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临床试验/NCT01970774
NCT01970774已完成不适用

Assessing Feasibility and Utility of Enhancing Medication Therapy Management With Pharmacist-Delivered Pharmacogenetic Testing

Duke University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Number of recommended drug selection/dosing adjustments

研究概览

简要总结

This study aims to investigate the benefit and feasibility of providing pharmacogenetic (PGx) testing as part of a standard medication therapy management (MTM) session for patients taking multiple medications, a high-risk population for adverse drug reactions and non-response. Research participants will attend two MTM sessions and undergo PGx testing to inform the MTM plan. Participants will also complete 2 surveys pre and post-MTM/PGx testing. Data analysis will assess the impact of MTM/PGx testing on recommendations for drug dosing, clinical outcomes, patient satisfaction, and feasibility of service delivery. Safety issues are minimal with the primary risks being associated with loss of confidentiality, typical discomfort associated with acquiring blood samples, and genetic discrimination.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

  • currently prescribed 3 medications, one of which must be simvastatin or clopidogrel
  • 18 years of age or older
  • English speaking
  • patients of Mahesh Patel or William Kraus at Duke Southpoint Clinic

排除标准

  • if patient has ever had MTM or PGx

结局指标

主要结局

Number of recommended drug selection/dosing adjustments

时间窗: approximately 9 months

Drug selection/doing changes will be compared between study population and chart-review controls

Patient satisfaction with MTM and PGx

时间窗: 3 months after completion of MTM2

This will be assessed by a quantitative survey

Change in clinical biomarkers associated with drug therapy

时间窗: baseline and 2 months

Changes in biomarkers before and after MTM/PGx will be measured. Biomarkers of study group will be compared to chart-review control

次要结局

  • Physician time to perform MTM and PGx(end of study, approx. 9 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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