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: 10599859
• 负责人: Wendy G. Lichtenthal
• 金额: $ 77.36万
• 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/10599859
• 关键词: Address; Advance Care Planning; Affect; Anger; Behavioral; Bereavement; Black race; Black, Indigenous, People of Color; Breathing; COVID-19; COVID-19 pandemic; COVID-19 patient; Caregivers; Caring; Cessation of life; Cognitive; Communication; Confusion; Conscious; Critical Illness; Data; Decision Making; Disease; Disorientation; 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; 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; Structure; Symptoms; Techniques; Thinking; Trauma; United States; United States National Institutes of Health; Videoconferencing; comparative efficacy; contextual factors; coronavirus pandemic; cultural competence; disease transmission; 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; 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 重症监护病房(ICU)是充满压力的地方，对那些充满悲伤和潜在创伤的人来说 亲眼目睹一个身患重病的家庭成员在痛苦中挣扎，挣扎着呼吸，保持意识，活着。 使他们更加痛苦的是，家庭照顾者经常被推到病人的“代孕”的位置上，需要 为病人做出生死攸关的决定。我们已经展示了生命周期终止(EoL)决策 由于痛苦和致残悲伤的症状增加而受到损害，导致家庭代孕 次优的EoL选择通常会延长患者的痛苦，进一步加剧代孕者的悲伤、创伤和 我后悔了。冠状病毒(新冠肺炎)的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)。之前为解决这些家庭代孕母亲的困境所做的努力 事实证明，这令人失望，一些代孕者的心理创伤明显恶化。然而，这些都不是 心理干预，更少使用已被证明有效的心理技术。致信地址 这些缺点，我们开发了一种简短、灵活的干预措施，应用经验支持 认知-行为和基于接受的技术。在R21试验中，这种干预赋予了 (增强和调动健康和情绪韧性的潜力)，极大地降低了体验感 回避、悲伤和创伤性压力，并与较高的提前护理计划率有关， 包括在BIPOC中。拟议的多点混合方法试验将随机选择172名家庭代孕者 获得授权(N=86)或标准化支持性对话(SC；N=86)，通过 视频会议。代理症状将在干预前、干预后立即进行评估，并 干预后3个月和12个月。这项研究的主要目的是比较赋权和 南加州大学。我们假设，与SC相比，Empower将在H1a产生显著更大的下降。 代孕悲痛和创伤后应激(主要结果)和H1B。经验回避，抑郁， 遗憾，并增加患者接受价值协调的护理(次要结果)。的次要目标 这项研究是为了将定量随机对照试验的结果与背景联系起来。H2。定性访谈将提供补充 症状改善、传播和实施的公认障碍和促进者的数据，如 以及对医疗不信任、感知歧视和新冠肺炎对结果影响的洞察。这个 第三个目标将探索经验回避作为干预效果的中介：H3。经验的减少- 回避TIAL将有助于减轻悲痛和创伤后压力。这项研究有望证实 增强远程保健的有效性，并加强对改善远程保健服务的方法的理解 易受伤害和历来服务不足的代孕妈妈。如果成功，Empower将解决以下迫切需求 对痛苦的代孕母亲进行有效的、有文化能力的干预，这可能会改善危重患者的 在极端挑战的背景下，新冠肺炎大流行加剧了对生命周期的体验。