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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05729802
Other study ID # 3777
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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