Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience (EMPOWER) among Surrogate Decision-Makers of ICU Patients: study protocol for a randomized controlled trial

Holly G Prigerson, Martin Viola, Chris R Brewin, Christopher Cox, Daniel Ouyang, Madeline Rogers, Cynthia X Pan, Shayna Rabin, Jiehui Xu, Susan Vaughan, Janna S Gordon-Elliot, David Berlin, Lindsay Lief, Wendy G Lichtenthal, Holly G Prigerson, Martin Viola, Chris R Brewin, Christopher Cox, Daniel Ouyang, Madeline Rogers, Cynthia X Pan, Shayna Rabin, Jiehui Xu, Susan Vaughan, Janna S Gordon-Elliot, David Berlin, Lindsay Lief, Wendy G Lichtenthal

Abstract

Background: Critical illness increases the risk for poor mental health outcomes among both patients and their informal caregivers, especially their surrogate decision-makers. Surrogates who must make life-and-death medical decisions on behalf of incapacitated patients may experience additional distress. EMPOWER (Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience) is a novel cognitive-behavioral, acceptance-based intervention delivered in the intensive care unit (ICU) setting to surrogate decision-makers designed to improve both patients' quality of life and death and dying as well as surrogates' mental health.

Methods: Clinician stakeholder and surrogate participant feedback (n = 15), as well as results from an open trial (n = 10), will be used to refine the intervention, which will then be evaluated through a multisite randomized controlled trial (RCT) (n = 60) to examine clinical superiority to usual care. Feasibility, tolerability, and acceptability of the intervention will be evaluated through self-report assessments. Hierarchical linear modeling will be used to adjust for clustering within interventionists to determine the effect of EMPOWER on surrogate differences in the primary outcome, peritraumatic stress. Secondary outcomes will include symptoms of post-traumatic stress disorder, prolonged grief disorder, and experiential avoidance. Exploratory outcomes will include symptoms of anxiety, depression, and decision regret, all measured at 1 and 3 months from post-intervention assessment. Linear regression models will examine the effects of assignment to EMPOWER versus the enhanced usual care group on patient quality of life or quality of death and intensity of care the patient received during the indexed ICU stay assessed at the time of the post-intervention assessment. Participant exit interviews will be conducted at the 3-month assessment time point and will be analyzed using qualitative thematic data analysis methods.

Discussion: The EMPOWER study is unique in its application of evidence-based psychotherapy targeting peritraumatic stress to improve patient and caregiver outcomes in the setting of critical illness. The experimental intervention will be strengthened through the input of a variety of ICU stakeholders, including behavioral health clinicians, physicians, bereaved informal caregivers, and open trial participants. Results of the RCT will be submitted for publication in a peer-reviewed journal and serve as preliminary data for a larger, multisite RCT grant application.

Trial registration: ClinicalTrials.gov, NCT03276559 . Retrospectively registered on 8 September 2017.

Keywords: Caregivers; Communication; Critical illness; Medical decision-making; Peritraumatic distress; Psychological distress; Surrogate decision-makers.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
EMPOWER timeline. EMPOWER Enhancing & Mobilizing the POTential for Wellness & Emotional Resilience among Surrogate Decision-Makers of ICU Patients, ICU intensive care unit
Fig. 2
Fig. 2
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure. BEAQ Brief Experiential Avoidance Questionnaire, CEQUEL caregiver evaluation of the quality of end-of-life care, EMPOWER Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience, EUC, ICU intensive care unit, IES-R Impact of Events Scale—Revised, PDEQ Peritraumatic Dissociative Experiences Questionnaire, PDI Peritraumatic Distress Inventory, PG-12/13 Prolonged Grief Disorder-12/13, PHQ-9 Patient Health Questionnaire, STAI State Trait Anxiety Questionnaire

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