NCT05222685

Brief Summary

Burnout refers to feelings of exhaustion, negativism, and reduced personal efficacy resulting from chronic workplace stress. In healthcare, burnout leads to increased medical errors, poorer patient care and negatively affects professional development and retention. Burnout is a growing problem that begins early in medical training. Women and those underrepresented in medicine (URM) experience a disproportionate amount of burnout likely due to the cognitive load required to manage microaggressions, stereotypes, and harmful socially adopted narratives around efficacy. Professional coaching is a metacognition tool with a sustainable positive effect on physician well-being but typically relies on expensive consultants or time-consuming faculty development, often making it infeasible for medical training programs to offer. To overcome this barrier, the investigators created Better Together Physician Coaching (BT) a 6-month coaching program for women residents at the University of Colorado (CU). BT includes regular online group-coaching, written coaching, and weekly self-study modules delivered by physician life coaches (Co-PIs). A pilot randomized controlled trial (RCT) of 101 BT participants demonstrated a statistically significant improvement in burnout, self-compassion, and imposter syndrome in the intervention group. BT will be scaled up to a national level and evaluated with an RCT mirroring our pilot in 10+ graduate medical education (GME) programs for 1000+ participants coordinated and evaluated by our CU team. To accomplish this goal, the investigators set the following major objectives for this project:

  • Prepare to expand the BT program by teaming with a cohort of diverse physician coaches.
  • Implement BT in 10+ GME programs to serve 1000+ trainee participants with deliberate inclusion of institutions with diverse GME trainee populations serving geographically rural and/or medically underserved areas.
  • Assess our outcomes: primary: reduce burnout as measured by the Maslach Burnout Index (goal: 10% relative improvement), and secondary: self-compassion, imposter syndrome and moral injury. Outcome generalizability and program feasibility at a national level will also be analyzed, as will participant experience to gain a richer understanding of how BT may help trainees, in particular those URM.
  • Advance the field of coaching in GME through innovation and dissemination of evidence-based approaches to GME trainee wellbeing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,017

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

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

First Submitted

Initial submission to the registry

January 18, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 3, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

January 18, 2022

Last Update Submit

September 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Burnout as defined by the Maslach Burnout Inventory (MBI)

    The Maslach burnout inventory (MBI) is a 22-item measurement of worker burnout which assesses emotional exhaustion (EE), depersonalization (DP), and personal fulfillment (PF) domains. Possible scores range from 0-6 on a Likert scale for each item. Scores of EE ≥ 27 points, DP ≥ 10, and PF \<33 would indicate a high degree of burnout. Scores of EE≤18 points, DP≤5 points, and PF≥40 points would indicate a low degree of burnout.

    pretest will occur prior to the intervention and post test will occur after the 6 month intervention. A post-post test will occur 6 and 12 months after the intervention is done.

Secondary Outcomes (1)

  • Self-Compassion as defined by Neff's Self Compassion Score Short Form (SCS-SF)

    pretest will occur prior to the intervention and post test will occur after the 6 month intervention. A post-post test will occur 6 and 12 months after the intervention is done.

Other Outcomes (2)

  • Moral Injury as defined by the Moral Injury Symptom Scale for Health Professions (MISS-HP)

    pretest will occur prior to the intervention and post test will occur after the 6 month intervention. A post-post test will occur 6 and 12 months after the intervention is done.

  • Imposter Syndrome as defined by Young's Imposter Syndrome Symptoms Scale (YISS)

    pretest will occur prior to the intervention and post test will occur after the 6 month intervention. A post-post test will occur 6 and 12 months after the intervention is done.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Will receive the 6 month online group coaching program from 9/1/2022-3/1/23

Behavioral: Better Together Physician Coaching

Control Group

NO INTERVENTION

Control group - no coaching intervention from 9/1/2022-3/1/23. (They will receive the coaching intervention after study completion from 3/1/23-9/1/23)

Interventions

Professional group coaching for medical trainees. A 6 month, online, group, positive psychology based coaching program for wellness.

Intervention Group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMedical trainees (residents or fellows) who identify as women, including trans women, as well as those who identify as gender non-conforming, non-binary, and gender queer.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medical trainees (residents or fellows)
  • Identify as female (including trans women, as well as those who identify as gender non-conforming, non-binary, and gender-queer).

You may not qualify if:

  • Non medical trainees
  • Those who do not identify as female (including trans women, as well as those who identify as gender non-conforming, non-binary, and gender-queer).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (10)

  • Villwock JA, Sobin LB, Koester LA, Harris TM. Impostor syndrome and burnout among American medical students: a pilot study. Int J Med Educ. 2016 Oct 31;7:364-369. doi: 10.5116/ijme.5801.eac4.

  • Pommier E, Neff KD, Toth-Kiraly I. The Development and Validation of the Compassion Scale. Assessment. 2020 Jan;27(1):21-39. doi: 10.1177/1073191119874108. Epub 2019 Sep 13.

  • Mantri S, Lawson JM, Wang Z, Koenig HG. Identifying Moral Injury in Healthcare Professionals: The Moral Injury Symptom Scale-HP. J Relig Health. 2020 Oct;59(5):2323-2340. doi: 10.1007/s10943-020-01065-w.

  • Dahlin ME, Runeson B. Burnout and psychiatric morbidity among medical students entering clinical training: a three year prospective questionnaire and interview-based study. BMC Med Educ. 2007 Apr 12;7:6. doi: 10.1186/1472-6920-7-6.

  • Dyrbye LN, Shanafelt TD, Gill PR, Satele DV, West CP. Effect of a Professional Coaching Intervention on the Well-being and Distress of Physicians: A Pilot Randomized Clinical Trial. JAMA Intern Med. 2019 Oct 1;179(10):1406-1414. doi: 10.1001/jamainternmed.2019.2425.

  • Palamara K, Chu JT, Chang Y, Yu L, Cosco D, Higgins S, Tulsky A, Mourad R, Singh S, Steinhauser K, Donelan K. Who Benefits Most? A Multisite Study of Coaching and Resident Well-being. J Gen Intern Med. 2022 Feb;37(3):539-547. doi: 10.1007/s11606-021-06903-5. Epub 2021 Jun 7.

  • Gazelle G, Liebschutz JM, Riess H. Physician burnout: coaching a way out. J Gen Intern Med. 2015 Apr;30(4):508-13. doi: 10.1007/s11606-014-3144-y. Epub 2014 Dec 20.

  • Abedini NC, Stack SW, Goodman JL, Steinberg KP. "It's Not Just Time Off": A Framework for Understanding Factors Promoting Recovery From Burnout Among Internal Medicine Residents. J Grad Med Educ. 2018 Feb;10(1):26-32. doi: 10.4300/JGME-D-17-00440.1.

  • Shaikh AA, Shaikh A, Kumar R, Tahir A. Assessment of Burnout and its Factors Among Doctors Using the Abbreviated Maslach Burnout Inventory. Cureus. 2019 Feb 19;11(2):e4101. doi: 10.7759/cureus.4101.

  • Mann A, Shah AN, Thibodeau PS, Dyrbye L, Syed A, Woodward MA, Thurmon K, Jones CD, Dunbar KS, Fainstad T. Online Well-Being Group Coaching Program for Women Physician Trainees: A Randomized Clinical Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2335541. doi: 10.1001/jamanetworkopen.2023.35541.

MeSH Terms

Conditions

Burnout, Professional

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Tyra Fainstad, MD

    University of Colorado School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: This randomized controlled trial will offer the intervention group the intervention of BT coaching during the first 6-months while the control group, or "waitlist group" will receive no intervention aside from the usual wellness activities of their institution.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2022

First Posted

February 3, 2022

Study Start

September 1, 2022

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

No sharing.

Locations