Design of a study to implement population-based risk assessment for hereditary cancer genetic testing in primary care.

Identifying patients with high genetic risk for cancer has important clinical ramifications, but hereditary cancer risk is often not identified because of testing barriers at both the provider and patient level. It is unknown how to best implement appropriate genetic testing and follow-up care into an operating primary care clinic. Implementation studies to date have been conducted in high resourced facilities under optimal conditions, often not at the clinic level. This study aims to compare and evaluate two population-wide engagement strategies for identifying members of a primary care clinic's population with a family or personal history of cancer and offering high-risk individuals genetic testing for cancer susceptibility mutations. The two engagement strategies are: 1) point of care screening (POC), conducted when a patient is scheduled for an appointment and 2) direct patient engagement (DPE), where outreach provides the patient an opportunity to complete screening online on their own time. The study will identify changes, problems, and inefficiencies in clinical flow during and after the implementation of risk assessment and genomic testing for cancer risk across primary care clinics. It will also evaluate the effects of the two engagement strategies on patient, provider, and clinic leader outcomes, including perceptions of benefits, harms, and satisfaction with the engagement strategy and process of cancer risk assessment and genetic testing, across gender, racial/ethnic, socioeconomic, and genetic literacy divides. Finally, the study will evaluate the cost-effectiveness and budget impact of each engagement strategy.