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

NCT ID: NCT01558791

Last Updated: 2019-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 1236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-01-31

Brief Summary

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.

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.

Conditions

TBI

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Arm 1

Participants will be "screened as usual". These participants will have the TBI screening as usual, without the educational intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Arm 2

Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.

Group Type: EXPERIMENTAL

TBI handout

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

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

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica L Hamblen, PhD

Role: PRINCIPAL_INVESTIGATOR

White River Junction VA Medical Center, White River Junction, VT

Locations

Bay Pines VA Healthcare System, Pay Pines, FL

Bay Pines, Florida, United States

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, United States

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, United States

White River Junction VA Medical Center, White River Junction, VT

White River Junction, Vermont, United States

Hampton VA Medical Center, Hampton, VA

Hampton, Virginia, United States

Countries

United States

Other Identifiers

RRP 10-221

Identifier Type: -

Identifier Source: org_study_id