Clinical trial NCT01401101: Violence and Stress Assessment (ViStA) Project to Improve Post Traumatic Stress Disorder Management in Primary Care
Official title: Improving PTSD Management in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stress Disorders, Post-Traumatic
Keywords: mental health
PTSD
primary care
quality improvement
collaborative care
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: Clinical Directors Network
name: Georgetown University
name: University of Washington
First posted: 2011-07-25
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Has PTSD
* Has a scheduled or walk-in appointment with a participating PCC
* Speaks English of Spanish
* Is between 18 and 65 years old
* Expects to receive care in the CHC during the next year

Exclusion Criteria:

* Acutely ill and cannot participate in a discussion
* Does not understand the information

Primary outcomes:
measure: PTSD Symptoms
timeFrame: 0 months (baseline)
measure: PTSD Symptoms
timeFrame: 6 months
measure: PTSD Symptoms
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jersey City
country: United States
facility: Metropolitan Family Health Center
state: New Jersey
city: Bronx
country: United States
facility: Morris Heights Health Center (Walton)
state: New York
city: Bronx
country: United States
facility: Community Health Care Network (Bronx Center)
state: New York
city: Bronx
country: United States
facility: Soundview Health Center
state: New York
city: Far Rockaway
country: United States
facility: Joseph P. Addabbo Health Centere
state: New York
city: New York
country: United States
facility: Ryan NENA Health Center
state: New York
city: Port Chester
country: United States
facility: Open Door Family Medical Center
state: New York
Study officials:
affiliation: RAND
name: Lisa S Meredith, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meredith LS, Eisenman DP, Green BL, Kaltman S, Wong EC, Han B, Cassells A, Tobin JN. 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. Contemp Clin Trials. 2014 Jul;38(2):163-72. doi: 10.1016/j.cct.2014.04.005. Epub 2014 Apr 18.
citation: Meredith LS, Eisenman DP, Han B, Green BL, Kaltman S, Wong EC, Sorbero M, Vaughan C, Cassells A, Zatzick D, Diaz C, Hickey S, Kurz JR, Tobin JN. Impact of Collaborative Care for Underserved Patients with PTSD in Primary Care: a Randomized Controlled Trial. J Gen Intern Med. 2016 May;31(5):509-17. doi: 10.1007/s11606-016-3588-3. Epub 2016 Feb 5.