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. 2023 Nov 6;18(1):57.
doi: 10.1186/s13012-023-01308-w.

Protocol to evaluate sequential electronic health record-based strategies to increase genetic testing for breast and ovarian cancer risk across diverse patient populations in gynecology practices

Heather Symecko  1   2 , Robert Schnoll  3   4   5 , Rinad S Beidas  6 , Justin E Bekelman  3   4 , Daniel Blumenthal  3   5 , Anna-Marika Bauer  3   5 , Peter Gabriel  3   4 , Leland Boisseau  3 , Abigail Doucette  3   4 , Jacquelyn Powers  3   7 , Jacqueline Cappadocia  3   7 , Danielle B McKenna  3   7 , Robert Richardville  3   7 , Lauren Cuff  3   7 , Ryan Offer  3 , Elizabeth G Clement  3 , Alison M Buttenheim  3   4   8 , David A Asch  3   4 , Katharine A Rendle  3   4 , Rachel C Shelton  9 , Oluwadamilola M Fayanju  3   4 , E Paul Wileyto  3   5 , Martina Plag  10 , Sue Ware  3   5 , Lawrence N Shulman  3   4 , Katherine L Nathanson  3   7   4 , Susan M Domchek  11   12   13
Affiliations

Protocol to evaluate sequential electronic health record-based strategies to increase genetic testing for breast and ovarian cancer risk across diverse patient populations in gynecology practices

Heather Symecko et al. Implement Sci. .

Abstract

Background: Germline genetic testing is recommended by the National Comprehensive Cancer Network (NCCN) for individuals including, but not limited to, those with a personal history of ovarian cancer, young-onset (< 50 years) breast cancer, and a family history of ovarian cancer or male breast cancer. Genetic testing is underused overall, and rates are consistently lower among Black and Hispanic populations. Behavioral economics-informed implementation strategies, or nudges, directed towards patients and clinicians may increase the use of this evidence-based clinical practice.

Methods: Patients meeting eligibility for germline genetic testing for breast and ovarian cancer will be identified using electronic phenotyping algorithms. A pragmatic cohort study will test three sequential strategies to promote genetic testing, two directed at patients and one directed at clinicians, deployed in the electronic health record (EHR) for patients in OB-GYN clinics across a diverse academic medical center. We will use rapid cycle approaches informed by relevant clinician and patient experiences, health equity, and behavioral economics to optimize and de-risk our strategies and methods before trial initiation. Step 1 will send patients messages through the health system patient portal. For non-responders, step 2 will reach out to patients via text message. For non-responders, Step 3 will contact patients' clinicians using a novel "pend and send" tool in the EHR. The primary implementation outcome is engagement with germline genetic testing for breast and ovarian cancer predisposition, defined as a scheduled genetic counseling appointment. Patient data collected through the EHR (e.g., race/ethnicity, geocoded address) will be examined as moderators of the impact of the strategies.

Discussion: This study will be one of the first to sequentially examine the effects of patient- and clinician-directed strategies informed by behavioral economics on engagement with breast and ovarian cancer genetic testing. The pragmatic and sequential design will facilitate a large and diverse patient sample, allow for the assessment of incremental gains from different implementation strategies, and permit the assessment of moderators of strategy effectiveness. The findings may help determine the impact of low-cost, highly transportable implementation strategies that can be integrated into healthcare systems to improve the use of genomic medicine.

Trial registration: ClinicalTrials.gov. NCT05721326. Registered February 10, 2023. https://www.

Clinicaltrials: gov/study/NCT05721326.

Keywords: Behavioral economics; Electronic health record; Genetic testing; Implementation science; Nudges; Pragmatic; Rapid cycle approaches; Sequential.

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Conflict of interest statement

RSB is the principal at Implementation Science & Practice, LLC. She receives royalties from Oxford University Press, consulting fees from United Behavioral Health and OptumLabs, and serves on the advisory boards for Optum Behavioral Health, AIM Youth Mental Health Foundation, and the Klingenstein Third Generation Foundation outside of the submitted work. JEB reports grants from AstraZeneca, Emerson Collective, Loxo@Lilly, and Gilead and personal fees from Reimagine Care, Healthcare Foundry, and AstraZeneca, outside the submitted work. DBM reports having been a one-time consultant for Nest Genomics. DAA is a partner at VAL Health. KAR reports receiving grants from Pfizer and AstraZeneca paid to her institution, personal fees from Merck for serving as a scientific consultant, and honoraria and travel paid as an invited speaker from MJH Life Sciences outside the submitted work. KLN reports serving on a Scientific Advisory Board for Merck, unrelated to the current study. SMD reports consulting fees from AstraZeneca and GlaxoSmithKline.

Figures

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Fig. 1
Study design
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Fig. 2
Patient nudges
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Fig. 3
Clinician nudge
See this image and copyright information in PMC

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