Aligning Resources to Care for Homeless Veterans (ARCH)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01550757
First received: September 13, 2011
Last updated: July 9, 2014
Last verified: July 2014

September 13, 2011
July 9, 2014
March 2012
September 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01550757 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Aligning Resources to Care for Homeless Veterans
Aligning Resources to Care for Homeless Veterans (ARCH)

"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.

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.

Status:

Currently, 59% (317) of the total RCT study sample of 540 across both sites (San Francisco and Providence) is enrolled. Providence has enrolled 70% (139) of its total sample of 200 (83% of its H-PACT sample and 50% of its PACT target). San Francisco has enrolled 52% (178) of its targeted enrollment of 340 (77% of its H-PACT sample and 27% of its PACT sample). Six month follow-up interviews continue to be a priority with retention rates hovering close to 70% in Providence. We are aggressively aiming to achieve or surpass 70% follow-up or greater as more participants become due for follow-up interviews.

Project enrollment in San Francisco has been temporarily suspended since 09/06/2013 because of staffing changes. We have currently identified a replacement for the RA and are working through the HR and hiring process and hope to have the new candidate on board by 10/20/2013. There is also transition in Providence RA staff; however, there is only one week of no RA staffing and the new coordinator starts 10/06/2013.

Working with Dr. Yoon in Palo Alto and Drs. Smelson and Ellison in Bedford, the peer mentoring intervention continues to be analyzed. In addition to non-VA utilization data, Dr. Yoon is collecting peer time sheet data. We have worked with the Central IRB to refine the process of obtaining non-VA inpatient stays and emergency department visits. We continue to have monthly phone calls between the peers and Drs. Smelson and Ellison to resolve questions the peers have from their encounters with the research participants and to continue their training in with the MISSION-Vet workbook.

Upon completion of enrollment, qualitative focus groups will begin. We have begun drafting the protocol, consent, and human subjects protections portions of the C-IRB sub-study that will approve focus groups. That portion of the study will be submitted to the C-IRB for review in Q1 of FY'14. We continue to hold monthly calls with all investigators to ensure study fidelity.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
  • Homeless Persons
  • Primary Health Care
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 1
    Normal PACT Clinical Care
  • Experimental: Arm 2
    Normal PACT Clinical Care + Embedded Peer Mentor
    Intervention: Behavioral: Embedded Peer Mentor
  • No Intervention: Arm 3
    Normal Homeless Oriented PACT Clinical Care
  • Experimental: Arm 4
    Normal Homeless Oriented PACT Clinical Care + Embedded Peer Mentor
    Intervention: Behavioral: Embedded Peer Mentor
Yoon J, Scott JY, Phibbs CS, Wagner TH. Recent trends in Veterans Affairs chronic condition spending. Popul Health Manag. 2011 Dec;14(6):293-8. doi: 10.1089/pop.2010.0079. Epub 2011 Nov 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
600
July 2015
September 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01550757
SDR 11-230
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Thomas P O'Toole, MD VA Medical Center, Providence
Department of Veterans Affairs
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP