Pharmacogenomics Testing for Overmedication

RU
Overseen ByRyley Uber, Pharm.D.
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: Geisinger Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if a special DNA test can help doctors select better medications and doses for older adults. It focuses on individuals taking five or more medications who visit a Geisinger 65 Forward clinic. Some participants will receive a multigene pharmacogenomics test, which uses DNA to guide medication choices, while others will continue with their regular care. Participants who have had a liver or certain stem cell transplants, or who have participated in another genetics study, are not eligible. The goal is to reduce medication problems and healthcare costs for participants. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance medication management for older adults.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop your current medications. However, since the study involves testing the impact of DNA testing on medication selection and dosing, it's possible that changes to your medication regimen could occur.

What prior data suggests that this pharmacogenomics test is safe?

Previous studies have shown promise in testing multiple genes through pharmacogenomics (a DNA test that examines several genes) for making medications safer and more effective. Research indicates that this type of testing is generally well-tolerated. For example, one study found that it improves medication use in primary care, helping doctors select the right drugs and doses for patients.

No reports of serious side effects or adverse events have been linked to the multigene pharmacogenomics test itself. The test usually involves a simple blood draw, a common and low-risk procedure. So far, evidence suggests this testing is safe for study participants.12345

Why are researchers excited about this trial?

Researchers are excited about pharmacogenomics testing for overmedication because it offers a personalized approach to medication management. Unlike the standard practice, which often involves trial and error with medications, this test uses a patient's genetic information to predict how they will respond to different drugs. This means medications can be tailored specifically to the individual's genetic makeup, potentially reducing the risk of overmedication and adverse drug reactions. Additionally, by understanding genetic variations, healthcare providers can make more informed decisions, leading to safer and more effective treatments.

What evidence suggests that this pharmacogenomics test is effective for overmedication?

Research has shown that testing how genes affect medicine response can enhance treatment effectiveness, particularly for older adults. In this trial, participants in the experimental arm will receive a multigene pharmacogenomics test. This test aids doctors in selecting the right medications, potentially reducing healthcare costs and improving treatment outcomes. Testing multiple genes simultaneously, rather than just one, has proven more cost-effective. This approach helps doctors determine the best medicines and doses based on a patient's genetic makeup. By personalizing treatments, patients may experience fewer side effects and achieve better overall results.678910

Who Is on the Research Team?

RU

Ryley Uber, Pharm.D.

Principal Investigator

Geisinger Clinic

Are You a Good Fit for This Trial?

This trial is for older adults who are patients at Geisinger 65 Forward clinics and take five or more medications. It's not open to those who've had liver transplants, stem cell transplants, or were part of the eMERGE pharmacogenomics study.

Inclusion Criteria

I am currently taking 5 or more medications.
Follows at a Geisinger 65 Forward clinic location

Exclusion Criteria

I have had a stem cell transplant from a donor.
Previous enrollment in the Electronic Medical Records and Genomics (eMERGE) pharmacogenomics cohort
I have had a liver transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization

Participants are randomly assigned to either the pharmacogenomics testing group or the standard care group

1 week

Pharmacogenomics Testing

Participants in the experimental arm undergo a multigene pharmacogenomics test with results reported in the medical record

1 month
1 visit (in-person for blood draw)

Follow-up

Participants are monitored for changes in medication therapy, healthcare utilization, and costs of care

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Multigene pharmacogenomics test
Trial Overview The trial is testing a multigene pharmacogenomics test that examines DNA to guide medication choices and dosages for geriatric patients, aiming to improve healthcare outcomes and reduce costs.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Pharmacogenomics TestingExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Geisinger Clinic

Lead Sponsor

Trials
159
Recruited
1,976,000+

Published Research Related to This Trial

Pharmacogenomics can help predict adverse drug reactions (ADRs) by identifying genetic variations that affect how individuals respond to medications, addressing a significant issue in drug safety.
The review highlights successful examples of pharmacogenomics influencing clinical practice and discusses future areas where it could improve drug safety, while also acknowledging the challenges in implementing these tests in healthcare.
The emerging era of pharmacogenomics: current successes, future potential, and challenges.Lee, JW., Aminkeng, F., Bhavsar, AP., et al.[2021]
A staggering 99% of veterans using VHA pharmacy services are projected to carry at least one actionable pharmacogenetic variant, indicating a high potential for personalized medicine to improve drug prescribing.
Over half of the veterans (54.8%) received at least one level A drug that could be influenced by these genetic variants, suggesting that pharmacogenetic testing could significantly impact treatment decisions for commonly prescribed medications.
Projected Prevalence of Actionable Pharmacogenetic Variants and Level A Drugs Prescribed Among US Veterans Health Administration Pharmacy Users.Chanfreau-Coffinier, C., Hull, LE., Lynch, JA., et al.[2020]

Citations

Real-World Impact of Pharmacogenomic Testing on ...Pharmacogenomic (PGx) testing is one tool that may improve medication outcomes in patients with MDD while reducing associated healthcare costs.
Cost Effectiveness of Pharmacogenetic Testing for Drugs ...The objective of this study was to evaluate the evidence on cost‐effectiveness of pharmacogenetic (PGx)–guided treatment for drugs with Clinical ...
Cost-Effectiveness of Multigene Pharmacogenetic Testing ...Multigene testing for Medicare patients post-PCI for ACS has a higher probability of being cost-effective over 24 months and the lifetime compared with single- ...
Cost-Effectiveness of Multigene Pharmacogenomic Testing ...The pharmacist explained that these PGx test results could be used to guide numerous potential future medication reg- imens as well, including certain ...
Navigating Pharmacogenomic Testing in Practice: Who to Test ...There is increasing attention on the clinical utility and value of pharmacogenetic (PGx) testing to individualize medication management.
Pharmacogenetic interventions to improve outcomes in ...Studies involving multi-medicine pharmacogenetics in adults with multimorbidity or polypharmacy, reporting on outcomes derived from relevant core outcome sets, ...
7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/37965783/
Pre-emptive pharmacogenomics implementation among ...Aim: Pre-emptive testing of pharmacogenomic (PGx) variations has potential to improve medication safety and effectiveness; however, ...
Abstracts - 2025 - Clinical Pharmacology & TherapeuticsBACKGROUND: Pharmacogenomic (PGx) testing using multi-gene panels (mgPGx) is documented to improve clinical outcomes; however, real-world data ...
Pharmacogenomic testing to support prescribing in primary ...The application of pharmacogenomics could meaningfully contribute toward medicines optimization within primary care.
Trends in and predictors of patient pharmacogenomic test ...This study examined patient and provider factors associated with PGx test ordering in a national health care system in which panel-based testing was implemented ...
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