A Brief Educational Intervention to Improve Traumatic Brain Injury (TBI) Screening Outcomes (TBI)

A Brief Educational Intervention to Improve TBI Screening Outcomes

This research study is designed to learn about Veterans' understanding of mild TBI (traumatic brain injury) and the VA TBI screening process. All OEF/OIF Veterans who come to one of the study-related clinics for TBI screening will be invited to participate. An educational handout on TBI will be given to half of the participants along with their TBI screening. The other half of the participants will have the usual TBI screening without the educational handout.

Veterans enrolled in the study will be asked to answer a 5-10 minute research questionnaire. The questionnaire will ask:

• About the individual: such as gender and branch of service
• About what happened during the TBI screening: such as whether the Veteran had a chance to ask the provider any questions
• About the Veteran's understanding of mild TBI: such as whether symptoms of mild TBI are long lasting

Veterans who receive the educational handout will be asked specific questions about the handout and its information.

Study Overview

• Status: Completed
• Conditions: TBI
• Intervention / Treatment: Other: TBI handout

Detailed Description

OBJECTIVE/HYPOTHESIS: The investigators propose to develop an educational handout on mild traumatic brain injury (mTBI) and to evaluate whether this brief, educational intervention improves knowledge and understanding of TBI and the screening results. The long-term goal is to promote expectations for a positive recovery in Veterans with mTBI. The specific aim is to evaluate the effect of the intervention on Veterans' knowledge and illness perceptions regarding TBI. Hypotheses are as follows:

1. Veterans who receive the educational intervention will have improved knowledge and understanding of TBI and the meaning of a positive TBI screen compared to Veterans who undergo screening as usual.
2. Veterans who screen positive for TBI and receive the educational intervention will have less negative illness perceptions regarding TBI compared to Veterans who screen positive in the control group.

Secondary analyses are to identify clinic-level barriers and facilitators to incorporation of the educational handout into the clinical encounter.

RESEARCH PLAN: The investigators will compare 2 groups of Veterans (N = 1500), half of whom are screened as usual and half of whom receive the educational intervention. Participants will be Veterans from 4 VA post-deployment clinics in Bay Pines, FL; Hampton, VA; Providence, RI; and Tampa, FL. The recruitment portion of the study will last 24 weeks at each site. The first 12 weeks of the study, all OEF/OIF Veterans that are screened for TBI will be enrolled into the screening as usual control group. The following 12 weeks all OEF/OIF Veterans screened for TBI will be enrolled into the intervention group. The investigators anticipate enrolling 750 Veterans in each group.

METHODOLOGY: All OEF/OIF Veterans screened for TBI in the 4 identified post-deployment clinics during the study period will be eligible for inclusion in the study. The primary outcome is knowledge gained about mTBI and illness perception. All participants will be given an instrument with questions on demographics and TBI knowledge and perceptions. Participants who receive the educational handout will be asked for additional feedback. The investigators will examine the effect of the intervention on the number of correct responses to the knowledge items as well as the rates of correct answers to each individual knowledge item. Further, the investigators will examine the effect of the intervention on each of the illness perception scores.

• Study Type: Interventional
• Enrollment (Actual): 1236
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Bay Pines, Florida, United States, 33708
      • Bay Pines VA Healthcare System, Pay Pines, FL
    • Tampa, Florida, United States, 33612
      • James A. Haley Veterans' Hospital, Tampa, FL
  • Rhode Island
    • Providence, Rhode Island, United States, 02908
      • Providence VA Medical Center, Providence, RI
  • Vermont
    • White River Junction, Vermont, United States, 05009-0001
      • White River Junction VA Medical Center, White River Junction, VT
  • Virginia
    • Hampton, Virginia, United States, 23667
      • Hampton VA Medical Center, Hampton, VA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All OEF/OIF Veterans screened for TBI at the designated clinic at 1 of the 4 study sites (during the 6 months of recruitment) will be eligible.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Arm 1; Participants will be "screened as usual". These participants will have the TBI screening as usual, without the educational intervention.
Experimental: Arm 2; Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.	Other: TBI handout; The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mTBI Questionnaire	The primary outcome is knowledge gained about mTBI and illness perception. This is evaluated by number correct out of 10 true or false questions.	One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.
Illness Perception - Current Symptoms	Participants rate on a Likert Scale from 0-10 how much their current symptoms affect their life, with 0 being no affect, and 10 being severe.	One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.
Illness Perception - Duration of Symptoms	Participants rate on a Likert Scale from 0-10 how long they think their current symptoms will continue with 0 being a very short time and 10 being forever.	One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility Questionnaire	A brief feasibility questionnaire will be used to evaluate provider feedback regarding administering the educational handout as part of the TBI clinical reminder.	One month- Providers complete a questionnaire within 1 month after data collection ends for the site.

Collaborators and Investigators

• Sponsor: VA Office of Research and Development

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: August 10, 2011
• First Submitted That Met QC Criteria: March 16, 2012
• First Posted (Estimate): March 20, 2012

Study Record Updates

• Last Update Posted (Actual): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 8, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: PTSD; patient education handout
• Other Study ID Numbers: RRP 10-221

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No