ABSTRACT
RATIONALE: The COVID-19 pandemic exacerbated psychological distress and burnout in frontline healthcare workers. Interventions addressing psychological distress and burnout among these workers are lacking. OBJECTIVE: Determine feasibility and explore impact of mobile mindfulness to treat psychological distress and burnout among nurses in frontline COVID-19 units. METHODS: Pilot randomized trial of 102 nurses working in COVID-19 units at a single hospital between May 2021 and January 2022. Participants were randomized to mobile mindfulness (intervention) or waitlist (control). The primary outcome was feasibility, assessed by comparing rates of randomization, retention, and intervention completion to predefined targets. Secondary outcomes were changes in psychological distress (Patient Health Questionnaire-9 [PHQ-9], General Anxiety Disorder-7 [GAD-7], Perceived Stress Scale-4 [PSS-4]) and burnout symptoms (Maslach Burnout Inventory [MBI]) after one month. MAIN RESULTS: We randomized 102 of 113 consented individuals (90%, target 80%), and 88 completed follow-up (86%, target 80%). Among 69 intervention participants, 19 completed ≥1 mindfulness session per week (28%, target 60%) and 13 completed ≥75% of mindfulness sessions (19%, target 50%). Intervention participants had greater decreases in PHQ-9 scores than controls (Difference in differences [DID] = -2.21; 95% CI, -3.99, -0.42; p = 0.016), but the MBI-depersonalization scores decreased more in controls arm compared to intervention (DID = 1.60; 95% CI, 0.18, 3.02; p = 0.027). There were no other changes in emotional distress or burnout symptoms. CONCLUSION: This trial of mobile mindfulness in frontline nurses met feasibility targets for randomization and retention, but participants had modest intervention usage. Intervention participants had a reduction in depression symptoms, but not burnout. This article is open access and distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/). Clinical trial registration available at www. CLINICALTRIALS: gov, ID: NCT04816708.
ABSTRACT
INTRODUCTION: The technologies used to treat the millions who receive care in intensive care unit (ICUs) each year have steadily advanced. However, the quality of ICU-based communication has remained suboptimal, particularly concerning for Black patients and their family members. Therefore we developed a mobile app intervention for ICU clinicians and family members called ICUconnect that assists with delivering need-based care. OBJECTIVE: To describe the methods and early experiences of a clustered randomized clinical trial (RCT) being conducted to compare ICUconnect vs. usual care. METHODS AND ANALYSIS: The goal of this two-arm, parallel group clustered RCT is to determine the clinical impact of the ICUconnect intervention in improving outcomes overall and for each racial subgroup on reducing racial disparities in core palliative care outcomes over a 3-month follow up period. ICU attending physicians are randomized to either ICUconnect or usual care, with outcomes obtained from family members of ICU patients. The primary outcome is change in unmet palliative care needs measured by the NEST instrument between baseline and 3 days post-randomization. Secondary outcomes include goal concordance of care and interpersonal processes of care at 3 days post-randomization; length of stay; as well as symptoms of depression, anxiety, and post-traumatic stress disorder at 3 months post-randomization. We will use hierarchical linear models to compare outcomes between the ICUconnect and usual care arms within all participants and assess for differential intervention effects in Blacks and Whites by adding a patient-race interaction term. We hypothesize that both compared to usual care as well as among Blacks compared to Whites, ICUconnect will reduce unmet palliative care needs, psychological distress and healthcare resource utilization while improving goal concordance and interpersonal processes of care. In this manuscript, we also describe steps taken to adapt the ICUconnect intervention to the COVID-19 pandemic healthcare setting. ENROLLMENT STATUS: A total of 36 (90%) of 40 ICU physicians have been randomized and 83 (52%) of 160 patient-family dyads have been enrolled to date. Enrollment will continue until the end of 2021.