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Aligning Resources to Care for Homeless Veterans (ARCH)

16. května 2017 aktualizováno: VA Office of Research and Development

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.

Přehled studie

Postavení

Dokončeno

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

382

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • California
      • San Francisco, California, Spojené státy, 94121
        • San Francisco VA Medical Center, San Francisco, CA
    • Rhode Island
      • Providence, Rhode Island, Spojené státy, 02908
        • Providence VA Medical Center, Providence, RI

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 80 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Výzkum zdravotnických služeb
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Žádný zásah: Arm 1
Normal PACT Clinical Care
Experimentální: Arm 2
Normal PACT Clinical Care + 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.
Žádný zásah: Arm 3
Normal Homeless Oriented PACT Clinical Care
Experimentální: Arm 4
Normal Homeless Oriented PACT Clinical Care + 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
A Primary Outcome for This Study is the Number of Non-acute Emergency Department Visits.
Časové okno: Two years.
A primary outcome for this study is non-acute emergency department visits.
Two years.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Thomas P O'Toole, MD, Providence VA Medical Center, Providence, RI

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. března 2012

Primární dokončení (Aktuální)

1. září 2014

Dokončení studie (Aktuální)

1. září 2016

Termíny zápisu do studia

První předloženo

13. září 2011

První předloženo, které splnilo kritéria kontroly kvality

7. března 2012

První zveřejněno (Odhad)

12. března 2012

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

11. října 2017

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

16. května 2017

Naposledy ověřeno

1. května 2017

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • SDR 11-230

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Primární zdravotní péče

Klinické studie na Embedded Peer Mentor

3
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