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

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.

Study Overview

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

Interventional

Enrollment (Actual)

8549

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

      • Nîmes Cedex 09, France, 30029
        • CHU de Nimes - Hopital Universitaire Caremeau

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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: 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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Patrick Richard, MD, Centre Hospitalier Universitaire de Nīmes

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

October 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

February 5, 2013

First Submitted That Met QC Criteria

February 5, 2013

First Posted (Estimate)

February 7, 2013

Study Record Updates

Last Update Posted (Estimate)

March 26, 2015

Last Update Submitted That Met QC Criteria

March 25, 2015

Last Verified

March 1, 2015

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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