NCT04474080

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
2 years until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

September 19, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

July 8, 2020

Last Update Submit

September 3, 2024

Conditions

Keywords

physicianburnoutCOVID-19public health responsestressdepressionvirtual peer support platformsfrontline healthcare workers

Outcome Measures

Primary Outcomes (7)

  • Acceptability as assessed through patient reported experiences with the virtual intervention.

    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

    Total number of participants recruited to the study

    To be assessed at three months

  • Retention

    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

    Measured as number of sessions completed

    To be assessed at the end of the three month intervention period.

  • Average group size

    Measured as the mean number of participants per group

    To be assessed at the end of the three month intervention period.

  • Data completion

    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.

    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 Outcomes (4)

  • Assess stress

    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

    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.

    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

    This is not a time to event variable. We will be evaluating the change from baseline and three months post initiation of intervention.

Study Arms (2)

Virtual Peer Support Platform

EXPERIMENTAL

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

Control period

ACTIVE COMPARATOR

Residents will continue with their regular academic day activities during the allotted intervention time.

Behavioral: Control Period

Interventions

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.

Virtual Peer Support Platform
Control PeriodBEHAVIORAL

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

Control period

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L4E4S4, Canada

Location

Related Publications (13)

  • Zis P, Anagnostopoulos F, Sykioti P. Burnout in medical residents: a study based on the job demands-resources model. ScientificWorldJournal. 2014;2014:673279. doi: 10.1155/2014/673279. Epub 2014 Oct 30.

    PMID: 25531003BACKGROUND
  • Grobler L, Mehtar S, Dheda K, Adams S, Babatunde S, van der Walt M, Osman M. The epidemiology of tuberculosis in health care workers in South Africa: a systematic review. BMC Health Serv Res. 2016 Aug 20;16(1):416. doi: 10.1186/s12913-016-1601-5.

    PMID: 27544429BACKGROUND
  • Lai J, Ma S, Wang Y, Cai Z, Hu J, Wei N, Wu J, Du H, Chen T, Li R, Tan H, Kang L, Yao L, Huang M, Wang H, Wang G, Liu Z, Hu S. Factors Associated With Mental Health Outcomes Among Health Care Workers Exposed to Coronavirus Disease 2019. JAMA Netw Open. 2020 Mar 2;3(3):e203976. doi: 10.1001/jamanetworkopen.2020.3976.

    PMID: 32202646BACKGROUND
  • Montemurro N. The emotional impact of COVID-19: From medical staff to common people. Brain Behav Immun. 2020 Jul;87:23-24. doi: 10.1016/j.bbi.2020.03.032. Epub 2020 Mar 30. No abstract available.

    PMID: 32240766BACKGROUND
  • Ishak W, Nikravesh R, Lederer S, Perry R, Ogunyemi D, Bernstein C. Burnout in medical students: a systematic review. Clin Teach. 2013 Aug;10(4):242-5. doi: 10.1111/tct.12014.

    PMID: 23834570BACKGROUND
  • Thomas NK. Resident burnout. JAMA. 2004 Dec 15;292(23):2880-9. doi: 10.1001/jama.292.23.2880.

    PMID: 15598920BACKGROUND
  • Sasangohar F, Jones SL, Masud FN, Vahidy FS, Kash BA. Provider Burnout and Fatigue During the COVID-19 Pandemic: Lessons Learned From a High-Volume Intensive Care Unit. Anesth Analg. 2020 Jul;131(1):106-111. doi: 10.1213/ANE.0000000000004866. No abstract available.

    PMID: 32282389BACKGROUND
  • Shiao JS, Koh D, Lo LH, Lim MK, Guo YL. Factors predicting nurses' consideration of leaving their job during the SARS outbreak. Nurs Ethics. 2007 Jan;14(1):5-17. doi: 10.1177/0969733007071350.

    PMID: 17334166BACKGROUND
  • Koh D, Lim MK, Chia SE, Ko SM, Qian F, Ng V, Tan BH, Wong KS, Chew WM, Tang HK, Ng W, Muttakin Z, Emmanuel S, Fong NP, Koh G, Kwa CT, Tan KB, Fones C. Risk perception and impact of Severe Acute Respiratory Syndrome (SARS) on work and personal lives of healthcare workers in Singapore: what can we learn? Med Care. 2005 Jul;43(7):676-82. doi: 10.1097/01.mlr.0000167181.36730.cc.

    PMID: 15970782BACKGROUND
  • Li Y, Wang H, Jin XR, Li X, Pender M, Song CP, Tang SL, Cao J, Wu H, Wang YG. Experiences and challenges in the health protection of medical teams in the Chinese Ebola treatment center, Liberia: a qualitative study. Infect Dis Poverty. 2018 Aug 16;7(1):92. doi: 10.1186/s40249-018-0468-6.

    PMID: 30134982BACKGROUND
  • Barbour RS. Responding to a challenge: nursing care and AIDS. Int J Nurs Stud. 1995 Jun;32(3):213-23. doi: 10.1016/0020-7489(95)00003-g.

    PMID: 7665310BACKGROUND
  • Whooley MA, Avins AL, Miranda J, Browner WS. Case-finding instruments for depression. Two questions are as good as many. J Gen Intern Med. 1997 Jul;12(7):439-45. doi: 10.1046/j.1525-1497.1997.00076.x.

    PMID: 9229283BACKGROUND
  • Spitzer RL, Williams JB, Kroenke K, Linzer M, deGruy FV 3rd, Hahn SR, Brody D, Johnson JG. Utility of a new procedure for diagnosing mental disorders in primary care. The PRIME-MD 1000 study. JAMA. 1994 Dec 14;272(22):1749-56.

    PMID: 7966923BACKGROUND

MeSH Terms

Conditions

Burnout, PsychologicalCOVID-19Depression

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Zainab Samaan, MBChB, PhD

    St. Joseph's Healthcare Hamilton

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 8, 2020

First Posted

July 16, 2020

Study Start

July 1, 2022

Primary Completion

January 1, 2023

Study Completion

August 1, 2023

Last Updated

September 19, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations