The Holographic Standardized Patient

NCT05729802 | Recruiting

• 1 other identifier: 3777
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Medical Emergencies; Educational Problems; Simulation of Physical Illness

Keywords

Mixed Reality; Augmented Reality; Medical Simulation; Hololens

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• System Usability Scale (SUS)

  Immediately after exposure

• Modified Simulation Effectiveness Tool (SET-M)

  Immediately after exposure

• Time required to complete critical crisis related tasks

  30 days post exposure

• anaphylaxis knowledge test

  30 days post exposure

Study Arms (2)

Group A: HoloSIM (intervention)

EXPERIMENTAL

Training by Mixed Reality Simulation

Device: HoloSIM Software via Hololens 2

Group B: Mannequin (control)

ACTIVE COMPARATOR

Training by Mannequin Based Simulation

Other: Training by Mannequin Based Simulation

Interventions

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

Group A: HoloSIM (intervention)

Training by Mannequin Based Simulation OTHER

Participants will train a via traditional mannequin based medical crisis scenario

Group B: Mannequin (control)

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Resident or fellow level volunteers from acute care postgraduate training programs (Internal Medicine, Emergency Medicine, Anesthesiology, Critical Care Medicine at Sunnybrook Health Sciences Centre

You may not qualify if:

• Unwilling to enter the study
• Previous experience with simulator based teaching on anaphylaxis

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4E 3M4, Canada

RECRUITING

Study Officials

• Julian Wiegelmann, Dr.

  Sunnybrook Health Science Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: February 15, 2023
• Study Start: March 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: April 1, 2026
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data will become available only after publication in a Peer reviewed medical journal and will follow the paper's policy regarding the specific limit time to remain public.
• Access Criteria: After publication

Locations

CA (1)