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

支持 ICU 代理决策者的干预措施的阶梯楔形试验

• 批准号: 8930192
• 负责人: Douglas B White
• 金额: $ 51.11万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-19 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8930192
• 关键词: Address; Adult; Advance Care Planning; Affect; American; Bereavement; Caring; Cessation of life; Clinical; Communication; Cost Savings; Critical Illness; Decision Making; Economics; Emotional; Empirical Research; Engineering; Ensure; Family; Family member; Future; Goals; Health; Health Care Costs; Healthcare; Healthcare Systems; Hospital Costs; Hospitalization; Intensive Care Units; Intervention; Intervention Trial; Length of Stay; Letters; Life; Mental Depression; Multicenter Trials; Nurses; Outcome; Pain; Palliative Care; Patients; Pilot Projects; Post-Traumatic Stress Disorders; Process; Proxy; Psychology; Public Health; Randomized; Randomized Controlled Trials; Regrets; Research; Research Personnel; Resources; Role; Services; Site; Social Work; Social Workers; Solutions; Structure; Surveys; Symptoms; System; Testing; Time; Training; Uncertainty; United States; Vulnerable Populations; Work; anxiety symptoms; behavioral economics; design; effective intervention; efficacy testing; empowered; end of life; experience; follow-up; health care service utilization; improved; indexing; innovation; instrument; intervention effect; meetings; member; novel; outcome forecast; post-traumatic stress; preference; prevent; primary outcome; programs; psychological distress; psychological outcomes; skills training; success; successful intervention; surrogate decision maker; treatment as usual

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.

描述（由申请人提供）：在美国进行了三十年的研究表明，死亡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。成年人中有五分之一的死亡发生在重症监护病房中或出院后不久，那里有充分记录的临床医生 - 家庭交流和临终关怀的问题。这些缺陷与家庭成员之间的不良丧亲结果和质量较差的临终护理相关。不幸的是，没有证明可以有效缓解这些公共卫生问题的实际，可推广的干预措施。在一个试点项目中，我们开发了合作伙伴干预措施（将重新设计的ICU团队与护士驱动的情感支持和建立关系建设配对），这是一种跨学科的干预措施，即1）为ICU团队的当地护士领导者和社会工作成员提供新的责任和高级沟通技巧培训； 2）更改护理“默认”以确保频繁的临床医生家庭会议； 3）补充说，在临床医生家庭会议之前和期间，由护士管理的教练和情感支持以及对预后不良的患者使用姑息治疗服务的使用。我们为期两年的试点研究表明，干预措施是可行的，可持续的，并且与ICU较短的住院时间和较低的医院费用有关。该提案的目的是进行一项多中心的，随机的梯级楔形试验，对1000例患有晚期危重疾病及其代理的患者中的5例ICU进行伴侣干预。在AIM 1中，我们将在6个月的随访中评估干预措施对代理人焦虑，抑郁，PTSD和决策的遗憾的影响。在AIM 2中，我们将使用经过验证的工具来评估干预措施对临终决策和患者终止终身经历的沟通的影响。在AIM 3中，我们将评估干预措施对指数住院期间的医疗保健利用的影响以及超过6个月的随访。如果成功的话，合作伙伴的干预将产生很大的影响，因为这将是对重要的公共卫生问题的实用解决方案，这些问题可能会影响每年在ICU中死亡的60万以上成年人。干预措施在决策心理学和行为经济学，提供给替代物提供的支持和强度，干预的系统级设计以及使用现有临床团队部署干预措施而不是雇用外部干预者的策略方面具有创新的基础。这项工作在我们手中是可行的，因为我们成熟的研究人员团队开发并成功地试用了干预措施，并且由于我们在ICU中进行了多中心试验的成功记录。