Clinical trial NCT04474080: Reducing Burnout Among Frontline Healthcare Workers During COVID-19
Official title: The Role of Virtual Peer Support Platforms for Reducing Stress and Burnout Among Frontline Healthcare Workers During COVID-19: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout
Keywords: physician
burnout
COVID-19
public health response
stress
depression
virtual peer support platforms
frontline healthcare workers
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The following trial uses a nested stepped-wedge randomized controlled trial 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. An in-depth evaluation of the interventions acceptability will be completed using a nested qualitative study design, wherein 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.
Primary purpose: PREVENTION

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 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.

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, the investigators 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, the investigators 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, the investigators 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.

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)

Primary outcomes:
measure: Acceptability as assessed through patient reported experiences with the virtual intervention.
timeFrame: Month 3
measure: Recruitment
timeFrame: To be assessed at three months
measure: Retention
timeFrame: 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.
measure: Number of sessions completed
timeFrame: To be assessed at the end of the three month intervention period.
measure: Average group size
timeFrame: To be assessed at the end of the three month intervention period.
measure: Data completion
timeFrame: To be assessed at the end of the three month intervention period
measure: 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.
timeFrame: To be assessed at the end of the three month intervention period.
Secondary outcomes:
measure: Assess stress
timeFrame: This is not a time to event variable. We will be evaluating the change from baseline and three months post initiation of intervention
measure: Assess depression
timeFrame: This is not a time to event variable. We will be evaluating the change from baseline and three months post initiation of intervention
measure: Quality of life as assessed by a validated single item linear analogue scale.
timeFrame: This is not a time to event variable. We will be evaluating the change from baseline and three months post initiation of intervention
measure: Assess and measure overall burnout
timeFrame: This is not a time to event variable. We will be evaluating the change from baseline and three months post initiation of intervention.
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: St. Joseph's Healthcare Hamilton
name: Zainab Samaan, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
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