NCT00821678

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2009

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2009

Completed
10 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

April 23, 2015

Completed
Last Updated

January 8, 2019

Status Verified

December 1, 2018

Enrollment Period

2.8 years

First QC Date

January 9, 2009

Results QC Date

February 19, 2015

Last Update Submit

December 14, 2018

Conditions

Posttraumatic Stress Disorder

Keywords

telemedicineruralveteranscare managementpsychotherapy

Outcome Measures

Primary Outcomes (1)

  • Change in PTSD Symptom Severity (PDS)

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

    Baseline, 6 months

Secondary Outcomes (7)

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

    Baseline, 6 months

  • Change in Continuous Measure of Alcohol Use (Audit Score)

    Baseline, 6 months

  • Change in Continuous Measure of Health Status (SF12V PCS)

    6 months

  • Change in Continuous Measure of Quality of Life (QWB)

    Baseline, 6 months

  • Satisfaction With Care (ECHO)

    6 months

  • +2 more secondary outcomes

Study Arms (2)

Arm 1 Telemedicine Outreach for PTSD

EXPERIMENTAL

Telemedicine-Based Collaborative Care

Other: Telemedicine Outreach for PTSD

Arm 2 Treatment as usual

NO INTERVENTION

Usual Care

Interventions

Telemedicine Outreach for PTSDOTHER

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.

Also known as: Telemedicine-Based Collaborative Care
Arm 1 Telemedicine Outreach for PTSD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Central Arkansas Veterans Healthcare System (North Little Rock)

North Little Rock, Arkansas, 72114-1706, United States

Location

VA Medical Center, Loma Linda

Loma Linda, California, 92357, United States

Location

Overton Brooks VA Medical Center, Shreveport, LA

Shreveport, Louisiana, 71101, United States

Location

Related Publications (5)

  • 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.

    PMID: 25409287RESULT

  • 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.

    PMID: 26625355RESULT

  • 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.

    PMID: 28112433RESULT

  • 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.

    PMID: 28669290RESULT

  • 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.

    PMID: 32521100DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Limitations and Caveats

High enrollment refusal rates may limit external validity.

Results Point of Contact

Title
John Fortney
Organization
VA HSR&D
john.fortney@va.gov
206.764.2821

Study Officials

  • John C. Fortney, PhD

    Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2009

First Posted

January 13, 2009

Study Start

November 1, 2009

Primary Completion

September 1, 2012

Study Completion

September 1, 2013

Last Updated

January 8, 2019

Results First Posted

April 23, 2015

Record last verified: 2018-12

Locations

US(3)