Brief Summary

"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.

Trial Health

On Track

Trial Health Score

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

Enrollment

382

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach

1 country

2 active sites

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

4.5 years study duration

First Submitted

Initial submission to the registry

September 13, 2011

Completed

6 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed

11 days until next milestone

First Posted

Study publicly available on registry

March 12, 2012

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

October 11, 2017

Completed

Last Updated

October 11, 2017

Status Verified

May 1, 2017

Enrollment Period

2.5 years

First QC Date

September 13, 2011

Results QC Date

May 16, 2017

Last Update Submit

May 16, 2017

Conditions

Homeless Persons Primary Health Care

Outcome Measures

Primary Outcomes (1)

A Primary Outcome for This Study is the Number of Non-acute Emergency Department Visits.
A primary outcome for this study is non-acute emergency department visits.
Two years.

Study Arms (4)

Arm 1

NO INTERVENTION

Normal PACT Clinical Care

Arm 2

EXPERIMENTAL

Normal PACT Clinical Care + Embedded Peer Mentor

Behavioral: Embedded Peer Mentor

Arm 3

NO INTERVENTION

Normal Homeless Oriented PACT Clinical Care

Arm 4

EXPERIMENTAL

Normal Homeless Oriented PACT Clinical Care + Embedded Peer Mentor

Behavioral: Embedded Peer Mentor

Interventions

Embedded Peer MentorBEHAVIORAL

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.

Arm 2Arm 4

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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).
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.

You may not qualify if:

Currently enrolled in Mental Health Intensive Case Management (MHICM) or other VA-based case/care managed program;
Stated plans to leave the area within 6 months of enrollment;
Unable or unwilling to provide informed consent;
Pregnant women will because excluded because we do not wish to detract from the amount of specialty care and services they receive and need.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

VA Office of Research and Developmentlead

Study Sites (2)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121, United States

Location

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908, United States

Location

Related Publications (4)

Resnik L, Ekerholm S, Johnson EE, Ellison ML, O'Toole TP. Which Homeless Veterans Benefit From a Peer Mentor and How? J Clin Psychol. 2017 Sep;73(9):1027-1047. doi: 10.1002/jclp.22407. Epub 2016 Oct 20.
PMID: 27764527BACKGROUND
Yoon J, Lo J, Gehlert E, Johnson EE, O'Toole TP. Homeless Veterans' Use of Peer Mentors and Effects on Costs and Utilization in VA Clinics. Psychiatr Serv. 2017 Jun 1;68(6):628-631. doi: 10.1176/appi.ps.201600290. Epub 2017 Feb 1.
PMID: 28142391RESULT
Van Voorhees EE, Resnik L, Johnson E, O'Toole T. Posttraumatic stress disorder and interpersonal process in homeless veterans participating in a peer mentoring intervention: Associations with program benefit. Psychol Serv. 2019 Aug;16(3):463-474. doi: 10.1037/ser0000231. Epub 2018 Jan 25.
PMID: 29369660DERIVED
Gundlapalli AV, Redd A, Bolton D, Vanneman ME, Carter ME, Johnson E, Samore MH, Fargo JD, O'Toole TP. Patient-aligned Care Team Engagement to Connect Veterans Experiencing Homelessness With Appropriate Health Care. Med Care. 2017 Sep;55 Suppl 9 Suppl 2:S104-S110. doi: 10.1097/MLR.0000000000000770.
PMID: 28806373DERIVED

Limitations and Caveats

All AE and SAE monitoring was discussed with and approved by all regulatory authorities (IRB, DSMB, and research compliance officer).

Results Point of Contact

Title: Thomas O'Toole, MD
Organization: US Department of Veterans Affairs

Study Officials

Thomas P O'Toole, MD
Providence VA Medical Center, Providence, RI
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: CARE PROVIDER
Purpose: HEALTH SERVICES RESEARCH
Intervention Model: PARALLEL
Sponsor Type: FED
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 13, 2011

First Posted

March 12, 2012

Study Start

March 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2016

Last Updated

October 11, 2017

Results First Posted

October 11, 2017

Record last verified: 2017-05

Locations

US(2)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (4)

Arm 1

Arm 2

Arm 3

Arm 4

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (4)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations