Summative Assessment of the BurntOut 3D Simulation With Medical Students
Phase: NA
Conditions: Burnout, Student, Alcohol; Harmful Use, Quality of Life, Depression, Resilience, Drug Use, Burnout, Professional
Sponsor: Clinical Tools, Inc.

Project Title: BurntOut: Role-Play Simulation for Building Medical Student Resiliency
Institution: CLINICAL TOOLS, INC.
Grant Number: 5R44AA026474-03
Principal Investigator: Tanner, Bradley
NCT 04494633
December 6, 2023
STUDY PROTOCOL
Study Purpose and Rationale
We will assess an internet-based role-playing simulation in which medical students explore common 
stresses and challenges in the clinical years of medical school, identify potential coping strategies, 
make decisions, and perceive negative and positive outcomes associated with those choices. If 
successful, students will gain confidence in how to best apply attitudes and actions that ameliorate the 
stresses identified, investigate external wellness resources if coping mechanisms fail, and anonymously 
communicate the challenges to the institution in order to foster institutional change.  
Physician burnout has downstream negative effects on patient care. Additionally, burnout and resiliency 
(the ability to recover quickly from stress and difficulties) are best addressed early in medical training 
so physicians can recognize poor coping strategies and build resiliency to the stresses of clinical 
practice. Specific health behavior topics, such as use of alcohol, are related to burnout; thus, addressing 
burnout decreases the risk of alcohol use in professionals. 
The specific aim of NCT04494633 is to assess impact of the intervention on burnout and related 
indices using standardized measures adapted to be relevant to the intervention and target audience.
Methodology
During Phase II of this Small Business Innovation Research Phase II project, individuals in 
NCT04494633 will use the simulation and complete online assessments. 
Subjects will be asked to use the simulation and fill out online surveys/instruments using personal 
computers with Internet connection. 
Demographic information will be obtained (sex, race, age, education). 
Use of the online simulation will involve engaging with scenarios presented in 3D imagery of typical 
challenges that medical students face, making choices on how to respond to the challenges, 
experiencing a storyline typical for the choice made, and reviewing feedback on the choice made. They 
will also be presented lessons on developing resiliency. 
Summative Study Description: We will use a pre-/post-intervention parallel design with controls who 
also will have the opportunity to use the intervention if they choose to do so. We will recruit and enroll 
up to 80 medical students who are in US medical schools (DO and MD) for the two arms. The number 
of participants selected is based on a power analysis of our design and our experience of low dropout 
rate with this target audience; to reach a medium effect size we are aiming for a final sample size of 60 
medical students. 
Participants will 1) Complete the simulation experience: a simulation/story, educational case studies, 
and didactic material (taking around 2 hours over a period of around 2 weeks); and 2) Complete 

pre-/post- assessments (each taking around 1 hour) plus a follow-up survey after 2-4 weeks, and will be 
compensated for the assessments. 
The primary clinical endpoint will be burnout as measured by an adaptation of the Maslach Burnout 
Inventory, tailored to medical students and the content in the intervention, so that results are relevant to 
this specific study.
Secondary endpoints will be measured via the following assessments, all of which will be 
adapted/edited to be targeted to this group of users.
•
Medical Student Quality of Life, 
•
Patient Health Questionaire 2/Patient Health Questionaire 9 aka PHQ2 and PHQ9, which are 
depression screening questions, 
•
Connor-Davidson Resilience Scale, 
•
Alcohol Use Disorders Identification Test  aka AUDIT-C/AUDIT for alcohol use disorder and 
•
NIDA Quick Screen -two drug question screening for drug use, 
Completion of online instruments will involve answering questions on their personal computers. For 
example, the assessments ask participants to self-rate their level of burnout symptoms, perception of 
the quality of their life, their level of resiliency, screening for alcohol and other substance use 
problems, screening for depression. Participation will take up to 4 hours (for use of the simulation plus 
assessments) over a 4-6 week period depending on the student’s pace through the scenarios and 
participation in the optional activities. 
Statistical Analysis
Study Population
Number, age, gender, ethnicity, and whether healthy volunteers. If patients, specify the disease or 
condition and indicate how potential subjects will be identified.
Students must be currently enrolled in a US based medical school. Women and minorities will be 
recruited according to their percentages in the medical student/faculty population.
Phase II Study Component 
Subjects
Time
Evaluate Intervention with the Target Audience 
Up to 80 
≈ 4.5 hours
Planned Distribution of Subjects
We will stratify our sample to assure that we have appropriate representation of both women and 
minorities. Women will comprise 50% of the sample. In 2017-2018 50.7% of medical school 
matriculates were female1. The Association of American Medical Colleges provides the following 
information for matriculation in medical school in 2017 of the 21,326 matriculants.
Race/Ethnicity
% of matriculation (2017)*
American Indian or Alaskan Native 
0.7
Asian 
23.3

Race/Ethnicity
% of matriculation (2017)*
Black or African-American
7.4
Hispanic, Latino, or of Spanish Origin 
9.9
Native Hawaiian or Other Pacific Islander 
0.1
White 
50.4
Other
0.8
Multiple Race / Ethnicity 
1.8
Unknown Race / Ethnicity 
3.6
Non-US Citizen and Non-Permanent Resident 
1.3
*Numbers total = ~ 100%
We will stratify our sample to match the US distribution of the current medical school population by 
gender, and by race and ethnicity.
Children
Children are defined by the NIH as those under the age of 18. The intervention is targeted for medical 
students and thus is only of use to adults aged 18 and over. According to the Association of American 
Medical Colleges (AAMC),2010-2016 https://www.aamc.org/download/321468/data/factstablea6.pdf), 
the minimum age of entering medical students was 20 (women) and 21 (men). Therefore, the target 
audience will be over the age of 21 and will not include children.
Recruitment Information
Recruitment
All participant medical students will be recruited via advertisements sent via e-mail listservs, and by 
posting notices on Facebook and Twitter. 
Consent Process
Subjects will be e-mailed all study materials (informed consent forms if need, explanatory materials 
otherwise) before the scheduled test or will be invited via email to fill out secure online forms on our 
website. The forms will include information about the purpose of the study as well as risks in 
participating and possible benefits. The forms will include information about the purpose of the study 
as well as risks in participating and possible benefits. The forms will include the contact information 
for the PI and the IRB. 
We will email or conduct a short phone or internet-based chat session with subjects in order to answer 
any questions, and confirm informed consent signatures have been witnessed prior to beginning 
participation in the study. Electronic signatures will be allowed where possible under 45 CFR 46 and 
approved by the CTI IRB. After subjects complete informed consent forms, participation can begin. 

Risks and measures to minimize risks
We will make it clear to all participants that participation is voluntary and will not impact any aspect of 
their medical school evaluation or faculty standing. We will also stress that any information gathered 
on the assessment instruments or during interviews will be kept confidential and will not have any 
influence on current course work, grades, or evaluations. 
Written or electronic consent will be obtained from all subjects prior to the interview or experience. 
Personal information will be collected and stored. Confidentiality will be maintained by removing any 
identifying information from demographic material, tests, and questionnaires. Subject ID numbers will 
be used rather than names in all instances. All records will be kept on a secure server with password 
protections and available only to the PI, Co-I, and project assistant involved in this research. All 
electronic records will be kept in one location in a password-protected file. Any results published from 
this research will not include any personal identifying information. We will assure the subjects that they 
can stop the interview or experience at any time.
Response to individual assessments that indicate a potential problem for a specific participant:  Drs. 
Tanner or Rossie will review all subjects’ assessment responses and directly contact any subject whose 
response to assessments (the PHQ9 depression assessment, substance use assessments – AUDIT and 
drug questions, Maslach Burnout Inventory, CD-RISK-2, Medical Student Quality of Life) are at a 
level that these instrument scoring indicates is of concern and in need of follow-up in total or for a 
significant question. Students will receive messages recommending the follow-up appropriate for their 
results, including education and relevant resources, recommendations for further evaluation or 
treatment, and encouragement. We will also provide local resource information, and offer to work with 
the subject to help assure that they receive appropriate care. HIPPA does not apply as this is a benign 
behavioral intervention and not intended to be a medical treatment delivered in a medical setting 
provided by a health care professional working as a health care professional. 
Benefits to subjects and/or society
The personal benefits include increased awareness of the risks of physician burn out and strategies to 
compensate for that for both students and faculty. The information is designed to provide an 
educational supplement to their medical school education. It is possible that students will enjoy using 
the prototype simulation. These benefits will easily outweigh the risks identified above.