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Telemedicine Outreach for Post Traumatic Stress in CBOCs

Telemedicine Outreach for Post Traumatic Stress in CBOCs

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00821678
Acronym
TOP
Enrollment
265
Registered
2009-01-13
Start date
2009-11-30
Completion date
2013-09-30
Last updated
2019-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder

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

OTHERTelemedicine 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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Change in PTSD Symptom Severity (PDS)Baseline, 6 monthsrange - 0-51 (higher score represents greater severity)

Secondary

MeasureTime frameDescription
Change in Continuous Measure of Alcohol Use (Audit Score)Baseline, 6 monthsrange - 0-12 (higher score represents greater severity)
Change in Continuous Measure of Health Status (SF12V PCS)6 monthsrange - 0-100 (higher score represents greater physical health status)
Change in Continuous Measure of Quality of Life (QWB)Baseline, 6 monthsrange - 0-1 (higher score represents greater wellbeing)
Change in Continuous Measure of Depression Symptom Severity (SCL-20)Baseline, 6 monthsrange - 0-4 (higher score represents greater severity
Medication Adherence, Defined as Taking Medication <80% of Days6 months0 - taking medication \<80% of days; 1 - taking medications \>=80%
Received at Least 8 Sessions of Exposure Based Therapy12 months0 - received \<8 sessions of exposure based therapy; 1 - received \>=8 sessions of exposure based therapy
Satisfaction With Care (ECHO)6 monthsUsing 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

ArmCount
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
Total265

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath02
Overall StudyLost to Follow-up1312
Overall StudyWithdrawal by Subject80

Baseline characteristics

CharacteristicArm 2 Treatment as UsualArm 1 Telemedicine Outreach for PTSDTotal
Age, Continuous52.5 years
STANDARD_DEVIATION 13.6
51.9 years
STANDARD_DEVIATION 14
52.2 years
STANDARD_DEVIATION 13.8
Race/Ethnicity, Customized
African American
21 participants31 participants52 participants
Race/Ethnicity, Customized
Caucasian Hispanic
8 participants12 participants20 participants
Race/Ethnicity, Customized
Caucasian Non-Hispanic
92 participants77 participants169 participants
Race/Ethnicity, Customized
Other Race/Ethnicity
11 participants13 participants24 participants
Sex: Female, Male
Female
12 Participants15 Participants27 Participants
Sex: Female, Male
Male
120 Participants118 Participants238 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1330 / 132
serious
Total, serious adverse events
0 / 1335 / 132

Outcome results

Primary

Change in PTSD Symptom Severity (PDS)

range - 0-51 (higher score represents greater severity)

Time frame: Baseline, 6 months

ArmMeasureValue (MEAN)Dispersion
Arm 1 Telemedicine Outreach for PTSDChange in PTSD Symptom Severity (PDS)-5.31 units on a scaleStandard Deviation 10.91
Arm 2 Treatment as UsualChange in PTSD Symptom Severity (PDS)-1.07 units on a scaleStandard Deviation 7.73
p-value: 0.00295% CI: [-6.19, -1.43]Mixed Models Analysis
Secondary

Change in Continuous Measure of Alcohol Use (Audit Score)

range - 0-12 (higher score represents greater severity)

Time frame: Baseline, 6 months

ArmMeasureValue (MEAN)Dispersion
Arm 1 Telemedicine Outreach for PTSDChange in Continuous Measure of Alcohol Use (Audit Score)-0.36 units on a scaleStandard Deviation 2.19
Arm 2 Treatment as UsualChange in Continuous Measure of Alcohol Use (Audit Score)-0.17 units on a scaleStandard Deviation 1.73
p-value: 0.4895% CI: [-0.33, 0.7]t-test, 2 sided
Secondary

Change in Continuous Measure of Depression Symptom Severity (SCL-20)

range - 0-4 (higher score represents greater severity

Time frame: Baseline, 6 months

ArmMeasureValue (MEAN)Dispersion
Arm 1 Telemedicine Outreach for PTSDChange in Continuous Measure of Depression Symptom Severity (SCL-20)-0.43 units on a scaleStandard Deviation 0.62
Arm 2 Treatment as UsualChange in Continuous Measure of Depression Symptom Severity (SCL-20)-0.16 units on a scaleStandard Deviation 0.56
p-value: 0.00195% CI: [-0.4, -0.1]Mixed Models Analysis
Secondary

Change in Continuous Measure of Health Status (SF12V PCS)

range - 0-100 (higher score represents greater physical health status)

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Arm 1 Telemedicine Outreach for PTSDChange in Continuous Measure of Health Status (SF12V PCS)0.77 units on a scaleStandard Deviation 7.5
Arm 2 Treatment as UsualChange in Continuous Measure of Health Status (SF12V PCS)-1.45 units on a scaleStandard Deviation 9.47
p-value: 0.0295% CI: [0.45, 4.91]Mixed Models Analysis
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Arm 1 Telemedicine Outreach for PTSDChange in Continuous Measure of Quality of Life (QWB)-0.00407 Units on a Scale from 0-1Standard Deviation 0.1086
Arm 2 Treatment as UsualChange in Continuous Measure of Quality of Life (QWB)-0.00800 Units on a Scale from 0-1Standard Deviation 0.1019
Secondary

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.

ArmMeasureValue (NUMBER)
Arm 1 Telemedicine Outreach for PTSDMedication Adherence, Defined as Taking Medication <80% of Days62 participants
Arm 2 Treatment as UsualMedication Adherence, Defined as Taking Medication <80% of Days68 participants
p-value: 0.6595% CI: [0.46, 1.62]Mixed Models Analysis
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

Time frame: 12 months

Population: Full Baseline Sample

ArmMeasureValue (NUMBER)
Arm 1 Telemedicine Outreach for PTSDReceived at Least 8 Sessions of Exposure Based Therapy36 participants
Arm 2 Treatment as UsualReceived at Least 8 Sessions of Exposure Based Therapy7 participants
p-value: <0.00195% CI: [3.2, 19.6]Mixed Models Analysis
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?

Time frame: 6 months

Population: Full sample. Data missing for 1 Arm 1 subject and 3 Arm 2 subjects

ArmMeasureValue (MEAN)Dispersion
Arm 1 Telemedicine Outreach for PTSDSatisfaction With Care (ECHO)8.83423 0-10 self reported ratingStandard Deviation 1.17964
Arm 2 Treatment as UsualSatisfaction With Care (ECHO)7.7043 0-10 self reported ratingStandard Deviation 2.2671

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026