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

NCT ID: NCT04723576

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7444 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-11
• Study Completion Date: 2022-07-29

Brief Summary

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

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).

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Stress First Aid

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Non-English speaking

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

Clinical Directors Network

NETWORK

Sponsor Role: collaborator

Vizient

UNKNOWN

Sponsor Role: collaborator

RAND

OTHER

Sponsor Role: lead

Responsible Party

Lisa Meredith

Senior Behavioral Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melanie Renzi

Role: STUDY_DIRECTOR

RAND

Locations

Clinical Directors Network, Inc

New York, New York, United States

Vizient Inc.

Irving, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 35470104 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38687482 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37652873 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38553036 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38907369 (View on PubMed)

Timmins G, Williamson S, Cassells A, Davis K, Dong L, Tobin JN, Gidengil C, Meredith LS, Chen PG. Health care worker experiences with a brief peer support and well-being intervention during the COVID-19 pandemic. BMC Health Serv Res. 2025 Sep 30;25(1):1253. doi: 10.1186/s12913-025-13268-6.

Reference Type: DERIVED

PMID: 41029307 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

COVID-2020C2-10721

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

COVID-2020C2-10721

Identifier Type: -

Identifier Source: org_study_id