Effectiveness of Engaging in Advance Care Planning Talks (ENACT) Group Visits Intervention in Primary Care for Older Adults with and without Alzheimer's Dementia

项目总结 患有阿尔茨海默病和相关痴呆(ADRD)的人可能会经历不想要的， 重症或繁重的临终护理，因为他们的医疗人员不知道他们对护理的偏好 决策者。例如，近41%的ADRD患者至少经历了一次强化治疗 在生命的最后3个月进行干预(如机械通风、人工营养)，这可能会延长生命 但没有涉及生活质量。因此，关于提前护理计划(ACP)的及时讨论 当务之急是在痴呆症患者失去决策能力之前。有认知障碍的人， 从轻度认知障碍到痴呆症，通常在初级保健中得到照顾。然而，主要的 护理环境没有有效的模式，可以系统地整合临床医生和患者的讨论和 认知障碍老年人与非认知障碍老年人关于ACP的决策 制造能力。为了解决这些差距，我们设计、改进了涉众意见，并演示了 基于理论和实践的ACP团体访视干预措施的可行性、可接受性和有效性 老年初级保健患者的小组访问(参与高级护理计划讲座)。制定组 访问是两次促进的讨论，相隔一个月，由医生或高级实践提供者和 社会工作者。干预使用了基于证据的ACP材料，并利用集团的动态来 提高患者的目标设定和自我效能。在一项单一临床试点研究中，患者被随机分成两组 小组访问干预组在6个月时的ACP文档率比对照组高26% 邮寄机场核心计划资料(p=0.007)。这项研究的目的是测试制定团体访问以增加 ACP文档(ACP的一个方面)，并评估其在不同患者中的有效性 认知障碍，包括早期痴呆症。拟议的两组患者水平的随机试验将是 在五家初级保健诊所进行，并有权对团体访问干预与对照进行比较 邮寄ACP材料。我们将使用1：1分配和患者级别的随机分组，根据有无 是CI的。这项研究将使用Prepare™的组件，这是一个基于证据的非加太计划，旨在减少 认知负担，以及易于阅读的提前指令。目标1将决定颁布的效力 6个月后小组访视与对照组比较，以增加ACP文档(主要结果)、ACP准备情况、 决策自我效能感和沟通质量(次要结果)。目标2将决定是否 制定团体访视干预的有效性因认知障碍而异，包括ADRD。目标3将 描述颁布的可接受性和可行性，以及干预的保真度和实施结果 团体访视干预采用定性和混合方法。这项以初级保健为基础的有效性试验 在包括痴呆症患者在内的老年人中实施团体访问干预将产生所需的 在现实世界的初级保健环境中实施有效的非加太干预措施的证据。

PROJECT SUMMARY Individuals living with Alzheimer's Disease and Related dementias (ADRD) may experience unwanted, intensive or burdensome end-of-life care because their preferences for care are unknown to their medical decision makers. For example, nearly 41% of individuals with ADRD undergo at least one intensive intervention (e.g., mechanical ventilation, artificial nutrition) in the last 3 months of life, which may prolong life but does not address quality of life. Thus, timely discussions about advance care planning (ACP) are imperative before individuals with dementia lose decision making capacity. Persons with cognitive impairment, spanning from mild cognitive impairment to dementia, are often cared for in primary care. However, primary care settings do not have effective models that can systematically integrate clinician-patient discussions and decision-making about ACP for older adults with and without cognitive impairment who still have decision making capacity. To address these gaps, we designed, refined with stakeholder input, and demonstrated the feasibility, acceptability, and efficacy of a theory-based and practical ACP group visit intervention, ENACT Group Visits (Engaging in Advance Care Planning Talks) among older primary care patients. ENACT Group Visits are two facilitated discussions, one month apart, led by a physician or advanced practice provider and a social worker. The intervention uses evidence-based ACP materials and leverages the group dynamic to promote patient goal-setting and self-efficacy. In a single-clinic pilot study, patients randomized to the ENACT Group Visits intervention had a 26% higher rate of ACP documents at 6 months, compared to a control arm of mailed ACP materials (p=0.007). This study aims to test the effectiveness of ENACT Group Visits to increase ACP documentation (one aspect of ACP) and to evaluate its effectiveness among patients across a spectrum of cognitive impairment, including early dementia. The proposed 2-arm, patient-level randomized trial will be conducted in five primary care clinics and is powered to compare ENACT Group Visits intervention vs control mailed ACP materials. We will use 1:1 allotment and patient-level block randomization by presence or absence of CI. The study will use components of PREPARE™, an evidence-based ACP program designed to decrease cognitive burden, and an easy-to-read advance directive. Aim 1 will determine the effectiveness of ENACT Group Visits vs control at 6 months to increase ACP documentation (primary outcome), ACP readiness, decision self-efficacy, and quality of communication (secondary outcomes). Aim 2 will determine whether the effectiveness of ENACT Group Visits intervention varies by cognitive impairment, including ADRD. Aim 3 will describe acceptability and feasibility, as well as intervention fidelity and implementation outcomes, of ENACT Group Visits intervention using qualitative and mixed methods. This primary care-based effectiveness trial of ENACT Group Visits intervention among older adults, including those with dementia, will generate needed evidence for implementing effective ACP interventions into real-world primary care settings.