Improving Advance Care Planning by Preparing Diverse Seniors for Decision Making

描述（由申请人提供）：数百万不同的老年人和他们的代理决策者将在慢性和晚期疾病的过程中面临许多复杂的、持续的决策。决策准备是制定或预先护理计划（ACP），传统上侧重于通过完成预先指示来制定有关延长生命程序（例如，机械通气）的决策。然而，事先指示往往不能使患者做好准备，以确定他们的价值或与代理人和临床医生沟通。因此，研究小组开发了一种更广泛的ACP模式，其重点是让患者做好准备，沟通他们的愿望，并参与临床医生在疾病过程中做出实时、复杂的医疗决策。研究小组基于这种新的ACP模式创建了一个易于理解、以患者为中心的网站，名为PREPARE。PREPARE组织通过视频和ACP行为建模，教会患者如何识别自己的意愿，并与代孕母亲和临床医生沟通。本提案的目的是在一项双盲、随机、疗效试验中测试prep。本研究的目的是：(1)确定prep对不同种族的老年人参与一系列ACP行为的效果（即，与代理人和临床医生识别和讨论愿望以及完成预先指示）；(2)确定PREPARE在临床接触中激活患者的功效（即向临床医生提问并讨论ACP）；(3)评估prep的疗效是否因患者亚组而异，如种族/民族和文化水平（目标3）。研究人员还将从患者、代理人和临床医生那里获得关于在安全网环境中实施PREPARE的信息。方法：来自旧金山总医院的500名55岁慢性疾病患者将被随机分配到干预组（prep加预先指示）或对照组（仅预先指示）。患者报告参与ACP的主要结果将在1周、3、6和12个月时通过有效的调查进行测量（目的1）。在音频记录的临床接触（目标2）期间的激活将通过经过验证的定量分析技术和定性分析进行测量。我们将使用混合效应广义线性模型来评估两组之间纵向结果的差异，并对两组之间不同的变量进行对照。我们还将根据临床医生的分组进行调整。为了评估患者亚组的疗效，我们将在模型中纳入种族/民族和研究部门文化的相互作用条件（目标3）。与NIH和公共卫生的相关性：如果PREPARE是有效的，研究人员将有一个新颖的，实用的，可扩展的ACP指南，将易于在不同人群中使用和传播。这将导致多样化的老年人准备好沟通他们的愿望，并在严重和慢性疾病的过程中做出复杂的医疗决定。

DESCRIPTION (provided by applicant): Millions of diverse, older adults and their surrogate decision makers will face many complex, ongoing decisions over the course of chronic and advanced illness. Preparation for decision is making or advance care planning (ACP), has traditionally focused on making decisions about life-prolonging procedures (e.g., mechanical ventilation) by completing advance directives. Yet, advance directives often fail to prepare patients to identify their values or to communicate with surrogates and clinicians. Therefore, the research team developed a broader paradigm of ACP that focuses instead on preparing patients to communicate their wishes and to participate with clinicians in making real-time, complex medical decisions over the course of illness. The research team has created an easy-to-understand, patient-centered website called PREPARE that is based on this new ACP paradigm. PREPARE teaches patients, through videos and modeling of ACP behaviors, how to identify their wishes and communicate with surrogates and clinicians. The objective of this proposal is to test PREPARE in a double-blind, randomized, efficacy trial. The aims of this study are: (1) to determine the efficacy of PREPARE to engage ethnically diverse, older adults in a range of ACP behaviors (i.e., identify and discuss wishes with surrogates and clinicians as well as complete advance directives); (2) to determine the efficacy of PREPARE to activate patients within clinical encounters (i.e., ask clinicians questions and discuss ACP); and (3) to assess whether the efficacy of PREPARE varies by patient subgroups, such as race/ethnicity and literacy level (Aim 3). The researchers will also obtain input from patients, surrogates, and clinicians about implementation of PREPARE in safety-net settings. Methods: 500 patients aged e 55 years with chronic illness from San Francisco General Hospital will be randomly assigned to either the intervention arm (PREPARE plus an advance directive) or the control arm (advance directive only). Main outcomes of patient- reported engagement in ACP will be measured with validated surveys at 1 week, 3, 6, and 12 months (Aim 1). Activation during audio-recorded clinical encounters (Aim 2) will be measured with validated quantitative analysis techniques and qualitative analysis. We will use mixed-effects generalized linear models to assess differences in longitudinal outcomes between arms and control for variables that differ between arms. We will also adjust for clustering by clinician. To assess efficacy by patient subgroups, we will include interaction terms of race/ethnicity and literacy by study arm in the modeling (Aim 3). Relevance to NIH and public health: If PREPARE is efficacious, the researchers will have a novel, practical, scalable ACP guide that will be easy to use and disseminate within diverse populations. This will result in diverse, older adults who are prepared to communicate their wishes and make complex medical decisions over the course of serious and chronic illness.