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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Three Component Model | Experimental | Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians. |
|
| Usual Care | No Intervention | Patients randomized to "Usual Care" will receive care as usual by VA clinicians. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Three Component Model of Collaborative Care | Behavioral | Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PTSD Symptom Severity | PTSD Symptom Severity was measured using the Postraumatic Diagnostic Scale (PDS) | 3 and 6 months after initial assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Depression | Measure using the Hopkins Symptom Checklist-20 | 3 and 6 months after initial assessment |
| SF-36 Mental Component | 3 and 6 months after initial assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paula P Schnurr, PhD | White River Junction VA Medical Center, White River Junction, VT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | Dallas | Texas | 75216 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22865017 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Three Component Model of Collaborative Care and Usual Care | Participants randomized to this arm received the Three Component Model of Collaborative Care (3CM) as well as usual care. 3CM model consists of 1) education and tools for primary care clinicians and staff including content regarding PTSD; 2) telephone care management by a centrally located care manager (the purpose of the calls was to identify barriers to adherance with the primary care provider's plan, aid participant to overcome them, and measure treatment response. Calls occurred 1, 4, and 8 weeks after the initial visit and then every 4 weeks for 6 months or until a participant acheived 30% reduction in PTSD symptoms as measure by the PCL); 3) support from a psychiatrist who supervises care managers by telephone, provides consultation to primary care clinicians, and facilitates mental health referral. Participant's "Usual Care" is at the VA provider's discretion and could include referral to mental health specialty care.specialty care. |
| FG001 | Usual Care | Participants randomized to "Usual Care" received care at the VA provider's discretion and could include referral to mental health specialty care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
To be included, subjects had to meet diagnostic criteria for PTSD, have regular access to a telephone, and speak English. Exclusion criteria were cognitive impairment, history of psychosis or mania, prominent current suicidal ideation, current substance dependence, and current engagement in mental health treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Usual Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PTSD Symptom Severity | PTSD Symptom Severity was measured using the Postraumatic Diagnostic Scale (PDS) | Posted | Mean | Standard Deviation | units on a scale | 3 and 6 months after initial assessment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospitalization | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paula Schnurr and Dr. Mathew Friedman | VA Medical Center, White River Junction, VT | 802-296-5132 | Paula.Schnurr@va.gov; Matthew.Friedman@va.gov |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D003863 | Depression |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| SF-36 Physical Component | 3 and 6 months after initial assessment |
| Central Texas Veterans Health Care System, Temple, TX |
| Temple |
| Texas |
| 76504 |
| United States |
| Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX | Waco | Texas | 76711 | United States |
| White River Junction VA Medical Center, White River Junction, VT | White River Junction | Vermont | 05009-0001 | United States |
Patients randomized to "Usual Care" will receive care as usual by VA clinicians.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| PTSD symptom severity (used Posttraumatic Diagnostic Scale (PDS)) | The PDS yields a total severity score (ranging from 0 to 51, where 0 is the best and 51 is the worst) that largely reflects the frequency of the 17 symptoms of PTSD. 17 symptoms of PTSD are rated individually on a scale from 0 to 3, with 3 being the highest. Total severity score is calculated by adding the number from each individual symptom. A PDS Profile Report also provides a preliminary determination of DSM-IV PTSD diagnostic status, a count of the number of symptoms endorsed, a rating of symptom severity, and a rating of the level of impairment of functioning. | Mean | Standard Deviation | units on a scale |
|
| Depression (Hopkins Symptom Checklist-20) | Depression severity (ranging 0-4) was measured with the Hopkins Symptom Checklist-20. This self-assessment measure consists of 20 questions with possible scores ranging from 0 to 4, with higher scores indicating worse symptoms. Means and the standard deviations of the 20 questions are presented with higher scores indicating worse depression. | Mean | Standard Deviation | units on a scale |
|
| SF-36 Mental Component | SF-36 Mental Component is measured as part of SF-36 Health Survey. Scores can range from 0 (poorest possible health ) to 100 (highest possible health). | Mean | Standard Deviation | units on a scale |
|
| SF-36 Physical Component | SF-36 Physical Component is measured as part of SF-36 Health Survey. Scores can range from 0 (poorest possible health ) to 100 (highest possible health). | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Depression | Measure using the Hopkins Symptom Checklist-20 | Posted | Mean | Standard Deviation | units on a scale | 3 and 6 months after initial assessment |
|
|
|
| Secondary | SF-36 Mental Component | Posted | Mean | Standard Deviation | units on a scale | 3 and 6 months after initial assessment |
|
|
|
| Secondary | SF-36 Physical Component | Posted | Mean | Standard Deviation | units on a scale | 3 and 6 months after initial assessment |
|
|
|
| 5 |
| 96 |
| 0 |
| 96 |
| EG001 | Usual Care | Patients randomized to "Usual Care" will receive care as usual by VA clinicians. | 4 | 99 | 0 | 99 |
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| D001519 | Behavior |