用标准ACP，其中患者(但不是家庭照顾者)使用标准ACP材料进行ACP；第2组：单独决策援助，其中患者(但不是家庭照顾者)使用决策辅助工具参与ACP；第3组：标准ACP，其中患者和家庭照顾者一起使用标准ACP材料；以及第4组：决策辅助工具，患者和家庭照顾者一起使用决策辅助材料。将有3次研究访问：访问1，患者(/-家庭照顾者)使用标准材料或决策辅助工具参与ACP；访问2，患者和家庭照顾者独立完成假设的小插曲，然后对照顾者进行采访；访问3，家庭照顾者(而不是患者)接受关于他们在代孕决策方面的经验和准备意识的采访。我们假设，共同参与ACP(患者家属照顾者)将比单独参与ACP的患者更好，并且使用在线决策辅助将优于使用标准ACP。我们还预计，在家庭照顾者方面，共同使用Decision Assistant(第4组)参与ACP的人将优于其他3组：1)自我效能；2)知识；3)关于ACP的沟通深度；4)他们对小插曲和患者决定的一致意见；5)对代孕决定应该如何做出的理解；以及6)对ACP过程的满意度。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)较少的痛苦；8)较少的决策冲突；9)对决策的更高满意度；以及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工具与患有危及生命的疾病的患者一起参与ACP的家庭照顾者是否有更好的准备和更好的代孕决策经验。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照顾者和患者建立一种易于获得、可靠和具有成本效益的机制来解决一个关键的公共卫生问题，以便他们参与有效的提前护理计划。 公共卫生相关性：如果这个项目的目标得以实现，我们将表明，提前护理计划干预可以减少家庭照顾者所经历的相当大的痛苦，他们是重病亲人的代理决策者。此外，我们将确定一个实用的、可输出的战略，帮助数百万护理人员为他们作为代孕决策者的角色做好准备。

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. PUBLIC HEALTH RELEVANCE: If the aims of this project are achieved, we will have shown that an advance care planning intervention can decrease the considerable distress experienced by family caregivers who serve as surrogate decision-makers for their seriously-ill loved ones. Furthermore, we will have identified a practical, exportable strategy for helping millions of caregivers prepare for their roles as surrogate decision-makers.