- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00935428
Causes and Circumstances of Horse Related Injuries and Impact on Quality of Life
Study Overview
Status
Conditions
Detailed Description
Introduction and Background:
Horse-related activity (HRA) can be risky. The National Electronic Injury Surveillance System (NEISS) estimated that in 2006, 68,060 Americans went to a U.S. emergency room with horse-related injuries (HRI), of which 5,676 were hospitalized. However, Thomas et al estimated that 102,904 people each year from 2001 to 2003 were treated for HRI in emergency rooms nationwide. In Oregon, horses are the leading cause of animal-related fatalities in Oregon and Oregon's annual death rate from animals is 45% higher than the national rate. In a survey of 679 Northwest equestrians in Oregon, Washington, and Idaho, 81% riders reported at least one injury during their career, and 1 in 5 equestrians required hospitalization, surgery, or sustained permanent disability as a result of a HRI.
The long-term goal of our research is to develop a horse-related injury prevention program. Our preliminary study indicated that lower levels of experience were strong indicators of greater risk. The period of greatest danger appears to be during the initial 100 hours of HRA, with the incidence of injury nearly 8 times greater among novices as compared to instructors or professionals. The extent to which HRI is preventable is currently not clear, but it may be substantial. 64% of injured, experienced riders believed their incident was preventable and 47% altered their riding habits as a result.
Rationale:
There is a need to develop specific safety and prevention recommendations to reduce the number of HRIs. We intend to retrospectively determine what decisions, conditions, or other influential circumstances occurred that led to the subject's injury incident and to question the subject whether any measures could have prevented the incident from occurring. By interviewing injured equestrians, we may be able to determine patterns of decision-making and behavior from their collective experience and develop useful safety recommendations.
The investigators will also interview injured equestrians to determine the impact that the injury has had on their quality of life. There is very little information in the literature on this subject. One study indicated that in the pediatric population, 41% of injured children and adolescents had residual complaints and were still hampered in their daily activities an average of 4 years after HRI. If we can document what we suspect will be a high impact of HRI on quality of life in both adults and children, the imperative to develop injury prevention measures will be further supported.
2. Briefly summarize how participants are recruited.
The Trauma Service at OHSU keeps a state-mandated registry of all patients admitted to the Trauma Service that can be searched by injury diagnosis code. Demographic, injury, and hospital outcome data can be easily obtained and matched. Consenting subjects who were treated at OHSU between January 1, 2001 and September 20, 2008 will be contacted by mail and asked to participate in this study. Potential subjects who are currently > 18 years of age can be included in the study if a Child Assent Form has been completed and a legally authorized representative (LAR) provides consent for study participation. . Investigators will be available to answer any questions that subjects may have concerning the study.
3. Briefly describe the procedures subjects will undergo.
This study involves responding to an electronic survey that will be emailed to subjects agreeing to participate in this research study. Subjects will not undergo any physical procedures. The researchers may contact study participants by email or telephone if necessary, to clarify responses from the survey questionnaire.
4. If applicable, briefly describe survey/interview instruments used.
Study participants will respond to an equestrian survey that asks questions about the horse-related injury, including causes and circumstances surrounding the injury, experience and skill level at the time of injury, safety equipment used, ideas on how the injury might have been prevented, how it has impacted quality of life, and current health status, work status, and activity level. Study participants will also complete the Rand 36-Item Health Survey, a short survey that evaluates health status. A single survey, emailed to the subject, will include both the equestrian survey and the Rand 36. Completion of the survey will require approximately 30 minutes.
5. Briefly describe how the data will be analyzed to address the purpose of the protocol.
The responses to our study questionnaires will allow us to perform statistical analysis to determine the causes and circumstances surrounding the injury to see if safety prevention measures can be identified. It will also assess the impact of the injury on the quality of life.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subjects must have been treated at OHSU from January 1, 2001 through September 30, 2008 for any horse related traumatic injury.
- The subject will have signed an IRB approved written informed consent and HIPAA authorization to participate in the study.
- Subjects must have access to the internet and an e-mail account to participate in the survey.
- Subjects must be able to complete surveys written in English.
Exclusion Criteria:
- Subjects who are deceased.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Injury Severity Score (ISS)
Time Frame: 2008-2011
|
The Injury Severity Score (ISS) is based upon the Abbreviated Injury Scale (AIS) and is calculated by dividing the body into 6 regions.
Each region is scored on a scale of 1 (minor severity/better) to 5 (most severity/worse).
ISS total score is calculated by squaring each of the 3 most severely injured body regions, then summing the three squared numbers.
Total ISS score can range from 3 to 75.
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2008-2011
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Helmet Use
Time Frame: 2001-2008
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Those patients who were wearing a helmet at the time of injury
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2001-2008
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Preventable Head Injuries
Time Frame: 2001-2008
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Percentage of potentially preventable head injuries among those patients not wearing a helmet at the time of injury
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2001-2008
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Hospital Cost
Time Frame: 2001-2008
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Total inpatient hospital charges, does not include outpatient costs or any non-hospital charges such as long term therapy, insurance costs, legal cost, etc.
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2001-2008
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Long Term Disability
Time Frame: 2001-2008
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Those patients who responded to a survey regarding long term disability
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2001-2008
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Causes of Horse Related Injuries
Time Frame: 2001- 2008
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Causes of Horse Related Injuries as related by surveyed patients to investigators
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2001- 2008
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Collaborators and Investigators
Investigators
- Principal Investigator: John C Mayberry, MD, FACS, Oregon Health and Science University
Publications and helpful links
General Publications
- Thomas KE, Annest JL, Gilchrist J, Bixby-Hammett DM. Non-fatal horse related injuries treated in emergency departments in the United States, 2001-2003. Br J Sports Med. 2006 Jul;40(7):619-26. doi: 10.1136/bjsm.2006.025858. Epub 2006 Apr 12.
- Mayberry JC, Pearson TE, Wiger KJ, Diggs BS, Mullins RJ. Equestrian injury prevention efforts need more attention to novice riders. J Trauma. 2007 Mar;62(3):735-9. doi: 10.1097/ta.0b013e318031b5d4.
- Ball CG, Ball JE, Kirkpatrick AW, Mulloy RH. Equestrian injuries: incidence, injury patterns, and risk factors for 10 years of major traumatic injuries. Am J Surg. 2007 May;193(5):636-40. doi: 10.1016/j.amjsurg.2007.01.016.
- Dekker R, Van Der Sluis CK, Kootstra J, Groothoff JW, Eisma WH, Duis HJ. Long-term outcome of equestrian injuries in children. Disabil Rehabil. 2004 Jan 21;26(2):91-6. doi: 10.1080/09638280310001629688.
- Guyton K, Houchen-Wise E, Peck E, Mayberry J. Equestrian injury is costly, disabling, and frequently preventable: the imperative for improved safety awareness. Am Surg. 2013 Jan;79(1):76-83.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB e4084
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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