Ankle InjuriesPARIAONCT04021511
Early Prescription of Radiography Using the Ottawa Ankle Rules by a Nurse in the Management of Isolated Ankle Trauma
A study testing OAR application by a nurse in people with Ankle Injuries and Nurse's Role, run by Centre Hospitalier de Saint-Brieuc at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Ankle Injuries, Nurse's Role, Emergencies
- What is being tested?
- OAR application by a nurse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jul 2019to 7 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- With closed ankle injury less than 10 days old
- Affiliation to the national health insurance
- Written informed consent must be obtained
Who cannot join
- 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
Show all 16Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Ankle Injuries, Nurse's Role, Emergencies
- Being tested
- OAR application by a nurse
- Keywords
- overcrowding, x rays, emergency department, Ottawa Ankle Rules, nurse practitioner
- Medical subject headings
- Ankle Injuries, Emergencies, Crowding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OAR application by a nurseOther
As per protocol, in the Phase B, nurses will be allowed to apply OAR which can lead to an early radiography prescription.
| Study group | Role | What they receive |
|---|---|---|
| Phase A | No intervention | 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 | 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. Receives: Other: OAR application by a nurse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent in emergency departement
Difference of time spent in minutes in emergency department between Phase A group and Phase B group.
Measured: through study completion, between 2 and 3 months
Secondary outcomes (7)
Percentage of x-rays
Difference of the percentage of x-rays between Phase A group and Phase B group.
Measured: through study completion, between 2 and 3 months
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.
Measured: through study completion, between 2 and 3 months
Comparaison of x-rays prescription between physicians and nurses
Difference of percentage of x-rays prescribed by nurses and physicians in Phase B group.
Measured: through study completion, between 2 and 3 months
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.
Measured: through study completion, between 2 and 3 months
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.
Measured: through study completion, between 2 and 3 months
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.
Measured: through study completion, between 2 and 3 months
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
Measured: through study completion, between 2 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start16 Jul 2019
- Primary completion6 Sep 2019
- Study completion7 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Brieuc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre Kergaravat, Centre Hospitalier de Saint-Brieuc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021511
- Sponsor's protocol ID
- CHSB_201905_P1_PARIAO
- Acronym
- PARIAO
- Status last verified
- Oct 2019
- First submitted
- 10 Jul 2019
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Participant Data (anonymized) that underlie results in a publication
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. doi: 10.1016/s0196-0644(05)82656-3.
PubMed 1554175Stiell 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.
PubMed 8433468Stiell 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.
PubMed 7663253Fan 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.
PubMed 16436790Ho 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.
PubMed 27592083Allerston 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.
PubMed 10818378Derlet 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.
PubMed 10613941Lau 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.
PubMed 23953094
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04021511
- Acronym / sponsor ID
- PARIAO / CHSB_201905_P1_PARIAO
- Conditions
- Ankle Injuries, Nurse's Role, Emergencies
- Keywords
- overcrowding, x rays, emergency department, Ottawa Ankle Rules, nurse practitioner
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Centre Hospitalier de Saint-BrieucUniversity, hospital or other
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 6 Sep 2019 (actual)
- Study completion
- 7 Oct 2019 (actual)
- First posted
- 16 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase A | No intervention | –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 | Other: OAR application by a nurseThe 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- With closed ankle injury less than 10 days old
- Affiliation to the national health insurance
- Written informed consent must be obtained
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OAR application by a nurseAs per protocol, in the Phase B, nurses will be allowed to apply OAR which can lead to an early radiography prescription. | Other | Phase B |
Primary outcome
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.
7 secondary outcomes
Percentage of x-rays
Time frame: 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
Comparaison of x-rays prescription between physicians and nurses
Time frame: 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
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
Other x-rays required
Time frame: through study completion, between 2 and 3 months
Satisfaction rate of nurses
Time frame: through study completion, between 2 and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Results publication: PubMed 1554175Stiell 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 publication: PubMed 8433468Stiell 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 publication: PubMed 7663253Stiell 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 publication: PubMed 16436790Fan 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 publication: PubMed 27592083Ho 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 publication: PubMed 10818378Allerston 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.
- Results publication: PubMed 10613941Derlet 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 publication: PubMed 23953094Lau 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.
- Individual participant dataSharing planned: Yes. All Individual Participant Data (anonymized) that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OAR application by a nurse in people with Ankle Injuries and Nurse's Role, run by Centre Hospitalier de Saint-Brieuc at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time spent in emergency departement (time frame: through study completion, between 2 and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04021511, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2019.