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

Bone Fracture Clinical Trial

— IMMEDIAT  

Official title:

Intelligence for the Interpretation of Bone Standard X-rays Prescribed by the Emergency Department

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05882435
• Other study ID #: 21OLE
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: April 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Olivier LUCIDARME, MD, PhD
• Phone: 01 42 17 63 22
• Email: olivier.lucidarme[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 8400
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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"

Related Conditions & MeSH terms

• Bone Fracture
• Emergencies
• Fractures, Bone

Intervention

Other:
• Organization with AI
X-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.

Locations

Country	Name	City	State
France	Hopital Saint Antoine	Paris
France	Hôpital Salpétrière	Paris
France	Hôpital Tenon	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic error rate	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.	Through patient's discharge from the emergency department, an average of 1 day
Secondary	Time between x-ray and first diagnostic	Time between x-ray and first diagnostic, either by the emergency physician or by the radiologist	Through patient's discharge from the emergency department, an average of 1 day
Secondary	Time between x-ray and first diagnostic by the emergency physician	Time between x-ray and first diagnostic by the emergency physician in the patient medical file	Through patient's discharge from the emergency department, an average of 1 day
Secondary	Time between x-ray and final diagnostic by the emergency physician	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	30 days
Secondary	Rate of X-rays interpretation by radiologist without delay	Rate of X-rays interpretation by radiologist without delay (i.e within 1 hour)	1 hour
Secondary	Number of all radiological exam per patient prescribed by the ED	Number of all radiological exam per patient prescribed by the ED (MRI, scanner, x-rays, echography)	Through patient's discharge from the emergency department, an average of 1 day
Secondary	Number of X-rays with a report by a radiologist at 30 days	Number of X-rays with a report by a radiologist at 30 days	30 days
Secondary	Time spent in the ED by the patient	Time spent in the ED by the patient	Through patient's discharge from the emergency department, an average of 1 day
Secondary	Number of patients invited to come back in the ED	Number of patients invited to come back in the ED	30 days
Secondary	30 days morbidity	New ED visit, hospitalization, radiological exam or outpatient visit, for the same reason as the first ED visit	30 days
Secondary	Total cost from the hospital viewpoint	Total cost from the hospital viewpoint	30 days