The Geriatric Emergency Department Pharmacologic Harm Prevention Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Recurrent falls -self reported and chart review
研究概览
简要总结
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.
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 110 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over the age of 65 with a ground level fall
排除标准
- •hospice and/or DNR status.
研究组 & 干预措施
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.
干预措施: DNA care pathway (Other)
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.
结局指标
主要结局
Recurrent falls -self reported and chart review
时间窗: 6-7 months
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
时间窗: Time Frame: 6-7 months
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
时间窗: Time Frame: 6-7 months
During 6-7 months of follow-up. All participants will be cross-referenced with the Florida Death Registry to identify mortality outcomes
次要结局
未报告次要终点
研究者
Richard Shih
Principal Investigator, MD
Florida Atlantic University