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

摘要 美国国家医学科学院和国家卫生研究院呼吁紧急 采取行动改善向#年死亡的近100万美国老年人提供的护理 每年入住重症监护病房(ICU)，或患有严重残疾而存活。问题包括：1) 预后不佳的患者通常接受比他们更具侵入性的、负担更大的治疗 会自己选择；2)作为代理决策者的家庭成员发现 经历情绪压抑并遭受持久的心理痛苦；3)治疗 重症监护室的费用增加了临终保健费用。这些问题尤其突出。 对老年患者来说很重要，他们愿意接受侵入性、延长生命的治疗 多种多样，取决于高度的个人价值观和偏好。尽管人们普遍承认 在这些问题上，没有任何易于扩展的干预措施被证明是有效的 重症监护室里的代孕妈妈。在过去3年(R21AG050252)中，我们使用了多利益相关者流程 首先开发，然后反复改进家庭支持工具，这是一个基于Web的交互式工具，以 帮助老年、无行为能力患者的家属在情感、心理、 以及作为代理决策者的认知复杂性。然后我们在一个 单中心随机对照试验表明干预是可行的、可接受的，提高了临床医生的素质-- 家庭沟通，并被ICU中的代孕妇女视为非常有益。我们 建议对家庭支持进行一项适当有效的随机临床试验 450名有高死亡风险或危重的老年、危重患者的代理人中的工具 残疾。在目标1和目标2中，我们将确定家庭支持工具对患者 临床结果、代孕者的心理结果、决策质量的测量和结束 生命周期医疗保健利用率。在目标3中，我们将在进行随机对照研究的同时进行定性研究 找出可能影响治疗效果的背景因素、障碍和促进者 家庭支持工具。这项研究具有非常重要的意义，因为它将确立 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 每年数以千计的美国人。这一提议是创新的，因为干预 挑战现有的范式，即如何支持面临困难决策的代理人 生命的终结。这项工作在我们手中是可行的，因为我们的老牌调查团队 成功开发并试行测试了家庭支持工具，拥有经过验证的 成功地在重症监护室进行试验，并得到了来自所有地点的参与。

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.