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

Healthy Clinical Trial

— COVER-HCW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04723576
• Other study ID #: COVID-2020C2-10721
• Secondary ID: COVID-2020C2-107
• Status: Completed
• Phase: N/A
• Start date: March 11, 2021
• Est. completion date: July 29, 2022

Study information

• Verified date: April 2024
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2077
• Est. completion date: July 29, 2022
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Non-English speaking

Related Conditions & MeSH terms

• COVID-19
• Healthy

Intervention

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.

Locations

Country	Name	City	State
United States	Vizient Inc.	Irving	Texas
United States	Clinical Directors Network, Inc	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
RAND	Clinical Directors Network, Stanford University, Vizient

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Burnout	Dolan single item burnout inventory; participants choose the description of burnout level that reflects their experience.	Pre-SFA intervention: months 1 to 2
Secondary	Burnout	Dolan single item burnout inventory; participants choose the description of burnout level that reflects their experience.	Post-SFA intervention: months 3 to 5
Secondary	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
Secondary	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