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Telemedicine Outreach for Post Traumatic Stress in CBOCs (TOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00821678
Recruitment Status : Completed
First Posted : January 13, 2009
Results First Posted : April 23, 2015
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Other: Telemedicine Outreach for PTSD Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 265 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Telemedicine Outreach for Post Traumatic Stress in CBOCs
Study Start Date : November 2009
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1 Telemedicine Outreach for PTSD
Telemedicine-Based Collaborative Care
Other: Telemedicine Outreach for PTSD
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 Name: Telemedicine-Based Collaborative Care

No Intervention: Arm 2 Treatment as usual
Usual Care



Primary Outcome Measures :
  1. Change in PTSD Symptom Severity (PDS) [ Time Frame: Baseline, 6 months ]
    range - 0-51 (higher score represents greater severity)


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821678


Locations
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United States, Arkansas
Central Arkansas Veterans Healthcare System (North Little Rock)
North Little Rock, Arkansas, United States, 72114-1706
United States, California
VA Medical Center, Loma Linda
Loma Linda, California, United States, 92357
United States, Louisiana
Overton Brooks VA Medical Center, Shreveport, LA
Shreveport, Louisiana, United States, 71101
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: John C. Fortney, PhD Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
Publications of Results:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00821678    
Other Study ID Numbers: MHI 08-098
First Posted: January 13, 2009    Key Record Dates
Results First Posted: April 23, 2015
Last Update Posted: January 8, 2019
Last Verified: December 2018
Keywords provided by VA Office of Research and Development:
telemedicine
rural
veterans
care management
psychotherapy
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders