Clinical Evaluation of an AI Risk Prediction and Decision Support System for Early Management of Injured Patients: a Stepped-wedge Cluster Randomised Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 1,200
研究概览
简要总结
The goal of this clinical study is to evaluate a software device and its impact on clinician behaviour during the initial management of trauma patients in a real-world clinical setting. Known as the AI-TRiPS Device this software uses real-time prehospital data and machine learning-based risk predictions which are displayed digitally for hospital trauma teams prior patient arrival.
The investigators will use a Stepped Wedge Cluster Randomised Controlled study design with an integrated process evaluation.
The Device will be deployed across the London Major Trauma System where the Major Trauma Centres will be the clusters. Each cluster will transition from control (standard care) to intervention at a pre-specified time (time of transition is randomised).
Primary Outcome: Clinician behaviour, assessed via the accuracy of risk prediction and clinician confidence.
Secondary Outcome: Clinician acceptability, care process metrics, patient outcomes, and safety endpoints.
Primary study population: Hospital trauma clinicians, following initial resuscitation of each eligible trauma patient, who will complete electronic questionnaires.
Secondary study population: Adult trauma patients, data will be collected for the duration of their index admission to hospital, to assess outcomes and enable comparison with clinician risk predictions.
详细描述
This project evaluates a bespoke risk prediction system developed by trauma surgeons, pre-hospital clinicians, and computer scientists. The device aims to enhance the situational awareness of hospital trauma teams via a digital display, located in the resuscitation suite, depicting pre-hospital patient status and individualised risk predictions.
Evidence Base and Prior Work
The AI-TRiPS Device builds on an extensive, multi-phase programme of research led by the Centre for Trauma Sciences at Queen Mary University of London, funded by the US Department of Defense, UK Ministry of Defence, and Rosetrees Trust. This programme has:
- Investigated trauma clinical decision-making, demonstrating that situational awareness is often impaired by uncertainty and cognitive load, and highlighting the need for decision support during early trauma resuscitation.
- Developed clinically relevant, explainable Bayesian network models using hybrid data- and knowledge-driven methods, with internal and external validation across large civilian and military trauma datasets.
- Designed and iteratively refined a web-based clinical decision support system (CDSS) to deliver model outputs through an interface tailored to trauma resuscitation workflows, incorporating end-user feedback.
- Conducted simulation and operational studies demonstrating improved clinician performance with the CDSS compared to unaided judgement.
- Contributed methodological work to support the safe and effective translation of prediction algorithms into usable and trustworthy clinical tools, including published frameworks for usability testing, implementation evaluation, and explainability in clinical decision support.
The current stage of development is consistent with early-stage clinical evaluation of a Software as a Medical Device (SaMD) under UK MDR 2002 and ISO 14155.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinician Participants
- •Senior clinical decision-maker involved in the initial trauma resuscitation (e.g. consultant or senior trainee in emergency medicine, anaesthesia, intensive care medicine, or surgery).
- •Based at one of the four participating Major Trauma Centres.
- •Able and willing to provide informed consent.
- •Completed the required study-specific training.
- •Trauma Patients
- •Aged 16 years and above.
- •Treated and transported to a participating Major Trauma Centre by London's Air Ambulance.
- •Managed by one or more participating trauma clinicians during the resuscitation.
排除标准
- •Clinician Participants
- •● Decline or withdraw informed consent at any stage.
- •Trauma Patients
- •Aged under 16
- •Not treated by London's Air Ambulance.
- •Transported to a non-participating hospital.
- •Not managed by any participating clinicians.
- •Presenting with injuries resulting from burns, hangings, drownings, or isolated psychiatric emergencies.
- •Have registered a national NHS data opt-out or otherwise requested that their routine clinical data not be used for research.