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

Stress Disorders, Post-Traumatic Clinical Trial

— ViStA  

Official title:

Improving PTSD Management in Primary Care

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01401101
• Other study ID #: 1R01MH082768
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 26, 2010
• Last updated: May 6, 2014
• Start date: June 2010
• Est. completion date: March 2015

Study information

• Verified date: May 2014
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 CHCs and evaluate its effectiveness on improving the processes and outcomes of care for PTSD.

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 Community Health Centers (CHCs) in Northeastern USA.

The three specific aims are to:

1. Evaluate the effectiveness of the PCM intervention compared to a Treatment-as-Usual (TAU) 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 CHCs 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 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. The TAU 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, CHC 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: March 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• quality improvement
Care Manager (CM) intervention
• Treatment-as-Usual
The TAU condition will consist of only the clinician education and patient screening without written feedback.

Locations

Country	Name	City	State
United States	Community Health Care Network (Bronx Center)	Bronx	New York
United States	Morris Heights Health Center (Walton)	Bronx	New York
United States	Soundview Health Center	Bronx	New York
United States	Joseph P. Addabbo Health Centere	Far Rockaway	New York
United States	Metropolitan Family Health Center	Jersey City	New Jersey
United States	Ryan NENA Health Center	New York	New York
United States	Open Door Family Medical Center	Port Chester	New York

Sponsors (4)

Lead Sponsor	Collaborator
RAND	Clinical Directors Network, Georgetown University, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD symptoms		0 months	No
Primary	PTSD symptoms		6 months	No
Primary	PTSD symptoms		12 months	No
Secondary	perceived barriers to health care		0 months	No
Secondary	resilience to stress	10-item version of the Connor-Davidson Resilience scale (CD-RISC)	0 months	No
Secondary	use of and satisfaction with health care services		0 months	No
Secondary	health-related quality of life	SF-12 mental and physical functioning	0 months	No
Secondary	perceived barriers to health care		6 months	No
Secondary	perceived barriers to health care		12 months	No
Secondary	resilience to stress		6 months	No
Secondary	resilience to stress		12 months	No
Secondary	use of and satisfaction with health care services		6 months	No
Secondary	use of and satisfaction with health care services		12 months	No
Secondary	health-related quality of life		6 months	No
Secondary	health-related quality of life		12 months	No