Preparing Older Veterans with Serious and Chronic Illness for Decision Making

描述(由申请人提供)： 450万退伍军人年龄在65岁以上，越来越多的退伍军人患有慢性病和严重疾病。大多数年长的退伍军人和他们的代理决策者最终将在慢性病过程中面临复杂的、持续的决定。这些决定是困难的，特别是对于健康素养有限的50%的老年退伍军人来说。早期护理计划的旧模式侧重于通过完成预先指令来做出关于延长生命程序(例如，复苏)的决定。然而，这种旧模式是有问题的。这些形式很难理解，而且往往对文化不敏感。他们也没有让患者具备具体的技能，比如如何识别自己的价值观，以及如何与代理人和临床医生沟通。我们已经发布了一种先进护理计划的新范例，相反，我们专注于准备患者与他们的代理人沟通，并积极参与临床医生做出可能的最佳即时决策。新的范例试图确保复杂的、持续的决定是基于一套全面的考虑因素，包括当前的临床背景、不断演变的目标以及患者和代理人的需求。为了有效地做到这一点，退伍军人需要做好准备。然而，目前还没有一个易于使用、符合文化背景的准备指南。我们已经根据我们的新范式创建了一份易于理解的(5年级阅读水平)准备指南，称为准备、激活、反思和参与预先护理计划或准备。Prepare旨在教授退伍军人的准备技能，包括如何选择代孕和讨论代孕决策，澄清特定健康状态的个人价值观，并向临床医生提出问题以做出明智的选择。本研究的目的是：(1)进行随机对照试验，以确定准备在患有慢性病的老年退伍军人中参与准备技能行为的有效性(即，他们是否选择代理，澄清他们的价值观，向临床医生提问)；(2)确定准备在临床接触中激活退伍军人和临床医生的有效性(即，退伍军人是否询问临床医生问题或讨论准备主题，以及临床医生是否做出回应)，并提高对决策的满意度；以及(3)从退伍军人、代理人和临床医生那里获得关于在退伍军人管理局内实施准备的意见。为了实现目标1,205名退伍军人将被随机分配到干预组(准备材料和提前指令)，205名退伍军人将被分配到对照组(仅限于提前指令)。在准备部门的退伍军人将在学习访谈期间浏览易于理解的多媒体准备网站，然后将准备材料以照片手册和小册子的形式带回家，以确保信息的普遍获取。主要结果是退伍军人报告的在3个月和6个月时参与准备技能行为，这将用标准的认知行为测量。对于目标2，将使用经过验证的录音定量分析技术来测量临床接触中的激活情况。对决策的满意度将通过经过验证的自我报告的测量方法进行衡量。对于目标3，我们将询问被随机分配到准备臂的退伍军人及其代理人和临床医生如何在临床环境中最好地实施准备。我们将使用标准的参数或非参数统计检验来评估组内差异，对随机化组之间不同的人口学或其他变量进行控制，并根据临床医生的潜在分组进行调整。对于目标1和目标2，我们将评估种族/民族、识字和性别在参与度和满意度方面的差异。研究团队在随机试验中测试适合识字的多媒体健康教育材料方面拥有丰富的经验。研究小组准备测试Prepare的疗效，这项研究的结果将为Prepare的多地点有效性测试和广泛的VA传播铺平道路。

DESCRIPTION (provided by applicant): 4.5 million Veterans are over age 65 and an increasing number are living with chronic and serious illness. Most older Veterans and their surrogate decision makers will eventually face complex, ongoing decisions over the course of chronic illness. These decisions are difficult, especially for the 50% of older Veterans with limited health literacy. The old paradigm of advance care planning has focused on making decisions about life- prolonging procedures (e.g., resuscitation) by completing advance directives. Yet, this old paradigm is problematic. The forms are difficult to understand and often culturally insensitive. They also fail to prepare patients with concrete skills, such as how to identify one's values and communicate with surrogates and clinicians. We have published a new paradigm of advance care planning that focuses instead on preparing patients to communicate with their surrogates and to actively participate with clinicians in making the best possible in-the-moment decisions. The new paradigm seeks to ensure that complex, ongoing decisions are based on a comprehensive set of considerations including the current clinical context, evolving goals, and patients' and surrogates' needs. To do this effectively, Veterans need to prepare. However, an easy-to-use, culturally-appropriate preparation guide does not exist. We have created an easy-to-understand (5th grade reading level) preparation guide based on our new paradigm called PREParation, Activation, Reflection, and Engagement in advance care planning or PREPARE. PREPARE is designed to teach Veterans preparation skills including how to choose a surrogate and discuss surrogate decision making, clarify personal values for specific health states, and ask clinicians questions to make informed choices. The aims of this study are: (1) to conduct a randomized control trial to determine the efficacy of PREPARE to engage older Veterans with chronic illness in preparation skill behaviors (i.e., did they choose a surrogate, clarify their values, ask clinicans questions); (2) to determine the efficacy of PREPARE to activate Veterans and clinicians within clinical encounters (i.e., did Veterans ask clinicians questions or discuss preparation topics and did clinicians respond) and to improve satisfaction with decision making, and (3) to obtain input from Veterans, surrogates, and clinicians about implementation of PREPARE within the VA. To achieve Aim 1, 205 Veterans will be randomly assigned to the intervention (PREPARE materials plus an advance directive) and 205 will be assigned to the control group (advance directive only). Veterans in the PREPARE arm will view the easy-to-understand, multi- media PREPARE website during the study interview and then take home PREPARE materials in photo booklet and pamphlet format to ensure universal access to the information. The primary outcome is Veteran-reported engagement in preparation skill behaviors at 3 and 6 months, which will be measured with standard cognitive behavioral measures. For Aim 2, activation within the clinical encounters will be measured with validated quantitative analysis techniques of audio-recordings. Satisfaction with decision making will be measured with validated, self-reported measures. For Aim 3, we will ask Veterans randomized to the PREPARE arm and their surrogates and clinicians how best to implement PREPARE within the clinical setting. We will use standard parametric or non-parametric statistical tests to assess group differences, will control for demographic or other variables that differ between randomization groups, and adjust for potential clustering by clinician. For Aims 1 and 2 we will assess differences in engagement and satisfaction by race/ethnicity, literacy, and gender. The research team has extensive experience testing literacy-appropriate, multi-media health education materials in randomized trials. The study team is poised to test the efficacy of PREPARE, and findings from this study will pave the way for multi-site effectiveness testing and widespread VA dissemination of PREPARE.