Back to resultsPrehospital Provider Training With Augmented Reality (AR)
Primary Purpose
Hypoglycemia, Pediatric ALL
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Augmented Reality Headset
Sponsored by
About this trial
This is an interventional treatment trial for Hypoglycemia
Eligibility Criteria
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
Sites / Locations
- Mountain View Fire Department
- Lucile Packard Children's Hospital at Stanford
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Augmented Reality Enhanced Simulation (Treatment group)
Arm Description
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.
Outcomes
Primary Outcome Measures
Thematic Analysis of Post-Simulation Discussions
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)
The first secondary aim is to evaluate AR simulation usability amongst prehospital providers via the System Usability Scale (SUS).
Headset Ergonomics
The final secondary aim will evaluate the ergonomics of the headset via the ISO 9241-400 assessment of human-ergonomic factors.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05686590
Brief Title
Prehospital Provider Training With Augmented Reality (AR)
Official Title
Prehospital Provider Training Using Augmented Reality Simulation: A Mixed-Methods Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 12, 2022 (Actual)
Primary Completion Date
December 12, 2023 (Anticipated)
Study Completion Date
December 12, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas Caruso
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoglycemia, Pediatric ALL
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Augmented Reality Enhanced Simulation (Treatment group)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Augmented Reality Headset
Intervention Description
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.
Primary Outcome Measure Information:
Title
Thematic Analysis of Post-Simulation Discussions
Description
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.
Time Frame
Duration of post-simulation debrief (15-20 minutes)
Secondary Outcome Measure Information:
Title
System Usability Scale (SUS)
Description
The first secondary aim is to evaluate AR simulation usability amongst prehospital providers via the System Usability Scale (SUS).
Time Frame
Duration of Intervention (less than one hour)
Title
Headset Ergonomics
Description
The final secondary aim will evaluate the ergonomics of the headset via the ISO 9241-400 assessment of human-ergonomic factors.
Time Frame
Duration of Intervention (less than one hour)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Mountain View Fire Department
City
Mountain View
State/Province
California
ZIP/Postal Code
94041
Country
United States
Facility Name
Lucile Packard Children's Hospital at Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prehospital Provider Training With Augmented Reality (AR)
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