Occupational Therapy Driving Intervention for Returning Combat Veterans.

NCT ID: NCT02764983

Last Updated: 2018-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2018-11-30

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).

Detailed 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.

Conditions

Traumatic Brain Injury (TBI); Post Traumatic Stress Disorder (PTSD)

Keywords

Combat Veterans; Automobile Driving; Fitness to Drive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

Participants 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.

Group Type: ACTIVE_COMPARATOR

Driving Behavior Interview

Intervention Type: BEHAVIORAL

This will be completed thrice, at baseline, post-test1 and at post-test2

Fitness-to-Drive Screening Measure

Intervention Type: BEHAVIORAL

This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)

Clinical Driving Assessment

Intervention Type: OTHER

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)

Propensity for Angry Driving Scale

Intervention Type: BEHAVIORAL

This questionnaire will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)

Community Integration Questionnaire

Intervention Type: BEHAVIORAL

This questionnaire will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)

Satisfaction with Life Questionnaire

Intervention Type: BEHAVIORAL

This questionnaire will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)

Driving simulator evaluation

Intervention Type: PROCEDURE

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.

Experimental Group

Participants 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.

Group Type: EXPERIMENTAL

Driving Behavior Interview

Intervention Type: BEHAVIORAL

This will be completed thrice, at baseline, post-test1 and at post-test2

Fitness-to-Drive Screening Measure

Intervention Type: BEHAVIORAL

This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)

Clinical Driving Assessment

Intervention Type: OTHER

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)

Propensity for Angry Driving Scale

Intervention Type: BEHAVIORAL

This questionnaire will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)

Community Integration Questionnaire

Intervention Type: BEHAVIORAL

This questionnaire will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)

Satisfaction with Life Questionnaire

Intervention Type: BEHAVIORAL

This questionnaire will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)

Driving simulator evaluation

Intervention Type: PROCEDURE

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.

Caregiver Control Group

Participants 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.

Group Type: ACTIVE_COMPARATOR

Fitness-to-Drive Screening Measure

Intervention Type: BEHAVIORAL

This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)

Caregiver Experimental Group

Participants 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.

Group Type: ACTIVE_COMPARATOR

Fitness-to-Drive Screening Measure

Intervention Type: BEHAVIORAL

This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)

Focus Group Discussion Interview Guide

This 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.

Group Type: OTHER

Focus Group Discussion Interview Guide

Intervention Type: OTHER

Focus group discussion will occur once using the interview guide

Interventions

Driving Behavior Interview

This will be completed thrice, at baseline, post-test1 and at post-test2

Intervention Type: BEHAVIORAL

Fitness-to-Drive Screening Measure

This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)

Intervention Type: BEHAVIORAL

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)

Intervention Type: OTHER

Propensity for Angry Driving Scale

This questionnaire will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)

Intervention Type: BEHAVIORAL

Community Integration Questionnaire

This questionnaire will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)

Intervention Type: BEHAVIORAL

Satisfaction with Life Questionnaire

This questionnaire will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)

Intervention Type: BEHAVIORAL

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.

Intervention Type: PROCEDURE

Focus Group Discussion Interview Guide

Focus group discussion will occur once using the interview guide

Intervention Type: OTHER

Other Intervention Names

Road rage questionnaire

Eligibility Criteria

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.

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

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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

US Department of Veterans Affairs

FED

Sponsor Role: collaborator

University of Western Ontario, Canada

OTHER

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandra Winter, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Malcom Randall VA Medical Center

Gainesville, Florida, United States

University of Florida

Gainesville, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27830643 (View on PubMed)

Other Identifiers

IRB201702264

Identifier Type: OTHER

Identifier Source: secondary_id

JW140063

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

652-2011

Identifier Type: -

Identifier Source: org_study_id