The Holographic Standardized Patient

Study Overview
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Brief Summary
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The current pandemic has revealed in-person simulation training and evaluation is vulnerable to disruption, and alternatives are needed which allow remote evaluation. The recently developed Microsoft Hololens headset device allows interactable holograms to be inserted into a user's workspace (mixed reality) - permitting the augmentation of existing clinical and training spaces with holographic (i.e. virtual) patients via the prototype HoloSIM software. This study is the first known research initiative aiming to demonstrate the feasibility and effectiveness of mixed reality for acute medicine training and assessment at a distance. Space, time, personnel, pandemic, and cost constraints limit opportunities for high-fidelity simulation exercises for post-graduate trainees at Sunnybrook. By developing and demonstrating the effectiveness of this new training modality, increased simulation exercises will lead to a higher quality education experience, better functioning teams, and better patient outcomes.

Detailed Description
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The study is the first known research initiative aiming to demonstrate that a mixed reality simulation training and assessment modality can be implemented in different clinical contexts and can improve decision making skills and management in a complex crisis scenario. The investigators hypothesize that a mixed reality simulation training solution is usable, feasible, and can improve decision making skills and management. It is a two stage study: 1) iteratively develop and usability test the HoloSIM software with acute care medicine specialties at Sunnybrook, and 2) determine if the HoloSIM platform is non-inferior to the current teaching and assessment standard of high-fidelity mannequin-based crisis simulation. The understanding is that this will be a first-of-its-kind study that will generate an accessible, easy to administer tool to educate residents and fellows. The presented HoloSIM software will allow teams to practice and assess their responses to a variety of scenarios in clinical environments such as the trauma bay and ICU. This has the potential to improve team function and enhance quality of care across the healthcare system. Healthcare facilities without expensive simulation centres are unable to participate in high-fidelity medical simulation. Inequities in access to high quality training and professional development have been repeatedly cited as a barrier to retention of rural health care providers. The SHSC simulation centre will adapt this approach and offer training at a distance and medical crisis coaching to rural health care providers utilizing the this mentioned platform. Lastly, all simulation resources developed during the project will be made freely available via the project website. Other institutions internationally may use them to improve their team performance, patient safety, and postgraduate education programs.

Official Title
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The Holographic Standardized Patient: Using Mixed Reality to Reduce Barriers to Crisis

Conditions
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Medical Emergencies, Educational Problems, Simulation of Physical Illness

Intervention / Treatment
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* Device: HoloSIM Software via Hololens 2
* Other: Training by Mannequin Based Simulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Resident or fellow level volunteers from acute care postgraduate training programs (Internal Medicine, Emergency Medicine, Anesthesiology, Critical Care Medicine at Sunnybrook Health Sciences Centre Exclusion Criteria: Unwilling to enter the study Previous experience with simulator based teaching on anaphylaxis

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: It is a two stage study that will: 1) iteratively develop and usability test the HoloSIM software with acute care medicine specialties at Sunnybrook, and 2) determine if the HoloSIM platform is non-inferior to the current teaching and assessment standard of high-fidelity mannequin-based crisis simulation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: HoloSIM (intervention)<br>Training by Mixed Reality Simulation | Device: HoloSIM Software via Hololens 2<br>* Participants will train via a mixed reality simulated crisis scenario using the HoloSIM software on the Microsoft Hololens 2<br>|
| Active Comparator: Group B: Mannequin (control)<br>Training by Mannequin Based Simulation | Other: Training by Mannequin Based Simulation<br>* Participants will train a via traditional mannequin based medical crisis scenario<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anaphylaxis Checklist of Core Decision Making Steps | Expert consensus based checklists of critical scenario actions on a mannequin based crisis scenario. Student scenario performance graded from 0 to 45, with higher scores representing a better performance. | 30 days post exposure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System Usability Scale (SUS) | Likert scale (5 point) based assessment of software usability. Higher scores on a scale of 1 to 5 represent a better software system usability. | Immediately after exposure | 
| Modified Simulation Effectiveness Tool (SET-M) | likert scale (3 point) validated assessment of learning satisfaction tool | Immediately after exposure | 
| Time required to complete critical crisis related tasks | Measured time until critical scenario management events occur | 30 days post exposure | 
| anaphylaxis knowledge test | validated multiple choice quiz of anaphylaxis knowledge developed by allergists for use with the same curriculum included in our study | 30 days post exposure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mixed Reality, Augmented Reality, Medical Simulation, Hololens