Clinical trial NCT04723576: Mental and Physical Well-Being of Frontline Health Care Workers During Coronavirus Disease 2019 (COVID-19)
Official title: Mental and Physical Well-Being of Frontline Health Care Workers During Coronavirus Disease 2019 (COVID-19)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: healthcare worker
stress
fatigue
anxiety
burnout
COVID-19
stress first aid
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: Stanford University
name: Clinical Directors Network
name: Vizient
First posted: 2021-01-25
Enrollment: 7444
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Non-English speaking

Primary outcomes:
measure: PTSD Symptom Severity
timeFrame: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)
measure: Psychological Distress
timeFrame: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)
Secondary outcomes:
measure: Sleep-Related Impairment
timeFrame: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)
measure: Workplace Stress
timeFrame: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)
measure: Resilience
timeFrame: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)
measure: Burnout
timeFrame: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)
measure: Moral Distress
timeFrame: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)
Other outcomes:
Locations:
city: New York
country: United States
facility: Clinical Directors Network, Inc
state: New York
city: Irving
country: United States
facility: Vizient Inc.
state: Texas
Study officials:
affiliation: RAND
name: Melanie Renzi
role: STUDY_DIRECTOR
References:
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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.