Remotely-Delivered Benefits Counseling for Service Connection Applicants

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT02677428
Collaborator
(none)
150
2
2
59
75
1.3

Study Details

Study Description

Brief Summary

A significant portion of Veterans who apply for disability benefits have difficulty finding and sustaining employment, and are concerned that working for pay will jeopardize their receipt of service-connection benefits. In a completed clinical trial, Veterans who received Motivational Interview-formatted counseled about opportunities to work and receive service-connection went on to work for pay significantly more often than controls. The proposed clinical trial will test this counseling's efficacy when it is delivered by an automated computer program.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Remotely-Delivered Benefits Counseling
  • Behavioral: Control
N/A

Detailed Description

Current application rates suggest that more than half of Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans will eventually apply for some form of service-connection, with approximately 100,000 Veterans per year being evaluated for psychiatric conditions. Veterans applying for service-connection for psychiatric conditions are in distress, and often are having occupational difficulties, but these are unaddressed during a typical Compensation and Pension evaluation. Counseling that addresses beneficiaries' concerns about losing compensation payments if working for pay, when supplemented by vocational supports, has been associated with increased employment among people disabled by chronic psychiatric conditions. This group has developed an online Benefits Counseling intervention tailored to help Veterans applying for service-connection engage in work-related activities. The investigators have demonstrated the efficacy of a face-to-face version of Benefits Counseling in a completed Rehabilitation Research & Development-funded six-month clinical trial in which Veterans assigned to Benefits Counseling worked significantly more days than controls,(p<.05, effect size = 0.69), reflecting an average of three more days of employment at six month follow-up. The investigators then used a supplement from Rehabilitation Research & Development to develop a web-based version of this counseling, so that the counseling could be delivered without a counselor on-site. The web-based intervention was modified based on user feedback, but the extent to which it will be used by Veterans at home and how it will impact their behavior is unknown. In the proposed clinical trial, Veterans working two or fewer days per week who are presenting for a Compensation & Pension examination for a psychiatric disorder will be assessed at baseline and then urged to log in afterwards to a website for random assignment to either Remotely-Delivered Benefits Counseling (n=65) or Veterans Benefits Administration web sites (n=65), and will then be assessed at 4, 12, and 24 weeks after randomization in order to calculate standardized group mean differences between the slopes over time. The primary outcome measure will be the treatment-by-time slope of hours of paid work. Exploratory analyses will estimate associations of potential mediators of treatment response with this outcome. The proposed study will provide estimates of the efficacy of remotely-delivered Benefits Counseling initiated at Compensation and Pension examinations, a widely-used point of contact with VA.

Study Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Remotely-Delivered Benefits Counseling for Service Connection Applicants
Actual Study Start Date :
Dec 1, 2015
Actual Primary Completion Date :
Jul 1, 2019
Actual Study Completion Date :
Nov 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: 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.

Active Comparator: Control

The control condition will involve 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 about benefits-related websites 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.

Behavioral: Control
The control condition will involve 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 about benefits-related websites 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 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.

Outcome Measures

Primary Outcome Measures

  1. Hours Per Week of Paid Work [Assessed at baseline, and 4, 12 and 24 weeks post-randomization. Each assessment is for the period since prior assessment]

    This calendar measure will be used to determine whether, and on what days the Veteran engaged in paid work activities.

Secondary Outcome Measures

  1. Work Importance and Confidence Ruler [Assessed at baseline, and 4, 12 and 24 weeks post-randomization. Each assessment is for the period since prior assessment]

    This 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All enrolled participants will have difficulty working as evidenced by a "Yes" response to any sub-part of the following question:

  • During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious):

  • (a) Cut down on the amount of time you spent on work or other activities?

  • (b) Accomplished less than you would like?

  • (c) Didn't do work or other activities as carefully as usual?

  • Participants will also meet the following inclusion criteria:

    1. A Compensation and Pension evaluation by a psychiatrist or psychologist is scheduled
    1. Does not have a service-connected physical disability rated over 30%
    1. Is not service-connected for a psychiatric condition (0% service-connection is allowed, as Veterans with 0% service-connection have not received any benefit payments)
    1. Age 18-65
    1. Reports access to an internet-connected computer/tablet and a working telephone
    1. Reports working an average of two or fewer days per week for pay over the preceding 4 weeks
    1. Self-reported ability to participate psychologically and physically, able to give informed consent and complete assessments; viii. Reports being able to read (this is necessary for understanding the website)
    1. Expressed interest in sampling whatever website is provided
Exclusion Criteria:
  • Already receiving Supplemental Security Income (SSI) or Social Security Disability Insurance (SSDI)

  • Has a conservator

Contacts and Locations

Locations

Site City State Country Postal Code
1 VA Connecticut Healthcare System West Haven Campus, West Haven, CT West Haven Connecticut United States 06516
2 VA Central Western Massachusetts Healthcare System, Leeds, MA Leeds Massachusetts United States 01053-9764

Sponsors and Collaborators

  • VA Office of Research and Development

Investigators

  • Principal Investigator: Marc I. Rosen, MD, VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT02677428
Other Study ID Numbers:
  • D1319-R
First Posted:
Feb 9, 2016
Last Update Posted:
Nov 20, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by VA Office of Research and Development

Study Results

Participant Flow

Recruitment Details 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.
Pre-assignment Detail
Arm/Group Title Remotely Delivered Benefits Counseling Control Website
Arm/Group Description 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. 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.
Period Title: Overall Study
STARTED 63 55
COMPLETED 63 55
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title Remotely Delivered Benefits Counseling Control Total
Arm/Group Description 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. 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 of all reporting groups
Overall Participants 63 55 118
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
38.7
(12.6)
41.1
(11.0)
39.8
(11.9)
Sex: Female, Male (Count of Participants)
Female
14
22.2%
11
20%
25
21.2%
Male
49
77.8%
44
80%
93
78.8%
Race/Ethnicity, Customized (Count of Participants)
White
41
65.1%
36
65.5%
77
65.3%
Hispanic
12
19%
10
18.2%
22
18.6%
Black
5
7.9%
7
12.7%
12
10.2%
Other
5
7.9%
2
3.6%
7
5.9%
Problematic Substance Use (Count of Participants)
Count of Participants [Participants]
41
65.1%
37
67.3%
78
66.1%
Provisional PTSD Diagnosis (Count of Participants)
Count of Participants [Participants]
41
65.1%
38
69.1%
79
66.9%
Brief Severity Index (units on a scale) [Mean (Standard Deviation) ]
Global Severity index
1.6
(.7)
1.4
(.6)
1.5
(.7)
Depression subscale
1.6
(1.0)
1.7
(.9)
1.7
(.9)
Competitive Work (hours per week) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [hours per week]
2.8
(6.6)
2.0
(5.1)
2.4
(6.0)
Any work-related activities (days per month) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days per month]
7.4
(8.1)
5.8
(7.4)
6.7
(7.8)
Income, past 28 days (dollars) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [dollars]
1790
(1730)
2318
(2498)
2036
(2130)

Outcome Measures

1. Primary Outcome
Title Hours Per Week of Paid Work
Description This calendar measure will be used to determine whether, and on what days the Veteran engaged in paid work activities.
Time Frame Assessed at baseline, and 4, 12 and 24 weeks post-randomization. Each assessment is for the period since prior assessment

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Remotely Delivered Benefits Counseling Control
Arm/Group Description 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. 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.
Measure Participants 63 55
Baseline
2.8
(6.6)
2.0
(5.1)
Week 4
4.8
(10.7)
4.0
(10.7)
Week 12
6.8
(14.6)
5.6
(12.8)
Week 24
9.6
(19.5)
7.0
(14.1)
2. Secondary Outcome
Title Work Importance and Confidence Ruler
Description This 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.
Time Frame Assessed at baseline, and 4, 12 and 24 weeks post-randomization. Each assessment is for the period since prior assessment

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Remotely Delivered Benefits Counseling Control
Arm/Group Description 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. 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.
Measure Participants 63 55
Baseline
7.03
(1.81)
6.72
(2.57)
Week 4
7.17
(2.02)
7.08
(1.98)
Week 12
7.34
(1.99)
7.28
(2.32)
Week 24
7.42
(1.76)
7.54
(2.19)

Adverse Events

Time Frame 24 weeks (study participation)
Adverse Event Reporting Description
Arm/Group Title Remotely Delivered Benefits Counseling Control
Arm/Group Description 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. 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.
All Cause Mortality
Remotely Delivered Benefits Counseling Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/63 (0%) 0/55 (0%)
Serious Adverse Events
Remotely Delivered Benefits Counseling Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/63 (1.6%) 1/55 (1.8%)
Psychiatric disorders
Suicide Risk 1/63 (1.6%) 1 1/55 (1.8%) 1
Other (Not Including Serious) Adverse Events
Remotely Delivered Benefits Counseling Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/63 (0%) 0/55 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Marc Rosen
Organization VA Connecticut Healthcare System
Phone 203-932-5711 ext 2112
Email marc.rosen@va.go
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT02677428
Other Study ID Numbers:
  • D1319-R
First Posted:
Feb 9, 2016
Last Update Posted:
Nov 20, 2020
Last Verified:
Nov 1, 2020