Clinical trial NCT03257605: A Pharmacist Implemented Pharmacogenomics Service in the Program of All-inclusive Care for the Elderly
Official title: Implementation of a Pharmacist-Led Pharmacogenomics Service for the Program of All-inclusive Care for the Elderly (PHARM-GENOME-PACE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pharmacogenomics
Medication Therapy Management
Keywords: Pharmacogenomics
Medication Therapy Management
Lead sponsor: Tabula Rasa HealthCare
Sponsor class: INDUSTRY
Collaborators: name: Coriell Life Sciences
First posted: 2017-08-22
Enrollment: 296
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In the United States, PACE is a medical home model for participants \>=55 years of age who are certified by their state as needing nursing-facility level of care but can reside safely in the community through PACE, as an alternative to institutionalization. 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 were eligible for inclusion.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Implementation Primary
timeFrame: 24 months
Secondary outcomes:
measure: Implementation Secondary
timeFrame: 24 months
measure: Pharmacogenomic Testing
timeFrame: 24 months
measure: Pharmacist Recommendations
timeFrame: 24 months
measure: Prescriber Acceptances
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Tabula Rasa HealthCare
name: Kevin T Bain, PharmD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Bain KT, Knowlton CH, Matos A. Cost avoidance related to a pharmacist-led pharmacogenomics service for the Program of All-inclusive Care for the Elderly. Pharmacogenomics. 2020 Jul;21(10):651-661. doi: 10.2217/pgs-2019-0197. Epub 2020 Jun 9.
citation: Bain KT, Matos A, Knowlton CH, McGain D. Genetic variants and interactions from a pharmacist-led pharmacogenomics service for PACE. Pharmacogenomics. 2019 Jul;20(10):709-718. doi: 10.2217/pgs-2019-0047. Epub 2019 Aug 1.