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

August 17, 2017 updated by: Tabula Rasa HealthCare

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

296

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Study group
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implementation Primary
Time Frame: 24 months
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
Time Frame: 24 months
Qualitative description of pharmacists' roles as assessed by observation
24 months
Pharmacogenomic Testing
Time Frame: 24 months
Quantitative description of pharmacogenomic testing results as assessed by analysis of genotype and phenotype
24 months
Pharmacist Recommendations
Time Frame: 24 months
Qualitative and quantitative descriptions of pharmacists' pharmacogenomic-based recommendations to prescribers as assessed by evaluation of consultations
24 months
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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tabula Rasa HealthCare

Collaborators

Coriell Life Sciences

Investigators

  • Principal Investigator: Kevin T Bain, PharmD, MPH, Tabula Rasa HealthCare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

August 17, 2017

First Submitted That Met QC Criteria

August 17, 2017

First Posted (Actual)

August 22, 2017

Study Record Updates

Last Update Posted (Actual)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 17, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PHARM-GENOME-PACE 1173

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Information about participants' drugs will not be shared with either the laboratory company or laboratory interpretive company. There will be no disclosure of participant information and no details of participant identity will be part of any presentation or publication of the research. Participant confidentiality will be held in strict trust by the project investigators. This confidentiality extends to any participation-related information as well as biological samples and PGx test results. The project data or other information generated will be held in strict confidence. No information concerning the project or the data will be released to any unauthorized third party without prior written consent.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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