A Multisite Randomized Controlled Trial of EMPOWER for Family Surrogates of Critically Ill Patients - ABSTRACT 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 often opting for costly EoL care that has consumed a quarter of annual Medicare expenditures, prolonged suffering and exacerbated surrogates’ grief, trauma, and regrets. 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. 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 with qualitative findings. H2. Qualitative interviews will provide complementary data on perceived barriers to and facilitators of symptom improvement, dissemination, and implementation of EMPOWER in critical care settings. The third aim will explore experiential avoidance as a mediator of intervention effects. H3. Reductions in experiential 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 its delivery to psychologically vulnerable surrogates. If successful, EMPOWER will address the urgent need for effective interventions for distressed surrogates, preventing adverse mental and physical health outcomes for these vulnerable caregivers as well as poor EoL outcomes among patients, decreasing related healthcare spending.
