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Implementation of the Low Risk Ankle Rule

Primary Purpose

Ankle Injury

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

LRAR Implementation

About this trial

This is an interventional diagnostic trial for Ankle Injury focused on measuring Paediatric, Emergency Department, Ankle, Injury, Low risk ankle rule

Eligibility Criteria

3 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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:

Children with ankle injuries who were referred from outside the hospital with radiographs.
Children with ankle injuries who returned for reassessment of the same ankle injury.
Children with open wounds on their ankle and/or foot
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.
Congenital anomalies of the feet and/or ankles (eg club feet, tarsal coalition). These abnormalities may have features which may complicate clinical assessment.
Patients with known coagulopathies. Underlying hemarthrosis may complicate clinical assessment.
Patients with cognitive and/or developmental delay. These patients may not localize pain.
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.
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.
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.

Sites / Locations

Children's Hospital of Eastern Ontario
North York General Hospital
The Hospital for Sick Children
Toronto East General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Arm Description

Control Sites

Intervention Sites

Outcomes

Primary Outcome Measures

To assess the impact of a LRAR implementation strategy on paediatric ankle radiography rates in participating EDS.

Secondary Outcome Measures

Ankle x-ray rate changes at individual hospital from pre-LRAR to post-LRAR implementation phases.

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

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

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

To compare total costs of "low risk injuries" at intervention versus control sites during the post-LRAR implementation phase.

Full Information

NCT ID

NCT00785876

First Posted

November 4, 2008

Last Updated

October 6, 2017

Sponsor

The Hospital for Sick Children

1. Study Identification

Unique Protocol Identification Number

NCT00785876

Brief Title

Implementation of the Low Risk Ankle Rule

Official Title

Controlled Radiography for Ankle Injury Cases in Kids in the Emergency Department: Implementation of the Low Risk Ankle Rule

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Hospital for Sick Children

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ankle Injury

Keywords

Paediatric, Emergency Department, Ankle, Injury, Low risk ankle rule

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

No Intervention

Arm Description

Control Sites

Arm Title

Arm Type

Experimental

Arm Description

Intervention Sites

Intervention Type

Other

Intervention Name(s)

LRAR Implementation

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Ankle x-ray rate changes at individual hospital from pre-LRAR to post-LRAR implementation phases.

Time Frame