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

NCT03257605 | Completed

• 1 other identifier: PHARM-GENOME-PACE 1173
• Study Type: observational
• Target: 296
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pharmacogenomics; Medication Therapy Management

Keywords

Pharmacogenomics; Medication Therapy Management

Outcome Measures

Primary Outcomes (1)

• Implementation Primary

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

  24 months

Secondary Outcomes (4)

• Implementation Secondary

  24 months

• Pharmacogenomic Testing

  24 months

• Pharmacist Recommendations

  24 months

• Prescriber Acceptances

  24 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tabula Rasa HealthCare: lead
• Coriell Life Sciences: collaborator

Related Publications (11)

• 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.

  PMID: 12571262 BACKGROUND

• 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.

  PMID: 26721535 BACKGROUND

• 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.

  PMID: 11701642 BACKGROUND

• 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.

  PMID: 24745854 BACKGROUND

• 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.

  PMID: 24632932 BACKGROUND

• 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.

  PMID: 25410893 BACKGROUND

• 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.

  PMID: 25493566 BACKGROUND

• 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.

  PMID: 26409205 BACKGROUND

• 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.

  PMID: 22922173 BACKGROUND

• 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.

  PMID: 32515286 DERIVED

• 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.

  PMID: 31368837 DERIVED

Study Officials

• Kevin T Bain, PharmD, MPH

  Tabula Rasa HealthCare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 22, 2017
• Study Start: May 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2017
• Last Updated: August 22, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share