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Burnout, ProfessionalNCT05222685

Better Together Physician Coaching: An Innovative Solution to Medical Trainee Burnout

A study testing Better Together Physician Coaching in people with Burnout, Professional, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Burnout, Professional
What is being tested?
Better Together Physician Coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,017 participants
Where
1 siteUnited States
Study dates
1 Sep 2022to 1 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Colorado

    Aurora, Colorado, 80045

Other trials in United States

About this study

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.
Read the detailed description

Background and Significance:

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. This project will scale Better Together 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.

III. Preliminary Studies/Progress Report:

Within the past year, Co-PIs Drs. Adrienne Mann and Tyra Fainstad (AM, TF) created and implemented Better Together Physician Coaching (Better Together, or BT) at the University of Colorado School of Medicine. BT is a coaching program for female identifying GME trainees at CU and its affiliate hospitals (Denver Health, Rocky Mountain Regional VA Medical Center, and The Children's Hospital). Using coaching techniques, BT challenges long-held paradigms fostered by medical training. BT aims primarily to reduce burnout as measured by the MBI with secondary aims to increase self-compassion, reduce imposter syndrome and decrease moral injury among residents who identify as women.

The Co-PIs (AM, TF) are both certified coaches through The Life Coach School™, a training institution for thought-based coaching. This type of coaching focuses on thoughts and beliefs. It combines a cognitive behavioral therapy (CBT) model with mindfulness-based awareness and integrates theories of acceptance and commitment therapy (ACT), nonattachment, and radical questioning from Socratic and Greek philosophies. BT delivers a robust coaching experience via a 6-month web-based, group-coaching model. This novel program allows residents to participate as actively as they are inclined and able, offering flexibility via multiple modalities of coaching: twice weekly group coaching calls, unlimited anonymous written coaching, and weekly self-study modules that are housed on a secure members-only website.

To study the BT program, the Co-PIs received institutional support from the CU Department of Medicine to conduct a pilot randomized controlled trial (RCT), which included support for professional research assistants to both implement and evaluate the program. A convenience sample of 101 female-identifying CU GME trainees from 12 specialties (IM, Family Medicine, Otolaryngology, Pediatrics, OBGYN, General Surgery, Emergency Medicine, Dermatology, Psychiatry, Medicine-Pediatrics, Pathology, and Neurology) was recruited and randomized to receive the 6-month Better Together Program or no-intervention from January-June 2021. The median participant age was 29 years, and all were female-identifying. Of the 101 participants, 33 (32.7%) were PGY-1, 43 (42.6%) were PGY-2, 18 (17.8%) were PGY-3, and 7 (7%) PGY-4 or greater. Nineteen (19%) of participants were in a surgical residency specialty (general surgery, OBGYN, otolaryngology). There were no significant differences in these characteristics between the intervention and control groups at baseline.

All participants completed a pre-survey assessing burnout with the MBI which defines burnout by three subscales (Emotional Exhaustion (EE), Depersonalization (DP), and Personal Accomplishment (PA) as described above). Each item is a 7-point Likert-type question with a frequency response scale ranging from 0 = never to 6 = every day. Higher scores on the EE and DP, and lower scores on the PA subscales indicate greater burnout. Secondary outcomes included Self-compassion with Self-Compassion Scale Short-form (SCSS) where higher scores indicate greater self-compassion,30 the Young Imposter Syndrome Scale (YISS) where a score of more than 5 out of 8 points is diagnostic for Imposter Syndrome31 and the Moral Injury Symptom Scale (MISS) (score 10-100 points) where higher scores equal more moral injury.32

Participants were randomized to the intervention group, (N=50) or control group (N= 51). The intervention group received the 6-month BT coaching program. The control group received the usual wellbeing curriculum provided by their training program, but no BT intervention. Within the BT coaching group, the most frequent topics of coaching included feedback reception, professional appearance, approval-addiction, deficit hiding, balancing motherhood with residency, and low self-confidence. Participants engaged in the live coaching sessions with curiosity, vulnerability, and authenticity, often bringing highly personal and emotional issues to the sessions and supporting each other through encouragement in the Zoom chat function.

From the pilot RCT, the investigators found that at baseline over half of all participants were experiencing moderate or high burnout, consistent with national data. Participants were also experiencing low-moderate self-compassion (mean = 33.6 out of 60; SD=7.17); imposter syndrome (mean = 5.4 out of 8, where score of 5+ is diagnostic for imposter syndrome; SD=2.13); and moderate moral injury (mean =42.02 out of 100; SD=11.08). At the end of 6 months of coaching, a post-survey was offered to both the intervention and control groups. Of the 101 initial survey respondents, 79 responded to the post-survey (78%). A t-test was used to compare the change in subscale score means from baseline to 6 months in the BT coaching versus control groups for the primary and secondary outcomes.

The results on the MBI showed a statistically significant decrease in the emotional exhaustion (EE) dimension of burnout in the intervention group (p=0.03), and the DP and PA components of burnout both trended toward improvement. Self-compassion improved significantly in the intervention group compared to the control group, and imposter syndrome scores improved in the BT coaching group from 5.4 to 4.2 (p=0.01), effectively improving mean scores out of the range for imposter syndrome in this group. Moral injury also trended towards an improvement in the coaching vs control group from baseline to 6 months (40.7 to 35.6 versus 43.7 to 41.7 in intervention vs control, mean difference -3.84, p 0.10), but was not statistically significant.

Based on these promising findings in our pilot RCT, the investigators propose scaling Better Together to a national level to address the unmet need in GME programs to reduce burnout. The investigators are now preparing for a multi-institutional RCT to serve more female identifying trainees with a focus on those who are URM and practicing in medically underserved communities nationwide. The investigators aim to enroll GME programs with geographic and ethnic diversity as well as representative URM trainees to understand the impact of coaching in this vulnerable population.

This randomized controlled trial will mirror our pilot study in which all participants take a pre-survey with outcome measures, then they will be randomized into an intervention or control arm. The intervention group will receive BT 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. Then all participants will take a post survey. Finally, the control or "waitlist group" will be offered the 6-mont BT program following completion of the study.

The study will begin in September 2022 with approximately 1000 trainees 10+ participating sites. Following the pre-survey, participants will be randomized to the intervention group or the control group. The intervention group will receive the 6-month BT program from 9/2022-2/2023. All participants will complete the post survey in 2/2023. Participants in the intervention group will be offered opportunities to complete qualitative interviews around the program experience after completion of the program. The control group will then be offered the Better Together program from 3/2023 - 9/2023.

Wrap-up:

The final 3 months will focus on preparing our final results for dissemination and finalizing our sustainability plan as the investigators prepare for our future planned funding model.

Being tested
Better Together Physician Coaching
Medical subject headings
Burnout, Professional

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Better Together Physician CoachingBehavioural

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

Study groups in NCT05222685
Study groupRoleWhat they receive
Intervention GroupExperimentalWill receive the 6 month online group coaching program from 9/1/2022-3/1/23
Receives: Behavioral: Better Together Physician Coaching
Control GroupNo interventionControl 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)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. Self-Compassion as defined by Neff's Self Compassion Score Short Form (SCS-SF)

    Neff's Self Compassion Score Short Form (SCS-SF) is a 12-item measurement of self compassion. Possible scores range from 0-6 on a Likert scale for each item, where the higher scale scores indicate greater self-compassion. Scores of 1.0- 2.49 are considered to be low, between 2.5-3.5 to be moderate, and 3.51-5.0 to be high.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2022
  2. Study start1 Sep 2022
  3. Primary completion1 Sep 2023
  4. Study completion1 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Model description
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.
Masking
None (open label)
Enrolment
1,017 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05222685
Sponsor's protocol ID
22-0028
Status last verified
Sep 2023
First submitted
18 Jan 2022
Last updated
28 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No sharing.

Publications

  • 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.

    PubMed 27802178
  • 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.

    PubMed 31516024
  • 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.

    PubMed 32681398
  • 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.

    PubMed 17430583
  • 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.

    PubMed 31380892
  • 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.

    PubMed 34100238
  • 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.

    PubMed 25527340
  • 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.

    PubMed 29467969
  • 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.

    PubMed 31057995
  • 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.

    PubMed 37792378

Questions about this trial

What is this clinical trial studying?

A study testing Better Together Physician Coaching in people with Burnout, Professional, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Burnout as defined by the Maslach Burnout Inventory (MBI) (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05222685, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.

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