Pilot of Preemptive Pharmacogenetics in Medically Underserved Patients
Condition: Pharmacogenetic Testing
Study type: Interventional

Summary: 
      This is a pragmatic clinical trial of 100 patients who self-identify as black or Latino.
      Patients with active prescriptions for at least 3 medications and a medication change within
      the past 6-months will be recruited from the University of Florida (UF) Health primary care
      clinics for panel-based pharmacogenetic testing. Participants will be followed for 6 months
      and will undergo assessments with the Treatment Satisfaction Questionnaire for Medication
      (TSQM) three times (baseline visit, 3-month visit, and 6-month visit post pharmacogenetic
      testing). In addition, data on effectiveness outcomes and socioeconomic measures will be
      collected via the electronic health record (EHR) and patient report. Participation is
      expected to last approximately 6 months and the study will be open for approximately 12-14
      months.
    

Detailed description: 
      Little information exists regarding clinical implementation of pharmacogenetics in medically
      underserved patient populations. Preliminary data indicate that underserved patients are
      prescribed a higher rate of drugs associated with pharmacogenetic guidelines (pharmacogenetic
      drugs). Thus, an important knowledge gap exists regarding the use of pharmacogenetic in a
      patient population that may be the most likely to clinically benefit. The objective of this
      study is to develop key feasibility data to equitably advance preemptive pharmacogenetic
      testing within UF Health, and to generate important preliminary data to support future larger
      studies. This objective will be accomplished by pursuing three specific aims: (1) assess the
      feasibility of preemptive pharmacogenetic clinical implementation in primary care clinics
      predominantly serving medically underserved patients; (2) understand perspectives about
      preemptive pharmacogenetic among key stakeholders in the primary care clinics predominantly
      serving medically underserved patients; and (3) identify specific socioeconomic
      characteristics most strongly associated pharmacogenetic drug prescription rate.

      One hundred patients who self-identify as black or Latino with active prescriptions for at
      least 3 medications, one of which can be informed by panel-based pharmacogenetic testing, and
      a medication change within the past 6-months will be recruited from UF Health primary care
      clinics for panel-based pharmacogenetic testing. Participants will be followed for 6 months
      and will undergo assessments with the Treatment Satisfaction Questionnaire for Medication
      (TSQM) three times (at baseline and then again during the 3and 6-month follow-up post
      pharmacogenetic testing). In addition, data on effectiveness outcomes and socioeconomic
      measures will be collected via the EHR and patient report. Records for patients receiving
      care at UF Health primary care clinics will be screened based on inclusion/exclusion criteria
      for participation in the study. Those that meet criteria will be offered participation.
      Participation is expected to last approximately 6 months and the study will be open for
      approximately 12-14 months.
    

Intervention name(s): Panel-based pharmacogenetic genotyping
Intervention type(s): Diagnostic Test
Intervention description(s): A DNA sample by saliva (via mouthwash swish and expectorate collection) or buccal cell (via buccal brush) will be obtained for pharmacogenetic testing and questionnaires will be administered at baseline and then again at 3 months and 6 months after receiving PGx results.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Pharmacogenetics; Medically underserved; Implementation; Effectiveness