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

NCT ID: NCT03257605

Last Updated: 2017-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

296 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-08-31

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.

Conditions

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Pharmacogenomics Medication Therapy Management

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Coriell Life Sciences

UNKNOWN

Sponsor Role collaborator

Tabula Rasa HealthCare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kevin T Bain, PharmD, MPH

Role: PRINCIPAL_INVESTIGATOR

Tabula Rasa HealthCare

References

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Evans WE, McLeod HL. Pharmacogenomics--drug disposition, drug targets, and side effects. N Engl J Med. 2003 Feb 6;348(6):538-49. doi: 10.1056/NEJMra020526. No abstract available.

Reference Type BACKGROUND
PMID: 12571262 (View on PubMed)

Hocum BT, White JR Jr, Heck JW, Thirumaran RK, Moyer N, Newman R, Ashcraft K. Cytochrome P-450 gene and drug interaction analysis in patients referred for pharmacogenetic testing. Am J Health Syst Pharm. 2016 Jan 15;73(2):61-7. doi: 10.2146/ajhp150273.

Reference Type BACKGROUND
PMID: 26721535 (View on PubMed)

Evans WE, Johnson JA. Pharmacogenomics: the inherited basis for interindividual differences in drug response. Annu Rev Genomics Hum Genet. 2001;2:9-39. doi: 10.1146/annurev.genom.2.1.9.

Reference Type BACKGROUND
PMID: 11701642 (View on PubMed)

Tannenbaum C, Sheehan NL. Understanding and preventing drug-drug and drug-gene interactions. Expert Rev Clin Pharmacol. 2014 Jul;7(4):533-44. doi: 10.1586/17512433.2014.910111. Epub 2014 Apr 19.

Reference Type BACKGROUND
PMID: 24745854 (View on PubMed)

Ferreri SP, Greco AJ, Michaels NM, O'Connor SK, Chater RW, Viera AJ, Faruki H, McLeod HL, Roederer MW. Implementation of a pharmacogenomics service in a community pharmacy. J Am Pharm Assoc (2003). 2014 Mar-Apr;54(2):172-80. doi: 10.1331/JAPhA.2014.13033.

Reference Type BACKGROUND
PMID: 24632932 (View on PubMed)

Haga SB, LaPointe NM, Cho A, Reed SD, Mills R, Moaddeb J, Ginsburg GS. Pilot study of pharmacist-assisted delivery of pharmacogenetic testing in a primary care setting. Pharmacogenomics. 2014 Sep;15(13):1677-86. doi: 10.2217/pgs.14.109.

Reference Type BACKGROUND
PMID: 25410893 (View on PubMed)

Haga SB, Allen LaPointe NM, Moaddeb J, Mills R, Patel M, Kraus WE. Pilot study: incorporation of pharmacogenetic testing in medication therapy management services. Pharmacogenomics. 2014 Nov;15(14):1729-1737. doi: 10.2217/pgs.14.118.

Reference Type BACKGROUND
PMID: 25493566 (View on PubMed)

Moaddeb J, Mills R, Haga SB. Community pharmacists' experience with pharmacogenetic testing. J Am Pharm Assoc (2003). 2015 Nov-Dec;55(6):587-594. doi: 10.1331/JAPhA.2015.15017.

Reference Type BACKGROUND
PMID: 26409205 (View on PubMed)

Welch BM, Kawamoto K. Clinical decision support for genetically guided personalized medicine: a systematic review. J Am Med Inform Assoc. 2013 Mar-Apr;20(2):388-400. doi: 10.1136/amiajnl-2012-000892. Epub 2012 Aug 25.

Reference Type BACKGROUND
PMID: 22922173 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32515286 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31368837 (View on PubMed)

Other Identifiers

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PHARM-GENOME-PACE 1173

Identifier Type: -

Identifier Source: org_study_id

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