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TOP Implementation Project

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ClinicalTrials.gov Identifier: NCT02737098
Recruitment Status : Active, not recruiting
First Posted : April 13, 2016
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:

The Veterans Health Administration (VHA) provides care to 3.3 million Veterans living in rural areas, comprising 36% of all VHA enrollees. In 1995, VHA began expanding its system of Community Based Outpatient Clinics (CBOCs) in order to improve access for the geographically dispersed Veteran population. There are now approximately 900 CBOCs delivering a range of services to approximately 64% of VHA enrollees. While these CBOCs have dramatically improved access to first class primary care services, it has been more challenging to deliver specialty mental health care to rural Veterans. Evidence based specialty mental care practices developed for large VA Medical Centers are often not feasible to deploy in small CBOCs and thus not accessible to rural Veterans. Rural Veterans with posttraumatic stress disorder (PTSD) treated at CBOCs experience little to no improvement in their symptoms over time. A major contributor of poor PTSD outcomes is that trauma-focused evidence-based psychotherapy is not being provided to Veterans in the CBOC setting. Moreover, travel barriers prevent most rural Veterans from receiving trauma-focused evidence-based psychotherapy at large VHA Medical Centers (VAMC). Telemedicine Outreach for PTSD (TOP) is a technology-facilitated virtual care clinical intervention that is designed to enhance access to evidence based psychotherapy and pharmacotherapy. The VHA Office of Rural Health and Office of Connected Health and Telehealth Services intend to deploy the TOP intervention nationally. This project will lay the ground work for this national implementation initiative.

The goal of this implementation project is to support the national deployment of the TOP intervention and evaluate its clinical effectiveness in routine care. The specific aims are to compare the cost and effectiveness of alternative implementation strategies to promote uptake of TOP and assess impact on access and PTSD outcomes.

The project will be conducted at 6 VAMCs and affiliated CBOCs without on-site psychologists trained in trauma-focused evidence-based psychotherapy. The total anticipated sample size will be 600.

The TOP clinical intervention is delivered by a virtual care team comprising a CBOC provider, and a telephone care manager, telepsychologist and telepsychiatrist located at the VAMC. The telephone care managers will coordinates care. The telepsychologists will deliver of trauma-focused evidence-based therapy. The telepsychiatrists will provide psychiatric consultation. The standard VA implementation strategy will follow standard procedures for deploy clinical practices in the VA include disseminating support materials, providing technical assistance and transfer funds to hire clinical personnel. The enhanced implementation strategy will add external facilitation to the standard VA implementation strategies. External facilitation will begin with an assessment of the current workflow at the VHA Medical Center and the affiliated CBOCs. The external facilitation team will then generate a clinical workflow chart that describes the current process of care. With advice from the external facilitation team, local staff will then incorporate the clinical process of the TOP intervention into the current clinical workflow chart.

The project will compare the standard VA implementation strategy to the enhanced implementation strategy. All VAMCs will receive the enhanced implementation strategy if they need it, but the time period during which they will receive the enhanced implementation strategy will be randomized. This will allow us to determine whether more patients are reached by the TOP intervention during standard implementation compared to enhanced implementation. This design will also allow us to document improvements in perceived access and PTSD outcomes for patients at sites that successfully implement the TOP intervention. Data will be collected from patient survey and chart review for all patients sampled for the evaluation. Participating patients will complete a baseline survey and 3 follow-up surveys. The reach implementation outcome measure will be specified as the proportion of sampled patients who received the TOP intervention. PTSD outcomes will be specified as a continuous change in patient self-reported symptom severity between baseline and follow-up. Perceived access will be measured using items specifically developed for the project. Provider adoption will be assessed with qualitative interviews of all CBOC clinicians treating a sampled patient as well as members of the TOP intervention team. Costs - The investigators will measure the cost of both implementation strategies both prospectively and retrospectively. The investigators will collect data on implementation activities during both the standard VA and enhanced implementation strategies.


Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Other: Enhanced Implementation Strategy Other: Standard Implementation Strategy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Implementation of Telemedicine Outreach for PTSD (TOP) in Small Rural CBOCs (QUE 15-282)
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : July 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard Implementation
Standard VA implementation strategies will include disseminating a clinical intervention manual, a local champion guide, care manager training materials, PTSD case-finder tool, and technical support from the facility level telehealth technician. Internal facilitation will be conducted by the designated local champion. In addition, each VAMC will receive funds to hire a full time telephone care manager.
Other: Standard Implementation Strategy
Standard VA implementation strategies will include disseminating a clinical intervention manual, a local champion guide, care manager training materials, PTSD case-finder tool, and technical support from the facility level telehealth technician. Internal facilitation will be conducted by the designated local champion. In addition, each VAMC will receive funds to hire a full time telephone care manager.

Active Comparator: Enhanced Implementation Strategy
The enhanced implementation strategy will add external facilitation to the standard VA implementation strategies. External facilitation will begin with an assessment of the current workflow at the VHA Medical Center and the affiliated CBOCs using System Redesign methods. The external facilitation team will then generate a clinical workflow chart that describes the current process of care. With advice from the external facilitation team, the local champion will then incorporate the clinical process of the TOP intervention into the current clinical workflow chart, making changes to the TOP intervention and/or current clinical workflow as needed. The local champion will also meet monthly with external facilitators to troubleshoot and make refinements.
Other: Enhanced Implementation Strategy
The enhanced implementation strategy will add external facilitation to the standard VA implementation strategies. External facilitation will begin with an assessment of the current workflow at the VHA Medical Center and the affiliated CBOCs using System Redesign methods. The external facilitation team will then generate a clinical workflow chart that describes the current process of care. With advice from the external facilitation team, the local champion will then incorporate the clinical process of the TOP intervention into the current clinical workflow chart, making changes to the TOP intervention and/or current clinical workflow as needed. The local champion will also meet monthly with external facilitators to troubleshoot and make refinements.




Primary Outcome Measures :
  1. Reach: the proportion of sampled patients who received the core element of the TOP intervention [ Time Frame: 33 months ]
    The reach implementation outcome measure will be specified as the proportion of sampled patients who received the core element of the TOP intervention (documentation in the electronic health record of a case review of the patient by the virtual care team).


Secondary Outcome Measures :
  1. PTSD symptom severity [ Time Frame: 22 months ]
    PTSD symptom severity will be measured using the PTSD Check List (version 5). The outcome will be the average change score on this scale (from baseline to follow-up).

  2. Perceived travel burden: Degree to which sampled patients report that traveling interferes with getting services. [ Time Frame: 33 months ]
    How much does having to travel to VA appointments interfere with getting the PTSD services you want? Would you say it? Completely interferes, Interferes a great deal, Interferes somewhat, Interferes a little bit, Does not interfere at all. The outcome will be the proportion responding that it completely interferes or interferes a great deal.

  3. Perceived wait time: Degree to which sampled patients report that appointment wait time interferes with getting services. [ Time Frame: 33 months ]
    How much does having to wait for VA appointments interfere with getting the PTSD services you want? Would you say it? Completely interferes, Interferes a great deal, Interferes somewhat, Interferes a little bit, Does not interfere at all. The outcome will be the proportion responding that it completely interferes or interferes a great deal.

  4. Perceived trust: Degree to which sampled patients report that lack of trust in providers interferes with getting services. [ Time Frame: 33 months ]
    How much does lack of trust in VA providers interfere with getting the PTSD services you want? Would you say it? Completely interferes, Interferes a great deal, Interferes somewhat, Interferes a little bit, Does not interfere at all. The outcome will be the proportion responding that it completely interferes or interferes a great deal.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PTSD Diagnosis
  • Positive PTSD Screen

Exclusion Criteria:

  • No specialty mental health encounters at the VAMC

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737098


Locations
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United States, Arkansas
Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR
Little Rock, Arkansas, United States, 72205-5484
United States, California
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161
United States, Colorado
VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, United States, 80220
United States, Iowa
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, United States, 52246-2208
United States, South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, United States, 29401-5799
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: John C. Fortney, PhD VA Puget Sound Health Care System Seattle Division, Seattle, WA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02737098     History of Changes
Other Study ID Numbers: QUX 16-005
QUE 15-282 ( Other Grant/Funding Number: VA QUERI )
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
PTSD
virtual care
implementation
telepsychiatry
telepsychology
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders