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

Primary Purpose

Healthy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stress First Aid
Sponsored by
RAND
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Healthy focused on measuring healthcare worker, stress, fatigue, anxiety, burnout, COVID-19, stress first aid

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-English speaking

Sites / Locations

  • Clinical Directors Network, IncRecruiting
  • Vizient Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Stress First Aid

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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
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.
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.

Secondary Outcome Measures

Sleep Impairment
PROMIS Sleep Related Impairment. A 4-item subscale which is rated from 1-5 (not at all to very much).
Sleep Impairment
PROMIS Sleep Related Impairment. A 4-item subscale which is rated from 1-5 (not at all to very much).
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
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
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)
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)
Burnout
Dolan single item burnout inventory; participants choose the description of burnout level that reflects their experience.
Burnout
Dolan single item burnout inventory; participants choose the description of burnout level that reflects their experience.
Moral Distress
Moral Distress Thermometer; single item Sliding scale with responses rated on a 0-10 scale from none to worst possible.
Moral Distress
Moral Distress Thermometer; single item Sliding scale with responses rated on a 0-10 scale from none to worst possible.

Full Information

First Posted
January 14, 2021
Last Updated
October 24, 2022
Sponsor
RAND
Collaborators
Stanford University, Clinical Directors Network, Vizient
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1. Study Identification

Unique Protocol Identification Number
NCT04723576
Brief Title
Mental and Physical Well-Being of Frontline Health Care Workers During Coronavirus Disease 2019 (COVID-19)
Acronym
COVER-HCW
Official Title
Mental and Physical Well-Being of Frontline Health Care Workers During Coronavirus Disease 2019 (COVID-19)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2021 (Actual)
Primary Completion Date
July 29, 2022 (Actual)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RAND
Collaborators
Stanford University, Clinical Directors Network, Vizient

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
healthcare worker, stress, fatigue, anxiety, burnout, COVID-19, stress first aid

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
2132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stress First Aid
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Stress First Aid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Posttraumatic Stress Disorder (PTSD)
Description
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
Time Frame
Pre-SFA intervention: months 1 to 2
Title
PTSD
Description
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
Time Frame
Post-SFA intervention: months 3 to 5
Title
Psychological Distress
Description
Kessler 6 Distress Scale (K-6) for general psychological distress. This is a 6-item inventory rated on a 5 point Likert-type scale.
Time Frame
Pre-SFA intervention: months 1 to 2
Title
Psychological Distress
Description
Kessler 6 Distress Scale (K-6) for general psychological distress. This is a 6-item inventory rated on a 5 point Likert-type scale.
Time Frame
Post-SFA intervention: months 3 to 5
Secondary Outcome Measure Information:
Title
Sleep Impairment
Description
PROMIS Sleep Related Impairment. A 4-item subscale which is rated from 1-5 (not at all to very much).
Time Frame
Pre-SFA intervention: months 1 to 2
Title
Sleep Impairment
Description
PROMIS Sleep Related Impairment. A 4-item subscale which is rated from 1-5 (not at all to very much).
Time Frame
Post-SFA intervention: months 3 to 5
Title
Workplace stress
Description
American Psychological Association's Stress in the Workplace survey; 3 items rated on a 1-5 scale from strongly disagree to strongly agree
Time Frame
Pre-SFA intervention: months 1 to 2
Title
Workplace stress
Description
American Psychological Association's Stress in the Workplace survey; 3 items rated on a 1-5 scale from strongly disagree to strongly agree
Time Frame
Post-SFA intervention: months 3 to 5
Title
Resilience
Description
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)
Time Frame
Pre-SFA intervention: months 1 to 2
Title
Resilience
Description
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)
Time Frame
Post-SFA intervention: months 3 to 5
Title
Burnout
Description
Dolan single item burnout inventory; participants choose the description of burnout level that reflects their experience.
Time Frame
Pre-SFA intervention: months 1 to 2
Title
Burnout
Description
Dolan single item burnout inventory; participants choose the description of burnout level that reflects their experience.
Time Frame
Post-SFA intervention: months 3 to 5
Title
Moral Distress
Description
Moral Distress Thermometer; single item Sliding scale with responses rated on a 0-10 scale from none to worst possible.
Time Frame
Pre-SFA intervention: months 1 to 2
Title
Moral Distress
Description
Moral Distress Thermometer; single item Sliding scale with responses rated on a 0-10 scale from none to worst possible.
Time Frame
Post-SFA intervention: months 3 to 5

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Health care workers and patient-facing support staff (e.g., front desk staff) Exclusion Criteria: Non-English speaking
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah E Dalton, MA
Phone
310-393-0411
Ext
7301
Email
sdalton@rand.org
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Meredith, PhD
Phone
310-393-0411
Ext
7365
Email
seidel@rand.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie Renzi
Organizational Affiliation
RAND
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Directors Network, Inc
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Cassells, MPH
Email
ACass@cdnetwork.org
Facility Name
Vizient Inc.
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will follow the funder's protocol for uploading data.
IPD Sharing Time Frame
December 2022.
Citations:
PubMed Identifier
35470104
Citation
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.
Results Reference
derived

Learn more about this trial

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

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