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

• ClinicalTrials.gov Identifier: NCT04723576
• Recruitment Status: Completed
• First Posted: January 25, 2021
• Last Update Posted: April 11, 2024
• Sponsor: RAND
• Collaborators: Stanford University; Clinical Directors Network; Vizient
• Information provided by (Responsible Party): Lisa Meredith, RAND

Tracking Information

• First Submitted Date: January 14, 2021
• First Posted Date: January 25, 2021
• Last Update Posted Date: April 11, 2024
• Actual Study Start Date: March 11, 2021
• Actual Primary Completion Date: July 29, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 22, 2021)

• Posttraumatic Stress Disorder (PTSD) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 22, 2021)

• Sleep Impairment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Pre-SFA intervention: months 1 to 2 ]
  Dolan single item burnout inventory; participants choose the description of burnout level that reflects their experience.
• Burnout [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Mental and Physical Well-Being of Frontline Health Care Workers During Coronavirus Disease 2019 (COVID-19)
• Official Title: Mental and Physical Well-Being of Frontline Health Care Workers During Coronavirus Disease 2019 (COVID-19)
• 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).
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: 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.

Study Arms

• 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.
  Intervention: Behavioral: Stress First Aid
• 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.

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 9, 2024): 2077
• Original Estimated Enrollment (submitted: January 22, 2021): 2132
• Actual Study Completion Date: July 29, 2022
• Actual Primary Completion Date: July 29, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Non-English speaking

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04723576
• Other Study ID Numbers: COVID-2020C2-10721; COVID-2020C2-10721 ( Other Grant/Funding Number: PCORI )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: We will follow the funder's protocol for uploading data.
• Supporting Materials: Study Protocol
• Supporting Materials: Informed Consent Form (ICF)
• Time Frame: December 2022.

• Current Responsible Party: Lisa Meredith, RAND
• Original Responsible Party: Same as current
• Current Study Sponsor: RAND
• Original Study Sponsor: Same as current

Collaborators

• Stanford University
• Clinical Directors Network
• Vizient

Investigators

• Study Director: Melanie Renzi; RAND

• PRS Account: RAND
• Verification Date: April 2024