Genetic Testing for Emergency Care

(TOPMEDs Trial)

Recruiting at 2 trial locations

Overseen By Erica N Elwood, MHA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Prior PGx test, Life expectancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2-4 weeks

1200 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{3 6 7 8 9}

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

Documentation of a prior ED visit within the past 6 months

I am 18 years or older and visiting a participating emergency department.

I might have a condition that could be treated with a specific genetic-based drug.

Exclusion Criteria

Any medical condition that would prohibit the ability to complete the study

Life expectancy less than 6 months

My medical records include genetic test results relevant to this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Immediate panel-based pharmacogenetic genotyping is conducted and results are provided within 2-4 weeks

2-4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for ED recidivism and clinician review of PGx results

6 months

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?

Group I: Experimental: Immediate panel-based pharmacogenetic genotyping Experimental Treatment 1 Intervention

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.

Group II: Delayed panel-based pharmacogenetic genotyping Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Human Genome Research Institute (NHGRI)

Collaborator

Trials

273

Recruited

299,000+

Published Research Related to This Trial

In a study of 52,942 patients over five years, 64.8% were prescribed at least one medication that could be influenced by genetic variants, highlighting the commonality of pharmacogenetic prescribing opportunities.

Implementing a preemptive genotyping program could potentially prevent 383 adverse events linked to specific medications, suggesting that this approach may enhance patient safety compared to traditional reactive methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing drug outcomes through pharmacogenetics: a case for preemptive genotyping. Schildcrout, JS., Denny, JC., Bowton, E., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-emergencies-8-2024-b5c0e

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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10373039/

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.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11652815/

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 ...

4. annualreviews.org annualreviews.org/content/journals/10.1146/annurev-pharmtox-061724-080935?crawler=true&mimetype=application/pdf

Pharmacogenetic 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 ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0140673622018414

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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10942860/

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.

7. academic.oup.com academic.oup.com/qjmed/article/118/3/154/7825353

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 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7214641/

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 ...

9. mdpi.com mdpi.com/1999-4923/16/8/1079

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 ...