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| ID | Type | Description | Link |
|---|---|---|---|
| COVID-2020C2-10721 | Other Grant/Funding Number | PCORI |
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| Name | Class |
|---|---|
| Stanford University | OTHER |
| Clinical Directors Network | NETWORK |
| Vizient | UNKNOWN |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stress First Aid | Experimental | The cluster Randomized Controlled Trial (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. |
|
| Usual Care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stress First Aid | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD Symptom Severity | Posttraumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual (DSM) of Mental Disorders (PCL-5). The PCL-5 is a 20-item measure of PTSD symptom severity. Each item is rated on 0-4 frequency scale. Items are summed to create a total score ranging from 0-80 where a higher score indicates worse outcomes. | Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline) |
| Psychological Distress | Kessler 6 Distress Scale (K-6) for general psychological distress in the past 30 days. This is a 6-item inventory. Each of the items is scored from "none of the time" (0) to "all of the time" (4). Items are summed for a total score ranging from 0-24 where a higher score indicates worse outcomes. | Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep-Related Impairment | The Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment (SRI) includes 4 items to assess sleep impairment over the past seven days. Each of the items are rated from 1-5 (not at all to very much). Items are summed into a scale ranging from 4-20 where a higher score indicates worse outcomes. | Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melanie Renzi | RAND | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Directors Network, Inc | New York | New York | 10018 | United States | ||
| Vizient Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35470104 | Background | 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. | |
| 38687482 |
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We will follow the funder's protocol for uploading data.
December 2022
The study data are available to qualified researchers and provided a de-identified copy of the study data and related documentation to the REGENTS OF THE UNIVERSITY OF MICHIGAN on behalf of the INTER-UNIVERSITY CONSORTIUM FOR POLITICAL AND SOCIAL RESEARCH (ICPSR) for the purpose of allowing ICPSR to examine, process, and distribute the data to qualified researchers as determined by ICPSR.
Health care worker (HCW) participants completed a pre-intervention survey prior to randomization.
28 hospitals and Federally Qualified Health Centers (FQHCs) throughout the US were recruited in 3 consecutive cohorts and enrolled from March 2021 through July 2022. Participating sites were matched as pairs by type, size, and COVID-19 burden and then randomized to the intervention arm or usual care arm.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PTSD Symptom Severity | Posttraumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual (DSM) of Mental Disorders (PCL-5). The PCL-5 is a 20-item measure of PTSD symptom severity. Each item is rated on 0-4 frequency scale. Items are summed to create a total score ranging from 0-80 where a higher score indicates worse outcomes. | Posted | Mean | Standard Deviation | score on a scale | Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline) |
|
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This trial included health professionals as participants and the intervention was low to no risk because it was a prevention approach. We did not monitor any adverse events because participation involved completing Web-based surveys by self-report. Thus, the research team had no direct interaction with participants so there would be no way to know of any adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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Response rate was low (only 28% completed both the pre-intervention and post-intervention surveys).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa S. Meredith | RAND | 310.393.0411 | 7365 | seidel@rand.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 24, 2024 | Jun 14, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D001008 | Anxiety Disorders |
| D000077062 | Burnout, Psychological |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D013315 | Stress, Psychological |
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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.
|
| Workplace Stress | American Psychological Association's (APA) Stress in the Workplace survey; 3 items rated on a 1-5 scale from strongly disagree to strongly agree. A summed scale is formed ranging from 3-15 in which a higher score indicates worse outcomes/more stress. | Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline) |
| Resilience | Connor Davidson Resilience Scale (CDRISC); a brief (2-item) version of the scale with items rated from 0-4 (not true at all to true nearly all the time). Items are summed into a total scale ranging from 0-8 in which a higher score indicates better outcomes. | Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline) |
| Burnout | Dolan single item with 5 responses options ranging from 1[I enjoy my work. I haven symptoms of burnout.] to 5 [I feel completely burned out.]; We created a binary indicator to measure the percent of participants who reported experiencing symptoms of burnout. | Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline) |
| Moral Distress | We used the Moral Distress Thermometer, a single item sliding scale with responses rated on a 0-10 scale (none to worst possible) where a higher score indicates worse outcomes. | Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline) |
| Irving |
| Texas |
| 75062 |
| United States |
| Background |
| Meredith LS, Ahluwalia S, Chen PG, Dong L, Farmer CM, Bouskill KE, Dalton S, Qureshi N, Blagg T, Timmins G, Schulson LB, Huilgol SS, Han B, Williamson S, Watson P, Schnurr PP, Martineau M, Davis K, Cassells A, Tobin JN, Gidengil C. Testing an Intervention to Improve Health Care Worker Well-Being During the COVID-19 Pandemic: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e244192. doi: 10.1001/jamanetworkopen.2024.4192. |
| 37652873 | Background | Bandini JI, Ahluwalia SC, Timmins G, Bialas A, Meredith L, Gidengil C. "It Haunts Me": Impact of COVID-19 Deaths on Frontline Clinicians In Acute Care Settings-A Qualitative Study. Am J Crit Care. 2023 Sep 1;32(5):368-374. doi: 10.4037/ajcc2023257. |
| 38553036 | Background | Timmins GT, Bandini JI, Ahluwalia SC, Bialas A, Meredith LS, Gidengil C. 'You just don't feel like your work goes recognised': healthcare worker experiences of tension related to public discourse around the COVID-19 pandemic. BMJ Lead. 2024 Dec 23;8(4):324-328. doi: 10.1136/leader-2024-000983. |
| 38907369 | Background | Qureshi N, Huilgol SS, Timmins G, Meredith LS, Gidengil CA. Misaligned Supports: Differences in Reported Health Care Worker Well-being Supports Provided and Needed During the COVID-19 Pandemic. Am J Health Promot. 2025 Jan;39(1):63-75. doi: 10.1177/08901171241255764. Epub 2024 Jun 21. |
| 41029307 | Derived | Timmins G, Williamson S, Cassells A, Davis K, Dong L, Tobin JN, Gidengil C, Meredith LS, Chen PG. Health care worker experiences with a brief peer support and well-being intervention during the COVID-19 pandemic. BMC Health Serv Res. 2025 Sep 30;25(1):1253. doi: 10.1186/s12913-025-13268-6. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Numbers differ due to missing responses. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Professional Role | Count of Participants | Participants |
|
| Time at Site | Count of Participants | Participants |
|
| Time in Profession | Count of Participants | Participants |
|
| OG001 | 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 | Psychological Distress | Kessler 6 Distress Scale (K-6) for general psychological distress in the past 30 days. This is a 6-item inventory. Each of the items is scored from "none of the time" (0) to "all of the time" (4). Items are summed for a total score ranging from 0-24 where a higher score indicates worse outcomes. | Posted | Mean | Standard Deviation | score on a scale | Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline) |
|
|
|
|
| Secondary | Sleep-Related Impairment | The Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment (SRI) includes 4 items to assess sleep impairment over the past seven days. Each of the items are rated from 1-5 (not at all to very much). Items are summed into a scale ranging from 4-20 where a higher score indicates worse outcomes. | Posted | Mean | Standard Deviation | score on a scale | Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline) |
|
|
|
|
| Secondary | Workplace Stress | American Psychological Association's (APA) Stress in the Workplace survey; 3 items rated on a 1-5 scale from strongly disagree to strongly agree. A summed scale is formed ranging from 3-15 in which a higher score indicates worse outcomes/more stress. | Posted | Mean | Standard Deviation | score on a scale | Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline) |
|
|
|
|
| Secondary | Resilience | Connor Davidson Resilience Scale (CDRISC); a brief (2-item) version of the scale with items rated from 0-4 (not true at all to true nearly all the time). Items are summed into a total scale ranging from 0-8 in which a higher score indicates better outcomes. | Posted | Mean | Standard Deviation | score on a scale | Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline) |
|
|
|
|
| Secondary | Burnout | Dolan single item with 5 responses options ranging from 1[I enjoy my work. I haven symptoms of burnout.] to 5 [I feel completely burned out.]; We created a binary indicator to measure the percent of participants who reported experiencing symptoms of burnout. | Posted | Count of Participants | Participants | Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline) |
|
|
|
|
| Secondary | Moral Distress | We used the Moral Distress Thermometer, a single item sliding scale with responses rated on a 0-10 scale (none to worst possible) where a higher score indicates worse outcomes. | Posted | Mean | Standard Deviation | score on a scale | Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline) |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |