Condition category
Mental and Behavioural Disorders
Date applied
20/03/2017
Date assigned
21/03/2017
Last edited
23/03/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
For the past 20 years, there has been a movement in the United States to move care out of nursing homes and other institutions and into the home or community for older adults with physical or cognitive (mental) limitations. One type of program that is designed to help individuals remain in their homes as long as possible is participant-directed services, where individuals are provided with monthly funds to purchase personal care services, medical equipment, or home modifications. The Department of Veterans Affairs’ version of this program is called Veteran Directed Home and Community Based Services (VD-HCBS). This program has been implemented in some Veterans Affairs Medical Centers (VAMCs) and will be rolled out nationwide in the next three years. The aims of this study are to understand whether VD-HCBS reduces hospital admissions, emergency department admissions, nursing home admissions, and health care costs relative to usual care among veterans at risk for nursing home placement.

Who can participate?
VAMCs that have not started the VD-HCBS programs. The VD-HCBS program targets patients enrolled in the Veterans Health Administration who have physical or cognitive limitations and are at risk of a nursing home placement.

What does the study involve?
Medical centers are randomly allocated to when they begin enrolling patients in VD-HCBS. This program provides patients with more support for home care (provides modifications to their homes, provides medical equipment or supplies and allows them to choose a personal care worker). Sites that have VD-HCBS are compared to sites with the usual care, and by the end of the study period, all eligible VAMCs will have VD-HCBS programs. Healthcare use and costs for veterans with physical or cognitive limitations are also compared across VAMCs with and without the VD-HCBS programs.

What are the possible benefits and risks of participating?
Medical centers with VD-HCBS may have lower facility-wide rates of preventable hospital admissions, emergency department admissions, and nursing home admissions. There are no notable risks with participating.

Where is the study run from?
This study is being coordinated by the Partnered Evidence-based Policy Resource Center (PEPReC) at the VA Boston Healthcare System (USA) and takes place in many VAMCs across the USA.

When is the study starting and how long is it expected to run for?
October 2015 to September 2020

Who is funding the study?
U.S. Department of Veterans Affairs (USA)

Who is the main contact?
Dr Melissa Garrido
peprec@va.gov

Trial website

Contact information

Type

Scientific

Primary contact

Dr Melissa Garrido

ORCID ID

http://orcid.org/0000-0002-8986-3536

Contact details

Partnered Evidence-Based Policy Resource Center
Boston VA Healthcare System
150 South Huntington Ave. Mail Stop 152H
Boston
02130
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

VA Boston Healthcare System IRB Protocol # 3069

Study information

Scientific title

Evaluation of Veteran-Directed Home and Community Based Services on older veterans’ health care use and costs: a stepped wedge cluster randomized trial

Acronym

VD-HCBS

Study hypothesis

The availability of Veteran Directed Home and Community Based Services (VD-HCBS) will be associated with a reduction in hospital admissions, emergency department visits, nursing home admissions, and health care costs among older veterans with functional limitations.

Ethics approval

VA Boston Healthcare System IRB and R&D Committees, 02/02/2017, ref: Protocol # 3069

Study design

Stepped wedge cluster randomized trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Functional (needs assistance with 3 or more Activities of Daily Living) and/or cognitive limitations that place individuals at risk of nursing home placement

Intervention

The VD-HCBS program is a participant-directed program that enables veterans with functional or cognitive limitations to purchase care services in their homes. The goal of this program is to reduce these veterans’ risk of placement in a nursing home or other long-term care facility. Clinicians within the VA can refer patients to the VD-HCBS program, wherein the VA pays for services coordinated by Aging and Disability Network Agencies (ADNAs). Veterans receive a monthly allotment to pay for personal care workers of their own choosing (including family members), medical equipment or supplies, or modifications to the home. ADNA representatives work with veterans to identify and monitor care needs, facilitate purchasing of appropriate services or equipment, and to monitor spending.

As of December 2016, there are 78 Veterans Affairs Medical Centers (VAMCs) not yet participating in the VD-HCBS program. GEC plans to roll the VD-HCBS program out nationally over a period of 3 years. At the beginning of each six-month period, GEC identifies a list of 14 VAMCs (sites) that are ready to begin offering VD-HCBS to veterans within the next six months. These sites are in the process of creating contract agreements with local ADNAs who work directly with the patients. The subset of sites are randomized to begin enrolling patients in VD-HCBS at month one or month four. This process is repeated every six months until the remaining VAMCs have implemented VD-HCBS.

Simple randomization in a stepped wedge approach like this is likely to lead to imbalance across sites that enroll patients at month 1 vs month 4 in important characteristics that may be associated with the outcomes of interest. Examples of such characteristics include facility case-mix and facility engagement in providing other Geriatrics and Extended Care (GEC) services to older veterans. Imbalance could occur because GEC is constrained in each six-month period to randomize start times for only about 14 VAMCs — those that are capable of enrolling patients within the next six months. Therefore, just by chance, those that are randomized to start in month 1 could be different in important ways than those randomized to a month 4 start.

To address this concern, covariate constrained randomization (also known as restricted randomization) is used to assign start times. This allows for better baseline balance on more potential confounders than simple randomization, matching, or stratification. From the VAMCs ready for participation each six month period, the full set of all potential variations in start times among them is evaluated and these combinations are ranked according to site characteristic balance. Site characteristics used in covariate constrained randomization includes sites’ percent of long-term services and supports (LTSS) expenditures going to HCBS, whether the site has a Community Living Center (CLC [nursing home]), market penetration of non-institutionalized care services among veterans 75 or older, urban/rural location, state participation in early participant-directed care initiatives, percent of state Medicaid LTSS expenditures going to HCBS, and case-mix for patients 75 and older (number of patients per site, mean Care Assessment Need (CAN) score (predicts 1-year mortality), mean Jen Frailty Index (based on VA data), and mean prospective VA data-based NOSOS score (measure of chronic disease burden). These characteristics are all likely to influence facility likelihood of referring patients to VD-HCBS and patient cost and utilization outcomes. For each combination, the difference between the month 1 facilities’ mean values of standardized variables and month 4 facilities’ mean values of standardized variables are calculated, squared, and summed to create a balancing score. Lower values of the balancing score indicate better covariate balance. From the combinations in the top 1% of covariate balance, one option is randomly selected.

The degree of follow up varies across different sites.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Any hospitalization is measured using administrative data collected by the VA Corporate Data Warehouse at 60-day increments for six months
2. Any emergency department visit is measured using administration data collected by the VA Corporate Data Warehouse at 60-day increments for six months
3. Nursing home admissions (VA community living center and contracted nursing homes) is measured using administrative data collected by the VA Corporate Data Warehouse at 60-day increments for six months
4. Total health care costs (VA, Medicare, Medicaid) are assessed using administration data collected by VA Corporate Data Warehouse data, Medicare data, and Medicaid data at 60-day increments for six months

Secondary outcome measures

1. Frequency of hospitalisation is measured using administrative data collected by the VA, Medicare, and/or Medicaid at 60-day increments for six months
2. Incidence and frequency of ambulatory care sensitive hospitalization is measured using administrative data collected by the VA, Medicare, and/or Medicaid at 60-day incrementsfor six months
3. Costs attributed to HCBS measured using administrative data collected by the VA, Medicare, and/or Medicaid at 60-day increments for six months
4. Costs attributed to nursing home stays are measured using administrative data collected by the VA, Medicare, and/or Medicaid at 60-day increments for six months
5. Costs attributed to outpatient care are measured using administrative data collected by the VA, Medicare, and/or Medicaid at 60-day increments for six months
6. Days at home (days not in an acute care setting or long-term care facility) are measured using administrative data collected by the VA, Medicare, and/or Medicaid at 60-day increments for six months

Overall trial start date

15/10/2015

Overall trial end date

01/09/2020

Reason abandoned

Eligibility

Participant inclusion criteria

VAMC inclusion criteria (cluster level):
Site does not yet have an operational VD-HCBS program

VHA enrollee criteria (individual level)*:
1. Aged 75 and older
2. Jen Frailty Index (VA-data only) of 6 or higher
3. Had at least one inpatient or outpatient visit in the VHA system in the past year”
*Exact enrollee criteria will differ by site, as sites are allowed flexibility in choosing who to refer to the program

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

1800

Participant exclusion criteria

VAMC criteria (cluster level)
1. Site has nearly completed readiness review and is unable to delay enrollment
2. Facility leadership not interested in implementing VD-HCBS program

VHA enrollee criteria (individual level)
There are no exclusion criteria for individual enrollment in VHA.

Recruitment start date

22/03/2017

Recruitment end date

29/02/2020

Locations

Countries of recruitment

United States of America

Trial participating centre

Partnered Evidence-Based Policy Resource Center
Boston VA Healthcare System 150 South Huntington Ave. Mail Stop 152H 02130
Boston
02130
United States of America

Sponsor information

Organisation

Department of Veterans Affairs Health Services Research & Development

Sponsor details

1100 1st Street NE
Suite 6
Washington DC
20002
United States of America

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

U.S. Department of Veterans Affairs

Alternative name(s)

United States Department of Veterans Affairs, VA

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Results and Publications

Publication and dissemination plan

Planned publications in high-impact peer reviewed journal.

IPD sharing plan:
The datasets generated during and/or analysed during the current study is not expected to be made available due to confidentiality reasons. Data will be stored on a secure server behind the Department of Veterans Affairs firewall.

Intention to publish date

28/02/2021

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

23/03/2017: Recruitment date changed