About this trial
Prehospital providers interpret 12-lead electrocardiograms (ECGs) under time pressure and without immediate expert support. Missed acute coronary occlusion - occlusion myocardial infarction (OMI) - delays reperfusion, while false positive interpretations trigger unnecessary catheterization laboratory activations. Multimodal large language models (LLMs) available on any smartphone can now analyze a photographed ECG, and prehospital providers have begun using them spontaneously. No randomized trial has evaluated whether this practice improves diagnostic performance.
This randomized controlled trial compares the diagnostic performance of prehospital providers interpreting ECG clinical vignettes with and without mandatory assistance from a single, version-locked smartphone large language model. Participants - paramedics, emergency medical technicians, nurses and physicians practicing in prehospital care in French-speaking Switzerland - are randomized 1:1 on a dedicated digital platform and answer 14 clinical vignettes presented in individually randomized order. Each vignette is built around a real, anonymized 12-lead ECG obtained during routine clinical care.
The primary outcome is the proportion of vignettes for which the participant correctly identifies the presence or absence of an OMI. Secondary outcomes are sensitivity, specificity, and the accuracy of the prehospital priority decision level.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Prehospital care provider practising in French-speaking Switzerland
Any level of training: emergency medical technician, paramedic (ES), nurse (ES/HES) in prehospital emergency care, or prehospital emergency physician
Electronic informed consent signed before randomization
Disqualifiers
Cardiologist
Any person not practising in prehospital care
Insufficient command of written French to answer the vignettes reliably
Refusal to participate or withdrawal of consent
Trial design
Parallel
Treatments tested in this trial
Smartphone large language model assistance (GPT-4o, version-locked)
Diagnostic testThe platform transmits the ECG image to a single large language model (OpenAI GPT-4o, API snapshot gpt-4o-2024-08-06), locked for the entire study, together with a standardised prompt identical for all participants and all vignettes: "I am on an urgent prehospital call with a patient who presents this ECG. Analyse it and tell me what you think." Participants cannot modify the prompt, ask follow-up questions or provide additional clinical context. The model version and system fingerprint returned by the API are recorded for every call. The model's interpretation is displayed within the vignette. Use of the tool is mandatory; adherence to its interpretation is not.
Treatment groups
Trial outcomes
Primary outcomes
Proportion of vignettes with correct identification of occlusion myocardial infarction (OMI) status
For each of the 14 vignettes, the participant answers a binary question: "At this stage of care, is an OMI (acute coronary occlusion) likely? Yes / No". Responses are scored against a reference standard defined a priori, vignette by vignette, by the study cardiologist and locked before data collection. This reference standard is the answer expected of a prehospital provider at the point of care, anchored on coronary angiography wherever angiography is discriminant. For non-ischaemic mimics the expected answer depends on whether the acute presentation allows the condition to be distinguished from a coronary occlusion: it does not for the Takotsubo case (expected answer "yes"), whereas acute pericarditis is usually recognisable (expected answer "no"). This pre-specified departure from a purely angiographic standard is reported as such, and the analysis is repeated in a sensitivity analysis classifying all mimics as non-OMI. The outcome is the proportion of correctly classified vignettes
Secondary outcomes
Sensitivity of OMI detection
Proportion of correctly identified OMI among vignettes whose expected answer is "yes", compared between arms. Analysed by mixed-effects logistic regression restricted to these vignettes, with arm as fixed effect and a random intercept per participant.
Specificity of OMI detection
Proportion of correctly identified non-OMI among vignettes whose expected answer is "no" (non-occlusive ischaemia, indeterminate ischaemia, recognisable non-ischaemic mimics, normal or non-specific ECGs), compared between arms. Same modelling approach as for sensitivity.
Accuracy of the prehospital priority decision level
Proportion of vignettes for which the participant selects the correct prehospital priority decision level, on a pre-specified five-level scale ranging from high-risk acute coronary syndrome with activation of the STEMI pathway to clearly non-cardiac symptoms. The expected level is defined a priori for each vignette and locked before data collection.
Other outcomes
Diagnostic accuracy on the closed-list diagnosis question
For each vignette the participant selects a single diagnosis from a closed list of 86 items grouped in 8 families, using a filterable selector. Two variables are produced automatically: exact match with the expected diagnosis, and match with the expected diagnosis or with any diagnosis pre-specified as clinically acceptable. Reported descriptively by ECG category and by arm, then modelled by mixed-effects logistic regression if numbers allow. The primary analysis uses the exact-or-acceptable variable; the strict variable is reported as a sensitivity analysis.
Self-reported confidence and calibration
Confidence in the answer is reported by the participant for each vignette on a five-point Likert scale of self-reported diagnostic confidence, ranging from 1 (not at all confident) to 5 (very confident). A higher score indicates greater self-reported confidence; confidence is a descriptive measure and a higher score is not in itself a better outcome. Confidence is compared between arms by mixed-effects ordinal logistic regression. Calibration is assessed as the concordance between reported confidence and the actual correctness of the answer, using calibration curves and the Brier score, which ranges from 0 to 1, a lower score indicating better calibration.
Self-reported influence of the AI on the final answer
Degree to which the participant reports having been influenced by the model's interpretation, on a five-point Likert scale, collected for each vignette in the intervention arm only. Analysed descriptively and in relation to the correctness of the answer. No comparison between AI tools is conducted, the model version being fixed.
Response time per vignette
Time from display of the vignette to submission of the answer, measured automatically in seconds by the platform. Analysed by linear mixed-effects model on the log of the response time, with arm as fixed effect and a random intercept per participant; a sensitivity analysis compares individual median times between arms. A longer time is expected in the intervention arm owing to consultation of the model, and is treated as a feasibility outcome for prehospital use.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
École Supérieure de Soins Ambulanciers - College of Higher Education in Prehospital Care
Lead sponsor
University Hospital, Geneva
Collaborator
Swissrescue.ch, Website for Prehospital Healthcare Providers, Les Pontins, Switzerland
Collaborator