- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04125615
Resident Physician Burnout and Well-being
Resident Physician Burnout and Well-being: One Intervention and Its Impact
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- all resident physicians (PGY1 - PGY5) in the Department of Otolaryngology that were willing to complete the study protocol
Exclusion Criteria:
- principal investigator(s) were excluded from participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NON_RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Protected Non-Clinical Time
Protected non-clinical time
|
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.
|
|
NO_INTERVENTION: Control Period
No protected non-clinical time
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
baseline, end of intervention (32 weeks)
|
|
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).
|
baseline, end of intervention (32 weeks)
|
|
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).
|
baseline, end of intervention (32 weeks)
|
|
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.).
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baseline, end of intervention (32 weeks)
|
|
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.
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baseline, end of intervention (32 weeks)
|
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Change in Quality-of-Life (QOL) Single-Item Self-Assessment (SA)
Time Frame: baseline, end of intervention (32 weeks)
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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.
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baseline, end of intervention (32 weeks)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kristin Stevens, MD, University of Minenesota
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1612E02561
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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