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

Primary Purpose

Genetic Predisposition to Disease, Breast Cancer Female, Ovarian Cancer

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sequential EHR Communications
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Genetic Predisposition to Disease focused on measuring 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

Eligibility Criteria

25 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Abramson Cancer Center of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sequential Communications

Arm 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 30, 2023
Last Updated
June 30, 2023
Sponsor
Abramson Cancer Center at Penn Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05721326
Brief Title
Sequential EHR Based Interventions to Increase Genetic Testing for Breast and Ovarian Cancer Predisposition
Official Title
Sequential EHR Based Interventions to Increase Genetic Testing for Breast and Ovarian Cancer Predisposition Across Diverse Patient Populations in Gynecology Practices at Penn Medicine
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genetic Predisposition to Disease, Breast Cancer Female, Ovarian Cancer, Hereditary Breast and Ovarian Cancer, Hereditary Cancer Syndrome, Hereditary Diseases, Gene Mutation-Related 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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
N/A
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sequential Communications
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Sequential EHR Communications
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Genetic Counseling Appointments Completed Following MPM Delivery
Description
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.
Time Frame
Within six months of MPM delivery
Title
Number of Genetic Counseling Appointments Completed Following Provider Nudge
Description
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.
Time Frame
Within six months of provider nudge
Secondary Outcome Measure Information:
Title
Open Rate of MPM
Description
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.
Time Frame
Within one month of receiving MPM
Title
Response Rate of Way To Health text
Description
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.
Time Frame
Within one month of receiving text
Other Pre-specified Outcome Measures:
Title
Number of Signed Referrals
Description
The total number of referrals signed by the patient's Ob/Gyn provider for genetic counseling and testing.
Time Frame
Within one month of receiving referral

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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28931403
Citation
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Sequential EHR Based Interventions to Increase Genetic Testing for Breast and Ovarian Cancer Predisposition

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