Clinical trial NCT05882435: Use of Augmented Intelligence for the Interpretation of Bone Standard X-rays Prescribed by the Emergency Department (IMMEDIAT Urgences)
Official title: Intelligence for the Interpretation of Bone Standard X-rays Prescribed by the Emergency Department
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Fracture
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 8400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study evaluates, in 3 emergency departments (ED) and on randomized alternate periods, the use of SmartUrgences®, Augmented Intelligence (AI) software to help the interpretation of bone standard X-rays prescibed by the ED.

Detailed description: "The study evaluates, in 3 emergency departments (ED) and on randomized alternate periods, the use of SmartUrgences®, Augmented Intelligence (AI) software to help the interpretation of bone radiographs prescibed by the ED.

The primary objective of the organizational study is to evaluate, compared to the current organization for the interpretation of standard bone radiographs requested by the ED, the impact of an organization incorporating the Milvue solution, on the reduction of the patient diagnostic error rate.

A cost-consequence study is carried out, comparing from the point of view of the community (production costs according to the HAS recommendations), the radiological diagnosis within the framework of an organization with the Milvue solution, to that within the framework of the current organization without the use of the Milvue solution.

The economic study will follow the scheme of the organizational study, comparing the periods with and without the Milvue solution and analyzing the costs and consequences, by period and by patient.

This is an open-label randomized cluster multiple period cross-over study with 6 alternate periods (3 with AI, 3 with usual organization) of 1 month in each ED. The choice of the intervention for the first period will be randomized."

Eligibility criteria: Inclusion Criteria:

1. All adult referred by the ED for a conventional X-rays of all or part of the appendicular skeleton and/or pelvis and/or costal gril
2. Not opposed to participate"

Primary outcomes:
measure: Diagnostic error rate
timeFrame: Through patient's discharge from the emergency department, an average of 1 day
Secondary outcomes:
measure: Time between x-ray and first diagnostic
timeFrame: Through patient's discharge from the emergency department, an average of 1 day
measure: Time between x-ray and first diagnostic by the emergency physician
timeFrame: Through patient's discharge from the emergency department, an average of 1 day
measure: Time between x-ray and final diagnostic by the emergency physician
timeFrame: 30 days
measure: Rate of X-rays interpretation by radiologist without delay
timeFrame: 1 hour
measure: Number of all radiological exam per patient prescribed by the ED
timeFrame: Through patient's discharge from the emergency department, an average of 1 day
measure: Number of X-rays with a report by a radiologist at 30 days
timeFrame: 30 days
measure: Time spent in the ED by the patient
timeFrame: Through patient's discharge from the emergency department, an average of 1 day
measure: Number of patients invited to come back in the ED
timeFrame: 30 days
measure: 30 days morbidity
timeFrame: 30 days
measure: Total cost from the hospital viewpoint
timeFrame: 30 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: Hôpital Salpétrière
city: Paris
country: France
facility: Hôpital Tenon
Study officials:
References: