StressNCT04125615
Resident Physician Burnout and Well-being
A study testing Protected Time Intervention in people with Stress, run by University of Minnesota at 1 site in United States.
Trial summary
Pilot study shows that two hours of weekly protected non-clinical time is associated with decreased burnout and increased well-being in otolaryngology residents Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress
- What is being tested?
- Protected Time Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 30 Jun 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all resident physicians (PGY1 - PGY5) in the Department of Otolaryngology that were willing to complete the study protocol
Who cannot join
- principal investigator(s) were excluded from participation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Resident Physician Burnout and Well-being: One Intervention and Its Impact
Pilot study shows that two hours of weekly protected non-clinical time is associated with decreased burnout and increased well-being in otolaryngology residents
Read the detailed description
Burnout amongst physicians is high with resulting concern over quality of care. With burnout beginning early in training, much-needed data is lacking on interventions to decrease burnout and improve well-being amongst resident physicians. The primary objective was to design and evaluate the impact of a departmental-level burnout intervention for otolaryngology residents. The secondary objective was to describe how residents utilized and perceived the study intervention.
All current residents in the Department of Otolaryngology at the University of Minnesota were solicited for participation. Inclusion criteria included all residents willing to complete the study protocol. Exclusion criteria included the principal investigator. All 19 eligible residents consented to participate. All participants were assigned two hours of weekly, protected non-clinical time alternating with a control period of no intervention at 6 week intervals.
Burnout was measured by the Maslach Burnout Inventory (MBI) and Mini-Z Questionnaire (Mini-Z). Well-being was measured by the Resident and Fellow Well-Being Index (WBI) and a quality-of-life (QOL) single-item self-assessment (SA). In addition to baseline demographic survey, participants completed the aforementioned surveys at approximately 6-week intervals from October 2017 to July 2018.
- Conditions
- Stress
- Being tested
- Protected Time Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protected Time InterventionBehavioural
Participants were assigned two hours of protected, non-clinical time by the chief resident of the service. Chief residents were instructed to assign this time when clinical learning opportunities were lowest. Each participant acted as their own control and was on the intervention phase of the study for the first or last 6 weeks of a quarterly rotation. Residents were concurrently assigned to the same phase of the study (intervention versus control). Participants were not specifically limited in what they could do during their non-clinical time, but they were encouraged to use this time in a way they felt would decrease their own personal burnout and increase their well-being, whether this be performing work-related administrative duties previously done on personal time or fulfilling obligations that are integral to personal health and well-being that can only be completed during normal business hours.
| Study group | Role | What they receive |
|---|---|---|
| Protected Non-Clinical Time | Experimental | Protected non-clinical time Receives: Behavioral: Protected Time Intervention |
| Control Period | No intervention | No protected non-clinical time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maslach Burnout Inventory (MBI) Emotional Exhaustion (EE) Subscale
The MBI is a 22-item questionnaire with three subscales: emotional exhaustion (EE), depersonalization (DP), and personal achievement (PA). Lower EE and DP scores and higher PA are associated with decreased burnout. MBI subscale scores are calculated as the average of the component MBI items (9 items for MBI EE, 5 items for MBI DP, 8 items for MBI PA) with each scale resulting in MBI scale scores that ranged from 0 (Never) to 6 (Every day).
Measured: baseline, end of intervention (32 weeks)
Change in Maslach Burnout Inventory (MBI) Depersonalization (DP) Subscale
The MBI is a 22-item questionnaire with three subscales: emotional exhaustion (EE), depersonalization (DP), and personal achievement (PA). Lower EE and DP scores and higher PA are associated with decreased burnout. MBI subscale scores are calculated as the average of the component MBI items (9 items for MBI EE, 5 items for MBI DP, 8 items for MBI PA) with each scale resulting in MBI scale scores that ranged from 0 (Never) to 6 (Every day).
Measured: baseline, end of intervention (32 weeks)
Change in Maslach Burnout Inventory (MBI) Personal Achievement (PA) Subscale
The MBI is a 22-item questionnaire with three subscales: emotional exhaustion (EE), depersonalization (DP), and personal achievement (PA). Lower EE and DP scores and higher PA are associated with decreased burnout. MBI subscale scores are calculated as the average of the component MBI items (9 items for MBI EE, 5 items for MBI DP, 8 items for MBI PA) with each scale resulting in MBI scale scores that ranged from 0 (Never) to 6 (Every day).
Measured: baseline, end of intervention (32 weeks)
Change in Mini-Z Questionnaire (Mini-Z) Question 3
The Mini-Z is derived from the "Z" Clinician Questionnaire and has been validated with 10 stand-alone questions measuring feelings of burnout. For this study, only question 3 was used. This multiple-choice question assesses feelings of burnout using the participant's own definition. Answers range from A (I enjoy my work. I have no symptoms of burnout.) to E (I feel completely burned out. I am at the point where I may need to seek help.).
Measured: baseline, end of intervention (32 weeks)
Change in Resident and Fellow Well-Being Index (WBI)
The WBI is a 7-item validated screening tool designed specifically for resident physicians to evaluate fatigue, depression, burnout, anxiety/stress, and mental/physical QOL. The WBI scale score is the total number of negative conditions that were experienced in the past month resulting in a scale score ranging from 0 - 7 with lower scores indicating higher well-being.
Measured: baseline, end of intervention (32 weeks)
Change in Quality-of-Life (QOL) Single-Item Self-Assessment (SA)
The QOL SA has 5 response options to the question "Which of the following best describes your overall quality of life?" 0: As bad as it can be, 1: Somewhat bad, 2: Neutral, 3: Somewhat good, 4: As good as it can be, with higher QOL scores indicating higher quality of life.
Measured: baseline, end of intervention (32 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start1 Sep 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristin Stevens, MD, Principal investigator, University of Minenesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125615
- Sponsor's protocol ID
- 1612E02561
- Status last verified
- Oct 2019
- First submitted
- 10 Oct 2019
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resident Physician Burnout and Well-being: One Intervention and Its Impact
- ClinicalTrials.gov ID
- NCT04125615
- Acronym / sponsor ID
- 1612E02561
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 14 Oct 2019 (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.
Pilot study shows that two hours of weekly protected non-clinical time is associated with decreased burnout and increased well-being in otolaryngology residents
Detailed description
Burnout amongst physicians is high with resulting concern over quality of care. With burnout beginning early in training, much-needed data is lacking on interventions to decrease burnout and improve well-being amongst resident physicians. The primary objective was to design and evaluate the impact of a departmental-level burnout intervention for otolaryngology residents. The secondary objective was to describe how residents utilized and perceived the study intervention.
All current residents in the Department of Otolaryngology at the University of Minnesota were solicited for participation. Inclusion criteria included all residents willing to complete the study protocol. Exclusion criteria included the principal investigator. All 19 eligible residents consented to participate. All participants were assigned two hours of weekly, protected non-clinical time alternating with a control period of no intervention at 6 week intervals.
Burnout was measured by the Maslach Burnout Inventory (MBI) and Mini-Z Questionnaire (Mini-Z). Well-being was measured by the Resident and Fellow Well-Being Index (WBI) and a quality-of-life (QOL) single-item self-assessment (SA). In addition to baseline demographic survey, participants completed the aforementioned surveys at approximately 6-week intervals from October 2017 to July 2018.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protected Non-Clinical Time | Experimental | Behavioral: Protected Time InterventionProtected non-clinical time |
| Control Period | No intervention | –No protected non-clinical time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all resident physicians (PGY1 - PGY5) in the Department of Otolaryngology that were willing to complete the study protocol
Key exclusion criteria (1 listed)
- principal investigator(s) were excluded from participation
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 |
|---|---|---|
| Protected Time InterventionParticipants were assigned two hours of protected, non-clinical time by the chief resident of the service. Chief residents were instructed to assign this time when clinical learning opportunities were lowest. Each participant acted as their own control and was on the intervention phase of the study for the first or last 6 weeks of a quarterly rotation. Residents were concurrently assigned to the same phase of the study (intervention versus control). Participants were not specifically limited in what they could do during their non-clinical time, but they were encouraged to use this time in a way they felt would decrease their own personal burnout and increase their well-being, whether this be performing work-related administrative duties previously done on personal time or fulfilling obligations that are integral to personal health and well-being that can only be completed during normal business hours. | Behavioural | Protected Non-Clinical Time |
Primary outcome
Change in Maslach Burnout Inventory (MBI) Emotional Exhaustion (EE) Subscale
Time frame: baseline, end of intervention (32 weeks)
The MBI is a 22-item questionnaire with three subscales: emotional exhaustion (EE), depersonalization (DP), and personal achievement (PA). Lower EE and DP scores and higher PA are associated with decreased burnout. MBI subscale scores are calculated as the average of the component MBI items (9 items for MBI EE, 5 items for MBI DP, 8 items for MBI PA) with each scale resulting in MBI scale scores that ranged from 0 (Never) to 6 (Every day).
Change in Maslach Burnout Inventory (MBI) Depersonalization (DP) Subscale
Time frame: baseline, end of intervention (32 weeks)
The MBI is a 22-item questionnaire with three subscales: emotional exhaustion (EE), depersonalization (DP), and personal achievement (PA). Lower EE and DP scores and higher PA are associated with decreased burnout. MBI subscale scores are calculated as the average of the component MBI items (9 items for MBI EE, 5 items for MBI DP, 8 items for MBI PA) with each scale resulting in MBI scale scores that ranged from 0 (Never) to 6 (Every day).
Change in Maslach Burnout Inventory (MBI) Personal Achievement (PA) Subscale
Time frame: baseline, end of intervention (32 weeks)
The MBI is a 22-item questionnaire with three subscales: emotional exhaustion (EE), depersonalization (DP), and personal achievement (PA). Lower EE and DP scores and higher PA are associated with decreased burnout. MBI subscale scores are calculated as the average of the component MBI items (9 items for MBI EE, 5 items for MBI DP, 8 items for MBI PA) with each scale resulting in MBI scale scores that ranged from 0 (Never) to 6 (Every day).
Change in Mini-Z Questionnaire (Mini-Z) Question 3
Time frame: baseline, end of intervention (32 weeks)
The Mini-Z is derived from the "Z" Clinician Questionnaire and has been validated with 10 stand-alone questions measuring feelings of burnout. For this study, only question 3 was used. This multiple-choice question assesses feelings of burnout using the participant's own definition. Answers range from A (I enjoy my work. I have no symptoms of burnout.) to E (I feel completely burned out. I am at the point where I may need to seek help.).
Change in Resident and Fellow Well-Being Index (WBI)
Time frame: baseline, end of intervention (32 weeks)
The WBI is a 7-item validated screening tool designed specifically for resident physicians to evaluate fatigue, depression, burnout, anxiety/stress, and mental/physical QOL. The WBI scale score is the total number of negative conditions that were experienced in the past month resulting in a scale score ranging from 0 - 7 with lower scores indicating higher well-being.
Change in Quality-of-Life (QOL) Single-Item Self-Assessment (SA)
Time frame: baseline, end of intervention (32 weeks)
The QOL SA has 5 response options to the question "Which of the following best describes your overall quality of life?" 0: As bad as it can be, 1: Somewhat bad, 2: Neutral, 3: Somewhat good, 4: As good as it can be, with higher QOL scores indicating higher quality of life.
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 14 Oct 2019.
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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.
Kristin Stevens, MD principal investigator
University of Minenesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protected Time Intervention in people with Stress, run by University of Minnesota 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: finished, as of the sponsor's last update on 14 Oct 2019. 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 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?
Change in Maslach Burnout Inventory (MBI) Emotional Exhaustion (EE) Subscale (time frame: baseline, end of intervention (32 weeks)). The study lists 6 primary outcomes in all. 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 14 Oct 2019.