A Pharmacist Implemented Pharmacogenomics Service in the Program of All-inclusive Care for the Elderly

Tabula Rasa HealthCare296 enrolled

Overview

The aim of this study is to evaluate and describe the feasibility of implementing a pharmacist-led pharmacogenomics service for the Program of All-inclusive Care for the Elderly (PACE), a community-based practice setting.

To determine if a pharmacogenomics (PGx) service can become a component of everyday practice, feasibility assessments are needed. While some researchers have begun to assess the feasibility of implementing PGx into pharmacy practice in community-based practice settings, none that we are aware have assessed such feasibility for the Program of All-inclusive Care for the Elderly (PACE). The primary objective of this feasibility study is to evaluate the processes that were involved in implementing a pharmacist-led PGx service for PACE and to describe process-related challenges and solutions associated with implementation. Secondary objectives include: describe pharmacists' roles in the implementation process; report aggregate PGx test results, including genetic variants and drug-gene interactions; and describe pharmacists' recommendations to personalize drug regimens for PACE participants and prescribers' acceptance of these recommendations.

Study Type

OBSERVATIONAL

Enrollment

296

Conditions

Pharmacogenomics Medication Therapy Management

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participant enrolled in PACE contractually receiving pharmacy services from Tabula Rasa Healthcare (CareKinesis Pharmacy) during the project time period (May 2014 through June 2016); and * PACE prescriber ordered a pharmacogenomics test for the participant as part of clinical care; and, * PACE participant consented to a pharmacogenomics test; and, * CareKinesis pharmacist provided a consultation directly to PACE prescriber based on the participant's pharmacogenomics test results. Exclusion Criteria: * Participant dis-enrolled from PACE prior to receiving pharmacogenomics test results and/or prior to CareKinesis pharmacist providing consultative services; or, * Participant did not complete the pharmacogenomics test.

Outcomes

Primary Outcomes

Implementation Primary

Qualitative description of process-related challenges and successes as assessed by observation

Time frame: 24 months

Secondary Outcomes

Implementation Secondary

Qualitative description of pharmacists' roles as assessed by observation

Time frame: 24 months

Pharmacogenomic Testing

Quantitative description of pharmacogenomic testing results as assessed by analysis of genotype and phenotype

Time frame: 24 months

Pharmacist Recommendations

Qualitative and quantitative descriptions of pharmacists' pharmacogenomic-based recommendations to prescribers as assessed by evaluation of consultations

Time frame: 24 months

Prescriber Acceptances

Qualitative and quantitative descriptions of prescribers' acceptances of pharmacists' recommendations as assessed by responses and post-consultation drug profile reviews

Time frame: 24 months

Data from ClinicalTrials.gov

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