Engaging Homeless Veterans in Primary Care

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00858507
Collaborator
(none)
221
1
2
53
4.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: RN Brief Intervention
  • Behavioral: Social Worker Outreach
N/A

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

Study Type:
Interventional
Actual Enrollment :
221 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Engaging Homeless Veterans in Primary Care
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Oct 1, 2012
Actual Study Completion Date :
Mar 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Personal Health Assessment/RN Brief Intervention

RN-based medical outreach, administration of a personal health assessment and brief intervention

Behavioral: RN 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)

Behavioral: Social Worker Outreach
Social worker will encounter homeless veteran in the community and encourage to come to the VA for care

Outcome Measures

Primary Outcome Measures

  1. Receipt of Primary Care at the VA [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 VA Medical Center, Providence Providence Rhode Island United States 02908-4799

Sponsors and Collaborators

  • VA Office of Research and Development

Investigators

  • Principal Investigator: Thomas P O'Toole, MD, VA Medical Center, Providence

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00858507
Other Study ID Numbers:
  • IIR 07-184
First Posted:
Mar 9, 2009
Last Update Posted:
Jul 21, 2016
Last Verified:
Jun 1, 2016

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Arm 1: RN-based Medical Outreach, Administration of a Personal Arm 2: Social Work Based Outreach (Usual Care)
Arm/Group Description 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 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
Period Title: Overall Study
STARTED 105 116
COMPLETED 83 101
NOT COMPLETED 22 15

Baseline Characteristics

Arm/Group Title Arm 1: RN-based Medical Outreach, Administration of a Personal Arm 2: Social Work Based Outreach (Usual Care) Total
Arm/Group Description 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 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 Total of all reporting groups
Overall Participants 83 101 184
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
79
95.2%
97
96%
176
95.7%
>=65 years
4
4.8%
4
4%
8
4.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
48.8
(11.6)
48.5
(10.2)
48.6
(10.8)
Sex: Female, Male (Count of Participants)
Female
6
7.2%
4
4%
10
5.4%
Male
77
92.8%
97
96%
174
94.6%
Region of Enrollment (participants) [Number]
United States
83
100%
101
100%
184
100%

Outcome Measures

1. Primary Outcome
Title Receipt of Primary Care at the VA
Description 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.
Time Frame within 4 weeks of intervention

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Outreach Arm 2: Usual Care
Arm/Group Description 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 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
Measure Participants 83 101
Number [participants]
50
60.2%
39
38.6%

Adverse Events

Time Frame
Adverse Event Reporting Description 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.
Arm/Group Title Arm 1: Outreach Arm 2: Usual Care
Arm/Group Description 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 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
All Cause Mortality
Arm 1: Outreach Arm 2: Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN)
Serious Adverse Events
Arm 1: Outreach Arm 2: Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN)
Other (Not Including Serious) Adverse Events
Arm 1: Outreach Arm 2: Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Thomas O'Toole, MD
Organization Providence VA Medical Center
Phone 4012737100
Email thomas.otoole@va.gov
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00858507
Other Study ID Numbers:
  • IIR 07-184
First Posted:
Mar 9, 2009
Last Update Posted:
Jul 21, 2016
Last Verified:
Jun 1, 2016