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Use of Augmented Intelligence for the Interpretation of Bone Standard X-rays Prescribed by the Emergency Department (IMMEDIAT Urgences)

Not Applicable
Recruiting
Conditions
Bone Fracture
Interventions
Other: Organization with AI
Registration Number
NCT05882435
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
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."

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
8400
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"
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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Organization with AIOrganization with AIX-rays are done in the radiology department and the images are made available to emergency physicians with the AI interpretation. X-rays flagged by IA as anormal or suspicious will be reviewed without delay by the radiologist, non-flagged X-rays will be reviewed by radiologists on a delayed basis.
Primary Outcome Measures
NameTimeMethod
Diagnostic error rateThrough patient's discharge from the emergency department, an average of 1 day

A diagnostic error is defined as a final consensus diagnosis that differs from the diagnosis documented in the medical record by the emergency physician prior to patient's discharge from the ED.

A diagnostic error is defined as a final consensus diagnosis that differs from the diagnosis documented in the medical record by the emergency physician prior to patient's discharge from the ED.

Secondary Outcome Measures
NameTimeMethod
Time between x-ray and first diagnosticThrough patient's discharge from the emergency department, an average of 1 day

Time between x-ray and first diagnostic, either by the emergency physician or by the radiologist

Time between x-ray and first diagnostic by the emergency physicianThrough patient's discharge from the emergency department, an average of 1 day

Time between x-ray and first diagnostic by the emergency physician in the patient medical file

Number of X-rays with a report by a radiologist at 30 days30 days

Number of X-rays with a report by a radiologist at 30 days

Total cost from the hospital viewpoint30 days

Total cost from the hospital viewpoint

Rate of X-rays interpretation by radiologist without delay1 hour

Rate of X-rays interpretation by radiologist without delay (i.e within 1 hour)

Time spent in the ED by the patientThrough patient's discharge from the emergency department, an average of 1 day

Time spent in the ED by the patient

30 days morbidity30 days

New ED visit, hospitalization, radiological exam or outpatient visit, for the same reason as the first ED visit

Time between x-ray and final diagnostic by the emergency physician30 days

Time between x-ray and final diagnostic by the emergency physician in the patient medical file. A diagnostic will be considered as final if the same as the consensus one

Number of all radiological exam per patient prescribed by the EDThrough patient's discharge from the emergency department, an average of 1 day

Number of all radiological exam per patient prescribed by the ED (MRI, scanner, x-rays, echography)

Number of patients invited to come back in the ED30 days

Number of patients invited to come back in the ED

Trial Locations

Locations (3)

Hopital Saint Antoine

🇫🇷

Paris, France

Hôpital Salpétrière

🇫🇷

Paris, France

Hôpital Tenon

🇫🇷

Paris, France

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