Back to resultsReferral Guidelines for Imaging Exams: Impact on Exam Relevance and Associated Delays (RIU)
Primary Purpose
Emergency Department Admission, Imaging Techniques
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Implementation of guidelines
Baseline observation
Sponsored by
About this trial
This is an interventional health services research trial for Emergency Department Admission focused on measuring guidelines, referral guidelines, exam delays, exam relevance
Eligibility Criteria
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
Sites / Locations
- CHU de Nîmes - Hôpital Universitaire Carémeau
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Before guideline implementation
After guideline implementation
Arm Description
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
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
Outcomes
Primary Outcome Measures
Change in the % of initial, suspected diagnoses that are confirmed positive by the requested exam
Measured over an observation period of 1 month.
Secondary Outcome Measures
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.
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.
Change in the positivity rate for each suspected diagnosis
Measured over an observation period of 1 month.
Change in the % of exams performed identical to the exam requested
Measured over an observation period of 1 month.
Change in the average delay between the time marked on the request and the exam.
Measured over an observation period of 1 month.
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.
Change in the number of admissions in the emergency department
Measured over an observation period of 1 month.
Change in the number of requests for imaging exams made by the emergency department
Measured over an observation period of 1 month.
Change in the % of patients admitted to the emergency department and needing an imaging exam.
Measured over an observation period of 1 month.
Change in the frequency of each type of exam carried out.
Measured over an observation period of 1 month.
Change in the frequency of each type of clinical situation associated with imaging exams.
Measured over an observation period of 1 month.
Change in the average number of imaging exams requested per patient
Measured over an observation period of 1 month.
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.
Change in the % agreement between the clinical situation coded by the emergency doctor and the radiologist
Measured over an observation period of 1 month.
Change in the total radiation exposure per patient
Measured over an observation period of 1 month.
Change in the frequency of injection of contrast agents
Measured over an observation period of 1 month.
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.
Full Information
NCT ID
NCT01785368
First Posted
February 5, 2013
Last Updated
March 25, 2015
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT01785368
Brief Title
Referral Guidelines for Imaging Exams: Impact on Exam Relevance and Associated Delays
Acronym
RIU
Official Title
Implementing Referral Guidelines for Imaging Exams Requested Via the Emergency Department: Impact on Exam Relevance and Associated Delays
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergency Department Admission, Imaging Techniques
Keywords
guidelines, referral guidelines, exam delays, exam relevance
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8549 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Before guideline implementation
Arm Type
Other
Arm Description
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
Arm Title
After guideline implementation
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Implementation of guidelines
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Baseline observation
Intervention Description
During this period of the study, baseline data will be collected.
Primary Outcome Measure Information:
Title
Change in the % of initial, suspected diagnoses that are confirmed positive by the requested exam
Description
Measured over an observation period of 1 month.
Time Frame
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
Secondary Outcome Measure Information:
Title
Change in the classification of exam results in relation to initial, suspected diagnosis
Description
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.
Time Frame
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
Title
Change in the % of requested exams that do not conform with the exam recommended by the implemented guidelines
Description
Measured over an observation period of 1 month.
Time Frame
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
Title
Change in the positivity rate for each suspected diagnosis
Description
Measured over an observation period of 1 month.
Time Frame
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
Title
Change in the % of exams performed identical to the exam requested
Description
Measured over an observation period of 1 month.
Time Frame
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
Title
Change in the average delay between the time marked on the request and the exam.
Description
Measured over an observation period of 1 month.
Time Frame
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
Title
Change in the average delay between the time marked on the request and the distribution of written exam results.
Description
Measured over an observation period of 1 month.
Time Frame
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
Title
Change in the number of admissions in the emergency department
Description
Measured over an observation period of 1 month.
Time Frame
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
Title
Change in the number of requests for imaging exams made by the emergency department
Description
Measured over an observation period of 1 month.
Time Frame
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
Title
Change in the % of patients admitted to the emergency department and needing an imaging exam.
Description
Measured over an observation period of 1 month.
Time Frame
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
Title
Change in the frequency of each type of exam carried out.
Description
Measured over an observation period of 1 month.
Time Frame
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
Title
Change in the frequency of each type of clinical situation associated with imaging exams.
Description
Measured over an observation period of 1 month.
Time Frame
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
Title
Change in the average number of imaging exams requested per patient
Description
Measured over an observation period of 1 month.
Time Frame
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
Title
Change in the frequency of imaging exams requested per type of emergency situation
Description
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.
Time Frame
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
Title
Change in the % agreement between the clinical situation coded by the emergency doctor and the radiologist
Description
Measured over an observation period of 1 month.
Time Frame
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
Title
Change in the total radiation exposure per patient
Description
Measured over an observation period of 1 month.
Time Frame
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
Title
Change in the frequency of injection of contrast agents
Description
Measured over an observation period of 1 month.
Time Frame
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
Title
Change in the frequency of patients requiring contrast agents AND whose exam results are classified as "the suspected diagnosis was not confirmed, exam normal"
Description
Measured over an observation period of 1 month.
Time Frame
baseline (days 0 to 30) versus the 6th month after implementation of guidelines
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Richard, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
ZIP/Postal Code
30029
Country
France
12. IPD Sharing Statement
Learn more about this trial
Referral Guidelines for Imaging Exams: Impact on Exam Relevance and Associated Delays
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