Homeless PersonsNCT00858507
Engaging Homeless Veterans in Primary Care
A study testing RN Brief Intervention and Social Worker Outreach in people with Homeless Persons, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Homeless Persons
- What is being tested?
- RN Brief Intervention and Social Worker Outreach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 221 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Mar 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- VA eligible
- currently homeless
Who cannot join
- cognitively impaired
- not planning on staying in area for next 6 months
- currently enrolled in VA primary care
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center, Providence
Providence, Rhode Island, 02908-4799
About this study
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.
Read the 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.
- Conditions
- Homeless Persons
- Being tested
- RN Brief Intervention, Social Worker Outreach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RN Brief InterventionBehavioural
RN administered personal health assessment along with a brief intervention for behavior change administered to homeless veterans in the community
Social Worker OutreachBehavioural
Social worker will encounter homeless veteran in the community and encourage to come to the VA for care
| Study group | Role | What they receive |
|---|---|---|
| Personal Health Assessment/RN Brief Intervention | Experimental | RN-based medical outreach, administration of a personal health assessment and brief intervention Receives: Behavioral: RN Brief Intervention |
| Social Work-Administered Outreach | Placebo comparator | Social work based outreach (usual care) Receives: Behavioral: Social Worker Outreach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2012
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Homeless PersonsStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Thomas P O'Toole, MD, Principal investigator, VA Medical Center, Providence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858507
- Sponsor's protocol ID
- IIR 07-184
- Status last verified
- Jun 2016
- First submitted
- 5 Mar 2009
- Last updated
- 21 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 20966377O'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.
PubMed 21989622O'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.
PubMed 25673574O'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.
PubMed 26946863
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Homeless Veterans in Primary Care
- ClinicalTrials.gov ID
- NCT00858507
- Acronym / sponsor ID
- IIR 07-184
- Conditions
- Homeless Persons
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Oct 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 9 Mar 2009 (estimated)
- Results
- Posted 21 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personal Health Assessment/RN Brief Intervention | Experimental | Behavioral: RN Brief InterventionRN-based medical outreach, administration of a personal health assessment and brief intervention |
| Social Work-Administered Outreach | Placebo comparator | Behavioral: Social Worker OutreachSocial work based outreach (usual care) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- VA eligible
- currently homeless
Key exclusion criteria (3 listed)
- cognitively impaired
- not planning on staying in area for next 6 months
- currently enrolled in VA primary care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RN Brief InterventionRN administered personal health assessment along with a brief intervention for behavior change administered to homeless veterans in the community | Behavioural | Personal Health Assessment/RN Brief Intervention |
| Social Worker OutreachSocial worker will encounter homeless veteran in the community and encourage to come to the VA for care | Behavioural | Social Work-Administered Outreach |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20966377O'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.
- Results publication: PubMed 21989622O'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.
- Results publication: PubMed 25673574O'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.
- Results publication: PubMed 26946863O'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas P O'Toole, MD principal investigator
VA Medical Center, Providence
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RN Brief Intervention and Social Worker Outreach in people with Homeless Persons, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Receipt of Primary Care at the VA (time frame: within 4 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00858507, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2016.