Reducing Burnout Among Frontline Healthcare Workers During COVID-19 (RESTORE)

February 7, 2024 updated by: Zainab Samaan (Zena), St. Joseph's Healthcare Hamilton

The Role of Virtual Peer Support Platforms for Reducing Stress and Burnout Among Frontline Healthcare Workers During COVID-19: A Pilot Randomized Controlled Trial

Physician burnout has a significant impact on the wellness and productivity of physicians as well as patient health outcomes. Managing burnout among frontline workers is critical to Canada's response to the COVID-19 pandemic, in order to support frontline workers and reduce inefficiencies and medical errors frequently linked to burnout, ultimately improving our ability to detect, treat and manage COVID-19 cases. Therefore, this trial aims to assess the effects of an 8-session intervention over 3 months for burnout in physician residents in residency programs at McMaster University in Canada during the COVID-19 pandemic. This trial will provide evidence to inform health system management and public health response early and effectively so as to maintain the integrity of our workforce during and post-pandemic. The virtual delivery platform renders the proposed intervention easily disseminated internationally, in low- middle- and high- income countries and across urban and rural cities.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Physician burnout has come to the forefront of discourse within the medical field due to its significant impact on the wellness and productivity of physicians as well as patient health outcomes. Burnout is defined as physical, mental and emotional exhaustion resulting from persistent exposure to an emotionally demanding trigger, and is comprised of three dimensions: emotional exhaustion (EE), depersonalization (DP) and lack of personal accomplishment (PA). Residency is a particularly stressful time; the junior physician is tasked with a tremendous responsibility of providing high quality care while learning and integrating new skills during training. Adapting to these job demands has a direct consequence on one's emotional reserve and ability to establish a healthy home-work interface. Recent data indicates 47% of residents around the world suffer from burnout, and that rates are highest in North America.

During times of lethal pandemics, healthcare workers (HCWs) have a duty to serve on the frontline. Within three months of the first report of COVID-19, a global pandemic was declared and social separation and economic shutdowns were enforced around the globe. Meanwhile, resident physicians were redeployed to the frontline by their training institutions, inevitably jeopardizing their speciality training. In addition to the detrimental personal and substantial financial stressors generally incurred by persons during a pandemic, residents bear the burden of caring for others and witnessing tragic outcomes thus putting them at risk of "accelerated burnout". HCWs on the frontline during times of crisis and natural disaster historically suffer from more severe emotional distress, depression, anxiety, and social isolation. This is consistent with findings from a recent study of frontline workers in Wuhan, China during the COVID-19 pandemic, and reports of suicide among frontline workers attributed to COVID-19 associated stressors.

Many studies have aimed to delineate contributors of burnout and common themes that have emerged include excessive workloads, feeling unsupported, lack of autonomy, and lack of work-home integration. In addition to traditional causes of burnout, the heightened risk of occupational exposure to infection, process inefficiencies, limited resources, and financial instability have been established as additional stressors among HCWs during COVID-19. These factors, in addition to social stigmatization and ostracism by family and the fearful public have also been cited as major contributors to stress among HCWs during the Severe Acute Respiratory Syndrome (SARS) pandemic, the Ebola epidemic, and among HCWs caring for AIDS patients during the late 1980s.

Addressing burnout among frontline workers is essential to supporting Canada's response to the COVID-19 pandemic, in order to 1) keep our frontline workers on the frontline, and 2) reduce inefficiencies and medical errors frequently linked to burnout, ultimately improving our ability to detect, treat and manage COVID-19 cases. Based on evidence from previous pandemics, we anticipate the grave impact of the pandemic on frontline workers will outlive the pandemic itself, and HCWs will continue to struggle with post-traumatic stress in the midst of a crashing economy and more than ever strained healthcare system. To address this serious threat to health workers globally, we wish to evaluate the effectiveness and acceptability of a virtual peer support program in reducing overall burnout among resident physicians during COVID-19 pandemic. Using an adapted intervention from West et. al, modified to six support sessions delivered across three months, we will randomize different medical specialties to receiving this intervention employing a stepped wedged pilot randomized trial design. The goals of the pilot trial will be to assess feasibility of adapting an in-person group-based intervention to virtual platforms across multiple subspecialty residency programs at a single post-graduate medical education (PGME) institution in Ontario, Canada.

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L4E4S4
        • St. Joseph's Healthcare Hamilton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Physician residents across all medical specialties at McMaster University, McGill University, and Stanford University.
  • Must be able to provide written informed consent

Exclusion Criteria:

  • Residents who are on prolonged leave (>4 weeks)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Peer Support Platform
The intervention program content will be informed by "the BASICS"-a guide for supporting resilience against burnout, developed by the Ontario Medical Association Physician Health Program, as well as the Person-Environment-Occupation (PEO) model, a transactive approach to modelling occupational performance issues in the field of Occupational Therapy. "The BASICS" highlights six fundamental domains will underlie the focus of group therapy sessions, where participants will be encouraged to consider how they may incorporate healthy physical and emotional practices both on their own (Person), and during the practice of medicine (Occupation), in addition to identifying barriers to adopting these practices within the healthcare environment (Environment).
Behavioral: Virtual Peer Support Platform
The intervention program will consist of 6 virtual 30-minute sessions delivered across three months. Sessions will follow a structured format including: check-in, issue identification & context, facilitated discussion, environmental strategies, occupational strategies, experiential component, as well as summary and sign-out. Meetings will finish with a stress relieving activity, to be performed together on the web-based platform. The facilitated discussions will follow important themes including focus on self, patients, and external stressors.
Active Comparator: Control period
Residents will continue with their regular academic day activities during the allotted intervention time.
Behavioral: Control Period
The control period will be the time prior to randomization and commencement of the intervention, whereby residents will continue with their regular academic day activities during the allotted intervention time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability as assessed through patient reported experiences with the virtual intervention.
Time Frame: Month 3
Qualitative interviews to explore participants impressions and experiences with virtually adapted burnout intervention. A subgroup of participants (preferably across residency programs), will be invited to participate in a brief 10-minute interview to explore their experiences with the intervention through semi-structured open ended interview questions.
Month 3
Recruitment
Time Frame: To be assessed at three months
Total number of participants recruited to the study
To be assessed at three months
Retention
Time Frame: To be assessed at the end of the observation period. The duration of the observation period will be based on the total number of residency programs enrolled in the study given the stepped-wedge design.
Total number of participants who remain in the study until the end of observation
To be assessed at the end of the observation period. The duration of the observation period will be based on the total number of residency programs enrolled in the study given the stepped-wedge design.
Number of sessions completed
Time Frame: To be assessed at the end of the three month intervention period.
Measured as number of sessions completed
To be assessed at the end of the three month intervention period.
Average group size
Time Frame: To be assessed at the end of the three month intervention period.
Measured as the mean number of participants per group
To be assessed at the end of the three month intervention period.
Data completion
Time Frame: To be assessed at the end of the three month intervention period
Measured as the percentage of instruments completed
To be assessed at the end of the three month intervention period
Feasibility of adapting an in-person group-based intervention to virtual platforms as assessed by group participation rates and self-reported experiences with the intervention.
Time Frame: To be assessed at the end of the three month intervention period.
Feasibility will be assessed by evaluation of 1) participation rates across the intervention period, and 2) self-reported feedback about experiences with the intervention as gathered through survey responses. Survey questions will specifically ask about user experience with the intervention materials, technology including virtual platform.
To be assessed at the end of the three month intervention period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess stress
Time Frame: This is not a time to event variable. We will be evaluating the change from baseline and three months post initiation of intervention
Instrument/method of measurement: Stress will be measured using the Perceived Stress Scale, a 10-item scale ranging from 0-4 representing never to very often, with total scores between 0-40.
This is not a time to event variable. We will be evaluating the change from baseline and three months post initiation of intervention
Assess depression
Time Frame: This is not a time to event variable. We will be evaluating the change from baseline and three months post initiation of intervention
Instrument/method of measurement: Depression will be measured using a feasible two question approach developed by Spitzer et. al, validated by Whooley et. al.
This is not a time to event variable. We will be evaluating the change from baseline and three months post initiation of intervention
Quality of life as assessed by a validated single item linear analogue scale.
Time Frame: This is not a time to event variable. We will be evaluating the change from baseline and three months post initiation of intervention
Instrument/method of measurement: Single item linear analog scale. A score of 5 or less on this scale has known association with poor outcomes across clinical research of burnout.
This is not a time to event variable. We will be evaluating the change from baseline and three months post initiation of intervention
Assess and measure overall burnout
Time Frame: This is not a time to event variable. We will be evaluating the change from baseline and three months post initiation of intervention.
Instrument/method of measurement: Maslach Burnout Inventory (MBI) will be administered to measure overall burnout. The MBI is a 22-item measure of the three dimensions of burnout: emotional exhaustion (EE), depersonalization (DP) and lack of personal accomplishment (PA) on a 7-point Likert scale ranging from 0 to 6. High scores on EE (≥26) or DP (≥9), and low scores on PA (≤34) are indicative of burnout.
This is not a time to event variable. We will be evaluating the change from baseline and three months post initiation of intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Joseph's Healthcare Hamilton

Investigators

  • Principal Investigator: Zainab Samaan, MBChB, PhD, St. Joseph's Healthcare Hamilton

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

July 8, 2020

First Submitted That Met QC Criteria

July 15, 2020

First Posted (Actual)

July 16, 2020

Study Record Updates

Last Update Posted (Actual)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11136 (Fred Hutchinson Cancer Center IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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