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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bone Fracture
• Intervention / Treatment: Other: Organization with AI

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."

• Study Type: Interventional
• Enrollment (Estimated): 8400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olivier LUCIDARME, MD, PhD; Phone Number: 01 42 17 63 22; Email: olivier.lucidarme@aphp.fr

Study Locations

• France
  • Paris, France, 75012
    • Recruiting
    • Hopital Saint Antoine
    • Contact: ANNE Miquel
  • Paris, France, 75020
    • Recruiting
    • Hôpital Tenon
    • Contact: HELENE GOULET
  • Paris, France, 75012
    • Recruiting
    • Hopital Salpetriere
    • Contact: Olivier LUCIDARME, MD, PhD; Phone Number: 01 42 17 63 22; Email: olivier.lucidarme@aphp.fr
    • Contact: Imene HADDADOU, clinical project manager; Phone Number: 01 42.16.77. 14; Email: imene.haddadou@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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"

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Organization; X-rays are done in the radiology department and the images are made available to emergency physicians without waiting for the radiologist's report, which is usually done on a delayed basis.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
Number of patients invited to come back in the ED	Number of patients invited to come back in the ED	30 days
30 days morbidity	New ED visit, hospitalization, radiological exam or outpatient visit, for the same reason as the first ED visit	30 days
Total cost from the hospital viewpoint	Total cost from the hospital viewpoint	30 days

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): May 31, 2023
• Primary Completion (Estimated): December 15, 2023
• Study Completion (Estimated): December 15, 2023

Study Registration Dates

• First Submitted: April 21, 2023
• First Submitted That Met QC Criteria: May 26, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease Attributes; Emergencies; Fractures, Bone
• Other Study ID Numbers: 21OLE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No