Pharmacogenomic Testing Of the Elderly To Reduce Morbidity
试验速览
- 阶段
- 不适用
- 入组人数
- 280,000
- 试验地点
- 8
- 主要终点
- Occurrence of Meaningful Change in Drug Regimen
研究概览
简要总结
The goal of the POETRY Registry is to determine whether data from Pharmacogenomic (PGx) Testing for elderly and disabled patients can help physicians manage patient medication regimens and assess if the testing has an effect on reducing adverse drug events, hospitalizations, and emergency department visits.
The way an individual processes or metabolizes a drug is in part determined by their genes, and there is known to be genetic variation from one human to another. The study of the way in which genes affect an individual's response to drugs is known as "Pharmacogenomics."
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject underwent PGx testing for the alleles appropriate to the target drugs within the prior 90 days ('index PGx test')
- •Males and females aged ≥65 years or male and females aged ≥18 years who have a disability
- •Subject is able and willing to provide written informed consent
- •Subject was receiving at least one medication known to be associated with allelic variation at the time of the index PGx test, including over-the-counter medications
- •Subject has a history of at least one target drug-related adverse event (TDAE) over the 12-month period preceding receipt of PGx test results, or has experienced inadequate efficacy from a target drug
排除标准
- •Subject is currently hospitalized
- •Subject's medical and medication history is unavailable over the 90-day period preceding the receipt of PGx test results
- •Subject is unable to provide an accurate history due to mental incapacity
- •Subject is known to have undergone prior PGx testing for genes specific to the target drug(s), exclusive of the PGx test relating to this Registry
结局指标
主要结局
Occurrence of Meaningful Change in Drug Regimen
时间窗: 90 days
The primary endpoint of the study is the binary occurrence of meaningful change in drug regimen, defined in each subject when: 1. A genotype known to affect a drug the subject is taking is identified, and 2. The subject's treating physician makes at least one target drug regimen change, dose, substitution, or discontinuation.
次要结局
- Binary occurrence of meaningful change in drug regimen, defined at the gene level over the 90-day period following receipt of PGx test results(90 days)
- Binary occurrence of whether, in the Investigator's opinion, the subject experienced clinical benefit from drug regimen changes made as a result of the PGx test(90 days)
- Number of changes in a subject's target drugs, tabulated on a per-subject basis by number and percentage of target drugs and total drugs(90 days)
- Binary change (yes/no) in the regimen of drugs controlled by genes of interest over the 90-day period preceding PGx testing compared with the change (yes/no) over the 90-day period following receipt of PGx test results(90 days)
- Number of target drug-related adverse events over the 90-day period prior to and following PGx testing(90 days)
- Emergency department visits over the 90-day periods prior to and following PGx testing(90 days)
- Binary occurrence of meaningful change in drug regimen, defined at the drug level over the 90-day period following receipt of PGx test results(90 days)
- Hospitalizations over the 90-day period prior to and following receipt of PGx test results(90 days)