Posttraumatic Stress Disorder
Conditions
Keywords
telemedicine, rural, veterans, care management, psychotherapy
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.
Interventions
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.
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PTSD Symptom Severity (PDS) | Baseline, 6 months | range - 0-51 (higher score represents greater severity) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Continuous Measure of Alcohol Use (Audit Score) | Baseline, 6 months | range - 0-12 (higher score represents greater severity) |
| Change in Continuous Measure of Health Status (SF12V PCS) | 6 months | range - 0-100 (higher score represents greater physical health status) |
| Change in Continuous Measure of Quality of Life (QWB) | Baseline, 6 months | range - 0-1 (higher score represents greater wellbeing) |
| Change in Continuous Measure of Depression Symptom Severity (SCL-20) | Baseline, 6 months | range - 0-4 (higher score represents greater severity |
| Medication Adherence, Defined as Taking Medication <80% of Days | 6 months | 0 - taking medication \<80% of days; 1 - taking medications \>=80% |
| Received at Least 8 Sessions of Exposure Based Therapy | 12 months | 0 - received \<8 sessions of exposure based therapy; 1 - received \>=8 sessions of exposure based therapy |
| Satisfaction With Care (ECHO) | 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? |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 Telemedicine Outreach for PTSD Telemedicine-Based Collaborative Care
Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (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). 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. | 133 |
| Arm 2 Treatment as Usual Treatment as usual | 132 |
| Total | 265 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 2 |
| Overall Study | Lost to Follow-up | 13 | 12 |
| Overall Study | Withdrawal by Subject | 8 | 0 |
Baseline characteristics
| Characteristic | Arm 2 Treatment as Usual | Arm 1 Telemedicine Outreach for PTSD | Total |
|---|---|---|---|
| Age, Continuous | 52.5 years STANDARD_DEVIATION 13.6 | 51.9 years STANDARD_DEVIATION 14 | 52.2 years STANDARD_DEVIATION 13.8 |
| Race/Ethnicity, Customized African American | 21 participants | 31 participants | 52 participants |
| Race/Ethnicity, Customized Caucasian Hispanic | 8 participants | 12 participants | 20 participants |
| Race/Ethnicity, Customized Caucasian Non-Hispanic | 92 participants | 77 participants | 169 participants |
| Race/Ethnicity, Customized Other Race/Ethnicity | 11 participants | 13 participants | 24 participants |
| Sex: Female, Male Female | 12 Participants | 15 Participants | 27 Participants |
| Sex: Female, Male Male | 120 Participants | 118 Participants | 238 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 133 | 0 / 132 |
| serious Total, serious adverse events | 0 / 133 | 5 / 132 |
Outcome results
Change in PTSD Symptom Severity (PDS)
range - 0-51 (higher score represents greater severity)
Time frame: Baseline, 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 Telemedicine Outreach for PTSD | Change in PTSD Symptom Severity (PDS) | -5.31 units on a scale | Standard Deviation 10.91 |
| Arm 2 Treatment as Usual | Change in PTSD Symptom Severity (PDS) | -1.07 units on a scale | Standard Deviation 7.73 |
Change in Continuous Measure of Alcohol Use (Audit Score)
range - 0-12 (higher score represents greater severity)
Time frame: Baseline, 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 Telemedicine Outreach for PTSD | Change in Continuous Measure of Alcohol Use (Audit Score) | -0.36 units on a scale | Standard Deviation 2.19 |
| Arm 2 Treatment as Usual | Change in Continuous Measure of Alcohol Use (Audit Score) | -0.17 units on a scale | Standard Deviation 1.73 |
Change in Continuous Measure of Depression Symptom Severity (SCL-20)
range - 0-4 (higher score represents greater severity
Time frame: Baseline, 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 Telemedicine Outreach for PTSD | Change in Continuous Measure of Depression Symptom Severity (SCL-20) | -0.43 units on a scale | Standard Deviation 0.62 |
| Arm 2 Treatment as Usual | Change in Continuous Measure of Depression Symptom Severity (SCL-20) | -0.16 units on a scale | Standard Deviation 0.56 |
Change in Continuous Measure of Health Status (SF12V PCS)
range - 0-100 (higher score represents greater physical health status)
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 Telemedicine Outreach for PTSD | Change in Continuous Measure of Health Status (SF12V PCS) | 0.77 units on a scale | Standard Deviation 7.5 |
| Arm 2 Treatment as Usual | Change in Continuous Measure of Health Status (SF12V PCS) | -1.45 units on a scale | Standard Deviation 9.47 |
Change in Continuous Measure of Quality of Life (QWB)
range - 0-1 (higher score represents greater wellbeing)
Time frame: Baseline, 6 months
Population: Full sample
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 Telemedicine Outreach for PTSD | Change in Continuous Measure of Quality of Life (QWB) | -0.00407 Units on a Scale from 0-1 | Standard Deviation 0.1086 |
| Arm 2 Treatment as Usual | Change in Continuous Measure of Quality of Life (QWB) | -0.00800 Units on a Scale from 0-1 | Standard Deviation 0.1019 |
Medication Adherence, Defined as Taking Medication <80% of Days
0 - taking medication \<80% of days; 1 - taking medications \>=80%
Time frame: 6 months
Population: Sample only for 205 patients prescribed medications.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 Telemedicine Outreach for PTSD | Medication Adherence, Defined as Taking Medication <80% of Days | 62 participants |
| Arm 2 Treatment as Usual | Medication Adherence, Defined as Taking Medication <80% of Days | 68 participants |
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
Population: Full Baseline Sample
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 Telemedicine Outreach for PTSD | Received at Least 8 Sessions of Exposure Based Therapy | 36 participants |
| Arm 2 Treatment as Usual | Received at Least 8 Sessions of Exposure Based Therapy | 7 participants |
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
Population: Full sample. Data missing for 1 Arm 1 subject and 3 Arm 2 subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 Telemedicine Outreach for PTSD | Satisfaction With Care (ECHO) | 8.83423 0-10 self reported rating | Standard Deviation 1.17964 |
| Arm 2 Treatment as Usual | Satisfaction With Care (ECHO) | 7.7043 0-10 self reported rating | Standard Deviation 2.2671 |