Telemedicine Outreach for Post Traumatic Stress in CBOCs
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 265
- 试验地点
- 6
- 主要终点
- Change in PTSD Symptom Severity (PDS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnostic Criteria for PTSD (CAPS),
- •veterans,
- •treated in CBOC
排除标准
- •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
研究组 & 干预措施
Arm 1 Telemedicine Outreach for PTSD
Telemedicine-Based Collaborative Care
干预措施: Telemedicine Outreach for PTSD (Other)
Arm 2 Treatment as usual
Usual Care
结局指标
主要结局
Change in PTSD Symptom Severity (PDS)
时间窗: Baseline, 6 months
range - 0-51 (higher score represents greater severity)
次要结局
- 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)
