Occupational Therapy Driving Intervention for Returning Combat Veterans.

Traumatic Brain Injury (TBI) Clinical Trial

Official title:

Efficacy of a Driving Program on Safe Community Mobility for Combat Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02764983
• Other study ID #: 652-2011
• Secondary ID: IRB201702264JW14
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: November 2018

Study information

• Verified date: December 2018
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

This research study is being done to determine 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).

Baseline testing—Pre-test 1-- will include clinical battery of tests and a simulated driving test, a Brief Driving Questionnaire, Community Integration Questionnaire, and a Satisfaction with Life Questionnaire. Caregivers/ family members will rate the participants' driving behaviors using a Fitness-to-Drive Screening Measure( FTDS). After baseline testing the 60 participants (and 60 associated caregivers) will be randomly assigned to a balanced intervention group (15 participants with Traumatic Brain Injury (TBI)/ Post Traumatic Stress Disorder (PTSD) and 15 participants with orthopedic conditions and caregivers) and a control group (15 with TBI/PTSD and 15 with orthopedic conditions and caregivers).

The intervention group receives Occupational Therapy Driving Intervention (OT-DI), consisting of three x 1 hour sessions will include: Session 1: Driving evaluator reviews explicit driving errors with participants; Session 2: Driving evaluator provide 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 knowledge of the road discussion; Session 3: drive the simulator without any feedback from traffic safety professional). Immediately after session 3, Post-test 1 will occur using the same standardized protocol outlined for baseline testing. Post-test 2 will consist of testing with the same standardized protocol as administered during baseline testing. Caregivers/ family members will rate the participant driving behaviors using the FTDS. In addition, the investigators will obtain driving data from the Department of Motor Vehicles which will include: citations, violations, driving mishaps, and crashes that have occurred for each participant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 2018
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Inclusion Criteria for Caregivers:

• ability to complete a driving questionnaire pre and post intervention.

Exclusion Criteria for Caregivers:

• the presence of a cognitive or physical impairment that would hinder participants ability to complete the questionnaires or make an active contribution.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Post Traumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Traumatic Brain Injury (TBI)

Intervention

Behavioral:
• Driving Behavior Interview
This will be completed thrice, at baseline, post-test1 and at post-test2
• Fitness-to-Drive Screening Measure
This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)

Other:
• Clinical Driving Assessment
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)

Behavioral:
• Propensity for Angry Driving Scale
This questionnaire will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)
• Community Integration Questionnaire
This questionnaire will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)
• Satisfaction with Life Questionnaire
This questionnaire will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)

Procedure:
• Driving simulator evaluation
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.

Other:
• Focus Group Discussion Interview Guide
Focus group discussion will occur once using the interview guide

Locations

Country	Name	City	State
United States	Malcom Randall VA Medical Center	Gainesville	Florida
United States	University of Florida	Gainesville	Florida

Sponsors (4)

Lead Sponsor	Collaborator
University of Florida	United States Department of Defense, University of Western Ontario, Canada, US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Perceptions of Combat Veterans regarding driving performance	Semi-structured interview questions will be used to guide the focus group discussions. The results will be outlined in an intervention matrix which will be used to address specific driving errors and the behavior underlying those errors in the intervention process.	Occurs approximately 2 months after baseline (75 minutes)
Secondary	Change in driving records from baseline and at 11months	Driving records from the Department of Motor Vehicle will be collected to determine if driving errors have reduced.	From baseline (approximately 11months)