The Holographic Standardized Patient: Using Mixed Reality to Reduce Barriers to Crisis
Phase: NA
Conditions: Medical Emergencies, Educational Problems, Simulation of Physical Illness
Sponsor: Sunnybrook Health Sciences Centre

STUDY PROTOCOL: 
The Holographic Standardized Patient: Using Mixed Reality to Reduce Barriers to 
Crisis Simulation in Acute Care 
Study ID: NCT05729802 
Version Date: 2025-01-17 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
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STUDY PROTOCOL: 
 
The Holographic Standardized Patient: Using Mixed Reality to Reduce Barriers to 
Crisis Simulation in Acute Care 
Background and Rationale: 
The current state-of-the-art in medical simulation and assessment is mannequin 
based and reliant on highly specialized personnel, equipment, and dedicated space. 
Costs are exorbitant and therefore access is limited1. Health care facilities and 
educational institutions without such a model are unable to participate in high fidelity 
medical simulation for initial training, continuing medical education, and assessment 
purposes. Simulation centres are also limited to trainees able to easily reach their 
facilities, which means lost potential revenue and impact. In addition, in-person 
evaluation is also vulnerable to disruption from the current pandemic, and alternatives 
are needed which allow evaluation2.  
We have created a prototype platform, HoloSIM3,4, which disrupts this model. HoloSIM 
is a mixed reality platform consisting of laptop- or tablet-based instructor software and 
Microsoft Hololens 2 headset-based student software. The Microsoft Hololens 2 allows 
for mixed reality: spatially stable, interactable, and animated holograms inserted into a 
user’s workspace (See Figure 1).  
 
Figure 1: HoloSIM allows instructors to view a composite video of students interacting 
with the mixed reality learning environment. Follow this link to see a video of a prototype 
HoloSIM mixed reality learning environment (as experienced by a student). 
This permits the augmentation of existing operating rooms and training spaces with 
holographic (i.e. virtual) equipment and patients. In addition, ubiquitous resources such 
as cardiopulmonary resuscitation (CPR) training mannequins may be extended to have 
animations, interactivity, and dynamic visual features as required.  

 
 
 
 
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Figure 2: This image depicts the student’s mixed reality view of a holographic patient with 
the symptoms of anaphylaxis (red facial rash and new wheeze). Breath sounds are 
auscultated by moving a holographic stethoscope over the correct area of the virtual 
patient. Follow this link to see a simulated patient experiencing anaphylaxis. 
Telesimulation capable platforms are defined as being capable of controlling medical 
simulations for education, training, and assessment at off-site locations5.   A wide variety 
of medical emergencies can be initiated using the HoloSIM instructor software, and then 
monitored/controlled from any distance using a high-speed internet connection. There 
are no reports, to our knowledge, of a mixed reality telesimulation-capable platform such 
as HoloSIM. However, the platforms usability, desired frequency and subject matter of 
use, and the barriers to adoption require investigation. 
 
Though infrequent, anaphylaxis is a high risk and complex crisis seen in all acute care 
specialties; this scenario requires a focused examination and rapid decisive action, which 
presents a challenge for trainees6. Failure to effectively identify and treat anaphylaxis can 
lead to severe patient harms. We have therefore selected it as an archetypal medical 
crisis model to test the effectiveness of HoloSIM in learner acquisition of technical and 
nontechnical skills, scenario related declarative knowledge, as well as learner perceptions 
of this novel assessment method. 
Mixed reality technology could potentially create infinite numbers of immersive clinical 
scenarios. By validating its effectiveness as an educational and assessment tool with this 
study we aim to demonstrate its feasibility in enhancing medical education curricula. This 
modality could provide a lower cost learning and assessment platform that can align with 
any context-specific clinical practice and professional development. With the 
telesimulation abilities allowing it to be applied locally and internationally, this solution 
may advance clinical teaching and assessment in a wide-ranging manner. Therefore, the 
use of a mixed reality high fidelity simulation model may allow for significant cost savings 
and increased access to simulation training and evaluation both within, and outside of, 
academic centres. 

 
 
 
 
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Hypothesis/Research Questions: 
 
In this study we propose to refine and evaluate an innovative holographic medical crisis 
simulation technique which can be used both as an assessment tool and for teaching 
technical and nontechnical skills in a novel simulation curriculum.  
 
Two main research questions will be addressed:  
 
1. Does the novel simulation platform have sufficient usability for regular teaching 
and assessment use?  
2. Is a mixed reality simulation platform curriculum non-inferior to the current teaching 
and assessment standard of high-fidelity mannequin-based crisis simulation in 
terms of student acquisition of technical and non-technical skills?  
This study is the first known research initiative aiming to demonstrate that a mixed 
reality simulation training and assessment solution is usable and can improve decision 
making skills and management in a complex crisis scenario. We hypothesize the 
HoloSIM platform is non-inferior to traditional mannequin-based simulation in acquiring 
and assessing technical and non-technical skills in a model life threatening health 
condition (e.g. anaphylaxis).  
Research Design and Methodology 
Platform design: 
We have created the prototype HoloSIM mixed reality simulation platform utilizing an 
iterative development process through resident morning teaching rounds over the past 
year. Immersed in the mixed reality simulations, learners undertake the decision-making 
steps in managing the medical care for a patient with an acute medical crisis. They then 
navigate through the scenarios that—by instructor control—provide feedback depending 
on their actions in the form of either the patient’s hemodynamic changes, verbal prompts 
from the holographic patient in the scenario, or a holographic medical team confederate. 
We have designed the HoloSIM ‘student experience’ for use with typical Hololens controls 
of intuitive hand gestures and directing visual gaze towards holographic areas of interest. 
A limited set of dialogue, facial expressions, animations, clothing, skin visual cues, 
auscultations, physical exam findings, holographic confederates, and patient monitor 
physiologic changes have been incorporated to date. However, the underlying prototype 
program structure has been designed to allow this catalogue to be rapidly and easily 
expanded, allowing the software to be used to simulate a practically limitless variety of 
crisis scenarios.  
 
Overall Experimental Strategy and Workflow: 
The success of this proposal rests on our ability to optimize and adapt the HoloSIM 
platform to educate and assess acute care medical residents; the two research questions 
will be addressed by separate study phases. In the first phase of the study, the focus will 
be on software/scenario development and usability testing of the student and instructor 
experience. In the second study phase the HoloSIM platform will be incorporated into a 

 
 
 
 
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novel anaphylaxis education and assessment curriculum for acute care residents with the 
impact on technical and nontechnical skills, scenario related declarative knowledge, as 
well as learner perceptions of the novel assessment tool evaluated by randomized control 
trial. 
 
First Research Question (Study Phase I): Software/Scenario Development and its 
Usability Evaluation 
 
To address the first research question, throughout the first study phase we will follow best 
practices in software development for optimizing medical education software usability to 
maximize the impact of the final software7. By doing so the project development team will: 
• Ensure participation from all target user groups as both instructors and students.  
• Test usability iteratively and systematically with the product under development, 
not solely with the final product. Testing will occur in situ when possible, within 
unused clinical areas which participants typically use as clinical and teaching 
workspaces. 
• Use a broad representation of participants in terms of technological as well as 
simulation teaching experience.  
 
Upon receiving institutional research ethics approval, an initial two-month piloting period 
will allow the creation of two mixed reality anaphylaxis scenarios. The first scenario will 
be drawn from a recent trial of a telesimulation compatible mannequin based simulation 
system8, which is similar to other anaphylaxis scenarios used in Critical Care, Anesthesia, 
and Emergency Medicine literature9,10,11. The second scenario10 involves different inciting 
events, patient characteristics, hemodynamics, and environmental stimuli. However, the 
same core anaphylaxis management concepts are required. These scenarios will then be 
piloted on medical students, residents, staff anesthesiologists, and other experts in the 
field not involved in the study. 
 
Recruitment and Study Groups: 
Participants from acute care postgraduate training programs at Sunnybrook Health 
Sciences Centre, a tertiary academic institution, will be recruited for 1-hour sessions via 
email invitation. Consent will be obtained via REDCap at the time of recruitment, as well 
as a questionnaire to survey demographic information and previous experience with 
simulation and immersive reality technologies. This will include resident learners of all 
levels, recruited to use the software in the student role while paired with staff physicians 
(i.e. instructors/assessors) from the same specialty using the software in the instructor 
role, drawn together from the same fields of Anesthesiology (Group 1), Internal Medicine 
(Group 2), Critical Care Medicine (Group 3), or Emergency Medicine (Group 4).  
 
Instructors will be informed two weeks in advance that the session content will include 
time for orientation to mixed reality, free experimentation, an anaphylaxis scenario, as 
well as a scenario of their choosing drawn from a study generated database of publicly 
available peer reviewed content within their specialty12,13,14.  
 
Usability evaluation: 

 
 
 
 
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The pairings will use HoloSIM to conduct medical crisis simulations in both a structured 
and unstructured manner. Usability will be assessed in an ethnographic manner15 using 
audio recorded semi-structured interviews with thematic analysis. Usability will also be 
assessed via the System Usability Scale(SUS)16, a widely cited, validated, and industry 
standard Likert scale questionnaire (see Supplementary Figure 4) utilized across a variety 
of software platforms17. No validated tools exist to specifically assess mixed reality 
software, however a comprehensive multidomain Likert questionnaire, will be 
administered (previously developed to assess a mixed reality medical simulation learning 
tool18) to students to delineate factors that enhance or limit learning via the Hololens 2 
headset and HoloSIM. Additional Likert items will assess the participants age, previous 
experience with simulation-based teaching, and their desired frequency of future use of 
the platform. 
 
An iterative process will be undertaken to improve the user experience of participants in 
both the student and instructor roles through the aid of rapid prototyping, each session 
prompting refinement and feature addition both pre and post. Significant feature and crisis 
scenario addition based on user feedback is expected as well as efforts related to 
discovery and remedy of software errors/failures. We expect the final product educational 
and assessment software will provide a unique opportunity for knowledge and skills 
acquisition as well as assessment in a variety of clinically relevant training scenarios. As 
the medium of mixed reality is in its infancy, we will also learn potential accessibility issues 
and barriers to use. 
 
The study team and all academic collaborators are committed to the principles of Free 
and Open Access Medical education (FOAM19) with regards to HoloSIM. All software 
code and resources developed related to this grant will be made freely available via our 
website3 and the software repository github20. This will enable other groups to modify or 
adapt our work as per their needs.  
 
Study conduct and data collection/management: 
A total of 6 sessions within each specialty will be planned (24 sessions with 48 total 
participants), or until interim analysis demonstrates thematic saturation. This is in keeping 
with data demonstrating 5-6 of any type of user is typically enough to reveal 95% of 
usability issues21. 
 
Statistical Analysis: 
SUS and mixed reality specific questionnaire results will be compiled in aggregate and 
descriptive statistics will be presented as frequencies. For the items of the SUS, the score 
will be calculated using Brooke’s standard scoring method16. 
 
Second Research Question (Study Phase II): Evaluation of the novel mixed reality based 
anaphylaxis curriculum as a teaching and assessment tool 
 
In the second study phase the HoloSIM platform will be incorporated into a novel 
anaphylaxis education and assessment curriculum and evaluated by randomized control 
trial. The primary outcome will be the impact on technical and nontechnical skill 

 
 
 
 
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acquisition as assessed by performance checklist; secondary outcomes include the 
scenario related declarative knowledge assessed by multiple choice quiz, as well as 
learner perceptions of the mixed reality assessment tool as measured by questionnaire. 
The nature, timing, and validity of these measurement tools is outlined below. 
 
Recruitment and study workflow: 
Acute care residents will be recruited and consented for a randomized control trial via 
email invitation and REDCap software22. Participants will be asked to complete baseline 
measurements of simulation, anaphylaxis management, and immersive device (virtual 
reality or mixed reality) experience.  
 
Randomization and Study Groups 
Randomization will be accomplished at the time of consent, to one of the two groups: A) 
HoloSIM based simulation (Intervention) or B) mannequin-based simulation (Control). 
Both groups will require students to learn and practice decision-making concepts for the 
management of anaphylaxis using their assigned modality (HoloSIM or traditional 
mannequin). Randomization will be stratified by specialty, as there is a potential for 
training background as a bias. We have chosen not to stratify by training level, due to 
data that both staff physicians and residents of all levels frequently have delayed or 
missed management steps when undergoing anaphylaxis simulations6. 
 
Sample Size Calculation and Feasibility: 
Power analysis was conducted in SealedEnvelope23 running an analysis for continuous 
outcome non-inferiority trial using a power of 0.9, alpha level of 0.05, and standard 
deviation calculated using RevMan24 software from a previous study9 utilizing the same 
anaphylaxis checklist evaluation tool. A non-inferiority limit of 3 out of a possible 45 total 
checklist points, equal to one major checklist criterion, was determined by investigator 
consensus to be significant.  The items on the checklist are similar to those previously 
validated in earlier anaphylaxis simulation studies10,25. The required sample size was 
calculated as 28. We consider this feasible as an estimated 20 new residents rotate 
through the included services each month. To compensate for a 10-20% loss to follow-
up and increased robustness for secondary outcomes, we will recruit a total of 40 
participants (20 in each group) over a period of 12 months. 
 
We have chosen a noninferiority comparison as we believe a finding of comparable 
efficacy for the HoloSIM platform in light of its potential advantages in telesimulation 
capabilities, scenario flexibility of mixed reality, and potential for cost effectiveness would 
be significant. 
 
Study Conduct and Data Collection: 
Group A (Intervention). Participants randomized to Group A will arrive on day 0 to be 
given an orientation to the immersive HoloSIM platform. When they feel accustomed to 
its technical aspects an anaphylaxis management scenario will be initiated10.  
Group B (Control). Participants randomized to Group B will be assigned to mannequin-
based scenario practice, which is the current gold standard in medical education and 

 
 
 
 
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assessment. Similar to the HoloSIM group, participants will arrive on day 0 to be given an 
orientation to the mannequin-based simulation environment so that they feel accustomed 
to its technical aspects. The anaphylaxis management scenario will match the HoloSIM 
environment and sequence of events. 
All participants will receive learning objectives and a handout with educational content 
previously developed by a panel of allergists26 and be asked to review it approximately 
48 hours prior to the intervention simulation session. 
Participants will have access to the same handouts provided at the time on enrollment for 
debriefing after each practice session, as well as an instructor led debrief. All participants 
will then complete a validated assessment of learning satisfaction tool, the Modified 
Simulation Effectiveness Tool (SET-M, see Supplementary Figure 5) 27; if HoloSIM is 
utilized, participants will complete usability questionnaires as in the first study phase.  
 
Study follow-up: 
 We will invite participants to return one month later to assess the impact of the 
intervention with a validated anaphylaxis knowledge test developed by allergists for use 
with the same curriculum included in our study26 and a mannequin-based anaphylaxis 
assessment scenario, the parameters of which were piloted in the first study stage 
utilizing HoloSIM28. Participants from the intervention group (Group A) will be oriented to 
the mannequin simulation environment prior to managing the scenario as they will not 
have had previous exposure to this modality. All participant sessions will be video 
recorded and evaluated by two trained assessors. Scoring of the assessment scenario 
will involve a weighted checklist (See Supplementary Figure 6) of critical events similar 
to other validated anaphylaxis scoring tools10 and used in a previous similar trial28. Scores 
in percentage points will be averaged between assessors, with a significant deviation 
being referred to a third assessor. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 3: Study Design 
 
Study limitations: 
Day 0 
Simulation 
randomization 
48 hours prior 
to Day 0 
Day 30  
Simulation 
Written 
anaphylaxis 
handout 
HoloSIM 
High fidelity 
mannequin 
High fidelity 
mannequin 
Tools Administered: 
SET-M 
SUS 
Tools Administered: 
Anaphylaxis checklist 
Anaphylaxis MCQ 
 
Day 0  
Simulation 

 
 
 
 
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 We understand that participants in Group B (Control) will be learning on and then 
assessed using the same modality (mannequin-based simulation), which creates an 
advantage for these participants. However, practice and assessments cannot be done on 
live patients, and the current gold standard is mannequin-based simulation training. Thus, 
there are no alternatives but to compare HoloSIM to mannequin-based simulation. 
 
We acknowledge that no pretesting will be performed prior to the intervention, this is to 
avoid repeated exposure to anaphylaxis related content immediately prior to the 
intervention. However, we have randomized carefully to avoid bias.    
 
Statistical analysis: 
Demographic characteristics of participants will be summarized with appropriate 
measures of central tendency and dispersion (count/percent for categorical data). The 
mean checklist scores in each group will be presented as mean/standard deviation and 
inferential testing will be done with the t-test. The inter-assessor agreement will be 
measured using the interclass correlation coefficient (ICC). 
I. APPENDICES 
 
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Kurrek MM, Devitt JH. The cost for construction and operation of a simulation 
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2.  
Ormsby M. Royal College CEO apologizes to medical residents for delaying final 
exams | The Star. The Toronto Star. 
https://www.thestar.com/news/canada/2020/04/09/royal-college-ceo-apologizes-
to-medical-residents-for-delaying-final-exams.html. Published April 9, 2020. 
Accessed June 22, 2020. 
3.  
Wiegelmann J. HoloSIM. https://holosim.ca/. Published 2019. Accessed January 
12, 2020. 
4.  
Matys M. Using augmented reality (AR) to train health-care providers from 
virtually anywhere. Your Health Matters. 
http://health.sunnybrook.ca/innovation/augmented-reality-ar-train-medical-
experts/. Published 2019. Accessed January 12, 2020. 
5.  
McCoy CE, Sayegh J, Alrabah R, Yarris LM. Telesimulation: An Innovative Tool 
for Health Professions Education. AEM Educ Train. 2017;1(2):132-136. 
doi:10.1002/aet2.10015 
6.  
Kolawole H, Guttormsen AB, Hepner DL, Kroigaard M, Marshall S. Use of 
simulation to improve management of perioperative anaphylaxis: a narrative 
review. Br J Anaesth. 2019;123(1):e104-e109. doi:10.1016/j.bja.2019.01.035 

 
 
 
 
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7.  
Sandars J, Lafferty N. Twelve Tips on usability testing to develop effective e-
learning in medical education. Med Teach. 2010;32(12):956-960. 
doi:10.3109/0142159X.2010.507709 
8.  
McCoy CE, Sayegh J, Rahman A, Landgorf M, Anderson C, Lotfipour S. 
Prospective Randomized Crossover Study of Telesimulation Versus Standard 
Simulation for Teaching Medical Students the Management of Critically Ill 
Patients. AEM Educ Train. 2017;1(4):287-292. doi:10.1002/aet2.10047 
9.  
McCoy CE, Menchine M, Anderson C, Kollen R, Langdorf MI, Lotfipour S. 
Prospective randomized crossover study of simulation vs. didactics for teaching 
medical students the assessment and management of critically ill patients. J 
Emerg Med. 2011;40(4):448-455. doi:10.1016/j.jemermed.2010.02.026 
10.  McEvoy MD, Hand WR, Furse CM, et al. Validity and reliability assessment of 
detailed scoring checklists for use during perioperative emergency simulation 
training. Simul Healthc. 2014;9(5):295-303. doi:10.1097/SIH.0000000000000048 
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to problem-based learning for the acquisition of critical assessment and 
management skills. Crit Care Med. 2006;34(1):151-157. 
doi:10.1097/01.CCM.0000190619.42013.94 
12.  Journal Information. MedEdPortal - American Association of American Medical 
Colleges. https://www.mededportal.org/about/journalinformation. Published 2020. 
Accessed December 28, 2020. 
13.  Caners K, Kuuskne M. EM Sim Cases - Peer-reviewed simulation cases for 
Emergency Medicine programs available in FOAMed spirit. 
https://emsimcases.com/. Published 2020. Accessed December 28, 2020. 
14.  SIM Scenario Exchange. Simulation Canada. https://www.sim-one.ca/scenario. 
Published 2020. Accessed December 28, 2020. 
15.  Chu A, Biancarelli D, Drainoni ML, et al. Usability of Learning Moment: Features 
of an E-learning Tool That Maximize Adoption by Students. West J Emerg Med. 
2019;21(1):78-84. doi:10.5811/westjem.2019.6.42657 
16.  Brooke J. SUS-A Quick and Dirty Usability Scale. 
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Benchmarks & Best Practices. CreateSpace Independent Publishing Platform; 
2011. 
18.  Ingrassia PL, Mormando G, Giudici E, et al. Augmented Reality Learning 
Environment for Basic Life Support and Defibrillation Training: Usability Study. J 
Med Internet Res. 2020;22(5):e14910. doi:10.2196/14910 

 
 
 
 
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19.  Cadogan M, Thoma B, Chan TM, Lin M. Free Open Access Meducation (FOAM): 
the rise of emergency medicine and critical care blogs and podcasts (2002-2013). 
Emerg Med J. 2014;31(e1):e76-e77. doi:10.1136/emermed-2013-203502 
20.  GitHub: Where the world builds software · GitHub. https://github.com/. Accessed 
December 30, 2020. 
21.  Nielsen J. Usability Engineering. San Francisco, CA, USA: Morgan Kaufmann 
Publishers Inc.; 1994. 
22.  Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research 
electronic data capture (REDCap)-A metadata-driven methodology and workflow 
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2009;42(2):377-381. doi:10.1016/j.jbi.2008.08.010 
23.  Sealed Envelope | Power calculator for continuous outcome non-inferiority trial. 
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29, 2020. 
24.  RevMan Calculator | Cochrane Training. 
https://training.cochrane.org/resource/revman-calculator. Accessed May 29, 2020. 
25.  Morgan PJ, Cleave-Hogg D, Desousa S, Tarshis J. High-Fidelity patient 
simulation: validation of performance checklists. doi:10.1093/bja/aeh081 
26.  Jongco AM, Bina S, Sporter RJ, et al. A Simple Allergist-Led Intervention 
Improves Resident Training in Anaphylaxis. J Allergy. 2016;2016:1-7. 
doi:10.1155/2016/9040319 
27.  Leighton K, Ravert P, Mudra V, Macintosh C. Updating the Simulation 
Effectiveness Tool: Item modifications and reevaluation of psychometric 
properties. Nurs Educ Perspect. 2015;36(5):317-323. doi:10.5480/15-1671 
28.  McCoy CE, Sayegh J, Rahman A, Landgorf M, Anderson C, Lotfipour S. 
Prospective Randomized Crossover Study of Telesimulation Versus Standard 
Simulation for Teaching Medical Students the Management of Critically Ill 
Patients. AEM Educ Train. 2017;1(4):287-292. doi:10.1002/aet2.10047 
29.  Wiegelmann J, Matava C, Mchardy P, et al. DEVELOPMENT OF A HEAD-
MOUNTED HOLOGRAPHIC NEEDLE GUIDANCE SYSTEM FOR ENHANCED 
ULTRASOUND GUIDED REGIONAL ANESTHESIA. In: International Anesthesia 
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Montreal; 2019:951. https://iars.app.box.com/v/AM19AbstractSupplement. 
Accessed May 10, 2020. 
Additional Figures: 
 

 
 
 
 
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Figure 4: System Usability Scale (SUS) 
 
Figure 5: Simulation Effectiveness Tool (SET-M) 
 

 
 
 
 
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Figure 6: Anaphylaxis Checklist of Core Decision Making Steps  
 
1. Score _______ (Out of 45) 
History (10 points) 
❑ Symptom duration [1]  
❑ Inciting factors [2]  
❑ Airway management questions (i.e. sob) [2]  
❑ Other symptoms [1]  
❑ Past medical history [1]  
❑ Medications [1]  
❑ Allergies [2] 
Physical (15 points) 
❑ Airway assessment [3]  
❑ Breath sounds [3]  
❑ Pulse oximetry [3]  
❑ Respiratory rate [2]  
❑ Cardiac exam [1]  
❑ Blood pressure [1]  
❑ Pulse [1]  
❑ Extremity/skin [1] 
Diagnostic evaluation (0 points)  
Management (20 points) 
❑ Epinephrine [3]  
❑ Oxygen (mask or intubation) [3]  
❑ H1 blocker [2]  
❑ H2 blocker [1]  
❑ Steroids [2]  
❑ IV with fluids [3]  
❑ Monitor [1]  
❑ Albuterol nebs [1]  
❑ Observation [1]  
❑ Notify PMD [1]  
❑ Bracelet [1]  
❑ Epi-pen Rx [1]