EHR Intervention to Increase HBOC Genetic Testing

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT07876349
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
21 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ELISABETH Evidence-Informed Program (EIP) — BEHAVIORAL
    * 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

Study Details

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.

Key Dates

First listed
Oct 15, 2026
Start date
Sep 1, 2026
Status verified
Oct 2026
Primary completion
Feb 28, 2028
Completion
Feb 28, 2028

Study Design

Enrollment
55 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: ELISABETH Evidence-Informed Program (EIP)
    The ELISABETH evidence-informed program (EIP) to increase HBOC genetic testing in primary care includes: 1) systematic family history intake among women, age 21-75 years, during screening mammography and gynecology clinic visits; 2) tracking patients who meet family history criteria for HBOC genetic testing; 3) notifying patients and primary care providers (PCPs) of positive screens; 4) integrating patient and provider decision support into clinical workflow; 5) facilitating genetic counseling referrals and mainstream genetic testing; 6) providing training for clinic staff to order mainstream genetic testing and deliver post-test counseling for return of results (RoR); 7) providing follow-up care for high-risk patients.

Primary Outcome Measure

Genetic Testing Knowledge [ Time Frame: Baseline to 1 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032
Research Nurse Navigator
[email protected]
212-342-5162
Katherine Crew, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

Nationwide
Breast cancer trialsOvarian cancer trialsOncology trialsBreast oncology trialsWomen's health trialsGynecologic oncology trials
By condition
Breast cancerOvarian cancer
By specialty
OncologyBreast oncologyWomen's healthGynecologic oncology
By research site
Columbia University Irving Medical Center· New York, NY

Related Studies