Psychological Well-being and Burnout in Healthcare Workers During the COVID-19 (Coronavirus Disease 2019) Pandemic

NCT05394051 | Completed DMC

• 1 other identifier: STU00212515
• Study Type: interventional
• Target: 555
• Locations: 1 country
• Sites: 1

Brief Summary

Healthcare systems around the world have faced tremendous stress because of the COVID-19 pandemic. Healthcare workers (HCWs) (ie. physicians, nurses, and support staff), who serve as the foundation of the healthcare system, report high levels of psychological stress and burnout, which will likely worsen as the pandemic continues. The consequences of stress and burnout can reduce quality of life for providers and lead to adverse health behaviors (poor dietary choices, reduced physical activity, increased alcohol intake, increases in weight etc.) among HCWs. In addition, burnout can have dire consequences on healthcare delivery effectiveness including poor quality of care and significant cost implications due to medical errors and HCW absenteeism and turnover. In fact, annual estimates of burn-out related turnover range from $7,600 per physician to \>$16,000 per nurse. However, programs focused on reducing burnout in HCWs have the potential to reduce costs to the healthcare system by $5,000 per HCW per year. Maintaining and recovering psychological and behavioral well-being is essential to ensuring we have a workforce that is resilient to acute and ongoing stressors such as the COVID-19 pandemic, ensuring that they are capable of providing the highest level of quality and compassionate care to patients. In this project, we will strengthen the resiliency of the Northwestern Medicine (NM) healthcare system by implementing an online psychological well-being intervention (PARK). We will assess HCW willingness to engage in PARK, which has been shown in other populations experiencing stress (e.g. dementia caregivers, general public coping with COVID-19) to be effective. We will also assess if the PARK is effective in reducing stress and associated-burnout, absenteeism, and intentions to leave the workforce in a subset of 750 persons who have been participating in a study of HCWs at NM since Spring 2020. In the entire cohort, we will measure the psychological well-being, levels of burnout, health behaviors, absenteeism, and plans to leave the workforce at three time periods: the start, middle, and end of the study period and assess whether they differ by HCW characteristics including gender, race, and role in health care. Results from this study will provide much-needed information: 1) about the current state of psychological well-being and burnout among NM HCWs, now over 1 ½ years into the pandemic; 2) on the role of an online wellness intervention to improve well-being during a protracted pandemic; and 3) about the contribution of PARK to reduce burnout, HCW absenteeism and turnover, and potential impacts on costs. PARK has the potential to have a significant impact on not only NM HCWs but also to be generalizable to other healthcare organizations for addressing burnout and to contribute to lessons learned on how to support HCWs responding to future pandemics; ensuring resiliency in the healthcare delivery system. In addition, we will work with our already engaged stakeholder committee to ensure results can provide actionable policy and fiscal insights. Future opportunities will include collaboration with other healthcare systems to expand roll-out of the successful PARK intervention.

Conditions

COVID-19; Burnout; Burnout, Professional; Work-related Illness; Work-Related Stress; SARS-CoV-2 Infection

Keywords

healthcare worker; psychological wellbeing; pandemic

Outcome Measures

Primary Outcomes (4)

• Psychological well-being

  Assess the psychological well-being (depression, anxiety, positive affect, meaning and purpose) and burnout in an existing cohort of 3,569 HCWs working at Northwestern Medicine (NM) during the COVID-19 pandemic using self-report questionnaires. Psychological well-being will be measured using the PROMIS (Patient-Reported Outcomes Measurement Information System)/NIH Toolbox. The PROMIS/NIH Toolbox measures of psychosocial well-being will be used to measure psychological well-being using a Computer Adaptive Test (CAT) on anxiety, depression, social isolation, positive affect, and meaning and purpose. Approach: Participants will complete a \~15-minute survey with questions on psychological well-being, burnout, health and cardio-metabolic behaviors, and absenteeism. These data will serve as a baseline assessment on the current mental and physical health of HCWs. The cohort will also receive the same assessments at the last follow-up assessment given to the trial participants.

  Survey will be sent out at baseline

• Psychological well-being at 3 months

  Assess the psychological well-being (depression, anxiety, positive affect, meaning and purpose) and burnout in an existing cohort of 3,569 HCWs working at Northwestern Medicine (NM) during the COVID-19 pandemic using self-report questionnaires. Psychological well-being will be measured using the PROMIS/NIH Toolbox. The PROMIS/NIH Toolbox measures of psychosocial well-being will be used to measure psychological well-being using a Computer Adaptive Test (CAT) on anxiety, depression, social isolation, positive affect, and meaning and purpose. Approach: Participants will complete a \~15-minute survey with questions on psychological well-being, burnout, health and cardio-metabolic behaviors, and absenteeism. These data will serve as an updated assessment on the current mental and physical health of HCWs. The cohort will also receive the same assessments at the last follow-up assessment given to the trial participants.

  Survey will be sent out at 3 months

• Burnout

  Assess the psychological well-being (depression, anxiety, positive affect, meaning and purpose) and burnout in an existing cohort of 3,569 HCWs working at Northwestern Medicine (NM) during the COVID-19 pandemic using self-report questionnaires. Burnout will be measured using the Oldenburg Burnout Inventory (OLBI) which is a validated 16-item inventory which measures affective, physical, and cognitive aspects of burnout across positive and negative framed items of two core dimensions: exhaustion and disengagement (from work). Approach: Participants will complete a \~15-minute survey with questions on psychological well-being, burnout, health and cardio-metabolic behaviors, and absenteeism. These data will serve as a baseline assessment on the current mental and physical health of HCWs. The cohort will also receive the same assessments at the last follow-up assessment given to the trial participants.

  Survey will be sent out at baseline

• Burnout at 3 months

  Assess the psychological well-being (depression, anxiety, positive affect, meaning and purpose) and burnout in an existing cohort of 3,569 HCWs working at Northwestern Medicine (NM) during the COVID-19 pandemic using self-report questionnaires. Burnout will be measured using the Oldenburg Burnout Inventory (OLBI) which is a validated 16-item inventory which measures affective, physical, and cognitive aspects of burnout across positive and negative framed items of two core dimensions: exhaustion and disengagement (from work). Approach: Participants will complete a \~15-minute survey with questions on psychological well-being, burnout, health and cardio-metabolic behaviors, and absenteeism. These data will serve as an updated assessment on the current mental and physical health of HCWs. The cohort will also receive the same assessments at the last follow-up assessment given to the trial participants.

  Survey will be sent out at 3 months.

Secondary Outcomes (2)

• Cardio-metabolic behaviors and health-related absenteeism

  Survey will be sent out at baseline.

• Cardio-metabolic behaviors and health-related absenteeism at 3 months

  Survey will be sent out at 3 months

Study Arms (2)

PARK Now

EXPERIMENTAL

6-Week Self-Guided Program: PARK Positive Emotion Skills: The skills will be delivered over approximately 6 weeks, and individuals can participate from any device and location with internet access. A week will consist of 1-2 days of didactic material and 5-6 days of real-life skills practice and reporting. The maximum amount of time engaged in the PARK program for any participant is 5 hours over the 6-week period, plus completion of the REDCap surveys assessments (burnout, well-being, health behaviors). The intervention will focus on developing the following skills that will be supplemented by home practice: (1) positive events, capitalizing, gratitude; (2) mindfulness; (3) positive reappraisal; (4) personal strength and achievable goals; (5) and self-compassion. PARK is delivered through the BrightOutcome online platform.

Behavioral: Positive Affect Regulation sKills (PARK)

Wait List Control-PARK Later

NO INTERVENTION

Wait list controls will be assessed at similar time intervals and will be offered PARK at end of follow-up.

Interventions

Positive Affect Regulation sKills (PARK) BEHAVIORAL

The goal of the PARK program is to reduce feelings of anxiety, depression, and social isolation, as well as increase well-being and a sense of meaning and purpose through the practice of positive emotion skills via a self-guided online platform. The total time involved from the beginning to the end of the intervention portion of the study is approximately 6 months (includes 6-week PARK course, baseline and follow-up assessments. Wait list controls will be assessed at similar time intervals and will be offered PARK at end of follow-up.

Also known as: PARK

PARK Now

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Northwestern Medicine Healthcare worker \>18 years old
• Participants will be eligible if they are a participant in the NM HCW Serology Study and they provide electronic informed consent to participate.
• Pregnant women and all employees of Northwestern Medicine are eligible for study.

You may not qualify if:

• If the participant no longer works for Northwestern Medicine.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (8)

• Valdivia N, Hirschhorn LR, Vu TH, Dubois C, Moskowitz JT, Wilkins JT, Evans CT. Utilization of at-home tests for coronavirus disease 2019 (COVID-19) among healthcare workers in Chicago. Antimicrob Steward Healthc Epidemiol. 2024 Apr 24;4(1):e58. doi: 10.1017/ash.2024.17. eCollection 2024.

  PMID: 38698942 RESULT

• Wilkins JT, Hirschhorn LR, Gray EL, Wallia A, Carnethon M, Zembower TR, Ho J, DeYoung BJ, Zhu A, Rasmussen-Torvik LJ, Taiwo B, Evans CT. Serologic Status and SARS-CoV-2 Infection over 6 Months of Follow Up in Healthcare Workers in Chicago: A Cohort Study. Infect Control Hosp Epidemiol. 2022 Sep;43(9):1207-1215. doi: 10.1017/ice.2021.367. Epub 2021 Aug 9.

  PMID: 34369331 RESULT

• Wilkins JT, Gray EL, Wallia A, Hirschhorn LR, Zembower TR, Ho J, Kalume N, Agbo O, Zhu A, Rasmussen-Torvik LJ, Khan SS, Carnethon M, Huffman M, Evans CT. Seroprevalence and Correlates of SARS-CoV-2 Antibodies in Health Care Workers in Chicago. Open Forum Infect Dis. 2020 Dec 9;8(1):ofaa582. doi: 10.1093/ofid/ofaa582. eCollection 2021 Jan.

  PMID: 33447642 RESULT

• Evans CT, DeYoung BJ, Gray EL, Wallia A, Ho J, Carnethon M, Zembower TR, Hirschhorn LR, Wilkins JT. Coronavirus disease 2019 (COVID-19) vaccine intentions and uptake in a tertiary-care healthcare system: A longitudinal study. Infect Control Hosp Epidemiol. 2022 Dec;43(12):1806-1812. doi: 10.1017/ice.2021.523. Epub 2021 Dec 27.

  PMID: 34955103 RESULT

• Stone TD, Lee C, Bannon J, Vu TT, Hirschhorn LR, Wilkins JT, Evans CT. Intentions for uptake of the coronavirus disease 2019 (COVID-19) vaccine booster in healthcare workers. Infect Control Hosp Epidemiol. 2023 Apr;44(4):690-692. doi: 10.1017/ice.2022.307. Epub 2023 Mar 13. No abstract available.

  PMID: 36912328 RESULT

• Moskowitz JT, Jackson KL, Cummings P, Addington EL, Freedman ME, Bannon J, Lee C, Vu TH, Wallia A, Hirschhorn LR, Wilkins JT, Evans C. Feasibility, acceptability, and efficacy of a positive emotion regulation intervention to promote resilience for healthcare workers during the COVID-19 pandemic: A randomized controlled trial. PLoS One. 2024 Jun 24;19(6):e0305172. doi: 10.1371/journal.pone.0305172. eCollection 2024.

  PMID: 38913665 RESULT

• Bannon J, Evans CT, Freedman M, Lee C, Vu TH, Wallia A, Wilkins JT, Moskowitz JT, Hirschhorn LR. Psychological wellbeing and the association with burnout in a cohort of healthcare workers during the COVID-19 pandemic. Front Health Serv. 2022 Oct 25;2:994474. doi: 10.3389/frhs.2022.994474. eCollection 2022.

  PMID: 36925776 RESULT

• Lee C, Vu TT, Fuller JA, Freedman M, Bannon J, Wilkins JT, Moskowitz JT, Hirschhorn LR, Wallia A, Evans CT. The association of burnout with work absenteeism and the frequency of thoughts in leaving their job in a cohort of healthcare workers during the COVID-19 pandemic. Front Health Serv. 2023 Nov 29;3:1272285. doi: 10.3389/frhs.2023.1272285. eCollection 2023.

  PMID: 38093812 RESULT

MeSH Terms

Conditions

COVID-19; Burnout, Psychological; Burnout, Professional; Occupational Stress

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Stress, Psychological; Behavioral Symptoms; Behavior; Occupational Diseases

Study Officials

• Charlesnika Evans, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a single group randomized trial. After baseline measures of burnout, well-being, and health behaviors are obtained, participants will be recruited for participation in the Positive Affect Regulation sKills (PARK) intervention from the NM HCW SARS-CoV-2 Cohort via direct email. Interested individuals will be provided with the URL (Uniform Resource Locator) to complete eligibility screening via REDCap. All HCWs will be eligible to participate unless they have already been identified as a participant in a previous PARK trial. Once they agree to enroll, they will be randomized to participate in the intervention (PARK) or the 'wait list control' arm (No PARK, but offered at the end of follow-up).

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 27, 2022
• Study Start: December 1, 2021
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

US (1)