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

H

Hospital Center of Saint-Brieuc

Status

Completed

Conditions

Emergencies
Nurse's Role
Ankle Injuries

Treatments

Other: OAR application by a nurse

Study type

Interventional

Funder types

Other

Identifiers

NCT04021511
CHSB_201905_P1_PARIAO

Details and patient eligibility

About

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.

Full 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.

Enrollment

63 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

63 participants in 2 patient groups

Phase A
No Intervention group
Description:
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 group
Description:
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.
Treatment:
Other: OAR application by a nurse

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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