Implementation of Point-of-Care Pharmacogenomic Decision Support Accounting for Minority Disparities

This study aims to determine whether preemptively obtained pharmacogenomic information can be
delivered and utilized at the point-of-care across multiple institutions specifically in
African American patients at risk for minority health disparities. The investigators have
chosen the high-stakes, rapid-paced setting of inpatient medicine for this implementation
study. The investigators seek to examine whether the availability of pharmacogenomic
information improves prescribing.

The investigators will enroll adults at one of three institutions, The University of Chicago,
University of Illinois at Chicago, and Northwestern University. During an initial
(enrollment) hospital inpatient encounter, patients will be consented and a blood sample will
be obtained for preemptive genotyping across a panel of actionable germline variants
predicting drug response or toxicity risk. Patients will also be targeted for enrollment who
are highly likely to initiate future warfarin therapy. Patients will be recruited to two
primary cohorts. In the feasibility cohort, all patients will have their actionable
pharmacogenomic results (with decision support) available to inpatient treating physicians
for the duration of the study, once genotyping is completed, via the Genomic Prescribing
System (GPS). Physicians and pharmacists will be individually approached for enrollment
through a process of direct stakeholder engagement and informed consent. Participating
providers will give permission for their medication decisions to be analyzed. Providers will
never be instructed how to practice nor how to prescribe, and it is their choice whether or
not to use GPS. GPS accession, use, and all medications prescribed throughout the admission
will be passively recorded by the research team, for all patients, and an analysis of the
impact of GPS results and decision-supports will be performed.

For the African American warfarin cohort, patients newly-starting warfarin will be enrolled
at the time of new warfarin initiation and then randomized such that their treating
physicians and pharmacists either have access to African American-specific warfarin dosing
guidance via GPS, or not. The frequency of unfavorable (high-risk) scenarios related to
warfarin-related clinical outcomes will be examined in each group.

Inclusion Criteria:

- Patients must be at least 18 years of age.

Exclusion Criteria:

- Patients who have undergone, or are being actively considered for, liver or kidney
transplantation.

Patients with known active or prior leukemia. Inability to understand and give informed
consent to participate. For patients being recruited to the warfarin sub-study, those with
a glomerular filtration rate or creatinine clearance <30 mL/min34.