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

TBI Clinical Trial

— TBI  

Official title:

A Brief Educational Intervention to Improve TBI Screening Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01558791
• Other study ID #: RRP 10-221
• Status: Completed
• Phase: Phase 1
• Start date: September 2011
• Est. completion date: January 2013

Study information

• Verified date: March 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1236
• Est. completion date: January 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• TBI

Intervention

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.

Locations

Country	Name	City	State
United States	Bay Pines VA Healthcare System, Pay Pines, FL	Bay Pines	Florida
United States	Hampton VA Medical Center, Hampton, VA	Hampton	Virginia
United States	Providence VA Medical Center, Providence, RI	Providence	Rhode Island
United States	James A. Haley Veterans' Hospital, Tampa, FL	Tampa	Florida
United States	White River Junction VA Medical Center, White River Junction, VT	White River Junction	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.