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Clinical Evaluation of an AI Risk Prediction System (AI-TRiPS)

Study acronym: AI-TRiPS
StatusNot Yet Recruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07634185
Lead Sponsor Queen Mary University of London
Collaborators: Congressionally Directed Medical Research Programs, University of Aberdeen, Barts & The London NHS Trust, St George's University Hospitals NHS Foundation Trust, Imperial College Healthcare NHS Trust, King's College Hospital NHS Trust, London Ambulance Service NHS Trust, London's Air Ambulance Charity
Conditions
(from sponsor)
Trauma, Injury, Decision Support Systems, Clinical
Related terms Wounds and Injuries
Enrollment 1,200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov