The Geriatric Emergency Department Pharmacologic Harm Prevention Project

NCT ID: NCT07216846

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-12-31

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:

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.

Detailed Description

Background and Rationale Medication prescribing is one of the most common medical interventions. In the U.S., 81% of adults report taking at least one medication in the past week, and 50% take prescription medications. Among older adults, 39% meet the criteria for polypharmacy, defined as the use of five or more chronic medications.

Polypharmacy is strongly associated with adverse drug events (ADEs). Each day, approximately 750 older adults in the U.S. are hospitalized due to ADEs, with half of these patients taking five or more medications. Nearly 60% of older adults are prescribed at least one potentially unnecessary medication.

Traditional prescribing often follows a "one-size-fits-all" approach, which does not account for genetic differences in how individuals metabolize drugs. These genetic variations can lead to ineffective treatment or harmful side effects. Pharmacogenomic-guided prescribing may provide a safer, more personalized approach by identifying drug-gene interactions and tailoring medication choices.

Falls and Medication Safety Falls are one of the most serious and preventable ADEs among older adults. Falls are the leading cause of injury-related morbidity and mortality in older populations, with over 700,000 hospital falls in the U.S. annually. Polypharmacy, especially the use of fall-risk-increasing drugs (FRIDs), contributes substantially to this problem.

By integrating pharmacogenomic testing into medication management, clinicians may be able to reduce fall-related ADEs and improve overall prescribing safety.

Study Objectives and Aims The Geriatric Emergency Department Pharmacologic Harm Prevention Project (The GREAT PHARM) seeks to evaluate whether pharmacogenomic-guided prescribing can reduce ADEs and falls among older adults.

Aim 1: Compare the incidence of recurrent falls, ADE-related emergency department (ED) visits, and all-cause mortality in patients receiving pharmacogenomic-guided medication optimization versus usual care.

Secondary Aim 1: Assess barriers to implementing pharmacogenomic-based prescribing. Aim 2: Determine the prevalence of harmful gene-drug interactions and abnormal drug levels in older adults presenting to the ED after a fall.

Aim 3: Compare self-reported wellbeing and health satisfaction between patients who receive pharmacogenomic-guided prescribing and those receiving usual care.

Study Design

• This is a randomized clinical trial enrolling approximately 1,000 participants aged 65 and older.
• Eligibility: Adults ≥65 years presenting to the ED with a ground-level fall.
• Exclusion criteria: Hospice care or Do Not Resuscitate (DNR) status.

Randomization: Participants will be randomized (via REDCap) into two study arms:

1. Control Group (Current Care) - Standard prescribing practices; pharmacogenomic results provided to primary care physicians only after study completion.

2. Intervention Group (Pharmacogenomic-Guided Prescribing) - Standard care plus pharmacogenomic results provided to the primary care physician during the study for medication optimization.

Interventions

All participants will:

• Provide a one-time cheek swab sample for DNA analysis (testing 26 metabolic enzyme systems).
• If blood is drawn for routine ED care, provide an additional small blood sample (~5cc) for drug-level analysis. Blood concentrations will be assessed using mass spectrometry at the Florida Atlantic University Bioanalytical Core Facility.
• Complete a monthly calendar to record medication changes, falls, and fall-related injuries.
• Participate in monthly follow-up phone calls (for 6-7 months) to track falls, side effects, and overall health.
• Authorize access to primary care physician medical records for up to one year to confirm study outcomes.

Outcome Measures

Primary Outcomes:

1. Incidence of recurrent falls during 6-7 months of follow-up.

2. Incidence of ADE-related ED visits.

3. All-cause mortality.

Secondary Outcomes:

1. Prevalence of harmful gene-drug interactions in older adults presenting with falls.

2. Prevalence of abnormal drug levels in patients with pharmacogenomic variations.

3. Patient-reported wellbeing and health satisfaction.

4. Barriers to implementation of pharmacogenomic-guided prescribing.

Duration of Participation Each participant will be followed for approximately 6-7 months, with ongoing monitoring through phone calls, calendars, and medical record review.

Significance This trial will evaluate whether personalized prescribing guided by DNA testing can reduce medication-related harm, prevent recurrent falls, and improve overall quality of life for older adults. If successful, the study will provide strong evidence for integrating pharmacogenomic-guided prescribing into standard clinical care for geriatric patients at risk of medication-related harm.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

DNA care pathway

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• hospice and/or DNR status.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Florida Atlantic University

OTHER

Sponsor Role: lead

Responsible Party

Richard Shih

Principal Investigator, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Shih, MD

Role: PRINCIPAL_INVESTIGATOR

Florida Atlantic University

Locations

Delray Medical Center

Delray Beach, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Richard Shih, Professor, MD

Role: CONTACT

rshih@health.fau.edu

561-737-7733 ext. 87410

Scott Alter, Professor, MD

Role: CONTACT

alters@health.fau.edu

561-737-7733 ext. 87410

Facility Contacts

Gabriella Engstrom

Role: primary

gengstr1@health.fau.edu

Other Identifiers

2505160

Identifier Type: -

Identifier Source: org_study_id