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

Primary Purpose

Bone Fracture

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Organization with AI
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Bone Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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"

Sites / Locations

  • Hopital Saint AntoineRecruiting
  • Hôpital SalpétrièreRecruiting
  • Hôpital TenonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Usual Organization

Organization with AI

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time between x-ray and first diagnostic
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 physician
Time between x-ray and first diagnostic by the emergency physician in the patient medical file
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
Rate of X-rays interpretation by radiologist without delay
Rate of X-rays interpretation by radiologist without delay (i.e within 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)
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
Time spent in the ED by the patient
Time spent in the ED by the patient
Number of patients invited to come back in the ED
Number of patients invited to come back in the ED
30 days morbidity
New ED visit, hospitalization, radiological exam or outpatient visit, for the same reason as the first ED visit
Total cost from the hospital viewpoint
Total cost from the hospital viewpoint

Full Information

First Posted
April 21, 2023
Last Updated
May 26, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05882435
Brief Title
Use of Augmented Intelligence for the Interpretation of Bone Standard X-rays Prescribed by the Emergency Department (IMMEDIAT Urgences)
Acronym
IMMEDIAT
Official Title
Intelligence for the Interpretation of Bone Standard X-rays Prescribed by the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2023 (Anticipated)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Fracture

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Organization
Arm Type
No Intervention
Arm Description
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.
Arm Title
Organization with AI
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Organization with AI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diagnostic error rate
Description
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.
Time Frame
Through patient's discharge from the emergency department, an average of 1 day
Secondary Outcome Measure Information:
Title
Time between x-ray and first diagnostic
Description
Time between x-ray and first diagnostic, either by the emergency physician or by the radiologist
Time Frame
Through patient's discharge from the emergency department, an average of 1 day
Title
Time between x-ray and first diagnostic by the emergency physician
Description
Time between x-ray and first diagnostic by the emergency physician in the patient medical file
Time Frame
Through patient's discharge from the emergency department, an average of 1 day
Title
Time between x-ray and final diagnostic by the emergency physician
Description
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
Time Frame
30 days
Title
Rate of X-rays interpretation by radiologist without delay
Description
Rate of X-rays interpretation by radiologist without delay (i.e within 1 hour)
Time Frame
1 hour
Title
Number of all radiological exam per patient prescribed by the ED
Description
Number of all radiological exam per patient prescribed by the ED (MRI, scanner, x-rays, echography)
Time Frame
Through patient's discharge from the emergency department, an average of 1 day
Title
Number of X-rays with a report by a radiologist at 30 days
Description
Number of X-rays with a report by a radiologist at 30 days
Time Frame
30 days
Title
Time spent in the ED by the patient
Description
Time spent in the ED by the patient
Time Frame
Through patient's discharge from the emergency department, an average of 1 day
Title
Number of patients invited to come back in the ED
Description
Number of patients invited to come back in the ED
Time Frame
30 days
Title
30 days morbidity
Description
New ED visit, hospitalization, radiological exam or outpatient visit, for the same reason as the first ED visit
Time Frame
30 days
Title
Total cost from the hospital viewpoint
Description
Total cost from the hospital viewpoint
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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"
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier LUCIDARME, MD, PhD
Phone
01 42 17 63 22
Email
olivier.lucidarme@aphp.fr
Facility Information:
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANNE Miquel
Facility Name
Hôpital Salpétrière
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier LUCIDARME, MD, PhD
Phone
01 42 17 63 22
Email
olivier.lucidarme@aphp.fr
First Name & Middle Initial & Last Name & Degree
Imene HADDADOU, clinical project manager
Phone
01 42.16.77. 14
Email
imene.haddadou@aphp.fr
Facility Name
Hôpital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HELENE GOULET

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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