NCT01785368

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,549

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2014

Completed
Last Updated

November 17, 2025

Status Verified

March 1, 2015

Enrollment Period

8 months

First QC Date

February 5, 2013

Last Update Submit

November 14, 2025

Conditions

Keywords

guidelinesreferral guidelinesexam delaysexam relevance

Outcome Measures

Primary Outcomes (1)

  • Change in the % of initial, suspected diagnoses that are confirmed positive by the requested exam

    Measured over an observation period of 1 month.

    baseline (days 0 to 30) versus the 6th month after implementation of guidelines

Secondary Outcomes (17)

  • 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

  • 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

  • Change in the positivity rate for each suspected diagnosis

    baseline (days 0 to 30) versus the 6th month after implementation of guidelines

  • Change in the % of exams performed identical to the exam requested

    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.

    baseline (days 0 to 30) versus the 6th month after implementation of guidelines

  • +12 more secondary outcomes

Study Arms (2)

Before guideline implementation

OTHER

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

After guideline implementation

OTHER

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

Interventions

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.

After guideline implementation

During this period of the study, baseline data will be collected.

Before guideline implementation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • The patient is under judicial protection
  • The patient (or his/her guardian/parent/person-of-trust) refuses to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Related Publications (1)

  • Claret PG, Bobbia X, Macri F, Stowell A, Motte A, Landais P, Beregi JP, de La Coussaye JE. Impact of a computerized provider radiography order entry system without clinical decision support on emergency department medical imaging requests. Comput Methods Programs Biomed. 2016 Jun;129:82-8. doi: 10.1016/j.cmpb.2016.03.006. Epub 2016 Mar 17.

Study Officials

  • Patrick Richard, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2013

First Posted

February 7, 2013

Study Start

October 1, 2013

Primary Completion

June 2, 2014

Study Completion

June 2, 2014

Last Updated

November 17, 2025

Record last verified: 2015-03

Locations