The Geriatric Emergency Department Pharmacologic Harm Prevention Project

Conditions

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

Eligibility Criteria

Sex

ALL

Age

65 Years - 110 Years

Healthy Volunteers

Not accepted

Interventions

• DNA care pathway — OTHER
  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.

Study Details

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.

Key Dates

Start date

Jan 1, 2026

Status verified

Jan 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

1,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Pharmacogenomic-Guided Prescribing 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.
• No Intervention: Emergency Department care pathway ---control
  Participants randomized to the current Emergency Department care pathway will continue to receive standard prescribing practices without immediate use of pharmacogenomic results. Follow-up assessments will occur by telephone approximately 14 days after enrollment and then monthly for six months. These calls will collect data on falls, fall-related injuries, medication changes, adverse drug effects, and new medical conditions. Participants will also complete a monthly calendar documenting medication changes, falls, and fall-related injuries. Medical records from the participant's primary care physician will be reviewed to identify additional falls, injuries, medication changes, side effects, and new medical problems. At the conclusion of the study, pharmacogenomic testing results will be provided to the participant's primary care physician to support future prescribing decisions.

Primary Outcome Measure

Recurrent falls -self reported and chart review [ Time Frame: 6-7 months ]

Central Contacts

• Richard Shih, Professor, MD
  561-737-7733
  [email protected]
• Scott Alter, Professor, MD
  561-737-7733
  [email protected]

Locations (1)

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