Telemedicine Outreach for Post Traumatic Stress in CBOCs

Study Overview
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Brief Summary
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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
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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.

Official Title
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Telemedicine Outreach for Post Traumatic Stress in CBOCs

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Other: Telemedicine Outreach for PTSD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 Telemedicine Outreach for PTSD<br>Telemedicine-Based Collaborative Care | Other: Telemedicine Outreach for PTSD<br>* The intervention involves an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and uses telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager educates/activates patients, identifies preferences, overcomes treatment barriers, monitors symptoms, side-effects and adherence, identifies psychiatric comorbidities, and encourages patient self-management. Tele-pharmacists provide medication management by phone. Tele-psychologists provide Cognitive Processing Therapy via interactive video. Tele-psychiatrists supervise the off-site care team as well as conduct consultations and provide medication management via interactive video.<br>* Other names: Telemedicine-Based Collaborative Care;|
| No Intervention: Arm 2 Treatment as usual<br>Usual Care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PTSD Symptom Severity (PDS) | range - 0-51 (higher score represents greater severity) | Baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Continuous Measure of Depression Symptom Severity (SCL-20) | range - 0-4 (higher score represents greater severity | Baseline, 6 months | 
| Change in Continuous Measure of Alcohol Use (Audit Score) | range - 0-12 (higher score represents greater severity) | Baseline, 6 months | 
| Change in Continuous Measure of Health Status (SF12V PCS) | range - 0-100 (higher score represents greater physical health status) | 6 months | 
| Change in Continuous Measure of Quality of Life (QWB) | range - 0-1 (higher score represents greater wellbeing) | Baseline, 6 months | 
| Satisfaction With Care (ECHO) | Using any number from 0 to 10, where 0 is the worst care possible and 10 is the best care possible, what number would you use to rate all the care you received for personal or emotional problems in the last 6 months? | 6 months | 
| Medication Adherence, Defined as Taking Medication <80% of Days | 0 - taking medication <80% of days; 1 - taking medications >=80% | 6 months | 
| Received at Least 8 Sessions of Exposure Based Therapy | 0 - received <8 sessions of exposure based therapy; 1 - received >=8 sessions of exposure based therapy | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telemedicine, rural, veterans, care management, psychotherapy