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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00858507
Other study ID # IIR 07-184
Secondary ID
Status Completed
Phase N/A
First received March 5, 2009
Last updated July 10, 2014
Start date October 2009
Est. completion date March 2014

Study information

Verified date July 2014
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The objectives of this study are to test an evidence-based model for improving primary and preventive care engagement among homeless veterans not currently receiving care and to demonstrate the additive benefit of primary care-based treatment engagement by this population.


Description:

One out of three homeless men and nearly one quarter of all homeless adults are veterans. This translates to almost 200,000 veterans being homeless on any given night. The Department of Veteran Affairs (VA) is a major service provider to homeless persons and has developed several very successful and innovative programs that have been effective in securing housing, economic stability and needed services for these men and women. However, despite these efforts in many communities, veterans are not accessing these services despite aggressive outreach and state-of-the art programming. We are conducting a prospective randomized controlled trial to test the hypothesis that a personalized health assessment linked to community outreach is more likely to both engage the homeless veteran in a primary care based chronic disease management model and to sustain that care and associated behavior changes necessary to exit homelessness. The key questions to be addressed in this study are: (1) Will a community-based health-oriented outreach increase health seeking behavior in the intervention group?; (2) can initial engagement be sustained in a continuity care model in this population?; (3) will this intervention facilitate changes/improvements in health seeking behavior that include participation in substance abuse treatment care, compliance with mental health care, and enrollment in VA-based employment/financial support programs?; and (4) can this intervention impact chronic disease management of key cardiovascular risk indicators that disproportionately affect homeless persons?; and (5) do any observed changes correlate with serial behavioral measures and qualitative assessments?

Our working hypothesis is that a targeted outreach to homeless persons that capitalizes on either established or newly realized physical health concerns to affect both health seeking behavior and sustained behavior change. It is grounded in two complementary behavioral models: the Behavioral Model for Vulnerable Populations and the body of research describing intrinsic versus extrinsic motivators for sustained behavior change.

Two hundred and eighty homeless veterans will be randomized to receive either a personalized health assessment based outreach or usual care (social work/housing focused) outreach. Baseline assessments will include demographics, medical, mental health and substance use co-morbidities, pre-intervention health seeking behavior, readiness for behavior change (URICA), motivation for health care. Serial assessments at months 1, and 6 will assess evolving readiness and motivation as well as changes in their homeless status (sheltering, employment/income, etc.) Actual utilization of services will be assessed using the CPRS electronic medical records.


Recruitment information / eligibility

Status Completed
Enrollment 221
Est. completion date March 2014
Est. primary completion date October 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- VA eligible

- currently homeless

Exclusion Criteria:

- cognitively impaired

- not planning on staying in area for next 6 months

- currently enrolled in VA primary care

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
Personal Health Assessment/brief intervention
RN administered personal health assessment along with a brief intervention for behavior change administered to homeless veterans in the community
Social work administered outreach
Social worker will encounter homeless veteran in the community and encourage to come to the VA for care

Locations

Country Name City State
United States VA Medical Center, Providence Providence Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

O'Toole TP, Buckel L, Bourgault C, Blumen J, Redihan SG, Jiang L, Friedmann P. Applying the chronic care model to homeless veterans: effect of a population approach to primary care on utilization and clinical outcomes. Am J Public Health. 2010 Dec;100(12) — View Citation

O'Toole TP, Pirraglia PA, Dosa D, Bourgault C, Redihan S, O'Toole MB, Blumen J; Primary Care-Special Populations Treatment Team. Building care systems to improve access for high-risk and vulnerable veteran populations. J Gen Intern Med. 2011 Nov;26 Suppl — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary receipt of primary care at the VA within 2 weeks of intervention No
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