Remotely-Delivered Benefits Counseling for Service Connection Applicants
5 novembre 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
150
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Connecticut
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West Haven, Connecticut, États-Unis, 06516
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT
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Massachusetts
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Leeds, Massachusetts, États-Unis, 01053-9764
- VA Central Western Massachusetts Healthcare System, Leeds, MA
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 64 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Comparateur actif: 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.
|
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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Hours Per Week of Paid Work
Délai: 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.
|
Assessed at baseline, and 4, 12 and 24 weeks post-randomization. Each assessment is for the period since prior assessment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Work Importance and Confidence Ruler
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 décembre 2015
Achèvement primaire (Réel)
1 juillet 2019
Achèvement de l'étude (Réel)
1 novembre 2020
Dates d'inscription aux études
Première soumission
22 janvier 2016
Première soumission répondant aux critères de contrôle qualité
3 février 2016
Première publication (Estimation)
9 février 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
20 novembre 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 novembre 2020
Dernière vérification
1 novembre 2020
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- D1319-R
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Only with a data sharing agreement.
There is no provision for data sharing in the approved IRB protocol.
Délai de partage IPD
By June 2020.
Critères d'accès au partage 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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .