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AR Vs In-Person Simulation Assessment of Medical Personnel

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ClinicalTrials.gov Identifier: NCT04376255
Recruitment Status : Enrolling by invitation
First Posted : May 6, 2020
Last Update Posted : December 21, 2020
Sponsor:
Information provided by (Responsible Party):
Thomas Caruso, Stanford University

Brief Summary:
In order to improve the quality of care we provide to patients, medical trainees need to experience low incident, high mortality events in a safe learning environment. There is a selection bias for predisposing characteristics of health care providers, as most people who have pursued a career in medicine are motivated to learn how to manage medical emergencies. Resources have been traditionally enabled with conventional simulation centers or mobile simulation units. However, these are costly and difficult to access. The purpose of this study is to evaluate a mixed reality alternative to conventional simulation. The need for this is inherent in becoming a medical provider and use of these resources will improve health practices and health services.

Condition or disease Intervention/treatment Phase
Educational Problems Other: Augmented Reality (AR) Other: Standard In Person Training Simulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Augmented Reality vs In Person Simulation: A Prospective, Randomized, Non-Inferiority Study of Medical Trainees
Actual Study Start Date : August 18, 2020
Estimated Primary Completion Date : August 18, 2021
Estimated Study Completion Date : August 18, 2022

Arm Intervention/treatment
Experimental: Mixed Reality Simulation (Phase 2)
Participants in the experimental arm will be introduced to workplace training modules through an Augmented Reality (AR) headset.
Other: Augmented Reality (AR)
AR headset - 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

Active Comparator: Conventional Simulation (Phase 2)
Participants in the control arm will be introduced to workplace training modules using standard in person training.
Other: Standard In Person Training Simulation
No AR will be used- participants will be trained using standard in person simulation

Active Comparator: Remote Mixed Reality Simulation (Phase 1)
During the initial phase of the study, up to 40 participants will enroll in mixed reality simulation remotely for a qualitative assessment of simulation transcripts
Other: Augmented Reality (AR)
AR headset - 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 Measures :
  1. Qualitative Interview Assessment of Remote Simulations [ Time Frame: (Study-Phase 1) Post-simulation recordings analysis (1-3 months after completing final simulation) ]
    Thematic analysis of the interview transcripts broken down into four domains: experiential satisfaction, learning engagement, technology learning curve, and opportunities for improvement

  2. Anesthetists non-technical skill (ANTS) Assessment [ Time Frame: (Study-Phase 2) Post-simulation recordings analysis (1-3 months after completing final simulation) ]
    Individual improvement in non-technical skills using the Anesthetists non-technical skill (ANTS) assessment within study arms. Individual improvements will also be compared between study arms. (explicitly calling out the construct: behavioral skills, using ANTS as the assessment)


Secondary Outcome Measures :
  1. Behaviorally Anchored Rating System (BARS) Assessment [ Time Frame: (Study-Phase 2) Post-simulation recordings analysis (1-3 months after completing final simulation) ]
    Group improvement in non-technical skills using the behavioral anchored rating scale (BARS) assessment. Group improvements between groups will be compared (scored by video review).

  2. Time to first compression (measured in seconds) [ Time Frame: (Study-Phase 2) Post-simulation recordings analysis (1-3 months after completing final simulation) ]
    Mean time to first compression will be compared between groups (scored by video review).

  3. Positive and Negative Affect Schedule [ Time Frame: (Study-Phase 2) Duration of the simulation interventions (1-3 days) ]
    Factors that predict primary aim will be explored with a multivariate analysis of demographics and mood, measured with the PANAS.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Trainees or personnel working and/or volunteering at Lucile Packard Children's Hospital Stanford / Stanford Health Care facilities
  • 18 years and older

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04376255


Locations
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United States, California
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States, 94303
Sponsors and Collaborators
Stanford University
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Responsible Party: Thomas Caruso, Clinical Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT04376255    
Other Study ID Numbers: 55657
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Caruso, Stanford University:
Augmented Reality
Simulation
Education