Clinical trial NCT04646642: Psychological Health, Coping Strategies and Preferences of Military COVID-19 Deployers
Official title: Psychological Health, Coping Strategies and Preferences of David Grant USAF Medical Center COVID-19 Deployers: A Critical Needs Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coping Skills
Healthcare Workers
Covid19
Lead sponsor: David Grant U.S. Air Force Medical Center
Sponsor class: FED
First posted: 2020-11-30
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Active duty healthcare workers assigned to David Grant U.S. Air Force Medical Center (DGMC) who deployed in July 2020, under the command of Col Justin Nast and the COVID Theater Hospital (CTH), in support of 8 civilian California hospitals.

Brief summary: The proposed research study aims to better understand COVID deployer needs. The study, informally referred to as Project COPE, asks David Grant U.S. Air Force Medical Center (DGMC) members who deployed in support of COVID-19 operations to complete a needs assessment questionnaire. The purpose of this study is to understand the stressful experiences of our COVID Theater Hospital (CTH) deployers, the typical coping strategies used and recommended preferences for support so that the investigators can provide the best evidence-based resources for post-deployment and to aid future CTH deployers.

Detailed description: Objective: This study focuses on exploring David Grant USAF Medical deployer psychological status and the coping skills utilized during deployment as well as a needs assessment of preferred coping resources.

Specific Aims:

* Aim 1: Describe the post-deployment state of psychological health for COVID-19 Theater Hospital (CTH) deployers
* Aim 2: Identify the deployer identified COVID-19-related stressors reported post deployment
* Aim 3: Identify coping and cognition regulating strategies used by deployers in response to COVID-19 deployment stressors
* Aim 4: Identify deployer coping resource preferences for future deployment support packages

Methods: Recruitment of eligible participants will include email invitations, packets with pre-printed needs assessment folders placed next to posters, flyers, and briefing at DGMC events. Eligible participants (n=160) returning from COVID Theater Hospital (CTH) deployment (est. Oct 2020) will receive a needs assessment that includes:

1. Patient Health Questionnaire-2 (PHQ-2) is a 2-item screening tool for depression that uses the first two items from the 9-item Patient Health Questionnaire. Respondents are asked to report symptom frequency ranging from 0 (not at all) to 3 (nearly every day) for the following questions, "Over the last 2 weeks, how often have you been bothered by any of the following problems: 1) little interest or pleasure in doing things, and 2) feeling down, depressed, or hopeless?" Total scores exceeding 2 suggest a positive depression screening. Participants who screen positive should be evaluated with the PHQ-9 to identify diagnostic depressive disorder criteria. It is important to note that all CTH deployers will complete a PHQ-9 during their post-deployment health assessment. Construct and criterion validity were established in a sample of 6000 primary care and obstetrics patients where the PHQ-2 score had a sensitivity of ≥ 83% and a specificity of 92% for major depression. A PHQ-2 score of 3 was identified as the optimal cut point as indicated by likelihood ratio and receiver operator characteristic analysis (Kroenke, Spitzer, \& Williams, 2003). This tool provides a brief, practical, valid, and reliable screening instrument.
2. Generalized Anxiety Disorder-2 (GAD-2) is a 2-item screening tool for Generalized Anxiety Disorder. The tool asks respondents to report symptom frequency ranging from 0 (not at all) to 3 (nearly every day) for the following two questions: "Over the last 2 weeks, how often have you been bothered by the following problems:1) Feeling nervous, anxious or on edge, and, 2) Not being able to stop or control worrying?" A total score of 3 points or greater identifies a positive screen and warrants further diagnostic evaluation with the GAD-7 for Generalized Anxiety Disorder criteria. It is important to note that all CTH deployers will complete a GAD-7 during their post-deployment health assessment. The GAD-2 was validated in a randomized sample of 965 primary care patients demonstrating a sensitivity of 86% and specificity of 83% with an 0.908 area under the curve (95% CI) for a diagnosis of Generalized Anxiety Disorder (Kroenke, Spitzer, Williams, Monahan, \& Lö, 2007). This tool provides a brief, practical, valid, and reliable screening instrument.
3. Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI-A) is a 7-item questionnaire used to examine disruptive nocturnal behaviors (hot flashes, nervousness, traumatic memories, anxiety, bad dreams, terror/screaming, acting out dreams) common in adults with PTSD. Response items are endorsed for frequency (not during the past month, less than once a week, once or twice a week, three or more times a week). Good internal consistency and convergent validity were demonstrated with anxiety, depression, sleep quality, combat exposure, and PTSD symptoms. The PSQI-A had a Cronbach's #= 0.72 and an average inter-item correlation r = 0.44 (range 0.27-0.57) with the PSQI-A total score. Area under the curve was 0.81, for a cut point ≥ 4 resulting in 71% sensitivity, 82% specificity, and 60% positive and 83% negative predictive value for clinically diagnostic PTSD purposes and a 74% correct classification (Insana, Hall, Buysse, \& Germain, 2013). Sleep disturbances reflect a core dysfunction underlying PTSD. The PSQI-A is a valid instrument for PTSD applicable to both clinical and research settings.It is important to note that all CTH deployers will complete a Post-Traumatic Stress Disorder screening during the post-deployment health assessment.
4. Deployer Identified COVID-19 Stressors. Currently there are no valid and reliable instruments specific to COVID-19 distress. Given this is a novel pandemic, investigators requested deployers to list top 3 stressors experienced during deployment. Participants rated listed items as: 1-no distress, 2-mildy distressing, 3-distressing 4-very distressing, and 5-extremely distressing.
5. The Brief Coping Orientation to Problems Experienced (Brief COPE) is a 28-item multidimensional measure of 14 strategies (humor, positive reframing, acceptance, active coping, planning, behavioral disengagement, self-distraction, substance use, denial, self-blame, venting, emotional support, instrumental support, religion) used for coping or regulating cognitions in response to stressors. This abbreviated inventory (based on the complete 60-item COPE Inventory) is comprised of items that assess the frequency with which a person uses different coping strategies rated on a scale from 0-"I haven't been doing this at all" to 4-"I've been doing this a lot." (Amoyal et al., 2011). Investigators eliminated two items that deal with drugs and alcohol to maintain the eligibility of exempt protocol status.
6. COVID-19 Coping Strategy and Resource Inventory is an 18-item resource inventory developed by the DGMC research team to assess preferred strategic resources to manage COVID-19-related stressors. The inventory includes 5 categories of coping resources: 1) interactive \[exercise, spiritual, social, mental health visit\], 2) self-help videos/webinars, 3) mobile applications, 4) electronic toolkits, 5) podcasts.
7. Demographic questionnaire includes 10 questions regarding individual deployer sex, COVID-19 risk status, mental health risk status, COVID-19 risk status of any family members at home, years of experience in current occupation and specific healthcare role, typical work setting at DGMC, any recent deployments

Study participation will occur through a single collection of anonymous self-report measures using paper pencil which will be completed with an anticipated time burden of under 15 minutes (based on preliminary practice trials) and returned to locked drop-boxes strategically placed on four inpatient/outpatient areas.

Results: Findings will inform the development of a DGMC COVID-19 healthcare worker psychological coping and well-being toolkit.

Eligibility criteria: Inclusion Criteria:

* The eligible participant group includes David Grant United States Air Force (USAF) Medical Center Active Duty personnel:

  1. Medical technicians (4N)
  2. Liaison officers (LNO's)
  3. Nurses
  4. Physician assistants
  5. Advanced practice nurses
  6. Respiratory therapists
  7. Psychologists
  8. Social workers
  9. Chaplains
  10. Physicians
* Deployed in July 2020, under the command of Col Justin Nast and the COVID Theater Hospital (CTH) in support of the following civilian facilities:

  1. Adventist Health Lodi Memorial Hospital, Lodi, CA
  2. Eisenhower Medical Center, Rancho Mirage, CA
  3. Community Regional Medical Center, Fresno, CA
  4. Kaweah Delta Health Care, Visalia, CA
  5. Adventist Health Dameron Hospital, Stockton, CA
  6. Adventist Health Hanford, Hanford, CA
  7. Los Angeles County-University of Southern California (LA County-USC) Medical Center, Los Angeles, CA
  8. Harbor-University of California Los Angeles (UCLA) Medical Center, Torrance, CA

Exclusion Criteria:

* Activated guard, reserve, or civilian healthcare deployers in support of COVID-19
* Active duty healthcare deployers from MTF's other than DGMC in support of California (CA) civilian hospitals other than the eight facilities named in the above inclusion criteria.

Primary outcomes:
measure: Positive Patient Health Questionnaire-2 (PHQ-2)
timeFrame: 1-2 months
measure: Positive PHQ-2 + High risk COVID physical condition
timeFrame: 1-2 months
measure: Positive PHQ-2 + pre-existing mental health conditions
timeFrame: 1-2 months
measure: Positive Generalized Anxiety Disorder-2 (GAD-2)
timeFrame: 1-2 months
measure: Positive GAD-2 + High risk COVID physical condition
timeFrame: 1-2 months
measure: Positive GAD-2 + pre-existing mental health conditions
timeFrame: 1-2 months
measure: Positive Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI-A)
timeFrame: 1-2 months
measure: Positive PSQI-A + High risk COVID physical condition
timeFrame: 1-2 months
measure: Positive PSQI-A + pre-existing mental health conditions
timeFrame: 1-2 months
measure: Deployer Identified COVID-19 Stressors
timeFrame: 1-2 months
measure: Positive Brief Coping Orientation to Problems Experienced (Brief COPE)
timeFrame: 1-2 months
measure: Negative Brief Coping Orientation to Problems Experienced (Brief COPE)
timeFrame: 1-2 months
measure: COVID-19 Coping Strategy and Resource Inventory
timeFrame: 1-2 months
measure: Demographic questionnaire
timeFrame: 1-2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Travis Air Force Base
country: United States
facility: David Grant Medical Center (DGMC)
state: California
Study officials:
affiliation: David Grant Medical Center, Travis Air Force Base
name: Amanda A Fox, MSN
role: PRINCIPAL_INVESTIGATOR
affiliation: David Grant Medical Center, Travis Air Force Base
name: Laurie A Migliore, PhD
role: PRINCIPAL_INVESTIGATOR
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