Applying Population Management Best Practices to Preventative Genomic Medicine Trial

Conditions

• Neoplastic Syndromes, Hereditary

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Jul 1, 2025

Status verified

Jun 2025

Primary completion

Jul 1, 2027

Completion

Jul 1, 2028

Study Design

Enrollment

900 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• No Intervention: Usual care
  No intervention
• Experimental: Web resources
  Individuals randomized to web resources will be sent materials refined in Aim 1 (via patient portal and USPS mail) within 1-2 weeks after their birthday. Messages will be sent in English or preferred language noted in the EHR.
• Experimental: Personalized outreach
  Individuals randomized to personalized outreach will be contacted by the care coordinator in their birthday month for a brief phone call discussing due and overdue screening. The coordinator will attempt to contact patients up to 3 times to complete the phone conversation before considering them opting out of the intervention. If needed, the coordinator can place orders and pending referrals for PCP signature.

Primary Outcome Measure

Proportion time covered [ Time Frame: 12 months following randomization ]

Locations (2)

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