Effectiveness of a Driving Intervention on Safe Community Mobility for Returning Combat Veterans
Condition: Traumatic Brain Injury (TBI); Post Traumatic Stress Disorder (PTSD)
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The main objective of this study is to discern if an Occupational Therapy Driving
      Intervention (OT-DI) improves fitness to drive abilities of Combat Veterans and also
      investigate if results leads to reduced driving errors on the driving simulator and an
      on-road test. The driving behavior of 260 Combat Veterans will be studied on a driving
      simulator at baseline after which they will be randomized into control and intervention
      groups. The intervention group will receive sessions of Occupational Therapy Driving
      Intervention by a trained driving rehabilitation specialist. The control group on the other
      hand will receive driving safety education sessions by a driving safety professional. Both
      groups will be evaluated for driving performance on the driving simulator to ascertain
      whether there have been changes in the number of driving errors at two and three months upon
      enrollment. Caregiver responses on driving behavior of Combat Veteran and public driving
      records from The Department of Motor Vehicles will be analyzed to for changes in number of
      driving errors.
    

Detailed description: 
      This research study is being done to determine if Occupational Therapy Driving intervention
      (OT-DI) can improve the safe driving performance immediately following intervention and
      intermediate term (3months).

      Baseline testing to post test1 will include Clinical battery of tests and a Simulated Driving
      test, a Brief Driving Questionnaire, Community Integration Questionnaire, and Satisfaction
      with Life Questionnaire. Caregivers/family member will rate the participants' driving
      behaviors using a Fitness-to-Drive Screening Measure (FTDS). After baseline testing the 260
      participants (and associated caregivers) will be randomly assigned to balanced intervention
      and control groups.

      The intervention group receives Occupational Therapy Driving Intervention (OT-DI) consisting
      of three x 1hour sessions will include Sessions1: Driving evaluator reviews explicit driving
      errors with participants; Session 2: Driving evaluator provides tailored strategies to
      mitigate errors; Session 3: Participants drive simulator with targeted feedback from driving
      evaluator.

      The control group will receive from a driving safety professional, three x 1 hour general
      safety sessions (session 1: general traffic safety discussion; Session 2: Rules of the road
      and acknowledgement of the road discussion; Session 3: drive the simulator without any
      feedback from a driving safety professional). Immediately after session 3, Post test1 will
      occur using the same standardized protocol outline for baseline testing.

      Post test2: will consist of testing with the same standardized protocol as administered
      during baseline testing. Caregivers/family members will rate the participants driving
      behavior using FTDS in addition the investigators will obtain driving data from the
      Department of Motor Vehicles which include citations, violations, driving mishaps that have
      occurred for each participant.

      To ascertain impact of the OT-DI and driving safety education on real world driving, a subset
      of 30 participants will be created from the control and intervention groups to perform
      on-road driving test. The results from this test will be compared with driving performance on
      the simulated drives.
    

Intervention name(s): Driving Behavior Interview; Clinical Driving Assessment; Propensity for Angry Driving Scale; Community Integration Questionnaire; Satisfaction with Life; Fitness-to-Drive Screening Measure (FTDS); Simulated Driving Evaluation; Driving Safety Education; Occupational Therapy Driving Intervention (OT-DI); On-road driving test; Driving triggers evaluation
Intervention type(s): Behavioral; Other; Behavioral; Behavioral; Behavioral; Behavioral; Procedure; Procedure; Procedure; Procedure; Procedure
Intervention description(s): This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1); Clinical Driving Assessment includes Optec vision screening, Useful Field of View, Range of Motion, Mini-Mental State Examination (MMSE) and Strength tests. This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1); This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1); This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1); This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1; Fitness-to-Drive-Screening Measure will be completed twice, at baseline and at end of study; This involves driving a simulator fitted simulated drives engineered to to address Veteran's driving concerns such as reactions to other drivers and road conditions(e.g. debris). The simulator is used at baseline and at post-test1 and 2. The intervention and traffic safety education session 3 also occurs using the driving simulator.; This involves the following: Session1: general traffic safety discussion; Session 2: Rules of the road and acknowledgement of the road discussion and Session 3: driving the simulator without any feedback from traffic safety professional; This has three sessions: 1. Driving evaluator reviews explicit driving errors with Combat Veteran; 2. driving evaluator provide tailored strategies to mitigate errors; Combat Veteran drives simulator with targeted feedback from driving evaluator.; This involves and on-road driving test supervised by Driving Rehabilitation Specialist. To be completed at baseline and at month 5; The simulator-drives evaluation group will evaluate the current simulator-triggers prior to baseline testing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Combat Veterans; Automobile Driving; Fitness to Drive