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 volunteersQualifiers
Patients over the age of 65 with a ground level fall
Disqualifiers
hospice and/or DNR status.
Trial design
Parallel
Treatments tested in this trial
DNA care pathway
Other interventionPharmacogenomic 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
Trial outcomes
Primary outcomes
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.
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.
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
Sponsors and contacts
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