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Clinical Trials/NCT00821678
NCT00821678
Completed
Phase 4

Telemedicine Outreach for Post Traumatic Stress in CBOCs

VA Office of Research and Development3 sites in 1 country265 target enrollmentNovember 2009

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Posttraumatic Stress Disorder
Sponsor
VA Office of Research and Development
Enrollment
265
Locations
3
Primary Endpoint
Change in PTSD Symptom Severity (PDS)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The purpose of this study is improved outcomes for veterans with Post Traumatic Stress Disorder (PTSD) treated in small VA Community Based Outpatient Clinics (CBOCs). Although psychotherapy and pharmacotherapy treatments for PTSD have been proven to be efficacious in controlled trials, geographic barriers often prevent veterans from accessing these evidence-based treatments. Telemedicine technologies will be used to overcome geographic barriers to care. Specifically, we will evaluate the Telemedicine Outreach for PTSD (TOP) intervention which is based on the principals of the Chronic Care Model and Disease Management, and builds on the evidence base of quality improvement for depression in primary care settings. The TOP intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records) to treat CBOC patients with a newly emerging or chronic PTSD. We hypothesize that study participants randomized to the TOP intervention will receive higher quality of care and experience better outcomes compared to study participants randomized to treatment as usual.

Detailed Description

Approximately 400 Veterans with PTSD will be recruited from nine CBOCs in VISN 16 and 22. Veterans screening positive for PTSD and those already in active treatment will be recruited. Patients actively engaged in specialty PTSD treatment at the parent VAMC will be excluded. Patients will be the unit of randomization. A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video. Telephone interviews will be administered at baseline, six and twelve months by blinded research assistants. Process of care measures will include: 1) whether the veteran received a documented treatment concordant with VA/DoD PTSD Treatment Guidelines, 2) self-reported adherence to treatment, and 3) satisfaction with care as measured by Experience of Care and Health Outcomes (ECHO) Survey. Clinical outcomes will include: 1) PTSD severity as measured by the Posttraumatic Diagnostic Scale (PDS), 2) depression severity as measured by the PHQ9, 3) quantity and frequency of alcohol consumption, 4) health status as measured by the SF12V and 5) quality of life as measured by the Quality of Well-Being (QWB) scale. Activity based costing methods will be used to measure intervention cost data.

Registry
clinicaltrials.gov
Start Date
November 2009
End Date
September 2013
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • diagnostic Criteria for PTSD (CAPS),
  • veterans,
  • treated in CBOC

Exclusion Criteria

  • schizophrenia,
  • bipolar disorder,
  • current substance dependence,
  • current specialty PTSD treatment at VA Medical Center,
  • no access to telephone,
  • hearing or speech impediment,
  • terminal illness,
  • non-capacity to consent

Outcomes

Primary Outcomes

Change in PTSD Symptom Severity (PDS)

Time Frame: Baseline, 6 months

range - 0-51 (higher score represents greater severity)

Secondary Outcomes

  • Change in Continuous Measure of Depression Symptom Severity (SCL-20)(Baseline, 6 months)
  • Change in Continuous Measure of Alcohol Use (Audit Score)(Baseline, 6 months)
  • Change in Continuous Measure of Health Status (SF12V PCS)(6 months)
  • Change in Continuous Measure of Quality of Life (QWB)(Baseline, 6 months)
  • Satisfaction With Care (ECHO)(6 months)
  • Medication Adherence, Defined as Taking Medication <80% of Days(6 months)
  • Received at Least 8 Sessions of Exposure Based Therapy(12 months)

Study Sites (3)

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