Developing a Process for Returning Medically Actionable Genomic Variants to Latino Patients in a Federally Qualified Health Center.

Shaibi GQ1, Kullo IJ2, Singh DP3, Sharp RR4, De Filippis E5, Cuellar I4, Hernandez V3, Levey S4, Radecki Breitkopf C4, Olson JE4, Cerhan JR4, Mandarino LJ6, Thibodeau SN7, Lindor NM4.

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Abstract

AIM:

To develop a process for returning medically actionable genomic variants to Latino patients receiving care in a Federally Qualified Health Center.

METHODS:

Prior to recruitment, researchers met with primary care providers to (1) orient clinicians to the project, (2) establish a process for returning actionable and nonactionable results to participants and providers through the electronic health record, and (3) develop a process for offering clinical decision support for follow-up education and care. A Community Advisory Board was engaged to provide input on recruitment strategies and materials for conveying results to participants. Participants in the Sangre Por Salud (Blood for Health) Biobank with hyperlipidemia or colon polyps represented the pool of potentially eligible participants.

RESULTS:

A total of 1,621 individuals were invited to participate and 710 agreed to an in- person consenting visit (194 no-showed and 16 declined). Over 12-months, 500 participants were enrolled. Participants were primarily Spanish-speaking (81.6%), female (74.2%), and enrolled because of hyperlipidemia (95.4%). All but 2 participants opted to receive primary (i.e., related to enrollment phenotypes) as well as secondary actionable results.

CONCLUSION:

Efforts to bring precision medicine to community-based health centers serving minority patients may require multilevel engagement activities to include individuals, providers, health systems, and the community.