Assessing Mixed Reality for Emergency Medical Care Delivery in a Simulated Environment

Not Applicable

Completed

• Conditions: Emergency Medicine
• Interventions: Device: HoloLens2TM; Other: Standard care

• Registration Number: NCT05870137
• Lead Sponsor: Imperial College London

Brief Summary

This study assessed the feasibility and effectiveness of using Mixed Reality (MR) through the use of HoloLens2TM technology to enhance emergency clinical care delivery in a simulated environment. This was achieved by inviting 22 resident grade doctors to complete two scenarios. Each scenario was supported either by standard care methods or Mixed reality. The participants were randomised to at the start of the scenarios to determine which support they would receive first. The main outcome was to see if there was difference in error rates. This was assessed using the ICECAP multidimensional error capture tool. Secondary outcomes included teamwork, scenario completion, stress/cognitive load, and Mixed reality device user acceptability.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-17
• Primary Completion: 2021-11-26
• Study Completion: 2021-11-26
• Status Verified: 2023-05
• Study First Submitted: 2023-05-03
• Study First Submitted QC: 2023-05-11
• Last Update Submitted: 2023-05-11
• Study First Posted: 2023-05-23
• Last Update Posted: 2023-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• All participants must provide consent to participate in the study
• Participants must receive a standardised HL2 headset and operational tutorial
• Participants must complete a qualitative questionnaire to determine their clinical experience and exposure to the technology prior to commencement of the study
• Participants must pass a competency test to ensure standardised basic technical competency and mitigate device related first-use learning effects

Exclusion Criteria

• Not currently working in emergency medicine/trauma setting
• No prior course completion (Advance trauma and Basic Life support)

Prior to the commencement of the study, all eligible participants were required to provide their consent to participate. Participants were then provided with a standardized HL2 headset and operational tutorial, and completed a qualitative questionnaire to assess their clinical experience and exposure to the technology. The tutorial, which was guided by the research team, included a practical induction providing fundamentals of use, how to make and receive calls, and how to use the clinical data assets provided. Participants were also required to pass a competency test to ensure standardized basic technical competency and mitigate device-related first-use learning effects.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mixed reality - HoloLens2TM Supported care	HoloLens2TM	HL2 supported care made all of these resources available through interaction with the HL2 device. Participants had access to all resources through the Mixed reality device (HoloLens2). Access to senior support through using the HL2 device.
Standard care	Standard care	Standard care was delivered by the participants with access to didactic instruction and telephonic support. Participants had access to all resources through standard ward base computer systems. Access to senior support through telephone call using a bleep/on call system standard to practice within the institution.

Primary Outcome Measures

Name	Time	Method
Error Rate	Through study completion, an average of 8 minutes per scenario	The primary outcome measure for this study was the error rate, which was assessed using the ICECAP tool (Imperial College Error CAPture). This is a validated, multidimensional tool that assesses errors across several domains, including equipment, communication, technical aspects, patient-related factors, procedure-independent pressures, and a category for capturing any other errors that are not specified. Using the ICECAP tool provides a comprehensive assessment of errors and allows for identifying areas of improvement across multiple domains. Each time an error is observed the participant is attributed 1 score per error within the respective category. The total number of errors is accumulated throughout completion of the scenario. The error is reported as a sum of the total errors observed, as well as per category to determine if there is any specific areas that error rate is impacted.

Secondary Outcome Measures

Name	Time	Method
Scenario completion success	Through study completion, an average of 8 minutes per scenario	The secondary outcome measure was the successful completion of the clinical scenario. This was determined by the simulation team assessing whether the participant was able to successfully insert the chest drain and complete a life-saving intervention in the simulated environment. If the participant was unable to appropriately insert the chest drain, this was considered an adverse outcome for the simulated patient, and thus the scenario was deemed unsuccessful.
Team performance	Through study completion, an average of 8 minutes per scenario	The T-SAW-C Tool (Teamwork Skills Assessment for Ward Care) was used by observers to assess teamwork during the simulated scenarios. This tool measures various aspects of teamwork, such as communication, coordination, and cooperation, and has been validated for use in healthcare settings. By including this information, it clarifies the measurement tool being used to assess the specific outcome measure of interest.
Team workload	Through study completion, an average of 8 minutes per scenario	The NASA Task Load Index (TLX) is a subjective multidimensional assessment tool that rates perceived workload in order to assess a task, system, or team's effectiveness or other aspects of performance. It uses a Likert scale with six domains, each attributed a weight ranging from 0 to 5. The scale ratings are scored based on where the user marked the scale. Tick marks range from 0 to 100 by 5 point increments, and scores are given for the tick at or immediately above the mark. Higher scores indicate a greater perceived workload.
Scenario completion duration	Through study completion, an average of 8 minutes per scenario	The secondary outcome measure was the time taken to complete the clinical scenario. This was recorded by the simulation team from the initiation of the scenario to the successful completion, which involved both the insertion of the chest drain and the completion of the intervention. If the participant expressed their desire to discontinue the intervention, this was also recorded as the endpoint of the scenario.

Trial Locations

Locations (1)

Department of Surgery and Cancer Imperial College London; 🇬🇧 London, United Kingdom