Menu
Enrolling by invitation NCT07053813

Applying Population Management Best Practices to Preventative Genomic Medicine Trial

No phase Interventional Neoplastic Syndromes, Hereditary

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Web resources, Personalized outreach.
Who it may be relevant to
Registry conditions: Neoplastic Syndromes, Hereditary. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Applying Population Management Best Practices to Preventive Genomic Medicine

Overview

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.

Detailed description

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.

Interventions

  • Behavioral Web resources
    Mailed educational resources through portal and USPS mail
  • Behavioral Personalized outreach
    Phone call to discuss due and overdue screening and other personalized risk management recommendations

Primary outcome measures

  • Proportion time covered [Time frame: 12 months following randomization]
Secondary outcome measures (1)
  • Risk reducing surgery [Time frame: 12 months following randomization]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 2 centers
  • Denver Health — Denver
  • Kaiser Northwest — Portland

Identifiers

NCT: NCT07053813 · STUDY00021623 · R01HG013021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗