Development and preliminary evaluation of EMPOWER for surrogate decision-makers of critically ill patients.

OBJECTIVE: The objectives of this study were to develop and refine EMPOWER (Enhancing and Mobilizing the POtential for Wellness and Resilience), a brief manualized cognitive-behavioral, acceptance-based intervention for surrogate decision-makers of critically ill patients and to evaluate its preliminary feasibility, acceptability, and promise in improving surrogates' mental health and patient outcomes. METHOD: Part 1 involved obtaining qualitative stakeholder feedback from 5 bereaved surrogates and 10 critical care and mental health clinicians. Stakeholders were provided with the manual and prompted for feedback on its content, format, and language. Feedback was organized and incorporated into the manual, which was then re-circulated until consensus. In Part 2, surrogates of critically ill patients admitted to an intensive care unit (ICU) reporting moderate anxiety or close attachment were enrolled in an open trial of EMPOWER. Surrogates completed six, 15-20 min modules, totaling 1.5-2 h. Surrogates were administered measures of peritraumatic distress, experiential avoidance, prolonged grief, distress tolerance, anxiety, and depression at pre-intervention, post-intervention, and at 1-month and 3-month follow-up assessments. RESULTS: Part 1 resulted in changes to the EMPOWER manual, including reducing jargon, improving navigability, making EMPOWER applicable for a range of illness scenarios, rearranging the modules, and adding further instructions and psychoeducation. Part 2 findings suggested that EMPOWER is feasible, with 100% of participants completing all modules. The acceptability of EMPOWER appeared strong, with high ratings of effectiveness and helpfulness (M = 8/10). Results showed immediate post-intervention improvements in anxiety (d = -0.41), peritraumatic distress (d = -0.24), and experiential avoidance (d = -0.23). At the 3-month follow-up assessments, surrogates exhibited improvements in prolonged grief symptoms (d = -0.94), depression (d = -0.23), anxiety (d = -0.29), and experiential avoidance (d = -0.30). SIGNIFICANCE OF RESULTS: Preliminary data suggest that EMPOWER is feasible, acceptable, and associated with notable improvements in psychological symptoms among surrogates. Future research should examine EMPOWER with a larger sample in a randomized controlled trial.

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

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.

Sex Differences in Tobacco Use Among Persons Living With HIV/AIDS: A Systematic Review and Meta-Analysis.

BACKGROUND: Persons living with HIV/AIDS (PLWH) smoke at higher rates than other adults and experience HIV-related and non-HIV-related adverse smoking consequences. This study conducted a systematic review to synthesize current knowledge about sex differences in smoking behaviors among PLWH. METHODS: Over 3000 abstracts from MEDLINE were reviewed and 79 publications met all the review inclusion criteria (ie, reported data on smoking behaviors for PLWH by sex). Sufficient data were available to conduct a meta-analysis for one smoking variable: current smoking prevalence. RESULTS: Across studies (n = 51), the meta-analytic prevalence of current smoking among female PLWH was 36.3% (95% confidence interval [CI]: 28.0% to 45.4%) and male PLWH was 50.3% (95% CI: 44.4% to 56.2%; meta-analytic odds ratio = 1.78, 95% CI: 1.29 to 2.45). When analyses were repeated just on the US studies (n = 23), the prevalence of current smoking was not significantly different for female PLWH (55.1%, 95% CI: 47.6% to 62.5%) compared with male PLWH (55.5%, 95% CI: 48.2% to 62.5%; meta-analytic odds ratio = 1.04, 95% CI: 0.86 to 1.26). Few studies reported data by sex for other smoking variables (eg, quit attempts, noncigarette tobacco product use) and results for many variables were mixed. DISCUSSION: Unlike the general US population, there was no difference in smoking prevalence for female versus male PLWH (both >50%) indicating that HIV infection status was associated with a greater relative increase in smoking for women than men. More research is needed in all areas of smoking behavior of PLWH to understand similarities and differences by sex to provide the best interventions to reduce the high smoking prevalence for all sexes.