This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04723576
Recruitment Status : Recruiting
First Posted : January 25, 2021
Last Update Posted : October 25, 2022
Sponsor:
Collaborators:
Stanford University
Clinical Directors Network
Vizient
Information provided by (Responsible Party):
Lisa Meredith, RAND

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 Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 11, 2021
Actual Primary Completion Date : July 29, 2022
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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

  4. 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

  5. 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)

  6. 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)

  7. 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.

  8. 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.

  9. 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.

  10. 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.



Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-English speaking

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Sarah E Dalton, MA 310-393-0411 ext 7301 sdalton@rand.org
Contact: Lisa Meredith, PhD 310-393-0411 ext 7365 seidel@rand.org

Locations
Layout table for location information
United States, New York
Clinical Directors Network, Inc Recruiting
New York, New York, United States, 10018
Contact: Andrea Cassells, MPH       ACass@cdnetwork.org   
United States, Texas
Vizient Inc. Active, not recruiting
Irving, Texas, United States, 75062
Sponsors and Collaborators
RAND
Stanford University
Clinical Directors Network
Vizient
Investigators
Layout table for investigator information
Study Director: Melanie Renzi RAND
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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: October 25, 2022
Last Verified: October 2022
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lisa Meredith, RAND:
healthcare worker
stress
fatigue
anxiety
burnout
COVID-19
stress first aid
Additional relevant MeSH terms:
Layout table for MeSH terms
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