Referral Guidelines for Imaging Exams: Impact on Exam Relevance and Associated Delays

Not Applicable

Completed

• Conditions: Emergency Department Admission; Imaging Techniques
• Interventions: Other: Baseline observation; Other: Implementation of guidelines

• Registration Number: NCT01785368
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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

Study Timeline

• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-02-05
• Study First Posted: 2013-02-07
• Study Start: 2013-10
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8549

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Before guideline implementation	Baseline observation	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
After guideline implementation	Implementation of guidelines	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

Primary Outcome Measures

Name	Time	Method
Change in the % of initial, suspected diagnoses that are confirmed positive by the requested exam	baseline (days 0 to 30) versus the 6th month after implementation of guidelines	Measured over an observation period of 1 month.

Secondary Outcome Measures

Name	Time	Method
Change in the classification of exam results in relation to initial, suspected diagnosis	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.
Change in the frequency of each type of clinical situation associated with imaging exams.	baseline (days 0 to 30) versus the 6th month after implementation of guidelines	Measured over an observation period of 1 month.
Change in the % agreement between the clinical situation coded by the emergency doctor and the radiologist	baseline (days 0 to 30) versus the 6th month after implementation of guidelines	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	baseline (days 0 to 30) versus the 6th month after implementation of guidelines	Measured over an observation period of 1 month.
Change in the % of exams performed identical to the exam requested	baseline (days 0 to 30) versus the 6th month after implementation of guidelines	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.	baseline (days 0 to 30) versus the 6th month after implementation of guidelines	Measured over an observation period of 1 month.
Change in the number of requests for imaging exams made by the emergency department	baseline (days 0 to 30) versus the 6th month after implementation of guidelines	Measured over an observation period of 1 month.
Change in the positivity rate for each suspected diagnosis	baseline (days 0 to 30) versus the 6th month after implementation of guidelines	Measured over an observation period of 1 month.
Change in the frequency of imaging exams requested per type of emergency situation	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.
Change in the frequency of injection of contrast agents	baseline (days 0 to 30) versus the 6th month after implementation of guidelines	Measured over an observation period of 1 month.
Change in the frequency of each type of exam carried out.	baseline (days 0 to 30) versus the 6th month after implementation of guidelines	Measured over an observation period of 1 month.
Change in the average number of imaging exams requested per patient	baseline (days 0 to 30) versus the 6th month after implementation of guidelines	Measured over an observation period of 1 month.
Change in the total radiation exposure per patient	baseline (days 0 to 30) versus the 6th month after implementation of guidelines	Measured over an observation period of 1 month.
Change in the average delay between the time marked on the request and the exam.	baseline (days 0 to 30) versus the 6th month after implementation of guidelines	Measured over an observation period of 1 month.
Change in the number of admissions in the emergency department	baseline (days 0 to 30) versus the 6th month after implementation of guidelines	Measured over an observation period of 1 month.
Change in the % of patients admitted to the emergency department and needing an imaging exam.	baseline (days 0 to 30) versus the 6th month after implementation of guidelines	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"	baseline (days 0 to 30) versus the 6th month after implementation of guidelines	Measured over an observation period of 1 month.

Trial Locations

Locations (1)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France