Trial of Preemptive Pharmacogenetics in Underserved Patients

NCT05141019 | Active Not Recruiting

• 2 other identifiers: IRB202101316 -NR01HG011800
• Study Type: interventional
• Target: 492
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Use of Prescription Medications; Pharmacogenetic Testing

Keywords

Pharmacogenetics; Medically underserved; Implementation; Effectiveness

Outcome Measures

Primary Outcomes (1)

• Change in Patient Treatment Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)

  The primary feasibility outcome will be change in patient treatment satisfaction between baseline and 12 months after enrollment into the study. 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. Both global satisfaction and scores from individual domains will be analyzed.

  12-14 months

Study Arms (2)

Immediate panel-based pharmacogenetic genotyping

EXPERIMENTAL

Subjects assigned to the immediate pharmacogenetic genotyping group will be tested and have their results both entered into their electronic health record as well as provided to them within 2-4 weeks from enrollment.

Diagnostic Test: Panel-based pharmacogenetic genotyping

Delayed panel-based pharmacogenetic genotyping

OTHER

Subjects assigned to delayed panel-based pharmacogenetic genotyping will be tested, but their results will not be released until after their participation in the study has ended (12 months after enrollment).

Diagnostic Test: Panel-based pharmacogenetic genotyping

Interventions

Panel-based pharmacogenetic genotyping DIAGNOSTIC_TEST

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.

Delayed panel-based pharmacogenetic genotyping; Immediate panel-based pharmacogenetic genotyping

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults \> 18 years of age
• at least 3 active prescriptions documented within medical records
• Experienced a change to an active prescription within the past 8 months, defined by:
• Addition of a new medication
• Change in the dose of a current medication
• Diagnosis of any condition that could be treated with a medication that can be informed by the pharmacogenetic testing panel.
• This will likely include:
• generalized depression or anxiety disorder
• gastroesophageal reflux disorder
• erosive esophagitis
• gastric ulcer
• acute coronary syndrome
• chronic pain
• surgery (orthopedic, gastrointestinal, cardiovascular etc.)
• osteoarthritis

You may not qualify if:

• Any history of previous pharmacogenetic testing
• Any medical condition that would prohibit the ability to answer study questions
• History of Allogenic stem cell or liver transplant
• History of chronic kidney dialysis
• Life expectancy less than 12 months

Sponsors & Collaborators

• University of Florida: lead
• National Human Genome Research Institute (NHGRI): collaborator

Study Sites (1)

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

Location

Study Officials

• Julio Duarte, PharmD, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 2, 2021
• Study Start: August 1, 2022
• Primary Completion: September 8, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)