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临床试验/NCT03748355
NCT03748355已完成不适用

Using Pharmacogenetics to Identify Patients With Polypharmacy at Risk of Medication Adverse Effects

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年10月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
80
试验地点
2
主要终点
Reduction of Potential Drug Interactions

研究概览

简要总结

The Researchers are trying to learn more about how individuals break down and process medications based on their genes. The Researchers want to find out whether subjects will have fewer side effects if they take different medications based on their pharmacogenomics profile.

详细描述

The Researchers are trying to learn more about how individuals break down and process medications based on their genes. The Researchers are doing this in order to assess the number of potential genotype-based drug interactions and side effects in patients with polypharmacy as well as to assess the number of potential individualized (based on the patient's genotype) drug interactions and side effects in these patients. After completing the OneOme genetic testing and relaying those results to the patients care team, the Researchers will then assess, at 30 days post-recommendations, whether the medication recommendations to reduce individualized drug interactions and adverse effects were followed, and (2) whether the adverse effects decrease compared to admission.

Patients will be recruited from the inpatient units listed in the inclusion criteria and, upon admission, each patient will complete a 24 item questionnaire measuring medication side effects, have a review of their medications for potential drug-drug and drug-genotype interactions (classified as low, medium or high risk), and then undergo the buccal swab to collect the DNA cells which will then be sent to OneOme for analysis. When the results are available, the study investigators will review the medications again for potential drug-drug and drug-genotype interactions and then communicate to the patients clinical team those results and whether medication changes are recommended to minimize the drug-drug and drug-genotype interactions.

Thirty days after the recommendations are communicated to the patient's clinical team, the patient will be contacted by phone. During this phone call, the following information will be obtained:

  1. The patient's current medication list.
  2. The patient's 24 item questionnaire measuring medication side effects.
  3. The patient's one item self rating of improvement Once this phone call is completed, the research team will determine whether the medication recommendations were followed by the patient's clinical team, whether the adverse effects decreased compared to hospital admission, and whether the patient reported improvement.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 18 and older
  • Hospitalized on Generose 2E (Acute Care Psychiatry), 3E (Medical and Geriatric Psychiatry), or 3W (Mood Disorders Unit).
  • A voluntary patient
  • Having 5 or more medications (scheduled or as needed) on their medication list.
  • Ability to give informed consent

排除标准

  • Patient with cognitive impairments such as moderate to severe dementia.
  • Patients who do not communicate in English or cannot comprehend the rating scales used.
  • Patients who have had pharmacogenetics testing performed within the previous 5 years.

结局指标

主要结局

Reduction of Potential Drug Interactions

时间窗: 30 days

Reduction of potential drug interactions risk measured by the numbers in low, medium and high categories.

次要结局

  • Reduction of Side Effects(30 days)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Simon Kung

Principal Investigator

Mayo Clinic

研究点 (2)

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