Prehospital Provider Training With Augmented Reality (AR)

Sponsor

Thomas Caruso (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05686590

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal is to evaluate the acceptance of Augmented Reality (AR) simulation as a learning modality for prehospital providers. The simulation itself is grounded in traditional best practices for simulation delivery and design as well as prior literature on simulation training for prehospital providers; the focus of this study is the participants' experiential interaction with AR and the simulation resources.

Condition or Disease	Intervention/Treatment	Phase
Hypoglycemia Pediatric ALL	Behavioral: Augmented Reality Headset	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Prehospital Provider Training Using Augmented Reality Simulation: A Mixed-Methods Study

Actual Study Start Date :

Dec 12, 2022

Anticipated Primary Completion Date :

Dec 12, 2023

Anticipated Study Completion Date :

Dec 12, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Augmented Reality Enhanced Simulation (Treatment group) Each simulation will have between two and five participants. After consent, demographic data will be collected. Then, a study RA will fit a Magic Leap One (ML1) headsets (Magic Leap Inc., Plantation, FL) to participants. Following a scripted briefing, the instructor will also orient the participants to the ML1 headset for those in that group. After orienting the participant to the use of the headsets, the instructor will remain in a room separate from the participants, who will conduct the scenario outside. This will enable assessment of the feasibility of providing simulation instruction remotely. Prior to starting the scenario, the simulation instructor will conduct an orientation to review the core tenets of effective communication skills during prehospital care.	Behavioral: Augmented Reality Headset The simulation scenario will be a pediatric hypoglycemia-induced seizure case, which will be done through an AR simulation. AR (Augmented Reality) headset, which is a device that the participants will wear over their head and eyes and will add holographic elements to a live view of workplace training scenario.

Arm

Intervention/Treatment

Experimental: Augmented Reality Enhanced Simulation (Treatment group)

Each simulation will have between two and five participants. After consent, demographic data will be collected. Then, a study RA will fit a Magic Leap One (ML1) headsets (Magic Leap Inc., Plantation, FL) to participants. Following a scripted briefing, the instructor will also orient the participants to the ML1 headset for those in that group. After orienting the participant to the use of the headsets, the instructor will remain in a room separate from the participants, who will conduct the scenario outside. This will enable assessment of the feasibility of providing simulation instruction remotely. Prior to starting the scenario, the simulation instructor will conduct an orientation to review the core tenets of effective communication skills during prehospital care.

Behavioral: Augmented Reality Headset

The simulation scenario will be a pediatric hypoglycemia-induced seizure case, which will be done through an AR simulation. AR (Augmented Reality) headset, which is a device that the participants will wear over their head and eyes and will add holographic elements to a live view of workplace training scenario.

Outcome Measures

Primary Outcome Measures

Thematic Analysis of Post-Simulation Discussions [Duration of post-simulation debrief (15-20 minutes)]
The primary aim is to study the acceptance of AR simulation amongst prehospital providers via thematic analysis of semi-structured discussions using qualitative research methods.

Secondary Outcome Measures

System Usability Scale (SUS) [Duration of Intervention (less than one hour)]
The first secondary aim is to evaluate AR simulation usability amongst prehospital providers via the System Usability Scale (SUS).
Headset Ergonomics [Duration of Intervention (less than one hour)]
The final secondary aim will evaluate the ergonomics of the headset via the ISO 9241-400 assessment of human-ergonomic factors.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Trainees/ faculty working and/or volunteering at LPCH/SHC facilities as well as community based prehospital providers
18 years and older

Exclusion Criteria:

Participants who do not consent
Have a history of severe motion sickness
Currently have nausea
History of seizures
Are clinically unstable
Currently using corrective glasses (not compatible with AR headset)
Currently pregnant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mountain View Fire Department	Mountain View	California	United States	94041
2	Lucile Packard Children's Hospital at Stanford	Palo Alto	California	United States	94305

Sponsors and Collaborators

Thomas Caruso

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thomas Caruso, Clinical Professor, Stanford University

ClinicalTrials.gov Identifier:

NCT05686590

Other Study ID Numbers:

67544

First Posted:

Jan 17, 2023

Last Update Posted:

Jan 17, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypoglycemia

Study Results

No Results Posted as of Jan 17, 2023