NCT04630093

Pilot of Preemptive Pharmacogenetics in Medically Underserved Patients

Completed NA Results posted Last updated 4 October 2023

What this trial tests

NA trial testing Panel-based pharmacogenetic genotyping in Pharmacogenetic Testing in 100 participants. Completed in 22 June 2022.

Timeline

13 May 2021

Primary endpoint
22 June 2022

22 June 2022

Quick facts

Lead sponsor	University of Florida
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	100
Start date	13 May 2021
Primary completion	22 June 2022
Estimated completion	22 June 2022
Sites	1 location across United States

Drugs / interventions tested

• Panel-based pharmacogenetic genotyping

Conditions studied

• Pharmacogenetic Testing — all drugs for Pharmacogenetic Testing →

Sponsor

University of Florida

Who can join

Adults 18 to 99, any sex, with Pharmacogenetic Testing. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Global Patient Treatment Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) Primary · 6 months

The primary feasibility outcome will be change in patient treatment satisfaction between baseline and 6 months after pharmacogenetic testing. This patient reported outcome will be measured via the TSQM. The TSQM is a validated tool that assesses three medication-related domains (effectiveness, side effects, and convenience) to synthesize a global satisfaction score. TSQM domain scores range from 0 to 100 with higher scores representing higher satisfaction for that each domain.

Baseline

Group	Value	95% CI
Panel-based Pharmacogenetic Genotyping	59.9	± 16.9

6 months

Group	Value	95% CI
Panel-based Pharmacogenetic Genotyping	64.4	± 13.6

Change in Patient Treatment Effectiveness Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) Secondary · 6 months

Change in patient treatment effectiveness satisfaction between baseline and 6 months after pharmacogenetic testing. This patient reported outcome will be measured via the TSQM. The TSQM is a validated tool that assesses three medication-related domains (effectiveness, side effects, and convenience) and a global satisfaction score. TSQM domain scores range from 0 to 100 with higher scores representing higher satisfaction for that each domain.

baseline

Group	Value	95% CI
Panel-based Pharmacogenetic Genotyping	59.6	± 14.4

6 months

Group	Value	95% CI
Panel-based Pharmacogenetic Genotyping	63.3	± 11.7

Change in Patient Treatment Side Effect Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) Secondary · 6 months

Change in patient treatment side effect satisfaction between baseline and 6 months after pharmacogenetic testing. This patient reported outcome will be measured via the TSQM. The TSQM is a validated tool that assesses three medication-related domains (effectiveness, side effects, and convenience) and a global satisfaction score. TSQM domain scores range from 0 to 100 with higher scores representing higher satisfaction for that each domain.

baseline

Group	Value	95% CI
Panel-based Pharmacogenetic Genotyping	84.2	± 24.0

6 months

Group	Value	95% CI
Panel-based Pharmacogenetic Genotyping	85.5	± 24.0

Change in Patient Treatment Convenience Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) Secondary · 6 months

Change in patient treatment convenience satisfaction between baseline and 6 months after pharmacogenetic testing. This patient reported outcome will be measured via the TSQM. The TSQM is a validated tool that assesses three medication-related domains (effectiveness, side effects, and convenience) and a global satisfaction score. TSQM domain scores range from 0 to 100 with higher scores representing higher satisfaction for that each domain.

baseline

Group	Value	95% CI
Panel-based Pharmacogenetic Genotyping	67.7	± 13.2

6 months

Group	Value	95% CI
Panel-based Pharmacogenetic Genotyping	70.1	± 11.7

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Feasibility of preemptive pharmacogenetic testing and improvement of medication treatment satisfaction among medically underserved patients.
   Lteif C, Eddy E, Terrell J, Cavallari LH, et al · · 2024 · cited 11× · PMID 38013396 · DOI 10.1111/cts.13692