The Geriatric Emergency Department Pharmacologic Harm Prevention Project

NCT07216846 | Recruiting

• 1 other identifier: 2505160
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Keywords

Fall; Geriatric; Pharmacogenomic; adverse drug event

Outcome Measures

Primary Outcomes (3)

• Recurrent falls -self reported and chart review

  Incidence of recurrent falls during 6-7 months of follow-up. Around the fourteenth day of the study and then once a month for the following six months, participants will receive a follow-up phone call to assess any falls that may have occurred. In addition, each participant will receive a calendar to record falls during the month. At six-month, the primary care physician medical records will be reviewed to check for any additional falls.

  6-7 months

• Incidence of ADE-related ED visits- self reported and chart review

  Incidence of ADE-related ED visits during 6-7 months of follow-up. Around the fourteenth day of the study and then once a month for the following six months, participants will receive a follow-up phone call to assess any ADE-related ED visits that may have occurred. At six-month, the primary care physician medical records will be reviewed to check for any additional ADE-related ED visits.

  Time Frame: 6-7 months

• All-cause mortality - Florida Death Registry

  During 6-7 months of follow-up. All participants will be cross-referenced with the Florida Death Registry to identify mortality outcomes

  Time Frame: 6-7 months

Study Arms (2)

Pharmacogenomic-Guided Prescribing pathway

EXPERIMENTAL

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.

Other: DNA care pathway

Emergency Department care pathway ---control

NO INTERVENTION

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.

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.

Pharmacogenomic-Guided Prescribing pathway

Eligibility Criteria

• Age: 65 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients over the age of 65 with a ground level fall

You may not qualify if:

• hospice and/or DNR status.

Sponsors & Collaborators

• Florida Atlantic University: lead

Study Sites (1)

Delray Medical Center

Delray Beach, Florida, 33484, United States

RECRUITING

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Richard Shih, MD

  Florida Atlantic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Shih, Professor, MD

CONTACT

561-737-7733; rshih@health.fau.edu

Scott Alter, Professor, MD

CONTACT

561-737-7733; alters@health.fau.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Study Record Dates

• First Submitted: October 9, 2025
• First Posted: October 15, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)