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Burnout, ProfessionalNCT04883307

Investigating the Impact of Professional Development Coaching Programs in Residents & Fellows

A study testing Coaching and Wellness resources in people with Burnout, Professional, run by Massachusetts General Hospital 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

The goal of the Professional Development Coaching Program is to allow trainees to understand their development over time, find meaning and purpose in their work, and identify their strengths and how to use these to overcome challenges and stressors. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Burnout, Professional
What is being tested?
Coaching and Wellness resources
Could I receive a placebo?
No, everyone receives an active treatment
How many people
237 participants
Where
1 siteUnited States
Study dates
1 Aug 2018to 25 Jun 2020
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 Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Surgical resident in the US or Canada

Who cannot join

  • Surgical resident from other countries; non-surgical residents

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: A Randomized Trial to Investigate the Impact of Professional Development Coaching Programs in MGH Residency & Fellowship Programs, and in Women Residents in a Professional Surgical Society

The goal of the Professional Development Coaching Program is to allow trainees to understand their development over time, find meaning and purpose in their work, and identify their strengths and how to use these to overcome challenges and stressors. Additionally, the program connects trainees with a faculty member who will work with them, grow to know them in-depth over time, and provide meaningful guidance throughout the relationship. There is an additional benefit to the coaches themselves, who are able to connect with other faculty coaches in a rewarding way, that provides faculty development in leadership development and positive psychology, and space to interact with a group of like-minded physicians.

Read the detailed description

A randomized controlled trial was performed to evaluate the effects of coaching on wellness, fulfillment and burnout through AWS from 2018-2020. The research protocol and all research materials and methods were reviewed and approved by the Mass General Brigham Institutional Review Board (Protocol #: 2017P00056) and funded through a grant provided by the Physicians Foundation.

AWS is a global, professional surgical society whose mission is to "to inspire, encourage, and enable women surgeons to realize their professional and personal goals."9 Concordant with its mission, the organization launched a formal coaching program in which practicing surgeons would volunteer to be trained in positive psychology coaching and paired with women surgical trainees for a remote coaching relationship.

Participants, randomization and outcome measures Members of AWS were recruited to participate in the study as coaches (attendings) or coachees (residents) via direct emails and social media. Attending surgeons were required to be women members of AWS, be in active surgical or surgical subspecialty practice and were required to reside in the United States (US) or Canada to be eligible to be a coach. Coachees were also women members of AWS, residents of the US and Canada, and were actively in residency training for the duration of the program.

All participants (coaches and coachees) were required to complete a baseline questionnaire including an informed consent item, demographic characteristics, Professional Fulfillment Index (PFI), Positive Emotion, Engagement, Relationship, Meaning, and Accomplishment scale (PERMA), Intolerance of Uncertainty scale (IUS), and Hardiness Resilience Score (HRS).10-13 Region was determined using self-reported cities and states as laid out in the US Census Divisions.14 Field of specialty or prospective specialty was also noted. The participating surgical residents were then randomized to the intervention group or the control group based on PFI's burnout sub-scale's quartile scores at pre-survey. After the 9-month study period, all participants received a follow up questionnaire similar to the baseline questionnaire. Those who completed the follow up questionnaire received a digital $10 gift card to an online shopping vendor as remuneration for study completion.

Intervention - The AWS Coaching Project Coaches who participated in the study completed a 3-hour in-person coaching training program at the 2018 and 2019 Association of Women Surgeons national meetings. Coaching materials were created by an author who is an expert in professional development coaching (K.P). in conjunction with the McLean Hospital Institute of Coaching. Training was interactive and led by Dr. Palamara and emphasized the basics principles of positive psychology and coaching. The coaches were supplied with a training manual with step by step guides for three coaching sessions with their coachees developed for this program (link to website). Each meeting was expected to be 45-60 minutes in length. In addition, coaches were also invited to participate in up to two additional optional 90-minute refresher training sessions which were offered virtually over a web-based video platform. Unique aspects of the curriculum tailored to the study population included discussion of imposter syndrome, the glass ceiling in surgery, and microaggressions. Additional details regarding the coaching training and program are published separately. 6,7 Upon completion of training, coaches were paired with 1-2 residents who were randomized to the coaching intervention group. Coach-coachee pairings were constructed based on divergent surgical specialty and geographic location to create a safe space and minimize the possibility of a more traditional mentoring relationship. All coaching sessions occurred remotely over voice or video calls. Participants were encouraged to meet for at least 3 coaching sessions over the 9-month intervention period but could meet more frequently if amenable to both parties.

Residents in the control group received three emails across the 9 month study period that contained materials related to physician well-being such as personal development and resilience, mindfulness, and work life-integration. Materials included recommended readings, videos, and exercises and were curated by members of the Association of Women Surgeons who were not involved in the coaching program.

Being tested
Coaching, Wellness resources
Keywords
physician burnout, physician well-being, coaching, graduate medical education, surgery
Medical subject headings
Burnout, Professional

What participants receive

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

  • CoachingBehavioural

    Professional development coaching based on a curriculum of positive psychology principles and coaching principles.

  • Wellness resourcesBehavioural

    Residents in the control group received three emails across the 9 month study period that contained materials related to physician well-being such as personal development and resilience, mindfulness, and work life-integration. Materials included recommended readings, videos, and exercises and were curated by members of the Association of Women Surgeons who were not involved in the coaching program.

Study groups in NCT04883307
Study groupRoleWhat they receive
Coaching InterventionExperimentalPaired with a coach outside of their specific area of interest; encouraged to meet 3 times over 9 months for a 1:1 coaching meeting
Receives: Behavioral: Coaching
Wellness ResourcesActive comparatorEmailed wellness resources
Receives: Behavioral: Wellness resources

What is being measured

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

  1. Professional Fulfillment Index

    Stanford PFI

    Measured: Change from Baseline PFI to End of Study PFI at 9 months

  2. PERMA 15-item Self-scoring Instrument

    Positive Emotion, Engagement, Relationship, Meaning, and Accomplishment 15 item self-scoring scale (15-75); higher scores mean a better outcome

    Measured: Change from Baseline PERMA to End of Study PERMA at 9 months

Secondary outcomes (4)
  1. Intolerance of Uncertainty

    IUS 10; higher scores mean a worse outcome

    Measured: Change from Baseline IUS to End of Study IUS at 9 months

  2. Hardiness Resilience Score

    Dispositional-resilience Scale-15; range from 0-80; higher scores mean a better outcome

    Measured: Change from Baseline HRS to End of Study HRS at 9 months

  3. Gratitude Questionnaire Six Item Form (GQ-6)

    GQ6; Range 6-42; higher scores mean a better outcome

    Measured: Change from Baseline gratitude to End of Study gratitude at 9 months

  4. Measurement of Current Status Part A

    MOCS Part A Questions 5-7; Range 0-12; higher scores mean a better outcome

    Measured: Change from Baseline coping to End of Study coping at 9 months

Timeline

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

  1. First posted12 May 2021
  2. Study start1 Aug 2018
  3. Primary completion25 Jun 2020
  4. Study completion25 Jun 2020

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
All participants (coaches and coachees) were required to complete a baseline questionnaire including an informed consent item, demographic characteristics, Professional Fulfillment Index (PFI), Positive Emotion, Engagement, Relationship, Meaning, and Accomplishment scale (PERMA), Intolerance of Uncertainty scale (IUS), and Hardiness Resilience Score (HRS).10-13 Region was determined using self-reported cities and states as laid out in the US Census Divisions.14 Field of specialty or prospective specialty was also noted. The participating surgical residents were then randomized to the intervention group or the control group based on PFI's burnout sub-scale's quartile scores at pre-survey. Residents in the intervention group were encouraged to meet with a trained faculty coach for a 1:1 coaching meeting 3 times over 9 months. Residents in the control group were emailed wellness resources.
Masking
None (open label)
Enrolment
237 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04883307
Sponsor's protocol ID
2017P000569
Status last verified
May 2021
First submitted
30 Apr 2021
Last updated
12 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This is well-being and burnout data on surgical residents in training; sharing individual participant data may impact their career trajectory.

Publications

  • Palamara K, McKinley SK, Chu JT, Merrill AL, Yu L, Parangi S, Makowski MS, Park YS, Donelan K, Stein SL. Impact of a Virtual Professional Development Coaching Program on the Professional Fulfillment and Well-Being of Women Surgery Residents: A Randomized Controlled Trial. Ann Surg. 2023 Feb 1;277(2):188-195. doi: 10.1097/SLA.0000000000005562. Epub 2022 Jun 29.

    PubMed 35766397

Questions about this trial

What is this clinical trial studying?

A study testing Coaching and Wellness resources in people with Burnout, Professional, run by Massachusetts General Hospital 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 1 inclusion and 1 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 12 May 2021. 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?

Professional Fulfillment Index (time frame: Change from Baseline PFI to End of Study PFI at 9 months). The study lists 2 primary outcomes in all. 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 NCT04883307, which also lists 1 linked publication.

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 12 May 2021.

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