Clinical trial NCT01558791: A Brief Educational Intervention to Improve Traumatic Brain Injury (TBI) Screening Outcomes
Official title: A Brief Educational Intervention to Improve TBI Screening Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: TBI
Keywords: PTSD
patient education handout
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2012-03-20
Enrollment: 1236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: mTBI Questionnaire
timeFrame: One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.
measure: Illness Perception - Current Symptoms
timeFrame: One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.
measure: Illness Perception - Duration of Symptoms
timeFrame: One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.
Secondary outcomes:
measure: Feasibility Questionnaire
timeFrame: One month- Providers complete a questionnaire within 1 month after data collection ends for the site.
Other outcomes:
Locations:
city: Bay Pines
country: United States
facility: Bay Pines VA Healthcare System, Pay Pines, FL
state: Florida
city: Tampa
country: United States
facility: James A. Haley Veterans' Hospital, Tampa, FL
state: Florida
city: Providence
country: United States
facility: Providence VA Medical Center, Providence, RI
state: Rhode Island
city: White River Junction
country: United States
facility: White River Junction VA Medical Center, White River Junction, VT
state: Vermont
city: Hampton
country: United States
facility: Hampton VA Medical Center, Hampton, VA
state: Virginia
Study officials:
affiliation: White River Junction VA Medical Center, White River Junction, VT
name: Jessica L Hamblen, PhD
role: PRINCIPAL_INVESTIGATOR
References: