Study to support the mental and physical well-being of US health care workers during the COVID-19 pandemic and ensure high-quality care for patients through Stress First Aid.
The goal of the project is to support the mental and physical well-being of U.S. health care workers (HCWs) during the COVID-19 pandemic to ensure high-quality care for patients, by establishing the effectiveness of a tailored Stress First Aid (SFA) intervention, compared to usual care (UC). The RAND Corporation will conduct a cluster randomized controlled trial (cRCT) with three cohorts containing matched pairs in approximately 40 diverse sites (hospitals and clinics) to evaluate whether SFA for HCWs improves mental and physical well-being compared to UC. Sequential roll-out of the intervention to three cohorts will allow investigators to quickly incorporate lessons learned and stakeholder feedback from each iteration into subsequent trainings, and share actionable findings given the urgency due to the pandemic. The end result will be an SFA toolkit tailored for HCWs that can be implemented and scaleable across multiple settings. The proposed SFA intervention addresses an important and compelling clinical care delivery challenge during COVID-19 by improving the mental well-being of HCWs, who will benefit directly and be better equipped to provide higher quality, more sustained, and more patient-centered care to patients. The specific aims of the project are to: (1) test the comparative effectiveness of SFA versus UC on mental and physical well-being (quantitative); (2) understand and document any UC activities to support HCW well-being prior to implementing SFA across sites; and (3) assess the experiences of HCWs and sites with SFA (acceptability, likelihood of uptake, lessons learned) and impact on HCW well-being (qualitative).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
7,444
Stress First Aid (SFA) is an evidence-based intervention to mitigate the psychosocial impact of COVID-19 on Health Care Workers (HCWs). SFA was initially developed for the United States Navy and Marine Corps as a framework of actions for peer support delivered by individuals without mental health training. SFA is designed to teach simple, supportive actions that can be seamlessly integrated into work environments. SFA training focuses on five essential principles: cover (restore and support a sense of safety), calm (encourage simple strategies such as breathing), connect (engage in and promote social support), competence (improve ability to address crucial needs and concerns), and confidence (increase hope and limit self-doubt and guilt). In this study, we are adapting the SFA model to include HCW-specific examples of SFA actions and case scenarios specific to the COVID-19 pandemic and will implement SFA using a "train-the trainer" model.
Clinical Directors Network, Inc
New York, New York, United States
Vizient Inc.
Irving, Texas, United States
PTSD Symptom Severity
Posttraumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual (DSM) of Mental Disorders (PCL-5). The PCL-5 is a 20-item measure of PTSD symptom severity. Each item is rated on 0-4 frequency scale. Items are summed to create a total score ranging from 0-80 where a higher score indicates worse outcomes.
Time frame: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)
Psychological Distress
Kessler 6 Distress Scale (K-6) for general psychological distress in the past 30 days. This is a 6-item inventory. Each of the items is scored from "none of the time" (0) to "all of the time" (4). Items are summed for a total score ranging from 0-24 where a higher score indicates worse outcomes.
Time frame: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)
Sleep-Related Impairment
The Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment (SRI) includes 4 items to assess sleep impairment over the past seven days. Each of the items are rated from 1-5 (not at all to very much). Items are summed into a scale ranging from 4-20 where a higher score indicates worse outcomes.
Time frame: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)
Workplace Stress
American Psychological Association's (APA) Stress in the Workplace survey; 3 items rated on a 1-5 scale from strongly disagree to strongly agree. A summed scale is formed ranging from 3-15 in which a higher score indicates worse outcomes/more stress.
Time frame: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)
Resilience
Connor Davidson Resilience Scale (CDRISC); a brief (2-item) version of the scale with items rated from 0-4 (not true at all to true nearly all the time). Items are summed into a total scale ranging from 0-8 in which a higher score indicates better outcomes.
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Time frame: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)
Burnout
Dolan single item with 5 responses options ranging from 1\[I enjoy my work. I haven symptoms of burnout.\] to 5 \[I feel completely burned out.\]; We created a binary indicator to measure the percent of participants who reported experiencing symptoms of burnout.
Time frame: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)
Moral Distress
We used the Moral Distress Thermometer, a single item sliding scale with responses rated on a 0-10 scale (none to worst possible) where a higher score indicates worse outcomes.
Time frame: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)