Telemedicine Outreach for Post Traumatic Stress in CBOCs (TOP)

• 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: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Tracking Information

• First Submitted Date: January 9, 2009
• First Posted Date: January 13, 2009
• Results First Submitted Date: February 19, 2015
• Results First Posted Date: April 23, 2015
• Last Update Posted Date: January 8, 2019
• Study Start Date: November 2009
• Actual Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: January 9, 2009): PTSD symptom severity (PDS) [ Time Frame: Baseline, 6, 12, 18 months ]

Current Secondary Outcome Measures (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 (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: Telemedicine Outreach for Post Traumatic Stress in CBOCs
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Posttraumatic Stress Disorder

Intervention

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

• 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 *

• Fortney JC, Pyne JM, Kimbrell TA, Hudson TJ, Robinson DE, Schneider R, Moore WM, Custer PJ, Grubbs KM, Schnurr PP. Telemedicine-based collaborative care for posttraumatic stress disorder: a randomized clinical trial. JAMA Psychiatry. 2015 Jan;72(1):58-67. doi: 10.1001/jamapsychiatry.2014.1575. Erratum In: JAMA Psychiatry. 2015 Jan;72(1):96.
• Grubbs KM, Fortney JC, Pyne JM, Hudson T, Moore WM, Custer P, Schneider R, Schnurr PP. Predictors of Initiation and Engagement of Cognitive Processing Therapy Among Veterans With PTSD Enrolled in Collaborative Care. J Trauma Stress. 2015 Dec;28(6):580-4. doi: 10.1002/jts.22049.
• Grubbs KM, Fortney JC, Kimbrell T, Pyne JM, Hudson T, Robinson D, Moore WM, Custer P, Schneider R, Schnurr PP. Usual Care for Rural Veterans With Posttraumatic Stress Disorder. J Rural Health. 2017 Jun;33(3):290-296. doi: 10.1111/jrh.12230. Epub 2017 Jan 23.
• Painter JT, Fortney JC, Austen MA, Pyne JM. Cost-Effectiveness of Telemedicine-Based Collaborative Care for Posttraumatic Stress Disorder. Psychiatr Serv. 2017 Nov 1;68(11):1157-1163. doi: 10.1176/appi.ps.201600485. Epub 2017 Jul 3.
• Campbell SB, Erbes C, Grubbs K, Fortney J. Social Support Moderates the Association Between Posttraumatic Stress Disorder Treatment Duration and Treatment Outcomes in Telemedicine-Based Treatment Among Rural Veterans. J Trauma Stress. 2020 Aug;33(4):391-400. doi: 10.1002/jts.22542. Epub 2020 Jun 10.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 19, 2013): 265
• Original Estimated Enrollment (submitted: January 9, 2009): 400
• Actual Study Completion Date: September 2013
• Actual Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00821678
• Other Study ID Numbers: MHI 08-098
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: 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: VA Office of Research and Development
• Original Study Sponsor: US Department of Veterans Affairs
• Collaborators: Not Provided

Investigators

• 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