Telemedicine Outreach for Post Traumatic Stress in CBOCs

Posttraumatic Stress Disorder Clinical Trial

— TOP  

Official title:

Telemedicine Outreach for Post Traumatic Stress in CBOCs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00821678
• Other study ID #: MHI 08-098
• Status: Completed
• Phase: Phase 4
• Start date: November 2009
• Est. completion date: September 2013

Study information

• Verified date: December 2018
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: September 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

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.

Locations

Country	Name	City	State
United States	VA Medical Center, Loma Linda	Loma Linda	California
United States	Central Arkansas Veterans Healthcare System (North Little Rock)	North Little Rock	Arkansas
United States	Overton Brooks VA Medical Center, Shreveport, LA	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PTSD Symptom Severity (PDS)	range - 0-51 (higher score represents greater severity)	Baseline, 6 months
Secondary	Change in Continuous Measure of Depression Symptom Severity (SCL-20)	range - 0-4 (higher score represents greater severity	Baseline, 6 months
Secondary	Change in Continuous Measure of Alcohol Use (Audit Score)	range - 0-12 (higher score represents greater severity)	Baseline, 6 months
Secondary	Change in Continuous Measure of Health Status (SF12V PCS)	range - 0-100 (higher score represents greater physical health status)	6 months
Secondary	Change in Continuous Measure of Quality of Life (QWB)	range - 0-1 (higher score represents greater wellbeing)	Baseline, 6 months
Secondary	Satisfaction With Care (ECHO)	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 months
Secondary	Medication Adherence, Defined as Taking Medication <80% of Days	0 - taking medication <80% of days; 1 - taking medications >=80%	6 months
Secondary	Received at Least 8 Sessions of Exposure Based Therapy	0 - received <8 sessions of exposure based therapy; 1 - received >=8 sessions of exposure based therapy	12 months