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

Abramson Cancer Center at Penn Medicine

Status: Completed

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

Treatments: Other: Sequential EHR Communications

Study type: Interventional

Funder types: Other

Identifiers

NCT05721326

851980 (Other Identifier)

25922

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,330 patients

Sex: Female

Ages: 25 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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1,330 participants in 1 patient group

Sequential Communications

Experimental group

Description:

This sequential arm contains three types of communication to be employed following non-response to the previous type. The initial communication will be a direct message to the patient via the MyPennMedicine. The subsequent message will be sent as a text via the Way To Health app(lication). The final communication will be a nudge to the patient's physician which will send upon opening the patient's chart and will remain as a flag thereafter.

Treatment:

Other: Sequential EHR Communications