跳至主要内容
临床试验/NCT05053815
NCT05053815Enrolling By Invitation不适用

Retrospective Study Assessing the Value of Pharmacogenomic Testing in a Program of All-inclusive Care for the Elderly (PACE) Setting

Tabula Rasa HealthCare1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2021年11月2日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
1,500
试验地点
1
主要终点
Evaluate the value of PGx testing for pharmacogenes and subsequent CDSS-informed, pharmacist-led PGx consultation and its impact on recommendations and prescribing decisions.

研究概览

简要总结

Tabula Rasa HealthCare (TRHC), doing business as CareKinesis, is the first national pharmacy that provides science-based medication risk identification and mitigation technologies and services. CareKinesis utilizes medication decision support tools and pharmacists certified in geriatrics to provide pharmacy services for various healthcare organizations including PACE organizations.

Program of All-inclusive Care for the Elderly (PACE) is a Medicare-Medicaid program that provides comprehensive medical and supportive services to individuals >55 years of age who are certified by their state as needing nursing home care. As an alternative to institutionalization, PACE helps these individuals live safely in their community. The aim of PACE is to improve overall quality of life in four domains (physical, psychological, social, and spiritual) using a multidisciplinary approach. In the United States, the vast majority of PACE organizations collaborate with one pharmacy to dispense drugs, in addition to other pharmacy services, for their population of participants. Presently, CareKinesis services approximately 140 PACE sites, across the country. As a national PACE pharmacy provider since 2011, CareKinesis focuses on improving medication regimens to reduce medication-related risks while enhancing economic, clinical and humanistic outcomes.

详细描述

Pharmacist-led pharmacogenomics (PGx) clinical services and medication safety reviews are currently being offered to PACE organizations under the direction of licensed healthcare prescribers by CareKinesis d/b/a Tabula Rasa HealthCare. This project aims to include patients enrolled in the PACE organization who received PGx testing. PGx testing was performed by one of several contracted PGx vendors with TRHC (e.g., Corriel, CQuentia, OneOme) at the time. Upon return from the laboratory, PGx results were integrated into TRHC's proprietary Clinical Decision Support System (Medication Risk Mitigation™ Matrix, CareKinesis, Moorestown, NJ) that guides pharmacists to identify DDIs, DGIs, and DDGIs. As part of this workflow, clinical pharmacists utilized PGx results combined with a comprehensive DDI review (via PGx consult, medication safety review, and/or polypharmacy call) to inform their recommendations to PACE prescribers to address medication problems, including those related to DDIs, DGIs, and/or DDGIs (drug-induced phenoconversion). Upon reviewing the pharmacist's recommendation(s) and based on their clinical assessment, PACE prescribers decided whether to implement the recommended changes. This current study plans to collect data retrospectively from the past six years (2016-2021) on specific PGx test results, genotype-guided and interacting drugs, and recommendations, in order to look for any patterns that may help optimize the process of PGx consultation and/or PGx-guided recommendations, with the ultimate goal of reducing adverse drug events and improving patient outcomes.

研究设计

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

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

  • •Patient received PGx testing; and
  • •Patient enrolled in a PACE organization when PGx test results were returned; and
  • •PACE organization contractually received pharmacy services from CareKinesis upon PGx return of results.

排除标准

  • •a) Patient did not receive PGx test results.

结局指标

主要结局

Evaluate the value of PGx testing for pharmacogenes and subsequent CDSS-informed, pharmacist-led PGx consultation and its impact on recommendations and prescribing decisions.

时间窗: 1 year

Quantitative

Measure PGx-guided interventions on improvement of adverse drug events.

时间窗: 1 year

Quantitative

Measure PGx-guided interventions on improvement of therapy response.

时间窗: 1 year

Quantitative

次要结局

未报告次要终点

研究者

发起方
Tabula Rasa HealthCare
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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