Pandemic-Proofing Simulation-based Education

COVID 19 Clinical Trial

Official title:

Pandemic-Proofing Simulation-based Education: Development and Evaluation of Interactive Virtual Educational Content for Medical Trainees

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05931679
• Other study ID #: 20210197-01H
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2023
• Est. completion date: December 2025

Study information

• Verified date: June 2023
• Source: Ottawa Hospital Research Institute
• Contact: Glenn Posner
• Phone: 613-737-8899
• Email: gposner[@]toh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal is to develop and evaluate two VR simulations (interactive VR, 3600 video) applied to the context of Emergency Medicine. The aim of this pilot study is to develop two VR simulations, and to compare their effectiveness with traditional theatre-based simulations.

Primary Objectives: to compare knowledge retention and application of knowledge during emergency crisis scenarios following VR-360, interactive VR and theatre-based simulation sessions.

Secondary Objectives: to assess the usability and feasibility (resources), as well as the emotional engagement, of the above three modalities.

Description:

Phase 1: Creation of Content: A software engineer with expertise in video-game development will be hired to develop the computer-generated emergency department in collaboration with the educators and clinicians on the team. A theatre-based trauma scenario from the current uOttawa Emergency Department curriculum will be adapted to the VR platform. This virtual environment will allow a team of students to manage a patient simultaneously through their avatars, from a first-person perspective. In parallel, the same scenario will be scripted, in all its permutations, and recorded using a 360-degree HD video camera. The recording will be made using the investigators as actors, with additional interprofessional volunteers recruited as needed. These videos will be edited and then converted to an application that can be uploaded to the Oculus platform. Both platforms will undergo piloting for content and usability. The amount of time, money and other resources required to develop each of these scenarios will be calculated.

Phase 2: Evaluating the intervention:

Pre-test: Prior to participating in one of the 3 educational interventions, participants will complete a pre-test of their content-specific knowledge and knowledge application with respect to trauma resuscitation. As well, they will participate in a video-recorded in-situ simulation of a trauma resuscitation. Team performance will be recorded for subsequent scoring (see measures and analysis section below). During the in-situ sessions, the investigators will measure the learners' heart rate (HR) and heart rate variability (HRV) with the use of a Polar H10 chest belt linked with a commercial capture and analysis software program on an iPad. This will allow us to measure both arousal and stress responses, as physiological indication of the learners' emotional engagement.

Intervention: Following the pre-test, residents will either participate in the interactive VR, the 360o video or the in-person theatre-based simulation sessions.

Post-test. Two weeks after the education session, all participants will complete a post-test of their knowledge and knowledge application (matched in difficulty with pre-test), as well as lead an in-situ simulated trauma resuscitation. The sessions will be videotaped for subsequent rating of clinical and team performance.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Participants will be residents or medical students

Exclusion Criteria:

Anyone who is not a resident or medical student

Related Conditions & MeSH terms

• COVID 19

Intervention

Device:
• VR Headset
A VR headset will be used for participants in the Interactive VR and 360 degree video groups.

Other:
• Traditional Theatre-based simulation
Traditional theatre-based simulation sessions require the physical presence of interdisciplinary groups of learners caring for a physical mannequin-based patient, where social distancing is challenging.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Sunnybrook Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measures will be changes in knowledge and in clinical performance from pre-test to post-test.	Two experienced trauma resuscitation instructors will view and score the videos independently, blinded to the group allocation and whether the scenario is pre or post the intervention. The raters will evaluate the learners using the Ottawa Global Rating Scale which is a 7 point anchored ordinal scale for performance in five major categories of Crisis Resource Management (CRM) and an overall performance. The score provides 12 items in five category of CRM with a maximum score of 30 points. The higher the number of points, the "better" the individual's performance (better outcome).	Two weeks, will be done prior to post-test of knowledge and Knowledge application
Secondary	Mean heart rate (HR)	The investigators will compare arousal levels between the 3 experimental conditions (interactive VR, 360o video, theatre-based) by heart rate monitoring. Continuous heart rate (R-R intervals) will be measured with the POLAR® H10 device, a non-invasive chest strap with a transducer worn directly against the sternum paired with a smart device application (EliteHRV). The participants heart rate will be recorded for 5 minutes prior to start of each scenario (Pre-scenario - to capture anticipatory stress responses), for the duration of the debriefing (divided into sequential 5 min periods), for the duration of the post-test (divided into sequential 5 min periods]. For each participant, the investigators will analyse the participant's mean heart rate (averaged over each measured time period)..	During the simulation sessions, throughout the study: 5 minutes prior to start of each scenario, for the duration of each scenario, for the duration of the debriefing, for the duration of the post-test over a 2 week period
Secondary	Peak heart rate (HR)	The investigators will compare arousal levels between the 3 experimental conditions (interactive VR, 360o video, theatre-based) by heart rate monitoring. Continuous heart rate (R-R intervals) will be measured with the POLAR® H10 device, a non-invasive chest strap with a transducer worn directly against the sternum paired with a smart device application (EliteHRV). The participants heart rate will be recorded for 5 minutes prior to start of each scenario (Pre-scenario - to capture anticipatory stress responses), for the duration of the debriefing, for the duration of the post-test. For each participant, the investigators will analyse the participant's peak heart rate over each time period.	During the simulation sessions, throughout the study: 5 minutes prior to start of each scenario, for the duration of each scenario, for the duration of the debriefing, for the duration of the post-test over a 2 week period
Secondary	Heart rate variability - rMSSD	The investigators will compare individual stress scores between the 3 experimental conditions (interactive VR, 360o video, theatre-based) by heart rate variability (HRV) monitoring. Continuous heart rate (R-R intervals) will be measured with the POLAR® H10 device, a non-invasive chest strap with a transducer worn directly against the sternum paired with a smart device application (EliteHRV). The participants HRV will be recorded for 5 minutes prior to start of each scenario (Pre-scenario - to capture anticipatory stress responses), for the duration of the debriefing (divided into sequential 5 min periods), for the duration of the post-test (divided into sequential 5 min periods]. For each participant, the investigators will analyse the participant's root mean square of successive R-R interval differences (rMSSD).	During the simulation sessions, throughout the study: 5 minutes prior to start of each scenario, for the duration of each scenario, for the duration of the debriefing, for the duration of the post-test
Secondary	Heart rate variability - pNN50	The investigators will compare individual stress scores between the 3 experimental conditions (interactive VR, 360o video, theatre-based) by heart rate variability (HRV) monitoring. Continuous heart rate (R-R intervals) will be measured with the POLAR® H10 device, a non-invasive chest strap with a transducer worn directly against the sternum paired with a smart device application (EliteHRV). The participants HRV will be recorded for 5 minutes prior to start of each scenario (Pre-scenario - to capture anticipatory stress responses), for the duration of the debriefing (divided into sequential 5 min periods), for the duration of the post-test (divided into sequential 5 min periods]. For each participant, the investigators will analyse the participant's percentage of successive R-R intervals that differ by more than 50Ms (pNN50).	During the simulation sessions, throughout the study: 5 minutes prior to start of each scenario, for the duration of each scenario, for the duration of the debriefing, for the duration of the post-test over a 2 week period