NCT03489720

Brief Summary

This study seeks to evaluate the prevalence and characterize predictors of physician burnout in the anesthesia residency at Vanderbilt University Medical Center. The study also seeks to evaluate the effect of an exercise intervention on burnout and personal resiliency (i.e., less individual stress given the same workload).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 5, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2018

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 14, 2020

Completed
Last Updated

April 14, 2020

Status Verified

February 1, 2020

Enrollment Period

7 months

First QC Date

March 29, 2018

Results QC Date

February 21, 2020

Last Update Submit

April 1, 2020

Conditions

Outcome Measures

Primary Outcomes (9)

  • The Change in the Emotional Exhaustion (EE) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI)From Baseline to End of Each Exercise Phase.

    The change in the Emotional Exhaustion (EE) burnout score(as measured by the Maslach Burnout Inventory (MBI)from baseline to end of each exercise phase. MBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS EE score includes 9 items to evaluate emotional exhaustion (EE), with scores ranging from 0 to 6 on the Likert scale. MBI-HSS EE total score ranges from 0 to 54 points. We consider a high degree of burnout in the case of EE ≥ 27 points. Moderate burnout will be considered in the case of 26\<EE\<19 points. Low levels will be considered for EE≤18 points.

    Baseline to 8 weeks

  • The Change in the Depersonalization (DP) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI))From Baseline to End of Each Exercise Phase.

    The change in the Depersonalization (DP) burnout score(as measured by the Maslach Burnout Inventory (MBI))from baseline to end of each exercise phase. MBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS DP score includes 5 items to evaluate depersonalization (DP) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS DP total score ranges from 0 to 30 points. We consider a high degree of burnout in the case of DP≥ 13 points. Moderate burnout will be considered in the case of 7-12 DP points. Low levels will be considered for DP ≤6 points.

    Baseline to 8 weeks

  • The Change in the Personal Accomplishment (PA) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI))From Baseline to End of Each Exercise Phase.

    The change in the Personal Accomplishment (PA) burnout score(as measured by the Maslach Burnout Inventory (MBI))from baseline to end of each exercise phase. MBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS PA score includes 8 items to evaluate Personal Accomplishment (PA) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS PA total score ranges from 0 to 48 points. We consider a high degree of burnout in the case of PA≥ 39 points. Moderate burnout will be considered in the case of 32-38 PA points. Low levels will be considered for PA ≤31 points.

    Baseline to 8 weeks

  • Change in the Emotional Exhaustion (EE) Burnout Score(as Measured by MBI From Baseline to End of Each Exercise Phase Stratified by Training Level (Post Graduate Year 1 (PGY1), Post Graduate Year 2 (PGY2), and Post Graduate Year 3 (PGY3))

    The change in the Emotional Exhaustion burnout score(as measured by the Maslach Burnout Inventory (MBI)from baseline to end of each exercise phase stratified by training level. MBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS includes 9 items to evaluate emotional exhaustion (EE) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS EE total score ranges from 0 to 54 points. We consider a high degree of burnout in the case of EE ≥ 27 points. Moderate burnout will be considered in the case of 26\<EE\<19 points. Low levels will be considered for EE≤18 points.

    Baseline to 8 weeks

  • The Change in the Depersonalization (DP) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI))From Baseline to End of Each Exercise Phase Stratified by Training Level.

    The change in the Depersonalization (DP) burnout score(as measured by the Maslach Burnout Inventory (MBI))from baseline to end of each exercise phase stratified by training level. MBI-HSS is a survey to measure burnout in professionals in human services. DP MBI-HSS includes 5 items to evaluate depersonalization (DP) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS DP total score ranges from 0 to 30 points. We consider a high degree of burnout in the case of DP ≥ 10. Moderate burnout will be considered in the case of 6\<DP\<9 points. Low levels will be considered for DP≤5 points.

    Baseline to 8 weeks

  • The Change in the Personal Accomplishment (PA) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI))From Baseline to End of Each Exercise Phase Stratified by Training Level.

    The change in the PA burnout score(as measured by the Maslach Burnout Inventory (MBI))from baseline to end of each exercise phase stratified by training level. MBI-HSS is a survey to measure burnout in professionals in human services. PA MBI-HSS includes 8 items to evaluate personal accomplishment (PA), with scores ranging from 0 to 6 on the Likert scale. MBI-HSS PA total score ranges from 0 to 48 points. We consider a high degree of burnout in the case of PA≥ 39 points. Moderate burnout will be considered in the case of 32-38 PA points. Low levels will be considered for PA ≤31 points.

    Baseline to 8 weeks

  • The Degree of Burnout Among VUMC Anesthesia Interns and Residents as Quantified by Baseline Emotional Exhaustion (EE) MBI-HSS Scores Broken Down by Level of Residency Training Completed.

    The degree of burnout among VUMC anesthesia interns and residents as quantified by baseline Emotional Exhaustion MBI-HSS scores broken down by level of residency training completed. MBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS EE score includes 9 items to evaluate emotional exhaustion (EE), with scores ranging from 0 to 6 on the Likert scale. MBI-HSS EE total score ranges from 0 to 54 points. We consider a high degree of burnout in the case of EE ≥ 27 points. Moderate burnout will be considered in the case of 26\<EE\<19 points. Low levels will be considered for EE≤18 points.

    Baseline

  • The Degree of Burnout Among VUMC Anesthesia Interns and Residents as Quantified by Baseline Depersonalization MBI-HSS Scores Broken Down by Level of Residency Training Completed.

    The degree of burnout among VUMC anesthesia interns and residents as quantified by baseline Depersonalization MBI-HSS scores broken down by level of residency training completed. MBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS DP score includes 5 items to evaluate depersonalization (DP) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS DP total score ranges from 0 to 30 points. We consider a high degree of burnout in the case of DP≥ 13 points. Moderate burnout will be considered in the case of 7-12 DP points. Low levels will be considered for DP ≤6 points.

    Baseline

  • The Degree of Burnout Among VUMC Anesthesia Interns and Residents as Quantified by Baseline Personal Accomplishment (PA) MBI-HSS Scores Broken Down by Level of Residency Training Completed.

    The degree of burnout among VUMC anesthesia interns and residents as quantified by baseline Personal Accomplishment MBI-HSS scores broken down by level of residency training completed. MBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS PA score includes 8 items to evaluate Personal Accomplishment (PA) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS PA total score ranges from 0 to 48 points. We consider a high degree of burnout in the case of PA≥ 39 points. Moderate burnout will be considered in the case of 32-38 DP points. Low levels will be considered for DP ≤31 points.

    Baseline

Study Arms (2)

Arm A: Exercise intervention then usual exercise program

EXPERIMENTAL

8 weeks of exercise intervention followed by 8 weeks of usual exercise program

Behavioral: Prescribed Exercise ProgramBehavioral: Usual Exercise Program

Arm B: Usual Exercise Program then exercise intervention

ACTIVE COMPARATOR

8 weeks of usual exercise program followed by 8 weeks of exercise intervention

Behavioral: Prescribed Exercise ProgramBehavioral: Usual Exercise Program

Interventions

Brief cardiovascular exercise training (\>70% of maximum heart rate) for 15 minutes a day, 5 days a week for 8 weeks. The exercise intervention will be a 15-minute per day of vigorous exercise that as monitored by a Fitbit Charge 2. Examples of possible 15-minute exercise regimens to be used include: * Walking quickly or running up and down stairs * Plyometric exercises such as jumping jacks, high knees, squats, lunges, speed skaters, froggers, etc * Walking up an incline on a treadmill * Jogging or running on a treadmill or elliptical * Stationary cycling or rowing

Arm A: Exercise intervention then usual exercise programArm B: Usual Exercise Program then exercise intervention

Usual exercise activity for 8 weeks

Arm A: Exercise intervention then usual exercise programArm B: Usual Exercise Program then exercise intervention

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Vanderbilt University Medical Center Anesthesiology residents (Class 1(CA-1), Class 2 (CA-2)

You may not qualify if:

  • Failure to sign informed consent
  • Will not be in town and available for the full duration of the study (e.g., 2 or more weeks of vacation or absence)
  • Physical inability to perform the exercise intervention (including health indications)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt Unversity Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Burnout, ProfessionalBurnout, Psychological

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Results Point of Contact

Title
Dr. Uma Shastri
Organization
Vanderbilt University Medical Center

Study Officials

  • Uma Shastri, MD, PhD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: balanced order-randomized, 16-week within-subject crossover study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesiology

Study Record Dates

First Submitted

March 29, 2018

First Posted

April 5, 2018

Study Start

June 1, 2018

Primary Completion

December 26, 2018

Study Completion

December 26, 2018

Last Updated

April 14, 2020

Results First Posted

April 14, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations