Violence and Stress Assessment (ViStA) Project to Improve Post Traumatic Stress Disorder Management in Primary Care
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to conduct a randomized trial of a Post Traumatic Stress
      Disorder (PTSD) Care Management (PCM) program to detect, treat, and improve PTSD treatment
      processes and outcomes in patients seeking primary care from FQHCs and evaluate its
      effectiveness on improving the processes and outcomes of care for PTSD.
    

Detailed description: 
      Post-traumatic Stress Disorder (PTSD) is a common problem seen in primary care but the
      identification and management of PTSD is not routine and would benefit from new approaches.
      Efforts must overcome patient-, clinician-, and system-level barriers, such as patients' fear
      of stigma, clinician's time constraints for dealing with psychological issues, gaps in
      clinician treatment knowledge, and difficulty arranging for referrals to mental health
      specialists.

      Unlike mood disorders such as depression, little is known about improving care for PTSD in
      primary care settings. However, previous experience for treating depression, as well as
      existing guidelines for addressing PTSD in primary care, provide evidence that effective
      interventions exist and that multi-faceted interventions are more effective than a
      single-component approaches.

      In this project, the RAND Corporation, Clinical Directors Network Inc., Georgetown University
      Department of Psychiatry, and University of Washington will implement and evaluate a
      randomized controlled trial (RCT) of a PTSD Care Management (PCM) intervention to detect,
      treat, and improve PTSD treatment processes and health outcomes in patients seeking primary
      care from Federally Qualified Health Centers (FQHCs) in Northeastern USA.

      The three specific aims are to:

        1. Evaluate the effectiveness of the PCM intervention compared to a minimally enhanced
           usual care (MEU) control in reducing PTSD and other mental health symptoms, and
           improving patients' health-related quality-of-life.

        2. Assess the success of the PCM intervention implementation and,

        3. Examine the direct costs of the PCM intervention compared to the TAU control treatment.

      The PCM intervention was developed using principles of Community-Based Participatory Research
      (CPBR) methods in FQHCs that provide care to the underserved, and is tailored to the settings
      and populations we will study. This intervention is multi-faceted and includes components and
      strategies implemented through a Care Manager (CM) to overcome patient-, clinician-, and
      system-level barriers.

      There are six PCM intervention components: 1) patient education, 2) patient screening and
      written feedback of screening information to primary care clinicians, 3) clinician education
      on practice guidelines , 4) structured feedback between primary care and mental health
      clinicians, 5) continuity of patient care, and 6) a resource guide detailing available
      community services where the FQHC has established reciprocal referrals. All of the
      intervention components will be implemented through the CM, except for the clinician
      education component, which will combine onsite and online continuing medical education
      (CME)-accredited sessions. The MEU condition will consist of only the clinician education and
      patient screening without written feedback.

      Patients will be interviewed during a pre-screening stage to determine PTSD status. A total
      of 400 of the patients who screen positive will be randomly assigned to the PCM intervention
      or TAU.

      Data will be collected from several sources. First, patients will be assessed at baseline, 6
      and 12 months via interviews using validated instruments. Second, CMs will compile monthly
      aggregate data on patient management for patients assigned to the PCM program. Third, FQHC
      staff will be asked for their feedback about their experiences with implementing the program
      at the end of the study. The study team will use these data to estimate the direct costs of
      implementing the PCM program.
    

Intervention name(s): PCM; MEU
Intervention type(s): Other; Other
Intervention description(s): Care Manager (CM) intervention; The MEU condition consists of only the clinician education and patient screening without written feedback.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: mental health; PTSD; primary care; quality improvement; collaborative care