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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要重症监护病房 (ICU) 是一个压力很大的地方，充满了悲伤和潜在的创伤性暴露目睹一位病重的家庭成员痛苦不堪、呼吸困难、维持意识并维持生命。家庭护理人员常常被推到病人“代理人”的位置，需要帮助，这让他们的痛苦更加复杂。代表患者做出生死攸关的决定我们已经证明了临终 (EoL) 决策。因令人痛苦和丧失能力的悲伤症状加剧而受到损害，导致家庭代理人做出次优的 EoL 选择往往会延长患者的痛苦，进一步加剧代理人的悲伤、创伤和遗憾的是，冠状病毒（COVID-19）的流行使这种糟糕的情况变得更糟，特别是在黑人中，原住民和有色人种 (BIPOC) 之前为解决这些家庭代孕妈妈的困境所做的努力。事实证明，结果令人失望，一些代孕妈妈的心理创伤明显恶化，但事实并非如此。心理干预，更不用说使用已被证明有效的心理技术来解决。针对这些缺点，我们应用经验支持的方法开发了一种简短的、灵活管理的干预措施在 R21 试点中，这种干预措施是 EMPOWER。（增强和调动健康和情绪弹性的潜力），大大减少了经验回避、悲伤和创伤性压力，并与较高的预先护理计划率相关，拟议的多地点、混合方法试验将随机分配 172 个家庭代孕者。接收 EMPOWER (N=86) 或标准化支持性对话 (SC; N=86) 将在干预前、干预后立即评估替代症状。本研究的主要目的是比较 EMPOWER 与干预后 3 个月和 12 个月的疗效。 SC。我们认为，与 SC 相比，EMPOWER 将在上半年产生更大的下降。替代悲伤和创伤后应激（主要结果）和 H1b 体验性回避、抑郁、遗憾，并增加患者接受有价值的一致护理（次要结果）。这项研究旨在将定量 RCT 结果置于背景中，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，如以及对医疗不信任、感知歧视和 COVID-19 对结果影响的见解。第三个目标将探索体验回避作为干预效果的中介：H3。回避将有助于减轻悲伤和创伤后压力，这项研究有望得到证实。 EMPOWER 的功效并增强对改善心理健康远程医疗服务的方法的理解如果成功，EMPOWER 将解决弱势且历来服务不足的代孕妈妈的迫切需求。对陷入困境的代理人进行有效的、文化上合适的干预措施，这可能会改善危重患者的病情在 COVID-19 大流行加剧的极端挑战背景下的 EoL 经验。