NCT04021511

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 16, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

July 16, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2019

Completed
Last Updated

October 10, 2019

Status Verified

October 1, 2019

Enrollment Period

2 months

First QC Date

July 10, 2019

Last Update Submit

October 9, 2019

Conditions

Ankle InjuriesNurse's RoleEmergencies

Keywords

overcrowdingx raysemergency departmentOttawa Ankle Rulesnurse practitioner

Outcome Measures

Primary Outcomes (1)

  • Time spent in emergency departement

    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 Outcomes (7)

  • Percentage of x-rays

    through study completion, between 2 and 3 months

  • Time spent by nurse for patient care

    through study completion, between 2 and 3 months

  • Comparaison of x-rays prescription between physicians and nurses

    through study completion, between 2 and 3 months

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

    through study completion, between 2 and 3 months

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

    through study completion, between 2 and 3 months

  • +2 more secondary outcomes

Study Arms (2)

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.

Other: OAR application by a nurse

Interventions

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.

Phase B

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • With closed ankle injury less than 10 days old
  • Affiliation to the national health insurance
  • Written informed consent must be obtained

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de Saint-Brieuc

Saint-Brieuc, 22027, France

Location

Related Publications (8)

  • 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.

    PMID: 1554175RESULT

  • 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.

    PMID: 8433468RESULT

  • 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.

    PMID: 7663253RESULT

  • 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.

    PMID: 16436790RESULT

  • 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.

    PMID: 27592083RESULT

  • 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.

    PMID: 10818378RESULT

  • 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.

    PMID: 10613941RESULT

  • 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.

    PMID: 23953094RESULT

MeSH Terms

Conditions

Ankle InjuriesEmergenciesCrowding

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSpatial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hospital physician, principal Investigator

Study Record Dates

First Submitted

July 10, 2019

First Posted

July 16, 2019

Study Start

July 16, 2019

Primary Completion

September 6, 2019

Study Completion

October 7, 2019

Last Updated

October 10, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
From the end of the study for 15 years.
Access Criteria
Access through secure platform with personal username and password

Locations

FR(1)