MedPath

Telemedicine Outreach for Post Traumatic Stress in CBOCs

Phase 4
Completed
Conditions
Posttraumatic Stress Disorder
Interventions
Other: Telemedicine Outreach for PTSD
Registration Number
NCT00821678
Lead Sponsor
VA Office of Research and Development
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
265
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Arm 1 Telemedicine Outreach for PTSDTelemedicine Outreach for PTSDTelemedicine-Based Collaborative Care
Primary Outcome Measures
NameTimeMethod
Change in PTSD Symptom Severity (PDS)Baseline, 6 months

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

Secondary Outcome Measures
NameTimeMethod
Change in Continuous Measure of Depression Symptom Severity (SCL-20)Baseline, 6 months

range - 0-4 (higher score represents greater severity

Change in Continuous Measure of Alcohol Use (Audit Score)Baseline, 6 months

range - 0-12 (higher score represents greater severity)

Change in Continuous Measure of Health Status (SF12V PCS)6 months

range - 0-100 (higher score represents greater physical health status)

Change in Continuous Measure of Quality of Life (QWB)Baseline, 6 months

range - 0-1 (higher score represents greater wellbeing)

Satisfaction With Care (ECHO)6 months

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?

Medication Adherence, Defined as Taking Medication <80% of Days6 months

0 - taking medication \<80% of days; 1 - taking medications \>=80%

Received at Least 8 Sessions of Exposure Based Therapy12 months

0 - received \<8 sessions of exposure based therapy; 1 - received \>=8 sessions of exposure based therapy

Trial Locations

Locations (3)

Central Arkansas Veterans Healthcare System (North Little Rock)

🇺🇸

North Little Rock, Arkansas, United States

Overton Brooks VA Medical Center, Shreveport, LA

🇺🇸

Shreveport, Louisiana, United States

VA Medical Center, Loma Linda

🇺🇸

Loma Linda, California, United States

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