- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01550757
Aligning Resources to Care for Homeless Veterans (ARCH)
Aligning Resources to Care for Homeless Veterans (ARCH)
Přehled studie
Postavení
Podmínky
Intervence / Léčba
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:
- 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.
- 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.
- To determine differential costs and cost offsets associated with each PACT model adaptation in relation to care outcomes for homeless Veterans.
- 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
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
California
-
San Francisco, California, Spojené státy, 94121
- San Francisco VA Medical Center, San Francisco, CA
-
-
Rhode Island
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Providence, Rhode Island, Spojené státy, 02908
- Providence VA Medical Center, Providence, RI
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
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
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
Vyšetřovatelé
- Vrchní vyšetřovatel: Thomas P O'Toole, MD, Providence VA Medical Center, Providence, RI
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- SDR 11-230
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