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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:
Veterans who receive the educational handout will be asked specific questions about the handout and its information.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | No Intervention | Participants will be "screened as usual". These participants will have the TBI screening as usual, without the educational intervention. | |
| Arm 2 | Experimental | Participants will be given the TBI handout (educational intervention) along with the usual TBI screen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TBI handout | 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica L Hamblen, PhD | White River Junction VA Medical Center, White River Junction, VT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bay Pines VA Healthcare System, Pay Pines, FL | Bay Pines | Florida | 33708 | United States | ||
| James A. Haley Veterans' Hospital, Tampa, FL |
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| ID | Title | Description |
|---|---|---|
| FG000 | Screened as Usual | Participants will be "screened as usual". These participants will have the TBI screening as usual, without the educational intervention. |
| FG001 | TBI Handout | Participants will be given the TBI handout (educational intervention) along with the usual TBI screen. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All veterans screened for TBI
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| ID | Title | Description |
|---|---|---|
| BG000 | Screened as Usual | Participants will be "screened as usual". These participants will have the TBI screening as usual, without the educational intervention. |
| BG001 | TBI Handout |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Of the total study population, 7 participants did not provide their age. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All veterans screened who accepted the questionnaire. | Posted | Mean | Standard Deviation | correct answers out of 10 | One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment. |
|
Adverse event data were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | Participants will be "screened as usual". These participants will have the TBI screening as usual, without the educational intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jessica Hamblen, PI | National Center for PTSD | 802-296-5132 | 5389 | Jessica.Hamblen@va.gov |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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|
| Tampa |
| Florida |
| 33612 |
| United States |
| Providence VA Medical Center, Providence, RI | Providence | Rhode Island | 02908 | United States |
| White River Junction VA Medical Center, White River Junction, VT | White River Junction | Vermont | 05009-0001 | United States |
| Hampton VA Medical Center, Hampton, VA | Hampton | Virginia | 23667 | United States |
Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.
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.
| BG002 | Total | Total of all reporting groups |
| Number |
| participants |
|
| Sex/Gender, Customized | Of the total study population, 69 participants did not provide their gender. | Number | participants |
|
| Marital status | Of the total study population, 13 participants did not provide their marital status. | Number | participants |
|
| Service Branch | Participants were able to select all that apply, so there is overlap for those who have served in more than one service branch and those who were in the reserves. N=1231 provided information on service era. | Number | participants |
|
| Employment | Of the total study population, 10 participants did not provide their employment status. | Number | participants |
|
| Service connection | Of the total study population, 65 participants did not provide information about service connection. | Number | participants |
|
| Reported PTSD diagnosis | Of the total study population, 29 participants did not provide information on PTSD diagnosis. | Number | participants |
|
|
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| 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. | All veterans who accepted questionnaire | Posted | Mean | Standard Deviation | units on a scale | 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. | All veterans screened who accepted questionnaire | Posted | Mean | Standard Deviation | units on a scale | 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. | PI and project staff no longer have access to this data to report results. | Posted | One month- Providers complete a questionnaire within 1 month after data collection ends for the site. |
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| 0 |
| 0 |
| 0 |
| EG001 | Arm 2 | Participants will be given the TBI handout (educational intervention) along with the usual TBI screen. 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. | 0 | 0 | 0 | 0 |
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