Use of Prescription MedicationsToPP-UPNCT05141019
Trial of Preemptive Pharmacogenetics in Underserved Patients
A study testing Panel-based pharmacogenetic genotyping in people with Use of Prescription Medications and Pharmacogenetic Testing, run by University of Florida at 1 site in United States.
Trial summary
This trial aims to compare preemptive pharmacogenetic (PGx) testing to usual (standard) care in patients from primary care clinics that predominantly care for medically underserved patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Use of Prescription Medications, Pharmacogenetic Testing
- What is being tested?
- Panel-based pharmacogenetic genotyping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 535 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 29 Oct 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 23Show fewer
- 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
- Dyslipidemia
- Heart failure
- Deep vein thrombosis
- Atrial fibrillation
- Moderate to severe trauma
- stroke
- hypercholesterolemia
- conditions requiring chronic anticoagulation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health at the University of Florida
Gainesville, Florida, 32610
About this study
This trial aims to compare preemptive pharmacogenetic (PGx) testing to usual (standard) care in patients from primary care clinics that predominantly care for medically underserved patients. Participants will receive a clinical testing panel that includes multiple genes, and the test results will be entered into their electronic health record. Participants will be asked to complete surveys at baseline and after 6 and 12 months after enrollment. Health information from participants' electronic health records will also be collected.
Read the detailed description
Preemptive pharmacogenetic (PGx) testing may be particularly beneficial in medically underserved populations by reducing the number of appointments required to optimize drug therapy and increasing the effectiveness of less expensive off-patent medications - the type most often with pharmacogenetic guidelines available (PGx drugs). However, there is little data available to guide clinical implementation in these patient populations. Our long-term goal is to contribute toward the efficient implementation of PGx into clinical practice to improve the precision of medication prescribing. The overall objective for this project is to assess the feasibility and effectiveness of preemptive PGx testing in medically underserved patients. The central hypothesis is that preemptive PGx testing is feasible as well as effective in improving patient medication satisfaction. The rationale for the proposed research is that identifying patient populations that can most benefit from PGx testing will facilitate clinical implementation that may reduce medication treatment disparities.
The investigators plan to test the central hypothesis and accomplish the overall objective of this application by determining the feasibility of low-cost preemptive PGx testing in a medically underserved population as well as its effect on patient medication satisfaction. This will be accomplished by conducting a prospective, randomized, pragmatic hybrid clinical trial assessing both the real-world effectiveness as well as implementation outcomes associated with clinical use of a targeted preemptive PGx panel in medically underserved patients. After providing informed consent, participants will be randomized to receive either preemptive PGx testing or usual care over 12 months. Participants in both assignment groups will provide a DNA sample (either blood or buccal swab) at study enrollment. Participants assigned to the preemptive PGx group will be tested and have their results both entered into the EHR and provided to them within 4 weeks. Participants assigned to usual care will also be tested after their participation in the study has ended. The test results entered into the EHR will enable automated clinical decision support to alert healthcare providers about potential drug-gene interactions for that participant. A clinical consult note written by a precision medicine pharmacist will also be entered into the EHR. Participants will also receive a card containing their PGx test results and instructed to show the card to any healthcare provider that may prescribe them medication.
The primary outcome will be patient medication treatment satisfaction. This patient reported outcome will be measured via the Treatment Satisfaction Questionnaire for Medication (TSQM). In addition, other patient reported outcomes such as medication adherence and quality of life will also be measured. Lastly, rates of healthcare encounters will also be compared between study groups.
The proposed research is significant because it should contribute valuable preliminary data toward both the real-world effectiveness of preemptive PGx testing as well as the feasibility of studying and implementing this technology in medically underserved patients - an area of PGx research where few data are available. Ultimately, we expect to have developed valuable data identifying patients most likely to benefit from preemptive PGx testing, particularly in patients who are medically underserved and/or members of racial minorities. These results should have an important positive impact because they can inform further clinical implementation efforts of PGx as well as future large clinical trials of preemptive testing, ideally reducing healthcare disparities in the field of precision medicine.
- Being tested
- Panel-based pharmacogenetic genotyping
- Keywords
- Pharmacogenetics, Medically underserved, Implementation, Effectiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panel-based pharmacogenetic genotypingDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Diagnostic Test: Panel-based pharmacogenetic genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Reported Global Treatment Satisfaction Score From Baseline to 12 Months
The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated patient reported outcome tool that measures how satisfied patients are with a medication they are taking. Four medication-related domains (global satisfaction, effectiveness, side effects, and convenience) are measured, providing scores from 0 (least satisfaction) to 100 (most satisfaction) for each domain. Global satisfaction is the primary outcome, with other domains analyzed as predefined secondary outcomes.
Measured: 12 months
Secondary outcomes (6)
Change in Patient Reported Treatment Effectiveness Score From Baseline to 12 Months
The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated patient reported outcome tool that measures how satisfied patients are with a medication they are taking. Four medication-related domains (global satisfaction, effectiveness, side effects, and convenience) are measured, providing scores from 0 (least satisfaction) to 100 (most satisfaction) for each domain. Global satisfaction is the primary outcome, with other domains analyzed as predefined secondary outcomes.
Measured: 12 months
Change in Patient Reported Treatment Side Effect Score From Baseline to 12 Months
The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated patient reported outcome tool that measures how satisfied patients are with a medication they are taking. Four medication-related domains (global satisfaction, effectiveness, side effects, and convenience) are measured, providing scores from 0 (least satisfaction) to 100 (most satisfaction) for each domain. Global satisfaction is the primary outcome, with other domains analyzed as predefined secondary outcomes.
Measured: 12 months
Change in Patient Reported Treatment Convenience Score From Baseline to 12 Months
The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated patient reported outcome tool that measures how satisfied patients are with a medication they are taking. Four medication-related domains (global satisfaction, effectiveness, side effects, and convenience) are measured, providing scores from 0 (least satisfaction) to 100 (most satisfaction) for each domain. Global satisfaction is the primary outcome, with other domains analyzed as predefined secondary outcomes.
Measured: 12 months
Change in Patient Reported Medication Adherence Score From Baseline to 12 Months
Patient-Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale (PMAS) is a validated patient reported outcome tool that assesses how well patients adhere to their prescribed oral medications. The score ranges from 9 (poorest adherence) to 45 (best adherence).
Measured: 12 months
Change in Patient Reported Healthy Day Score From Baseline to 12 Months
The Center for Disease Control (CDC) Health-Related Quality of Life (HRQOL-14) is a validated measure commonly used to assess a patient's quality of life over the past 30 days. The reported number of days reported for each domain can span from 0 days to 30 days in the past month. Reported number of healthy days will be used as an estimate of quality of life.
Measured: 12 months
Number of Healthcare Encounters From Baseline to 12 Months
The number of healthcare encounters during the 12 month study period were abstracted from the participant's electronic health record.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start1 Aug 2022
- Primary completion8 Sep 2025
- Study completion29 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Use of Prescription MedicationsStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 535 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI)
- Responsible party
- Sponsor
- Investigators
- Julio Duarte, PharmD, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141019
- Sponsor's protocol ID
- IRB202101316 -N
- Other IDs
- R01HG011800
- Acronym
- ToPP-UP
- Status last verified
- Nov 2026
- First submitted
- 19 Nov 2021
- Last updated
- 5 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Preemptive Pharmacogenetics in Underserved Patients
- ClinicalTrials.gov ID
- NCT05141019
- Acronym / sponsor ID
- ToPP-UP / IRB202101316 -N
- Keywords
- Pharmacogenetics, Medically underserved, Implementation, Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 535 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 29 Oct 2026 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Posted 5 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial aims to compare preemptive pharmacogenetic (PGx) testing to usual (standard) care in patients from primary care clinics that predominantly care for medically underserved patients. Participants will receive a clinical testing panel that includes multiple genes, and the test results will be entered into their electronic health record. Participants will be asked to complete surveys at baseline and after 6 and 12 months after enrollment. Health information from participants' electronic health records will also be collected.
Detailed description
Preemptive pharmacogenetic (PGx) testing may be particularly beneficial in medically underserved populations by reducing the number of appointments required to optimize drug therapy and increasing the effectiveness of less expensive off-patent medications - the type most often with pharmacogenetic guidelines available (PGx drugs). However, there is little data available to guide clinical implementation in these patient populations. Our long-term goal is to contribute toward the efficient implementation of PGx into clinical practice to improve the precision of medication prescribing. The overall objective for this project is to assess the feasibility and effectiveness of preemptive PGx testing in medically underserved patients. The central hypothesis is that preemptive PGx testing is feasible as well as effective in improving patient medication satisfaction. The rationale for the proposed research is that identifying patient populations that can most benefit from PGx testing will facilitate clinical implementation that may reduce medication treatment disparities.
The investigators plan to test the central hypothesis and accomplish the overall objective of this application by determining the feasibility of low-cost preemptive PGx testing in a medically underserved population as well as its effect on patient medication satisfaction. This will be accomplished by conducting a prospective, randomized, pragmatic hybrid clinical trial assessing both the real-world effectiveness as well as implementation outcomes associated with clinical use of a targeted preemptive PGx panel in medically underserved patients. After providing informed consent, participants will be randomized to receive either preemptive PGx testing or usual care over 12 months. Participants in both assignment groups will provide a DNA sample (either blood or buccal swab) at study enrollment. Participants assigned to the preemptive PGx group will be tested and have their results both entered into the EHR and provided to them within 4 weeks. Participants assigned to usual care will also be tested after their participation in the study has ended. The test results entered into the EHR will enable automated clinical decision support to alert healthcare providers about potential drug-gene interactions for that participant. A clinical consult note written by a precision medicine pharmacist will also be entered into the EHR. Participants will also receive a card containing their PGx test results and instructed to show the card to any healthcare provider that may prescribe them medication.
The primary outcome will be patient medication treatment satisfaction. This patient reported outcome will be measured via the Treatment Satisfaction Questionnaire for Medication (TSQM). In addition, other patient reported outcomes such as medication adherence and quality of life will also be measured. Lastly, rates of healthcare encounters will also be compared between study groups.
The proposed research is significant because it should contribute valuable preliminary data toward both the real-world effectiveness of preemptive PGx testing as well as the feasibility of studying and implementing this technology in medically underserved patients - an area of PGx research where few data are available. Ultimately, we expect to have developed valuable data identifying patients most likely to benefit from preemptive PGx testing, particularly in patients who are medically underserved and/or members of racial minorities. These results should have an important positive impact because they can inform further clinical implementation efforts of PGx as well as future large clinical trials of preemptive testing, ideally reducing healthcare disparities in the field of precision medicine.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate panel-based pharmacogenetic genotyping | Experimental | Diagnostic Test: Panel-based pharmacogenetic genotypingSubjects 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. |
| Delayed panel-based pharmacogenetic genotyping | Other | Diagnostic Test: Panel-based pharmacogenetic genotypingSubjects 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Panel-based pharmacogenetic genotypingAfter 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. | Diagnostic test | Delayed panel-based pharmacogenetic genotyping, Immediate panel-based pharmacogenetic genotyping |
Primary outcome
Change in Patient Reported Global Treatment Satisfaction Score From Baseline to 12 Months
Time frame: 12 months
The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated patient reported outcome tool that measures how satisfied patients are with a medication they are taking. Four medication-related domains (global satisfaction, effectiveness, side effects, and convenience) are measured, providing scores from 0 (least satisfaction) to 100 (most satisfaction) for each domain. Global satisfaction is the primary outcome, with other domains analyzed as predefined secondary outcomes.
6 secondary outcomes
Change in Patient Reported Treatment Effectiveness Score From Baseline to 12 Months
Time frame: 12 months
Change in Patient Reported Treatment Side Effect Score From Baseline to 12 Months
Time frame: 12 months
Change in Patient Reported Treatment Convenience Score From Baseline to 12 Months
Time frame: 12 months
Change in Patient Reported Medication Adherence Score From Baseline to 12 Months
Time frame: 12 months
Change in Patient Reported Healthy Day Score From Baseline to 12 Months
Time frame: 12 months
Number of Healthcare Encounters From Baseline to 12 Months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julio Duarte, PharmD, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Panel-based pharmacogenetic genotyping in people with Use of Prescription Medications and Pharmacogenetic Testing, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Reported Global Treatment Satisfaction Score From Baseline to 12 Months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.