Pharmacogenetic TestingNCT04630093
Pilot of Preemptive Pharmacogenetics in Medically Underserved Patients
A study testing Panel-based pharmacogenetic genotyping in people with Pharmacogenetic Testing, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pharmacogenetic Testing
- What is being tested?
- Panel-based pharmacogenetic genotyping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2021to 22 Jun 2022
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with any history of pharmacogenetic testing within the EHR.
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
Official title: Clinical Implementation Pilot of Preemptive Pharmacogenetic Testing in Medically Underserved Patient Populations
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.
Read the detailed description
Little information exists regarding clinical implementation of pharmacogenetics in medically underserved patient populations. Preliminary data indicate that underserved patients are prescribed a higher rate of drugs associated with pharmacogenetic guidelines (pharmacogenetic drugs). Thus, an important knowledge gap exists regarding the use of pharmacogenetic in a patient population that may be the most likely to clinically benefit. The objective of this study is to develop key feasibility data to equitably advance preemptive pharmacogenetic testing within UF Health, and to generate important preliminary data to support future larger studies. This objective will be accomplished by pursuing three specific aims: (1) assess the feasibility of preemptive pharmacogenetic clinical implementation in primary care clinics predominantly serving medically underserved patients; (2) understand perspectives about preemptive pharmacogenetic among key stakeholders in the primary care clinics predominantly serving medically underserved patients; and (3) identify specific socioeconomic characteristics most strongly associated pharmacogenetic drug prescription rate.
One hundred patients who self-identify as black or Latino with active prescriptions for at least 3 medications, one of which can be informed by panel-based pharmacogenetic testing, and a medication change within the past 6-months will be recruited from 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 (at baseline and then again during the 3and 6-month follow-up post pharmacogenetic testing). In addition, data on effectiveness outcomes and socioeconomic measures will be collected via the EHR and patient report. Records for patients receiving care at UF Health primary care clinics will be screened based on inclusion/exclusion criteria for participation in the study. Those that meet criteria will be offered participation. Participation is expected to last approximately 6 months and the study will be open for approximately 12-14 months.
- Conditions
- Pharmacogenetic Testing
- 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
A DNA sample by saliva (via mouthwash swish and expectorate collection) or buccal cell (via buccal brush) will be obtained for pharmacogenetic testing and questionnaires will be administered at baseline and then again at 3 months and 6 months after receiving PGx results.
| Study group | Role | What they receive |
|---|---|---|
| Panel-based pharmacogenetic genotyping | Experimental | All patients will receive clinical preemptive pharmacogenetic testing. Genotype results and consult notes will returned in the EHR pre-emptively. Data on implementation success metrics and PROs via patient report and TSQM measures will be collected. In addition, data on effectiveness outcomes and socioeconomic measures will be collected via the EHR and patient report, respectively. 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 Global 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 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.
Measured: 6 months
Secondary outcomes (3)
Change in Patient Treatment Effectiveness Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)
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.
Measured: 6 months
Change in Patient Treatment Side Effect Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)
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.
Measured: 6 months
Change in Patient Treatment Convenience Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start13 May 2021
- Primary completion22 Jun 2022
- Study completion22 Jun 2022
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 Pharmacogenetic TestingStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Julio Duarte, PharmD, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630093
- Sponsor's protocol ID
- IRB202002594-N
- Other IDs
- UL1TR001427
- Status last verified
- Sep 2023
- First submitted
- 5 Nov 2020
- Last updated
- 4 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Implementation Pilot of Preemptive Pharmacogenetic Testing in Medically Underserved Patient Populations
- ClinicalTrials.gov ID
- NCT04630093
- Acronym / sponsor ID
- IRB202002594-N
- Conditions
- Pharmacogenetic Testing
- Keywords
- Pharmacogenetics, Medically underserved, Implementation, Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 13 May 2021 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Posted 4 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Little information exists regarding clinical implementation of pharmacogenetics in medically underserved patient populations. Preliminary data indicate that underserved patients are prescribed a higher rate of drugs associated with pharmacogenetic guidelines (pharmacogenetic drugs). Thus, an important knowledge gap exists regarding the use of pharmacogenetic in a patient population that may be the most likely to clinically benefit. The objective of this study is to develop key feasibility data to equitably advance preemptive pharmacogenetic testing within UF Health, and to generate important preliminary data to support future larger studies. This objective will be accomplished by pursuing three specific aims: (1) assess the feasibility of preemptive pharmacogenetic clinical implementation in primary care clinics predominantly serving medically underserved patients; (2) understand perspectives about preemptive pharmacogenetic among key stakeholders in the primary care clinics predominantly serving medically underserved patients; and (3) identify specific socioeconomic characteristics most strongly associated pharmacogenetic drug prescription rate.
One hundred patients who self-identify as black or Latino with active prescriptions for at least 3 medications, one of which can be informed by panel-based pharmacogenetic testing, and a medication change within the past 6-months will be recruited from 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 (at baseline and then again during the 3and 6-month follow-up post pharmacogenetic testing). In addition, data on effectiveness outcomes and socioeconomic measures will be collected via the EHR and patient report. Records for patients receiving care at UF Health primary care clinics will be screened based on inclusion/exclusion criteria for participation in the study. Those that meet criteria will be offered participation. Participation is expected to last approximately 6 months and the study will be open for approximately 12-14 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Panel-based pharmacogenetic genotyping | Experimental | Diagnostic Test: Panel-based pharmacogenetic genotypingAll patients will receive clinical preemptive pharmacogenetic testing. Genotype results and consult notes will returned in the EHR pre-emptively. Data on implementation success metrics and PROs via patient report and TSQM measures will be collected. In addition, data on effectiveness outcomes and socioeconomic measures will be collected via the EHR and patient report, respectively. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with any history of pharmacogenetic testing within the EHR.
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 genotypingA DNA sample by saliva (via mouthwash swish and expectorate collection) or buccal cell (via buccal brush) will be obtained for pharmacogenetic testing and questionnaires will be administered at baseline and then again at 3 months and 6 months after receiving PGx results. | Diagnostic test | Panel-based pharmacogenetic genotyping |
Primary outcome
Change in Global Patient Treatment Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: 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.
3 secondary outcomes
Change in Patient Treatment Effectiveness Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: 6 months
Change in Patient Treatment Side Effect Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: 6 months
Change in Patient Treatment Convenience Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 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 4 inclusion and 1 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 4 Oct 2023. 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 4 Oct 2023). 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 Global Patient Treatment Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) (time frame: 6 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 4 Oct 2023.