Mental and Physical Well-Being of Frontline Health Care Workers During Coronavirus Disease 2019 (COVID-19)

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Mental and Physical Well-Being of Frontline Health Care Workers During Coronavirus Disease 2019 (COVID-19)

Conditions
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Healthy

Intervention / Treatment
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* Behavioral: Stress First Aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Health care workers and patient-facing support staff (e.g., front desk staff) Exclusion Criteria: Non-English speaking
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stress First Aid<br>The cRCT will be comprised of three cohorts of matched pairs representing approximately 40 diverse sites (12-15 pairs of hospitals hospitals and 5-7 pairs of clinics/practices) to determine whether SFA for frontline HCWs improves mental and physical well-being compared to Usual Care (UC). Each pair will be assigned to either SFA or UC using a simple 1:1 randomization. SFA sites will implement SFA through a train-the-trainer model. | Behavioral: Stress First Aid<br>* 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.<br>|
| No Intervention: Usual Care<br>The cRCT will be comprised of three cohorts of matched pairs representing approximately 40 diverse sites (12-15 pairs of hospitals hospitals and 5-7 pairs of clinics/practices) to determine whether SFA for frontline HCWs improves mental and physical well-being compared to Usual Care (UC). Each pair will be assigned to either SFA or UC using a simple 1:1 randomization. UC sites will not implement SFA during the study period but will be given full access to all implementation materials following the conclusion of their participation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posttraumatic Stress Disorder (PTSD) | Posttraumatic Stress Checklist (PCL); a Diagnostic and Statistical Manual of Mental Disorders a 20-item measure of PTSD symptoms rated on 0-4 frequency scale | Pre-SFA intervention: months 1 to 2 | 
| PTSD | Posttraumatic Stress Checklist (PCL); a Diagnostic and Statistical Manual of Mental Disorders a 20-item measure of PTSD symptoms rated on 0-4 frequency scale | Post-SFA intervention: months 3 to 5 | 
| Psychological Distress | Kessler 6 Distress Scale (K-6) for general psychological distress. This is a 6-item inventory rated on a 5 point Likert-type scale. | Pre-SFA intervention: months 1 to 2 | 
| Psychological Distress | Kessler 6 Distress Scale (K-6) for general psychological distress. This is a 6-item inventory rated on a 5 point Likert-type scale. | Post-SFA intervention: months 3 to 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Impairment | PROMIS Sleep Related Impairment. A 4-item subscale which is rated from 1-5 (not at all to very much). | Pre-SFA intervention: months 1 to 2 | 
| Sleep Impairment | PROMIS Sleep Related Impairment. A 4-item subscale which is rated from 1-5 (not at all to very much). | Post-SFA intervention: months 3 to 5 | 
| Workplace stress | American Psychological Association's Stress in the Workplace survey; 3 items rated on a 1-5 scale from strongly disagree to strongly agree | Pre-SFA intervention: months 1 to 2 | 
| Workplace stress | American Psychological Association's Stress in the Workplace survey; 3 items rated on a 1-5 scale from strongly disagree to strongly agree | Post-SFA intervention: months 3 to 5 | 
| Resilience | Connor Davidson Resilience Scale (CDRISC); a brief (2-item) version of the scale, rated from 1-5 (not true at all to true nearly all the time) | Pre-SFA intervention: months 1 to 2 | 
| Resilience | Connor Davidson Resilience Scale (CDRISC); a brief (2-item) version of the scale, rated from 1-5 (not true at all to true nearly all the time) | Post-SFA intervention: months 3 to 5 | 
| Burnout | Dolan single item burnout inventory; participants choose the description of burnout level that reflects their experience. | Pre-SFA intervention: months 1 to 2 | 
| Burnout | Dolan single item burnout inventory; participants choose the description of burnout level that reflects their experience. | Post-SFA intervention: months 3 to 5 | 
| Moral Distress | Moral Distress Thermometer; single item Sliding scale with responses rated on a 0-10 scale from none to worst possible. | Pre-SFA intervention: months 1 to 2 | 
| Moral Distress | Moral Distress Thermometer; single item Sliding scale with responses rated on a 0-10 scale from none to worst possible. | Post-SFA intervention: months 3 to 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthcare worker, stress, fatigue, anxiety, burnout, COVID-19, stress first aid