Mental and Physical Well-Being of Frontline Health Care Workers During Coronavirus Disease 2019 (COVID-19) (COVER-HCW)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04723576 |
Recruitment Status :
Completed
First Posted : January 25, 2021
Last Update Posted : April 11, 2024
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Behavioral: Stress First Aid | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2077 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 : | March 11, 2021 |
Actual Primary Completion Date : | July 29, 2022 |
Actual Study Completion Date : | July 29, 2022 |
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.
|
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04723576
United States, New York | |
Clinical Directors Network, Inc | |
New York, New York, United States, 10018 | |
United States, Texas | |
Vizient Inc. | |
Irving, Texas, United States, 75062 |
Study Director: | Melanie Renzi | RAND |
Responsible Party: | Lisa Meredith, Senior Behavioral Scientist, RAND |
ClinicalTrials.gov Identifier: | NCT04723576 |
Other Study ID Numbers: |
COVID-2020C2-10721 COVID-2020C2-10721 ( Other Grant/Funding Number: PCORI ) |
First Posted: | January 25, 2021 Key Record Dates |
Last Update Posted: | April 11, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | We will follow the funder's protocol for uploading data. |
Supporting Materials: |
Study Protocol Informed Consent Form (ICF) |
Time Frame: | December 2022. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
healthcare worker stress fatigue anxiety |
burnout COVID-19 stress first aid |
COVID-19 Pneumonia, Viral Pneumonia Respiratory Tract Infections Infections Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |