Randomized Trial of a Scalable, Interactive Tool to Support Surrogate Decision-makers of Elderly Critically Ill Patients

支持老年危重患者代理决策者的可扩展交互式工具的随机试验

• 批准号: 10649739
• 负责人: Douglas B White
• 金额: $ 64.28万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-15 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10649739
• 关键词: Academy; Admission activity; Advance Care Planning; Affect; Affective; American; Caring; Cessation of life; Clinical; Cognitive; Communication; Conceptions; Critical Illness; Decision Aid; Decision Making; Decision Theory; Elderly; Emotional; Enhancement Technology; Evidence based intervention; Exposure to; Family; Family member; Fright; Goals; Guilt; Health Care Costs; Human Resources; Impairment; Intensive Care Units; Intervention; Length; Length of Stay; Letters; Life; Literature; Measures; Medicine; Modernization; Outcome; Patient-Centered Care; Patients; Process; Prognosis; Public Health; Qualitative Research; Quality of Care; Quality of life; Research; Research Personnel; Site; Specialist; United States National Institutes of Health; Work; advanced disease; anxiety symptoms; clinical research site; contextual factors; coping; cost; depressive symptoms; disability; efficacy evaluation; efficacy trial; emotional experience; end of life; evidence base; expectation; family burden; family support; follow-up; health care service utilization; health goals; high risk; improved; innovation; instrument; interactive tool; mortality risk; older patient; patient navigation; patient oriented; pilot test; post-traumatic stress; preference; prevent; primary outcome; prognostic; psychologic; psychological distress; psychological outcomes; quality of death; randomized trial; randomized, clinical trials; safety outcomes; success; support tools; surrogate decision maker; tool; treatment as usual; web-based tool; willingness

ABSTRACT The National Academy of Medicine and the National Institutes of Health have called for urgent action to improve the care delivered to the nearly 1,000,000 elderly Americans who die in intensive care units (ICUs) annually, or survive with severe disabilities. The problems include: 1) patients with a poor prognosis often receive more invasive, burdensome treatment than they would choose for themselves; 2) family members acting as surrogate decision-makers find the experience emotionally overwhelming and suffer lasting psychological distress; and 3) treatment in ICUs contributes to high end-of-life health care costs. These problems are especially important to elderly patients, whose willingness to undergo invasive, life-prolonging treatments varies and hinges on highly personal values and preferences. Despite widespread recognition of these problems, there are no readily-scalable interventions that are proven effective to assist surrogates in ICUs. Over the last 3 years (R21AG050252), we used a multi-stakeholder process to first develop, then iteratively refine the Family Support Tool, an interactive, web-based tool to help family members of elderly, incapacitated patients navigate the emotional, psychological, and cognitive complexities of being a surrogate decision-maker. We then established in a single-center RCT that the intervention is feasible, acceptable, improves the quality of clinician- family communication, and is perceived to be highly beneficial by surrogates in ICUs. We propose to conduct an appropriately powered randomized clinical trial of the Family Support Tool among the surrogates of 450 elderly, critically ill patients at high risk of death or severe disability. In Aims 1 and 2, we will determine the effect of the Family Support Tool on patients’ clinical outcomes, surrogates’ psychological outcomes, measures of decision quality, and end- of-life healthcare utilization. In Aim 3, we will conduct a qualitative study in parallel with the RCT to identify the contextual factors, barriers, and facilitators that may influence the efficacy of the Family Support Tool. The research is highly significant because it will establish the efficacy of a low-cost, scalable intervention to overcome major public health problems that affect hundreds of thousands of Americans annually. This proposal is innovative because the intervention challenges the existing paradigm of how to support surrogates facing difficult decisions near the end of life. The work is feasible in our hands because our team of established investigators successfully developed and pilot tested the Family Support Tool, has a proven record of success conducting trials in ICUs, and has buy-in for participation from all sites.

抽象的 美国国家医学院和美国国立卫生研究院已呼吁紧急 采取行动改善对近 1,000,000 名死于美国老年人的护理 每年都会进入重症监护病房（ICU），或者在严重残疾的情况下生存。问题包括：1） 预后不良的患者通常会接受比实际情况更具侵入性、更繁重的治疗 会为自己选择； 2）作为代理决策者的家庭成员发现 经历情绪上的压倒性打击并遭受持久的心理困扰； 3) 治疗 重症监护病房 (ICU) 导致临终医疗费用高昂。这些问题尤其 对于愿意接受侵入性、延长生命的治疗的老年患者来说很重要 变化并取决于高度个人的价值观和偏好。尽管人们普遍认识到 对于这些问题，目前还没有被证明可以有效帮助的易于扩展的干预措施 ICU 中的代理人。在过去 3 年中 (R21AG050252)，我们使用了多利益相关者流程 首先开发，然后迭代完善家庭支持工具，这是一个基于网络的交互式工具 帮助老年、无行为能力患者的家人应对情绪、心理、 以及作为代理决策者的认知复杂性。然后我们建立了一个 单中心随机对照试验表明干预措施可行、可接受，提高了临床医生的质量 家庭沟通，被 ICU 中的代理人认为非常有益。我们 建议对家庭支持进行适当的随机临床试验 450 名死亡高危或严重危重患者的代理人的工具 残疾。在目标 1 和 2 中，我们将确定家庭支持工具对患者的影响 临床结果、代理人的心理结果、决策质量的衡量以及最终结果 临终医疗保健利用。在目标 3 中，我们将与 RCT 并行进行定性研究 识别可能影响效果的背景因素、障碍和促进因素 家庭支持工具。这项研究非常重要，因为它将确定一种药物的功效 低成本、可扩展的干预措施，以克服影响数百人的重大公共卫生问题 每年有数千名美国人。这个提议是创新的，因为干预 挑战了如何支持面临困难决策的代理人的现有范式 生命的终结。这项工作在我们手中是可行的，因为我们的研究团队已建立 成功开发并试点测试了家庭支持工具，拥有良好的记录 成功在 ICU 进行试验，并得到所有地点的参与。