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

May 6, 2021 updated by: Kerri Palamara McGrath, MD, Massachusetts General Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
237

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Surgical resident in the US or Canada

Exclusion Criteria:

  • Surgical resident from other countries; non-surgical residents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Coaching Intervention
Paired with a coach outside of their specific area of interest; encouraged to meet 3 times over 9 months for a 1:1 coaching meeting
Behavioral: Coaching
Professional development coaching based on a curriculum of positive psychology principles and coaching principles.
ACTIVE_COMPARATOR: Wellness Resources
Emailed wellness resources
Behavioral: Wellness resources
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Professional Fulfillment Index
Time Frame: Change from Baseline PFI to End of Study PFI at 9 months
Stanford PFI
Change from Baseline PFI to End of Study PFI at 9 months
PERMA 15-item Self-scoring Instrument
Time Frame: Change from Baseline PERMA to End of Study PERMA at 9 months
Positive Emotion, Engagement, Relationship, Meaning, and Accomplishment 15 item self-scoring scale (15-75); higher scores mean a better outcome
Change from Baseline PERMA to End of Study PERMA at 9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intolerance of Uncertainty
Time Frame: Change from Baseline IUS to End of Study IUS at 9 months
IUS 10; higher scores mean a worse outcome
Change from Baseline IUS to End of Study IUS at 9 months
Hardiness Resilience Score
Time Frame: Change from Baseline HRS to End of Study HRS at 9 months
Dispositional-resilience Scale-15; range from 0-80; higher scores mean a better outcome
Change from Baseline HRS to End of Study HRS at 9 months
Gratitude Questionnaire Six Item Form (GQ-6)
Time Frame: Change from Baseline gratitude to End of Study gratitude at 9 months
GQ6; Range 6-42; higher scores mean a better outcome
Change from Baseline gratitude to End of Study gratitude at 9 months
Measurement of Current Status Part A
Time Frame: Change from Baseline coping to End of Study coping at 9 months
MOCS Part A Questions 5-7; Range 0-12; higher scores mean a better outcome
Change from Baseline coping to End of Study coping at 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 25, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 25, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017P000569

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is well-being and burnout data on surgical residents in training; sharing individual participant data may impact their career trajectory.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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