TOPMEDs
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StatusAccepting Candidates
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Age40 Years - N/A
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SexesAll
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Healthy VolunteersAccepts Healthy Volunteers
Objective
The objectives of this study are to (1) test the feasibility of the clinical implementation of preemptive pharmacogenetic (PGx) testing in the emergency department (ED) and (2) determine if PGx testing (with appropriate decision support) decreases ED return visits and hospitalizations. We will conduct a randomized, controlled, pragmatic clinical trial assessing both the real-world effectiveness as well as implementation outcomes using a targeted PGx testing panel in several BOBÌåÓý EDs.
Details
Full study title | Trial of Precision Medicine in Emergency Departments |
Protocol number | OCR45747 |
ClinicalTrials.gov ID | NCT06448091 |
Phase | N/A |
Eligibility
Inclusion Criteria:
Adults 40 years or older presenting to a participating ED
Receipt of a new order/prescription for a selected PGx medication (Appendix 1. , with a duration greater than 7 days, during the current ED visit or within 30 days prior.
Documentation of at least 2 prior ED or urgent care visits within the past 12 months
Exclusion Criteria:
Prior clinical pharmacogenetic test results within the EHR for genes relevant for this study (Appendix 1).
History of hepatic or renal transplant
History of severe liver disease (stage Child-Pugh C) or renal disease eGFR
Lead researcher
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Michael Marchick, MDEmergency Doctor
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
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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.