Occupational Therapy Driving Intervention for Returning Combat Veterans.
Efficacy of a Driving Program on Safe Community Mobility for Combat Veterans
3 other identifiers
interventional
66
1 country
2
Brief Summary
Driving is a portal into general life functioning, and impaired driving skill can pose a serious threat to the combat veterans (CV), passengers and others; and involves increased risk of subsequent injuries, medical expenses and legal sequelae. Motor vehicle crashes (MVC) among post deployed CV are one of the top four causes of injury and disability, hospitalization, and outpatient visits across the military, and are a leading cause of death among Army service members. The risk of motor vehicle (MV) death is significantly increased in years immediately following return from the battlefield. In sum, the effects of Traumatic Brain Injury (TBI)/ Post Traumatic Stress Disorder (PTSD) and other blast related injuries, combined with the "battlefield" mindset and lack of community reintegration programs place CV at risk for MVC and fatalities. On-road assessments, the gold standard, presents a risk for crash or adverse advents in this population of CV. Alternately, simulated driving evaluation measures driving performance in a safe, accurate and objective manner with evidence of absolute and relative validity when compared to real world (on-road) driving. Knowing participants can or cannot safely resume driving, and providing rehabilitation for those with a potential for resuming safe driving could result in: increased safe driving behaviors; avoidance of injuries, collisions, citations and participants residua; and resuming safe driving with its attendant benefits in the realms of family functioning, participation in society and satisfaction with life. The overarching objective of this proposal is to discern, after clinical and simulated driving performance testing , if Occupational Therapy Driving Intervention (OT-DI) can improve the safe driving performance (less errors) over the short term (immediately following intervention) and intermediate term (3 months).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2013
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 18, 2016
CompletedFirst Posted
Study publicly available on registry
May 6, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedDecember 17, 2018
December 1, 2018
2.7 years
April 18, 2016
December 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Driving errors changes between the groups at baseline, months 2 and 3
Determine if the Occupational Therapy Driving Intervention (OT-DI) reduces driving errors in the intervention group.
Changes in baseline months 2 and 3
Secondary Outcomes (2)
Perceptions of Combat Veterans regarding driving performance
Occurs approximately 2 months after baseline (75 minutes)
Change in driving records from baseline and at 11months
From baseline (approximately 11months)
Study Arms (5)
Control Group
ACTIVE COMPARATORParticipants in this group will have the following performed: Institute of Mobility Activity and Participation (I-MAP's) clinical battery of tests and a simulated driving test, a Brief Driving Behavior Interview, Propensity for Angry Driving Scale, Clinical Driving Assessment, Community Integration Questionnaire, and a Satisfaction with Life Questionnaire. Driving safety professional, three x 1 hour sessions to discuss traffic safety, rules of the road, defensive driving, driving under influence, driver attitudes and safety. Additionally, the study will obtain real world driving data from the Department of Motor Vehicles (public records) which will include citations, violations, and recorded collisions/ crashes.
Experimental Group
EXPERIMENTALParticipants in this group will have the following performed: Institute of Mobility Activity and Participation (I-MAP's) clinical battery of tests and a simulated driving test, a Brief Driving Behavior Interview, Propensity for Angry Driving Scale, Clinical Driving Assessment, Community Integration Questionnaire, and a Satisfaction with Life Questionnaire. Occupational Therapy Driving Intervention (OT-DI) consisting of three x 1 hour sessions to review explicit driving errors, strategies to mitigate errors, and driving simulator with feedback. The study will also obtain real world driving data from the Department of Motor Vehicles (public records) which includes citations, violations, and recorded collisions/crashes.
Caregiver Control Group
ACTIVE COMPARATORParticipants in this group will perform the following: Fitness-to-Drive Screening Measure(FTDS) will be filled out at baseline and again at the end of the study.
Caregiver Experimental Group
ACTIVE COMPARATORParticipants in this group will perform the following: Fitness-to-Drive Screening Measure(FTDS) will be filled out at baseline and again at the end of the study.
Focus Group Discussion Interview Guide
OTHERThis group will comprise of a subset of the control and experimental groups. A focus group with 8 participants (4 with Traumatic Brain Injury/Post Traumatic Stress Disorder and 4 with orthopedic conditions). The focus group will meet once for a discussion which will be guided with a semi-structured interview that will explore the driving behavior prior to war, during war and post-deployment. Responses will be outlined in an intervention matrix.
Interventions
This will be completed thrice, at baseline, post-test1 and at post-test2
This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)
Clinical Driving Assessment includes Optec vision screening, Useful Field of View, Range of Motion, Strength. This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)
This questionnaire will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)
This questionnaire will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)
This questionnaire will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)
The driving simulator evaluation uses a driving simulator with simulated drives engineered to address Veteran driving concerns such as reactions to other drivers and road conditions (e.g., debris). The simulator is used at baseline and post-tests 1 and 2. The intervention sessions (X3) also occur using simulator.
Focus group discussion will occur once using the interview guide
Eligibility Criteria
You may qualify if:
- A combat veteran with polytrauma (mild traumatic brain injury/with an accompanying post traumatic stress disorder (PTSD), traumatic limb amputation/ fractures), who drove prior to the injury/condition;
- have a valid driver's license or are eligible for a driver's license;
- are community dwelling;
- may experience self, physician or other clinical staff identified issues with driving behaviors;
- have a history of citations, violations or other driving mishaps in real world driving;
- have potential for following driving safety recommendations (Mini Mental State Examination, (MMSE 24/30);
- have potential for following community integration strategies (MMSE 24/30);
- are able to participate in driving evaluation battery.
You may not qualify if:
- A combat veteran diagnosed with a severe psychiatric (psychoses) or physical conditions (missing both arms and/or legs) that will limit ability to drive;
- have multiple psychotropic medications that may impact mental or physical (due to side-effects) functioning as per the consulting physician;
- have severe, irremediable medical conditions (severe TBI) as per the consulting physician;
- pregnant females (as determined by a urine test) or those planning pregnancy;
- VA Employees; and
- veterans who have received rehabilitation services for TBI/PTSD and who show, as per the screening of the driving rehabilitation specialist, a poor prognosis for improvement based on a driving intervention.
- ability to complete a driving questionnaire pre and post intervention.
- the presence of a cognitive or physical impairment that would hinder participants ability to complete the questionnaires or make an active contribution.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- United States Department of Defensecollaborator
- US Department of Veterans Affairscollaborator
- University of Western Ontario, Canadacollaborator
Study Sites (2)
Malcom Randall VA Medical Center
Gainesville, Florida, 32608, United States
University of Florida
Gainesville, Florida, 32610, United States
Related Publications (1)
Classen S, Winter S, Monahan M, Yarney A, Link Lutz A, Platek K, Levy C. Driving Intervention for Returning Combat Veterans. OTJR (Thorofare N J). 2017 Apr;37(2):62-71. doi: 10.1177/1539449216675582. Epub 2016 Nov 29.
PMID: 27830643DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandra Winter, PhD
University of Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2016
First Posted
May 6, 2016
Study Start
January 1, 2013
Primary Completion
September 1, 2015
Study Completion
November 1, 2018
Last Updated
December 17, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share