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

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.

Returning genomic results in a Federally Qualified Health Center: the intersection of precision medicine and social determinants of health

“…The processes, workflow, recruitment, and enrollment of the 500 participants have been described in detail elsewhere. 16 Briefly, primary care providers (PCPs) and staff from MPHC were engaged through a series of meetings and presentations to ensure that the processes for returning research results were consistent with those of the practice and that provisions for supporting providers and follow-up management were considered. The CAB was engaged to ensure that RAVE activities were responsive to the cultural, contextual, language, literacy, and socioeconomic factors of the local Latino population.…”

“…Through the process and collaboration with MPHC, 16 we were able to appreciate how SDoH may influence implementation of genomic medicine in a low resource setting. Although there was considerable enthusiasm and support at MPHC for the project, poverty, lack of insurance, language barriers, disconnected phones, transportation issues, low health literacy, lack of family history information/loss of contact and early deaths of key family members, and limited access to medical specialists were challenges experienced during the conduct of the RAVE study.…”

“…From this list, 500 participants provided written informed consent for sequencing their DNA, returning results, and scanning results into their electronic health record (EHR). As previously presented, 16 enrolled participants differed from the non-enrolled sample with respect to age, insurance, country of birth, and full-time employment status but did not differ in sex, language preference, or educational attainment.…”

Characteristics and utilisation of the Mayo Clinic Biobank, a clinic-based prospective collection in the USA: cohort profile

“…In addition to their role in Biobank stewardship, the CABs provide researchers with important resources to gain understanding of local attitudes relevant to their specific research projects, for example, in their consideration of a proposal to place research results into the EHR to facilitate translation of the results from a pharmacogenomics study 23. A unique collaboration between the Mayo Clinic and Mountain Park Health Center Biobanks and CABs has also helped to raise and address questions about under-representation of Latino patients in precision medicine research 24 25…”

Challenges in returning results in a genomic medicine implementation study: the Return of Actionable Variants Empirical (RAVE) study

“…In this report, we describe challenges encountered during RoR in the RAVE Rochester, Minnesota cohort. Challenges in returning results in the RAVE Phoenix, Arizona cohort including 500 Latino participants who received care at a Federally Qualified Health Center 9 are reported separately due to methodological differences in the RoR process at each site.…”