NCT00858507

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

July 21, 2016

Completed
Last Updated

July 21, 2016

Status Verified

June 1, 2016

Enrollment Period

3 years

First QC Date

March 5, 2009

Results QC Date

December 10, 2014

Last Update Submit

June 9, 2016

Conditions

Homeless Persons

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Personal Health Assessment/RN Brief Intervention

EXPERIMENTAL

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

Behavioral: RN Brief Intervention

Social Work-Administered Outreach

PLACEBO COMPARATOR

Social work based outreach (usual care)

Behavioral: Social Worker Outreach

Interventions

RN Brief InterventionBEHAVIORAL

RN administered personal health assessment along with a brief intervention for behavior change administered to homeless veterans in the community

Personal Health Assessment/RN Brief Intervention
Social Worker OutreachBEHAVIORAL

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

Social Work-Administered Outreach

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • VA eligible
  • currently homeless

You may not qualify if:

  • cognitively impaired
  • not planning on staying in area for next 6 months
  • currently enrolled in VA primary care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center, Providence

Providence, Rhode Island, 02908-4799, United States

Location

Related Publications (4)

  • 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.

    PMID: 20966377RESULT

  • 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.

    PMID: 21989622RESULT

  • 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.

    PMID: 25673574RESULT

  • 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.

    PMID: 26946863RESULT

Results Point of Contact

Title
Thomas O'Toole, MD
Organization
Providence VA Medical Center
thomas.otoole@va.gov
4012737100

Study Officials

  • Thomas P O'Toole, MD

    VA Medical Center, Providence

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2009

First Posted

March 9, 2009

Study Start

October 1, 2009

Primary Completion

October 1, 2012

Study Completion

March 1, 2014

Last Updated

July 21, 2016

Results First Posted

July 21, 2016

Record last verified: 2016-06

Locations

US(1)