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Telemedicine Outreach for Post Traumatic Stress in CBOCs (TOP)

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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

Tracking Information
First Submitted Date  ICMJE January 9, 2009
First Posted Date  ICMJE January 13, 2009
Results First Submitted Date  ICMJE February 19, 2015
Results First Posted Date  ICMJE April 23, 2015
Last Update Posted Date January 8, 2019
Study Start Date  ICMJE November 2009
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2015)
Change in PTSD Symptom Severity (PDS) [ Time Frame: Baseline, 6 months ]
range - 0-51 (higher score represents greater severity)
Original Primary Outcome Measures  ICMJE
 (submitted: January 9, 2009)
PTSD symptom severity (PDS) [ Time Frame: Baseline, 6, 12, 18 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2018)
  • Change in Continuous Measure of Depression Symptom Severity (SCL-20) [ Time Frame: Baseline, 6 months ]
    range - 0-4 (higher score represents greater severity
  • Change in Continuous Measure of Alcohol Use (Audit Score) [ Time Frame: Baseline, 6 months ]
    range - 0-12 (higher score represents greater severity)
  • Change in Continuous Measure of Health Status (SF12V PCS) [ Time Frame: 6 months ]
    range - 0-100 (higher score represents greater physical health status)
  • Change in Continuous Measure of Quality of Life (QWB) [ Time Frame: Baseline, 6 months ]
    range - 0-1 (higher score represents greater wellbeing)
  • 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?
  • Medication Adherence, Defined as Taking Medication <80% of Days [ Time Frame: 6 months ]
    0 - taking medication <80% of days; 1 - taking medications >=80%
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2009)
  • Change in continuous measure of depression symptom severity (SCL-20) [ Time Frame: 6, 12, 18 months ]
  • Change in continuous measure of alcohol use (Quantity times Frequency) [ Time Frame: 6, 12, 18 months ]
  • Change in continuous measure of health status (SF12V) [ Time Frame: 6, 12, 18 months ]
  • Change in continuous measure of Quality of Life (QWB) [ Time Frame: 6, 12, 18 months ]
  • Satisfaction with Care (ECHO) [ Time Frame: 6, 12 months ]
  • Treatment non-adherence, defined as taking medication <80% of days or attending <75% of therapy appointments [ Time Frame: 6, 12 18 months ]
  • Receipt of guideline-concordant care, defined as a prescription of an adequate dosage of medication for PTSD (as defined by the IPAP medication algorithm) or received at least 8 sessions of exposure based therapy [ Time Frame: 6, 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Telemedicine Outreach for Post Traumatic Stress in CBOCs
Official Title  ICMJE Telemedicine Outreach for Post Traumatic Stress in CBOCs
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Posttraumatic Stress Disorder
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Arm 1 Telemedicine Outreach for PTSD
    Telemedicine-Based Collaborative Care
    Intervention: Other: Telemedicine Outreach for PTSD
  • No Intervention: Arm 2 Treatment as usual
    Usual Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2013)
265
Original Estimated Enrollment  ICMJE
 (submitted: January 9, 2009)
400
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00821678
Other Study ID Numbers  ICMJE MHI 08-098
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party VA Office of Research and Development
Original Responsible Party Fortney, John - Principal Investigator, Department of Veterans Affairs
Current Study Sponsor  ICMJE VA Office of Research and Development
Original Study Sponsor  ICMJE US Department of Veterans Affairs
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John C. Fortney, PhD Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
PRS Account VA Office of Research and Development
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP