The Holographic Standardized Patient

Educational Problems Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05729802
• Other study ID #: 3777
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: February 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Educational Problems
• Emergencies
• Medical Emergencies
• Simulation of Physical Illness

Intervention

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

Other:
• Training by Mannequin Based Simulation
Participants will train a via traditional mannequin based medical crisis scenario

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Modified Simulation Effectiveness Tool (SET-M)	likert scale (3 point) validated assessment of learning satisfaction tool	Immediately after exposure
Secondary	Time required to complete critical crisis related tasks	Measured time until critical scenario management events occur	30 days post exposure
Secondary	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