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

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ClinicalTrials.gov Identifier: NCT01785368
Recruitment Status : Completed
First Posted : February 7, 2013
Last Update Posted : March 26, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Emergency Department Admission Imaging Techniques Other: Implementation of guidelines Other: Baseline observation Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
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 : October 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.


  14. 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.

  15. 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.

  16. 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.

  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" [ Time Frame: baseline (days 0 to 30) versus the 6th month after implementation of guidelines ]
    Measured over an observation period of 1 month.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785368


Locations
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France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Patrick Richard, MD Centre Hospitalier Universitaire de Nîmes

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01785368     History of Changes
Other Study ID Numbers: LOCAL/2012/PR-01
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
guidelines
referral guidelines
exam delays
exam relevance
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes