Re-Engineering Systems for the Primary Care Treatment for PTSD (RESPECT-PTSD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00373698
First received: September 6, 2006
Last updated: June 26, 2014
Last verified: June 2014

September 6, 2006
June 26, 2014
March 2008
April 2010   (final data collection date for primary outcome measure)
PTSD Severity at 3 and 6 months [ Time Frame: 3 months and 6 months after initial assessment ] [ Designated as safety issue: No ]
PTSD Severity at 3 and 6 months
Complete list of historical versions of study NCT00373698 on ClinicalTrials.gov Archive Site
Depression, functioning, types and amount of mental health treatment received, and cost of care at 3 and 6 months [ Time Frame: 3 months and 6 months after initial assessment ] [ Designated as safety issue: No ]
Depression, functioning, types and amount of mental health treatment received, and cost of care at 3 and 6 months
Not Provided
Not Provided
 
Re-Engineering Systems for the Primary Care Treatment for PTSD
Reengineering Systems for the Primary Care Treatment of PTSD

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Stress Disorders, Posttraumatic
  • Depression
Behavioral: Three Component Model of Collaborative Care
Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
  • Experimental: Arm 1
    Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
    Intervention: Behavioral: Three Component Model of Collaborative Care
  • No Intervention: Arm 2
    Patients randomized to "Usual Care" will receive care as usual by VA clinicians.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
195
April 2012
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00373698
IAC 06-073
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Paula P Schnurr, PhD White River Junction VA Medical Center, White River Junction, VT
Department of Veterans Affairs
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP