Bone FractureIMMEDIATNCT05882435
Use of Augmented Intelligence for the Interpretation of Bone Standard X-rays Prescribed by the Emergency Department (IMMEDIAT Urgences)
A study testing Organization with AI in people with Bone Fracture, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Fracture
- What is being tested?
- Organization with AI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,400 participants
- Where
- 3 sitesFrance
- Study dates
- 31 May 2023to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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"
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Hopital Saint Antoine
Paris, 75012
ANNE Miquel
- Recruiting
Hôpital Salpétrière
Paris, 75012
Olivier LUCIDARME, MD, PhD, 01 42 17 63 22, olivier.lucidarme@aphp.fr
Imene HADDADOU, clinical project manager, 01 42.16.77. 14, imene.haddadou@aphp.fr
- Recruiting
Hôpital Tenon
Paris, 75020
HELENE GOULET
About this study
Official title: 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.
Read the 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."
- Conditions
- Bone Fracture
- Being tested
- Organization with AI
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organization with AIOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Organization with AI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through patient's discharge from the emergency department, an average of 1 day
Secondary outcomes (10)
Time between x-ray and first diagnostic
Time between x-ray and first diagnostic, either by the emergency physician or by the radiologist
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 30 days
Time spent in the ED by the patient
Time spent in the ED by the patient
Measured: 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
Measured: 30 days
30 days morbidity
New ED visit, hospitalization, radiological exam or outpatient visit, for the same reason as the first ED visit
Measured: 30 days
Total cost from the hospital viewpoint
Total cost from the hospital viewpoint
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start31 May 2023 (estimated)
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone FractureStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882435
- Sponsor's protocol ID
- 21OLE
- Acronym
- IMMEDIAT
- Status last verified
- Apr 2023
- First submitted
- 21 Apr 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intelligence for the Interpretation of Bone Standard X-rays Prescribed by the Emergency Department
- ClinicalTrials.gov ID
- NCT05882435
- Acronym / sponsor ID
- IMMEDIAT / 21OLE
- Conditions
- Bone Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8,400 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 31 May 2023 (estimated)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Organization 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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"
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Organization 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. | Other | Organization with AI |
Primary outcome
Diagnostic error rate
Time frame: Through 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.
10 secondary outcomes
Time between x-ray and first diagnostic
Time frame: 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 frame: 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 frame: 30 days
Rate of X-rays interpretation by radiologist without delay
Time frame: 1 hour
Number of all radiological exam per patient prescribed by the ED
Time frame: 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
Time frame: 30 days
Time spent in the ED by the patient
Time frame: Through patient's discharge from the emergency department, an average of 1 day
Number of patients invited to come back in the ED
Time frame: 30 days
30 days morbidity
Time frame: 30 days
Total cost from the hospital viewpoint
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Organization with AI in people with Bone Fracture, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier LUCIDARME, MD, PhD (01 42 17 63 22, olivier.lucidarme@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic error rate (time frame: Through patient's discharge from the emergency department, an average of 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.