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
Phase: NA
Conditions: Burnout, Professional
Sponsor: Massachusetts General Hospital

PARTNERS HUMAN RESEARCH COMMITTEE 
PROTOCOL SUMMARY 
Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
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Answer all questions accurately and completely in order to provide the PHRC with the relevant 
information to assess the risk-benefit ratio for the study.  Do not leave sections blank. 
 
PRINCIPAL/OVERALL INVESTIGATOR 
Kerri Palamara, MD – Principal Investigator 
Karen Donelan, ScD – co-investigator 
Jacqueline Chu, MD – co-investigator 
John Mullen, MD – co-investigator 
Aria Olumi, MD – co-investigator 
Lori Berkowitz, MD – co-investigator 
Maria Troulis, DDS, MSc – co-investigator 
Alyssa Cappetta – co-investigator 
Richard Tannyhill, MD – co-investigator 
Liyang Yu – co-investigator 
Yuchaio Chang, PhD – co-investigator 
Andrea Merrill, MD – co-investigator 
Sareh Parangi, MD – co-investigator 
Sharon Stein, MD – co-investigator 
 
PROTOCOL 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 
 
FUNDING 
Physicians Foundation Grant - Fund #230925; $100,000; 10/31/17-
10/31/19 
 
VERSION DATE 
April 10, 2018 
 
SPECIFIC AIMS 
Concisely state the objectives of the study and the hypothesis being tested. 
 
Goal: 
1. Periodic reflection and performance review to allow trainees to 
visualize their progress and trajectory in training – where are you now 
and where are you going? 
2. Maximize the potential for professional development during residency 
and/or fellowship. 
3. improve burnout and response to stress by reinforcing coping skills 
and strengths. 
4. Ensure 1:1 relationship with core faculty to prevent trainees from 
going unnoticed in a large academic medical center. 

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
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Hypothesis: Residents & Fellows (herein referred to as trainees) will benefit 
from a Professional Development Coaching Program in the following ways: 
1. A Professional Development Coaching Program, based on the principles 
of positive psychology, will improve trainees well-being, compared to 
non-coached controls. 
2. A Professional Development Coaching Program, based on the principles 
of positive psychology, will improve trainees workplace satisfaction, 
compared to non-coached controls.     
3. A Professional Development Coaching Program will decrease trainees 
and faculty coach burnout and improve their resiliency by allowing 
them to visualize their accomplishments, improve their reponse to 
stress of uncertainty, and decrease emotional exhaustion, compared to 
controls.  
4. A Professional Development Coaching Program, based on the principles 
of positive psychology, will improve faculty coach well-being, 
compared to non-coach controls. 
 
 
BACKGROUND AND SIGNIFICANCE 
Provide a brief paragraph summarizing prior experience important for understanding the 
proposed study and procedures. 
 
Coaching is used in business and many other career paths to help the 
individual define and create their own goals and strategies for achieving 
those goals.   The MGH Professional Development Coaching Program applies 
this model to help our residents in their professional development as 
physicians.  While our housestaff have many evaluators, letter-writers and 
mentors, our coaching program provides them the opportunity for a non-
program director faculty member to review their entire portfolio and 
development throughout residency in a coaching role.  It was successfully 
developed and rolled out in 2011.  This program was evaluated from 2012-
present, and based on its success, it has since been adopted by >20 internal 
medicine residency programs around the country.  We have not yet 
embarked in evaluation in non-internal medicine residencies or internal 
medicine subspecialty fellowship.  Additionally, we have never investigated 
the impact of coaching compared to non-coached peers in a randomized 
trial.  We would like to pursue a randomized coaching intervention and 
evaluation across non-internal medicine residency programs and internal 
medicine subspecialty fellowship to understand the impact of this program 
and its generalizability. In addition, we would like to investigate the impact 
of this coaching program delivered remotely for women surgery residents in 
the Association of Women Surgeons. 
 
The goal of the Professional Development Coaching Program is to allow 
trainees to understand their development over time, find meaning and 

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Version Date:  June 1, 2005 
 
  
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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.   
 
The program design will be mirrored on our internal medicine coaching 
program - Each trainee is assigned a Professional Development Coach, who 
is a faculty member from a different department than theirs who has 
volunteered their time as a coach. In the Association of Women Surgeons 
cohort, the coach will be a faculty member who is a surgeon practicing in 
another area of the country than the resident. Professional Development 
Coaches are assigned on average 2 trainees and are responsible for meeting 
with them quarterly to review evaluations, encourage reflection, provide 
guidance, and motivate them to set learning goals for the upcoming 
rotations.  Once trainees are matched with their coach, they remain paired 
with their coach for the duration of the study (3 years).  There is a three-
year curriculum based on positive psychology and leadership development 
that is based on quarterly meetings.  The faculty coaches receive 2 hours of 
training in positive psychology coaching annually.   
 
Based on prior program evaluation, residents engage in the coaching 
program enthusiastically, and those who engage report lower levels of 
burnout, greater resiliency, greater satisfaction with their training 
experience, improved responses to stressors at work and in their personal 
life, and have increased opportunities for reflection and feedback.  We would 
like to continue to study the Professional Development Coaching Program in 
other specialties and stages of training, and to do so more rigorously than 
we have in the past, by engaging in a randomized trial comparing coaching 
to usual mentoring and well-being practices, and if successful, provide an 
opportunity for crossover in year 3 where all participants receive coaching.   
 
This study would be carried out at MGH, and the AWS cohort would be 
carried out remotely, with the study team primarily existing at MGH (with 
one collaborate from AWS at the Cleveland Clinic). All residents from general 
surgery, OMFS, urology, OB/GYN, and neurosurgery and all internal 
medicine first year subspecialty fellows will be enrolled in the study.  A 
baseline survey will be obtained to allow for randomization to either 
coaching, or usual mentoring and well-being practices that exist in the 
residency and/or fellowship. We will quantitatively surveying the trainees 
and coaches regarding their experiences with and assessment of the 

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Professional Development Coaching Program at the end of each year the 
study period.   
 
RESEARCH DESIGN AND METHODS 
Briefly describe study design and anticipated enrollment, i.e., number of subjects to be enrolled 
by researchers study-wide and by Partners researchers.  Provide a brief summary of the 
eligibility criteria (for example, age range, gender, medical condition).  Include any local site 
restrictions, for example, “Enrollment at Partners will be limited to adults although the sponsor’s 
protocol is open to both children and adults.”
 
• All residents from general surgery, OMFS, urology, OB/GYN, and 
neurosurgery and all internal medicine first year subspecialty fellows will 
be enrolled in the study.   
• All residents in the Association of Women’s Surgeons will be invited to 
participate in the study. 
• Control group – 50% of the study trainee population will be randomized 
to control in a 1:1 manner after baseline burnout data is obtained. 50% 
of the coaches who volunteer will be randomized to control in a 1:1 
manner after baseline burnout data is obtained. In year 3, these trainees 
and coaches will crossover into the coaching intervention. 
• Study group – 50% of the study population will be randomized to 
coaching in a 1:1 manner after baseline burnout data is obtained. 50% of 
the coaches who volunteer will be randomized to coaching in a 1:1 
manner after baseline burnout data is obtained. 
• Faculty and trainees will be surveyed at beginning and end of each 
academic year.  Surveys will be administered by a researcher not 
affiliated with the residency program, who has been involved in coaching 
research since 2011.  This researcher will collect the data centrally, which 
will be de-identified when shared with study staff or the training 
programs. 
• Training programs and the Association of Women Surgeons will be given 
access to the aggregate data, as well as the de-identified data from their 
training program.    
 
Briefly describe study procedures.  Include any local site restrictions, for example, “Subjects 
enrolled at Partners will not participate in the pharmacokinetic portion of the study.”  Describe 
study endpoints.
 
• Coaches are recruited via email to all teaching faculty within the 
representative training programs, and volunteer their time to serve as a 
faculty coach.  In the AWS cohort, they will be invited by email in 
advance of the annual meeting in October 2018. They participate in 2 
hours of mandatory faculty development coach training per academic 
year.  There is also an annual coach faculty development retreat that is 
not mandatory.  

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
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• Trainees will be assigned to a professional development coach who is not 
likely to be a mentor, evaluator or letter-writer for the trainee 
• All trainees are oriented to the coaching program during a mandatory 
orientation session and informed about the study.  All incoming interns 
and fellows will be sent an email in advance to inform them of the study. 
• All AWS trainees will be oriented during an informational session at the 
2018 AWS Annual Meeting. 
• All trainees and faculty (interventions and controls) will be asked to 
complete a baseline survey. 
• Intervention trainees and coaches will be expected to meet quarterly to 
review performance and establish learning goals for subsequent rotations. 
There is no consequence or repercussion for not meeting.  
• All trainees enrolled (interventions and controls) will be asked to 
complete a survey at the end of each academic year inquiring about their 
workplace experiences, workplace relationships, burnout, resiliency, 
response to stress, hardiness, happiness, and gratitude.  This will serve 
as their baseline for the following academic year. 
• All coaches (interventions and controls) will be asked to complete a 
survey at baseline enrollment in the program and the end of each 
academic year about their workplace experiences, workplace 
relationships, burnout, resiliency, response to stress, hardiness, 
happiness, and gratitude.  This will serve as their baseline for the 
following academic year. 
 
For studies involving treatment or diagnosis, provide information about standard of care at 
Partners (e.g., BWH, MGH) and indicate how the study procedures differ from standard care.  
Provide information on available alternative treatments, procedures, or methods of diagnosis.
 
This study does not involve treatment or diagnoses.
 
 
Describe how risks to subjects are minimized, for example, by using procedures which are 
consistent with sound research design and which do not unnecessarily expose subjects to risk or 
by using procedures already being performed on the subject for diagnostic or treatment purposes.
 
This study does not involve treatment, diagnoses, or procedures
 
 
Describe explicitly the methods for ensuring the safety of subjects.  Provide objective criteria for 
removing a subject from the study, for example, objective criteria for worsening disease/lack of 
improvement and/or unacceptable adverse events.  The inclusion of objective drop criteria is 
especially important in studies designed with placebo control groups.
 
The only potential harm that could be anticipated from this study is if there 
is a large difference in experience in interventions and controls. We have 

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seen from our experience with internal medicine coaching that those who do 
not engage in coaching (people who chose to opt-out of regular coaching) do 
have higher burnout, but it is not clear if coaching is the correlation, or if in 
fact these people are avoiding coaching due to their burnout.  This study will 
help determine if there is a difference.   
 
Confidentiality will be required of the coaches.  Specifically, they will be 
required not to share the details of confidential evaluations with other 
faculty. Coaches are not asked to report back on their meetings to the 
training program, unless they are concerned about the safety and well-being 
of the trainees, patients, or others.  The usual potential harms that these 
physicians may encounter in the course of their work in patient care are 
expected and their health and safety will be safeguarded as per 
the usual hospital policies at MGH. 
 
Since there are no treatment plans or procedures involved, there is no risk 
to the safety of the subjects.   
 
 
FORESEEABLE RISKS AND DISCOMFORTS 
Provide a brief description of any foreseeable risks and discomforts to subjects.  Include those 
related to drugs/devices/procedures being studied and/or administered/performed solely for 
research purposes.  In addition, include psychosocial risks, and risks related to privacy and 
confidentiality.  When applicable, describe risks to a developing fetus or nursing infant.
 
The only potential harm that could be anticipated from this study is if there 
is a large difference in experience in interventions and controls.  The usual 
potential harms that these physicians may encounter in the course of their 
work in patient care are expected and their health and safety will be 
safeguarded as per the usual hospital policies at MGH. 
 
The coaching program was agreed upon by the training programs involved in 
this study and leadership of AWS. All trainees will be randomized but 
coaching program and survey participation is voluntary. In the study there is 
risk of discomfort for the trainees and coaches in filling out surveys about 
burnout and their program experience. This risk will be minimized by 
surveys which are de-identified and only viewed by research staff not 
affiliated with the training program. There will be no consequence if trainees 
do not complete the survey and this will be explained before completing the 
survey. 
 
 
EXPECTED BENEFITS 
Describe both the expected benefits to individual subjects participating in the research and the 
importance of the knowledge that may reasonably be expected to result from the study.  Provide 
a brief, realistic summary of potential benefits to subjects, for example, “It is hoped that the 

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Version Date:  June 1, 2005 
 
  
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treatment will result in a partial reduction in tumor size in at least 25% of the enrolled subjects.”  
Indicate how the results of the study will benefit future patients with the disease/condition being 
studied and/or society, e.g., through increased knowledge of human physiology or behavior, 
improved safety, or technological advances. 
 
All trainees participating in the Professional Development Coaching Program 
are expected to receive the same benefit, regardless of participation in the 
surveys; which is increased increased awareness of their accomplishments, 
increased opportunity for reflection, decreased burnout, improved well-
being, increased resiliency, and increased opportunity to set self-directed 
learning goals.  Additional benefits which are likely, but may be harder to 
capture in a survey, are increased awareness of where to turn in the event 
that they are struggling with work, life or professional issues. 
 
 
EQUITABLE SELECTION OF SUBJECTS 
The risks and benefits of the research must be fairly distributed among the populations that stand 
to benefit from it.  No group of persons, for example, men, women, pregnant women, children, 
and minorities, should be categorically excluded from the research without a good scientific or 
ethical reason to do so.  Please provide the basis for concluding that the study population is 
representative of the population that stands to potentially benefit from this research.
 
All residents from general surgery, OMFS, urology, OB/GYN, and 
neurosurgery and all internal medicine first year subspecialty fellows will be 
enrolled in the study.  All residents who are members of AWS will be invited 
to participate. Randomization will be carefully done to ensure gender and 
other demographics are balanced between groups, with the exception of the 
AWS cohort, which is all women, and in that cohort, we will focus on 
balancing the remaining demographics.  
 
 
When people who do not speak English are excluded from participation in the research, provide 
the scientific rationale for doing so.  Individuals who do not speak English should not be denied 
participation in research simply because it is inconvenient to translate the consent form in 
different languages and to have an interpreter present.
 
All trainees have exhibited English proficiency at the time of enrollment in 
the training program.  
 
 
For guidance, refer to the following Partners policy: 
          Obtaining and Documenting Informed Consent of Subjects who do not Speak English
          http://healthcare.partners.org/phsirb/nonengco.htm 
 
 

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Version Date:  June 1, 2005 
 
  
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RECRUITMENT PROCEDURES 
Explain in detail the specific methodology that will be used to recruit subjects.  Specifically 
address how, when, where and by whom subjects will be identified and approached about 
participation.  Include any specific recruitment methods used to enhance recruitment of women 
and minorities.
 
Trainees will be asked to complete a de-identified survey in August of their 
training year. All trainees and faculty will be asked to complete de-identified 
surveys at the end of each academic year. These surveys will serve no 
evaluative purpose in the training program. It will be clearly described that 
their participation is not mandatory. 
 
 
Provide details of remuneration, when applicable.  Even when subjects may derive medical 
benefit from participation, it is often the case that extra hospital visits, meals at the hospital, 
parking fees or other inconveniences will result in additional out-of-pocket expenses related to 
study participation.  Investigators may wish to consider providing reimbursement for such 
expenses when funding is available
None 
 
For guidance, refer to the following Partners policies: 
          Recruitment of Research Subjects 
          http://healthcare.partners.org/phsirb/recruit.htm
 
          Guidelines for Advertisements for Recruiting Subjects
          http://healthcare.partners.org/phsirb/advert.htm
 
          Remuneration for Research Subjects
          http://healthcare.partners.org/phsirb/remun.htm
 
 
CONSENT PROCEDURES 
Explain in detail how, when, where, and by whom consent is obtained, and the timing of consent 
(i.e., how long subjects will be given to consider participation).  For most studies involving more 
than minimal risk and all studies involving investigational drugs/devices, a licensed physician 
investigator must obtain informed consent.  When subjects are to be enrolled from among the 
investigators’ own patients, describe how the potential for coercion will be avoided.
 
Consent will be obtained during the orientation following an overview of the 
study, as well as in emails when surveys are sent out.    
 
 
NOTE: When subjects are unable to give consent due to age (minors) or impaired decision-
making capacity, complete the forms for Research Involving Children as Subjects of Research 

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and/or Research Involving Individuals with Impaired Decision-making Capacity, available on 
the New Submissions page on the PHRC website: 
http://healthcare.partners.org/phsirb/newapp.htm#Newapp
 
For guidance, refer to the following Partners policy: 
          Informed Consent of Research Subjects
          http://healthcare.partners.org/phsirb/infcons.htm
 
 
 
DATA AND SAFETY MONITORING 
Describe the plan for monitoring the data to ensure the safety of subjects.  The plan should 
include a brief description of (1) the safety and/or efficacy data that will be reviewed; (2) the 
planned frequency of review; and (3) who will be responsible for this review and for determining 
whether the research should be altered or stopped.  Include a brief description of any stopping 
rules for the study, when appropriate.  Depending upon the risk, size and complexity of the 
study, the investigator, an expert group, an independent Data and Safety Monitoring Board 
(DSMB) or others might be assigned primary responsibility for this monitoring activity.        
 
NOTE: Regardless of data and safety monitoring plans by the sponsor or others, the principal 
investigator is ultimately responsible for protecting the rights, safety, and welfare of subjects 
under his/her care. 
 
Survey data will be reviewed quarterly using on-line, de-identified survey 
tools.  The data will be reviewed by study researcher within the MGH 
Department of Medicine. Anonymous, de-identified data will then be 
reviewed by study investigators.  Training programs will receive the 
aggregate de-identified data, as well as their de-identified individual 
program data. 
 
 
Describe the plan to be followed by the Principal Investigator/study staff for review of adverse 
events experienced by subjects under his/her care, and when applicable, for review of sponsor 
safety reports and DSMB reports.  Describe the plan for reporting adverse events to the sponsor 
and the Partners’ IRB and, when applicable, for submitting sponsor safety reports and DSMB 
reports to the Partners’ IRBs.  When the investigator is also the sponsor of the IND/IDE, include 
the plan for reporting of adverse events to the FDA and, when applicable, to investigators at 
other sites.   
 
NOTE: In addition to the adverse event reporting requirements of the sponsor, the principal 
investigator must follow the Partners Human Research Committee guidelines for Adverse Event 
Reporting
 
There are no anticipated adverse or safety events in this study.  Any adverse 
events that might occur will be directly reported to the IRB.   
 

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MONITORING AND QUALITY ASSURANCE 
Describe the plan to be followed by the principal investigator/study staff to monitor and assure 
the validity and integrity of the data and adherence to the IRB-approved protocol.  Specify who 
will be responsible for monitoring, and the planned frequency of monitoring.  For example, 
specify who will review the accuracy and completeness of case report form entries, source 
documents, and informed consent.   
 
NOTE: Regardless of monitoring plans by the sponsor or others, the principal investigator is 
ultimately responsible for ensuring that the study is conducted at his/her investigative site in 
accordance with the IRB-approved protocol, and applicable regulations and requirements of the 
IRB.
 
Online survey data will be used to assure validity and integrity of the data.  
The surveys will be submitted to the IRB as well, to assure adherence to 
IRB-approved protocol.  Study researchers will review the accuracy and 
completeness of all data and consent. 
 
 
For guidance, refer to the following Partners policies: 
          Data and Safety Monitoring Plans and Quality Assurance
          http://healthcare.partners.org/phsirb/datasafe.htm
 
          Adverse Event Reporting Guidelines
          http://healthcare.partners.org/phsirb/adverse_events.htm
 
 
 
PRIVACY AND CONFIDENTIALITY 
Describe methods used to protect the privacy of subjects and maintain confidentiality of data 
collected.  This typically includes such practices as substituting codes for names and/or medical 
record numbers; removing face sheets or other identifiers from completed 
surveys/questionnaires; proper disposal of printed computer data; limited access to study data; 
use of password-protected computer databases; training for research staff on the importance of 
confidentiality of data, and storing research records in a secure location.   
 
NOTE: Additional measures, such as obtaining a Certificate of Confidentiality, should be 
considered and are strongly encouraged when the research involves the collection of sensitive 
data, such as sexual, criminal or illegal behaviors.
Trainees and faculty will be asked to enter their names on any online survey 
data tools, for matching purposes (match their response to their 
coach/coachee response). There will be no written surveys.  This information 
will only be viewed by study researchers and not anyone affiliated with the 
training program. 
 

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Information gathered from the surveys will not be published or shared with 
individual identifying information.  Individual data will not be traceable. 
All data will be stored in a secure Partners electronic folder protected by a 
password on a network drive. All survey related papers will be disposed of 
properly.    
 
SENDING SPECIMENS/DATA TO RESEARCH COLLABORATORS OUTSIDE 
PARTNERS 
Specimens or data collected by Partners investigators will be sent to research collaborators 
outside Partners, indicate to whom specimens/data will be sent, what information will be sent, 
and whether the specimens/data will contain identifiers that could be used by the outside 
collaborators to link the specimens/data to individual subjects.
 
n/a 
 
Specifically address whether specimens/data will be stored at collaborating sites outside 
Partners for future use not described in the protocol.  Include whether subjects can withdraw 
their specimens/data, and how they would do so.  When appropriate, submit documentation of 
IRB approval from the recipient institution.
 
n/a 
 
RECEIVING SPECIMENS/DATA FROM RESEARCH COLLABORATORS OUTSIDE 
PARTNERS 
When specimens or data collected by research collaborators outside Partners will be sent to 
Partners investigators, indicate from where the specimens/data will be obtained and whether the 
specimens/data will contain identifiers that could be used by Partners investigators to link the 
specimens/data to individual subjects.  When appropriate, submit documentation of IRB 
approval and a copy of the IRB-approved consent form from the institution where the 
specimens/data were collected.