The Holographic Standardized Patient

Sponsor
Sunnybrook Health Sciences Centre (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05729802
Collaborator
(none)
40
1
2
16
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: HoloSIM Software via Hololens 2
  • Other: Training by Mannequin Based Simulation
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Holographic Standardized Patient: Using Mixed Reality to Reduce Barriers to Crisis
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A: HoloSIM (intervention)

Training by Mixed Reality Simulation

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

Active Comparator: Group B: Mannequin (control)

Training by Mannequin Based Simulation

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. Modified Simulation Effectiveness Tool (SET-M) [Immediately after exposure]

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

  3. Time required to complete critical crisis related tasks [30 days post exposure]

    Measured time until critical scenario management events occur

  4. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4E 3M4

Sponsors and Collaborators

  • Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Julian Wiegelmann, Dr., Sunnybrook Health Science Centre

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT05729802
Other Study ID Numbers:
  • 3777
First Posted:
Feb 15, 2023
Last Update Posted:
Feb 15, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sunnybrook Health Sciences Centre
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 15, 2023