A Phase 4 interventional study of Telemedicine Outreach for PTSD in Posttraumatic Stress Disorder, sponsored by VA Office of Research and Development. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-08.
Sponsored by VA Office of Research and Development · Phase 4, Interventional, and Treatment
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.
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.
2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 554 are open to participants now.
This study's enrollment of 265 is above the median of 70 across 1,858 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Telemedicine-Based Collaborative Care
Other: Telemedicine Outreach for PTSD
Usual Care
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.
Also known as: Telemedicine-Based Collaborative Care
Change in PTSD Symptom Severity (PDS)
range - 0-51 (higher score represents greater severity)
Time frame: Baseline, 6 months
Change in Continuous Measure of Depression Symptom Severity (SCL-20)
range - 0-4 (higher score represents greater severity
Time frame: Baseline, 6 months
Change in Continuous Measure of Alcohol Use (Audit Score)
range - 0-12 (higher score represents greater severity)
Time frame: Baseline, 6 months
Change in Continuous Measure of Health Status (SF12V PCS)
range - 0-100 (higher score represents greater physical health status)
Time frame: 6 months
Change in Continuous Measure of Quality of Life (QWB)
range - 0-1 (higher score represents greater wellbeing)
Time frame: Baseline, 6 months
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?
Time frame: 6 months
Medication Adherence, Defined as Taking Medication <80% of Days
0 - taking medication \<80% of days; 1 - taking medications \>=80%
Time frame: 6 months
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
Time frame: 12 months
| Milestone | Arm 1 Telemedicine Outreach for PTSD | Arm 2 Treatment as Usual |
|---|---|---|
| Started | 133 | 132 |
| Completed | 112 | 118 |
| Not completed | 21 | 14 |
| Withdrew: Withdrawal by subject | 8 | 0 |
| Withdrew: Lost to follow-up | 13 | 12 |
| Withdrew: Death | 0 | 2 |
range - 0-51 (higher score represents greater severity)
| units on a scale | Arm 1 Telemedicine Outreach for PTSD | Arm 2 Treatment as Usual |
|---|---|---|
| Change in PTSD Symptom Severity (PDS) | -5.31 ± 10.91 | -1.07 ± 7.73 |
range - 0-4 (higher score represents greater severity
| units on a scale | Arm 1 Telemedicine Outreach for PTSD | Arm 2 Treatment as Usual |
|---|---|---|
| Change in Continuous Measure of Depression Symptom Severity (SCL-20) | -0.43 ± 0.62 | -0.16 ± 0.56 |
range - 0-12 (higher score represents greater severity)
| units on a scale | Arm 1 Telemedicine Outreach for PTSD | Arm 2 Treatment as Usual |
|---|---|---|
| Change in Continuous Measure of Alcohol Use (Audit Score) | -0.36 ± 2.19 | -0.17 ± 1.73 |
range - 0-100 (higher score represents greater physical health status)
| units on a scale | Arm 1 Telemedicine Outreach for PTSD | Arm 2 Treatment as Usual |
|---|---|---|
| Change in Continuous Measure of Health Status (SF12V PCS) | 0.77 ± 7.50 | -1.45 ± 9.47 |
range - 0-1 (higher score represents greater wellbeing)
| Units on a Scale from 0-1 | Arm 1 Telemedicine Outreach for PTSD | Arm 2 Treatment as Usual |
|---|---|---|
| Change in Continuous Measure of Quality of Life (QWB) | -0.00407 ± 0.1086 | -0.00800 ± 0.1019 |
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?
| 0-10 self reported rating | Arm 1 Telemedicine Outreach for PTSD | Arm 2 Treatment as Usual |
|---|---|---|
| Satisfaction With Care (ECHO) | 8.83423 ± 1.17964 | 7.7043 ± 2.2671 |
0 - taking medication \<80% of days; 1 - taking medications \>=80%
| participants | Arm 1 Telemedicine Outreach for PTSD | Arm 2 Treatment as Usual |
|---|---|---|
| Medication Adherence, Defined as Taking Medication <80% of Days | 62 | 68 |
0 - received \<8 sessions of exposure based therapy; 1 - received \>=8 sessions of exposure based therapy
| participants | Arm 1 Telemedicine Outreach for PTSD | Arm 2 Treatment as Usual |
|---|---|---|
| Received at Least 8 Sessions of Exposure Based Therapy | 36 | 7 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 Telemedicine Outreach for PTSD | — | 0/133 (0%) | 0/133 (0%) |
| Arm 2 Treatment as Usual | — | 5/132 (3.8%) | 0/132 (0%) |
| Event | Arm 1 Telemedicine Outreach for PTSD | Arm 2 Treatment as Usual |
|---|---|---|
| Death (Not Study Related)General disorders | 0/133 | 5/132 |
| Age, Continuous(years) | Arm 1 Telemedicine Outreach for PTSD | Arm 2 Treatment as Usual | Total |
|---|---|---|---|
| Mean | 51.9 ± 14.0 | 52.5 ± 13.6 | 52.2 ± 13.8 |
| Sex: Female, Male(Participants) | Arm 1 Telemedicine Outreach for PTSD | Arm 2 Treatment as Usual | Total |
|---|---|---|---|
| Female | 15 | 12 | 27 |
| Male | 118 | 120 | 238 |
| Race/Ethnicity, Customized(participants) | Arm 1 Telemedicine Outreach for PTSD | Arm 2 Treatment as Usual | Total |
|---|---|---|---|
| Caucasian Non-Hispanic | 77 | 92 | 169 |
| Caucasian Hispanic | 12 | 8 | 20 |
| African American | 31 | 21 | 52 |
| Other Race/Ethnicity | 13 | 11 | 24 |
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Stress Disorders, Post-Traumatic→
VA Office of Research and Development