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: 10450052
• 负责人: Douglas B White
• 金额: $ 64.17万
• 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/10450052
• 关键词: Academy; Admission activity; Advance Care Planning; Affect; Affective; American; Anxiety; 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; Outcome Measure; Patients; Process; Prognosis; Public Health; Qualitative Research; Quality of Care; Quality of life; Randomized Clinical Trials; Research; Research Personnel; Site; Specialist; United States National Institutes of Health; Work; advanced disease; clinical research site; contextual factors; coping; cost; depressive symptoms; disability; 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 oriented; pilot test; post-traumatic stress; preference; prevent; primary outcome; prognostic; psychologic; psychological distress; psychological outcomes; quality of death; randomized trial; 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呼吁紧急 改善交付给近1,000,000名老年人死亡的美国人的措施 每年重症监护病房（ICU），或在严重残疾中生存。问题包括：1） 预后差的患者通常会受到比他们更具侵入性，振奋 会自己选择； 2）担任代理决策者的家庭成员发现 在情感上经历压倒性的经历，并遭受持久的心理困扰； 3）治疗 在ICU中，造成了较高的寿命卫生保健费用。这些问题尤其是 对古老的患者来说很重要，他们愿意接受侵入性，生命的治疗 多样性和取决于高度个人的价值观和偏好。尽管宽广的认可 这些问题，没有任何容易估计的干预措施可有效地协助 ICU中的代理。在过去的三年（R21AG050252）中，我们使用了多方利益相关者流程 首先开发，然后迭代地完善家庭支持工具，这是一种基于网络的交互式工具 帮助老年人，无能力的患者的家庭成员驾驭情感，心理， 成为代孕决策者的认知复杂性。然后，我们建立了 单中心RCT认为干预是可行的，可接受的，可以提高临床的质量 家庭交流，被ICU中的代理人认为是非常有益的。我们 提议对家庭支持进行适当动力的随机临床试验 450名替代物的工具，患者高死亡风险或严重患者 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，代孕的心理成果，决策质量的度量以及最终 寿命的医疗保健利用。在AIM 3中，我们将与RCT并行进行定性研究 确定可能影响可能影响效率的上下文因素，障碍和促进者 家庭支持工具。这项研究非常重要，因为它将确定 低成本，可扩展的干预措施，以克服影响数百个的主要公共卫生问题 每年成千上万的美国人。该提议具有创新性，因为干预 挑战现有的范式，即如何支持在附近面临艰难决定的代理人 生命的尽头。这项工作在我们手中是可行的，因为我们成立的调查员团队 成功开发和试点测试了家庭支持工具，具有可靠的记录 在ICU进行了成功进行试验，并已获得所有站点的参与。