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OpenTrials
Completed

NCT Number: NCT03257605

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

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Implementation Primary

    Time frame: 24 months

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

Secondary outcomes

  1. Implementation Secondary

    Time frame: 24 months

    Qualitative description of pharmacists' roles as assessed by observation

  2. Pharmacogenomic Testing

    Time frame: 24 months

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

  3. Pharmacist Recommendations

    Time frame: 24 months

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

  4. Prescriber Acceptances

    Time frame: 24 months

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

Sponsors and collaborators

Lead sponsor

Tabula Rasa HealthCare

Industry

Collaborators

  • Coriell Life Sciences

Registry information

Official study title

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

Acronym: PACE

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Aug 22, 2017
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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