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临床试验/NCT01600846
NCT01600846已完成不适用

Delivery of Pharmacogenetic Testing in a Primary Care Setting

Duke University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
400
试验地点
1
主要终点
Use of PGx testing

研究概览

简要总结

The purpose of this study is to further integrate pharmacogenetic (PGx) testing into clinical practice by educating physicians about pharmacogenetics and offering testing to their patients. Pharmacogenetic testing may help physicians choose the best drug and dosage for their patients which can reduce side effects, increase effectiveness, and improve patient adherence.

Two clinics will be involved. One clinic will have a pharmacist on-site as a resource to physicians and to advise what patients may benefit from PGx testing; the other clinic will have a pharmacist on call.

Patient and physician perspectives about PGx testing and their utilization will be examined via surveys.

The investigators hypothesize that with education about PGx testing, more physicians will utilize testing.

详细描述

This study aims to assess two delivery models of PGx testing (physician-initiated and pharmacist-initiated) for commonly prescribed drugs in primary care practices and evaluate the delivery of testing from three perspectives: physician, patient, and practice setting. We hypothesize that greater utilization will be influenced by increased physician knowledge and awareness of drugs with PGx testing, comfort in discussing PGx testing with patients and applying results to therapeutic decision-making and positive attitudes towards the testing process. We hypothesize that the pharmacist-initiated approach will result in the most effective use and rapid uptake of PGx testing given the hands-on educational approach with the pharmacist providing expert guidance. We also hypothesize that having a pharmacist with PGx testing expertise as part of the medical team will result in greater physician comfort with test ordering and application of results as compared with the physician-initiated model. In addition, an economic analysis will be conducted to evaluate and compare the costs of each model.

We will also examine patient perspectives about PGx testing and their utilization of test results. We hypothesize that patients who have experienced adverse responses or a poor drug outcome (no response) in the past, are taking chronic medications, and those who are older will be more likely to consent to PGx testing. We hypothesize that patients' increased awareness about their genetic predisposition to adverse responses will result in greater discussion with prescribing physicians and pharmacists about the PGx results when new treatments are prescribed, with greater attention to adverse effects of new drugs and potentially greater medication compliance.

We will implement and evaluate two delivery models of PGx testing into primary care practices: physician-initiated testing and pharmacist-initiated testing. Each practice will be provided an educational intervention and will be surveyed prior to the seminar and following the intervention period to assess primary care practitioner (PCP) knowledge and attitudes about PGx testing. These surveys will take about 10-15 minutes to complete and will be available through an online system like SurveyMonkey.

In the pharmacist-initiated group, a pharmacist based within the practice will identify prescribed drugs with available PGx testing through chart review and provide specific information and recommendations about PGx testing to the ordering physician. In the physician-initiated group, physicians will order testing as they deem necessary, but will also have on-call pharmacist support to consult.

Patients who are offered PGx testing will also be surveyed: once after deciding whether or not to pursue PGx testing and then, if they consent to testing, after they receive their test results. These surveys will take about 10-15 minutes to complete and will be on paper (pretest) and online through a system like SurveyMonkey (post-test). The pretest survey will have 3 sections: demographics, perceived risks and benefits of PGx testing, and satisfaction with test results. The post-test will assess information-seeking behavior, medication adherence, and knowledge of adverse drug reactions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • must be a patient or physician at one of the participating clinics
  • patients must be prescribed a medication that has PGx testing available
  • 18 years of age or older
  • English-speaking

排除标准

  • 未提供

结局指标

主要结局

Use of PGx testing

时间窗: 6 months, 12 months

次要结局

  • Number of adverse drug reactions(6 months, 12 months)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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