Emergency Department AdmissionRIUNCT01785368
Referral Guidelines for Imaging Exams: Impact on Exam Relevance and Associated Delays
A study testing Implementation of guidelines and Baseline observation in people with Emergency Department Admission and Imaging Techniques, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The main objective of this study is to evaluate the impact of the implementation of referral guidelines for imaging exams requested by the emergency department on exam relevance. The latter is assessed via the rate of suspected diagnoses that are confirmed by the requested exam. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Emergency Department Admission, Imaging Techniques
- What is being tested?
- Implementation of guidelines and Baseline observation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,549 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to 2 Jun 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- The patient is under judicial protection
- The patient (or his/her guardian/parent/person-of-trust) refuses to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementing Referral Guidelines for Imaging Exams Requested Via the Emergency Department: Impact on Exam Relevance and Associated Delays
The main objective of this study is to evaluate the impact of the implementation of referral guidelines for imaging exams requested by the emergency department on exam relevance. The latter is assessed via the rate of suspected diagnoses that are confirmed by the requested exam.
Read the 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:
- How exam results are classified in relation to the initial, suspected diagnosis.
- Further aspects of exam relevance.
- Delays associated with exams
- Changes in practice in terms of type of examination, clinical situations, the number of tests ordered per patient, and emergency situations
- Radiation and contrast agent exposures
- Conditions
- Emergency Department Admission, Imaging Techniques
- Being tested
- Implementation of guidelines, Baseline observation
- Keywords
- guidelines, referral guidelines, exam delays, exam relevance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of guidelinesOther
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.
Baseline observationOther
During this period of the study, baseline data will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Before guideline implementation | Other | 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 Receives: Other: Baseline observation |
| After guideline implementation | Other | 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 Receives: Other: Implementation of guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the % of initial, suspected diagnoses that are confirmed positive by the requested exam
Measured over an observation period of 1 month.
Measured: baseline (days 0 to 30) versus the 6th month after implementation of guidelines
Secondary outcomes (17)
Change in the classification of exam results in relation to initial, suspected diagnosis
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.
Measured: 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
Measured over an observation period of 1 month.
Measured: baseline (days 0 to 30) versus the 6th month after implementation of guidelines
Change in the positivity rate for each suspected diagnosis
Measured over an observation period of 1 month.
Measured: baseline (days 0 to 30) versus the 6th month after implementation of guidelines
Change in the % of exams performed identical to the exam requested
Measured over an observation period of 1 month.
Measured: 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.
Measured over an observation period of 1 month.
Measured: 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.
Measured over an observation period of 1 month.
Measured: baseline (days 0 to 30) versus the 6th month after implementation of guidelines
Change in the number of admissions in the emergency department
Measured over an observation period of 1 month.
Measured: 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
Measured over an observation period of 1 month.
Measured: 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.
Measured over an observation period of 1 month.
Measured: baseline (days 0 to 30) versus the 6th month after implementation of guidelines
Change in the frequency of each type of exam carried out.
Measured over an observation period of 1 month.
Measured: 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.
Measured over an observation period of 1 month.
Measured: baseline (days 0 to 30) versus the 6th month after implementation of guidelines
Change in the average number of imaging exams requested per patient
Measured over an observation period of 1 month.
Measured: 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
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.
Measured: 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
Measured over an observation period of 1 month.
Measured: baseline (days 0 to 30) versus the 6th month after implementation of guidelines
Change in the total radiation exposure per patient
Measured over an observation period of 1 month.
Measured: baseline (days 0 to 30) versus the 6th month after implementation of guidelines
Change in the frequency of injection of contrast agents
Measured over an observation period of 1 month.
Measured: 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"
Measured over an observation period of 1 month.
Measured: baseline (days 0 to 30) versus the 6th month after implementation of guidelines
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startOct 2013
- Primary completion2 Jun 2014
- Study completion2 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergency Department AdmissionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8,549 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Richard, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785368
- Sponsor's protocol ID
- LOCAL/2012/PR-01
- Other IDs
- 2013-A00113-42
- Acronym
- RIU
- Status last verified
- Mar 2015
- First submitted
- 5 Feb 2013
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Claret PG, Bobbia X, Macri F, Stowell A, Motte A, Landais P, Beregi JP, de La Coussaye JE. Impact of a computerized provider radiography order entry system without clinical decision support on emergency department medical imaging requests. Comput Methods Programs Biomed. 2016 Jun;129:82-8. doi: 10.1016/j.cmpb.2016.03.006. Epub 2016 Mar 17.
PubMed 27084323
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Referral Guidelines for Imaging Exams Requested Via the Emergency Department: Impact on Exam Relevance and Associated Delays
- ClinicalTrials.gov ID
- NCT01785368
- Acronym / sponsor ID
- RIU / LOCAL/2012/PR-01
- Conditions
- Emergency Department Admission, Imaging Techniques
- Keywords
- guidelines, referral guidelines, exam delays, exam relevance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,549 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- 2 Jun 2014 (actual)
- Study completion
- 2 Jun 2014 (actual)
- First posted
- 7 Feb 2013 (estimated)
- 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 main objective of this study is to evaluate the impact of the implementation of referral guidelines for imaging exams requested by the emergency department on exam relevance. The latter is assessed via the rate of suspected diagnoses that are confirmed by the requested exam.
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:
- How exam results are classified in relation to the initial, suspected diagnosis.
- Further aspects of exam relevance.
- Delays associated with exams
- Changes in practice in terms of type of examination, clinical situations, the number of tests ordered per patient, and emergency situations
- Radiation and contrast agent exposures
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before guideline implementation | Other | Other: Baseline observationThis 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 |
| After guideline implementation | Other | Other: Implementation of guidelinesThis 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- The patient is under judicial protection
- The patient (or his/her guardian/parent/person-of-trust) refuses to participate in the study
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 |
|---|---|---|
| Implementation of guidelinesThe 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. | Other | After guideline implementation |
| Baseline observationDuring this period of the study, baseline data will be collected. | Other | Before guideline implementation |
Primary outcome
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.
17 secondary outcomes
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
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
Change in the positivity rate for each suspected diagnosis
Time frame: 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
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
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
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
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
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
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
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
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
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
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
Change in the total radiation exposure per patient
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Results publication: PubMed 27084323Claret PG, Bobbia X, Macri F, Stowell A, Motte A, Landais P, Beregi JP, de La Coussaye JE. Impact of a computerized provider radiography order entry system without clinical decision support on emergency department medical imaging requests. Comput Methods Programs Biomed. 2016 Jun;129:82-8. doi: 10.1016/j.cmpb.2016.03.006. Epub 2016 Mar 17.
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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.
Patrick Richard, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of guidelines and Baseline observation in people with Emergency Department Admission and Imaging Techniques, run by Centre Hospitalier Universitaire de Nīmes at 1 site 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 2 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: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01785368, which also lists 1 linked publication.
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 17 Nov 2025.