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

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ClinicalTrials.gov Identifier: NCT00373698
Recruitment Status : Completed
First Posted : September 8, 2006
Results First Posted : November 7, 2014
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Tracking Information
First Submitted Date  ICMJE September 6, 2006
First Posted Date  ICMJE September 8, 2006
Results First Submitted Date  ICMJE July 31, 2014
Results First Posted Date  ICMJE November 7, 2014
Last Update Posted Date April 24, 2015
Study Start Date  ICMJE March 2008
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2014)
PTSD Symptom Severity [ Time Frame: 3 and 6 months after initial assessment ]
PTSD Symptom Severity was measured using the Postraumatic Diagnostic Scale (PDS)
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2006)
PTSD Severity at 3 and 6 months
Change History Complete list of historical versions of study NCT00373698 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2014)
  • Depression [ Time Frame: 3 and 6 months after initial assessment ]
    Measure using the Hopkins Symptom Checklist-20
  • SF-36 Mental Component [ Time Frame: 3 and 6 months after initial assessment ]
  • SF-36 Physical Component [ Time Frame: 3 and 6 months after initial assessment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2006)
Depression, functioning, types and amount of mental health treatment received, and cost of care at 3 and 6 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Re-Engineering Systems for the Primary Care Treatment for PTSD
Official Title  ICMJE Reengineering Systems for the Primary Care Treatment of PTSD
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Stress Disorders, Posttraumatic
  • Depression
Intervention  ICMJE Behavioral: Three Component Model of Collaborative Care
Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
Study Arms  ICMJE
  • Experimental: Three Component Model
    Three Component Model of Collaborative Care: 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: Usual Care
    Patients randomized to "Usual Care" will receive care as usual by VA clinicians.
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 19, 2012)
195
Original Enrollment  ICMJE
 (submitted: September 7, 2006)
220
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00373698
Other Study ID Numbers  ICMJE IAC 06-073
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party VA Office of Research and Development ( US Department of Veterans Affairs )
Study Sponsor  ICMJE US Department of Veterans Affairs
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paula P Schnurr, PhD White River Junction VA Medical Center, White River Junction, VT
PRS Account VA Office of Research and Development
Verification Date June 2014

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