Clinical trial NCT00821678: Telemedicine Outreach for Post Traumatic Stress in CBOCs
Official title: Telemedicine Outreach for Post Traumatic Stress in CBOCs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Posttraumatic Stress Disorder
Keywords: telemedicine
rural
veterans
care management
psychotherapy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-01-13
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in PTSD Symptom Severity (PDS)
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change in Continuous Measure of Depression Symptom Severity (SCL-20)
timeFrame: Baseline, 6 months
measure: Change in Continuous Measure of Alcohol Use (Audit Score)
timeFrame: Baseline, 6 months
measure: Change in Continuous Measure of Health Status (SF12V PCS)
timeFrame: 6 months
measure: Change in Continuous Measure of Quality of Life (QWB)
timeFrame: Baseline, 6 months
measure: Satisfaction With Care (ECHO)
timeFrame: 6 months
measure: Medication Adherence, Defined as Taking Medication <80% of Days
timeFrame: 6 months
measure: Received at Least 8 Sessions of Exposure Based Therapy
timeFrame: 12 months
Other outcomes:
Locations:
city: North Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare System (North Little Rock)
state: Arkansas
city: Loma Linda
country: United States
facility: VA Medical Center, Loma Linda
state: California
city: Shreveport
country: United States
facility: Overton Brooks VA Medical Center, Shreveport, LA
state: Louisiana
Study officials:
affiliation: Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
name: John C. Fortney, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.