Re-Engineering Systems for the Primary Care Treatment for PTSD

Depression Clinical Trial

— RESPECT-PTSD  

Official title:

Reengineering Systems for the Primary Care Treatment of PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00373698
• Other study ID #: IAC 06-073
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2006
• Last updated: April 6, 2015
• Start date: March 2008
• Est. completion date: April 2012

Study information

• Verified date: June 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: April 2012
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Stress Disorders, Post-Traumatic
• Stress Disorders, Posttraumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Three Component Model of Collaborative Care
Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.

Locations

Country	Name	City	State
United States	VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX	Dallas	Texas
United States	Central Texas Veterans Health Care System, Temple, TX	Temple	Texas
United States	Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX	Waco	Texas
United States	White River Junction VA Medical Center, White River Junction, VT	White River Junction	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD Symptom Severity	PTSD Symptom Severity was measured using the Postraumatic Diagnostic Scale (PDS)	3 and 6 months after initial assessment	No
Secondary	Depression	Measure using the Hopkins Symptom Checklist-20	3 and 6 months after initial assessment	No
Secondary	SF-36 Mental Component		3 and 6 months after initial assessment	No
Secondary	SF-36 Physical Component		3 and 6 months after initial assessment	No