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

Primary Purpose

Burnout

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Virtual Peer Support Platform
Control Period
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Burnout focused on measuring physician, burnout, COVID-19, public health response, stress, depression, virtual peer support platforms, frontline healthcare workers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • St. Joseph's Healthcare Hamilton

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual Peer Support Platform

Control period

Arm Description

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 underly 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).

Residents receive a 30 minutes break during their weekly academic half-day.

Outcomes

Primary Outcome Measures

Assess and measure overall burnout
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.

Secondary Outcome Measures

Assess stress
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.
Assess depression
depression will be measured using a feasible two question approach developed by Spitzer et. al, validated by Whooley et. al.
Assess quality of life
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.

Full Information

First Posted
July 8, 2020
Last Updated
October 21, 2020
Sponsor
St. Joseph's Healthcare Hamilton
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1. Study Identification

Unique Protocol Identification Number
NCT04474080
Brief Title
Reducing Burnout Among Frontline Healthcare Workers During COVID-19
Acronym
RESTORE
Official Title
The Role of Virtual Peer Support Platforms for Reducing Stress and Burnout Among Frontline Healthcare Workers During COVID-19: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2021 (Anticipated)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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 in Canada and the United States of America 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.
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 frontlines. 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 frontlines 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 frontlines 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 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 frontlines, and 2) 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 test the effects of a 3 month, 8-session intervention to reduce burnout in physician residents in residency programs in Canada and the United States of America 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout
Keywords
physician, burnout, COVID-19, public health response, stress, depression, virtual peer support platforms, frontline healthcare workers

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The following trial uses a nested stepped-wedge RCT design. Specialty residency programs will be the unit of randomization, with each program being randomized to receive the virtual peer support intervention across varying time-points.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1080 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Peer Support Platform
Arm Type
Experimental
Arm Description
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 underly 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).
Arm Title
Control period
Arm Type
Active Comparator
Arm Description
Residents receive a 30 minutes break during their weekly academic half-day.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Peer Support Platform
Intervention Description
The intervention program will consist of 8 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.
Intervention Type
Behavioral
Intervention Name(s)
Control Period
Intervention Description
The control period will be the time prior to randomization and commencement of the intervention, whereby residents will receive a 30 minute break each week during their academic half-day.
Primary Outcome Measure Information:
Title
Assess and measure overall burnout
Description
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.
Time Frame
Change from baseline at month 3 and 6.
Secondary Outcome Measure Information:
Title
Assess stress
Description
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.
Time Frame
Change from baseline at month 3 and 6.
Title
Assess depression
Description
depression will be measured using a feasible two question approach developed by Spitzer et. al, validated by Whooley et. al.
Time Frame
Change from baseline at month 3 and 6.
Title
Assess quality of life
Description
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.
Time Frame
Change from baseline at month 3 and 6.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacqueline Hudson
Phone
9055221155
Ext
39215
Email
jhudson@mcmaster.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Zainab Samaan, MBChB, PhD
Email
samaanz@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zainab Samaan, MBChB, PhD
Organizational Affiliation
St. Joseph's Healthcare Hamilton
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L4E4S4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Reducing Burnout Among Frontline Healthcare Workers During COVID-19

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