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

Sponsor
Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Completed
CT.gov ID
NCT01785368
Collaborator
(none)
8,549
1
2
8
1070.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Implementation of guidelines
  • Other: Baseline observation
N/A

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:

  1. How exam results are classified in relation to the initial, suspected diagnosis.

  2. Further aspects of exam relevance.

  3. Delays associated with exams

  4. Changes in practice in terms of type of examination, clinical situations, the number of tests ordered per patient, and emergency situations

  5. Radiation and contrast agent exposures

Study Design

Study Type:
Interventional
Actual Enrollment :
8549 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Implementing Referral Guidelines for Imaging Exams Requested Via the Emergency Department: Impact on Exam Relevance and Associated Delays
Study Start Date :
Oct 1, 2013
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

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

Other: 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

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Nîmes - Hôpital Universitaire Carémeau Nîmes Cedex 09 France 30029

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nīmes

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01785368
Other Study ID Numbers:
  • LOCAL/2012/PR-01
First Posted:
Feb 7, 2013
Last Update Posted:
Mar 26, 2015
Last Verified:
Mar 1, 2015
Keywords provided by Centre Hospitalier Universitaire de Nīmes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 26, 2015