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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Behavioral: Stress First Aid

Detailed Description

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
• Enrollment (Actual): 7444
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10018
      • Clinical Directors Network, Inc
  • Texas
    • Irving, Texas, United States, 75062
      • Vizient Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Health care workers and patient-facing support staff (e.g., front desk staff)

Exclusion Criteria:

• Non-English speaking

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; 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.
Experimental: Stress First Aid; The cluster Randomized Controlled Trial (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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)

Collaborators and Investigators

• Sponsor: RAND
• Collaborators: Stanford University; Clinical Directors Network; Vizient
• Investigators: Study Director: Melanie Renzi, RAND

Publications and helpful links

General Publications

• Dong L, Meredith LS, Farmer CM, Ahluwalia SC, Chen PG, Bouskill K, Han B, Qureshi N, Dalton S, Watson P, Schnurr PP, Davis K, Tobin JN, Cassells A, Gidengil CA. Protecting the mental and physical well-being of frontline health care workers during COVID-19: Study protocol of a cluster randomized controlled trial. Contemp Clin Trials. 2022 Jun;117:106768. doi: 10.1016/j.cct.2022.106768. Epub 2022 Apr 22.
• Meredith LS, Ahluwalia S, Chen PG, Dong L, Farmer CM, Bouskill KE, Dalton S, Qureshi N, Blagg T, Timmins G, Schulson LB, Huilgol SS, Han B, Williamson S, Watson P, Schnurr PP, Martineau M, Davis K, Cassells A, Tobin JN, Gidengil C. Testing an Intervention to Improve Health Care Worker Well-Being During the COVID-19 Pandemic: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e244192. doi: 10.1001/jamanetworkopen.2024.4192.
• Bandini JI, Ahluwalia SC, Timmins G, Bialas A, Meredith L, Gidengil C. "It Haunts Me": Impact of COVID-19 Deaths on Frontline Clinicians In Acute Care Settings-A Qualitative Study. Am J Crit Care. 2023 Sep 1;32(5):368-374. doi: 10.4037/ajcc2023257.
• Timmins GT, Bandini JI, Ahluwalia SC, Bialas A, Meredith LS, Gidengil C. 'You just don't feel like your work goes recognised': healthcare worker experiences of tension related to public discourse around the COVID-19 pandemic. BMJ Lead. 2024 Dec 23;8(4):324-328. doi: 10.1136/leader-2024-000983.
• Qureshi N, Huilgol SS, Timmins G, Meredith LS, Gidengil CA. Misaligned Supports: Differences in Reported Health Care Worker Well-being Supports Provided and Needed During the COVID-19 Pandemic. Am J Health Promot. 2025 Jan;39(1):63-75. doi: 10.1177/08901171241255764. Epub 2024 Jun 21.

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2021
• Primary Completion (Actual): July 29, 2022
• Study Completion (Actual): July 29, 2022

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: fatigue; COVID-19; anxiety; stress; healthcare worker; burnout; stress first aid
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: COVID-2020C2-10721 (Other Grant/Funding Number: PCORI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will follow the funder's protocol for uploading data.
• IPD Sharing Time Frame: December 2022
• IPD Sharing Access Criteria: The study data are available to qualified researchers and provided a de-identified copy of the study data and related documentation to the REGENTS OF THE UNIVERSITY OF MICHIGAN on behalf of the INTER-UNIVERSITY CONSORTIUM FOR POLITICAL AND SOCIAL RESEARCH (ICPSR) for the purpose of allowing ICPSR to examine, process, and distribute the data to qualified researchers as determined by ICPSR.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No