Perceived Organizational Support, Anxiety, BurnoutNCT04370938
Provider Burnout During COVID-19
A study testing Coping strategies video in people with Perceived Organizational Support, Anxiety, Burnout, run by University of Pittsburgh at 1 site in United States.
Trial summary
Since the novel coronavirus, SARS-CoV-2, was first reported in the Hubei province of China in December 2019, the US has become an epicenter for the pandemic, accounting for more than 220,000 cases and 4,800 deaths (CDC). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Perceived Organizational Support, Anxiety, Burnout
- What is being tested?
- Coping strategies video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2020to 29 Oct 2020
- 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
- All UPMC healthcare providers with patient-care responsibilities (respiratory therapists, physical therapists, nursing staff, residents, attendings, midlevel providers, and clinical faculty) will be contacted via email and asked if they would be willing to participate in this study (participant recruitment email).
Who cannot join
- All individuals <18 yo and those providers without direct patient-care responsibilities will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring Provider Burnout During the COVID-19 Pandemic
Since the novel coronavirus, SARS-CoV-2, was first reported in the Hubei province of China in December 2019, the US has become an epicenter for the pandemic, accounting for more than 220,000 cases and 4,800 deaths (CDC). The rapid spread of the associated disease, COVID-19, has overwhelmed healthcare systems in spite of unprecedented measures to reduce contagion. The resulting uncertainty with regard to the duration and magnitude of the pandemic and limited availability of resources and treatment have been detrimental to the mental health of frontline healthcare providers (NIH). Preserving the psychological wellbeing of these individuals is paramount to mitigating the effect of COVID-19 and delivering optimal patient care.
Of particularly grave concern is how professional and personal distress caused by the COVID-19 pandemic will affect provider burnout (Lai et al. JAMA Network Open 2020). Professional burnout, characterized by emotional exhaustion, career de-prioritization, and loss of self-efficacy, represents a significant threat to the US healthcare system (Shanafelt et al. Ann Surg 2010; Han et al. Annals of Internal Medicine 2019). While burnout has been described as a reaction to chronic work-related stress (Melamed et al. Psychol. Bull. 2006), individual factors such as anxiety increase susceptibility to burnout (Sun et al. J Occup Health 2012). Although data suggests that occupational stress might amplify risk of anxiety (DiGiacomo and Adamson J Allied Health 2001), we have yet to understand how intensified anxiety among frontline providers during global health crises contributes to burnout. Similarly, it is unknown whether factors such as perceived organizational support (POS), a key driver of job satisfaction and performance (Muse and Stamper, J Managerial Issues 2007), modify anxiety and burnout under these circumstances. We hypothesize that diminished POS in response to the COVID-19 pandemic is associated with burnout and that this relationship is mediated by an increase in providers' anxiety. Delineating this relationship is a critical first step in developing interventions that ease the mental health burden of this pandemic and future crises for healthcare providers.
- Being tested
- Coping strategies video
- Medical subject headings
- Anxiety Disorders, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coping strategies videoBehavioural
No additional description
| Study group | Role | What they receive |
|---|---|---|
| Coping strategies video | Experimental | Individuals will be asked to watch a 1 hour long video that discusses strategies helpful in coping with stress during the COVID-19 pandemic. Receives: Behavioral: Coping strategies video |
| Control | No intervention | No additional requests will be made of individuals in the control arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of undertaking task
As healthcare providers have limited time, it is unclear if this request to watch a 1 hour video on coping strategies will be a feasible intervention. We will assess how many individuals endorse actually watching this video.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start29 Apr 2020
- Primary completion29 Oct 2020 (estimated)
- Study completion29 Oct 2020 (estimated)
Why it stopped: No participants were enrolled and the study was never initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perceived Organizational Support, Anxiety, BurnoutStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A longitudinal survey-based research study investigating the domains of perceived organizational support, anxiety, and burnout will take place. Healthcare providers with patient-care contact will be asked to fill out these surveys once every 30 days over a period of 6 months. After the first survey is complete, 20% of participants will be randomized to watch a 1-hour long video discussing coping strategies for stress related to the COVID-19 pandemic.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Myers, University of Pittsburgh
- Investigators
- Sara P Myers, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370938
- Sponsor's protocol ID
- STUDY20040051
- Status last verified
- Dec 2020
- First submitted
- 29 Apr 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Provider Burnout During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04370938
- Acronym / sponsor ID
- STUDY20040051
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled and the study was never initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 29 Apr 2020 (actual)
- Primary completion
- 29 Oct 2020 (estimated)
- Study completion
- 29 Oct 2020 (estimated)
- First posted
- 1 May 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.
Since the novel coronavirus, SARS-CoV-2, was first reported in the Hubei province of China in December 2019, the US has become an epicenter for the pandemic, accounting for more than 220,000 cases and 4,800 deaths (CDC). The rapid spread of the associated disease, COVID-19, has overwhelmed healthcare systems in spite of unprecedented measures to reduce contagion. The resulting uncertainty with regard to the duration and magnitude of the pandemic and limited availability of resources and treatment have been detrimental to the mental health of frontline healthcare providers (NIH). Preserving the psychological wellbeing of these individuals is paramount to mitigating the effect of COVID-19 and delivering optimal patient care.
Of particularly grave concern is how professional and personal distress caused by the COVID-19 pandemic will affect provider burnout (Lai et al. JAMA Network Open 2020). Professional burnout, characterized by emotional exhaustion, career de-prioritization, and loss of self-efficacy, represents a significant threat to the US healthcare system (Shanafelt et al. Ann Surg 2010; Han et al. Annals of Internal Medicine 2019). While burnout has been described as a reaction to chronic work-related stress (Melamed et al. Psychol. Bull. 2006), individual factors such as anxiety increase susceptibility to burnout (Sun et al. J Occup Health 2012). Although data suggests that occupational stress might amplify risk of anxiety (DiGiacomo and Adamson J Allied Health 2001), we have yet to understand how intensified anxiety among frontline providers during global health crises contributes to burnout. Similarly, it is unknown whether factors such as perceived organizational support (POS), a key driver of job satisfaction and performance (Muse and Stamper, J Managerial Issues 2007), modify anxiety and burnout under these circumstances. We hypothesize that diminished POS in response to the COVID-19 pandemic is associated with burnout and that this relationship is mediated by an increase in providers' anxiety. Delineating this relationship is a critical first step in developing interventions that ease the mental health burden of this pandemic and future crises for healthcare providers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A longitudinal survey-based research study investigating the domains of perceived organizational support, anxiety, and burnout will take place. Healthcare providers with patient-care contact will be asked to fill out these surveys once every 30 days over a period of 6 months. After the first survey is complete, 20% of participants will be randomized to watch a 1-hour long video discussing coping strategies for stress related to the COVID-19 pandemic.
| Arm | Type | Receives |
|---|---|---|
| Coping strategies video | Experimental | Behavioral: Coping strategies videoIndividuals will be asked to watch a 1 hour long video that discusses strategies helpful in coping with stress during the COVID-19 pandemic. |
| Control | No intervention | –No additional requests will be made of individuals in the control arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All UPMC healthcare providers with patient-care responsibilities (respiratory therapists, physical therapists, nursing staff, residents, attendings, midlevel providers, and clinical faculty) will be contacted via email and asked if they would be willing to participate in this study (participant recruitment email).
Key exclusion criteria (1 listed)
- All individuals <18 yo and those providers without direct patient-care responsibilities will be excluded.
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 |
|---|---|---|
| Coping strategies videoNo additional description | Behavioural | Coping strategies video |
Primary outcome
Feasibility of undertaking task
Time frame: 6 months
As healthcare providers have limited time, it is unclear if this request to watch a 1 hour video on coping strategies will be a feasible intervention. We will assess how many individuals endorse actually watching this video.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Individual participant dataSharing planned: Undecided
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.
Sara P Myers, MD, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coping strategies video in people with Perceived Organizational Support, Anxiety, Burnout, run by University of Pittsburgh at 1 site in United States.
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: withdrawn, as of the sponsor's last update on 29 Dec 2020. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Feasibility of undertaking task (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2020; AzTrials last refreshed its copy on 30 Oct 2026.