跳至主要内容
临床试验/NCT07053813
NCT07053813Enrolling By Invitation不适用

Applying Population Management Best Practices to Preventive Genomic Medicine

University of Washington4 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2025年7月1日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
900
试验地点
4
主要终点
Proportion time covered

研究概览

简要总结

Preventive genomic medicine, particularly identification of individuals with inherited cancer risk, can improve longevity and quality of life, yet adherence to risk management following cancer genomic testing is poor. The proposed research refines and evaluates two highly scalable population management interventions, web resources and personalized outreach, designed to improve access and use of recommended risk management following cancer genetic testing. Research activities will be conducted in a vertically integrated health system and federally qualified health center and will address post-testing quality and patient safety concerns that are minimizing patient benefit and slowing investments in real world genomic medicine implementation.

详细描述

Preventive genomic medicine, particularly identification of individuals with inherited cancer risk, provides health systems with the opportunity to improve longevity and quality of life for their patients. The ability to uncover substantially elevated risk of disease through genomic testing, act to reduce that risk, and improve outcomes while lowering costs has been the longstanding promise of genomic medicine. In the case of inherited cancer, however, adherence to recommended risk management following genomic testing is low. Further, our pilot data suggests that health systems are reluctant to expand cancer genomic testing without a clearer idea of how to manage tested patients over time. Our goal in this application is to address this roadblock to genomic medicine implementation. Specifically, we will demonstrate the benefits that adopting population management interventions following genomic testing can provide health systems, using hereditary cancer as a case example. We will revise and rigorously evaluate two population management interventions (web resources and personalized outreach) that improve timely patient outreach and end-to-end tracking without burdening providers. Web resources is a low-touch intervention that links patients with existing educational resources. Personalized outreach is a high-touch intervention that connects patients with a dedicated care manager to discuss risk management and provide care reminders.

Both interventions are highly scalable and mirror population management programs that health systems have used to support cancer screening, diabetes management, and other evidence-based care for decades. We will compare web resources and personalized outreach to usual care in a pragmatic hybrid type-1 randomized trial that engages patients captured in hereditary cancer registries within two health systems, Kaiser Permanente Northwest (KPNW) and Denver Health (DH). KPNW is a vertically integrated health system and DH is a federally qualified health center, providing two highly unique evaluation settings. Our primary effectiveness outcome is adherence to recommended cancer screening over one year. We will collect secondary implementation outcomes, including the acceptability, appropriateness, feasibility, sustainability, and costs of high- and low-touch intervention approaches. By providing clinical champions with essential data and tools to select and implement population management interventions that address critical gaps in post-testing quality and patient safety, this innovative project will advance preventive genomic medicine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinically actionable variant in at least one high penetrance cancer-related gene
  • Age- and sex- eligible for guideline indicated risk management
  • Remains eligible for risk management, given personal cancer and surgical history

排除标准

  • Previously opted out of research
  • Previously opted out of genetic research
  • On hospice or palliative care
  • Has advanced dementia or severe cognitive impairment

结局指标

主要结局

Proportion time covered

时间窗: 12 months following randomization

Proportion time covered by recommended cancer screening

次要结局

  • Risk reducing surgery(12 months following randomization)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah Knerr

Assistant Professor, Health Systems and Population Health

University of Washington

研究点 (4)

Loading locations...

相似试验

Applying Population Management Best Practices to... | 临床试验