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Posttraumatic Stress DisorderPhase 4TOPNCT00821678

Telemedicine Outreach for Post Traumatic Stress in CBOCs

A Phase 4 study testing Telemedicine Outreach for PTSD in people with Posttraumatic Stress Disorder, run by VA Office of Research and Development at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Posttraumatic Stress Disorder
What is being tested?
Telemedicine Outreach for PTSD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
265 participants
Where
3 sitesUnited States
Study dates
Nov 2009to Sep 2013
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • diagnostic Criteria for PTSD (CAPS),
  • veterans,
  • treated in CBOC

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • VA Medical Center, Loma Linda

    Loma Linda, California, 92357

  • Central Arkansas Veterans Healthcare System (North Little Rock)

    North Little Rock, Arkansas, 72114-1706

  • Overton Brooks VA Medical Center, Shreveport, LA

    Shreveport, Louisiana, 71101

Other trials in United States

About this study

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.

Read the 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.

Being tested
Telemedicine Outreach for PTSD
Keywords
telemedicine, rural, veterans, care management, psychotherapy
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telemedicine Outreach for PTSDOther

    Also called Telemedicine-Based Collaborative 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.

Study groups in NCT00821678
Study groupRoleWhat they receive
Arm 1 Telemedicine Outreach for PTSDExperimentalTelemedicine-Based Collaborative Care
Receives: Other: Telemedicine Outreach for PTSD
Arm 2 Treatment as usualNo interventionUsual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in PTSD Symptom Severity (PDS)

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

    Measured: Baseline, 6 months

Secondary outcomes (7)

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

    range - 0-4 (higher score represents greater severity

    Measured: Baseline, 6 months

  2. Change in Continuous Measure of Alcohol Use (Audit Score)

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

    Measured: Baseline, 6 months

  3. Change in Continuous Measure of Health Status (SF12V PCS)

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

    Measured: 6 months

  4. Change in Continuous Measure of Quality of Life (QWB)

    range - 0-1 (higher score represents greater wellbeing)

    Measured: Baseline, 6 months

  5. 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?

    Measured: 6 months

  6. Medication Adherence, Defined as Taking Medication <80% of Days

    0 - taking medication <80% of days; 1 - taking medications >=80%

    Measured: 6 months

  7. 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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionSep 2012
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
265 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00821678
Sponsor's protocol ID
MHI 08-098
Acronym
TOP
Status last verified
Dec 2018
First submitted
9 Jan 2009
Last updated
8 Jan 2019
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25409287

  • 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.

    PubMed 26625355

  • 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.

    PubMed 28112433

  • 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.

    PubMed 28669290

  • 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.

    PubMed 32521100

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Telemedicine Outreach for PTSD in people with Posttraumatic Stress Disorder, run by VA Office of Research and Development at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in PTSD Symptom Severity (PDS) (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00821678, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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