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Aligning Resources to Care for Homeless Veterans

Aligning Resources to Care for Homeless Veterans (ARCH)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01550757
Acronym
ARCH
Enrollment
382
Registered
2012-03-12
Start date
2012-03-31
Completion date
2016-09-30
Last updated
2017-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Homeless Persons, Primary Health Care

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.

Detailed description

Background: Primary care, and specifically primary care directed to homeless Veterans represents an opportunity to engage individuals in care, address unmet health needs and facilitate receipt of services necessary to exit homelessness. However, it is unclear what the best and most cost-efficient approach is to providing this care. Past research suggests two alternative approaches to organizing and delivering primary care to homeless Veterans: (1) structurally realigned and organized care and (2) embedded peer mentoring. The overall purpose of our research is to compare and contrast outcomes from 4 different adaptations and combinations of primary care delivery to homeless Veterans within the construct of the Patient Aligned Care Team (PACT) model for primary care. Objectives: 1. To test whether a peer mentor intervention embedded in the Patient Aligned Care Team (PACT) model will be more effective than usual-care PACT or, in a separate randomized controlled trial, within a homeless-oriented PACT (H-PACT) model, in reducing emergency department use and hospitalizations, improving chronic disease management, and increasing participation in homeless programming. 2. To compare clinical outcomes, service use, treatment engagement, self-efficacy, and patient satisfaction of participants in usual care-PACT with and without peer mentoring to H-PACT with and without peer mentoring. 3. To determine differential costs and cost offsets associated with each PACT model adaptation in relation to care outcomes for homeless Veterans. 4. To determine whether a structurally adapted health care delivery model for homeless Veterans (homeless PACT) affects treatment engagement, as measured by utilization of services over time, compared with assignment to a general population Patient Aligned Care Team or no primary care assignment. Methods: Substudy #1- Two multi-center Randomized Controlled Trials: The first comparing PACT to PACT+Peer Support (PACT+P); and the second comparing Homeless-oriented PACT (H-PACT) to H-PACT+Peer Support (H-PACT+P). Within each site we will conduct a 1:1 RCT of embedded peer support. Substudy #2- A qualitative study using focus groups of study participants from each of the intervention arms to assess perceptions of care, treatment engagement, and satisfaction within each approach. These findings will be triangulated with survey data and conditional logistic regression modeling to address the question of how each model is perceived by those receiving care within it and what outcomes can be ascribed to each care approach. This submission will occur at the end of Year 2 of the project and be specific for the focus group activities. Substudy #3- Cost-Utilization Analysis Study: We will conduct a cost-utilization analysis assessing cost offsets using CPRS, DSS, and PCMM labor mapping data to develop cost models for each care approach. Substudy #4- VINCI Data Extraction & Natural Language Processing: Use VINCI to analyze for PACT and H-PACT emergency department visits, including diagnosis, whether substance abuse was a factor, whether it resulted in a hospital admission, and what type of aftercare occurred (primary care follow-up, case manager telephone call note, etc.); hospital admissions (diagnosis, length of stay, and aftercare follow-up), ambulatory care utilization (primary care, mental health, specialty clinics, outpatient substance abuse treatment, and homeless programming - VRRC), including both face-to-face and remote-based care (My HealtheVet, telehealth, telephone notes), medication compliance with continuous prescriptions (i.e. insulin, antihypertensives), and chronic disease monitoring and management (blood pressure, diabetes care, hyperlipidemia in heart disease and diabetic patients). Baseline utilization (prior 6 months) of emergency department, inpatient and primary care prior to cohort tracking will be conducted to allow for post-hoc stratification of patient subgroups based on predicted risk for high use patterning.

Interventions

BEHAVIORALEmbedded 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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

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

Countries

United States

Participant flow

Participants by arm

ArmCount
Arm 1: Normal PACT Clinical Care
Normal Patient Aligned Care Team Clinical Care
56
Arm 2: Normal PACT Clinical Care + Embedded Peer Mentor
Normal PACT Clinical Care + Embedded Peer Mentor 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.
52
Arm 3: Normal Homeless Oriented PACT Clinical Care
Normal Homeless Oriented Patient Aligned Care Team Clinical Care
130
Arm 4: Normal Homeless Oriented PACT Clinical Care + Embedded
Normal Homeless Oriented PACT Clinical Care + Embedded Peer Mentor 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.
144
Total382

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyLost to Follow-up21144253
Overall StudyWithdrawal by Subject2031

Baseline characteristics

CharacteristicTotalArm 2: Normal PACT Clinical Care + Embedded Peer MentorArm 1: Normal PACT Clinical CareArm 3: Normal Homeless Oriented PACT Clinical CareArm 4: Normal Homeless Oriented PACT Clinical Care + Embedded
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
31 Participants3 Participants4 Participants10 Participants14 Participants
Age, Categorical
Between 18 and 65 years
351 Participants49 Participants52 Participants120 Participants130 Participants
Age, Continuous52.2 years
STANDARD_DEVIATION 1.8
50.3 years
STANDARD_DEVIATION 10
54.5 years
STANDARD_DEVIATION 8.8
51.2 years
STANDARD_DEVIATION 9.5
52.6 years
STANDARD_DEVIATION 9.4
Region of Enrollment
United States
366 participants51 participants49 participants128 participants138 participants
Sex: Female, Male
Female
16 Participants1 Participants7 Participants2 Participants6 Participants
Sex: Female, Male
Male
366 Participants51 Participants49 Participants128 Participants138 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
1 / 560 / 521 / 1301 / 144
other
Total, other adverse events
0 / 560 / 520 / 1300 / 144
serious
Total, serious adverse events
0 / 560 / 520 / 1300 / 144

Outcome results

Primary

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.

Time frame: Two years.

Population: Veterans enrolled in the study based on the type of care they received at VA and then randomized to receive a peer or not.

ArmMeasureValue (MEAN)Dispersion
Arm 1: Normal PACT Clinical CareA Primary Outcome for This Study is the Number of Non-acute Emergency Department Visits.1.1 number of visitsStandard Deviation 1.6
Arm 2: Normal PACT Clinical Care + Embedded Peer MentorA Primary Outcome for This Study is the Number of Non-acute Emergency Department Visits.0.8 number of visitsStandard Deviation 2.3
Arm 3: Normal Homeless Oriented PACT Clinical CareA Primary Outcome for This Study is the Number of Non-acute Emergency Department Visits.0.7 number of visitsStandard Deviation 1.2
Arm 4: Normal Homeless Oriented PACT Clinical Care + EmbeddedA Primary Outcome for This Study is the Number of Non-acute Emergency Department Visits.1.0 number of visitsStandard Deviation 1.7

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026