AzTrials
AzTrials

Burnout, ProfessionalCOPINGNCT04379063

COVID-19 Pandemic Short Interval National Survey Gauging Psychological Distress

An observational study of Burnout, Professional and Psychological Distress, run by Jon Bailey at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The Coronavirus Disease (COVID-19) pandemic is unprecedented in its scale of infection and the response required to decrease the mortality rates. Disturbingly, the European and United States experience demonstrates that health care systems in industrialized countries are at risk of becoming overwhelmed. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Burnout, Professional, Psychological Distress
What is being tested?
COVID-19 pandemic
How many people
342 participants
Where
1 siteCanada
Study dates
13 May 2020to 18 Jul 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: The membership of Canadian Medical Association (CMA) was 71,655 as of June 10, 2019. This includes medical students and retired physicians. The total number of residents (8,681) and practicing physicians (44,557) is 53,238 who could meet inclusion criteria. Response rates by medical trainees to web-based surveys without incentives are approximately 60%, based on previous survey studies. However, given the current situation and the potential for overwhelmed healthcare systems and personnel, we expect a much lower response rate of 20-30%.

Who may be able to join

  • Any physician who is currently practicing in Canada, whether they hold a full, provisional, or post-graduate in-training license.

Who cannot join

  • Non-physician healthcare providers, medical students, physicians without an active license to practice will be excluded.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Nova Scotia Health Authority

    Halifax, Nova Scotia, B3S 0H6

Other trials in Canada

About this study

Official title: COVID-19 Pandemic Short Interval National Survey Gauging Psychological Distress Among Physicians (COPING Survey): A Longitudinal Survey

The Coronavirus Disease (COVID-19) pandemic is unprecedented in its scale of infection and the response required to decrease the mortality rates. Disturbingly, the European and United States experience demonstrates that health care systems in industrialized countries are at risk of becoming overwhelmed. Physicians are already at risk of burnout under normal working conditions, and in particular, when responding to crisis situations. During the 2003 severe acute respiratory syndrome (SARS) outbreak, healthcare workers experienced high rates of psychological distress that lasted years. However, there may be protective factors that may decrease the rate or severity of psychological distress and burnout. This study seeks to investigate the rates of physician burnout assessed at multiple time points during the COVID-19 pandemic. Further, this study seeks to determine the factors that may increase or decrease burnout and psychological distress in such a setting.

This study will be a national longitudinal survey of physicians in Canada. It will include all physicians that currently hold a license to practice in Canada (whether in training or a full license). Consenting participants will complete an initial survey gathering information about their type of practice, health conditions, preparations the COVID-19 pandemic, burnout, and psychological distress. Every month, participants will be asked to complete a follow-up survey, describing their stressors, coping strategies, burnout, and psychological distress.

The investigators will analyze and report the initial results to help provincial and national organizations support our physicians and mitigate burnout during this pandemic. The results of the follow up surveys will be analyzed and reported following the pandemic. These findings will help keep our physician workforce healthy under normal working conditions and during future crises.

Read the detailed description

Background It has become ubiquitous to describe the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic and the global measures to decrease mortality rates of Coronavirus Disease (COVID-19) as 'unprecedented'. The Public Health Agency of Canada (PHAC) models released on April 8th predict that even with strict epidemiologic controls 934,000-1,879,000 people will be infected in Canada and 11,000- 22,000 will die. Disturbingly, the European and United States experience demonstrates that health care systems in industrialized countries are at risk of becoming overwhelmed. It has long been recognized that physicians are at risk for burnout, which can negatively affect their ability to care for patients, their colleagues and themselves. Infectious disease pandemics present many of the same challenges for physicians as natural disasters and mass casualty events, with the addition of a prolonged time frame, potential need for isolation away from family, and concern of becoming infected or infecting loved ones. During the 2003 severe acute respiratory syndrome (SARS) outbreak, 18-57% of health care workers (HCWs) experienced measurable psychological distress. Even 1-2 years following the SARS pandemic HCWs in Ontario experienced high levels of burnout (19-30%), psychological distress (30-45%), and PTSD symptoms (8-13%). Despite the overall high rates, there are several mitigating factors that may decrease the rate or severity of psychological distress and burnout.

Given that these studies generally measure burnout and psychological distress at one or two cross-sectional time points, it is difficult to tell how burnout develops over time. Additionally, the bulk of the studies assessed HCWs following natural disasters, which tend to present as a single time point with one large wave of patients. The current crisis is distinct in its sustained level of demand on HCWs with potential for multiple waves of patients or a sustained high number of patients outstripping the health care system resources for months at a time. This study seeks to investigate the rates of burnout assessed at multiple time points during the COVID-19 pandemic. Further, this study seeks to determine the relationship between patient numbers, mitigating factors, and exacerbating factors and the rates of burnout at various time points.

Objectives

  1. What are the rates of psychological distress and burnout among physicians and residents throughout the COVID-19 pandemic?
  2. What baseline factors are associated with reductions and increases in psychological distress and burnout over time (trajectories)?

Methods This study will be a national longitudinal survey of physicians in Canada. The sampling frame will be all physicians currently practicing in Canada, whether they hold a full, provisional, or post-graduate in-training license. The survey will be distributed by: 1. Advertisements on Twitter, 2. Provincial physician associations, and 3. National specialty groups for higher risk specialties (anesthesia, critical care, emergency medicine). Recipients will be directed to the survey site hosted by Redcap. Cross-sectional results of the initial survey to give immediate feedback to provincial and national organizations about the threat of physician burnout and psychological distress. Longitudinal results will analyze how burnout and distress change over time and will analyze the relationship to mitigating and exacerbating factors.

Consenting participants will complete an initial survey gathering demographic information (age, gender, trainee, years in practice, specialty, chronic health conditions, practice type (academic, community, rural), preparatory information (prior to first COVID-19 suspected case: COVID-19 pathways/procedures, simulation, designated areas, scheduling changes), and baseline measures (Maslach Burnout Inventory - General Survey (MBI-GS) short form, Pandemic Experience \& Perceptions Scale (PEPS), Hospital Anxiety and Depression Scale (HADS), stressors, resources, coping strategies). Participants will then receive follow up questionnaires every month until there is a sustained period of no new cases in their province (1 month without a new case) up to a maximum of one-year involvement. These follow up questionnaires will measure burnout (MBI-GS), psychological distress (HADS), pandemic specific stressors (PEPS), workplace stressors, and resources/coping strategies. A final follow-up survey will be sought one year after the end of the short- interval surveys to assess the long-term effects of responding to the COVID pandemic.

Statistical Analysis Objective 1. Variables will be described using mean and standard deviation when normally distributed or median and interquartile range when skewed as measured by the Shapiro-Wilk test.

Objective 2. The cross-sectional results of the initial survey will be analyzed using linear regression to quantify the strength of relationship between factors and burnout. In the longitudinal analysis, trajectory analysis using latent growth mixed modelling (LGMM) will be used to identify trajectories of burnout and psychological distress amongst physicians over time. LGMM is ideally suited to longitudinal data as it is robust to the effects of missing data. Furthermore, LGMM may prove very useful in an unprecedented situation such as this in which there is scant data on which to base hypotheses as LGMM allows trajectories to be identified more empirically based on the data rather than through a priori conceptual models.

Anticipated Outcomes The investigators will discover whether the characteristics of burnout during this pandemic are comparable to the current body of knowledge about physician burnout at baseline or during more limited periods of crisis. This will inform whether current interventions for physician burnout are appropriate during widespread pandemic events, both as physicians continue to deal with COVID-19 and in the future. Improved understanding of stressors and protective factors will be essential not only for planning therapeutic studies at an individual level but will also allow institutions to mobilize high yield supports for physicians at risk.

Being tested
COVID-19 pandemic
Keywords
COVID-19, Coronavirus, Pandemic, Outbreak
Medical subject headings
Burnout, Professional, COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COVID-19 pandemicOther

    Currently practicing during the COVID-19 pandemic

Study groups in NCT04379063
Study groupRoleWhat they receive
Canadian physicians during COVID-19 pandemicAny physician who is practicing in Canada during the COVID-19 pandemic, whether they hold a full, provisional, or post-graduate in-training license.
Receives: Other: COVID-19 pandemic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Burnout

    Measured by the Maslach Burnout Inventory - General Survey (MBI-GS) short form. The MBI-SF has three subscales (exhaustion, cynicism, efficacy). Each subscale is scored from 0-6 indicating the frequency of work-related feelings. A higher score in both exhaustion and cynicism indicate burnout is more likely; whereas, higher scores in efficacy indicate burnout is less likely.

    Measured: Start of survey until there is a sustained period of no new cases in their province (1 month without a new case)

  2. Psychological Distress

    Measured by the Hospital Anxiety and Depression Scale (HADS). The HADS scores both symptoms of depression and anxiety using 14-item measure (7 item with possible scores 0-21 each). Higher scores suggest that depression and/or anxiety are more likely.

    Measured: Start of survey until there is a sustained period of no new cases in their province (1 month without a new case)

Secondary outcomes (2)
  1. Post-traumatic stress symptoms

    Measured by the Post-Traumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5). Symptoms suggestive of PTSD are scored using a 20-item measure with possible scores ranging from 0-80. Higher scores are more suggestive of PTSD.

    Measured: One year following the end of the survey (no new cases in their province, 1 month without a new case)

  2. Post-traumatic growth

    Measured by the Post-traumatic Growth Inventory (PTGI-SF). The PTGI-SF is a 10-item measure with possible scores ranging from 0-50. Higher scores suggest that post-traumatic growth is more likely.

    Measured: One year following the end of the survey (no new cases in their province, 1 month without a new case)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2020
  2. Study start13 May 2020
  3. Primary completion28 Sep 2020
  4. Study completion18 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
342 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04379063
Sponsor's protocol ID
NSHA REB#1025690
Acronym
COPING
Status last verified
Dec 2022
First submitted
5 May 2020
Last updated
20 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bailey JG, Wong M, Bailey K, Banfield JC, Barry G, Munro A, Kirkland S, Leiter M. Pandemic-related factors predicting physician burnout beyond established organizational factors: cross-sectional results from the COPING survey. Psychol Health Med. 2023 Jul-Dec;28(8):2353-2367. doi: 10.1080/13548506.2021.1990366. Epub 2021 Oct 14.

    PubMed 34649468

Questions about this trial

What is this clinical trial studying?

An observational study of Burnout, Professional and Psychological Distress, run by Jon Bailey at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Burnout (time frame: Start of survey until there is a sustained period of no new cases in their province (1 month without a new case)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04379063, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in