N/A
Completed N=100
Pilot of Preemptive Pharmacogenetics in Medically Underserved Patients
Pharmacogenetic Testing
Source: ClinicalTrials.gov NCT04630093 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: Change in Global Patient Treatment Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) — 59.9; 64.4 score on a scale — p=0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Global Patient Treatment Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) |
59.9; 64.4 | 0.001 sig |
| SECONDARY Change in Patient Treatment Effectiveness Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) |
59.6; 63.3 | — |
| SECONDARY Change in Patient Treatment Side Effect Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) |
84.2; 85.5 | — |
| SECONDARY Change in Patient Treatment Convenience Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) |
67.7; 70.1 | — |
Eligibility Criteria
Inclusion Criteria
- Adults (18 years or older) with active prescriptions for at least 3 medications documented within the EHR.
- At least 1 drug/drug class that could be informed by the pharmacogenetics test panel available at the UF.
- A medication change within the past 6 months (associated with a healthcare provider encounter).
- Self-identify as black or Latino.
Exclusion Criteria
- Patients with any history of pharmacogenetic testing within the EHR.
Data sourced from ClinicalTrials.gov (NCT04630093). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.