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Violence and Stress Assessment (ViStA) Project to Improve Post Traumatic Stress Disorder Management in Primary Care (ViStA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01401101
First Posted: July 25, 2011
Last Update Posted: September 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Clinical Directors Network
Georgetown University
University of Washington
Information provided by (Responsible Party):
RAND
  Purpose
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.

Condition Intervention Phase
Stress Disorders, Post-Traumatic Other: PCM Other: MEU Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Improving PTSD Management in Primary Care

Resource links provided by NLM:


Further study details as provided by RAND:

Primary Outcome Measures:
  • PTSD Symptoms [ Time Frame: 0 months (baseline) ]
    Clinician-Administered PTSD Scale (CAPS) severity score: sum of ratings (from 0-4) for frequency and intensity across each of the 17 symptom items for a possible range of 0-136, where a higher score indicated higher severity.

  • PTSD Symptoms [ Time Frame: 6 months ]
    same as baseline

  • PTSD Symptoms [ Time Frame: 12 months ]
    same as baseline and 6 months


Enrollment: 404
Study Start Date: June 2010
Study Completion Date: March 2015
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PTSD Care Management (PCM)
PCM has six 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.
Other: PCM
Care Manager (CM) intervention
Placebo Comparator: Minimally Enhanced Usual Care (MEU)
The MEU condition consists of only the clinician education and patient screening without written feedback.
Other: MEU
The MEU condition consists of only the clinician education and patient screening without written feedback.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01401101


Locations
United States, New Jersey
Metropolitan Family Health Center
Jersey City, New Jersey, United States, 07304-2731
United States, New York
Morris Heights Health Center (Walton)
Bronx, New York, United States, 10453
Community Health Care Network (Bronx Center)
Bronx, New York, United States, 10459
Soundview Health Center
Bronx, New York, United States, 10473
Joseph P. Addabbo Health Centere
Far Rockaway, New York, United States, 11691
Ryan NENA Health Center
New York, New York, United States, 10009-7813
Open Door Family Medical Center
Port Chester, New York, United States, 10573
Sponsors and Collaborators
RAND
Clinical Directors Network
Georgetown University
University of Washington
Investigators
Principal Investigator: Lisa S Meredith, PhD RAND
  More Information

Publications:
Responsible Party: RAND
ClinicalTrials.gov Identifier: NCT01401101     History of Changes
Other Study ID Numbers: 1R01MH082768 ( U.S. NIH Grant/Contract )
First Submitted: August 26, 2010
First Posted: July 25, 2011
Results First Submitted: June 28, 2015
Results First Posted: September 2, 2016
Last Update Posted: September 2, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No data sharing plan was associated with this project at the time it was funded.

Keywords provided by RAND:
mental health
PTSD
primary care
quality improvement
collaborative care

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders