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

Study Overview
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Brief Summary
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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
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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: 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. 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).

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

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

Intervention / Treatment
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* Other: Sequential EHR Communications


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with serous ovarian cancer diagnosed more than two years prior to study contact Patients with breast cancer diagnosed at <50 years of age more than two years prior to study contact Patients with triple negative breast cancer diagnosed more than two years prior to study contact Unaffected individuals reporting a family history of ovarian cancer Unaffected individuals reporting a family history of male breast cancer Unaffected individuals reporting a family history of breast cancer <50 years Exclusion Criteria: 1. Patients who have previously received genetic counseling and/or testing

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Sequential Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequential Communications<br>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. | Other: Sequential EHR Communications<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Genetic Counseling Appointments Completed Following MPM Delivery | Scheduling 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. | Within six months of MPM delivery | 
| Number of Genetic Counseling Appointments Completed Following Provider Nudge | Scheduling 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. | Within six months of provider nudge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Open Rate of MPM | The 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. | Within one month of receiving MPM | 
| Response Rate of Way To Health text | The 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. | Within one month of receiving text | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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