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.
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
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:
- 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.
- Assess the success of the PCM intervention implementation and,
- 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.
- Conditions
- Stress Disorders, Post-Traumatic
- 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 group | Role | What they receive |
|---|---|---|
| PTSD Care Management (PCM) | Experimental | 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. Receives: Other: PCM |
| Minimally Enhanced Usual Care (MEU) | Placebo comparator | The 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.
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)
PTSD Symptoms
same as baseline
Measured: 6 months
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.
- First posted25 Jul 2011 (estimated)
- Study startJun 2010
- Primary completionFeb 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Directors Network, Georgetown University, University of Washington
- Responsible party
- Sponsor
- Investigators
- Lisa S Meredith, PhD, Principal investigator, RAND
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 24747932Meredith 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving PTSD Management in Primary Care
- ClinicalTrials.gov ID
- NCT01401101
- Acronym / sponsor ID
- ViStA / 1R01MH082768
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- mental health, PTSD, primary care, quality improvement, collaborative care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- Clinical Directors Network, Georgetown University, University of Washington
- Study start
- Jun 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 25 Jul 2011 (estimated)
- Results
- Posted 2 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Assess the success of the PCM intervention implementation and,
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTSD Care Management (PCM) | Experimental | Other: PCMPCM 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 comparator | Other: MEUThe MEU condition consists of only the clinician education and patient screening without written feedback. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Acutely ill and cannot participate in a discussion
- Does not understand the information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCMCare Manager (CM) intervention | Other | PTSD Care Management (PCM) |
| MEUThe MEU condition consists of only the clinician education and patient screening without written feedback. | Other | Minimally Enhanced Usual Care (MEU) |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24747932Meredith 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.
- Background: PubMed 26850413Meredith 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.
- Individual participant dataSharing planned: No. No data sharing plan was associated with this project at the time it was funded.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa S Meredith, PhD principal investigator
RAND
7 sites in 1 country: see every site and its status.
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.