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PharmacogenomicsPACENCT03257605

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

An observational study of Pharmacogenomics and Medication Therapy Management, run by Tabula Rasa HealthCare.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 years and older
How many people
296 participants
Where
No sites listed yet
Study dates
May 2014to Aug 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: 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.

Read the 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.

Keywords
Pharmacogenomics, Medication Therapy Management

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03257605
Study groupRoleWhat they receive
Study groupParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Implementation Primary

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

    Measured: 24 months

Secondary outcomes (4)

  1. Implementation Secondary

    Qualitative description of pharmacists' roles as assessed by observation

    Measured: 24 months

  2. Pharmacogenomic Testing

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

    Measured: 24 months

  3. Pharmacist Recommendations

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

    Measured: 24 months

  4. Prescriber Acceptances

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

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2017
  2. Study startMay 2014
  3. Primary completionJun 2016
  4. Study completionAug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
296 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03257605
Sponsor's protocol ID
PHARM-GENOME-PACE 1173
Acronym
PACE
Status last verified
Aug 2017
First submitted
17 Aug 2017
Last updated
22 Aug 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 12571262

  • 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.

    PubMed 26721535

  • 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.

    PubMed 11701642

  • 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.

    PubMed 24745854

  • 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.

    PubMed 24632932

  • 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.

    PubMed 25410893

  • 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.

    PubMed 25493566

  • 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.

    PubMed 26409205

  • 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.

    PubMed 22922173

  • 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.

    PubMed 32515286

  • 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.

    PubMed 31368837

Questions about this trial

What is this clinical trial studying?

An observational study of Pharmacogenomics and Medication Therapy Management, run by Tabula Rasa HealthCare.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implementation Primary (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03257605, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.

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