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

Sponsor

RAND (Other)

Overall Status

Recruiting

CT.gov ID

NCT04723576

Collaborator

Stanford University (Other), Clinical Directors Network (Other), Vizient (Other)

2,132

Enrollment

Locations

Arms

32.7

Anticipated Duration (Months)

1066

Patients Per Site

32.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Behavioral: Stress First Aid	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

2132 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Mar 11, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
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.

Arm

Intervention/Treatment

Experimental: 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.

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.

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.

Outcome Measures

Primary Outcome Measures

Posttraumatic Stress Disorder (PTSD) [Pre-SFA intervention: months 1 to 2]
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
PTSD [Post-SFA intervention: months 3 to 5]
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
Psychological Distress [Pre-SFA intervention: months 1 to 2]
Kessler 6 Distress Scale (K-6) for general psychological distress. This is a 6-item inventory rated on a 5 point Likert-type scale.
Psychological Distress [Post-SFA intervention: months 3 to 5]
Kessler 6 Distress Scale (K-6) for general psychological distress. This is a 6-item inventory rated on a 5 point Likert-type scale.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Non-English speaking

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Directors Network, Inc	New York	New York	United States	10018
2	Vizient Inc.	Irving	Texas	United States	75062

Sponsors and Collaborators

RAND
Stanford University
Clinical Directors Network
Vizient

Investigators

Study Director: Melanie Renzi, RAND

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lisa Meredith, Senior Behavioral Scientist, RAND

ClinicalTrials.gov Identifier:

NCT04723576

Other Study ID Numbers:

COVID-2020C2-10721
COVID-2020C2-10721

First Posted:

Jan 25, 2021

Last Update Posted:

Jun 8, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lisa Meredith, Senior Behavioral Scientist, RAND

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Jun 8, 2022