跳至主要内容
临床试验/NCT02737098
NCT02737098已完成不适用

Implementation of Telemedicine Outreach for PTSD (TOP) in Small Rural CBOCs (QUE 15-282)

VA Office of Research and Development12 个研究点 分布在 1 个国家目标入组 544 人开始时间: 2016年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
544
试验地点
12
主要终点
Reach: the proportion of sampled patients who received the core element of the TOP intervention

研究概览

简要总结

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.

详细描述

Background

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.

Specific Aims Impact Goal - The goal of this proposed Type III Hybrid effectiveness-implementation project is to support the national deployment of the TOP intervention and evaluate its clinical effectiveness in routine care.

Specific Aim 1 - Compare the effectiveness of a standard VA implementation strategy to an enhanced implementation strategy in promoting uptake of TOP.

Hypothesis 1 - For sites not implementing TOP performance metric benchmark with a standard implementation strategy, those randomized to the enhanced implementation strategy will have better reach and engagement outcomes than those randomized to continued standard VA implementation. Reach is defined using two variables: 1) the likelihood of having a care manager encounter and 2) the likelihood of having an evidence based psychotherapy encounter.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • PTSD Diagnosis
  • Positive PTSD Screen

排除标准

  • No specialty mental health encounters at the VAMC

研究组 & 干预措施

Standard Implementation

Active Comparator

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.

干预措施: Standard Implementation Strategy (Other)

Enhanced Implementation Strategy

Active Comparator

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.

干预措施: Enhanced Implementation Strategy (Other)

结局指标

主要结局

Reach: the proportion of sampled patients who received the core element of the TOP intervention

时间窗: 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).

Reach: the Proportion of Sampled Patients Who Received the Core Element of the TOP Intervention

时间窗: 31 months (Step 1 - 9 months; Gap 1 - 2 months; Step 2 - 9 months; Gap 2 - 2 months; Step 3 - 9 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 care manager encounter).

次要结局

  • PTSD symptom severity(22 months)
  • Perceived travel burden: Degree to which sampled patients report that traveling interferes with getting services.(33 months)
  • Perceived wait time: Degree to which sampled patients report that appointment wait time interferes with getting services.(33 months)
  • Perceived trust: Degree to which sampled patients report that lack of trust in providers interferes with getting services.(33 months)
  • PTSD Symptom Severity(31 months (Step 1 - 9 months; Gap 1 - 2 months; Step 2 - 9 months; Gap 2 - 2 months; Step 3 - 9 months))
  • Perceived Travel Burden: Degree to Which Sampled Patients Report That Traveling Interferes With Getting Services.(31 months (Step 1 - 9 months; Gap 1 - 2 months; Step 2 - 9 months; Gap 2 - 2 months; Step 3 - 9 months))
  • Perceived Wait Time: Degree to Which Sampled Patients Report That Appointment Wait Time Interferes With Getting Services.(31 months (Step 1 - 9 months; Gap 1 - 2 months; Step 2 - 9 months; Gap 2 - 2 months; Step 3 - 9 months))
  • Perceived Trust: Degree to Which Sampled Patients Report That Lack of Trust in Providers Interferes With Getting Services.(31 months (Step 1 - 9 months; Gap 1 - 2 months; Step 2 - 9 months; Gap 2 - 2 months; Step 3 - 9 months))

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (12)

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