Recruiting

Pharmacogenomic Testing

Sponsor:

Florida Atlantic University

Code:

NCT07216846

Conditions

Fall

Fall Accident

Poly Pharmacy

Adverse Drug Events

Pharmacogenomic Drug Interaction

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

Interventions

DNA care pathway

Study Details

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.

Conditions

Fall

Fall Accident

Poly Pharmacy

Adverse Drug Events

Pharmacogenomic Drug Interaction

Study ID

NCT07216846

Start date

Jan 1, 2026

Status verified date

Jan, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • hospice and/or DNR status.

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

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.

Primary outcome measure

  • Recurrent falls -self reported and chart review [ Time Frame: 6-7 months ]
  • Incidence of ADE-related ED visits- self reported and chart review [ Time Frame: Time Frame: 6-7 months ]
  • All-cause mortality - Florida Death Registry [ Time Frame: Time Frame: 6-7 months ]

Central Contacts and Locations

Central contacts

Richard Shih, Professor, MD

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

Scott Alter, Professor, MD

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

Locations

Delray Medical Center

Recruiting

Delray Beach, Florida, United States, 33484

Contacts

Gabriella Engstrom

gengstr1@health.fau.edu

More Information

Sponsor

Florida Atlantic University

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Keywords

  • Fall
  • Geriatric
  • Pharmacogenomic
  • adverse drug event

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Florida Atlantic University on 2026-01-08.