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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05280964
Other study ID # 20-2035
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2020
Est. completion date January 1, 2023

Study information

Verified date April 2023
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a single-institution randomized controlled trial. 101 female residents were recurited from the University of Colorado School of Medicine. They enrolled beginning in January 2021 and participated in the coaching program for 6 months via a web-based system. Participants were randomized into either the intervention or wait-list control arm. Participants in the intervention arm began the 6-month coaching program in January, 2021. Participants in the wait-list control arm have received no additional resources from the Better Together program between January and June 2021. The wait-list control group was invited to begin the 6-month coaching program in July 2021. In December 2021, participants from both the intervention and wait-list control groups will be invited to complete a 2nd post survey (identical to the post-survey from June 2021). There will be no incentive for completion of the 2nd post survey. Finally, the longitudinal effect of the program will be assessed by offering the same survey measuring wellbeing via various indices to the intervention arm at 6 months (1/2022), 12 months (7/2022) and 18 months (1/2023) after their intervention. Participation in this survey will be completely voluntary and not incentivized/compensated.


Description:

Background: Positive psychology coaching programs demonstrate efficacy in reducing emotional exhaustion (a construct of burnout) and improving coping skills among residents but rely on substantial faculty development and coordination for participants. Considering the disproportionate burnout risk faced by women trainees in medicine, novel strategies to mitigate this risk is needed. Among a national sample of resident physicians, 60% screen positive for burnout. Compared to age-matched peers, residents are significantly more likely to experience burnout and have burnout persist into early careers. Female trainees are particularly vulnerable, with long-term consequences affecting professional development and success. Disproportionate burnout among women may be a contributor to the "leaky pipeline" in academic medicine, where women start their careers as 46% of the resident workforce yet represent only 25% of full professors and 18% of department chairs. Social connectedness and the practice of self-compassion are important intervention in reducing burnout and increasing resilience among residents. Positive psychology coaching programs have specifically had demonstrated efficacy in faculty and residents. Web-based group coaching programs have not been assessed for their potential to reduce burnout and improve resilience and well-being among trainees. A. Outcome Measure(s): 1. participation (administrative data) 2. participant experience and reflection (interview) 3. measures of burnout and self-compassion as measured on a pre- and post- program survey including the Maslach Burnout Inventory (MBI) and Neff Self Compassion Score (SCS). Semi structured qualitative interviews will be led by a PRA upon completion of the 6-month pilot. The interview script will include questions about program content, participant experience, coping skills, interpersonal connectedness, personal and professional satisfaction, and general reflections. Description of Population to be Enrolled: This pilot study recruited individuals from the University of Colorado graduate medical education training programs. The pilot program is limited to female trainees who have greater than 1 year of training left in order to give trainees time to complete the program prior to graduation. Enrollment in the program is entirely voluntary and trainees can cease enrollment at any time. Study Design and Research Methods: This is a single-institution randomized controlled trial. 101 female residents were recruited from the University of Colorado School of Medicine. They enrolled beginning in January 2021 and participated in the coaching program for 6 months via a web-based system. The website is secure and only available for program participants. There are monthly modules with asynchronous, self-directed delivery, designed to mitigate the time constraints and faculty development required of traditional in-person coaching. Video recordings of group-coaching calls will be made available to the program participants via the secure website with the intent to allow participants to benefit from group coaching even if they aren't able to attend the calls live. These recordings do contain PHI of participants. 101 women trainees from 12 ACGME training programs enrolled in the program. Participants were randomized into either the intervention or wait-list control arm. Participants in the intervention arm began the 6-month coaching program in January, 2021. Participants in the wait-list control arm have received no additional resources from the Better Together program between January and June 2021. All participants in both intervention and wait-list control groups will be invited to complete the quantitative post-program survey in June 2021. At the time of the post-program survey in 6/2021, the wait-list control group will not have received the coaching intervention. Following the quantitative and qualitative data collection, the control group was be offered the 6-month coaching program from July-December 2021. The wait-list control group was invited to begin the 6-month coaching program in July 2021. In December 2021, participants from both the intervention and wait-list control groups will be invited to complete a 2nd post survey (identical to the post-survey from June 2021). There will be no incentive for completion of the 2nd post survey. Finally, the longitudinal effect of the program will be assessed by offering the same survey measuring wellbeing via various indices to the intervention arm at 6 months (1/2022), 12 months (7/2022) and 18 months (1/2023) after their intervention. Participation in this survey will be completely voluntary and not incentivized/compensated.


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date January 1, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - graduate medical education trainees (residents and fellows) at the University of Colorado - Female identifying Exclusion Criteria: - Non trainees - non- female identifying

Study Design


Intervention

Behavioral:
Better Together Physician Coaching
6 month, online group coaching program

Locations

Country Name City State
United States University of Colorado School of Medicine Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (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 — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

Rotenstein LS, Torre M, Ramos MA, Rosales RC, Guille C, Sen S, Mata DA. Prevalence of Burnout Among Physicians: A Systematic Review. JAMA. 2018 Sep 18;320(11):1131-1150. doi: 10.1001/jama.2018.12777. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline Burnout at 6 months, 12 months and 18 months The Maslach's burnout inventory 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 oof 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. Baseline measurement, post-intervention measurements at 6 months, 12 months and 18 months
Secondary Change from baseline Self Compassion at 6 months, 12 months and 18 months Neff's Self-Compassion Scale - Short Form is a 12 item measurement of self-compassion with higher scores indicating improved or better levels of self compassion. Baseline measurement, post-intervention measurements at 6 months, 12 months and 18 months
Secondary Change from baseline Imposter Syndrome at 6 months, 12 months and 18 months The Young Impostor Syndrome Scale is an 8 item measurement of imposter phenomenon with scores = 5 indicating "yes" to presence of imposter phenomenon and scores less than 5 being negative for presence of imposter phenomenon. Baseline measurement, post-intervention measurements at 6 months, 12 months and 18 months
Secondary Change from baseline Moral Injury at 6 months, 12 months and 18 months The Moral Injury Symptom Score for healthcare professionals is a 22 item measure of moral injury symptoms that assesses betrayal, guilt, shame, moral concerns, loss of trust, loss of meaning, difficulty forgiving, self-condemnation, religious struggle, and loss of religious/spiritual faith with scores of 60 or higher correlating with extreme problems, scores of 45-59 being moderate and scores of 30-45 being mild. Baseline measurement, post-intervention measurements at 6 months, 12 months and 18 months
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