- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03145818
Evaluation of Veteran-Directed Home and Community Based Services (VD-HCBS Eval)
October 29, 2020 updated by: VA Office of Research and Development
Evaluation of Veteran Directed Home and Community Based Services
Veteran-Directed Home and Community Based Services (VD-HCBS) is focused on preserving Veteran's independence and the VA Office of Geriatrics and Extended Care is planning an expansion of VD-HCBS to 90 additional VA Medical Centers over the next 3 years.
This proposal seeks to evaluate the VD-HCBS expansion to capture comprehensive information on the impact of VD-HCBS on Veterans' and Caregivers' outcomes, as well as, to identify how the program was implemented.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In the next decade, there will be a doubling of older Veterans for whom the VA has a requirement to provide long-term care.
At a cost of $110,000 per year for long-term care, Geriatrics and Extended Care (GEC) is seeking to preserve Veteran independence in the community.
VD-HCBS is a person-centered consumer-directed program that provides Veterans the opportunity to self-direct their long-term services and supports (LTSS) and continue to live independently at home.
GEC is planning to expand VD-HCBS to an additional 90 VAMCs over the next 3 years.
This proposal will provide important outcomes and context to the VD-HCBS expansion.
The specific aims of this proposal are: Aim 1: To describe the impact of VD-HCBS on Veterans' satisfaction, unmet need for services, quality of life and independence using mixed methods.
Aim 1 will utilize operations data to describe the change in Veteran-reported satisfaction, unmet needs, and independence from enrollment in VD-HCBS to 3 and 12 months.
Additionally, the investigators will conduct interviews with Veterans to capture their experiences with the program.
Aim 2: To understand the effect of VD-HCBS on Caregivers' well-being.
Aim 2 will compare Caregivers' financial strain, depressive symptoms, caregiving stress, and health status and positive caregiver experiences to a propensity matched population from existing VA data to determine the impact of the VD-HCBS program on Caregivers.
Aim 3: To examine the implementation of the VD-HCBS program expansion.
Aim 3 will utilize the Consolidated Framework for Implementation Research and Expert Recommendations for Implementing Change to interview coordinators, and other key informants, from VA and ADNA VD-HCBS pairs.
The analysis will shed light on how contextual factors and implementation strategies relate to implementation and Veteran outcomes.
VD-HCBS has tremendous opportunity to improve the fiscal outlook of GEC's LTSS while delivering the highest level of Veteran-centered care.
In concert with the outcomes of VD-HCBS, this implementation evaluation will be critical to determining how the VA system, in partnership with community-based organizations, implements programs and illuminating important leverage points to facilitate implementation effectiveness.
With the diverse team assembled and the comprehensive evaluation proposed, the investigators will produce evidence to inform VA program implementation and dissemination, a critical component of the VA's priorities to develop high-performing, highly-reliable, and consistent networks.
Study Type
Observational
Enrollment (Actual)
126
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Durham VA Medical Center, Durham, NC
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02908
- Providence VA Medical Center, Providence, RI
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Veterans enrolled in VD-HCBS tend to be older with functional impairments which could precipitate facility based care placement
Description
Inclusion Criteria:
- Veterans who are eligible and enrolled in VD-HCBS at the expansion VAMCs
Exclusion Criteria:
- Non-Veterans
- Those not eligible or enrolled in VD-HCBS
- Enrolled in VD-HCBS at a non-expansion VAMC
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Veterans
Veterans will be the primary group for whom the VD-HCBS Program is implemented.
Veterans enrolled in VD-HCBS will be functionally impaired
|
Like the participant-directed programs developed for Medicaid programs,VD-HCBS maximizes Veteran-centered care and independence.
VD-HCBS provides Veterans with a monthly financial allotment based on an assessment of the extent of their need for assistance with personal care due to injury or the impact of disease
|
|
Caregivers
Caregivers support Veterans independence in their home and community
|
Like the participant-directed programs developed for Medicaid programs,VD-HCBS maximizes Veteran-centered care and independence.
VD-HCBS provides Veterans with a monthly financial allotment based on an assessment of the extent of their need for assistance with personal care due to injury or the impact of disease
|
|
VHA Coordinators
VHA VD-HCBS Coordinators allow the program to operate within the VA
|
Like the participant-directed programs developed for Medicaid programs,VD-HCBS maximizes Veteran-centered care and independence.
VD-HCBS provides Veterans with a monthly financial allotment based on an assessment of the extent of their need for assistance with personal care due to injury or the impact of disease
|
|
ADNA Coordinators
ADNA Coordinators engage with the Veteran, Caregivers, and VA Coordinators to ensure the Veteran is able to maintain independence
|
Like the participant-directed programs developed for Medicaid programs,VD-HCBS maximizes Veteran-centered care and independence.
VD-HCBS provides Veterans with a monthly financial allotment based on an assessment of the extent of their need for assistance with personal care due to injury or the impact of disease
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Veteran's Unmet Need for Services, Satisfaction, Unmet Needs, and Quality of Life.
Time Frame: 12 months
|
Satisfaction Survey Number of Veterans responding to VA-specific program survey questions on Veteran satisfaction, unmet needs, and quality of life.
Veterans were asked to respond to a 6 question survey by choosing a number from a scale (either from 1-10 or 1-5; low numbers typically indicating satisfaction; higher numbers indicating dissatisfaction) to indicate their level of overall satisfaction with their current health needs and ability to participate in daily activities.
|
12 months
|
|
Caregiver Well-being Survey
Time Frame: 9 months
|
Number of caregivers who responded to a VA specific Caregiver survey on financial strain, depressive symptoms, caregiving stress, and health status and positive caregiver experiences.
Caregivers were asked to choose the best answer from a scale that reflected the level of intensity (low numbers typically indicating less intensity than the higher numbers) of common caregiving stressors.
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: James L. Rudolph, MD, Providence VA Medical Center, Providence, RI
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 8, 2017
Primary Completion (ACTUAL)
August 1, 2019
Study Completion (ACTUAL)
August 1, 2019
Study Registration Dates
First Submitted
May 1, 2017
First Submitted That Met QC Criteria
May 4, 2017
First Posted (ACTUAL)
May 9, 2017
Study Record Updates
Last Update Posted (ACTUAL)
November 20, 2020
Last Update Submitted That Met QC Criteria
October 29, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SDR 16-194
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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