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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 Telemedicine Outreach for PTSD | Experimental | Telemedicine-Based Collaborative Care |
|
| Arm 2 Treatment as usual | No Intervention | Usual Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine Outreach for PTSD | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PTSD Symptom Severity (PDS) | range - 0-51 (higher score represents greater severity) | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Continuous Measure of Depression Symptom Severity (SCL-20) | range - 0-4 (higher score represents greater severity | Baseline, 6 months |
| Change in Continuous Measure of Alcohol Use (Audit Score) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John C. Fortney, PhD | Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Arkansas Veterans Healthcare System (North Little Rock) | North Little Rock | Arkansas | 72114-1706 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25409287 | Result | 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. | |
| 26625355 | Result |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Arm 2 Treatment as Usual | Treatment as usual |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in PTSD Symptom Severity (PDS) | range - 0-51 (higher score represents greater severity) | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months |
|
1 year
Death (Not Study Related). Death was the only adverse event monitored.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death (Not Study Related) | General disorders | Chart Review | Systematic Assessment |
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High enrollment refusal rates may limit external validity.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Fortney | VA HSR&D | 206.764.2821 | john.fortney@va.gov |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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|
|
range - 0-12 (higher score represents greater severity)
| Baseline, 6 months |
| Change in Continuous Measure of Health Status (SF12V PCS) | range - 0-100 (higher score represents greater physical health status) | 6 months |
| Change in Continuous Measure of Quality of Life (QWB) | range - 0-1 (higher score represents greater wellbeing) | 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? | 6 months |
| Medication Adherence, Defined as Taking Medication <80% of Days | 0 - taking medication <80% of days; 1 - taking medications >=80% | 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 | 12 months |
| VA Medical Center, Loma Linda |
| Loma Linda |
| California |
| 92357 |
| United States |
| Overton Brooks VA Medical Center, Shreveport, LA | Shreveport | Louisiana | 71101 | United States |
| 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. |
| 28112433 | Result | 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. |
| 28669290 | Result | 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. |
| 32521100 | Derived | 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. |
| Death |
|
| BG001 | Arm 2 Treatment as Usual | Treatment as usual |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| OG001 | Arm 2 Treatment as Usual | Treatment as usual |
|
|
|
| Secondary | Change in Continuous Measure of Depression Symptom Severity (SCL-20) | range - 0-4 (higher score represents greater severity | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months |
|
|
|
|
| Secondary | Change in Continuous Measure of Alcohol Use (Audit Score) | range - 0-12 (higher score represents greater severity) | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months |
|
|
|
|
| Secondary | Change in Continuous Measure of Health Status (SF12V PCS) | range - 0-100 (higher score represents greater physical health status) | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
|
| Secondary | Change in Continuous Measure of Quality of Life (QWB) | range - 0-1 (higher score represents greater wellbeing) | Full sample | Posted | Mean | Standard Deviation | Units on a Scale from 0-1 | 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? | Full sample. Data missing for 1 Arm 1 subject and 3 Arm 2 subjects | Posted | Mean | Standard Deviation | 0-10 self reported rating | 6 months |
|
|
|
| Secondary | Medication Adherence, Defined as Taking Medication <80% of Days | 0 - taking medication <80% of days; 1 - taking medications >=80% | Sample only for 205 patients prescribed medications. | Posted | Number | participants | 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 | Full Baseline Sample | Posted | Number | participants | 12 months |
|
|
|
|
| 0 |
| 133 |
| 0 |
| 133 |
| EG001 | Arm 2 Treatment as Usual | Treatment as usual | 5 | 132 | 0 | 132 |
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