A Multisite Randomized Controlled Trial of EMPOWER for Family Surrogates of Critically Ill Patients

EMPOWER 对危重患者家庭代理人的多中心随机对照试验

• 批准号: 10367277
• 负责人: Wendy G. Lichtenthal
• 金额: $ 84.39万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2026-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10367277
• 关键词: Address; Advance Care Planning; Affect; Anger; Behavioral; Bereavement; Black race; Black, Indigenous, People of Color; COVID-19; COVID-19 pandemic; COVID-19 patient; Caregivers; Caring; Cessation of life; Cognitive; Communication; Conscious; Coronavirus; Critical Illness; Data; Decision Making; Disease; Dissemination and Implementation; Distress; Emotional; Equipment and supply inventories; Family; Family Caregiver; Family health status; Family member; Feeling; Goals; Grief reaction; Guilt; Hospitals; Indigenous; Intensive Care Units; Intervention; Interview; Left; Life; Life Experience; Loneliness; Mediating; Mediation; Mediator of activation protein; Medical; Medical center; Memorial Sloan-Kettering Cancer Center; Mental Depression; Mental Health; Methods; Modeling; Numbness; Outcome; Pain; Palliative Care; Parents; Patient Care; Patients; Persons; Positioning Attribute; Post-Traumatic Stress Disorders; Presbyterian Church; Psychological Techniques; Psychological adjustment; Quality of Care; Race; Randomized; Randomized Controlled Trials; Regrets; Reporting; Risk; Role; Severities; Site; Social Distance; Standardization; Stress; Structure; Symptoms; Techniques; Thinking; Trauma; United States; United States National Institutes of Health; Videoconferencing; Well in self; base; comparative efficacy; contextual factors; cultural competence; efficacy evaluation; end of life; end of life care; experience; flexibility; future implementation; improved; insight; intervention effect; loved ones; meetings; pandemic disease; people of color; perceived discrimination; post intervention; post-traumatic stress; post-traumatic symptoms; primary outcome; psychologic; psychological distress; psychological outcomes; psychological trauma; psychosocial; racial disparity; recruit; reduce symptoms; resilience; secondary outcome; stress symptom; symptomatic improvement; telehealth; traumatic stress; treatment as usual

Project Summary Intensive Care Units (ICUs) are stressful places fraught with grief and potentially traumatic exposures for those witnessing a critically ill family member in pain, struggling to breathe, maintain consciousness, and stay alive. Compounding their distress, family caregivers are often thrust into the position of patient “surrogate,” needing to make life-and-death decisions on the patient's behalf. We have shown that end-of-life (EoL) decision-making is compromised by elevated symptoms of distressing and disabling grief, resulting in family surrogates making suboptimal EoL choices that often prolong patient suffering, further exacerbating surrogates' grief, trauma, and regrets. The coronavirus (COVID-19) pandemic has made this bad situation worse, particularly among Black, Indigenous, and People of Color (BIPOC). Prior efforts to address the plight of these family surrogates have proved disappointing, with some significantly worsening surrogates' psychological trauma. Yet these were not psychological interventions, much less ones using psychological techniques with proven efficacy. To address these shortcomings, we developed a brief, flexibly administered intervention applying empirically supported cognitive-behavioral and acceptance-based techniques. In an R21 pilot, this intervention, EMPOWER (Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience), dramatically reduced experiential avoidance, grief, and traumatic stress, and was associated with higher rates of advance care planning, including among BIPOC. The proposed multisite, mixed-methods trial will randomize 172 family surrogates to receive EMPOWER (N=86) or a standardized supportive conversation (SC; N=86) delivered via videoconferencing. Surrogate symptoms will be assessed pre-intervention, immediately post-intervention, and 3- and 12-months post-intervention. The primary aim of this study is to compare the efficacy of EMPOWER to SC. We hypothesize that, compared to SC, EMPOWER will yield significantly greater declines in H1a. surrogate grief and posttraumatic stress (primary outcomes) and H1b. experiential avoidance, depression, regrets, and increase patients' receipt of value concordant care (secondary outcomes). The secondary aim of this study is to contextualize quantitative RCT results. H2. Qualitative interviews will provide complementary data on perceived barriers to and facilitators of symptom improvement, dissemination, and implementation, as well as insights into the impact of medical mistrust, perceived discrimination and COVID-19 on outcomes. The third aim will explore experiential avoidance as a mediator of intervention effects: H3. Reductions in experien- tial avoidance will mediate reductions in grief and posttraumatic stress. This study is expected to confirm EMPOWER's efficacy and enhance understanding of ways to improve telehealth delivery to psychologically vulnerable and historically underserved surrogates. If successful, EMPOWER will address the urgent need for effective, culturally competent interventions for distressed surrogates, which may improve critically ill patients' EoL experience in the context of extreme challenges that have been exacerbated by the COVID-19 pandemic.

项目摘要 重症监护室（ICU）是充满悲伤和潜在创伤暴露的压力场所， 目睹一个病重的家庭成员痛苦地挣扎着呼吸，维持意识，活下去。 更令他们痛苦的是，家庭照顾者经常被推到病人“代理人”的位置，需要 为病人做生死攸关的决定我们已经证明，生命终结（EoL）决策 由于痛苦和残疾的悲伤症状增加而受到损害，导致家庭代理人 次优的EoL选择，往往延长病人的痛苦，进一步加剧代理人的悲伤，创伤， 后悔冠状病毒（COVID-19）大流行使这种糟糕的情况变得更糟，特别是在黑人中， 土著和有色人种（BIPOC）。先前为解决这些家庭代理人的困境所做的努力， 结果令人失望，一些代理人的心理创伤明显恶化。然而， 心理干预，更不用说那些使用心理技术证明有效。解决 这些缺点，我们开发了一个简短的，灵活管理的干预应用经验支持 认知-行为和基于接受的技术。在R21试点中，这种干预， （增强和调动健康和情绪弹性的潜力），大大减少了体验 回避，悲伤和创伤性应激，并与更高的提前护理计划率相关， 包括BIPOC。拟议的多地点，混合方法试验将随机选择172个家庭代理人， 接受EMPOWER（N=86）或标准化支持性对话（SC; N=86），通过 视频会议。将在干预前、干预后立即评估替代症状， 3-和干预后12个月。本研究的主要目的是比较EMPOWER与 SC.我们假设，与SC相比，EMPOWER将产生H1 a的显著更大下降。 替代悲伤和创伤后应激（主要结局）和H1b。经验回避，抑郁， 遗憾，并增加患者接受价值一致的护理（次要结局）。第二个目的是 本研究将定量RCT结果置于情境中。H2。定性访谈将提供补充 关于症状改善、传播和实施的感知障碍和促进因素的数据， 以及对医疗不信任、感知歧视和COVID-19对结果的影响的见解。的 第三个目标将探讨经验回避作为中介的干预效果：H3。减少经验- 回避会减轻悲伤和创伤后压力。这项研究有望证实 增强权能方案的功效，并增进对如何改善远程保健服务的了解， 脆弱的和历史上得不到充分服务的代理人。如果成功，“增强权能”方案将解决以下迫切需要： 对痛苦的代理人进行有效的、文化上胜任的干预，这可能会改善危重患者的健康状况。 在COVID-19疫情加剧的极端挑战背景下，EoL的经验。