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Trial of Preemptive Pharmacogenetics in Underserved Patients
Sponsor: University of Florida
Summary
This proposed research is relevant to human health because preemptive clinical pharmacogenetic testing may improve the personalization of drug therapy which should improve patient outcomes. Better understanding of the effectiveness and feasibility of preemptive clinical pharmacogenetic testing will inform when and how this innovative healthcare technology is implemented into clinical care. To ensure equitable dissemination in all patient populations, such data is also needed in racial minorities and other traditionally underserved populations. The combined proposed research are relevant to the parts of the NIH's mission pertaining to protecting and improving health and developing scientific human resources that will ensure the Nation's capability to prevent and treat disease.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
492
Start Date
2022-08-01
Completion Date
2026-06-30
Last Updated
2025-11-17
Healthy Volunteers
No
Interventions
Panel-based pharmacogenetic genotyping
After providing consent, subjects will be randomized to receive either the immediate pharmacogenetic testing arm or the delayed arm. Subjects in both groups will provide a DNA sample by saliva, buccal cell, or blood at study enrollment. Subjects assigned to the immediate pharmacogenetic genotyping group will be tested and will have their results entered into their electronic health record (EHR) and provided to them within 2-4 weeks. Subjects assigned to the delayed pharmacogenetic genotyping group will also be tested, but their results will not be released until after their participation in the study has ended. Subjects in each arm will complete surveys and questionnaires regarding their medication satisfaction, as well as their healthcare utilization use at baseline and then again at 6- and 12-months. Implementation-specific questions will also be asked to assess the feasibility and sustainability of the intervention as well as assessments of intervention fidelity and adaptations.
Locations (1)
UF Health at the University of Florida
Gainesville, Florida, United States