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

3. června 2026 aktualizováno: Queen Mary University of London

Clinical Evaluation of an AI Risk Prediction and Decision Support System for Early Management of Injured Patients: a Stepped-wedge Cluster Randomised 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

This trial is designed to evaluate clinical performance and safety in real-world conditions, with a primary focus on effects on clinician behaviour and decision-making. While patient outcomes will be collected, the study is not powered to assess downstream impact on clinical outcomes.

Primary Objective To evaluate the impact of the AI-TRiPS device on clinician behaviour during the initial management of trauma patients in a real-world clinical setting, specifically situational awareness (clinician perception of individual patient risk), associated confidence, and cognitive load, compared with standard unassisted clinician performance.

Hypothesis The investigators hypothesise that delivering accurate, real-time risk estimates to trauma clinicians during the initial phase of trauma care will improve situational awareness - in particular, clinicians' perception of individual patient risks - along with increased confidence and reduced cognitive effort, compared with standard unassisted clinician performance.

Null Hypothesis There is no difference in clinician situational awareness (including perception of risk), confidence, or cognitive load between AI-assisted and unassisted clinician performance during initial trauma care.

Secondary objective(s)

Secondary Objectives

• Evaluate impact on Clinician Decision-Making: To assess the effect of the AI-TRiPS device on clinician decision-making, as a potential downstream effect of changes in clinician risk perception (situational awareness).

• Evaluate impact on Clinical Processes: To assess the effect of the AI-TRiPS device on early trauma care processes, including time to critical interventions and length of stay

• Evaluate Patient Impact: To examine patient outcomes associated with clinician exposure to the AI-TRiPS device, recognising these as indirect effects mediated by altered clinical decision-making.

• Evaluate Real-World System Performance: To assess the real-world performance of the AI-TRiPS device, including prediction calibration and the identification of system errors or underperformance that may affect clinical decision-making.

• Evaluate usability and acceptability (Integrated Process Evaluation): To explore the acceptability, usability, and contextual factors that influence the implementation and adoption of the AI-TRiPS device in real-world clinical settings.

Typ studie

Intervenční

Zápis (Odhadovaný)

1200

Fáze

  • Raná fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Jiný
  • Přidělení: Randomizované
  • Intervenční model: Sekvenční přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: AI TRIPS device intervention
Patients who fit the eligibility criteria are triaged and treated at the participating trauma centre by trauma clinicians who have been exposed to the individualised risk predictions for that patient.
Přístroj: 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).
Žádný zásah: Usual Standard Care
Patients who fit the eligibility criteria are triaged and treated at the participating trauma centre by trauma clinicians under standard conditions.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Clinician Risk Prediction - Mortality, Trauma Induced Coagulopathy, and Acute Kidney Injury
Časové okno: Baseline
Clinician participants will make probability estimates (0-100%) on index admission in each of the 3 domains.
Baseline
Clinician Risk Prediction - Estimation of Blood Transfusion Volume
Časové okno: Baseline
Clinicians will estimate the number(n) of packed red blood cell (pRBC) units required for transfusion in the first 24 hours. The estimation will take place immediately after initial resuscitation.
Baseline
Clinician Confidence
Časové okno: Baseline to 24 Hours - Immediately following initial clinician predictions
Clinician Participants will self-report their confidence in their predictions using the Post-Task Confidence Scale (PTCS), a Likert scale from 1-7, where the higher the score the higher the level confidence.
Baseline to 24 Hours - Immediately following initial clinician predictions
Clinician Cognitive Effort
Časové okno: Baseline to 24 Hours - immediately following risk predictions
Clinician participants self-report the mental effort required to make each prediction using the Paas Mental Effort Scale ( Likert Scale 1-9) where a lower score corresponds to low mental effort.
Baseline to 24 Hours - immediately following risk predictions
Risk Prediction Accuracy
Časové okno: From Discharge through to study completion, an average of 1 year.
For each of the 4 domains in which predictions have been made, accuracy of these predictions will be determined with a comparison to patient outcomes. This will be done using the Brier score, however other metrics of predictive performance may also be used to perform comparisons, including measures of discrimination, calibration, and accuracy (Brier skill Score, Mean Absolute Error)
From Discharge through to study completion, an average of 1 year.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Clinician Decision-Making Behaviour - Decision Making
Časové okno: From discharge through to study completion, an average of 1 year.

Measurement of whether a decision was made (Decision in this case refers to activation of the major haemorrhage protocol, or proceeding directly to definitive haemorrhage control). This data will be extracted from the National Major Trauma Registry and/or patient clinical records.

Binary (yes/no) based on whether the outcome was performed.
From discharge through to study completion, an average of 1 year.
Clinician Decision-Making Behaviour - Appropriateness of Decision Making
Časové okno: From Discharge through to study completion, an average of 1 year.

Expert panel review of decision making with regards to activation of major haemorrhage protocol/proceeding directly to definitive haemorrhage control. Expert review of extracted patient data from National Major Trauma Registry and/or Patient clinical records.

Binary (Appropriate/Inappropriate)
From Discharge through to study completion, an average of 1 year.
Clinician Decision-Making Behaviour - Clinician Confidence
Časové okno: Baseline to 24 hours - Immediately following initial clinician decision making
Clinician Participants will self-report their confidence in their predictions using the Post-Task Confidence Scale (PTCS), a Likert scale from 1-7, where the higher the score the higher the level confidence.
Baseline to 24 hours - Immediately following initial clinician decision making
Clinician Decision-Making Behaviour - Clinician Cognitive Effort
Časové okno: Baseline to 24 Hours - immediately following risk predictions
Clinician participants self-report the mental effort required to make each prediction using the Paas Mental Effort Scale ( Likert Scale 1-9) where a lower score corresponds to low mental effort.
Baseline to 24 Hours - immediately following risk predictions
Clinician Decision-Making Behaviour - Time Pressure
Časové okno: Baseline to 24 Hours - immediately following decision making
Clinicians self report time pressure using the NASA Task Load Index Temporal Demand Subscale (Likert Scale 1-10). This is measured immediately after each decision.
Baseline to 24 Hours - immediately following decision making
Clinical Process Measures - Time to Major Haemorrhage Protocol(MHP) Activation
Časové okno: Baseline - 12 Hours

Time to MHP activation in minutes(continuous) from arrival to activation of major haemorrhage protocol.

Data collected from National Major Trauma Registry and/or patient hospital records.
Baseline - 12 Hours
Clinical Process Measures - Time to Haemorrhage Control
Časové okno: Baseline - 12 Hours

Time to Haemorrhage control in minutes(continuous) from arrival to start of first definitive haemorrhage control intervention.

Data collected from National Major Trauma Registry and/or patient hospital records.
Baseline - 12 Hours
Clinical Process Measures - Length of Hospital Stay
Časové okno: Discharge through to study completion, an average of 1 year
Total number of inpatient hospital days (continuous), measured from index admission to discharge. Data obtained from National Major Trauma Registry and/or patient clinical records following discharge.
Discharge through to study completion, an average of 1 year
Clinical Process Measures - Intensive Care Unit (ICU) length of stay
Časové okno: Discharge through to study completion, an average of 1 year
Total number of intensive care unit days (continuous), measured from index admission to discharge. Data obtained from National Major Trauma Registry and/or patient clinical records following discharge.
Discharge through to study completion, an average of 1 year
Patient Outcome Measure - In Hospital Mortality
Časové okno: From Baseline to Discharge/Death
Patient death during index hospital admission, Binary (yes/No).
From Baseline to Discharge/Death
Patient Outcome Measure - Trauma Induced Coagulopathy
Časové okno: Baseline
Trauma-induced coagulopathy will be assessed using the admission prothrombin time ratio (PTr). This variable will be recorded as binary (yes/no), with trauma-induced coagulopathy defined as a PTr > 1.2
Baseline
Patient Outcome Measure - Blood Transfusion Volume
Časové okno: Baseline to 24 hours
The total number (N) of units of packed red blood cells (pRBC) transfused to the patient within the first 24 hours post injury.
Baseline to 24 hours
Patient Outcome Measure - Acute Kidney Injury
Časové okno: Baseline to 72 hours
The degree of acute kidney injury will be recorded using the Kidney Disease Improving Global Outcomes(KDIGO) stage 1-3, over the first 72 hours post injury.
Baseline to 72 hours

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Queen Mary University of London

Spolupracovníci

King's College Hospital NHS Trust
Barts & The London NHS Trust
Imperial College Healthcare NHS Trust
Congressionally Directed Medical Research Programs
St George's University Hospitals NHS Foundation Trust
University of Aberdeen
London Ambulance Service NHS Trust
London's Air Ambulance Charity

Vyšetřovatelé

  • Vrchní vyšetřovatel: Prof. N Tai, Queen Mary University London

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. června 2026

Primární dokončení (Odhadovaný)

1. června 2027

Dokončení studie (Odhadovaný)

1. prosince 2027

Termíny zápisu do studia

První předloženo

6. května 2026

První předloženo, které splnilo kritéria kontroly kvality

3. června 2026

První zveřejněno (Aktuální)

8. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

3. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 354225
  • 179821 (Jiný identifikátor: Queen Mary University)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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