Comparing models of delivery for cancer genetics services among patients receiving primary care who meet criteria for genetic evaluation in two healthcare systems: BRIDGE randomized controlled trial
Authors: Kaphingst Kimberly A. , Kohlmann Wendy , Chambers Rachelle Lorenz , Goodman Melody S. , Bradshaw Richard , Chan Priscilla A. , Chavez-Yenter Daniel , Colonna Sarah V. , Espinel Whitney F. , Everett Jessica N. , Gammon Amanda , Goldberg Eric R. , Gonzalez Javier , Hagerty Kelsi J. , Hess Rachel , Kehoe Kelsey , Kessler Cecilia , Kimball Kadyn E. , Loomis Shane , Martinez Tiffany R. , Monahan Rachel , Schiffman Joshua D. , Temares Dani , Tobik Katie , Wetter David W. , Mann Devin M. , Kawamoto Kensaku , Del Fiol Guilherme , Buys Saundra S. , Ginsburg Ophira ,   on behalf of the BRIDGE research team
Published: June 2021

Abstract
Background
Advances in genetics and sequencing technologies are enabling the identification of more individuals with inherited cancer susceptibility who could benefit from tailored screening and prevention recommendations. While cancer family history information is used in primary care settings to identify unaffected patients who could benefit from a cancer genetics evaluation, this information is underutilized. System-level population health management strategies are needed to assist health care systems in identifying patients who may benefit from genetic services. In addition, because of the limited number of trained genetics specialists and increasing patient volume, the development of innovative and sustainable approaches to delivering cancer genetic services is essential.

Methods
We are conducting a randomized controlled trial, entitled Broadening the Reach, Impact, and Delivery of Genetic Services (BRIDGE), to address these needs. The trial is comparing uptake of genetic counseling, uptake of genetic testing, and patient adherence to management recommendations for automated, patient-directed versus enhanced standard of care cancer genetics services delivery models. An algorithm-based system that utilizes structured cancer family history data available in the electronic health record (EHR) is used to identify unaffected patients who receive primary care at the study sites and meet current guidelines for cancer genetic testing. We are enrolling eligible patients at two healthcare systems (University of Utah Health and New York University Langone Health) through outreach to a randomly selected sample of 2780 eligible patients in the two sites, with 1:1 randomization to the genetic services delivery arms within sites. Study outcomes are assessed through genetics clinic records, EHR, and two follow-up questionnaires at 4 weeks and 12 months after last genetic counseling contactpre-test genetic counseling.

Discussion
BRIDGE is being conducted in two healthcare systems with different clinical structures and patient populations. Innovative aspects of the trial include a randomized comparison of a chatbot-based genetic services delivery model to standard of care, as well as identification of at-risk individuals through a sustainable EHR-based system. The findings from the BRIDGE trial will advance the state of the science in identification of unaffected patients with inherited cancer susceptibility and delivery of genetic services to those patients.

Trial registration
BRIDGE is registered as NCT03985852. The trial was registered on June 6, 2019 at clinicaltrials.gov.