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Clinical Trials/NCT04021511
NCT04021511CompletedNot Applicable

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

Centre Hospitalier de Saint-Brieuc2 sites in 1 country63 target enrollmentStarted: July 16, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
63
Locations
2
Primary Endpoint
Time spent in emergency departement

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Phase A

No Intervention

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

Phase B

Experimental

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.

Intervention: OAR application by a nurse (Other)

Outcomes

Primary Outcomes

Time spent in emergency departement

Time Frame: through study completion, between 2 and 3 months

Difference of time spent in minutes in emergency department between Phase A group and Phase B group.

Secondary Outcomes

  • Percentage of x-rays(through study completion, between 2 and 3 months)
  • Time spent by nurse for patient care(through study completion, between 2 and 3 months)
  • Comparaison of x-rays prescription between physicians and nurses(through study completion, between 2 and 3 months)
  • Numbers of fractures identified by an x-ray requested by the physician in group B(through study completion, between 2 and 3 months)
  • Numbers of fractures identified by an x-ray requested by a nurse in group B(through study completion, between 2 and 3 months)
  • Other x-rays required(through study completion, between 2 and 3 months)
  • Satisfaction rate of nurses(through study completion, between 2 and 3 months)

Investigators

Sponsor
Centre Hospitalier de Saint-Brieuc
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Pierre Kergaravat

Hospital physician, principal Investigator

Centre Hospitalier de Saint-Brieuc

Study Sites (2)

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