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

September 7, 2016 updated by: Marna Rayl Greenberg, Lehigh Valley Hospital

The Effect of Triage-Based Application of the Ottawa Ankle and Foot Rules (OAR/OFR) on the Number of Radiographs Ordered: A Pilot Study

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Study Variables:

This study's independent variable (or "intervention/predictor" variable) is the triage application of the OAR and OFR. Dependent variables (or "outcome" variables) include the number of X-rays ordered and LOS (co-primary outcomes), and measured patient and provider satisfaction (secondary outcomes). The Principal Investigator will create and validate his own study tool/survey to measure patient and provider satisfaction.

Confounding Variables:

Confounding variables include, but are not limited to: Patient age; patient gender; census volume on the days the study is conducted; assistance from ED staff from either site; difficulty in achieving enrollment goals in a timely fashion; season of the year (i.e., skateboarding versus skiing injuries); patient expectations about their ED care; and/or patient insurance status.

Study Design/Methods:

This study is designed to be a pilot, prospective, 2-stage study to examine the application of OAR/OFR at the 17th and Chew, and Cedar Crest site EDs that aims to determine if triage nursing application of these clinical decision rules can decrease the amount of radiographs ordered, as well as decrease patient LOS.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital and Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
OFAR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
amount of radiographs obtained in the ED.
Time Frame: Participants will be followed for the duration of their ED stay, expected not to be greater than an average of 4 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
waiting times/length of stay (LOS)
Time Frame: Participants will be followed for the duration of their ED stay, expected not to be greater than an average of 4 hours
The implementation of the OAR and OFR at triage by the nursing staff is expected to decrease the amount of radiographs obtained in the ED and decrease LOS.
Participants will be followed for the duration of their ED stay, expected not to be greater than an average of 4 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient satisfaction with their care in the ED. patient satisfaction with their care in the ED.
Time Frame: Participants will be assessed at the end of their ED stay, expected not to be greater than an average of 4 hours
It is anticipated that Both patient and provider satisfaction will increase as a result of OAR/OFR implementation.
Participants will be assessed at the end of their ED stay, expected not to be greater than an average of 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marna R Greenberg, DO, MPH, LeHigh Valley Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

January 22, 2013

First Submitted That Met QC Criteria

January 28, 2013

First Posted (Estimate)

January 30, 2013

Study Record Updates

Last Update Posted (Estimate)

September 8, 2016

Last Update Submitted That Met QC Criteria

September 7, 2016

Last Verified

June 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • PR000000185

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No plan to share IPD, just publish the study results.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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