VD-HCBS Eval: Evaluation of Veteran-Directed Home and Community Based Services

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT03145818
• Collaborator: VHA Geriatrics and Extended Care (Other), US Department of Health and Human Services Administration for Community Living (Other), VHA Partnered Evidence-Based Policy Resource Center (Other)
• Enrollment: 126
• Locations: 2
• Actual Duration (Months): 26.8
• Patients Per Site: 63
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Functional Impairment; Caregiving	Other: VD-HCBS

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

• Study Type: Observational
• Actual Enrollment: 126 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Evaluation of Veteran Directed Home and Community Based Services
• Actual Study Start Date: May 8, 2017
• Actual Primary Completion Date: Aug 1, 2019
• Actual Study Completion Date: Aug 1, 2019

Arms and Interventions

Arm	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	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

Outcome Measures

Primary Outcome Measures

1. Veteran's Unmet Need for Services, Satisfaction, Unmet Needs, and Quality of Life. [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.

2. Caregiver Well-being Survey [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Durham VA Medical Center, Durham, NC	Durham	North Carolina	United States	27705
2	Providence VA Medical Center, Providence, RI	Providence	Rhode Island	United States	02908

Sponsors and Collaborators

• VA Office of Research and Development
• VHA Geriatrics and Extended Care
• US Department of Health and Human Services Administration for Community Living
• VHA Partnered Evidence-Based Policy Resource Center

Investigators

• Principal Investigator: James L. Rudolph, MD, Providence VA Medical Center, Providence, RI

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 23, 2018

More Information

Additional Information:

• VA VD-HCBS

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT03145818
• Other Study ID Numbers: SDR 16-194; NCT04795791
• First Posted: May 9, 2017
• Last Update Posted: Nov 20, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by VA Office of Research and Development: dissemination

Study Results

Participant Flow

Recruitment Details	Recruitment letters to Veterans, Caregivers and Coordinators were sent inviting them to participate in qualitative interviews.

Arm/Group Title	Veterans	Caregivers	VHA Coordinators	ADNA Coordinators
Arm/Group Description	Veterans will be the primary group for whom the VD-HCBS Program is implemented. Veterans enrolled in VD-HCBS will be functionally impaired. The surveys are given at the onset of the program and quarterly and yearly thereafter. 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 support Veterans independence in their home and community 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 VD-HCBS Coordinators allow the program to operate within the VA 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 engage with the Veteran, Caregivers, and VA Coordinators to ensure the Veteran is able to maintain independence 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
Period Title: Overall Study
STARTED	99	8	10	9
COMPLETED	8	0	10	9
NOT COMPLETED	91	8	0	0

Baseline Characteristics

Arm/Group Title	Veterans	Caregivers	VHA Coordinators	ADNA Coordinators	Total
Arm/Group Description	Veterans will be the primary group for whom the VD-HCBS Program is implemented. Veterans enrolled in VD-HCBS will be functionally impaired 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 support Veterans independence in their home and community 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 VD-HCBS Coordinators allow the program to operate within the VA 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 engage with the Veteran, Caregivers, and VA Coordinators to ensure the Veteran is able to maintain independence 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	Total of all reporting groups
Overall Participants	99	8	10	9	126
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	75.4 (13.6)	63 (12.0)	74.4 (14.1)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	99 100%	8 100%	107 1070%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 3%	0 0%	3 30%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	37 37.4%	1 12.5%	38 380%
White	52 52.5%	6 75%	58 580%
More than one race	1 1%	0 0%	1 10%
Unknown or Not Reported	6 6.1%	1 12.5%	7 70%
Region of Enrollment (Count of Participants)
United States	99 100%	8 100%	10 100%	9 100%	126 100%

Outcome Measures

1. Primary Outcome

Title	Veteran's Unmet Need for Services, Satisfaction, Unmet Needs, and Quality of Life.
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Veterans enrolled in the Veteran Directed Home and Community Based Services program. Six Veterans did not participate in the survey.

Arm/Group Title	Veterans
Arm/Group Description	Veterans will be the primary group for whom the VD-HCBS Program is implemented. Veterans enrolled in VD-HCBS will be functionally impaired 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
Measure Participants	93
1. Satisfaction of VA home services	71 71.7%
2. Need additional help with everyday activities	63 63.6%
3. Able to attend recreational/social activities	35 35.4%
4. Worry about being able to remain in home	39 39.4%
5. Enough choice for services and products	66 66.7%
6. General life satisfaction	60 60.6%

2. Primary Outcome

Title	Caregiver Well-being Survey
Description	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.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

Caregivers who participated in a caregiver well-being survey.

Arm/Group Title	Caregivers
Arm/Group Description	Caregivers supporting Veterans independence in their home and community 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
Measure Participants	8
Serious Economic Situation	4 4%
Stressed between caregiving and other responsibili	3 3%
Reported Poor Health	0 0%
Felt lonely or isolated	5 5.1%

Adverse Events

Time Frame	12 months
Arm/Group Title	Veterans		Caregivers		VA Coordinators		VHA Coordinators
Arm/Group Description	Veterans enrolled in VD-HCBS have needs for services, the primary outcome are the needs which are not currently met		Caregiving wellbeing will be measured with a composite of financial strain, depressive symptoms, caregiving stress, and health status and positive caregiver experiences.		This semi-structured interview will identify constructs from the Consolidated Framework for Implementation Research and the Expert Recommendations for Implementing Change (ERIC).		This semi-structured interview will identify constructs from the Consolidated Framework for Implementation Research and the Expert Recommendations for Implementing Change (ERIC).
All Cause Mortality
	Veterans		Caregivers		VA Coordinators		VHA Coordinators
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/99 (0%)		0/8 (0%)		0/10 (0%)		0/9 (0%)
Serious Adverse Events
	Veterans		Caregivers		VA Coordinators		VHA Coordinators
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/99 (0%)		0/8 (0%)		0/10 (0%)		0/9 (0%)
Other (Not Including Serious) Adverse Events
	Veterans		Caregivers		VA Coordinators		VHA Coordinators
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/99 (0%)		0/8 (0%)		0/10 (0%)		0/9 (0%)

Limitations/Caveats

Unexpected events slowed expansion of VD-HCBS

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.