DNA Care Pathway for Reducing Side Effects

(GREAT PHARM Trial)

RS
SA
Overseen ByScott Alter, Professor, MD
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: Florida Atlantic University
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?

This trial explores whether DNA testing (pharmacogenomic testing) can help doctors prescribe medications to reduce side effects, such as falls, in older adults taking multiple medications. Participants will provide a cheek swab for DNA analysis. The trial will compare two groups: one where doctors use DNA results to guide prescriptions and another receiving usual care. It targets individuals over 65 who have experienced a fall. Monthly follow-up calls over six months will track falls, injuries, and medication changes. The goal is to determine if DNA-guided prescriptions can enhance medication safety. As an unphased trial, this study offers a unique opportunity to contribute to research that could improve medication safety for older adults.

Do I have to stop taking my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. It seems the study focuses on using DNA results to guide medication prescribing, so you may continue your current medications unless advised otherwise by your doctor.

What prior data suggests that pharmacogenomic testing is safe for optimizing medication prescribing?

Research has shown that DNA testing can help reduce medication side effects by guiding doctors in selecting the right drugs. By examining a patient's genetic makeup, doctors can identify potential drug interactions and side effects before they occur. This enables them to choose safer medications tailored to the individual.

Studies have demonstrated that using DNA information when prescribing can decrease the number of negative side effects patients experience. It acts as a personalized guide, assisting doctors in selecting the best medication plan.

This method improves medication safety by identifying the right drugs and doses for each person, helping to avoid unnecessary side effects. While DNA testing is not a treatment itself, it aids doctors in making better decisions about medications, making them safer and more effective for each unique genetic profile.12345

Why are researchers excited about this trial?

Researchers are excited about pharmacogenomic testing because it tailors medication prescriptions to an individual's genetic makeup, potentially reducing medication side effects and improving efficacy. Unlike current approaches that often rely on trial and error, this method uses genetic insights to guide precise medication choices. This personalized approach helps ensure that patients receive the right drug at the right dose, minimizing adverse reactions and enhancing overall treatment outcomes.

What evidence suggests that pharmacogenomic testing is effective for reducing medication-related side effects in older adults?

Research has shown that genetic testing can make prescribing medications safer and more effective. In this trial, participants in the Pharmacogenomic-Guided Prescribing pathway will have their medications adjusted based on genetic results, which studies have found can greatly reduce side effects. Specifically, patients who had their medications adjusted based on genetic results experienced better outcomes after just three months. This method helps prevent harmful drug reactions, making it a valuable tool in healthcare. Tailoring prescriptions with DNA testing could also lead to fewer falls and injuries among older adults taking multiple medications. Meanwhile, participants in the Emergency Department care pathway will continue with standard prescribing practices without immediate use of pharmacogenomic results.12678

Who Is on the Research Team?

RS

Richard Shih, MD

Principal Investigator

Florida Atlantic University

Are You a Good Fit for This Trial?

This trial is for older adults who take five or more medications and are at risk of falls and medication-related side effects. Participants must be willing to provide a cheek swab for DNA analysis and participate in monthly follow-ups for 6-7 months. The study excludes specific details not provided.

Inclusion Criteria

I am over 65 and have fallen on the same level.

Exclusion Criteria

I am not enrolled in hospice care and do not have a DNR order.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants provide a cheek swab sample for DNA analysis and complete initial assessments

1 day
1 visit (in-person)

Treatment

Participants are randomized into either the Pharmacogenomic-Guided Prescribing pathway or the Emergency Department Care pathway

6-7 months
Monthly follow-up calls

Follow-up

Participants are monitored for safety and effectiveness after treatment through phone calls and medical record reviews

6-7 months
Monthly follow-up calls

What Are the Treatments Tested in This Trial?

Interventions

  • Pharmacogenomic Testing
Trial Overview The study tests if using DNA to guide medication prescribing (DNA Care Pathway) can reduce side effects, like falls, compared to usual care without DNA guidance (Emergency Department Care Pathway). Doctors will either use patients' DNA results or provide standard care until the study ends.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Pharmacogenomic-Guided Prescribing pathwayExperimental Treatment1 Intervention
Group II: Emergency Department care pathway ---controlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Florida Atlantic University

Lead Sponsor

Trials
35
Recruited
10,700+

Citations

A review of real-world evidence on preemptive ...A review of real-world evidence on preemptive pharmacogenomic testing for preventing adverse drug reactions: a reality for future health care.
Effect of pharmacogenomic testing on the clinical treatment ...Effective drug therapy guided by pharmacogenomics can reduce side effects and greatly benefit patients and doctors in clinical decision ...
Pharmacogenomic testing could help reduce adverse drug ...This research highlights the potential of integrating pharmacogenomic testing into clinical practice to make medicines safer and more effective for patients.
Pharmacogenomics Guided Prescription Changes ...Following the prescription changes, the medication effectiveness scores significantly improved to an average of 2.30 (SD = 1.01) at 3 months of ...
Table of Pharmacogenetic AssociationsPharmacogenetic tests, along with other information about patients and their disease or condition, can play an important role in drug therapy.
How Pharmacogenomic Testing Can Improve Medication ...By analyzing an individual's genetic makeup, clinicians can identify potential drug interactions and adverse reactions before prescribing ...
Transforming Pharmacovigilance With PharmacogenomicsIncorporating pharmacogenomic guidance in prescribing is proven to decrease the incidence of adverse reactions and improve clinical outcomes.
Center for Individualized Medicine - Pharmacogenomics ...Pharmacogenomics is the study of how genes affect a person's response to drugs. Indications for pharmacogenomic testing may include:
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security