InjuryNCT00935428
Causes and Circumstances of Horse Related Injuries and Impact on Quality of Life
An observational study of Injury, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Horse-related activity can be risky. 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Injury
- How many people
- 231 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jun 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects will be identified through the OHSU Trauma Registry. Patients who were treated from January 1, 2001 through September 30, 2008 for any horse related injury will be invited to participate in the survey.
Who may be able to join
- 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.
Who cannot join
- Subjects who are deceased.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Horse-related activity can be risky. 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. By interviewing injured equestrians, the investigators may be able to determine patterns of decision-making and behavior from their collective experience and develop useful safety recommendations. The investigators will also determine the impact that the injury has had on quality of life. The long-term goal of the investigators research is to develop safety and prevention recommendations and a horse-related injury prevention program to reduce the number of horse related injuries.
Read the 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.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Injury
- Keywords
- Equestrian injury, Horse injury, Trauma
- Medical subject headings
- Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Injury Severity Score (ISS)
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.
Measured: 2008-2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for InjuryStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John C Mayberry, MD, FACS, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935428
- Sponsor's protocol ID
- IRB e4084
- Status last verified
- Dec 2019
- First submitted
- 15 Apr 2009
- Last updated
- 13 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 16611723Mayberry 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.
PubMed 17414356Ball 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.
PubMed 17434372Dekker 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.
PubMed 14668145Guyton 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.
PubMed 23317616
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causes and Circumstances of Horse Related Injuries and Impact on Quality of Life
- ClinicalTrials.gov ID
- NCT00935428
- Acronym / sponsor ID
- IRB e4084
- Conditions
- Injury
- Keywords
- Equestrian injury, Horse injury, Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 9 Jul 2009 (estimated)
- Results
- Posted 13 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Horse-related activity can be risky. 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. By interviewing injured equestrians, the investigators may be able to determine patterns of decision-making and behavior from their collective experience and develop useful safety recommendations. The investigators will also determine the impact that the injury has had on quality of life. The long-term goal of the investigators research is to develop safety and prevention recommendations and a horse-related injury prevention program to reduce the number of horse related injuries.
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.
- 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.
- 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.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects will be identified through the OHSU Trauma Registry. Patients who were treated from January 1, 2001 through September 30, 2008 for any horse related injury will be invited to participate in the survey.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects who are deceased.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16611723Thomas 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.
- Background: PubMed 17414356Mayberry 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.
- Background: PubMed 17434372Ball 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.
- Background: PubMed 14668145Dekker 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.
- Results publication: PubMed 23317616Guyton 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.
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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.
John C Mayberry, MD, FACS principal investigator
Oregon Health and Science University
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 Injury, run by Oregon Health and Science University 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 4 inclusion and 1 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 13 Jan 2020. 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?
Yes. Results are posted in the registry (first posted 13 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Injury Severity Score (ISS) (time frame: 2008-2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00935428, which also lists 5 linked publications.
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 13 Jan 2020.