Violence and Stress Assessment (ViStA) Project to Improve Post Traumatic Stress Disorder Management in Primary Care
ViStA
Improving PTSD Management in Primary Care
1 other identifier
interventional
404
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2010
Longer than P75 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 26, 2010
CompletedFirst Posted
Study publicly available on registry
July 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
September 2, 2016
CompletedSeptember 2, 2016
July 1, 2016
3.7 years
August 26, 2010
June 28, 2015
July 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
PTSD Symptoms
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.
0 months (baseline)
PTSD Symptoms
same as baseline
6 months
PTSD Symptoms
same as baseline and 6 months
12 months
Study Arms (2)
PTSD Care Management (PCM)
EXPERIMENTALPCM 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.
Minimally Enhanced Usual Care (MEU)
PLACEBO COMPARATORThe MEU condition consists of only the clinician education and patient screening without written feedback.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Acutely ill and cannot participate in a discussion
- Does not understand the information
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RANDlead
- Clinical Directors Networkcollaborator
- Georgetown Universitycollaborator
- University of Washingtoncollaborator
Study Sites (7)
Metropolitan Family Health Center
Jersey City, New Jersey, 07304-2731, United States
Joseph P. Addabbo Health Centere
Far Rockaway, New York, 11691, United States
Ryan NENA Health Center
New York, New York, 10009-7813, United States
Open Door Family Medical Center
Port Chester, New York, 10573, United States
Morris Heights Health Center (Walton)
The Bronx, New York, 10453, United States
Community Health Care Network (Bronx Center)
The Bronx, New York, 10459, United States
Soundview Health Center
The Bronx, New York, 10473, United States
Related Publications (2)
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.
PMID: 24747932BACKGROUNDMeredith 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.
PMID: 26850413BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lisa S. Meredith, PhD
- Organization
- RAND Corporation
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa S Meredith, PhD
RAND
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2010
First Posted
July 25, 2011
Study Start
June 1, 2010
Primary Completion
February 1, 2014
Study Completion
March 1, 2015
Last Updated
September 2, 2016
Results First Posted
September 2, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share
No data sharing plan was associated with this project at the time it was funded.