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Trial record 3 of 1104 for:    pharmacogenomics OR pharmacogenetics

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

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ClinicalTrials.gov Identifier: NCT03257605
Recruitment Status : Completed
First Posted : August 22, 2017
Last Update Posted : August 22, 2017
Sponsor:
Collaborator:
Coriell Life Sciences
Information provided by (Responsible Party):
Tabula Rasa HealthCare

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.

Condition or disease
Pharmacogenomics Medication Therapy Management

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.

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Study Type : Observational
Actual Enrollment : 296 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Implementation of a Pharmacist-Led Pharmacogenomics Service for the Program of All-inclusive Care for the Elderly (PHARM-GENOME-PACE)
Actual Study Start Date : May 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : August 2017

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.



Primary Outcome Measures :
  1. Implementation Primary [ Time Frame: 24 months ]
    Qualitative description of process-related challenges and successes as assessed by observation


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03257605


Sponsors and Collaborators
Tabula Rasa HealthCare
Coriell Life Sciences
Investigators
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Principal Investigator: Kevin T Bain, PharmD, MPH Tabula Rasa HealthCare

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tabula Rasa HealthCare
ClinicalTrials.gov Identifier: NCT03257605     History of Changes
Other Study ID Numbers: PHARM-GENOME-PACE 1173
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tabula Rasa HealthCare:
Pharmacogenomics
Medication Therapy Management