- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05053815
Pharmacogenomic Testing in a Program of All-inclusive Care for the Elderly (PACE) Setting
Retrospective Study Assessing the Value of Pharmacogenomic Testing in a Program of All-inclusive Care for the Elderly (PACE) Setting
Tabula Rasa HealthCare (TRHC), doing business as CareKinesis, is the first national pharmacy that provides science-based medication risk identification and mitigation technologies and services. CareKinesis utilizes medication decision support tools and pharmacists certified in geriatrics to provide pharmacy services for various healthcare organizations including PACE organizations.
Program of All-inclusive Care for the Elderly (PACE) is a Medicare-Medicaid program that provides comprehensive medical and supportive services to individuals >55 years of age who are certified by their state as needing nursing home care. As an alternative to institutionalization, PACE helps these individuals live safely in their community. The aim of PACE is to improve overall quality of life in four domains (physical, psychological, social, and spiritual) using a multidisciplinary approach. In the United States, the vast majority of PACE organizations collaborate with one pharmacy to dispense drugs, in addition to other pharmacy services, for their population of participants. Presently, CareKinesis services approximately 140 PACE sites, across the country. As a national PACE pharmacy provider since 2011, CareKinesis focuses on improving medication regimens to reduce medication-related risks while enhancing economic, clinical and humanistic outcomes.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Florida
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Orlando, Florida, United States, 32827
- Tabula Rasa HealthCare Precision Pharmacotherapy Research and Development Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient received PGx testing; and
- Patient enrolled in a PACE organization when PGx test results were returned; and
- PACE organization contractually received pharmacy services from CareKinesis upon PGx return of results.
Exclusion Criteria:
a) Patient did not receive PGx test results.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the value of PGx testing for pharmacogenes and subsequent CDSS-informed, pharmacist-led PGx consultation and its impact on recommendations and prescribing decisions.
Time Frame: 1 year
|
Quantitative
|
1 year
|
Measure PGx-guided interventions on improvement of therapy response.
Time Frame: 1 year
|
Quantitative
|
1 year
|
Measure PGx-guided interventions on improvement of adverse drug events.
Time Frame: 1 year
|
Quantitative
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TRHC-PACE-PGX-2021-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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