TOP Implementation Project
Part of paid clinical trials in Little Rock, Arkansas.
- Sponsor
- VA Office of Research and Development
- Study ID
- NCT02737098
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 99 Years
- Healthy Volunteers
- Not accepted
Interventions
- Enhanced Implementation Strategy — OTHERThe 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.
- Standard Implementation Strategy — OTHERStandard 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.
Study Details
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. 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 for posttraumatic stress disorder (PTSD). 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 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 effectiveness of alternative implementation strategies to promote uptake of TOP and assess impact on access and PTSD outcomes. 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. 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. 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.
Key Dates
- Start date
- Apr 1, 2016
- Status verified
- Apr 2026
- Primary completion
- Jul 31, 2019
- Completion
- Sep 30, 2020
Study Design
- Enrollment
- 544 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Active Comparator: Standard ImplementationStandard 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 StrategyThe 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 Measure
Reach: the Proportion of Sampled Patients Who Received the Core Element of the TOP Intervention [ Time Frame: 31 months (Step 1 - 9 months; Gap 1 - 2 months; Step 2 - 9 months; Gap 2 - 2 months; Step 3 - 9 months) ]
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR | Little Rock | Arkansas | 72205-5484 | - |
| VA San Diego Healthcare System, San Diego, CA | San Diego | California | 92161 | - |
| VA Eastern Colorado Health Care System, Denver, CO | Denver | Colorado | 80220 | - |
| Iowa City VA Health Care System, Iowa City, IA | Iowa City | Iowa | 52246-2208 | - |
| Ralph H. Johnson VA Medical Center, Charleston, SC | Charleston | South Carolina | 29401-5799 | - |
| VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington | 98108 | - |
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