Early Prescription of Radiography Using the Ottawa Ankle Rules by a Nurse in the Management of Isolated Ankle Trauma

Study Overview
=================
Brief Summary
-----------------
The study will be conducted in 2 phases (A and B) using two different groups of patients in order to prove that an early prescription of radiography using the Ottawa Ankle Rules by a nurse practitioner could shorten length of stay of a patient suffering from ankle trauma at the Hospital Center of Saint-Brieuc.

Detailed Description
-----------------
Ankle sprain is an injury very frequently encountered during consultation in hospitals emergency departments. Its mechanism may at times leads to fracture. The Ottawa Ankle Rules (OAR) provide guidelines to clinicians concerning the need to perform radiographic test to verify whether patients with ankle injuries are suffering from fracture. If all clinical and anamnestic criteria are negative in accordance with the OAR, the probability of a fracture being present is about 0% (IC 95%). OAR are validated for adults. Actually, a meta-analysis has suggested that it may be beneficial to introduce a nurse-initiated radiographic test protocol as a standard practice in emergency departments. However this early prescription is not a standard of care in most of emergency departments in France. The implementation of OAR decreases irradiation levels of patients and reduces medical expenses. In addition, it allows to reduce patient's duration of stay in already encumbered emergency departments, thus reducing also overcrowding, which is known to be a major factor of non quality of care in such departments. The study will be conducted in 2 phases of 4 weeks each : The first one (Phase A) will occur in the emergency department with the application of OAR only by the physicians (without changing the standard of care) The second one (Phase B) will occur after the Phase A, and nurses will apply OAR before physicians, according to the protocol.

Official Title
-----------------
Early Prescription of Radiography Using the Ottawa Ankle Rules by a Nurse in the Management of Isolated Ankle Trauma at the Emergency Department's Reception of the Hospital Center of Saint-Brieuc

Conditions
-----------------
Ankle Injuries, Nurse's Role, Emergencies

Intervention / Treatment
-----------------
* Other: OAR application by a nurse


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: With closed ankle injury less than 10 days old Affiliation to the national health insurance Written informed consent must be obtained Exclusion Criteria: Trauma dating more than 10 days Patient not affiliated to the national health insurance X-ray performed before patient admission Other trauma than an isolated trauma of the ankle Injury other than ankle injury : calcaneus, toes, and Achilles' tendon Paraplegic or quadriplegic patient Previous admission to the Emergency Department for the same traumatic event Patient already included in the PARIAO study Isolated skin injury / isolated superficial injury Ankle fracture or obvious deformation Neuro-vascular deficit Mental disorder Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty Excessive alcoholization or intoxication by other psychoactive substances (physician's decision) Uncooperative patient Pregnancy in progress

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Phase A<br>The first one (Phase A) will occur in the emergency department with the application of OAR only by the physicians (without changing the standard of care) during 4 weeks | |
| Experimental: Phase B<br>The second one (Phase B) will occur after the Phase A. Nurses will apply OAR according to the protocol. This phase will also lasts 4 weeks. | Other: OAR application by a nurse<br>* As per protocol, in the Phase B, nurses will be allowed to apply OAR which can lead to an early radiography prescription.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent in emergency departement | Difference of time spent in minutes in emergency department between Phase A group and Phase B group. | through study completion, between 2 and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of x-rays | Difference of the percentage of x-rays between Phase A group and Phase B group. | through study completion, between 2 and 3 months | 
| Time spent by nurse for patient care | Difference of the time spent by nurse for patient care between Phase A group and Phase B group. | through study completion, between 2 and 3 months | 
| Comparaison of x-rays prescription between physicians and nurses | Difference of percentage of x-rays prescribed by nurses and physicians in Phase B group. | through study completion, between 2 and 3 months | 
| Numbers of fractures identified by an x-ray requested by the physician in group B | For patients who have a fracture identified by an x-ray requested by the nurse or the physician : number of X-rays not requested by the nurse in the Phase B group. | through study completion, between 2 and 3 months | 
| Numbers of fractures identified by an x-ray requested by a nurse in group B | For patients who have a fracture identified by an x-ray requested by the nurse or the physician : number of X-rays not requested by the physician. | through study completion, between 2 and 3 months | 
| Other x-rays required | For patients whose x-ray was required, percentage of ankle x-ray performed while actually the trauma concerned the foot and not the ankle. | through study completion, between 2 and 3 months | 
| Satisfaction rate of nurses | Satisfaction rate of nurses evaluated through a questionnaire with 5 questions. Tittle : Nurse's satisfaction survey - evaluation of nurse's satisfaction for management of ankle trauma in usual management : scale from 0 to 10. 0 is no satisfaction ; 10 is important satisfaction. - evaluation of nurse's satisfaction for management of ankle trauma in this new management : scale from 0 to 10. 0 is no satisfaction ; 10 is important satisfaction. - question about Ottawa Ankle Rules application : does nurse think that this rules application improves patient's management (quality, quickness, …) ? : yes or no - evaluation of additional workload for nurse with the new management : scale from 0 to 10. 0 is no additional workload ; 10 is important additional workload - question if nurse is ready from now to realize an early prescription of radiography using the Ottawa Ankle Rules : yes or no | through study completion, between 2 and 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
overcrowding, x rays, emergency department, Ottawa Ankle Rules, nurse practitioner