Genetic Testing for Emergency Care
(TOPMEDs Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if genetic testing in the emergency room can reduce hospital readmissions. It focuses on using a genetic test (panel-based pharmacogenetic genotyping) to help doctors select the right medicine for patients, potentially reducing future hospital visits. Participants must be adults over 40, have recently been prescribed a new medicine, and have visited the emergency room or urgent care at least twice in the past year. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance emergency care for many.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this pharmacogenetic testing is safe for emergency care?
Research shows that using a panel to study genes, known as pharmacogenetic genotyping, is generally safe. This process involves taking a sample, usually through a blood or saliva test, to examine genes and understand how they might affect reactions to medications.
Studies indicate that this method is common and well-tolerated. For instance, one study found that nearly 98% of participants could safely undergo pharmacogenetic testing. Another study demonstrated that this testing could help doctors select better medications for patients, potentially improving treatment results.
No serious side effects have been linked to the testing itself, as it is similar to any regular blood test. Based on previous research, the testing process is expected to be safe for those who join this trial.12345Why are researchers excited about this trial?
Researchers are excited about panel-based pharmacogenetic genotyping in emergency care because it has the potential to personalize treatment by quickly determining how patients might respond to different medications based on their genetic makeup. Unlike current emergency protocols, which often rely on a one-size-fits-all approach, this method could lead to more effective and safer medication choices tailored to each individual. By integrating genetic information into the patient's electronic health record and making it available within weeks, healthcare providers can make more informed decisions that may improve outcomes and reduce adverse drug reactions.
What evidence suggests that panel-based pharmacogenetic genotyping is effective for reducing ED return visits and hospitalizations?
Research has shown that genetic testing can help doctors select the right medications and improve treatment outcomes. In this trial, participants will undergo either immediate or delayed panel-based pharmacogenetic genotyping. One study found that 76% of patients who underwent genetic testing required at least one medication change. These changes often depend on how a person's genes influence their drug reactions, leading to fewer side effects and improved effectiveness. Another study found that genetic testing reduced the number of serious drug reactions. This approach customizes treatments for each individual, potentially reducing emergency room visits and hospital stays.36789
Who Is on the Research Team?
Julio D Duarte, Pharm.D., Ph.D.
Principal Investigator
University of Florida
Are You a Good Fit for This Trial?
This trial is for adults over 18 who come to certain emergency departments and might need a drug that's affected by genetics. They should have been to the ED in the last 6 months. It's not clear who can't join because the exclusion criteria are missing.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Immediate panel-based pharmacogenetic genotyping is conducted and results are provided within 2-4 weeks
Follow-up
Participants are monitored for ED recidivism and clinician review of PGx results
What Are the Treatments Tested in This Trial?
Interventions
- Panel-based pharmacogenetic genotyping
Trial Overview
The study is testing if using genetic testing (PGx) in emergency rooms helps doctors choose better drugs for patients, which could lead to fewer return visits or hospital stays. Participants will be randomly chosen to either get this new approach or stick with standard care.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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 randomization.
Subjects assigned to delayed panel-based pharmacogenetic genotyping will not be tested until after their participation in the study has ended (6 months after enrollment).
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
National Human Genome Research Institute (NHGRI)
Collaborator
Published Research Related to This Trial
Citations
Genetic Testing for Emergency Care (TOPMEDs Trial)
What data supports the effectiveness of the treatment Panel-based pharmacogenetic genotyping? Research shows that using genetic testing to guide drug ...
Analysis of a panel-based pharmacogenomics testing ...
Based on the PGx test results, 62 of these medications (37.6%) had recommendations. Of members who received PGx testing, 76% had at least 1 recommended change.
Value of Pharmacogenetic Testing Assessed with Real ...
In this retrospective register‐based study, we analyzed a nationwide cohort of 1,425,000 patients discharged from internal medicine or surgical ...
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annualreviews.org
annualreviews.org/content/journals/10.1146/annurev-pharmtox-061724-080935?crawler=true&mimetype=application/pdfPharmacogenetic Panel Testing: A Review of Current ...
Results of the meta-analysis show that the superior effectiveness of ticagrelor and prasugrel compared to clopidogrel is indeed primarily based ...
A 12-gene pharmacogenetic panel to prevent adverse drug ...
Genotype-guided treatment using a 12-gene pharmacogenetic panel significantly reduced the incidence of clinically relevant adverse drug reactions.
A review of real-world evidence on preemptive ...
In the present narrative review, we examined the current evidence of pre-emptive PGx testing-based treatment for the prevention of ADRs incidence.
Pre-emptive pharmacogenetic testing in the acute hospital ...
This study demonstrates the relative ubiquity of pharmacogenetics as an intervention, with the vast majority of the cohort (97.9%) found to ...
Clinical Utility of Pharmacogene Panel‐Based Testing in ...
☑ Pre‐emptive, panel‐based testing at the time of PCI could lead to genotype‐guided prescribing decisions in over a third of patients, improving drug therapy ...
A Pharmacogenetic Panel-Based Prediction of the Clinical ...
Pharmacogenetic panel-based genotyping, particularly when conducted early or preemptively, has the potential to improve clinical outcomes and ...
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