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出境医 / 临床实验 / Early Prescription of Radiography Using the Ottawa Ankle Rules by a Nurse in the Management of Isolated Ankle Trauma (PARIAO)

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Ankle Injuries Nurse's Role Emergencies Other: OAR application by a nurse Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : July 16, 2019
Actual Primary Completion Date : September 6, 2019
Actual Study Completion Date : October 7, 2019
Arms and Interventions
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.
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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

    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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Locations
Layout table for location information
France
Centre Hospitalier de Saint-Brieuc
Saint-Brieuc, France, 22027
Sponsors and Collaborators
Centre Hospitalier de Saint-Brieuc
Tracking Information
First Submitted Date  ICMJE July 10, 2019
First Posted Date  ICMJE July 16, 2019
Last Update Posted Date October 10, 2019
Actual Study Start Date  ICMJE July 16, 2019
Actual Primary Completion Date September 6, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Prescription of Radiography Using the Ottawa Ankle Rules by a Nurse in the Management of Isolated Ankle Trauma
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Ankle Injuries
  • Nurse's Role
  • Emergencies
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: OAR application by a nurse
Publications *
  • 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.
  • 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.
  • 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.
  • 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.
  • 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: 10.1016/j.ijnurstu.2016.08.016. Epub 2016 Aug 25. Review.
  • 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.
  • 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.
  • 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 Jun 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2019) 		63
Original Estimated Enrollment  ICMJE
 (submitted: July 15, 2019) 		378
Actual Study Completion Date  ICMJE October 7, 2019
Actual Primary Completion Date September 6, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04021511
Other Study ID Numbers  ICMJE CHSB_201905_P1_PARIAO
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All Individual Participant Data (anonymized) that underlie results in a publication
Supporting Materials: Study Protocol
Supporting Materials: Clinical Study Report (CSR)
Time Frame: From the end of the study for 15 years.
Access Criteria: Access through secure platform with personal username and password
Responsible Party Pierre Kergaravat, Centre Hospitalier de Saint-Brieuc
Study Sponsor  ICMJE Centre Hospitalier de Saint-Brieuc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Hospitalier de Saint-Brieuc
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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