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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001427 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panel-based pharmacogenetic genotyping | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julio Duarte, PharmD, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health at the University of Florida | Gainesville | Florida | 32610 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Panel-based Pharmacogenetic Genotyping | 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. Panel-based pharmacogenetic genotyping: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Panel-based Pharmacogenetic Genotyping | 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. Panel-based pharmacogenetic genotyping: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Panel-based Pharmacogenetic Genotyping | 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. Panel-based pharmacogenetic genotyping: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Julio Duarte | University of Florida | 352-273-8132 | juliod@cop.ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 30, 2021 | Aug 22, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 20, 2021 | Aug 22, 2023 | ICF_001.pdf |
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| 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. | 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. | 6 months |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Reported annual household income | Count of Participants | Participants |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| 0 |
| 99 |
| 0 |
| 99 |
| 0 |
| 99 |
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