Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-02 @ 1:06 AM
Study NCT ID:
NCT01779804
Status:
COMPLETED
Last Update Posted:
2016-09-08
First Post:
2013-01-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Triage-Based Application of OFAR on the Number of Radiographs Ordered
Sponsor:
Lehigh Valley Hospital
Organization:
Study Overview
Official Title:
The Effect of Triage-Based Application of the Ottawa Ankle and Foot Rules (OAR/OFR) on the Number of Radiographs Ordered: A Pilot Study
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OFAR
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.
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: