Early Prescription of Radiography Using the Ottawa Ankle Rules by a Nurse in the Management of Isolated Ankle Trauma (PARIAO)
Primary Purpose
Ankle Injuries, Nurse's Role, Emergencies
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
OAR application by a nurse
Sponsored by
About this trial
This is an interventional diagnostic trial for Ankle Injuries focused on measuring overcrowding, x rays, emergency department, Ottawa Ankle Rules, nurse practitioner
Eligibility 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
Sites / Locations
- Centre Hospitalier de Saint-Brieuc
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Phase A
Phase B
Arm 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
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.
Outcomes
Primary Outcome Measures
Time spent in emergency departement
Difference of time spent in minutes in emergency department between Phase A group and Phase B group.
Secondary Outcome Measures
Percentage of x-rays
Difference of the percentage of x-rays between Phase A group and Phase B group.
Time spent by nurse for patient care
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
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
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
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
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
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
Full Information
NCT ID
NCT04021511
First Posted
July 10, 2019
Last Updated
October 9, 2019
Sponsor
Centre Hospitalier de Saint-Brieuc
1. Study Identification
Unique Protocol Identification Number
NCT04021511
Brief Title
Early Prescription of Radiography Using the Ottawa Ankle Rules by a Nurse in the Management of Isolated Ankle Trauma
Acronym
PARIAO
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
July 16, 2019 (Actual)
Primary Completion Date
September 6, 2019 (Actual)
Study Completion Date
October 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier de Saint-Brieuc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Injuries, Nurse's Role, Emergencies
Keywords
overcrowding, x rays, emergency department, Ottawa Ankle Rules, nurse practitioner
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phase A
Arm Type
No Intervention
Arm 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
Arm Title
Phase B
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
OAR application by a nurse
Intervention Description
As per protocol, in the Phase B, nurses will be allowed to apply OAR which can lead to an early radiography prescription.
Primary Outcome Measure Information:
Title
Time spent in emergency departement
Description
Difference of time spent in minutes in emergency department between Phase A group and Phase B group.
Time Frame
through study completion, between 2 and 3 months
Secondary Outcome Measure Information:
Title
Percentage of x-rays
Description
Difference of the percentage of x-rays between Phase A group and Phase B group.
Time Frame
through study completion, between 2 and 3 months
Title
Time spent by nurse for patient care
Description
Difference of the time spent by nurse for patient care between Phase A group and Phase B group.
Time Frame
through study completion, between 2 and 3 months
Title
Comparaison of x-rays prescription between physicians and nurses
Description
Difference of percentage of x-rays prescribed by nurses and physicians in Phase B group.
Time Frame
through study completion, between 2 and 3 months
Title
Numbers of fractures identified by an x-ray requested by the physician in group B
Description
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.
Time Frame
through study completion, between 2 and 3 months
Title
Numbers of fractures identified by an x-ray requested by a nurse in group B
Description
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.
Time Frame
through study completion, between 2 and 3 months
Title
Other x-rays required
Description
For patients whose x-ray was required, percentage of ankle x-ray performed while actually the trauma concerned the foot and not the ankle.
Time Frame
through study completion, between 2 and 3 months
Title
Satisfaction rate of nurses
Description
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
Time Frame
through study completion, between 2 and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Centre Hospitalier de Saint-Brieuc
City
Saint-Brieuc
ZIP/Postal Code
22027
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
1554175
Citation
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. doi: 10.1016/s0196-0644(05)82656-3.
Results Reference
result
PubMed Identifier
8433468
Citation
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. doi: 10.1001/jama.269.9.1127.
Results Reference
result
PubMed Identifier
7663253
Citation
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. doi: 10.1136/bmj.311.7005.594.
Results Reference
result
PubMed Identifier
16436790
Citation
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. doi: 10.1197/j.aem.2005.07.041. Epub 2006 Jan 25.
Results Reference
result
PubMed Identifier
27592083
Citation
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.
Results Reference
result
PubMed Identifier
10818378
Citation
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. doi: 10.1054/aaen.2000.0103. Erratum In: Accid Emerg Nurs 2000 Oct;8(4):253.
Results Reference
result
PubMed Identifier
10613941
Citation
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. doi: 10.1016/s0196-0644(00)70105-3.
Results Reference
result
PubMed Identifier
23953094
Citation
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.
Results Reference
result
Learn more about this trial
Early Prescription of Radiography Using the Ottawa Ankle Rules by a Nurse in the Management of Isolated Ankle Trauma
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