NCT04125615

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
Last Updated

October 14, 2019

Status Verified

October 1, 2019

Enrollment Period

10 months

First QC Date

October 10, 2019

Last Update Submit

October 11, 2019

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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).

    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).

    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).

    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.).

    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.

    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.

    baseline, end of intervention (32 weeks)

Study Arms (2)

Protected Non-Clinical Time

EXPERIMENTAL

Protected non-clinical time

Behavioral: Protected Time Intervention

Control Period

NO INTERVENTION

No protected non-clinical time

Interventions

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.

Protected Non-Clinical Time

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- all resident physicians (PGY1 - PGY5) in the Department of Otolaryngology that were willing to complete the study protocol

You may not qualify if:

  • \- principal investigator(s) were excluded from participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Study Officials

  • Kristin Stevens, MD

    University of Minenesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2019

First Posted

October 14, 2019

Study Start

September 1, 2017

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

October 14, 2019

Record last verified: 2019-10

Locations