Clinical trial NCT00373698: Re-Engineering Systems for the Primary Care Treatment for PTSD
Official title: Reengineering Systems for the Primary Care Treatment of PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stress Disorders, Posttraumatic
Depression
Keywords: Stress Disorders, Posttraumatic
Delivery of Health Care, Integrated
Primary Health Care
Veterans
Depression
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2006-09-08
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: PTSD Symptom Severity
timeFrame: 3 and 6 months after initial assessment
Secondary outcomes:
measure: Depression
timeFrame: 3 and 6 months after initial assessment
measure: SF-36 Mental Component
timeFrame: 3 and 6 months after initial assessment
measure: SF-36 Physical Component
timeFrame: 3 and 6 months after initial assessment
Other outcomes:
Locations:
city: Dallas
country: United States
facility: VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
state: Texas
city: Temple
country: United States
facility: Central Texas Veterans Health Care System, Temple, TX
state: Texas
city: Waco
country: United States
facility: Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX
state: Texas
city: White River Junction
country: United States
facility: White River Junction VA Medical Center, White River Junction, VT
state: Vermont
Study officials:
affiliation: White River Junction VA Medical Center, White River Junction, VT
name: Paula P Schnurr, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schnurr PP, Friedman MJ, Oxman TE, Dietrich AJ, Smith MW, Shiner B, Forshay E, Gui J, Thurston V. RESPECT-PTSD: re-engineering systems for the primary care treatment of PTSD, a randomized controlled trial. J Gen Intern Med. 2013 Jan;28(1):32-40. doi: 10.1007/s11606-012-2166-6. Epub 2012 Aug 3.