- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05669157
X-rays Trauma Request's by the Triage And Intake Nurse Intake and Referral Nurse: (DARIO)
July 31, 2023 updated by: Centre Hospitalier Régional d'Orléans
X-rays Trauma Request's by the Triage And Intake Nurse Intake and Referral Nurse: X-TRAIN Study
The number of consultations in emergency departments is increasing day by day, and the time to treat patients is getting longer.
Different French studies have shown a significant reduction in the time spent in the emergency department after the implementation of the national protocol for the delegation of early radiography prescriptions.
The investigators hypothesised that an early request for a standard X-ray by the intake and referral nurse in the case of isolated trauma to the extremities of a limb (from the knee to the toes and from the shoulder to the fingers) enables a reduction in medical management time and, consequently, in the time spent in the emergency department for the patient.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is divided into two steps to three month.
- The first step of the study corresponds to the current standard of care (SoC) in the emergency department of Orléans. In this first step, the intake and Referral Nurse (IRN) will carry out the usual triage and refer the participant to the appropriate emergency department before being appointed by the physician. The radiography will be requested after the medical consultation.
- In the second step, the intake and referral nurse will carry out the usual triage and then request one, or more, radiography(ies) depending on the standard protocol. This ensures that the physician has access to the imaging before the consultation with the patient. If necessary, the X-ray technician is authorized to refuse the exams or complete the request, the choice of the incidence is up to him/her according to the intake and referral nurse.
Study Type
Interventional
Enrollment (Actual)
400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Orléans, France
- CHR d'Orléans
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patient older than 15 years and 3 months admitted in adult emergency department of regional hospital center of ORLEANS with a simple and isolated trauma having occurred less than 48 hours prior to admission of a limb extremity (from the knee to the toes or from the shoulder to the fingers), and with no previous imagery assessment within 48 hours prior to admission in the emergency department.
Exclusion Criteria:
- Multiple trauma
- Patient with at least one Vittel criteria (except age)
- Patient refusing the protocol
- Hemodynamic instability and/or disorder of consciousness
- Sensory and/or vascular disorders downstream of the traumatized area
- Protected population (under guardianship or curators)
- Patient under court protection
- Pregnant or breastfeeding woman or one who declares herself to be pregnant or breastfeeding
- Patient with an expired blood alcohol level > 0.4 mg/L and/or positive blood alcohol level
- Patient with diagnosed dementia
- Patient hospitalized after being taken in charge
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Current practice: radiography request by physician
No interventions will be performed.
There is no change in current practice.
|
The physician prescribed the X-ray, the X-ray technician carries out the imagery and the physician interprets it afterwards
|
|
Experimental: Radiography request by the nurse
the intake and referral nurse will request a radiography if required according to the local cooperation protocol
|
Intervention group with radiography requested by the IRN instead of the physician.
The radiography will be interpreted by the physician afterwards, according to current practice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration between triage and exit of emergency unit
Time Frame: immediatly after the procedure
|
Total duration in minutes in the emergency department with or without anticipated request of X-ray
|
immediatly after the procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total duration of the stay
Time Frame: immediatly after the procedure
|
Total duration in minutes in the emergency department
|
immediatly after the procedure
|
|
Number of additional X-ray prescribed by the physician after physician assessment.
Time Frame: immediatly after the procedure
|
Number of new X-ray images taken after physician assessment.
|
immediatly after the procedure
|
|
Appropriateness of the X-rays requested by the IRN as per guidelines
Time Frame: immediatly after the procedure
|
Number of new X-ray images taken after physician assessment.
|
immediatly after the procedure
|
|
IRN's feeling about the anticipated request for X-ray (assessed as per anonym Quality of Life at Work questionnaire)
Time Frame: immediatly after the procedure
|
Quality of life questionnaire.
Min: not satisfied; max : satisfied
|
immediatly after the procedure
|
|
X-ray technician's feeling about the anticipated request for X-ray (assessed as per anonym Quality of Life at Work questionnaire)
Time Frame: immediatly after the procedure
|
Quality of life questionnaire.
Min: not satisfied; max : satisfied
|
immediatly after the procedure
|
|
Physician's feeling about the anticipated request for X-ray (assessed as per anonym Quality of Life at Work questionnaire) Physician's feeling about the anticipated request for X-ray (assessed as per anonym Quality of Life at Work questionnaire)
Time Frame: immediatly after the procedure
|
Quality of life questionnaire.
Min: not satisfied; max : satisfied
|
immediatly after the procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Vincent GARROUSTE, MD, Regional Hospital center of ORLEANS
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 16, 2023
Primary Completion (Actual)
June 25, 2023
Study Completion (Actual)
June 25, 2023
Study Registration Dates
First Submitted
December 12, 2022
First Submitted That Met QC Criteria
December 29, 2022
First Posted (Actual)
December 30, 2022
Study Record Updates
Last Update Posted (Actual)
August 1, 2023
Last Update Submitted That Met QC Criteria
July 31, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CHRO-2022-08
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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