- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00858507
Engaging Homeless Veterans in Primary Care
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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. 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02908-4799
- VA Medical Center, Providence
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Personal Health Assessment/RN Brief Intervention
RN-based medical outreach, administration of a personal health assessment and brief intervention
|
RN administered personal health assessment along with a brief intervention for behavior change administered to homeless veterans in the community
|
PLACEBO_COMPARATOR: Social Work-Administered Outreach
Social work based outreach (usual care)
|
Social worker will encounter homeless veteran in the community and encourage to come to the VA for care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
within 4 weeks of intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Thomas P O'Toole, MD, VA Medical Center, Providence
Publications and helpful links
General Publications
- 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):2493-9. doi: 10.2105/AJPH.2009.179416. Epub 2010 Oct 21.
- 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 2(Suppl 2):683-8. doi: 10.1007/s11606-011-1818-2.
- O'Toole TP, Johnson EE, Borgia ML, Rose J. Tailoring Outreach Efforts to Increase Primary Care Use Among Homeless Veterans: Results of a Randomized Controlled Trial. J Gen Intern Med. 2015 Jul;30(7):886-98. doi: 10.1007/s11606-015-3193-x. Epub 2015 Feb 12.
- O'Toole TP, Pape L. Innovative Efforts to Address Homelessness Among Veterans. N C Med J. 2015 Nov-Dec;76(5):311-4. doi: 10.18043/ncm.76.5.311.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IIR 07-184
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.
Clinical Trials on Homeless Persons
-
Unity Health TorontoCovenant House Toronto; The Living Rock Ministries; The Resource Association...CompletedHomeless PersonsCanada
-
Centre for Addiction and Mental HealthLOFT Community Services; Covenant House Toronto; Wellesley InstituteRecruiting
-
VA Office of Research and DevelopmentCompletedVeterans | Homeless Persons | Mentally Ill PersonsUnited States
-
Duke UniversityDurham VA Medical CenterCompletedSmoking | Homeless PersonsUnited States
-
VA Office of Research and DevelopmentCompletedPrimary Health Care | Homeless PersonsUnited States
-
Unity Health TorontoCanadian Institutes of Health Research (CIHR)RecruitingHospital Readmission | Primary Care | Case Management | Homeless PersonsCanada
-
Unity Health TorontoThe Physicians' Services Incorporated FoundationCompletedEmergency Medical Services | Homeless PersonsCanada
-
Hennepin Healthcare Research InstituteNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National... and other collaboratorsCompletedType 2 Diabetes | Homeless PersonsUnited States
-
Murdoch Childrens Research InstituteRoyal Children's Hospital; RCH League of Former Trainees and Associates IncCompletedHomeless YouthAustralia
-
Center for Social Innovation, MassachusettsColumbia University; Hunter College of City University of New YorkCompletedImplementation, Fidelity, and Outcomes Following Novel and Usual Critical Time Intervention TrainingHomeless Services | Human Services TrainingUnited States
Clinical Trials on RN Brief Intervention
-
i4HealthTerminated
-
New York State Psychiatric InstituteNot yet recruitingDepression | Mental Health Disorder | Adolescent Behavior | Stigma, SocialUnited States
-
University of Texas at AustinNational Institute on Drug Abuse (NIDA)Completed
-
Friends Research Institute, Inc.National Institute on Drug Abuse (NIDA)CompletedDrug Abuse | HIV Risk BehaviorUnited States
-
Wayne State UniversityNational Institute on Drug Abuse (NIDA)Completed
-
Marquette UniversityCompletedDischarge Transition of Patients Discharged to HomeUnited States
-
Friends Research Institute, Inc.National Institute on Drug Abuse (NIDA)CompletedRisk Behavior | Marijuana Use | Alcohol Consumption | Unsafe Sex
-
New York State Psychiatric InstituteNot yet recruitingDepression | Mental Health Disorder | Stigma, SocialUnited States
-
University of California, San FranciscoCompletedMetabolic HealthUnited States
-
University of MichiganNational Institute on Drug Abuse (NIDA)CompletedDrug Use | Sex BehaviorUnited States