We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Engaging Homeless Veterans in Primary Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00858507
Recruitment Status : Completed
First Posted : March 9, 2009
Results First Posted : July 21, 2016
Last Update Posted : July 21, 2016
Information provided by (Responsible Party):

March 5, 2009
March 9, 2009
December 10, 2014
July 21, 2016
July 21, 2016
October 2009
October 2012   (Final data collection date for primary outcome measure)
Receipt of Primary Care at the VA [ Time Frame: within 4 weeks of intervention ]
The primary aim of this study was to conduct a randomized controlled trial of different interventions aimed at increasing rates of treatment engagement among a community sample of treatment-naive homeless veterans.
Receipt of Primary Care at the VA [ Time Frame: within 2 weeks of intervention ]
Complete list of historical versions of study NCT00858507 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Engaging Homeless Veterans in Primary Care
Engaging Homeless Veterans in Primary Care
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.

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. The investigators 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?

The investigators' 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.

Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Homeless Persons
  • Behavioral: RN Brief Intervention
    RN administered personal health assessment along with a brief intervention for behavior change administered to homeless veterans in the community
  • Behavioral: Social Worker Outreach
    Social worker will encounter homeless veteran in the community and encourage to come to the VA for care
  • Experimental: Personal Health Assessment/RN Brief Intervention
    RN-based medical outreach, administration of a personal health assessment and brief intervention
    Intervention: Behavioral: RN Brief Intervention
  • Placebo Comparator: Social Work-Administered Outreach
    Social work based outreach (usual care)
    Intervention: Behavioral: Social Worker Outreach

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
March 2014
October 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
IIR 07-184
Not Provided
Not Provided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Thomas P O'Toole, MD VA Medical Center, Providence
VA Office of Research and Development
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP