Skip to main content
Clinical Trials/NCT00373698
NCT00373698
Completed
Phase 3

Reengineering Systems for the Primary Care Treatment of PTSD

US Department of Veterans Affairs4 sites in 1 country195 target enrollmentStarted: March 2008Last updated:

Overview

Phase
Phase 3
Status
Completed
Enrollment
195
Locations
4
Primary Endpoint
PTSD Symptom Severity

Overview

Brief Summary

The study is an evaluation of a systemic intervention to enhance the delivery of care according to practice guidelines for posttraumatic stress disorder (PTSD). The immediate objectives are to (1) implement three component model (3CM) in VA primary care clinics; and (2) evaluate the effects of 3CM on clinician behavior and patient outcomes. The long-term objectives are to generate information to support implementation research on the RESPECT model for treating PTSD in primary care and ultimately, the implementation of the model in VHA to provide care to veterans with PTSD.

Detailed Description

3CM consists of (1) a prepared practice, (2) care management, and (3) enhanced mental health support. A prepared practice refers to education for primary care clinicians and office staff about practice guidelines and evidence-based care, the skills needed for use of assessment measures, and the use of communication forms and routines. The education plan consists of predisposing activities, including active teaching and learning, and enabling and reinforcing activities in order to help clinicians use newly acquired skills and to reinforce the continued use of these skills in practice. Care management is accomplished by telephone, usually by a centrally located care manager during acute phase treatment and follow up to answer patient questions, promote adherence to the clinician's management plan, and help patients overcome barriers to adherence. Enhanced mental health support is provided by a psychiatrist who supervises care managers by telephone, provides informal consultation to primary care clinicians, and helps to increase the quantity or quality of mental health referral resources.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Military Veterans in Primary Care Clinics who meet diagnostic criteria for PTSD in one of the 5 sites in Texas where this study is being conducted.
  • Must have regular access to a telephone and speak English.

Exclusion Criteria

  • Cognitive impairment
  • A history of psychosis or mania
  • Prominent current suicidal ideation
  • Current substance dependence
  • Current engagement in mental health treatment

Outcomes

Primary Outcomes

PTSD Symptom Severity

Time Frame: 3 and 6 months after initial assessment

PTSD Symptom Severity was measured using the Postraumatic Diagnostic Scale (PDS)

Secondary Outcomes

  • Depression(3 and 6 months after initial assessment)
  • SF-36 Mental Component(3 and 6 months after initial assessment)
  • SF-36 Physical Component(3 and 6 months after initial assessment)

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (4)

Loading locations...

Similar Trials