Re-Engineering Systems for the Primary Care Treatment for PTSD

NCT ID: NCT00373698

Last Updated: 2015-04-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

195 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2012-04-30

Brief Summary

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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

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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.

Conditions

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Stress Disorders, Posttraumatic Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Three Component Model of Collaborative Care

Intervention Type BEHAVIORAL

Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.

Usual Care

Patients randomized to "Usual Care" will receive care as usual by VA clinicians.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Three Component Model of Collaborative Care

Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paula P Schnurr, PhD

Role: PRINCIPAL_INVESTIGATOR

White River Junction VA Medical Center, White River Junction, VT

Locations

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VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, United States

Site Status

Central Texas Veterans Health Care System, Temple, TX

Temple, Texas, United States

Site Status

Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX

Waco, Texas, United States

Site Status

White River Junction VA Medical Center, White River Junction, VT

White River Junction, Vermont, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 22865017 (View on PubMed)

Other Identifiers

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IAC 06-073

Identifier Type: -

Identifier Source: org_study_id

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