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Recruiting NCT05729802

The Holographic Standardized Patient

No phase Interventional Medical Emergencies Educational Problems Simulation of Physical Illness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HoloSIM Software via Hololens 2, Training by Mannequin Based Simulation.
Who it may be relevant to
Registry conditions: Medical Emergencies, Educational Problems, Simulation of Physical Illness. Basic parameters: 20 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Anaphylaxis Checklist of Core Decision Making Steps [Time frame: 30 days post exposure]
Secondary outcome measures (4)
  • System Usability Scale (SUS) [Time frame: Immediately after exposure]
  • Modified Simulation Effectiveness Tool (SET-M) [Time frame: Immediately after exposure]
  • Time required to complete critical crisis related tasks [Time frame: 30 days post exposure]
  • anaphylaxis knowledge test [Time frame: 30 days post exposure]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Canada · 1 center
  • Sunnybrook Health Sciences Centre — Toronto

Identifiers

NCT: NCT05729802 · 3777

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗