The Geriatric Emergency Department Pharmacologic Harm Prevention Project

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-110
SponsorFlorida Atlantic University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients over the age of 65 with a ground level fall

Disqualifiers

hospice and/or DNR status.

Trial design

Design model

Parallel

Treatments tested in this trial

  • DNA care pathway

    Other intervention

    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.

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Pharmacogenomic-Guided Prescribing pathwayExperimental treatment 1 intervention
Group B: Emergency Department care pathway ---controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
6-7 months
2

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
Time Frame: 6-7 months
3

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
Time Frame: 6-7 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.