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

Emergencies Clinical Trial

— PARIAO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04021511
• Other study ID #: CHSB_201905_P1_PARIAO
• Status: Completed
• Phase: N/A
• Start date: July 16, 2019
• Est. completion date: October 7, 2019

Study information

• Verified date: October 2019
• Source: Centre Hospitalier de Saint-Brieuc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: October 7, 2019
• Est. primary completion date: September 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Injuries
• Emergencies
• Nurse's Role

Intervention

Other:
• OAR application by a nurse
As per protocol, in the Phase B, nurses will be allowed to apply OAR which can lead to an early radiography prescription.

Locations

Country	Name	City	State
France	Centre Hospitalier de Saint-Brieuc	Saint-Brieuc

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier de Saint-Brieuc

Country where clinical trial is conducted

France, 

References & Publications (8)

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. Erratum in: Accid Emerg Nurs 2000 Oct;8(4):253. — View 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. Review. — View 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. Epub 2006 Jan 25. — View 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. — View 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 — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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