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

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age16+
SponsorQueen Mary University of London

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

1,200 Participants
are divided into 2 treatment groups

Locations

This trial has no 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