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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04723576

Acronym

COVER-HCW

Enrollment

7444

Registered

2021-01-25

Start date

2021-03-11

Completion date

2022-07-29

Last updated

2025-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

healthcare worker, stress, fatigue, anxiety, burnout, COVID-19, stress first aid

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).

Interventions

BEHAVIORALStress 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Outcomes Assessor)

Masking description

Masking of research staff will be performed to the extent possible in this study. The survey data can be analyzed in a blinded fashion. However, due to the nature of qualitative research (described below), masking will not be possible for this data collection effort. Given that no qualitative research can be performed in a blinded way, we do not anticipate the lack of masking to affect our qualitative results adversely.

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* Non-English speaking

Design outcomes

Primary

Measure	Time frame	Description
PTSD Symptom Severity	Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)	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.
Psychological Distress	Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)	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.

Secondary

Measure	Time frame	Description
Resilience	Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)	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.
Sleep-Related Impairment	Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)	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.
Moral Distress	Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)	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.
Burnout	Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)	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.
Workplace Stress	Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)	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.

Countries

United States

Participant flow

Recruitment details

28 hospitals and Federally Qualified Health Centers (FQHCs) throughout the US were recruited in 3 consecutive cohorts and enrolled from March 2021 through July 2022. Participating sites were matched as pairs by type, size, and COVID-19 burden and then randomized to the intervention arm or usual care arm.

Pre-assignment details

Health care worker (HCW) participants completed a pre-intervention survey prior to randomization.

Participants by arm

Arm	Count
Stress First Aid 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. 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.	862
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.	1,215
Total	2,077

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Withdrawal by Subject	2,133	3,234

Baseline characteristics

Characteristic	Total	Usual Care	Stress First Aid
Age, Customized <= 30	498 Participants	275 Participants	223 Participants
Age, Customized 31-50	1182 Participants	696 Participants	486 Participants
Age, Customized >= 51	392 Participants	240 Participants	152 Participants
Age, Customized Missing	5 Participants	4 Participants	1 Participants
Professional Role Administrative or Other	351 Participants	171 Participants	180 Participants
Professional Role Assistant or Technician	585 Participants	285 Participants	300 Participants
Professional Role Clinician	296 Participants	219 Participants	77 Participants
Professional Role Nurse	845 Participants	540 Participants	305 Participants
Race/Ethnicity, Customized Black	277 Participants	145 Participants	132 Participants
Race/Ethnicity, Customized Hispanic or Latino//Latina	416 Participants	259 Participants	157 Participants
Race/Ethnicity, Customized Other	439 Participants	331 Participants	108 Participants
Race/Ethnicity, Customized White	945 Participants	480 Participants	465 Participants
Sex: Female, Male Female	1643 Participants	947 Participants	696 Participants
Sex: Female, Male Male	418 Participants	259 Participants	159 Participants
Time at Site <= 5 years	1231 Participants	696 Participants	535 Participants
Time at Site >5 years	846 Participants	519 Participants	327 Participants
Time in Profession <= 5 years	767 Participants	419 Participants	348 Participants
Time in Profession > 5 years	1310 Participants	796 Participants	514 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 0	0 / 0
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

Primary

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.