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The Holographic Standardized Patient

Primary Purpose

Medical Emergencies, Educational Problems, Simulation of Physical Illness

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
HoloSIM Software via Hololens 2
Training by Mannequin Based Simulation
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Medical Emergencies focused on measuring Mixed Reality, Augmented Reality, Medical Simulation, Hololens

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A: HoloSIM (intervention)

Group B: Mannequin (control)

Arm Description

Training by Mixed Reality Simulation

Training by Mannequin Based Simulation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Modified Simulation Effectiveness Tool (SET-M)
likert scale (3 point) validated assessment of learning satisfaction tool
Time required to complete critical crisis related tasks
Measured time until critical scenario management events occur
anaphylaxis knowledge test
validated multiple choice quiz of anaphylaxis knowledge developed by allergists for use with the same curriculum included in our study

Full Information

First Posted
January 6, 2023
Last Updated
February 6, 2023
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05729802
Brief Title
The Holographic Standardized Patient
Official Title
The Holographic Standardized Patient: Using Mixed Reality to Reduce Barriers to Crisis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medical Emergencies, Educational Problems, Simulation of Physical Illness
Keywords
Mixed Reality, Augmented Reality, Medical Simulation, Hololens

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: HoloSIM (intervention)
Arm Type
Experimental
Arm Description
Training by Mixed Reality Simulation
Arm Title
Group B: Mannequin (control)
Arm Type
Active Comparator
Arm Description
Training by Mannequin Based Simulation
Intervention Type
Device
Intervention Name(s)
HoloSIM Software via Hololens 2
Intervention Description
Participants will train via a mixed reality simulated crisis scenario using the HoloSIM software on the Microsoft Hololens 2
Intervention Type
Other
Intervention Name(s)
Training by Mannequin Based Simulation
Intervention Description
Participants will train a via traditional mannequin based medical crisis scenario
Primary Outcome Measure Information:
Title
Anaphylaxis Checklist of Core Decision Making Steps
Description
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.
Time Frame
30 days post exposure
Secondary Outcome Measure Information:
Title
System Usability Scale (SUS)
Description
Likert scale (5 point) based assessment of software usability. Higher scores on a scale of 1 to 5 represent a better software system usability.
Time Frame
Immediately after exposure
Title
Modified Simulation Effectiveness Tool (SET-M)
Description
likert scale (3 point) validated assessment of learning satisfaction tool
Time Frame
Immediately after exposure
Title
Time required to complete critical crisis related tasks
Description
Measured time until critical scenario management events occur
Time Frame
30 days post exposure
Title
anaphylaxis knowledge test
Description
validated multiple choice quiz of anaphylaxis knowledge developed by allergists for use with the same curriculum included in our study
Time Frame
30 days post exposure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julian Wiegelmann, Dr.
Organizational Affiliation
Sunnybrook Health Science Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4E 3M4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
For confidentiality purpose, Participants personal information will not be shared, and any study data that will be sent outside of the research institution will be encrypted by an ID code for each participant.
IPD Sharing 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.
IPD Sharing Access Criteria
After publication

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The Holographic Standardized Patient

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