Development of a Risk Prediction Screening Tool for Opioid-Prescription Injury (STOP Injury) in Older Adults Initiated on Opioids From the Emergency Department (STOP Injury)
研究概览
地位
条件
详细说明
The experience from this project will lay the groundwork on prospective validation of STOP Injury in a large appropriately powered study. Aim 1 will provide data that will help narrow inclusion of candidate variables in the STOP Injury tool to include those that are most feasible to collect and most predictive. Aim 2 will help inform the possible inclusion of genetic factors into a predictive model. Finally, Aim 3 will help identify quality of life outcomes that should be considered when assessing opioid medication adverse events.
Aim 1. Evaluate the association between prescription opioid adverse events in older adults and candidate risk prediction variables proposed for STOP Injury prediction score The study team will conduct a pilot prospective observational study of 200 patients 50 years or older who are initiated on opioids from the emergency department (ED). The investigators will analyze the association between candidate risk factors and opioid adverse events (falls and OD).
Aim 2. Evaluate the association between prescription opioid adverse events and genetic factors.
In the cohort from Aim 1, the study team will test subjects for 12 genetic single nucleotide polymorphisms related to opioid metabolism, transport, and effect.
Aim 3. Measure the impact of opioid medications on quality of life measures in older adults The investigators will implement a series of quality of life measures on a subset of patients as a pilot study to determine which measures capture the impact prescription opioids have on older adults' quality of life
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
Florida
-
Jacksonville、Florida、美国、32209
- UF Health Jacksonville
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Presenting to UF JAX ED with pain or a pain-related complaint (i.e., fracture, burn, etc.)
- Patient has not used opioids 15 days or more within the last 30 days
- Patient does not have opioid medications at home
- Discharge to home with an opioid prescription
Exclusion Criteria:
- Bed-bound or uses wheelchair
- Living in skilled nursing facility or assisted living facility
- Non-English speaking
- Unable to provide consent
- Incarcerated
- Lack of reliable telephone access
- Use of opioids on most days for >3 months
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Safety, as measured by number of subjects with at least one fall adverse event
大体时间:Up to 30 days
|
The study team will analyze the association between candidate risk factors and opioid adverse events (falls and OD).
|
Up to 30 days
|
合作者和调查者
调查人员
- 首席研究员:Sophia Sheikh, MD、UF College of Medicine--Jacksonville
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.