Trial Outcomes & Findings for Remotely-Delivered Benefits Counseling for Service Connection Applicants (NCT NCT02677428)
NCT ID: NCT02677428
Last Updated: 2020-11-20
Results Overview
This calendar measure will be used to determine whether, and on what days the Veteran engaged in paid work activities.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
Assessed at baseline, and 4, 12 and 24 weeks post-randomization. Each assessment is for the period since prior assessment
Results posted on
2020-11-20
Participant Flow
Participants were recruited from two VA Medical Centers in New England between December 2015 and December 2018. 32 participants who consented to the study did not log into the study website and were thus excluded from analysis.
Participant milestones
| Measure |
Remotely Delivered Benefits Counseling
Veterans will complete three intervention modules online. For the first module, Veterans will be instructed on how to use the website and its purpose; will be asked about their perception of the relationship between disability benefits and work. An explanation of relationship between disability benefits and work will be provided. For the second module, Veterans' feelings and attitudes towards employment will be solicited. Motivational Interviewing exercises will be implemented; barriers to work including the disabling condition and consideration of treatment for disabling conditions will be reviewed. An action plan will be developed. For the third module, inquiries will be made regarding the Veteran's reaction to the service-connection decision; information will be provided on how to appeal the decision. Veterans will be asked to reconsider work and financial goals in light of service-connection award. Their action plan will be reviewed. Follow-up resources will be provided.
|
Control Website
The control website will involve a webpage containing referrals to VA websites and represents enhanced treatment-as-usual. A Veteran who completes a Compensation examination ordinarily has no further treatment or referral as part of the Compensation examination. The information provided on the control website controls for having information available about benefits and receiving encouragement to pursue that information. The control condition involves being urged to explore links to three VA websites with Compensation \& Pension-related information: (a) the Veterans Benefits Administration (VBA) website with links about VA disability compensation, (b) the VBA site with fact sheets about the different types of benefits available to Veterans, and (c) the VBA websites for the local C\&P office where issues pertaining to an individual Veteran's specific application are addressed.
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
55
|
|
Overall Study
COMPLETED
|
63
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Remotely-Delivered Benefits Counseling for Service Connection Applicants
Baseline characteristics by cohort
| Measure |
Remotely Delivered Benefits Counseling
n=63 Participants
Veterans will complete three intervention modules online. For the first module, Veterans will be instructed on how to use the website and its purpose; will be asked about their perception of the relationship between disability benefits and work. An explanation of relationship between disability benefits and work will be provided. For the second module, Veterans' feelings and attitudes towards employment will be solicited. Motivational Interviewing exercises will be implemented; barriers to work including the disabling condition and consideration of treatment for disabling conditions will be reviewed. An action plan will be developed. For the third module, inquiries will be made regarding the Veteran's reaction to the service-connection decision; information will be provided on how to appeal the decision. Veterans will be asked to reconsider work and financial goals in light of service-connection award. Their action plan will be reviewed. Follow-up resources will be provided.
|
Control
n=55 Participants
The control website will involve a webpage containing referrals to VA websites and represents enhanced treatment-as-usual. A Veteran who completes a Compensation examination ordinarily has no further treatment or referral as part of the Compensation examination. The information provided on the control website controls for having information available about benefits and receiving encouragement to pursue that information. The control condition involves being urged to explore links to three VA websites with Compensation \& Pension-related information: (a) the Veterans Benefits Administration (VBA) website with links about VA disability compensation, (b) the VBA site with fact sheets about the different types of benefits available to Veterans, and (c) the VBA websites for the local C\&P office where issues pertaining to an individual Veteran's specific application are addressed.
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.7 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
41.1 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
39.8 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
41 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Problematic Substance Use
|
41 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Provisional PTSD Diagnosis
|
41 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Brief Severity Index
Global Severity index
|
1.6 units on a scale
STANDARD_DEVIATION .7 • n=5 Participants
|
1.4 units on a scale
STANDARD_DEVIATION .6 • n=7 Participants
|
1.5 units on a scale
STANDARD_DEVIATION .7 • n=5 Participants
|
|
Brief Severity Index
Depression subscale
|
1.6 units on a scale
STANDARD_DEVIATION 1.0 • n=5 Participants
|
1.7 units on a scale
STANDARD_DEVIATION .9 • n=7 Participants
|
1.7 units on a scale
STANDARD_DEVIATION .9 • n=5 Participants
|
|
Competitive Work
|
2.8 hours per week
STANDARD_DEVIATION 6.6 • n=5 Participants
|
2.0 hours per week
STANDARD_DEVIATION 5.1 • n=7 Participants
|
2.4 hours per week
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Any work-related activities
|
7.4 days per month
STANDARD_DEVIATION 8.1 • n=5 Participants
|
5.8 days per month
STANDARD_DEVIATION 7.4 • n=7 Participants
|
6.7 days per month
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Income, past 28 days
|
1790 dollars
STANDARD_DEVIATION 1730 • n=5 Participants
|
2318 dollars
STANDARD_DEVIATION 2498 • n=7 Participants
|
2036 dollars
STANDARD_DEVIATION 2130 • n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at baseline, and 4, 12 and 24 weeks post-randomization. Each assessment is for the period since prior assessmentThis calendar measure will be used to determine whether, and on what days the Veteran engaged in paid work activities.
Outcome measures
| Measure |
Remotely Delivered Benefits Counseling
n=63 Participants
Veterans will complete three intervention modules online. For the first module, Veterans will be instructed on how to use the website and its purpose; will be asked about their perception of the relationship between disability benefits and work. An explanation of relationship between disability benefits and work will be provided. For the second module, Veterans' feelings and attitudes towards employment will be solicited. Motivational Interviewing exercises will be implemented; barriers to work including the disabling condition and consideration of treatment for disabling conditions will be reviewed. An action plan will be developed. For the third module, inquiries will be made regarding the Veteran's reaction to the service-connection decision; information will be provided on how to appeal the decision. Veterans will be asked to reconsider work and financial goals in light of service-connection award. Their action plan will be reviewed. Follow-up resources will be provided.
|
Control
n=55 Participants
The control website will involve a webpage containing referrals to VA websites and represents enhanced treatment-as-usual. A Veteran who completes a Compensation examination ordinarily has no further treatment or referral as part of the Compensation examination. The information provided on the control website controls for having information available about benefits and receiving encouragement to pursue that information. The control condition involves being urged to explore links to three VA websites with Compensation \& Pension-related information: (a) the Veterans Benefits Administration (VBA) website with links about VA disability compensation, (b) the VBA site with fact sheets about the different types of benefits available to Veterans, and (c) the VBA websites for the local C\&P office where issues pertaining to an individual Veteran's specific application are addressed.
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|---|---|---|
|
Hours Per Week of Paid Work
Week 24
|
9.6 hours per week
Standard Deviation 19.5
|
7.0 hours per week
Standard Deviation 14.1
|
|
Hours Per Week of Paid Work
Baseline
|
2.8 hours per week
Standard Deviation 6.6
|
2.0 hours per week
Standard Deviation 5.1
|
|
Hours Per Week of Paid Work
Week 4
|
4.8 hours per week
Standard Deviation 10.7
|
4.0 hours per week
Standard Deviation 10.7
|
|
Hours Per Week of Paid Work
Week 12
|
6.8 hours per week
Standard Deviation 14.6
|
5.6 hours per week
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: Assessed at baseline, and 4, 12 and 24 weeks post-randomization. Each assessment is for the period since prior assessmentThis measure consists of six questions about respondent's ability to work to his/her "fullest capacity" currently, how ready they are to work to fullest capacity, how important it is to work to fullest capacity, how important it is to work for pay, and how confident one in in ability work to fullest capacity. Items are rated on an 11 point Likert scale, ranging from 0 to 10, with higher scores indicating more importance (0 "not at all important" to 10 "very important") and more confidence (0 "not at all confident" to 10 "completely confident") in one's ability. We report the mean/median of the scores (range 0-10) at each timepoint by treatment group. This measure has been used to show that Veteran-rated importance of work was associated with engagement in Compensated Work Therapy among Veterans with vocational and psychiatric difficulties. It was collected at Baseline, Week 4, Week 12 and week 24.
Outcome measures
| Measure |
Remotely Delivered Benefits Counseling
n=63 Participants
Veterans will complete three intervention modules online. For the first module, Veterans will be instructed on how to use the website and its purpose; will be asked about their perception of the relationship between disability benefits and work. An explanation of relationship between disability benefits and work will be provided. For the second module, Veterans' feelings and attitudes towards employment will be solicited. Motivational Interviewing exercises will be implemented; barriers to work including the disabling condition and consideration of treatment for disabling conditions will be reviewed. An action plan will be developed. For the third module, inquiries will be made regarding the Veteran's reaction to the service-connection decision; information will be provided on how to appeal the decision. Veterans will be asked to reconsider work and financial goals in light of service-connection award. Their action plan will be reviewed. Follow-up resources will be provided.
|
Control
n=55 Participants
The control website will involve a webpage containing referrals to VA websites and represents enhanced treatment-as-usual. A Veteran who completes a Compensation examination ordinarily has no further treatment or referral as part of the Compensation examination. The information provided on the control website controls for having information available about benefits and receiving encouragement to pursue that information. The control condition involves being urged to explore links to three VA websites with Compensation \& Pension-related information: (a) the Veterans Benefits Administration (VBA) website with links about VA disability compensation, (b) the VBA site with fact sheets about the different types of benefits available to Veterans, and (c) the VBA websites for the local C\&P office where issues pertaining to an individual Veteran's specific application are addressed.
|
|---|---|---|
|
Work Importance and Confidence Ruler
Baseline
|
7.03 units on a scale
Standard Deviation 1.81
|
6.72 units on a scale
Standard Deviation 2.57
|
|
Work Importance and Confidence Ruler
Week 4
|
7.17 units on a scale
Standard Deviation 2.02
|
7.08 units on a scale
Standard Deviation 1.98
|
|
Work Importance and Confidence Ruler
Week 12
|
7.34 units on a scale
Standard Deviation 1.99
|
7.28 units on a scale
Standard Deviation 2.32
|
|
Work Importance and Confidence Ruler
Week 24
|
7.42 units on a scale
Standard Deviation 1.76
|
7.54 units on a scale
Standard Deviation 2.19
|
Adverse Events
Remotely Delivered Benefits Counseling
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Remotely Delivered Benefits Counseling
n=63 participants at risk
Veterans will complete three intervention modules online. For the first module, Veterans will be instructed on how to use the website and its purpose; will be asked about their perception of the relationship between disability benefits and work. An explanation of relationship between disability benefits and work will be provided. For the second module, Veterans' feelings and attitudes towards employment will be solicited. Motivational Interviewing exercises will be implemented; barriers to work including the disabling condition and consideration of treatment for disabling conditions will be reviewed. An action plan will be developed. For the third module, inquiries will be made regarding the Veteran's reaction to the service-connection decision; information will be provided on how to appeal the decision. Veterans will be asked to reconsider work and financial goals in light of service-connection award. Their action plan will be reviewed. Follow-up resources will be provided.
|
Control
n=55 participants at risk
The control website will involve a webpage containing referrals to VA websites and represents enhanced treatment-as-usual. A Veteran who completes a Compensation examination ordinarily has no further treatment or referral as part of the Compensation examination. The information provided on the control website controls for having information available about benefits and receiving encouragement to pursue that information. The control condition involves being urged to explore links to three VA websites with Compensation \& Pension-related information: (a) the Veterans Benefits Administration (VBA) website with links about VA disability compensation, (b) the VBA site with fact sheets about the different types of benefits available to Veterans, and (c) the VBA websites for the local C\&P office where issues pertaining to an individual Veteran's specific application are addressed.
|
|---|---|---|
|
Psychiatric disorders
Suicide Risk
|
1.6%
1/63 • Number of events 1 • 24 weeks (study participation)
|
1.8%
1/55 • Number of events 1 • 24 weeks (study participation)
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place