ToPP-UP
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StatusAccepting Candidates
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Age18 Years - N/A
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SexesAll
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Healthy VolunteersNo
Objective
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.
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 application is to identify PGx drug usage patterns in medically underserved patients, and assess the feasibility and effectiveness of preemptive PGx testing in this patient population. The central hypothesis is that medically underserved patients are prescribed more PGx drugs, and 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 pursuing three specific aims. The first aim is to identify clinical, demographic and socioeconomic factors associated with PGx drug prescribing patterns in a large, real-world, diverse patient population. The investigators will accomplish this aim by comparing clinical, demographic, and socioeconomic data with prescription data from millions of patients across the State of Florida. The second aim is to develop a low-cost, ancestrally inclusive PGx testing panel designed to inform commonly used PGx drugs. The investigators will design a low-cost, clinically validated panel that will include variants common in racial minorities in the U.S. The investigators plan to leverage extensive batching of tests and an already available genotyping platform that minimizes labor costs in order to achieve significant cost savings. The third aim is to determine the feasibility of low-cost preemptive PGx testing in a medically underserved population as well as its effect on patient medication satisfaction. The investigators will accomplish this aim by completing a randomized open-label clinical trial comparing medically underserved patients receiving preemptive PGx testing to those receiving usual care. The investigators will compare key implementation metrics and will also conduct semi-structured interviews in both patients and healthcare providers to assess PGx perceptions of feasibility and sustainability from stakeholders.
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. The proposed research is innovative because this project will utilize additional demographic and socioeconomic data that, with along with clinical data, should better identify patient populations most likely to benefit from PGx testing and allow focused of implementation efforts to those populations. Ultimately, the investigators 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.
Details
Full study title | Trial of Preemptive Pharmacogenetics in Underserved Patients |
Protocol number | OCR40848 |
ClinicalTrials.gov ID | NCT05141019 |
Phase | N/A |
Eligibility
Inclusion Criteria:
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
Dyslipidemia
Heart failure
Deep vein thrombosis
Atrial fibrillation
Moderate to severe trauma
stroke
hypercholesterolemia
conditions requiring chronic anticoagulation
Exclusion Criteria:
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
Participate in a study
Here are some general steps to consider when participating in a research study:
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Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
Julio Duarte -
Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
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Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
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Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.