search
Back to results

Telemedicine Outreach for Post Traumatic Stress in CBOCs (TOP)

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Telemedicine Outreach for PTSD
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring telemedicine, rural, veterans, care management, psychotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Central Arkansas Veterans Healthcare System (North Little Rock)
  • VA Medical Center, Loma Linda
  • Overton Brooks VA Medical Center, Shreveport, LA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm 1 Telemedicine Outreach for PTSD

Arm 2 Treatment as usual

Arm Description

Telemedicine-Based Collaborative Care

Usual Care

Outcomes

Primary Outcome Measures

Change in PTSD Symptom Severity (PDS)
range - 0-51 (higher score represents greater severity)

Secondary Outcome Measures

Change in Continuous Measure of Depression Symptom Severity (SCL-20)
range - 0-4 (higher score represents greater severity
Change in Continuous Measure of Alcohol Use (Audit Score)
range - 0-12 (higher score represents greater severity)
Change in Continuous Measure of Health Status (SF12V PCS)
range - 0-100 (higher score represents greater physical health status)
Change in Continuous Measure of Quality of Life (QWB)
range - 0-1 (higher score represents greater wellbeing)
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?
Medication Adherence, Defined as Taking Medication <80% of Days
0 - taking medication <80% of days; 1 - taking medications >=80%
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 Information

First Posted
January 9, 2009
Last Updated
December 14, 2018
Sponsor
VA Office of Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT00821678
Brief Title
Telemedicine Outreach for Post Traumatic Stress in CBOCs
Acronym
TOP
Official Title
Telemedicine Outreach for Post Traumatic Stress in CBOCs
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
telemedicine, rural, veterans, care management, psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
265 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 Telemedicine Outreach for PTSD
Arm Type
Experimental
Arm Description
Telemedicine-Based Collaborative Care
Arm Title
Arm 2 Treatment as usual
Arm Type
No Intervention
Arm Description
Usual Care
Intervention Type
Other
Intervention Name(s)
Telemedicine Outreach for PTSD
Other Intervention Name(s)
Telemedicine-Based Collaborative Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in PTSD Symptom Severity (PDS)
Description
range - 0-51 (higher score represents greater severity)
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Change in Continuous Measure of Depression Symptom Severity (SCL-20)
Description
range - 0-4 (higher score represents greater severity
Time Frame
Baseline, 6 months
Title
Change in Continuous Measure of Alcohol Use (Audit Score)
Description
range - 0-12 (higher score represents greater severity)
Time Frame
Baseline, 6 months
Title
Change in Continuous Measure of Health Status (SF12V PCS)
Description
range - 0-100 (higher score represents greater physical health status)
Time Frame
6 months
Title
Change in Continuous Measure of Quality of Life (QWB)
Description
range - 0-1 (higher score represents greater wellbeing)
Time Frame
Baseline, 6 months
Title
Satisfaction With Care (ECHO)
Description
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
Title
Medication Adherence, Defined as Taking Medication <80% of Days
Description
0 - taking medication <80% of days; 1 - taking medications >=80%
Time Frame
6 months
Title
Received at Least 8 Sessions of Exposure Based Therapy
Description
0 - received <8 sessions of exposure based therapy; 1 - received >=8 sessions of exposure based therapy
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John C. Fortney, PhD
Organizational Affiliation
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Arkansas Veterans Healthcare System (North Little Rock)
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72114-1706
Country
United States
Facility Name
VA Medical Center, Loma Linda
City
Loma Linda
State/Province
California
ZIP/Postal Code
92357
Country
United States
Facility Name
Overton Brooks VA Medical Center, Shreveport, LA
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25409287
Citation
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. Erratum In: JAMA Psychiatry. 2015 Jan;72(1):96.
Results Reference
result
PubMed Identifier
26625355
Citation
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.
Results Reference
result
PubMed Identifier
28112433
Citation
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.
Results Reference
result
PubMed Identifier
28669290
Citation
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.
Results Reference
result
PubMed Identifier
32521100
Citation
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.
Results Reference
derived

Learn more about this trial

Telemedicine Outreach for Post Traumatic Stress in CBOCs

We'll reach out to this number within 24 hrs