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

Trial Summary

What is the purpose of this trial?

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 UF Health EDs.

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 data supports the effectiveness of the treatment Panel-based pharmacogenetic genotyping?

Research shows that using genetic testing to guide drug prescriptions can improve treatment success and reduce adverse reactions. For example, preemptive genotyping (testing before treatment) has been shown to prevent adverse events in patients taking certain medications, suggesting that genetic testing can make drug therapy safer and more effective. ^{1 2 3 4 5}

Is genetic testing for emergency care generally safe for humans?

Research shows that using genetic testing to guide drug prescriptions can reduce adverse drug reactions, making it a safer option for patients. Studies have demonstrated that preemptive genotyping can prevent severe adverse events and improve patient safety by tailoring medication choices to individual genetic profiles. ^{1 4 6 7 8}

How does genetic testing for emergency care differ from other treatments?

Genetic testing for emergency care is unique because it uses a patient's genetic information to guide drug prescribing, potentially reducing adverse drug reactions and improving treatment outcomes. This approach is more personalized compared to standard treatments, which do not typically consider individual genetic differences. ^{2 3 4 6 7}

Research Team

Julio D Duarte, Pharm.D., Ph.D.

Principal Investigator

University of Florida

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of a HLA-B*15:02 screening policy on antiepileptic drug use and severe skin reactions. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

Pharmacogenomic Biomarkers for Improved Drug Therapy-Recent Progress and Future Developments. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Clinical Implementation of Pharmacogenetic Testing in a Hospital of the Spanish National Health System: Strategy and Experience Over 3 Years. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Optimizing drug outcomes through pharmacogenetics: a case for preemptive genotyping. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Implementation of pharmacogenetic testing in medication reviews in a hospital setting. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Genotype-guided drug prescribing vs. usual care reduced clinically relevant adverse drug reactions at 12 wk. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Use of a multi-gene pharmacogenetic panel reduces adverse drug effects. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Implementation of preemptive testing of a pharmacogenomic panel in clinical practice: Where do we stand? [2023]