Triage-Based Application of OFAR on the Number of Radiographs Ordered

NCT01779804 | Completed DMC

• 1 other identifier: PR000000185
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Foot and ankle injuries account for nearly two million visits to Emergency Departments (EDs) in the United States and Canada each year. Of these injured patients, only 15% are diagnosed with actual fractures of the ankle. Due to such a small percentage, the "Ottawa Ankle and Foot Rules" (OFAR) were developed, which are a set of clinical decision-making guidelines that have been shown to be effective in diagnosing ankle and foot fractures. These rules are internationally accepted by the medical community, but are inconsistently applied. At Lehigh Valley Health Network (LVHN), the ED triage nurses are routinely trained in how to use the Ottawa Ankle and Foot Rules, but the rules are not always applied which may result in unnecessary X-rays. These guidelines are current network "standard of care" (usual, established care) that allow nurses to decide treatment for foot and ankle injury patients; in other words, whether to send these patients for an X-ray or not. The research staff is conducting this study in order to find out if using these nurse-directed guidelines--on a regular and consistent basis--can decrease the number of X-rays ordered, decrease patient waiting times/length of stay (LOS) and increase patient satisfaction with their care in the ED. STUDY PURPOSE: The two main goals of this study are to find out if use of the Ottawa Ankle and Foot Rules by triage nurses can decrease the amount of X-rays ordered in the ED, as well as LOS. Secondary study goals are to: 1) see how many X-rays are ordered by physicians and physicians' assistants after patients are evaluated by the Ottawa Ankle and Foot Rules as not having had a fracture; and 2) evaluate patient and provider satisfaction with the care provided both when the Ottawa Foot and Ankle Rules are used and when they are not.

Conditions

Ankle Injuries; Foot Injuries

Keywords

foot , ankle, injury

Outcome Measures

Primary Outcomes (1)

• amount of radiographs obtained in the ED.

  This study aims to determine if triage application of the OAR and OFR can decrease the amount of radiographs obtained in the ED.

  Participants will be followed for the duration of their ED stay, expected not to be greater than an average of 4 hours

Secondary Outcomes (1)

• waiting times/length of stay (LOS)

  Participants will be followed for the duration of their ED stay, expected not to be greater than an average of 4 hours

Other Outcomes (1)

• patient satisfaction with their care in the ED. patient satisfaction with their care in the ED.

  Participants will be assessed at the end of their ED stay, expected not to be greater than an average of 4 hours

Study Arms (1)

Patients with foot and ankle injury

After baseline data is obtained a cohort of patients with acute foot and ankle injuries will have OFAR applied

Procedure: OFAR

Interventions

OFAR PROCEDURE

OFAR

Patients with foot and ankle injury

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to an urban and suburban community hospital with acute foot or ankle injury

You may qualify if:

• Pt must be 16 years of age (patients below 18 must be assented)
• Pt must not be pregnant
• Pt must have an isolated traumatic ankle or foot injury
• Pt must be outpatients (not admitted or assigned to observation)
• Pt must be able to speak English or Spanish
• Pt must be competent and able to give consent, (not in critical condition, intoxicated or otherwise incapacitated)
• Pt must have no neurovascular (nerve/blood vessel) compromise
• Pt must have no open fracture or visible limb deformity
• Pt must not be a pediatric patient who presents with a gait abnormality of unknown origin.

You may not qualify if:

• Pt must not be under the age of 16
• Pt must not be pregnant
• Pt must not have a non-isolated traumatic ankle or foot injury
• Pt must not be inpatients (may not be admitted or assigned to observation)
• Pt must not be unable to speak English or Spanish
• Pt must not be incompetent and unable to give consent, (in critical condition, intoxicated, or otherwise incapacitated)
• Pt must not have neurovascular (nerve/blood vessel) compromise
• Pt must not have an open fracture or visible limb deformity
• Pt must not be a pediatric patient who presents with a gait abnormality of unknown origin.

Sponsors & Collaborators

• Lehigh Valley Hospital: lead

Study Sites (1)

Lehigh Valley Hospital and Health Network

Allentown, Pennsylvania, 18103, United States

Location

MeSH Terms

Conditions

Ankle Injuries; Foot Injuries; Wounds and Injuries

Condition Hierarchy (Ancestors)

Leg Injuries

Study Officials

• Marna R Greenberg, DO, MPH

  Lehigh Valley Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Emergency Medicine Research

Study Record Dates

• First Submitted: January 22, 2013
• First Posted: January 30, 2013
• Study Start: January 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: June 1, 2014
• Last Updated: September 8, 2016

Record last verified: 2014-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)