A Pilot Randomised Cross-over Trial of HoloLens2™️ for the Delivery of Distributed Medical Care During COVID-19 in a Simulated Environment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Error Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Error Rate
时间窗: 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.
次要结局
- Scenario completion success(Through study completion, an average of 8 minutes per scenario)
- Team workload(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)