An Education and Behavioral, Single-center, Observational Cohort Study Evaluating the Effect of Emotion Regulation and Burnout on Medical Trainees' Learning and Documentation of Serious Illness Communication
Phase: NA
Conditions: Communication
Sponsor: Dartmouth-Hitchcock Medical Center

 
CONFIDENTIAL 
CLINICAL RESEARCH PROTOCOL 
 
 
 
 
 
 
 
 
AN EDUCATION AND BEHAVIORAL, SINGLE-CENTER, 
OBSERVATIONAL COHORT STUDY EVALUATING THE 
EFFECT OF EMOTION REGULATION AND BURNOUT ON 
MEDICAL TRAINEES’ LEARNING AND DOCUMENTATION OF 
SERIOUS ILLNESS COMMUNICATION 
 
 
Regulatory Sponsor: 
Garrett T. Wasp 
Internal Medicine, Section of Hematology-Oncology 
1 Medical Center Dr, Lebanon, NH 03765 
603-650-6715 
Funding Sponsor: 
Norris Cotton Cancer Center 
1 Medical Center Dr, Lebanon, NH 03765 
603-650-5000 
Study Product: 
n/a 
Protocol Number: 
Insert Protocol Number Used by Sponsor 
IND Number: 
n/a 
 
 
 
 
 
 
 
 
 
 
Initial version: 4/1/2019 
Amended: 
n/a 
Amended: 
n/a 
 
 

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Table of Contents 
STUDY SUMMARY ...................................................................................................................................... 1 
1 
INTRODUCTION .................................................................................................................................. 2 
1.1 
BACKGROUND ................................................................................................................................ 2 
1.2 
STUDY ASSESSMENT TOOLS ........................................................................................................... 2 
1.3 
STUDY SYTSEMS-BASED INTERVENTIONS ........................................................................................ 3 
1.4 
PRIOR WORK ................................................................................................................................. 3 
2 
STUDY OBJECTIVES ......................................................................................................................... 4 
3 
STUDY DESIGN ................................................................................................................................... 4 
3.1 
GENERAL DESIGN .......................................................................................................................... 4 
3.2 
PRIMARY STUDY ENDPOINTS .......................................................................................................... 5 
3.3 
SECONDARY STUDY ENDPOINTS ..................................................................................................... 5 
4 
SUBJECT SELECTION AND WITHDRAWAL .................................................................................... 5 
4.1 
INCLUSION CRITERIA ...................................................................................................................... 5 
4.2 
EXCLUSION CRITERIA ..................................................................................................................... 5 
4.3 
SUBJECT RECRUITMENT AND SCREENING ....................................................................................... 5 
4.4 
EARLY WITHDRAWAL OF SUBJECTS................................................................................................. 6 
4.4.1 
When and How to Withdraw Subjects ..................................................................................... 6 
4.4.2 
Data Collection and Follow-up for Withdrawn Subjects .......................................................... 6 
5 
STUDY PROCEDURES ....................................................................................................................... 6 
5.1 
BEFORE COMMUNICATION TRAINING ACTIVITIES .............................................................................. 6 
5.2 
TWO WEEK PALLIATIVE CARE ELECTIVE .......................................................................................... 6 
5.3 
ELECTRONIC COMMUNICATION EVERY TWO MONTHS. ...................................................................... 6 
5.4 
SEMI-STRUCTURED INTERVIEWS ..................................................................................................... 7 
5.5 
SIMULATED PATIENT ENCOUNTER AT SIX MONTHS ........................................................................... 7 
5.4 
SIX AND TWELVE MONTH ERSQ AND MBI ASSESSMENT .................................................................. 7 
 
6 
STATISTICAL PLAN ........................................................................................................................... 7 
6.1 
SAMPLE SIZE JUSTIFICATION .......................................................................................................... 7 
6.2 
ANALYSIS PLAN.............................................................................................................................. 7 
6.3 
SUBJECT POPULATION(S) FOR ANALYSIS ......................................................................................... 8 
7 
INVESTIGATOR REPORTING ............................................................................................................ 8 
7.1 
DEFINITIONS .................................................................................................................................. 8 
7.2 
REPORTING PROCES ...................................................................................................................... 8 
7.3 
OTHER REPORTABLE EVENTS ......................................................................................................... 9 
8 
DATA HANDLING AND RECORD KEEPING ..................................................................................... 9 
8.1 
CONFIDENTIALITY ........................................................................................................................... 9 
8.2 
SOURCE DOCUMENTS .................................................................................................................... 9 
8.3 
RECORDS RETENTION .................................................................................................................... 9 
9 
STUDY MONITORING ......................................................................................................................... 9 
10 
ETHICAL CONSIDERATIONS .......................................................................................................... 10 
11 
STUDY FINANCES ............................................................................................................................ 10 
11.1 
FUNDING SOURCE ........................................................................................................................ 10 
11.2 
CONFLICT OF INTEREST ................................................................................................................ 10 
11.3 
SUBJECT STIPENDS OR PAYMENTS ............................................................................................... 10 

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12 
PUBLICATION PLAN ........................................................................................................................ 11 
13 
REFERENCES ................................................................................................................................... 11 
 
 
 

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List of Abbreviations 
 
ERSQ – Emotion Regulation skills questionnaire.  Definition on page 2 
MBI – Maslach Burnout inventory.  Definition on Page 2  
PI – principal investigator 
SICG© - Serious illness conversation guide.  Defined on page 3. 
 
 

[Insert short name of protocol here] 
 
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Study Summary 
Title 
An Education and behavioral, single-center, Observational Cohort study 
evaluating the effect of emotion regulation and burnout on medical trainees’ 
Learning and Documentation of serious illness communication 
Short Title 
Emotion Regulation and Burnout Impact on Communication Documentation 
Protocol Number 
The standard protocol number used to identify this study.   
Phase 
n/a 
Methodology 
Observation cohort Study 
Study Duration 
Two Years 
Study Center(s) 
Single-center: Dartmouth-Hitchcock Medical Center 
Objectives 
Aim 1. Evaluate the efficacy of our multimodal communication skills training on 
trainee documentation, confidence and observed communication skills over 12 
months. 
 
Aim 2. Test the relationship between emotion regulation, and burnout on 
trainee skill enactment over 12 months. 
Number of Subjects 
42 
Diagnosis and Main 
Inclusion Criteria 
Internal Medicine Residents and Hematology-Oncology who undergo palliative 
care elective AND Serious Illness Communication training  
Study Product, Dose, 
Route, Regimen 
n/a 
Duration 
of 
administration 
n/a 
Reference therapy 
No gold standard for communication skills training 
Statistical 
Methodology 
one-side proportion test with exact test for primary outcome.  Secondary 
outcomes use different statistical tests: 1) a linear mixed model with random 
subject effect to test whether three different scores in simulated encounters are 
different; 2) summary statistics, 3) t-tests 
 

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1 Introduction 
This document is a protocol for a human research study. This study is to be conducted according to US 
and international standards of Good Clinical Practice (FDA Title 21 part 312 and International Conference 
on Harmonization guidelines), applicable government regulations and Institutional research policies and 
procedures.  
1.1 Background 
Effective communication around serious illness is an essential clinical competency for all 
physicians. Physicians, however, often fail to disclose prognostic information and to adequately 
solicit patient values.1,2,3  Cited barriers to effective communication include insufficient physician 
training in communication and difficulty in dealing with patient emotion.4,5 
While formal communication skills training programs improve learners’ behaviors in 
proximate, controlled settings (e.g., simulation), the evidence that this training has long-term 
impacts on learners’ behavior and associated patient outcomes is limited and mostly 
demonstrates null effects.6,7 Human behavior can be resistant to change, and psychologic 
theory suggests twelve domains for why physician behavior does not change.8 One of these 
twelve domains is emotion regulation. Emotion regulation, defined as the ability to respond to 
ongoing demands of experience with a sufficiently flexible range of emotions, is necessary for 
effective prognostic disclosure, given both patient and provider have emotional reactions to 
such information. Burnout, a process involving emotional exhaustion, depersonalization, and 
low personal accomplishment, adversely impacts emotion regulation. No studies have 
addressed the potential role of emotion regulation and burnout as physician factors affecting the 
acquisition of physician communication skills. 
 
The purpose of this study is to twofold. First, evaluate the efficacy of a communication 
skill training we integrated into graduate medical education by longitudinally tracking 
participants’ documentation behavior. Second, perform exploratory analyses of physicians’ 
emotion regulation skills and burnout as potential mechanisms for communication skill 
acquisition. 
1.2 Study Assessment Tools 
Confidence Survey – Using a 5 point Likert scale (i.e. 1=strongly disagree, 2=disagree, 
3=neutral, 4=agree 5=strongly agree) participants were asked to rate their confidence in various 
communication skills domains pre- and post-intervention via online survey. 
Emotion Regulation Skills Questionnaire (ERSQ) – This validated instrument consists of 27 
items, and includes subscales related to nine competencies of coping with negative emotion 
(awareness, sensations, clarity, understanding, acceptance, tolerance, readiness to confront, 
compassionate self-support and modification) which can be summed to a total score (TOTAL).9  
The ERSQ assesses each skill by means of three items introduced by the phrase “In the last 
week…” and answered on a 5-point Likert-scale. Higher scores indicate stronger emotion 
regulation skills.10  We will administer the ERSQ via online survey. 
Maslach Burnout InventoryTM(MBI) –This validated, psychological inventory consists of 22 items 
related to occupational burnout, and includes subscales related to Emotional exhaustion (EE; 9 
items), Depersonalization (DP; 5-items), and Personal Accomplishment (PA; 8 items). The MBI 
assesses each item on a 7-point Likert-scale. Higher scores indicated greater burnout. . We will 
use the MBI / Human Services Survey for Medical Personnel administered via online survey.11 
Semi-structured interview – At 6 months, participants (e.g. trained faculty, residents, and 
fellows) are asked a series of preselected questions in a one-on-one interview about their 
experience with the training, using the SICG with patients, benefits and difficulties of the training 
in the clinical setting. 

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Serious Illness Conversation Guide (SICG©) – improve the timing, frequency, quality, and 
tolerability (for both patient and clinician) of patient-centered values and goals conversations for 
patients living with serious illness.12 The SICG© was co-produced by clinicians, patients, and 
families and is a checklist of best-practice communication steps for use in patients with serious 
illness. 
Skills acquisition checklist - used by independent observer during simulated patient encounters 
to evaluate trainees. One point is assigned for each item used by the trainee. The checklist 
contains three scores: conversation guide specific items (16 points), global communication skills 
(9 points), and a combined score (25 points). This checklist was developed internally and based 
on the experience training residents in the Serious Illness Conversation Guide (SICG). 
Template Use –The analytics team at our institution is able to link the smartform to the physician 
who made alterations, the content of those alterations, patient and date of change.  
1.3    Study Systems-based Interventions 
Audit and profile feedback –Injunctive norms messaging with social comparisons is used to 
change attitudes by communicating approval or disapproval of behavior.13–19 This acknowledges 
that people make decisions based on social cues, self-image, local values and identities. We 
also leverage pre-commitment contracts.20 Trainees will receive their personal template use 
frequency compared to top performers via email. Non-top and top performers will receive 
different messages, customized through pre-testing with non-study residents and fellows. For 
example: “Talking to patients about their values is important but can take some pre-visit 
planning. Choose a patient you will see in the next two weeks to use the SICG” (non top-
performers) or “Good job! Talking to patients about their values is important. The way we 
continue to improve is by having more conversations. Choose a patient you will see in the next 
two weeks to use the SICG.” (top-performers). 
Priming – Priming physicians to reflect on whether their patients have serious illness is 
associated with more goals-of-care discussions.21 Using the chart review, we will generate a list 
unique to each trainee enriched for outpatients with a high likelihood of having serious illness. 
After completing the first training session, each trainee will review their list and be asked four 
“yes or no” questions: 1) “Does this patient have serious illness?”; 2) “Would you be surprised if 
this patient died in the next 12 months?;” 3) Would this patient benefit from a serious illness 
guide conversation?; 4) If you saw this patient again, would you use the serious illness 
conversation guide with him/ her? 
Template – We designed a template to standardize SICG documentation and embedded it in 
the medical record. This template exists in two forms: a “dotphrase” (user enters text in a note to 
display template) and as a central smartform where patient responses can be recorded.  
 
1.4 Prior Work 
Starting in 2017, we designed and implemented annual communication skills training. We trained 
16 internal medicine residents (hereafter referred to as residents), 6 hematology-oncology fellows 
(hereafter referred to as fellows), and used a train-the-trainer model to train faculty attendings to 
serve as trainers in the clinical setting with trainees: 5 hospitalists, 4 primary care and 4 
oncologists. We designed and embedded a template into the electronic medical record to 
standardize the documentation of the SICG. We developed a structured chart review protocol to 
identify outpatients with a high-likelihood of serious illness and evaluate trainee documentation 
habits 
. 

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2 Study Objectives 
Aim 1. Evaluate the efficacy of our multimodal communication skills training on trainee 
documentation, confidence and observed communication skills over 12 months. 
Hypotheses:  Template use for both trainee subgroups will increase from zero after training for 
≥50% of trainees (Ha1a). Trainee and faculty confidence will increase after training for ≥50% of 
participants (Ha1b). Observed communication skills scores at the second and third simulated 
patient encounter will improve over the first encounter. (Ha1c).  
Rationale: Augmenting standard training with priming, structured documentation templates, 
documentation audit and feedback, and embedded faculty coaches, we hope to increase the 
effect of communication skills training on clinical behavior change. 
Outcomes: Participant template use at 12 months (Primary). Trainee, post-intervention self-
rated confidence and performance in simulated patient encounters (Secondary). 
 
Aim 2. Test the relationship between emotion regulation and burnout on trainee skill 
enactment over 12 months. 
Hypothesis:  Trainees in the top half of template users will have higher a TOTAL emotion-
regulation score than trainees in the bottom half (Ha2a). Trainees in the top half of template 
users will have lower Emotional Exhaustion scores than trainees in the bottom half (Ha2b). 
Rationale: Given their high emotional content, a physician’s ability to regulate their own 
emotions and emotional exhaustion may impact their capacity to engage in serious illness 
conversations. 23 In a healthcare setting, the ESRQ was used to assess non-physician 
participants’ competence to cope with specific and general aspects of negative emotions.10 We 
know of no studies examining its role in physicians and specifically medical trainees. 
Outcomes: For ERSQ and MBI achieve complete data collection in ≥80% of willing participants 
(primary).  
 
 
3 Study Design 
3.1 General Design 
This is a single-institution cohort study with two tiers.  Tier 1 is an education study where 
participants can complete electronic surveys on their pre and post intervention confidence, 
perform two simulated patient encounters and have their documentation of electronic template 
monitored longitudinally over 12 months.  Participants are free to opt out of any activity related 
to education assessment or system-based interventions to promote the use of learned skills 
(e.g. priming or profile feedback).  Signed informed consent will Not be required for this tier.  
Tier 2 is a behavioral study where participants, in addition to all of Tier 1 activities, also 
complete psychological inventories at three time points to measure emotion regulation and 
burnout, and participate in a semi-structured interview.  We will require signed informed consent 
to participate in Tier 2. 
 
 
 
 
 
 
 
 
 

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Pariticipant duration – each participant will be followed for 12 months beginning with their first 
communication training 
3.2 Primary Study Endpoints 
Resident, Fellow and Faculty template use at 12 months. 
3.3 Secondary Study Endpoints 
Resident, Fellow and Faculty post-intervention self-rated confidence and performance in 
simulated patient encounters. 
4 Subject Selection and Withdrawal 
4.1 Inclusion Criteria 
All second-year internal medicine residents.  All first-year hematology-oncology fellows. 
4.2 Exclusion Criteria 
Missed more than five days (out of 10 possible days) of the two week palliative care elective 
4.3 Subject Recruitment and Screening 
Designated study staff will make a brief presentation at a residency meeting (e.g. morning report) 
to advertise study, send emails and study members who do not have a role in evaluating residents 
or fellows will approach residents in person.  Any resident who indicates they do not want to 
participate will not be approached again.  Study staff who evaluate residents and fellows, 
specifically Drs. Vergo, Cullinan and Chamberlin, will not be involved in the recruitment or 
consenting process. 
Figure 1 Study Design 
Fellows 
Residents 
Faculty 
Time 
0 
3 months 
6 months 
9 months 
12 months 
RED – Assessment 
BLUE – Implementation 
GREEN – Education  
Didactic Session 
Simulated Patient encounter 
Confidence 
Maslach Burnout Inventory 
Emotion Regulation Skill Questionnaire 
Interview 
Profile Feedback 
Priming 
2 week Palliative 
Care Elective 
4 hour 
Introduction 
Session 
8 hour 
Session 
C
CBE 
C
C
C
C
CHART 
REVIEW 
CHART 
REVIEW 
TEMPLATE USE 
AT 12 MONTHS 
TEMPLATE USE 
AT 12 MONTHS 
TEMPLATE USE 
AT 12 MONTHS 
4 hour 
Introduction 
Session 
B 
E 
CBE 
BE 
BE 
BE 
BE 

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4.4 Early Withdrawal of Subjects 
4.4.1 When and How to Withdraw Subjects 
The scenarios we imagine when a study subject would withdraw is when he or she indicated to 
study staff that they no longer wanted to participate OR no longer.  Verbal or electronic 
communication to the PI  
4.4.2 Data Collection and Follow-up for Withdrawn Subjects 
We would continue to follow to participants’ documentation over the 12 months from his or her 
initial training.  If no longer working at study institution would follow documentation until last day 
of employment. 
5 Study Procedures 
Please refer to Figure 1 – Study Design detailing study overview for the timing of interventions 
and assessments. 
5.1 Before Communication Training Activities 
Tier 1 (education-only subjects): Three to four weeks prior to the subject’s two-week palliative 
care elective they will be sent an email to complete an online confidence survey.  They will 
receive email reminders to complete the survey until survey is completed. 
Tier 2 (education + behavioral subjects): Subjects will have reviewed and signed consent 
documentation.  In addition to the above online confidence survey, they will also receive email 
to complete electronic ERSQ and MBI. 
5.2 Two week palliative care elective 
Tier 1 – Integrated into the two-week elective with the palliative care department, subjects 
undergo a 1) four-hour training focused on the SICG©; 2) two simulated patient encounters with 
trained actors and feedback provided after training, 3) participant sent electronic notification to 
take post intervention survey of confidence 
Tier 2 – In addition to above, these subjects will also complete a Priming intervention.  They will 
receive a list of patients whom 1) the study subjected documented at least one note on in the past 
and 2) have a high likelihood of serious illness as determined by a chart review process.  This list 
will be shared securely through Dartmouth secure file electronically, and participants will be asked 
three questions for each patient: 1) “Does this patient have serious illness?”; 2) “Would you be 
surprised if this patient died in the next 12 months?;” 3) Would this patient benefit from a serious 
illness guide conversation?; 4) If you saw this patient again, would you use the serious illness 
conversation guide with him/ her?Subjects will be asked to review no more than 30 patients.  
Subjects will be asked to return the completed email via Dartmouth secure file share. 
5.3 Electronic communication every two months following completion of 
elective 
Tier 1 – Every two months after completing the training, participants will receive email compare 
his or her own documentation of the taught template to top and average performers (comparison 
results given are anonymous).  Non-top and top performers will receive different messages, 
customized through pre-testing with non-study residents and fellows. For example: “Talking to 
patients about their values is important but can take some pre-visit planning. Choose a patient 
you will see in the next two weeks to use the SICG” (non top-performers) or “Good job! Talking to 

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patients about their values is important. The way we continue to improve is by having more 
conversations. Choose a patient you will see in the next two weeks to use the SICG.” (top-
performers).  At four months, subjects will be asked electronically to complete their final 
confidence survey. 
Tier 2 – For this part of the study, identical to Tier 1 
5.4 Semi-structured interviews 
Tier 2 only – Planned to occur about three months following training.  Subjects are asked a series 
of questions designed to assess subject perception of serious illness communication, obstacles 
to implementing the training in practice, barriers to documentation and coaching sessions in real 
patient encounters with trained faculty.  Interviews will be recorded, and expected duration is 20-
40 minutes. 
5.5 Simulated Patient encounter at six months 
Tier 1 – Subject is contacted to arrange one-hour for simulated patient encounter, about 20-30 
minutes for skill practice and the remainder for debrief.   Subject has permission from program to 
have this hour to be away from their clinical duties. 
Tier 2 – identical to Tier 1. 
5.6 Six and 12 month ERSQ and MBI assessment 
Tier 2 only – emails will be sent to participant to take ERSQ and MBI at month six and 12 following 
training 
 
 
6 Statistical Plan 
6.1 Sample Size Justification 
Primary Hypothesis: Template use for both trainee subgroups will increase from zero after 
training for ≥50% of trainee (Ha1a) 
Let null hypothesis Hnull1a be p<50% and alternative hypothesis be Ha1a be p=p1≥50%, where p 
is proportion of trainees who have any documented template use. Sample size of 42 (12 fellows 
and 30 eligible residents who have completed the education intervention by the end of the grant 
award period [June 2020]) enables us to have Minimum Detectable Difference (MDD) 19.05%, 
i.e., the least p1 is 69.05%, with 80% of power and 2.5% significance level using one-side 
proportion test with exact test.  
6.2 Analysis Plan 
Primary Hypothesis: Ha1a 
We will calculate the proportion of trainees with template use and provide 95% confidence 
intervals with exact method, then we will test the hypothesis using a proportion test.  
 
Secondary Hypotheses 
Ha1b: Trainee and faculty confidence will increase after training for ≥50% of participants. 
We define increased confidence as trainee and faculty post-intervention confidence scores of 4 
or 5 on a 5-point Likert scale. We will calculate proportion of subjects who have increased 
confidence and show 95% confidence intervals as well, then we will use a proportion test for the 
hypothesis.  
 

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Ha1c: Observed communication skills scores at the second and third simulated patient 
encounter will improve over the first encounter. 
The observed communication skills scores have three different scores (two sub-scores and one 
combined/total score).  We will apply a linear mixed model with random subject effect to test 
whether each of three scores are different from encounter 1 to 2 and 3 separately. P-values will 
be adjusted for multiple tests by the Dunnett method.   
 
Ha2a: Trainees in the top half of template users will have higher total emotion-regulation 
competences (TOTAL) than trainees in the bottom.    
The ERSQ yields 10 different scales of emotion regulation: 9 specific competences and 1 
TOTAL competency which is the average of the nine scales. We will provide summary statistics 
(mean and standard deviation) of TOTAL competency and use a two-sample t-test to test 
differences between the top half and low half groups of patients. P-value will be presented. 
  
Ha2b: Trainees in the top half of template users will have lower Emotional Exhaustion (EE) 
scores than trainees in the bottom half.   
We will provide summary statistics (mean and standard deviation) of EE scores and use a two- 
sample t-test to test differences between the top half and low half groups of patients. P-value 
will be presented 
6.3 Subject Population(s) for Analysis 
Primary outcome is all residents and fellows trained.  Secondary outcomes evaluating emotion 
regulation skill and burnout are in all residents and fellows who consented to be part of Tier 2 – 
the behavioral study part. 
7 Investigator reporting: notifying the Dartmouth IRB 
7.1      Definitions 
This section describes the requirements for safety reporting by investigators who are Dartmouth 
faculty, affiliated with a Dartmouth research site, or otherwise responsible for safety reporting to 
the Dartmouth IRB. The Dartmouth IRB requires reporting of those events related to study 
participation that are unforeseen and indicate that participants or others are at increased risk of 
harm.  The Dartmouth IRB requires researchers to submit reports of any incident, experience, or 
outcome that meets each of the following criteria: 
 Unanticipated in terms of nature, severity, or frequency given: (a) the research 
procedures that are described in the protocol-related documents, such as the IRB-
approved research protocol and consent document; and (b) the characteristics of the 
subject population being studied; and 
 Possibly related to participation in the research means there is a reasonable possibility 
that the incident, experience, or outcome may have been associated with research 
participation; and 
 The problem suggests that the research places subjects or others at a greater risk of 
harm (including physical, psychological, emotional, economic, legal, or social harms) 
than was previously known or recognized. 
 
7.2  Reporting Process 
Unanticipated problems posing risks to subjects or others as noted above will be reported to the 
Dartmouth IRB using the form: “Unanticipated Problem Involving Risks to Subjects or Others 
(UPR).” 
 

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Copies of each report and documentation of IRB notification and receipt will be kept in the Clinical 
Investigator’s study file. 
 
7.2     Other Reportable events: 
For behavioral trials, the following events are also reportable to the Dartmouth IRB: 
 Breach of confidentiality 
 Change to the protocol taken without prior IRB review to eliminate apparent immediate 
hazard to a research participant. 
 Complaint of a participant when the complaint indicates unexpected risks or the complaint 
cannot be resolved by the research team. 
 Protocol deviation (meaning an accidental or unintentional deviation from the IRB approved 
protocol) that in the opinion of the investigator placed one or more participants at increased 
risk, or affects the rights or welfare of subjects. 
. 
8 Data Handling and Record Keeping 
8.1 Confidentiality 
Information about study subjects will be kept confidential. Presentations of any results of the data 
that results from this study will be de-identified.  Results that could be linked to an individual will 
be aggregated or omitted in publication or presentations. 
 
In the event that a subject revokes authorization to collect or use their data, the investigator, by 
regulation, retains the ability to use all information collected prior to the revocation of subject 
authorization. 
8.2 Source Documents 
Source data is all information, original records of surveys, observations, interviews, or other 
activities in a study necessary for the reconstruction and evaluation of the study.  Source data are 
contained in source documents.  Examples of these original documents, and data records include: 
electronic survey results, psychologic inventory results (e.g. ERSQ and MBI), simulated patient 
encounter assessments, recorded semi-structured interviews, patient lists with subjects 
responses to priming questions, and documentation of template in the electronic medical record. 
8.3 Records Retention 
We plan to retain record of study subject for one year following the study completion of the last 
study participant enrolled (an additional 12 months after the subject’s initial 12 month assessment 
following training completion).  This will allow for additional data anaylsis as the investigators plan 
to publish the results of the study. 
 
 
9 Study Monitoring 
This study will be monitored according to the monitoring plan outlined IRB research plan, entitle 
Study Progress Monitoring.  The investigator will allocate adequate time for such monitoring 
activities.  

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10 Ethical Considerations 
This study is to be conducted according to US and international standards of Good Clinical 
Practice (FDA Title 21 part 312 and International Conference on Harmonization guidelines), 
applicable government regulations and Institutional research policies and procedures. 
 
This protocol and any amendments will be submitted to a properly constituted independent Ethics 
Committee (EC) or Institutional Review Board (IRB), in agreement with local legal prescriptions, 
for formal approval of the study conduct.  The decision of the EC/IRB concerning the conduct of 
the study will be made in writing to the investigator and a copy of this decision will be provided to 
the sponsor before commencement of this study.  The investigator should provide a list of EC/IRB 
members and their affiliate to the sponsor. 
 
For this study, participants in Tier 2 (behavioral research) will be provided a consent form 
describing this study and providing sufficient information for subjects to make an informed 
decision about their participation in this study.  See Attachment  for a copy of the Subject Informed 
Consent Form.  This consent form will be submitted with the protocol for review and approval by 
the EC/IRB for the study.  The formal consent of a subject, using the EC/IRB-approved consent 
form, must be obtained before that subject undergoes any study procedure.  The consent form 
must be signed by the subject or legally acceptable surrogate, and the investigator-designated 
research professional obtaining the consent.  
11 Study Finances 
11.1 Funding Source 
Funding from the Dartmouth-Hitchcock Medical Center Department of Internal Medicine section 
of Hematology-Oncology.  A grant application to the American Society of Clinical Oncology for 
this projected was submitted and its status is pending. 
11.2 Conflict of Interest 
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or 
financial gain greater than the minimum allowable by their institution, etc.) must have the conflict 
reviewed by a properly constituted Conflict of Interest Committee with a Committee-sanctioned 
conflict management plan that has been reviewed and approved by the study sponsor prior to 
participation in this study.  All Dartmouth-Hitchcock investigators will follow the Dartmouth-
Hitchcock conflict of interest policy. 
11.3 Subject Stipends or Payments 
For residents and fellows who enroll into the human subjects arm of the study (Tier 2), we plan to 
offer $20 in the form of gift card at four separate time points.  Each study time point is associated 
with the completion of study activities that do not provide the participants direct benefit and 
intended to compensate them for their time spent doing the activity.  The first compensation is 
around study start and is the completion of the psychological inventories (ERSQ and MBI).  The 
second compensation is around 3-4 months and provided for completing the second confidence 
survey and semi-structured interview.  The third compensation is at 6 months for completion of 
psychological inventories (ERSQ and MBI) and last simulated patient encounter.  The last 
compensation is at 12 months for completing the final psychological inventories (ERSQ and MBI).  
We plan at our first internal assessment time point (November 2019) to assess our recruitment 

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and participant time to complete study activities, and may decide at that time to modify 
compensation.  In the event of any changes to compensation regimen, we will notify this IRB. 
12 Publication Plan 
Study investigators do not need permission from study sponsor prior to publishing results of the 
study to a third party. 
13 References 
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