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Aligning Resources to Care for Homeless Veterans (ARCH)

This study is currently recruiting participants.
Verified February 2013 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01550757
First received: September 13, 2011
Last updated: February 8, 2013
Last verified: February 2013
History of Changes
  Purpose

"Aligning Resources to Care for Homeless Veterans" (ARCH) will study ways to best organize and deliver primary care for homeless Veterans. The investigators will assess 4 different adaptations of the PACT primary care model in a mixed methods study that includes multi-center, randomized-controlled trials of embedded peer-mentoring within different iterations of the PACT model, focus groups of study participants assessing satisfaction, treatment engagement and self-efficacy within the different care models and a cost-utility analysis to determine the most cost-efficient approach to organizing care for this population. Findings from this study will help determine optimal care approaches for reducing emergency department visits and acute hospitalizations, increasing patient satisfaction, and improving chronic disease management. Findings from this study will also substantively add to our understanding of health seeking behavior and the care of vulnerable/high-risk Veteran populations as well as clinical systems design. This project reflects a true "field-based study" to identify optimal and feasible approaches to patient care within our current VHA system. Finally, it will help inform pressing policy issues relevant to two identified T-21 priority areas: Ending Veteran Homelessness in 5 Years and Transforming to a Patient Centered Primary Care model.


Condition Intervention
Homeless Persons
Primary Health Care
 Behavioral: Embedded Peer Mentor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Aligning Resources to Care for Homeless Veterans (ARCH)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • A primary outcome for this study is non-acute emergency department visits. [ Time Frame: Two years. ] [ Designated as safety issue: No ]
    A primary outcome for this study is non-acute emergency department visits. This event was shown to decrease among Veterans enrolled in the homeless-oriented primary care model compared with usual care in our Providence-based study. Reductions in inappropriate emergency department use were also reported among homeless persons accessing Health Care for the Homeless clinics and by McGuire, et al., in a study evaluating a VA model similar to that in Providence.


Secondary Outcome Measures:
  • A primary outcome measure for this study is ambulatory sensitive admissions. [ Time Frame: Two years ] [ Designated as safety issue: No ]
    This event was shown to decrease among Veterans enrolled in the homeless-oriented primary care model compared with usual care in our Providence-based study.


Estimated Enrollment: 600
Study Start Date: March 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm 1
Normal PACT Clinical Care
Experimental: Arm 2
Normal PACT Clinical Care + Embedded Peer Mentor
 Behavioral: Embedded Peer Mentor
This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research.
No Intervention: Arm 3
Normal Homeless Oriented PACT Clinical Care
Experimental: Arm 4
Normal Homeless Oriented PACT Clinical Care + Embedded Peer Mentor
 Behavioral: Embedded Peer Mentor
This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The study population will be homeless Veterans enrolled in primary care (including both new and established patients who are homeless at the time of enrollment).
  2. Currently homeless to include: unsheltered; staying in an emergency shelter; in transitional/Grant and Per Diem housing; or doubled-up with a family member or friend and not paying rent.

Exclusion Criteria:

  1. Currently enrolled in Mental Health Intensive Case Management (MHICM) or other VA-based case/care managed program;
  2. Stated plans to leave the area within 6 months of enrollment;
  3. Unable or unwilling to provide informed consent;
  4. Pregnant women will because excluded because we do not wish to detract from the amount of specialty care and services they receive and need.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01550757

Contacts
Contact: Thomas P O'Toole, MD (401) 273-7100 ext 3045 thomas.otoole@va.gov

Locations
United States, California
San Francisco VA Medical Center, San Francisco, CA Recruiting
San Francisco, California, United States, 94121
Contact: Kristen Hay         kristen.hay@va.gov    
United States, Rhode Island
VA Medical Center, Providence Recruiting
Providence, Rhode Island, United States, 02908-4799
Contact: Erin Johnson     401-273-7100     Erin.Johnson4@va.gov    
Contact: Dawn Mello     (401) 273-7100 ext 6287     dawn.mello@va.gov    
Principal Investigator: Thomas P O'Toole, MD            
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Thomas P O'Toole, MD VA Medical Center, Providence
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01550757     History of Changes
Other Study ID Numbers: SDR 11-230
Study First Received: September 13, 2011
Last Updated: February 8, 2013
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on May 23, 2013