Pharmacogenetic Testing: Challenges of Clinical Integration

描述(由申请人提供)：药物遗传学(PGx)测试与初级保健的整合正在迅速发展。据估计，四分之一的门诊患者正在服用产品标签中含有PGx信息的药物，其中大部分是由初级保健医生开出的。我们之前从亲本R01(R01 GM081416，Haga，Pi)所做的工作表明，公众对PGx检测非常感兴趣。然而，由于缺乏对可用的测试的认识，缺乏关于遗传学和药物反应的知识，缺乏确凿的临床证据，关于何时以及为哪些药物或患者订购测试的问题，以及对覆盖范围和报销的担忧，医生对将PGx测试整合到临床实践中的热情不高。因此，为了提高医生的知识，解决如何以及何时将PGx测试整合到临床护理中的问题，并促进将PGx测试整合到治疗决策中，这项更新提案将侧重于评估PGx测试的交付模式。我们将在初级保健实践中实施和评估两种PGx检测交付模式：医生发起的测试和药剂师发起的测试。将为每种做法提供教育干预(研讨会、内联网模块和带有适用的PGx测试的药物袖珍指南)。在医生发起的小组中，医生也将得到随叫随到的药剂师支持。在药剂师发起的小组中，执业药剂师将通过图表检查确定可进行PGx测试的处方药，并向订购医生提供有关PGx测试的具体信息和建议。这项拟议的研究旨在从三个角度评估PGx检测的交付：医生、患者和执业环境。提供模式的有效性将通过以下指标来评估：与干预前6个月和干预后6个月相比，目标药物的新处方和新近处方(少于1个月)的剂量调整和不良反应次数以及每次诊所就诊次数，以评估任何变化的变化和持久性(目标1)。在研究开始和结束时，将对每种做法的提供者进行调查，以评估对PGx测试的知识和态度的变化，以及对测试的感知价值和障碍(目标2)。同样，我们将跟踪接受PGx检测的患者，以探索检测的感知价值和风险、影响他们做出检测决定的因素，以及他们对基于检测结果的治疗的满意度(目标3)。我们还将进行经济分析，以评估和比较与每种交付模式相关的成本，以及与靶向药物相关的成本、相关的监测成本和药物不良事件(目标4)。这些结果将提供关于在初级保健实践中整合PGx检测的两种交付模式的吸收、影响、障碍和成本的基本信息。 公共卫生相关性：通过增加医生对PGx检测的知识和认识，并为医生提供有关PGx检测的初级或二级药剂师支持，我们希望确定并克服采用适当的PGx检测的障碍，并促进PGx检测在初级保健实践中的无缝集成，以改善临床结果。

DESCRIPTION (provided by applicant): The integration of pharmacogenetic (PGx) testing into primary care is rapidly evolving. It has been estimated that one-fourth of outpatients are taking medications containing PGx information in their product labels, the majority of which are prescribed by primary care physicians. Our previous work from the parent R01 (R01 GM081416, Haga, PI) indicated that the general public is very interested in PGx testing. However, physicians are less enthusiastic about integrating PGx testing into clinical practice, due lack of awareness of available tests, lack of knowledge about genetics and drug response, lack of conclusive clinical evidence, questions about when to order testing and for which drugs or patients, and concerns regarding coverage and reimbursement. Thus, to improve physician knowledge, address issues about how and when to integrate PGx testing into clinical care, and to facilitate integration of PGx testing into therapeutic decision-making this renewal proposal will focus on assessing delivery models of PGx testing. 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 (seminars, Intranet module, and pocket guide of drugs with applicable PGx testing). In the physician-initiated group, physicians will also have on-call pharmacist support. 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. The proposed study aims to evaluate the delivery of PGx testing from three perspectives: physician, patient, and practice setting. Effectiveness of the delivery models will be evaluated by the number of dosage adjustments and adverse responses for new and recent prescriptions (less than 1month) of target drugs and number of office visits in each practice during the 6- month intervention period compared to the 6 months prior to the intervention and the 6 months following the intervention in order to assess change and durability of any changes (Aim 1). Providers in each practice will be surveyed at the start and conclusion of the study to assess changes in knowledge and attitudes of PGx testing and perceived value of and barriers to testing (Aim 2). Similarly, we will follow-up with patients offered PGx testing to explore the perceived value and risks of testing, factors influencing their decision about testing, , and their satisfaction with treatment based on the test result (Aim 3). We will also perform an economic analysis to evaluate and compare the costs associated with each delivery model as well as costs associated with targeted medications, associated monitoring costs, and adverse drug events (Aim 4). These results will provide essential information on the uptake, impact, barriers, and cost of two delivery models for integration of PGx testing in primary care practices. PUBLIC HEALTH RELEVANCE: By increasing physician knowledge and awareness of PGx testing and by providing physicians with primary or secondary pharmacist support on PGx testing, we hope to identify and overcome barriers to the uptake of appropriate PGx testing and to facilitate a seamless integration of PGx testing in primary care practices to improve clinical outcomes.