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

Improving PTSD Management in Primary Care

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01401101
Acronym
ViStA
Enrollment
404
Registered
2011-07-25
Start date
2010-06-30
Completion date
2015-03-31
Last updated
2016-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Disorders, Post-Traumatic

Keywords

mental health, PTSD, primary care, quality improvement, collaborative care

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.

Interventions

OTHERPCM

Care Manager (CM) intervention

OTHERMEU

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

Sponsors

Clinical Directors Network
CollaboratorNETWORK
Georgetown University
CollaboratorOTHER
University of Washington
CollaboratorOTHER
RAND
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
PTSD Symptoms0 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
PTSD Care Management (PCM)
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 CHC 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. quality improvement: Care Manager (CM) intervention
184
Treatment-as-Usual (TAU)
The TAU condition will consist of only the clinician education and patient screening without written feedback. Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback.
171
Total355

Baseline characteristics

CharacteristicPTSD Care Management (PCM)TotalTreatment-as-Usual (TAU)
Age, Continuous42.5 years
STANDARD_DEVIATION 12.4
42.4 years
STANDARD_DEVIATION 12.2
42.2 years
STANDARD_DEVIATION 12
Ethnicity (NIH/OMB)
Hispanic or Latino
95 Participants185 Participants90 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
79 Participants146 Participants67 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
10 Participants24 Participants14 Participants
Race (NIH/OMB)
American Indian or Alaska Native
95 Participants183 Participants88 Participants
Race (NIH/OMB)
Asian
64 Participants124 Participants60 Participants
Race (NIH/OMB)
Black or African American
14 Participants21 Participants7 Participants
Race (NIH/OMB)
More than one race
6 Participants10 Participants4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants15 Participants10 Participants
Race (NIH/OMB)
White
0 Participants1 Participants1 Participants
Region of Enrollment
United States
184 participants355 participants171 participants
Sex: Female, Male
Female
150 Participants286 Participants136 Participants
Sex: Female, Male
Male
34 Participants69 Participants35 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
20 / 20623 / 198
serious
Total, serious adverse events
0 / 2060 / 198

Outcome results

Primary

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.

Time frame: 0 months (baseline)

Population: all patients who completed the assessment

ArmMeasureValue (MEAN)
PTSD Care Management (PCM)PTSD Symptoms71.1 CAPS scores
Treatment-as-Usual (TAU)PTSD Symptoms71.0 CAPS scores
Comparison: Intent-to-treat (ITT) analysis using the linear mixed-method model to estimate the difference between the PCM and TAU conditionsp-value: 0.97Regression, Linear
Primary

PTSD Symptoms

same as baseline

Time frame: 6 months

Population: 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.

ArmMeasureValue (MEAN)
PTSD Care Management (PCM)PTSD Symptoms47.8 CAPS scores
Treatment-as-Usual (TAU)PTSD Symptoms49.5 CAPS scores
Comparison: Intent-to-treat (ITT) analysis using the linear mixed-method model to estimate the difference between the PCM and TAU conditionsp-value: 0.54Regression, Linear
Primary

PTSD Symptoms

same as baseline and 6 months

Time frame: 12 months

Population: 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.

ArmMeasureValue (MEAN)
PTSD Care Management (PCM)PTSD Symptoms46.9 CAPS scores
Treatment-as-Usual (TAU)PTSD Symptoms44.2 CAPS scores
Comparison: Intent-to-treat (ITT) analysis using the linear mixed-method model to estimate the difference between the PCM and TAU conditionsp-value: 0.33Regression, Linear

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026