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Stress Disorders, Post-TraumaticPhase 2ViStANCT01401101

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

A Phase 2 study testing PCM and MEU in people with Stress Disorders, Post-Traumatic, run by RAND at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Stress Disorders, Post-Traumatic
What is being tested?
PCM and MEU
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
404 participants
Where
7 sitesUnited States
Study dates
Jun 2010to Mar 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites
  • Joseph P. Addabbo Health Centere

    Far Rockaway, New York, 11691

  • Metropolitan Family Health Center

    Jersey City, New Jersey, 07304-2731

  • Ryan NENA Health Center

    New York, New York, 10009-7813

  • Open Door Family Medical Center

    Port Chester, New York, 10573

  • Morris Heights Health Center (Walton)

    The Bronx, New York, 10453

  • Community Health Care Network (Bronx Center)

    The Bronx, New York, 10459

  • Soundview Health Center

    The Bronx, New York, 10473

Other trials in United States

About this study

Official title: Improving PTSD Management in Primary Care

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.

Read the 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.

Being tested
PCM, MEU
Keywords
mental health, PTSD, primary care, quality improvement, collaborative care
Medical subject headings
Stress Disorders, Post-Traumatic, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PCMOther

    Care Manager (CM) intervention

  • MEUOther

    The MEU condition consists of only the clinician education and patient screening without written feedback.

Study groups in NCT01401101
Study groupRoleWhat they receive
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.
Receives: Other: PCM
Minimally Enhanced Usual Care (MEU)Placebo comparatorThe MEU condition consists of only the clinician education and patient screening without written feedback.
Receives: Other: MEU

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 0 months (baseline)

  2. PTSD Symptoms

    same as baseline

    Measured: 6 months

  3. PTSD Symptoms

    same as baseline and 6 months

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2011 (estimated)
  2. Study startJun 2010
  3. Primary completionFeb 2014
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
404 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01401101
Sponsor's protocol ID
1R01MH082768
Acronym
ViStA
Status last verified
Jul 2016
First submitted
26 Aug 2010
Last updated
2 Sep 2016
Data monitoring committee
No
Individual data sharing
No: No data sharing plan was associated with this project at the time it was funded.

Publications

  • 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.

    PubMed 24747932
  • 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.

    PubMed 26850413

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PCM and MEU in people with Stress Disorders, Post-Traumatic, run by RAND at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PTSD Symptoms (time frame: 0 months (baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01401101, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2016.

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