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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Veterans
Veterans will be the primary group for whom the VD-HCBS Program is implemented. Veterans enrolled in VD-HCBS will be functionally impaired
Other: VD-HCBS
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
Other: VD-HCBS
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
Other: VD-HCBS
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
Other: VD-HCBS
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
VHA Geriatrics and Extended Care
US Department of Health and Human Services Administration for Community Living
VHA Partnered Evidence-Based Policy Resource Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 8, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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