Trial Outcomes & Findings for A Brief Educational Intervention to Improve Traumatic Brain Injury (TBI) Screening Outcomes (NCT NCT01558791)
NCT ID: NCT01558791
Last Updated: 2019-03-25
Results Overview
The primary outcome is knowledge gained about mTBI and illness perception. This is evaluated by number correct out of 10 true or false questions.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
1236 participants
Primary outcome timeframe
One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.
Results posted on
2019-03-25
Participant Flow
Participant milestones
| Measure |
Screened as Usual
Participants will be "screened as usual". These participants will have the TBI screening as usual, without the educational intervention.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
607
|
629
|
|
Overall Study
COMPLETED
|
607
|
629
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Brief Educational Intervention to Improve Traumatic Brain Injury (TBI) Screening Outcomes
Baseline characteristics by cohort
| Measure |
Screened as Usual
n=607 Participants
Participants will be "screened as usual". These participants will have the TBI screening as usual, without the educational intervention.
|
TBI Handout
n=629 Participants
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.
|
Total
n=1236 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<20 years
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Age, Customized
20-29 years
|
287 participants
n=5 Participants
|
306 participants
n=7 Participants
|
593 participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
152 participants
n=5 Participants
|
158 participants
n=7 Participants
|
310 participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
123 participants
n=5 Participants
|
119 participants
n=7 Participants
|
242 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
39 participants
n=5 Participants
|
38 participants
n=7 Participants
|
77 participants
n=5 Participants
|
|
Age, Customized
60+ years
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
91 participants
n=5 Participants
|
99 participants
n=7 Participants
|
190 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
494 participants
n=5 Participants
|
483 participants
n=7 Participants
|
977 participants
n=5 Participants
|
|
Marital status
Married
|
269 participants
n=5 Participants
|
300 participants
n=7 Participants
|
569 participants
n=5 Participants
|
|
Marital status
Widowed
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Marital status
Divorced
|
117 participants
n=5 Participants
|
114 participants
n=7 Participants
|
231 participants
n=5 Participants
|
|
Marital status
Separated
|
42 participants
n=5 Participants
|
44 participants
n=7 Participants
|
86 participants
n=5 Participants
|
|
Marital status
Never married
|
171 participants
n=5 Participants
|
161 participants
n=7 Participants
|
332 participants
n=5 Participants
|
|
Service Branch
Army
|
346 participants
n=5 Participants
|
335 participants
n=7 Participants
|
681 participants
n=5 Participants
|
|
Service Branch
Navy
|
463 participants
n=5 Participants
|
477 participants
n=7 Participants
|
940 participants
n=5 Participants
|
|
Service Branch
Marine Corps
|
508 participants
n=5 Participants
|
533 participants
n=7 Participants
|
1041 participants
n=5 Participants
|
|
Service Branch
Air Force
|
524 participants
n=5 Participants
|
543 participants
n=7 Participants
|
1067 participants
n=5 Participants
|
|
Service Branch
National Guard
|
529 participants
n=5 Participants
|
571 participants
n=7 Participants
|
1100 participants
n=5 Participants
|
|
Service Branch
Reserves
|
570 participants
n=5 Participants
|
581 participants
n=7 Participants
|
1151 participants
n=5 Participants
|
|
Service Branch
Coast Guard
|
599 participants
n=5 Participants
|
617 participants
n=7 Participants
|
1216 participants
n=5 Participants
|
|
Employment
Full-time
|
178 participants
n=5 Participants
|
197 participants
n=7 Participants
|
375 participants
n=5 Participants
|
|
Employment
Part-time
|
37 participants
n=5 Participants
|
27 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Employment
Retired
|
69 participants
n=5 Participants
|
58 participants
n=7 Participants
|
127 participants
n=5 Participants
|
|
Employment
Student
|
150 participants
n=5 Participants
|
149 participants
n=7 Participants
|
299 participants
n=5 Participants
|
|
Employment
Unemployed
|
170 participants
n=5 Participants
|
191 participants
n=7 Participants
|
361 participants
n=5 Participants
|
|
Service connection
No
|
305 participants
n=5 Participants
|
277 participants
n=7 Participants
|
582 participants
n=5 Participants
|
|
Service connection
Yes
|
278 participants
n=5 Participants
|
311 participants
n=7 Participants
|
589 participants
n=5 Participants
|
|
Reported PTSD diagnosis
No
|
440 participants
n=5 Participants
|
469 participants
n=7 Participants
|
909 participants
n=5 Participants
|
|
Reported PTSD diagnosis
Yes
|
152 participants
n=5 Participants
|
146 participants
n=7 Participants
|
298 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.Population: All veterans screened who accepted the 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.
Outcome measures
| Measure |
Arm 1
n=607 Participants
Participants will be "screened as usual". These participants will have the TBI screening as usual, without the educational intervention.
|
Arm 2
n=629 Participants
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.
|
|---|---|---|
|
mTBI Questionnaire
|
5.38 correct answers out of 10
Standard Deviation 2.94
|
7.52 correct answers out of 10
Standard Deviation 2.65
|
PRIMARY outcome
Timeframe: One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.Population: All veterans who accepted questionnaire
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.
Outcome measures
| Measure |
Arm 1
n=607 Participants
Participants will be "screened as usual". These participants will have the TBI screening as usual, without the educational intervention.
|
Arm 2
n=329 Participants
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.
|
|---|---|---|
|
Illness Perception - Current Symptoms
|
6.92 units on a scale
Standard Deviation 2.46
|
6.79 units on a scale
Standard Deviation 2.40
|
PRIMARY outcome
Timeframe: One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.Population: All veterans screened who accepted questionnaire
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.
Outcome measures
| Measure |
Arm 1
n=607 Participants
Participants will be "screened as usual". These participants will have the TBI screening as usual, without the educational intervention.
|
Arm 2
n=629 Participants
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.
|
|---|---|---|
|
Illness Perception - Duration of Symptoms
|
7.59 units on a scale
Standard Deviation 2.55
|
7.61 units on a scale
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: One month- Providers complete a questionnaire within 1 month after data collection ends for the site.Population: PI and project staff no longer have access to this data to report results.
A brief feasibility questionnaire will be used to evaluate provider feedback regarding administering the educational handout as part of the TBI clinical reminder.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place