Back to resultsAssessing Mixed Reality for Emergency Medical Care Delivery in a Simulated Environment
Primary Purpose
Emergency Medicine
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
HoloLens2TM
Standard care
Sponsored by
About this trial
This is an interventional treatment trial for Emergency Medicine
Eligibility Criteria
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.
Sites / Locations
- Department of Surgery and Cancer Imperial College London
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard care
Mixed reality - HoloLens2TM Supported care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Scenario completion success
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.
Scenario completion duration
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.
Team performance
The OTAS tool (Observational Teamwork Assessment for Surgery) is a validated scale that is commonly used to assess team performance in surgery. It is a structured observation tool that allows for the assessment of teamwork in the operating room setting, and it has been shown to have good inter-rater reliability and construct validity.
The tool can also be used to compare the performance of individual team members and to determine how the use of technology influences cognitive load and individual perspective performance. For example, studies have used the OTAS tool to evaluate the impact of laparoscopic surgery on team performance and to determine how the use of surgical robots affects teamwork and communication in the operating room.
Team performance
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05870137
Brief Title
Assessing Mixed Reality for Emergency Medical Care Delivery in a Simulated Environment
Official Title
A Pilot Randomised Cross-over Trial of HoloLens2™️ for the Delivery of Distributed Medical Care During COVID-19 in a Simulated Environment.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 17, 2021 (Actual)
Primary Completion Date
November 26, 2021 (Actual)
Study Completion Date
November 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergency Medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomised cross-over trial
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Mixed reality - HoloLens2TM Supported care
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
HoloLens2TM
Intervention Description
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
Other
Intervention Name(s)
Standard care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Error Rate
Description
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.
Time Frame
Through study completion, an average of 8 minutes per scenario
Secondary Outcome Measure Information:
Title
Scenario completion success
Description
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.
Time Frame
Through study completion, an average of 8 minutes per scenario
Title
Scenario completion duration
Description
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.
Time Frame
Through study completion, an average of 8 minutes per scenario
Title
Team performance
Description
The OTAS tool (Observational Teamwork Assessment for Surgery) is a validated scale that is commonly used to assess team performance in surgery. It is a structured observation tool that allows for the assessment of teamwork in the operating room setting, and it has been shown to have good inter-rater reliability and construct validity.
The tool can also be used to compare the performance of individual team members and to determine how the use of technology influences cognitive load and individual perspective performance. For example, studies have used the OTAS tool to evaluate the impact of laparoscopic surgery on team performance and to determine how the use of surgical robots affects teamwork and communication in the operating room.
Time Frame
Through study completion, an average of 8 minutes per scenario
Title
Team performance
Description
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.
Time Frame
Through study completion, an average of 8 minutes per scenario
Title
Team workload
Description
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.
Time Frame
Through study completion, an average of 8 minutes per scenario
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Kinross, PhD FRCS
Organizational Affiliation
Senior Lecturer in Surgery and Consultant Surgeon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery and Cancer Imperial College London
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Assessing Mixed Reality for Emergency Medical Care Delivery in a Simulated Environment
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