BurnoutRESTORENCT04474080
Reducing Burnout Among Frontline Healthcare Workers During COVID-19
A study testing Virtual Peer Support Platform in people with Burnout, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout
- What is being tested?
- Virtual Peer Support Platform
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2022to 1 Aug 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physician residents across all medical specialties at McMaster University, McGill University, and Stanford University.
- Must be able to provide written informed consent
Who cannot join
- Residents who are on prolonged leave (>4 weeks)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Burnout
- Being tested
- Virtual Peer Support Platform, Control Period
- Keywords
- physician, burnout, COVID-19, public health response, stress, depression, virtual peer support platforms, frontline healthcare workers
- Medical subject headings
- Burnout, Psychological, COVID-19, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Peer Support PlatformBehavioural
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.
Control PeriodBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Virtual Peer Support Platform |
| Control period | Active comparator | Residents will continue with their regular academic day activities during the allotted intervention time. Receives: Behavioral: Control Period |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 3
Recruitment
Total number of participants recruited to the study
Measured: To be assessed at three months
Retention
Total number of participants who remain in the study until the end of observation
Measured: 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
Measured: To be assessed at the end of the three month intervention period.
Average group size
Measured as the mean number of participants per group
Measured: To be assessed at the end of the three month intervention period.
Data completion
Measured as the percentage of instruments completed
Measured: 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.
Measured: To be assessed at the end of the three month intervention period.
Secondary outcomes (4)
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.
Measured: 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
Instrument/method of measurement: Depression will be measured using a feasible two question approach developed by Spitzer et. al, validated by Whooley et. al.
Measured: 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.
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.
Measured: 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
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.
Measured: This is not a time to event variable. We will be evaluating the change from baseline and three months post initiation of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start1 Jul 2022
- Primary completion1 Jan 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for BurnoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zainab Samaan (Zena), St. Joseph's Healthcare Hamilton
- Investigators
- Zainab Samaan, MBChB, PhD, Principal investigator, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474080
- Sponsor's protocol ID
- 11136
- Acronym
- RESTORE
- Status last verified
- Feb 2024
- First submitted
- 8 Jul 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25531003Grobler 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.
PubMed 27544429Lai 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.
PubMed 32202646Montemurro 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.
PubMed 32240766Ishak 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.
PubMed 23834570Thomas NK. Resident burnout. JAMA. 2004 Dec 15;292(23):2880-9. doi: 10.1001/jama.292.23.2880.
PubMed 15598920Sasangohar 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.
PubMed 32282389Shiao 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.
PubMed 17334166Koh 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.
PubMed 15970782Li 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.
PubMed 30134982Barbour 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.
PubMed 7665310Whooley 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.
PubMed 9229283Spitzer 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.
PubMed 7966923
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04474080
- Acronym / sponsor ID
- RESTORE / 11136
- Conditions
- Burnout
- Keywords
- physician, burnout, COVID-19, public health response, stress, depression, virtual peer support platforms, frontline healthcare workers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtual Peer Support Platform | Experimental | Behavioral: Virtual Peer Support PlatformThe 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). |
| Control period | Active comparator | Behavioral: Control PeriodResidents will continue with their regular academic day activities during the allotted intervention time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Physician residents across all medical specialties at McMaster University, McGill University, and Stanford University.
- Must be able to provide written informed consent
Key exclusion criteria (1 listed)
- Residents who are on prolonged leave (>4 weeks)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Peer Support PlatformThe 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. | Behavioural | Virtual Peer Support Platform |
| Control PeriodThe 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 | Behavioural | Control period |
Primary outcome
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.
Recruitment
Time frame: To be assessed at three months
Total number of participants recruited to the study
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
Number of sessions completed
Time frame: To be assessed at the end of the three month intervention period.
Measured as number of sessions completed
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
Data completion
Time frame: To be assessed at the end of the three month intervention period
Measured as the percentage of instruments completed
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.
4 secondary outcomes
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
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 25531003Zis 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.
- Background: PubMed 27544429Grobler 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.
- Background: PubMed 32202646Lai 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.
- Background: PubMed 32240766Montemurro 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.
- Background: PubMed 23834570Ishak 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.
- Background: PubMed 15598920Thomas NK. Resident burnout. JAMA. 2004 Dec 15;292(23):2880-9. doi: 10.1001/jama.292.23.2880.
- Background: PubMed 32282389Sasangohar 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.
- Background: PubMed 17334166Shiao 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.
- Background: PubMed 15970782Koh 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.
- Background: PubMed 30134982Li 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.
- Background: PubMed 7665310Barbour 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.
- Background: PubMed 9229283Whooley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zainab Samaan, MBChB, PhD principal investigator
St. Joseph's Healthcare Hamilton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Peer Support Platform in people with Burnout, run by St. Joseph's Healthcare Hamilton 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 2 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 19 Sep 2024. 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?
Acceptability as assessed through patient reported experiences with the virtual intervention. (time frame: Month 3). The study lists 7 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 NCT04474080, which also lists 13 linked publications.
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 19 Sep 2024.