Ankle InjuriesOFARNCT01779804
Triage-Based Application of OFAR on the Number of Radiographs Ordered
An observational study of Ankle Injuries and Foot Injuries, run by Lehigh Valley Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ankle Injuries, Foot Injuries
- What is being tested?
- OFAR
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients presenting to an urban and suburban community hospital with acute foot or ankle injury
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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)
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lehigh Valley Hospital and Health Network
Allentown, Pennsylvania, 18103
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Ankle Injuries, Foot Injuries
- Being tested
- OFAR
- Keywords
- foot , ankle, injury
- Medical subject headings
- Ankle Injuries, Foot Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OFARProcedure or surgery
OFAR
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: OFAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Participants will be followed for the duration of their ED stay, expected not to be greater than an average of 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lehigh Valley Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marna Rayl Greenberg, Lehigh Valley Hospital
- Investigators
- Marna R Greenberg, DO, MPH, Principal investigator, Lehigh Valley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779804
- Sponsor's protocol ID
- PR000000185
- Acronym
- OFAR
- Status last verified
- Jun 2014
- First submitted
- 22 Jan 2013
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No plan to share IPD, just publish the study results.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01779804
- Acronym / sponsor ID
- OFAR / PR000000185
- Conditions
- Ankle Injuries, Foot Injuries
- Keywords
- foot , ankle, injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lehigh Valley HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with foot and ankle injury | – | Procedure: OFARAfter baseline data is obtained a cohort of patients with acute foot and ankle injuries will have OFAR applied |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presenting to an urban and suburban community hospital with acute foot or ankle injury
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OFAROFAR | Procedure or surgery | Patients with foot and ankle injury |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
- Individual participant dataSharing planned: No. No plan to share IPD, just publish the study results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marna R Greenberg, DO, MPH principal investigator
Lehigh Valley Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Injuries and Foot Injuries, run by Lehigh Valley Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2016.