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

Completed

• Conditions: Medication Therapy Management; Pharmacogenomics

• Registration Number: NCT03257605
• Lead Sponsor: Tabula Rasa HealthCare

Brief Summary

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

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 Timeline

• Study Start: 2014-05
• Primary Completion: 2016-06
• Status Verified: 2017-08
• Study Completion: 2017-08
• Study First Submitted: 2017-08-17
• Study First Submitted QC: 2017-08-17
• Last Update Submitted: 2017-08-17
• Study First Posted: 2017-08-22
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 296

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Implementation Primary	24 months	Qualitative description of process-related challenges and successes as assessed by observation

Secondary Outcome Measures

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