Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04125615
Other study ID # 1612E02561
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2017
Est. completion date June 30, 2018

Study information

Verified date October 2019
Source University of Minnesota - Clinical and Translational Science Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date June 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Protected Time Intervention
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.

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Primary 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)
See also
  Status Clinical Trial Phase
Completed NCT05130944 - Feasibility of Community Psychosocial Intervention for Women N/A
Recruiting NCT06079853 - Nurse Suicide: Physiologic Sleep Health Promotion Trial N/A
Completed NCT05881681 - A Mindfulness Approach to UA for Afro-descendants N/A
Recruiting NCT05449002 - Digital Single Session Intervention for Youth Mental Health N/A
Recruiting NCT04038190 - A Behavioral Activation Intervention Administered in a College Freshman Orientation Course Phase 2
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Active, not recruiting NCT05998161 - Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout N/A
Completed NCT03728062 - Mindfulness Meditation Versus Physical Exercise: Comparing Effects on Stress and Immunocompetence N/A
Terminated NCT04367636 - The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19 N/A
Completed NCT06405789 - The Effect of Yoga on Mindfulness and Perceived Stress N/A
Recruiting NCT06002074 - SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases N/A
Recruiting NCT05273996 - Predictors of Cognitive Outcomes in Geriatric Depression Phase 4
Completed NCT05245409 - Stress, EEG, ECG, and Chiropractic N/A
Completed NCT04722367 - Being Present With Art: The Impact of Mindful Engagement With Art on Awareness and Connection N/A
Recruiting NCT06273228 - Parenting Young Children in Pediatrics N/A
Completed NCT06057883 - Effects Of A Probiotic Formulation On Stress and Skin Health in Younger Adult Females Phase 2
Completed NCT05312749 - The Effect of Web Based Progressive Muscle Relaxation Exercise on Clinical Stress and Anxiety of Nursing Students N/A
Completed NCT05063305 - Probiotics, Immunity, Stress, and QofL N/A
Completed NCT05623826 - Feasibility and Efficacy of a Digital Training Intervention to Increase Reward Sensitivity- Imager N/A
Completed NCT04013451 - The Kiss of Kindness Study II N/A