Pilot of Preemptive Pharmacogenetics in Medically Underserved Patients

Pharmacogenetic Testing Clinical Trial

Official title: Clinical Implementation Pilot of Preemptive Pharmacogenetic Testing in Medically Underserved Patient Populations

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Pharmacogenetic Testing

• NCT number: NCT04630093
• Study type: Interventional
• Source: University of Florida
• Status: Completed
• Phase: N/A
• Start date: May 13, 2021
• Completion date: June 22, 2022