MedTrace Logo

The Geriatric Emergency Department Pharmacologic Harm Prevention Project

NCT07216846 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2026-01-08

No results posted yet for this study

Summary

The goal of this project is to determine whether pharmacogenomic testing (using participants' DNA) can help optimize medication prescribing and reduce side effects in older adults taking five or more medications.

The main questions it aims to answer are:

* Can DNA-based prescribing reduce medication-related side effects, especially falls and fall-related injuries?
* Does providing pharmacogenomic results to primary care physicians improve medication safety compared with usual care?

Researchers will compare two groups:

1. DNA Care Pathway: Physicians receive patients' DNA results to guide prescribing.
2. Emergency Department Care Pathway: Physicians provide usual care; DNA results are shared only after study completion.

Participants will:

* Provide a cheek swab sample for DNA analysis (1 minute).
* Receive monthly follow-up phone calls for 6 months to track falls, injuries, medication changes, and side effects.
* Complete a fall and medication calendar.
* Allow researchers to review primary care physician medical records for study outcomes.

Approximately 1,000 participants will take part, with follow-up lasting about 6-7 months.

Conditions

  • Fall
  • Fall Accident
  • Poly Pharmacy
  • Adverse Drug Events
  • Pharmacogenomic Drug Interaction
  • Pharmacogenomic Testing

Interventions

OTHER

DNA care pathway

Pharmacogenomic test results will be transmitted to the participant's primary care physician to support medication optimization and prescribing decisions. Follow-up assessments will be conducted by telephone approximately 14 days after enrollment and then monthly for six months. These structured interviews will capture information on falls, fall-related injuries, medication changes, adverse drug effects, and new medical conditions. Participants will also complete a monthly calendar to document medication changes, falls, and fall-related injuries. Medical records from the participant's primary care physician will be reviewed for corroborating information on falls, fall-related injuries, medication changes, medication-related side effects, and newly diagnosed medical problems.

Sponsors & Collaborators

  • Florida Atlantic University

    lead OTHER

Principal Investigators

  • Richard Shih, MD · Florida Atlantic University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07216846 on ClinicalTrials.gov