Leveraging an electronic medical record infrastructure to identify primary care patients eligible for genetic testing for hereditary cancer and evaluate novel cancer genetics service delivery models

SUPPLEMENT Abstract: This application is being submitted in response to the Notice of Special Interest (NOSI) identified as NOT-CA-20-042. The application is a proposed administrative supplement to the University of Utah (Utah)/New YorkUniversity (NYU) U01 entitled "Leveraging an electronic medical record infrastructure to identify primary carepatients eligible for genetic testing for hereditary cancer and evaluate novel cancer genetics service deliverymodels" (U01 CA232826). The parent U01 is employing a replicable electronic health record (EHR)-basedclinical decision support infrastructure to: (i) identify unaffected primary care patients who qualify for cancergenetics services based on current guidelines in the Utah and NYU healthcare systems (Aim 1); and (ii)compare two models of cancer genetics services delivery for 1,920 of these unaffected primary care patients ina randomized controlled trial (Aims 2 and 3). The parent trial will examine how race and ethnicity modify theeffects of the cancer genetics services delivery models. The landscape for delivering genetics services haschanged substantially due to the COVID-19 pandemic, and our pilot data suggest that patients' uptake ofcancer genetic testing and access to cancer screening has been adversely affected. This supplement wouldprovide us with an unparalleled opportunity to investigate COVID-19 impacts in two study sites with verydifferent pandemic contexts. We propose the following Supplemental Aims: (1) Characterize healthcareexperiences related to COVID-19 among the cohort of 22,208 primary care patients identified as being atincreased risk for hereditary cancer; and (2) Investigate how COVID-19 impacts primary care patients'decisions about and utilization of cancer genetics services. To address Supplemental Aim 1, we will abstractEHR data to investigate COVID-19 diagnosis, SARS-CoV-2 testing, and delays in cancer screening in theidentified cohort. Among the subset of the cohort invited to participate in the trial, we hypothesize that havingbeen diagnosed with or hospitalized for COVID-19 or having had a cancelled cancer screening will negativelyaffect trial participation. We will also investigate differences in these COVID-19 experiences by study site (Utahvs. NYU) and race/ethnicity. To address Supplemental Aim 2, among participants in the parent trial, we willexamine how the health, psychological, and financial impacts of COVID-19 affect decisions about andutilization of cancer genetic counseling and genetic testing using a combination of clinic records andquestionnaire data. Based on pilot data, we hypothesize that those having higher self-reported health,psychological, and financial impacts of COVID-19 will be less likely to complete cancer genetic testing. We willexamine how the effects of COVID-19 are modified by study site (Utah vs. NYU) and race/ethnicity. Together,the supplemental aims will allow us to build a comprehensive picture of how COVID-19 has affectedparticipation in and outcomes of the parent trial. The proposed supplement would also allow us to examinewhether COVID-19 is widening disparities in use of cancer genetics services by race and ethnicity.