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Completed

NCT Number: NCT00821678

Telemedicine Outreach for Post Traumatic Stress in CBOCs

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.

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Key information

Conditions

Posttraumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Central Arkansas Veterans Healthcare System (North Little Rock), North Little Rock, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemedicine Outreach for PTSD

Other

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.

Other names: Telemedicine-Based Collaborative Care

Primary outcomes

  1. Change in PTSD Symptom Severity (PDS)

    Time frame: Baseline, 6 months

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

Secondary outcomes

  1. Change in Continuous Measure of Depression Symptom Severity (SCL-20)

    Time frame: Baseline, 6 months

    range - 0-4 (higher score represents greater severity

  2. Change in Continuous Measure of Alcohol Use (Audit Score)

    Time frame: Baseline, 6 months

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

  3. Change in Continuous Measure of Health Status (SF12V PCS)

    Time frame: 6 months

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

  4. Change in Continuous Measure of Quality of Life (QWB)

    Time frame: Baseline, 6 months

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

  5. Satisfaction With Care (ECHO)

    Time frame: 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?

  6. Medication Adherence, Defined as Taking Medication <80% of Days

    Time frame: 6 months

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

  7. Received at Least 8 Sessions of Exposure Based Therapy

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Acronym: TOP

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Jan 13, 2009
Registry last updated
Jan 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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