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

NCT ID: NCT05870137

Last Updated: 2023-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-17

Study Completion Date

2021-11-26

Brief Summary

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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

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Conditions

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Emergency Medicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomised cross-over trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type 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.

Mixed reality - HoloLens2TM Supported care

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.

Group Type EXPERIMENTAL

HoloLens2TM

Intervention Type 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).

Interventions

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HoloLens2TM

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).

Intervention Type DEVICE

Standard care

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Kinross, PhD FRCS

Role: PRINCIPAL_INVESTIGATOR

Senior Lecturer in Surgery and Consultant Surgeon

Locations

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Department of Surgery and Cancer Imperial College London

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 37639272 (View on PubMed)

Other Identifiers

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21SM6714

Identifier Type: -

Identifier Source: org_study_id

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