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临床试验/NCT06825715
NCT06825715招募中不适用

Multilevel Veteran-centric Intervention to Improve Precision Oncology

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 2,653 人开始时间: 2025年7月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
2,653
试验地点
2
主要终点
Use of molecular testing

研究概览

简要总结

The investigators are rolling out a 3 level intervention designed to improve the use of Precision Oncology at 8 VA medical centers. The 3 components of the intervention are 1: a short educational video for patients, 2: audit and feedback to providers on their Precision Oncology practice patterns, and 3: a change in the electronic medical record to make it easier to order and review results of Precision Oncology tests.

详细描述

Background: Precision oncology (PO), the use of molecular testing to identify tumor specific abnormalities which facilitate targeted therapy, is proven to extend lives and improve quality of life for patients with cancer. Extensive study, however, documents that up to 50% of patients in the VA, especially those with adverse social determinants of health (older age, rural), do not receive guideline recommended PO.

Methodology: Building on the investigators' previous analyses, and the Theoretical Domains Framework, the investigators designed a mixed-methods type I hybrid effectiveness-implementation study of a multilevel intervention (MLI) to improve the use of PO. The MLI will be instituted for veterans with advanced cancers of the colon, lung, and prostate, as well as providers at 8 sites, chosen to represent diversity at the level of rurality, geographic region, cancer volume, and mode of delivery (virtual/in-person). The patient intervention is a 5-minute educational module accessible by QR code. The provider intervention is a 45-minute academic detailing session, as well as individualized audit and feedback on practice patterns. The facility level intervention is a previously piloted integration of PO ordering, interdepartmental communication, and results return into the primary electronic medical record via a consult function. The primary efficacy outcome is the rate of molecular testing/eligible veterans. Validated survey measures will be used for stakeholder engagement. The process evaluation employs a mixed methods approach based in the RE-AIM framework, which includes quantitative analyses of collected data, and interviews of patients and providers. The statistical design is a randomized stepped-wedge trial over 3 years which retains control data from across all sites.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients in the VA with cancer of the lung or prostate who are seen in the oncology clinic

排除标准

  • Cancer that did not originate in the prostate or the lung

研究组 & 干预措施

During intervention period

Experimental

All sites will receive the 3 level intervention of patient education, provider audit/feedback, and EMR order change.

干预措施: Multilevel intervention (Other)

结局指标

主要结局

Use of molecular testing

时间窗: 3 years

Proportion of eligible patients with lung and prostate cancer who have next generation sequencing molecular testing

次要结局

  • Use of targeted therapy(3 years)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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