Functional ImpairmentVD-HCBS EvalNCT03145818
Evaluation of Veteran-Directed Home and Community Based Services
An observational study of Functional Impairment and Caregiving, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Impairment, Caregiving
- What is being tested?
- VD-HCBS
- How many people
- 126 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 May 2017to 1 Aug 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Veterans enrolled in VD-HCBS tend to be older with functional impairments which could precipitate facility based care placement
Who may be able to join
- Veterans who are eligible and enrolled in VD-HCBS at the expansion VAMCs
Who cannot join
- Non-Veterans
- Those not eligible or enrolled in VD-HCBS
- Enrolled in VD-HCBS at a non-expansion VAMC
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908
About this study
Official title: 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.
Read the 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.
- Conditions
- Functional Impairment, Caregiving
- Being tested
- VD-HCBS
- Keywords
- dissemination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VD-HCBSOther
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
| Study group | Role | What they receive |
|---|---|---|
| Veterans | Veterans will be the primary group for whom the VD-HCBS Program is implemented. Veterans enrolled in VD-HCBS will be functionally impaired Receives: Other: VD-HCBS | |
| Caregivers | Caregivers support Veterans independence in their home and community Receives: Other: VD-HCBS | |
| VHA Coordinators | VHA VD-HCBS Coordinators allow the program to operate within the VA Receives: Other: VD-HCBS | |
| ADNA Coordinators | ADNA Coordinators engage with the Veteran, Caregivers, and VA Coordinators to ensure the Veteran is able to maintain independence Receives: Other: VD-HCBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Veteran's Unmet Need for Services, Satisfaction, Unmet Needs, and Quality of Life.
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.
Measured: 12 months
Caregiver Well-being Survey
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start8 May 2017
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional ImpairmentStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- US Department of Veterans Affairs, Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- James L. Rudolph, MD, Principal investigator, Providence VA Medical Center, Providence, RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145818
- Sponsor's protocol ID
- SDR 16-194
- Acronym
- VD-HCBS Eval
- Status last verified
- Oct 2020
- First submitted
- 1 May 2017
- Last updated
- 20 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garrido MM, Allman RM, Pizer SD, Rudolph JL, Thomas KS, Sperber NR, Van Houtven CH, Frakt AB. Innovation in a Learning Health Care System: Veteran-Directed Home- and Community-Based Services. J Am Geriatr Soc. 2017 Nov;65(11):2446-2451. doi: 10.1111/jgs.15053. Epub 2017 Aug 21.
PubMed 28832927
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Veteran Directed Home and Community Based Services
- ClinicalTrials.gov ID
- NCT03145818
- Acronym / sponsor ID
- VD-HCBS Eval / SDR 16-194
- Conditions
- Functional Impairment, Caregiving
- Keywords
- dissemination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- US Department of Veterans Affairs, Department of Health and Human Services
- Study start
- 8 May 2017 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 9 May 2017 (actual)
- Results
- Posted 20 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Veterans | – | Other: VD-HCBSVeterans will be the primary group for whom the VD-HCBS Program is implemented. Veterans enrolled in VD-HCBS will be functionally impaired |
| Caregivers | – | Other: VD-HCBSCaregivers support Veterans independence in their home and community |
| VHA Coordinators | – | Other: VD-HCBSVHA VD-HCBS Coordinators allow the program to operate within the VA |
| ADNA Coordinators | – | Other: VD-HCBSADNA Coordinators engage with the Veteran, Caregivers, and VA Coordinators to ensure the Veteran is able to maintain independence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans enrolled in VD-HCBS tend to be older with functional impairments which could precipitate facility based care placement
Key inclusion criteria (1 listed)
- Veterans who are eligible and enrolled in VD-HCBS at the expansion VAMCs
Key exclusion criteria (3 listed)
- Non-Veterans
- Those not eligible or enrolled in VD-HCBS
- Enrolled in VD-HCBS at a non-expansion VAMC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VD-HCBSLike 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 | Other | ADNA Coordinators, Caregivers, VHA Coordinators, Veterans |
Primary outcome
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28832927Garrido MM, Allman RM, Pizer SD, Rudolph JL, Thomas KS, Sperber NR, Van Houtven CH, Frakt AB. Innovation in a Learning Health Care System: Veteran-Directed Home- and Community-Based Services. J Am Geriatr Soc. 2017 Nov;65(11):2446-2451. doi: 10.1111/jgs.15053. Epub 2017 Aug 21.
- VA VD-HCBSLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James L. Rudolph, MD principal investigator
Providence VA Medical Center, Providence, RI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Impairment and Caregiving, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Veteran's Unmet Need for Services, Satisfaction, Unmet Needs, and Quality of Life. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03145818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.