Trial of Preemptive Pharmacogenetic Testing in Underserved Patients ( TOPP UP ): Study Framework and Baseline Characteristics of Randomized Controlled Trial Participants

Research in pharmacogenetics has advanced over the years, but its broad clinical implementation remains limited. While medically underserved patients may particularly benefit from preemptive pharmacogenetic testing, its clinical impact in this population has not been well explored. The aim of the Trial of Preemptive Pharmacogenetic Testing in Underserved Patients is to assess the feasibility of clinically implementing preemptive pharmacogenetic testing and determine its effect on patient medication satisfaction in medically underserved patients. The Trial of Preemptive Pharmacogenetic Testing in Underserved Patients is a randomized, controlled, pragmatic clinical trial conducted across four clinics in North Central and Northeast Florida. Primary care patients from clinics predominantly caring for medically underserved populations are randomized to receive either pharmacogenetic panel testing to support standard of care dose optimization or standard of care without pharmacogenetic testing. The primary effectiveness outcome will be the patient-reported Treatment Satisfaction Questionnaire for Medication score. The primary implementation outcome will be prescriber acceptance rates of pharmacogenetic clinical decision support. Patient-reported outcomes are collected through surveys at baseline, 6 and 12 months after enrollment. This manuscript presents an overview of the study design and provides the enrolled participants' baseline characteristics, which demonstrate recruitment of a diverse, medically underserved population from the primary care setting.