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Sequential EHR Based Interventions to Increase Genetic Testing for Breast and Ovarian Cancer Predisposition

Sequential EHR Based Interventions to Increase Genetic Testing for Breast and Ovarian Cancer Predisposition Across Diverse Patient Populations in Gynecology Practices at Penn Medicine

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05721326
Enrollment
1283
Registered
2023-02-10
Start date
2023-05-01
Completion date
2025-12-31
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Female, Gene Mutation-Related Cancer, Genetic Predisposition to Disease, Hereditary Breast and Ovarian Cancer, Hereditary Cancer Syndrome, Hereditary Diseases, Ovarian Cancer

Keywords

NCCN guidelines, genetic testing, hereditary cancer, breast cancer, ovarian cancer, intervention, sequential intervention, message-based intervention, text message, diverse patient population, genetics, female, digital health technology, germline genetic testing, nudge, EHR based intervention, genetic counseling

Brief summary

The goal of this sequential study design is to increase genetic testing in those meeting national clinical guidelines. The main question it aims to answer is: which intervention is most effective in uptake of genetic testing for the target population? Participants will receive genetic testing and counseling that may initiate life-saving screenings.

Detailed description

Germline genetic testing is recommended by the National Cancer Center Network (NCCN) for individuals with a personal history of ovarian cancer, young-onset (\<50 years) breast cancer, and a family history of ovarian cancer or male breast cancer, among others. Recent publications demonstrate that the uptake of genetic testing is under-utilized, overall, and rates are consistently lower in minority populations. EHR-based algorithms will be used to identify patients of two Penn Medicine Ob/Gyn practices for whom genetic testing is recommended based on NCCN guidelines and to test pragmatic methods using messages delivered to patients or clinicians to encourage testing. The ACC Electronic Phenotyping Core developed the algorithms based on cancer registry data along with family history fields and this study will develop and test messages directed at patients and clinicians to encourage testing. The aims are: 1. Identification of at-risk populations through electronic health record (EHR) searches followed by patient nudges (MPM and then Way To Health) to increase the uptake of genetic counseling referral and testing in patients at gynecology practices at Dickens Center and Penn Medicine Radnor. 2. In patients who have not responded to patient nudges (Aim 1), test a provider nudge to increase the uptake of genetic counseling referral and testing in gynecology practices at Dickens Center and Penn Medicine Radnor (Aim 2).

Interventions

OTHERSequential EHR Communications

The intervention includes 3 message types: an EHR message, followed by a text message, followed by physician nudge. Each subsequent type will be activated if the previous type does not yield a response.

Sponsors

Abramson Cancer Center at Penn Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Eligible patients will be sent a message through the patient portal to encourage genetic counseling and testing. If the patient does not respond, they will be sent a text message. Should there be no response, the patient's clinician will receive a nudge

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

1. Patients with serous ovarian cancer diagnosed more than two years prior to study contact 2. Patients with breast cancer diagnosed at \<50 years of age more than two years prior to study contact 3. Patients with triple negative breast cancer diagnosed more than two years prior to study contact 4. Unaffected individuals reporting a family history of ovarian cancer 5. Unaffected individuals reporting a family history of male breast cancer 6. Unaffected individuals reporting a family history of breast cancer \<50 years

Exclusion criteria

1\. Patients who have previously received genetic counseling and/or testing

Design outcomes

Primary

MeasureTime frameDescription
Number of Genetic Counseling Appointments Completed Following MPM DeliveryWithin six months of MPM deliveryScheduling and completion of genetic counseling appointments will be monitored through EHR. MPM stands for MyPennMedicine message which will be sent directly to the patient through the medical record.
Number of Genetic Counseling Appointments Completed Following Provider NudgeWithin six months of provider nudgeScheduling and completion of genetic counseling appointments will be monitored through EHR. The provider nudge will be delivered as a Best Practice Alert (BPA) upon opening the patient's chart.

Secondary

MeasureTime frameDescription
Open Rate of MPMWithin one month of receiving MPMThe proportion of eligible participants who open the invitation to receive genetic counseling and testing compared to the total amount of eligible participants sent an MPM.
Response Rate of Way To Health textWithin one month of receiving textThe proportion of eligible participants who respond to a text message invitation to receive genetic counseling and testing compared to the total amount of eligible participants sent a Way To Health (WTH) text.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026