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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Burnout, Professional
- 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 group | Role | What they receive |
|---|---|---|
| Coaching Intervention | Experimental | 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 Receives: Behavioral: Coaching |
| Wellness Resources | Active comparator | Emailed wellness resources Receives: Behavioral: Wellness resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Professional Fulfillment Index
Stanford PFI
Measured: Change from Baseline PFI to End of Study PFI at 9 months
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)
Intolerance of Uncertainty
IUS 10; higher scores mean a worse outcome
Measured: Change from Baseline IUS to End of Study IUS at 9 months
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
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
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.
- First posted12 May 2021
- Study start1 Aug 2018
- Primary completion25 Jun 2020
- Study completion25 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerri Palamara McGrath, MD, Massachusetts General Hospital
- Investigators
- Kerri Palamara, MD, Principal investigator, Massachusetts General Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04883307
- Acronym / sponsor ID
- 2017P000569
- Conditions
- Burnout, Professional
- Keywords
- physician burnout, physician well-being, coaching, graduate medical education, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- 25 Jun 2020 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Coaching Intervention | Experimental | Behavioral: CoachingPaired with a coach outside of their specific area of interest; encouraged to meet 3 times over 9 months for a 1:1 coaching meeting |
| Wellness Resources | Active comparator | Behavioral: Wellness resourcesEmailed wellness resources |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Surgical resident in the US or Canada
Key exclusion criteria (1 listed)
- Surgical resident from other countries; non-surgical residents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoachingProfessional development coaching based on a curriculum of positive psychology principles and coaching principles. | Behavioural | Coaching Intervention |
| Wellness resourcesResidents 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. | Behavioural | Wellness Resources |
Primary outcome
Professional Fulfillment Index
Time frame: Change from Baseline PFI to End of Study PFI at 9 months
Stanford PFI
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
4 secondary outcomes
Intolerance of Uncertainty
Time frame: 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
Gratitude Questionnaire Six Item Form (GQ-6)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- Derived from this study: PubMed 35766397Palamara 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.
- Individual participant dataSharing planned: No. This is well-being and burnout data on surgical residents in training; sharing individual participant data may impact their career trajectory.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerri Palamara, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
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.