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NCT Number: NCT05729802

The Holographic Standardized Patient

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.

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Key information

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4E 3M4, Canada

Location status: Recruiting

Location contact

Julian R Wiegelmann, MD

CONTACT

[email protected]

416-480-4864

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HoloSIM Software via Hololens 2

Device

Participants will train via a mixed reality simulated crisis scenario using the HoloSIM software on the Microsoft Hololens 2

Training by Mannequin Based Simulation

Other

Participants will train a via traditional mannequin based medical crisis scenario

Primary outcomes

  1. Anaphylaxis Checklist of Core Decision Making Steps

    Time frame: 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 outcomes

  1. System Usability Scale (SUS)

    Time frame: 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.

  2. Modified Simulation Effectiveness Tool (SET-M)

    Time frame: Immediately after exposure

    likert scale (3 point) validated assessment of learning satisfaction tool

  3. Time required to complete critical crisis related tasks

    Time frame: 30 days post exposure

    Measured time until critical scenario management events occur

  4. anaphylaxis knowledge test

    Time frame: 30 days post exposure

    validated multiple choice quiz of anaphylaxis knowledge developed by allergists for use with the same curriculum included in our study

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Feb 15, 2023
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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