The Holographic Standardized Patient

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Educational Problems; Simulation of Physical Illness; Medical Emergencies
• Intervention / Treatment: Device: HoloSIM Software via Hololens 2; Other: Training by Mannequin Based Simulation

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4E 3M4
      • Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: January 6, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Augmented Reality; Medical Simulation; Mixed Reality; Hololens
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 3777

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No