Remotely-Delivered Benefits Counseling for Service Connection Applicants
5 de noviembre de 2020 actualizado por: VA Office of Research and Development
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
150
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Connecticut
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West Haven, Connecticut, Estados Unidos, 06516
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT
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Massachusetts
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Leeds, Massachusetts, Estados Unidos, 01053-9764
- VA Central Western Massachusetts Healthcare System, Leeds, MA
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 64 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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:
- i. A Compensation and Pension evaluation by a psychiatrist or psychologist is scheduled
- ii. Does not have a service-connected physical disability rated over 30%
- iii. 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)
- iv. Age 18-65
- v. Reports access to an internet-connected computer/tablet and a working telephone
- vi. Reports working an average of two or fewer days per week for pay over the preceding 4 weeks
- vii. 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)
- ix. 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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
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.
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Comparador activo: 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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Hours Per Week of Paid Work
Periodo de tiempo: Assessed at baseline, and 4, 12 and 24 weeks post-randomization. Each assessment is for the period since prior assessment
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This calendar measure will be used to determine whether, and on what days the Veteran engaged in paid work activities.
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Assessed at baseline, and 4, 12 and 24 weeks post-randomization. Each assessment is for the period since prior assessment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Work Importance and Confidence Ruler
Periodo de tiempo: 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. |
Assessed at baseline, and 4, 12 and 24 weeks post-randomization. Each assessment is for the period since prior assessment
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de diciembre de 2015
Finalización primaria (Actual)
1 de julio de 2019
Finalización del estudio (Actual)
1 de noviembre de 2020
Fechas de registro del estudio
Enviado por primera vez
22 de enero de 2016
Primero enviado que cumplió con los criterios de control de calidad
3 de febrero de 2016
Publicado por primera vez (Estimar)
9 de febrero de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de noviembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
5 de noviembre de 2020
Última verificación
1 de noviembre de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- D1319-R
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Only with a data sharing agreement.
There is no provision for data sharing in the approved IRB protocol.
Marco de tiempo para compartir IPD
By June 2020.
Criterios de acceso compartido de IPD
After a data sharing agreement has been entered into.
The plan will specify the requester, purpose, and agreement to keep the data confidential and not disclose it further.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .