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

描述(由申请人提供)：美国30年的研究表明，垂死的美国人通常在痛苦中度过最后的日子，接受他们不会选择的治疗。成人中有五分之一的死亡发生在重症监护病房出院或出院后不久，在重症监护病房，临床医生与家人的沟通和临终关怀存在着有据可查的问题。这些缺陷与家庭成员丧失亲人的不良后果发生率高以及临终关怀质量差有关。不幸的是，没有任何实际的、可推广的干预措施被证明能有效地缓解这些公共卫生问题。在一个试点项目中，我们开发了合作伙伴干预(将重新设计的ICU团队与护士驱动的情绪支持和关系建立配对)，这是一种跨学科干预措施，1)赋予当地护士领导和ICU团队的社会工作成员新的责任和高级沟通技能培训；2)改变护理“默认设置”，以确保频繁的临床医生-家庭会议；3)在临床医生-家庭会议之前和期间增加对代理人的程序化、护士管理的指导和情感支持；以及4)增加对预后较差的患者使用姑息治疗服务。我们为期两年的初步研究证明，这种干预是可行的、可持续的，并与较短的ICU住院时间和较低的住院费用有关。这项建议的目标是进行一项多中心、随机阶梯式楔形试验，在1000名晚期危重病患者及其代理人中的5个ICU中测试伴侣干预。在目标1中，我们将评估干预对代孕者焦虑、抑郁、创伤后应激障碍和决策后悔症状的影响，为期6个月的随访。在目标2中，我们将使用经过验证的工具来评估干预对关于临终决策和患者临终经历的沟通的影响。在目标3中，我们将评估干预措施在指数住院期间和超过6个月的随访期间对卫生保健利用的影响。如果成功，伙伴干预将产生很大影响，因为它将是解决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重症监护病房死亡的60多万成年人。该干预在决策心理学和行为经济学的理论基础、向代理人提供支持的广度和强度、干预的系统级设计以及利用现有临床团队而不是聘请外部干预者的策略上具有创新性。这项工作在我们手中是可行的，因为我们的成熟研究团队开发并成功地进行了中试干预，也因为我们在ICU中成功地进行了多中心试验的已被证明的记录。

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.