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

NCT05870137 | Completed

• 1 other identifier: 21SM6714
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergency Medicine

Outcome Measures

Primary Outcomes (1)

• Error Rate

  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.

  Through study completion, an average of 8 minutes per scenario

Secondary Outcomes (5)

• Scenario completion success

  Through study completion, an average of 8 minutes per scenario

• Scenario completion duration

  Through study completion, an average of 8 minutes per scenario

• Team performance

  Through study completion, an average of 8 minutes per scenario

• Team performance

  Through study completion, an average of 8 minutes per scenario

• Team workload

  Through study completion, an average of 8 minutes per scenario

Study Arms (2)

Standard care

ACTIVE COMPARATOR

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.

Other: Standard care

Mixed reality - HoloLens2TM Supported care

EXPERIMENTAL

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.

Device: HoloLens2TM

Interventions

HoloLens2TM DEVICE

Participants assigned to Mixed Reality-supported care used the HoloLens2 device, which provided support using technology that was permitted by the device. This support included remote assistance and holographic versions of patient-specific investigation results, such as radiological findings, biochemistry, and guidelines for completing the procedure (insertion of chest drain).

Mixed reality - HoloLens2TM Supported care

Standard care OTHER

The standard care for the intervention involved participants performing the invasive technical procedure to treat a tension pneumothorax using their standard clinical skills and knowledge, without the aid of the HoloLens2 device. The participants in the standard care group did not receive any additional support or guidance beyond what is typically available in a clinical setting. The goal of the study was to compare the effectiveness of the standard care approach with the use of Mixed Reality-supported care using the HoloLens2 device.

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Department of Surgery and Cancer Imperial College London

London, W2 1NY, United Kingdom

Location

Related Publications (1)

• Lawson J, Martin G, Guha P, Gold M, Nimer A, Syed S, Kinross J. Effect of Mixed Reality on Delivery of Emergency Medical Care in a Simulated Environment: A Pilot Randomized Crossover Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2330338. doi: 10.1001/jamanetworkopen.2023.30338.

  PMID: 37639272 DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• James Kinross, PhD FRCS

  Senior Lecturer in Surgery and Consultant Surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To ensure masking in this clinical trial, the intervention sequence was randomized for each participant, and the assessors were kept blinded to the sequence. The assessors were not informed about which intervention was provided to each participant or which arm of the study each participant completed first. The trial achieved masking by randomly allocating participants to either the control or intervention groups and further by anonymizing the data after capturing the sequence, prior to releasing it to the outcome assessors. This approach ensured that the assessors were not biased in their assessments and were unaware of which intervention was provided to each participant. By blinding the assessors, the study was able to reduce potential sources of bias and increase the validity and reliability of the results. Overall, the masking approach used in this trial was designed to minimize the risk of bias and ensure that the results were as objective and accurate as possible.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised cross-over trial

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 23, 2023
• Study Start: September 17, 2021
• Primary Completion: November 26, 2021
• Study Completion: November 26, 2021
• Last Updated: May 23, 2023

Record last verified: 2023-05

Locations

GB (1)