About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Aged under 16
Not treated by London's Air Ambulance.
Transported to a non-participating hospital.
Not managed by any participating clinicians.
Trial design
Treatments tested in this trial
- AI-TRiPS Device
Treatment groups
Locations
Sponsors and collaborators
Queen Mary University of London
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator
University of Aberdeen
Collaborator
Barts & The London NHS Trust
Collaborator
St George's University Hospitals NHS Foundation Trust
Collaborator
Imperial College Healthcare NHS Trust
Collaborator
King's College Hospital NHS Trust
Collaborator
London Ambulance Service NHS Trust
Collaborator
London's Air Ambulance Charity
Collaborator