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、持续的决定。决策准备是制定或提前护理计划(ACP)，传统上侧重于通过完成预先指令来做出关于延长生命的程序(例如，机械通风)的决定。然而，预先指令往往无法让患者准备好识别自己的价值观，也无法与代理人和临床医生进行沟通。因此，研究团队开发了更广泛的ACP范式，转而专注于准备患者传达他们的愿望，并与临床医生一起在病程中做出实时、复杂的医疗决策。研究团队创建了一个基于这种新的ACP范例的、易于理解的、以患者为中心的网站，名为Prepare。Prepare通过视频和ACP行为模型教患者如何识别他们的愿望，并与代理人和临床医生沟通。这项建议的目的是在一项双盲、随机、疗效试验中进行测试准备。这项研究的目的是：(1)确定PREPARE的有效性，以使不同种族的老年人参与一系列的ACP行为(即，确定并讨论代理人和临床医生的意愿以及完整的预先指示)；(2)确定在临床接触中激活患者的PREPARE的有效性(即，向临床医生提问并讨论ACP)；以及(3)评估PREPARE的有效性是否因患者亚组而异，例如种族/民族和识字水平(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准备的意见。方法：将来自旧金山总医院的500例年龄为55岁的慢性疾病患者随机分为干预组(准备加提前指导)和对照组(仅提前指导)。患者报告的参与ACP的主要结果将在1周、3个月、6个月和12个月(目标1)通过验证调查进行衡量。将使用经过验证的定量分析技术和定性分析来测量录音临床会诊期间的激活情况(目标2)。我们将使用混合效应广义线性模型来评估武器之间纵向结果的差异，并对不同武器之间的变量进行控制。我们还将根据临床医生的分组进行调整。为了根据患者分组评估疗效，我们将在建模中包括种族/民族和识字的交互术语(目标3)。与美国国立卫生研究院和公共卫生的相关性：如果PREPARE是有效的，研究人员将拥有一份新颖、实用、可扩展的ACP指南，该指南将易于使用并在不同人群中传播。这将导致不同的老年人，他们准备在严重和慢性病的过程中传达自己的意愿并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.