Clinical trial NCT04021511: Early Prescription of Radiography Using the Ottawa Ankle Rules by a Nurse in the Management of Isolated Ankle Trauma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Injuries
Nurse's Role
Emergencies
Keywords: overcrowding
x rays
emergency department
Ottawa Ankle Rules
nurse practitioner
Lead sponsor: Centre Hospitalier de Saint-Brieuc
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Time spent in emergency departement
timeFrame: through study completion, between 2 and 3 months
Secondary outcomes:
measure: Percentage of x-rays
timeFrame: through study completion, between 2 and 3 months
measure: Time spent by nurse for patient care
timeFrame: through study completion, between 2 and 3 months
measure: Comparaison of x-rays prescription between physicians and nurses
timeFrame: through study completion, between 2 and 3 months
measure: Numbers of fractures identified by an x-ray requested by the physician in group B
timeFrame: through study completion, between 2 and 3 months
measure: Numbers of fractures identified by an x-ray requested by a nurse in group B
timeFrame: through study completion, between 2 and 3 months
measure: Other x-rays required
timeFrame: through study completion, between 2 and 3 months
measure: Satisfaction rate of nurses
timeFrame: through study completion, between 2 and 3 months
Other outcomes:
Locations:
city: Saint-Brieuc
country: France
facility: Centre Hospitalier de Saint-Brieuc
Study officials:
References:
citation: Stiell IG, Greenberg GH, McKnight RD, Nair RC, McDowell I, Worthington JR. A study to develop clinical decision rules for the use of radiography in acute ankle injuries. Ann Emerg Med. 1992 Apr;21(4):384-90. doi: 10.1016/s0196-0644(05)82656-3.
citation: Stiell IG, Greenberg GH, McKnight RD, Nair RC, McDowell I, Reardon M, Stewart JP, Maloney J. Decision rules for the use of radiography in acute ankle injuries. Refinement and prospective validation. JAMA. 1993 Mar 3;269(9):1127-32. doi: 10.1001/jama.269.9.1127.
citation: Stiell I, Wells G, Laupacis A, Brison R, Verbeek R, Vandemheen K, Naylor CD. Multicentre trial to introduce the Ottawa ankle rules for use of radiography in acute ankle injuries. Multicentre Ankle Rule Study Group. BMJ. 1995 Sep 2;311(7005):594-7. doi: 10.1136/bmj.311.7005.594.
citation: Fan J, Woolfrey K. The effect of triage-applied Ottawa Ankle Rules on the length of stay in a Canadian urgent care department: a randomized controlled trial. Acad Emerg Med. 2006 Feb;13(2):153-7. doi: 10.1197/j.aem.2005.07.041. Epub 2006 Jan 25.
citation: Ho JK, Chau JP, Cheung NM. Effectiveness of emergency nurses' use of the Ottawa Ankle Rules to initiate radiographic tests on improving healthcare outcomes for patients with ankle injuries: A systematic review. Int J Nurs Stud. 2016 Nov;63:37-47. doi: 10.1016/j.ijnurstu.2016.08.016. Epub 2016 Aug 25.
citation: Allerston J, Justham D. Nurse practitioners and the Ottawa Ankle Rules: comparisons with medical staff in requesting X-rays for ankle injured patients. Accid Emerg Nurs. 2000 Apr;8(2):110-5. doi: 10.1054/aaen.2000.0103.
citation: Derlet RW, Richards JR. Overcrowding in the nation's emergency departments: complex causes and disturbing effects. Ann Emerg Med. 2000 Jan;35(1):63-8. doi: 10.1016/s0196-0644(00)70105-3.
citation: Lau LH, Kerr D, Law I, Ritchie P. Nurse practitioners treating ankle and foot injuries using the Ottawa Ankle Rules: a comparative study in the emergency department. Australas Emerg Nurs J. 2013 Aug;16(3):110-5. doi: 10.1016/j.aenj.2013.05.007. Epub 2013 Jun 25.