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Completed

NCT Number: NCT04021511

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

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.

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Key information

Conditions

Ankle Injuries Behavior Crowding Disease Attributes Emergencies Leg Injuries Nurse's Role Pathologic Processes Pathological Conditions, Signs and Symptoms Spatial Behavior Wounds and Injuries

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de Saint-Brieuc

Saint-Brieuc, 22027, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OAR application by a nurse

Other

As per protocol, in the Phase B, nurses will be allowed to apply OAR which can lead to an early radiography prescription.

Primary outcomes

  1. 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

  1. Percentage of x-rays

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

    Difference of the percentage of x-rays between Phase A group and Phase B group.

  2. Time spent by nurse for patient care

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

    Difference of the time spent by nurse for patient care between Phase A group and Phase B group.

  3. Comparaison of x-rays prescription between physicians and nurses

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

    Difference of percentage of x-rays prescribed by nurses and physicians in Phase B group.

  4. Numbers of fractures identified by an x-ray requested by the physician in group B

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

    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.

  5. Numbers of fractures identified by an x-ray requested by a nurse in group B

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

    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.

  6. Other x-rays required

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

    For patients whose x-ray was required, percentage of ankle x-ray performed while actually the trauma concerned the foot and not the ankle.

  7. Satisfaction rate of nurses

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

    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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Saint-Brieuc

Other

Registry information

Official study 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

Acronym: PARIAO

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 16, 2019
Registry last updated
Oct 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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