The Holographic Standardized Patient

Not Applicable

Recruiting

• Conditions: Educational Problems; Medical Emergencies; Simulation of Physical Illness
• Interventions: Other: Training by Mannequin Based Simulation; Device: HoloSIM Software via Hololens 2

• Registration Number: NCT05729802
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-01-06
• Study First Submitted QC: 2023-02-06
• Study First Posted: 2023-02-15
• Study Start: 2023-03-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Primary Completion: 2025-09-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B: Mannequin (control)	Training by Mannequin Based Simulation	Training by Mannequin Based Simulation
Group A: HoloSIM (intervention)	HoloSIM Software via Hololens 2	Training by Mixed Reality Simulation

Primary Outcome Measures

Name	Time	Method
Anaphylaxis Checklist of Core Decision Making Steps	30 days post exposure	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada