Emergency Department Admission Clinical Trial
— RIUOfficial title:
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.
| Status | Completed |
| Enrollment | 8549 |
| Est. completion date | June 2014 |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
| Country | Name | City | State |
|---|---|---|---|
| France | CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes Cedex 09 |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Nimes |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | Change in the classification of exam results in relation to initial, suspected diagnosis | 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 | No |
| Secondary | Change in the % of requested exams that do not conform with the exam recommended by the implemented guidelines | Measured over an observation period of 1 month. | baseline (days 0 to 30) versus the 6th month after implementation of guidelines | No |
| Secondary | Change in the positivity rate for each suspected diagnosis | Measured over an observation period of 1 month. | baseline (days 0 to 30) versus the 6th month after implementation of guidelines | No |
| Secondary | Change in the % of exams performed identical to the exam requested | Measured over an observation period of 1 month. | baseline (days 0 to 30) versus the 6th month after implementation of guidelines | No |
| Secondary | Change in the average delay between the time marked on the request and the exam. | Measured over an observation period of 1 month. | baseline (days 0 to 30) versus the 6th month after implementation of guidelines | No |
| Secondary | Change in the average delay between the time marked on the request and the distribution of written exam results. | Measured over an observation period of 1 month. | baseline (days 0 to 30) versus the 6th month after implementation of guidelines | No |
| Secondary | Change in the number of admissions in the emergency department | Measured over an observation period of 1 month. | baseline (days 0 to 30) versus the 6th month after implementation of guidelines | No |
| Secondary | Change in the number of requests for imaging exams made by the emergency department | Measured over an observation period of 1 month. | baseline (days 0 to 30) versus the 6th month after implementation of guidelines | No |
| Secondary | Change in the % of patients admitted to the emergency department and needing an imaging exam. | Measured over an observation period of 1 month. | baseline (days 0 to 30) versus the 6th month after implementation of guidelines | No |
| Secondary | Change in the frequency of each type of exam carried out. | Measured over an observation period of 1 month. | baseline (days 0 to 30) versus the 6th month after implementation of guidelines | No |
| Secondary | Change in the frequency of each type of clinical situation associated with imaging exams. | Measured over an observation period of 1 month. | baseline (days 0 to 30) versus the 6th month after implementation of guidelines | No |
| Secondary | Change in the average number of imaging exams requested per patient | Measured over an observation period of 1 month. | baseline (days 0 to 30) versus the 6th month after implementation of guidelines | No |
| Secondary | Change in the frequency of imaging exams requested per type of emergency situation | 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 | No |
| Secondary | Change in the % agreement between the clinical situation coded by the emergency doctor and the radiologist | Measured over an observation period of 1 month. | baseline (days 0 to 30) versus the 6th month after implementation of guidelines | No |
| Secondary | Change in the total radiation exposure per patient | Measured over an observation period of 1 month. | baseline (days 0 to 30) versus the 6th month after implementation of guidelines | Yes |
| Secondary | Change in the frequency of injection of contrast agents | Measured over an observation period of 1 month. | baseline (days 0 to 30) versus the 6th month after implementation of guidelines | Yes |
| Secondary | Change in the frequency of patients requiring contrast agents AND whose exam results are classified as "the suspected diagnosis was not confirmed, exam normal" | Measured over an observation period of 1 month. | baseline (days 0 to 30) versus the 6th month after implementation of guidelines | Yes |