- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01785368
Referral Guidelines for Imaging Exams: Impact on Exam Relevance and Associated Delays (RIU)
Implementing Referral Guidelines for Imaging Exams Requested Via the Emergency Department: Impact on Exam Relevance and Associated Delays
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The secondary objectives of this study are to assess the impact of the implementation of referral guidelines for imaging exams requested by the emergency department on the following:
A. How exam results are classified in relation to the initial, suspected diagnosis.
B. Further aspects of exam relevance.
C. Delays associated with exams
D. Changes in practice in terms of type of examination, clinical situations, the number of tests ordered per patient, and emergency situations
E. Radiation and contrast agent exposures
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Nîmes Cedex 09, France, 30029
- CHU de Nimes - Hopital Universitaire Caremeau
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The patient (or his/her guardian/parent/person-of-trust) was correctly informed about the study
- A participating ER doctor has requested an imaging exam for the patient during one of the trial observation periods (ie the "before" period or the "after" period).
Exclusion Criteria:
- The patient is under judicial protection
- The patient (or his/her guardian/parent/person-of-trust) refuses to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Before guideline implementation
This study population consists of all patients for whom a participating ER doctor requests an imaging exam during the observation period BEFORE the implementation of the referral guidelines. [This study is composed of (1) a period of observation for 1 month BEFORE the implementation of the referral guidelines, followed by (2) the implementation of the referral guidelines, then (3) a 5-6 month washout period, and finally (4) a 1 month observational period AFTER the implementation of the referral guidelines.] Intervention: Baseline observation |
During this period of the study, baseline data will be collected.
|
Other: After guideline implementation
This study population consists of all patients for whom a participating ER doctor requests an imaging exam during the observation period AFTER the implementation of the referral guideline. [This study is composed of (1) a period of observation for 1 month BEFORE the implementation of the referral guidelines, followed by (2) the implementation of the referral guidelines, then (3) a 5-6 month washout period, and finally (4) a 1 month observational period AFTER the implementation of the referral guidelines.] Intervention: Implementation of guidelines |
The participating ER doctors are required to request imaging exams for their patients according to a guide mutually constructed by the emergency and imaging departments of the Nîmes university hospital.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the % of initial, suspected diagnoses that are confirmed positive by the requested exam
Time Frame: baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Measured over an observation period of 1 month.
|
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the classification of exam results in relation to initial, suspected diagnosis
Time Frame: baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Qualitative variable: (i) the suspected diagnosis is confirmed; (ii) the suspected diagnosis was not confirmed, the exam was normal; (iii) the suspected diagnosis was confirmed, and another unsuspected pathology was also found; (iv) the suspected diagnosis was not confirmed, and another unsuspected pathology was found. Measured over an observation period of 1 month. |
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Change in the % of requested exams that do not conform with the exam recommended by the implemented guidelines
Time Frame: baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Measured over an observation period of 1 month.
|
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Change in the positivity rate for each suspected diagnosis
Time Frame: baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Measured over an observation period of 1 month.
|
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Change in the % of exams performed identical to the exam requested
Time Frame: baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Measured over an observation period of 1 month.
|
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Change in the average delay between the time marked on the request and the exam.
Time Frame: baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Measured over an observation period of 1 month.
|
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Change in the average delay between the time marked on the request and the distribution of written exam results.
Time Frame: baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Measured over an observation period of 1 month.
|
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Change in the number of admissions in the emergency department
Time Frame: baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Measured over an observation period of 1 month.
|
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Change in the number of requests for imaging exams made by the emergency department
Time Frame: baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Measured over an observation period of 1 month.
|
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Change in the % of patients admitted to the emergency department and needing an imaging exam.
Time Frame: baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Measured over an observation period of 1 month.
|
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Change in the frequency of each type of exam carried out.
Time Frame: baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Measured over an observation period of 1 month.
|
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Change in the frequency of each type of clinical situation associated with imaging exams.
Time Frame: baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Measured over an observation period of 1 month.
|
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Change in the average number of imaging exams requested per patient
Time Frame: baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Measured over an observation period of 1 month.
|
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Change in the frequency of imaging exams requested per type of emergency situation
Time Frame: baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
vital; imaging needed in 4 - 6 hours; imaging needed in 6 to 24h, scheduled for hospitalisation, external demand, social requirements Measured over an observation period of 1 month. |
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Change in the % agreement between the clinical situation coded by the emergency doctor and the radiologist
Time Frame: baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Measured over an observation period of 1 month.
|
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Change in the total radiation exposure per patient
Time Frame: baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Measured over an observation period of 1 month.
|
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Change in the frequency of injection of contrast agents
Time Frame: baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Measured over an observation period of 1 month.
|
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Change in the frequency of patients requiring contrast agents AND whose exam results are classified as "the suspected diagnosis was not confirmed, exam normal"
Time Frame: baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Measured over an observation period of 1 month.
|
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
|
Collaborators and Investigators
Investigators
- Principal Investigator: Patrick Richard, MD, Centre Hospitalier Universitaire de Nīmes
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LOCAL/2012/PR-01
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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