NCT07876349 · Columbia University
EHR Intervention to Increase HBOC Genetic Testing
(ELISABETH)
What this study is about
The purpose of this research study is to test how well a new approach - using tools built into the electronic health record (EHR)- can help increase genetic testing for hereditary breast and ovarian cancer (HBOC) in women who have a family history that puts them at higher risk. The study will also look at what helps or gets in the way of using these tools in everyday clinical care.
View original scientific description
The purpose of this research study is to test how well a new approach - using tools built into the electronic health record (EHR)- can help increase genetic testing for hereditary breast and ovarian cancer (HBOC) in women who have a family history that puts them at higher risk. The study will also look at what helps or gets in the way of using these tools in everyday clinical care. As part of this study, the investigators are also evaluating a website called RealRisks, which is designed to support patients in understanding their risk and making informed decisions about genetic testing. By studying how patients and primary care providers use this tool, the investigators hope to improve the way decision support tools are used to guide conversations and decisions about HBOC testing.
Interventions
BEHAVIORAL
ELISABETH Evidence-Informed Program (EIP)
* Family history screening * Patient and provider BPA (Best Practice Alert) notifications * Referral information for genetic counseling * No RealRisks/BNAV (Breast cancer risk navigation) tools * No streamlined MGPT (multigene panel testing) implementation pathway
Primary outcome measures
Genetic Testing Knowledge
Time frame: Baseline to 1 month
Change in hereditary breast and ovarian cancer (HBOC) genetic testing knowledge, assessed using an 11-item true/false questionnaire evaluating knowledge of HBOC genetic testing. Total score ranges from 0 to 11, with higher scores indicating greater genetic testing knowledge
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Women, age 21-75 years
- Completed Six-Point Scale (SPS) family history screener with a score of 6 or higher.
- Seen in NewYork Presbyterian primary care clinic selected for pilot testing
- No personal history of breast or ovarian cancer
- No prior germline HBOC genetic testing
- English or Spanish-speaking
- Access to a smartphone, tablet, or computer
- Able to provide written, verbal, or online informed consent
Exclusion criteria
- \- Patients who previously participated in the development studies for RealRisks and BNAV.
Where
- New York, New York
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 15, 2026 · Source of record for eligibility and locations