Implementation of the Low Risk Ankle Rule

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kathy Boutis, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00785876
First received: November 4, 2008
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

Ankle injuries are a very common injury in children. Each year approximately 35000 kids present to Ontario emergency departments (ED) with this problem. Right now, about 90% of these children get x-rays of the injured ankle, even though only 12% of these x-rays show a break in the bone. Some excellent research has created some rules that doctors can use to help them decide which children really need x-rays. Unfortunately, even though these rules have been proven to safely reduce x-rays by as much as two-thirds, most doctors are not using these rules.

Therefore, this study will be the first to put the best paediatric ankle x-ray rule, the Low Rick Ankle Rule, into physician practice in EDs. Our main goal is to determine how much we can reduce ankle x-ray rates in EDs that use this rule regularly versus those that do not. If we show that doctors can safely use this rule regularly and the number of ankle x-rays will be significantly less, this will lessen unnecessary potentially harmful radiation exposure in children, these children will spend less time in an ED, and the health care system will save money.


Condition Intervention
Ankle Injury
Other: LRAR Implementation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Controlled Radiography for Ankle Injury Cases in Kids in the Emergency Department: Implementation of the Low Risk Ankle Rule

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • To assess the impact of a LRAR implementation strategy on paediatric ankle radiography rates in participating EDS. [ Time Frame: three six month phases of implementation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ankle x-ray rate changes at individual hospital from pre-LRAR to post-LRAR implementation phases. [ Time Frame: duration of subjects participation in study ] [ Designated as safety issue: No ]
  • Intervention and control sites will be compared individually and collectively, during the post-LRAR for: missed significant fractures, number of unscheduled x-rays following initial ED visit, total length of stay, patient and physician satisfaction [ Time Frame: duration of subjects participation in study ] [ Designated as safety issue: No ]
  • To determine the sustainability of the clinical impact of the LRAR strategy at intervention sites by comparing high and low intensity implementation phases with respect to weekly x-ray rates, missed fractures and physician and patient satisfaction [ Time Frame: duration of subjects participation in study ] [ Designated as safety issue: No ]
  • To evaluate the performance of the LRAR during the implementation period of the rule at intervention sites with respect to: sensitivity and specificity of the LRAR for detecting "high risk" fractures and physician compliance with use of the rule [ Time Frame: duration of subjects participation in study ] [ Designated as safety issue: No ]
  • To compare total costs of "low risk injuries" at intervention versus control sites during the post-LRAR implementation phase. [ Time Frame: duration of subjects participation in study ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: November 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Control Sites
Experimental: 2
Intervention Sites
Other: LRAR Implementation

Pre-LRAR - no changes in the usual procedures for the first 26 weeks except for flagging of all paediatric charts with ankle injuries, ED documentation which will not refer to the LRAR and phone follow up.

Post-LRAR: At 27 weeks, in addition to the aforementioned ED collection sheet and phone follow up, the implementation strategy for the LRAR rule and related management will be introduced at the intervention hospitals.


  Eligibility

Ages Eligible for Study:   3 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All otherwise healthy children between the ages of 3 and 16 years of age that present to the participating EDs with an isolated acute (< 72 hours) blunt ankle injury due to any mechanism of injury will be eligible for the study. The age criteria were chosen to match those ages in which the LRAR was validated.

Exclusion Criteria:

  1. Children with ankle injuries who were referred from outside the hospital with radiographs.
  2. Children with ankle injuries who returned for reassessment of the same ankle injury.
  3. Children with open wounds on their ankle and/or foot
  4. All children at risk for pathological fractures such as those with congenital or acquired generalized bony disease (Appendix I). Clinical presentation and risks in these cases may be altered.
  5. Congenital anomalies of the feet and/or ankles (eg club feet, tarsal coalition). These abnormalities may have features which may complicate clinical assessment.
  6. Patients with known coagulopathies. Underlying hemarthrosis may complicate clinical assessment.
  7. Patients with cognitive and/or developmental delay. These patients may not localize pain.
  8. Injuries greater than 72 hours old. The signs and symptoms of the most common fracture, the Salter-Harris I fracture of the distal fibula, may be diminished. Our ability to make this clinical diagnosis with confidence may thus be compromised.
  9. Recent history of surgery or closed reduction of the same ankle within the last 3 months. These prior events may confuse current presenting symptomatology and ability to weight-bear and recover normally.
  10. Patients with low risk injuries who do not have phone or electronic mail access and/or have an insurmountable language barrier. This will preclude follow up.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785876

Locations
Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
North York General Hospital
Toronto, Ontario, Canada
Toronto East General Hospital
Toronto, Ontario, Canada
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Kathy Boutis, MD The Hospital for Sick Children
  More Information

No publications provided by The Hospital for Sick Children

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kathy Boutis, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00785876     History of Changes
Other Study ID Numbers: 1000012792
Study First Received: November 4, 2008
Last Updated: May 12, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
Paediatric
Emergency Department
Ankle
Injury
Low risk ankle rule

Additional relevant MeSH terms:
Ankle Injuries
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014