Stepped Wedge Trial of an Intervention to Support Proxy Decision Makers in ICUs

描述（由申请人提供）：美国三十年的研究表明，垂死的美国人经常在痛苦中度过最后的日子，并接受他们不会选择的治疗。五分之一的成年人死亡发生在重症监护室或出院后不久，在那里，临床医生-家庭沟通和临终护理存在有据可查的问题。这些缺陷与家庭成员中的高比率的不利丧亲结果和质量差的临终关怀有关。不幸的是，没有实际的，普遍的干预措施证明有效地减轻这些公共卫生问题。在一个试点项目中，我们开发了PARTNER干预措施，（将重新设计的ICU团队与护士驱动的情感支持和友谊建设配对），这是一项跨学科干预措施，1）为ICU团队的当地护士领导和社会工作成员提供新的责任和高级沟通技能培训; 2）改变护理“默认”，以确保经常的临床医生家庭会议; 3）在临床医生-家庭会议之前和期间增加了对代理人的协议化的、护士管理的辅导和情感支持，以及4）增加了对预后不良的患者的姑息治疗服务的使用。我们为期2年的试点研究证明，干预是可行的，可持续的，并与较短的ICU住院时间和较低的住院费用。本提案的目的是在1000例晚期危重病患者及其替代者中进行一项多中心、随机化、阶梯式楔形试验，在5个ICU中测试PARTNER干预。在目标1中，我们将评估干预措施对代理人焦虑、抑郁、创伤后应激障碍和决策后悔症状的影响，随访时间超过6个月。在目标2中，我们将使用经过验证的工具来评估干预对临终决策和患者临终体验的沟通的影响。在目标3中，我们将评估干预措施对住院期间和6个月以上随访期间卫生保健利用的影响。PARTNER干预如果成功将产生很大影响，因为它将是重要公共卫生问题的务实解决方案，这些问题可能影响每年在ICU死亡的60多万成年人。干预是创新的决策心理学和行为经济学的理论基础，提供给代理人的支持的广度和强度，干预的系统级设计，以及使用现有的临床团队来部署干预而不是雇用外部干预者的策略。这项工作在我们手中是可行的，因为我们的研究人员团队开发并成功地进行了干预试验，而且我们在ICU中成功进行多中心试验的记录已经得到证实。

DESCRIPTION (provided by applicant): Three decades of research in the United States indicates that Americans who are dying often spend their final days in pain and receiving treatments they would not choose. One in five deaths among adults occurs in or shortly after discharge from an intensive care unit, where there are well-documented problems with clinician- family communication and end-of-life care. These deficiencies are associated with high rates of adverse bereavement outcomes among family members and poor quality end-of-life care. Unfortunately, there are no practical, generalizable interventions proven effective in mitigating these public health problems. In a pilot project, we developed the PARTNER intervention (PAiring Re-engineered ICU Teams with Nurse- driven Emotional Support and Relationship-building), an interdisciplinary intervention that 1) gives new responsibilities and advanced communication skills training to the local nurse leaders and social work members of the ICU team; 2) changes care "defaults" to ensure frequent clinician-family meetings; 3) adds protocolized, nurse-administered coaching and emotional support of surrogates before and during clinician- family meetings, and 4) increases use of palliative care services for patients with a poor prognosis. Our 2-year pilot study documented that the intervention is feasible, sustainable, and is associated with shorter ICU length of stay and lower hospital costs. The objective of this proposal is to conduct a multi-center, randomized stepped wedge trial testing the PARTNER intervention in 5 ICUs among 1000 patients with advanced critical illness and their surrogates. In Aim 1, we will assess the intervention's impact on surrogates' symptoms of anxiety, depression, PTSD, and decisional regret over 6 months of follow-up. In Aim 2, we will use validated instruments to assess the intervention's impact on communication about end-of-life decisions and patients' end-of-life experiences. In Aim 3, we will assess the intervention's impact on health care utilization during the index hospitalization and over 6 months of follow-up. The PARTNER intervention will have high impact if successful because it will be a pragmatic solution to important public health problems that potentially affect more than 600,000 adults who die annually in ICUs. The intervention is innovative in its theoretical grounding in decision psychology and behavioral economics, the breadth and intensity of support provided to surrogates, the systems-level design of the intervention, and the strategy to use the existing clinical team to deploy the intervention instead of hiring external interventionists. The work is feasible in our hands because our team of established investigators developed and successfully pilot-tested the intervention, and because we have a proven record of success conducting multi-center trials in ICUs.