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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personal Health Assessment/RN Brief Intervention | Experimental | RN-based medical outreach, administration of a personal health assessment and brief intervention |
|
| Social Work-Administered Outreach | Placebo Comparator | Social work based outreach (usual care) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RN Brief Intervention | Behavioral | RN administered personal health assessment along with a brief intervention for behavior change administered to homeless veterans in the community |
| Measure | Description | Time Frame |
|---|---|---|
| Receipt of Primary Care at the VA | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas P O'Toole, MD | VA Medical Center, Providence | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center, Providence | Providence | Rhode Island | 02908-4799 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20966377 | Result | 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. | |
| 21989622 | Result |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: RN-based Medical Outreach, Administration of a Personal | RN-based medical outreach, administration of a personal health assessment and brief intervention 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 |
| FG001 | Arm 2: Social Work Based Outreach (Usual Care) | Social work based outreach (usual care) Social work administered outreach: Social worker will encounter homeless veteran in the community and encourage to come to the VA for care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: RN-based Medical Outreach, Administration of a Personal | RN-based medical outreach, administration of a personal health assessment and brief intervention 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Receipt of Primary Care at the VA | 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. | Posted | Number | participants | within 4 weeks of intervention |
|
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Per IRB designation as 'minimal risk' and approval of safety monitoring plan, non-serious AEs were not assessed. Serious Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Outreach | RN-based medical outreach, administration of a personal health assessment and brief intervention 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas O'Toole, MD | Providence VA Medical Center | 4012737100 | thomas.otoole@va.gov |
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| Social Worker Outreach | Behavioral | Social worker will encounter homeless veteran in the community and encourage to come to the VA for care |
|
| 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. |
| 25673574 | Result | 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. |
| 26946863 | Result | 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. |
| BG001 |
| Arm 2: Social Work Based Outreach (Usual Care) |
Social work based outreach (usual care) Social work administered outreach: Social worker will encounter homeless veteran in the community and encourage to come to the VA for care |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Arm 2: Usual Care | Social work based outreach (usual care) Social work administered outreach: Social worker will encounter homeless veteran in the community and encourage to come to the VA for care | 0 | 0 | 0 | 0 |
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