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Clinical Evaluation of an AI Risk Prediction System (AI-TRiPS)
Sponsor: Queen Mary University of London
Summary
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.
Official title: Clinical Evaluation of an AI Risk Prediction and Decision Support System for Early Management of Injured Patients: a Stepped-wedge Cluster Randomised Trial
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1200
Start Date
2026-06-01
Completion Date
2027-12-01
Last Updated
2026-06-08
Healthy Volunteers
No
Interventions
AI-TRiPS Device
This is Software as a Medical Device designed to function as an aid to inform clinical situational awareness by presenting predictions of patient trajectory (probability of death, probability of trauma induced coagulopathy, probability of red cell transfusion, probability of acute kidney injury).