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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Implementation of a Pharmacist-Led Pharmacogenomics Service for the Program of All-inclusive Care for the Elderly (PHARM-GENOME-PACE)

Conditions
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Pharmacogenomics, Medication Therapy Management

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Participants enrolled in PACE who underwent pharmacogenomics testing as part of their medical care and also consented to the use of their de-identified data for research purposes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation Primary | Qualitative description of process-related challenges and successes as assessed by observation | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation Secondary | Qualitative description of pharmacists' roles as assessed by observation | 24 months | 
| Pharmacogenomic Testing | Quantitative description of pharmacogenomic testing results as assessed by analysis of genotype and phenotype | 24 months | 
| Pharmacist Recommendations | Qualitative and quantitative descriptions of pharmacists' pharmacogenomic-based recommendations to prescribers as assessed by evaluation of consultations | 24 months | 
| Prescriber Acceptances | Qualitative and quantitative descriptions of prescribers' acceptances of pharmacists' recommendations as assessed by responses and post-consultation drug profile reviews | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacogenomics, Medication Therapy Management