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

October 9, 2019 updated by: Pierre Kergaravat, Centre Hospitalier de Saint-Brieuc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Brieuc, France, 22027
        • Centre Hospitalier de Saint-Brieuc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Phase A
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
Experimental: Phase B
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, between 2 and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, between 2 and 3 months
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.
through study completion, between 2 and 3 months
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.
through study completion, between 2 and 3 months
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.
through study completion, between 2 and 3 months
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.
through study completion, between 2 and 3 months
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.
through study completion, between 2 and 3 months
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

  1. - 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.
  2. - 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.
  3. - question about Ottawa Ankle Rules application : does nurse think that this rules application improves patient's management (quality, quickness, …) ? : yes or no
  4. - 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
  5. - 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier de Saint-Brieuc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2019

Primary Completion (Actual)

September 6, 2019

Study Completion (Actual)

October 7, 2019

Study Registration Dates

First Submitted

July 10, 2019

First Submitted That Met QC Criteria

July 15, 2019

First Posted (Actual)

July 16, 2019

Study Record Updates

Last Update Posted (Actual)

October 10, 2019

Last Update Submitted That Met QC Criteria

October 9, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHSB_201905_P1_PARIAO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All Individual Participant Data (anonymized) that underlie results in a publication

IPD Sharing Time Frame

From the end of the study for 15 years.

IPD Sharing Access Criteria

Access through secure platform with personal username and password

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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