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.

项目总结