Patient Centered Clinical Decision Support for Hereditary Cancer Syndromes

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
HealthPartners Institute
Study ID
NCT06914726
Status
Enrolling By Invitation

Conditions

  • Genetic Variation
  • HBOC Syndrome
  • Hereditary Breast/Ovarian Cancer (brca1, brca2)
  • Hereditary Cancer Syndromes
  • Lynch Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Patient Centered Clinical Decision Support (PC-CDS) — OTHER
    The intervention provides patient specific recommendations on managing cancer risk due to hereditary cancer gene variants that is integrated into an existing point of care clinical decision support system that algorithmically identifies study-eligible patients and deploys patient-specific CDS output at an index visit and all subsequent primary care encounters using the most up to date available clinical information.

Study Details

The goal of this clinical trial is to address care gaps for participants at high risk of breast and ovarian cancer (HBOC), or Lynch syndrome (LS) because of testing positive for specific genetic variants. A patient-centered clinical decision support (PC-CDS) tool will help identify participants with genetic variations and display recommendations for referrals and testing to the clinician and participant at a primary care visit. The main question the study aims to answer is: \- Does clinical decision support for participants with hereditary cancer syndromes improve the use of evidence-based cancer prevention care. Participants being seen in the PC-CDS group are compared to participants being seen in usual care (UC) to see if they are up to date on guideline-based cancer prevention care and to see if participants in the PC-CDS group report more shared decision making and higher rates of self-management of their genetic cancer risks. Participants will be asked to answer survey questions.

Key Dates

Start date
Jul 9, 2025
Status verified
Aug 2025
Primary completion
Jun 30, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
2,488 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: Usual Care
    All patients and clinicians at UC clinics will continue to receive an existing EHR-linked clinical decision support for management of major uncontrolled cardiovascular risk factors and other selected chronic conditions. The existing CDS displayed at UC clinics does not include patient-specific information on recommended cancer prevention activities for those with HBOC or LS.
  • Other: Patient Centered Clinical Decision Support for Hereditary Genetic Cancer Syndromes
    All patients and clinicians at PC-CDS clinics will continue to receive an existing EHR-linked clinical decision support for management of major uncontrolled cardiovascular risk factors and other selected chronic conditions plus patient-specific information on recommended cancer prevention activities for those with HBOC or LS.

Primary Outcome Measure

Resolved care gaps [ Time Frame: 18 months after index date ]

Locations (1)

FacilityCityStateZIPSite coordinators
HealthPartners Medical GroupMinneapolisMinnesota55440-

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By research site
HealthPartners Medical Group· Minneapolis, MN

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