title: Design of the Violence and Stress Assessment (ViStA) study: a randomized controlled trial of care management for PTSD among predominantly Latino patients in safety net health centers.
abstract: Posttraumatic stress disorder (PTSD) is a common problem in primary care. Although effective treatments are available, little is known about whether such treatments are effective within the context of Federally Qualified Health Centers (FQHCs) that serve as national "safety nets" for providing primary care for low income and underinsured patients. The Violence and Stress Assessment (ViStA) study is the first randomized controlled trial (RCT) to test the impact of a care management intervention for treating PTSD in FQHCs. To develop a PTSD management intervention appropriate for lower resource FQHCs and the predominantly Latino patients they serve, formative work was conducted through a collaborative effort between researchers and an FQHC practice-based research network. This article describes how FQHC stakeholders were convened to review, assess, and prioritize evidence-based strategies for addressing patient, clinician, and system-level barriers to care. This multi-component care management intervention incorporates diagnosis with feedback, patient education and activation; navigation and linkage to community resources; clinician education and medication guidance; and structured cross-disciplinary communication and continuity of care, all facilitated by care managers with FQHC experience. We also describe the evaluation design of this five-year RCT and the characteristics of the 404 English or Spanish speaking patients enrolled in the study and randomized to either the intervention or to usual care. Patients are assessed at baseline, six months, and 12 months to examine intervention effectiveness on PTSD, other mental health symptoms, health-related quality-of-life, health care service use; and perceived barriers to care and satisfaction with care.
authors.affiliation: RAND Corporation, 1776 Main Street, Santa Monica, CA 90407-2138, USA; VA HSR&D Center for the Study of Healthcare Provider Behavior, 16111 Plummer Street (152), North Hills, CA 91343, USA. Electronic address: lisa_meredith@rand.org.
authors.forename: Lisa S
authors.initials: LS
authors.lastname: Meredith
authors.affiliation: RAND Corporation, 1776 Main Street, Santa Monica, CA 90407-2138, USA; Division of General Internal Medicine and Health Services Research, Department of Medicine, David Geffen School of Medicine at UCLA, 10833 Le Conte Ave, Los Angeles, CA 90095, USA.
authors.forename: David P
authors.initials: DP
authors.lastname: Eisenman
authors.affiliation: Department of Psychiatry, Georgetown University Medical School, 4000 Reservoir Road NW Suite 120, Washington, DC 20007, USA.
authors.forename: Bonnie L
authors.initials: BL
authors.lastname: Green
authors.affiliation: Department of Psychiatry, Georgetown University Medical School, 4000 Reservoir Road NW Suite 120, Washington, DC 20007, USA.
authors.forename: Stacey
authors.initials: S
authors.lastname: Kaltman
authors.affiliation: RAND Corporation, 1776 Main Street, Santa Monica, CA 90407-2138, USA.
authors.forename: Eunice C
authors.initials: EC
authors.lastname: Wong
authors.affiliation: RAND Corporation, 1776 Main Street, Santa Monica, CA 90407-2138, USA.
authors.forename: Bing
authors.initials: B
authors.lastname: Han
authors.affiliation: Clinical Directors Network (CDN), 5W 37th St # 10, New York, NY 10018, USA.
authors.forename: Andrea
authors.initials: A
authors.lastname: Cassells
authors.affiliation: Clinical Directors Network (CDN), 5W 37th St # 10, New York, NY 10018, USA; Department of Epidemiology and Population Health, Albert Einstein College of Medicine of Yeshiva University, 1300 Morris Park Ave, Bronx, NY 10461, USA; Center for Clinical and Translational Sciences, The Rockefeller University, 1230 York Avenue, New York, NY 10065, USA.
authors.forename: Jonathan N
authors.initials: JN
authors.lastname: Tobin
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D054521:Cultural Competency; D019468:Disease Management; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006630:Hispanic or Latino; D006801:Humans; D007400:Interprofessional Relations; D008297:Male; D008605:Mental Health Services / Q000458:organization & administration*; D008875:Middle Aged; D010348:Patient Care Team / Q000458:organization & administration; D010353:Patient Education as Topic / Q000458:organization & administration; D017060:Patient Satisfaction; D011320:Primary Health Care / Q000458:organization & administration*; D012107:Research Design; D064876:Safety-net Providers / Q000458:organization & administration*; D012959:Socioeconomic Factors; D013313:Stress Disorders, Post-Traumatic / Q000208:ethnology / Q000628:therapy*; D055815:Young Adult
keywords: Care management; Hispanic/Latino; Integrating primary care and mental health; Post-traumatic stress disorder; Primary care; Safety net Federally Qualified Health Centers (FQHCs)
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