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

NCT05882435 | Unknown

• 1 other identifier: 21OLE
• Study Type: interventional
• Target: 8,400
• Locations: 1 country
• Sites: 3

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.

Conditions

Bone Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Time between x-ray and first diagnostic

  Through patient's discharge from the emergency department, an average of 1 day

• Time between x-ray and first diagnostic by the emergency physician

  Through patient's discharge from the emergency department, an average of 1 day

• Time between x-ray and final diagnostic by the emergency physician

  30 days

• Rate of X-rays interpretation by radiologist without delay

  1 hour

• Number of all radiological exam per patient prescribed by the ED

  Through patient's discharge from the emergency department, an average of 1 day

Study Arms (2)

Usual Organization

NO INTERVENTION

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.

Organization with AI

OTHER

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

Interventions

Organization with AI OTHER

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.

Organization with AI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Not opposed to participate"

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (3)

Hopital Saint Antoine

Paris, 75012, France

RECRUITING

Hôpital Salpétrière

Paris, 75012, France

RECRUITING

Hôpital Tenon

Paris, 75020, France

RECRUITING

MeSH Terms

Conditions

Fractures, Bone

Interventions

Organizations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Health Care Economics and Organizations

Central Study Contacts

Olivier LUCIDARME, MD, PhD

CONTACT

01 42 17 63 22; olivier.lucidarme@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 31, 2023
• Study Start: May 31, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)