Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT05053815 |
Other study ID # |
TRHC-PACE-PGX-2021-001 |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
|
First received |
|
Last updated |
|
Start date |
November 2, 2021 |
Est. completion date |
March 1, 2024 |
Study information
Verified date |
September 2022 |
Source |
Tabula Rasa HealthCare |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
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.
Description:
Pharmacist-led pharmacogenomics (PGx) clinical services and medication safety reviews are
currently being offered to PACE organizations under the direction of licensed healthcare
prescribers by CareKinesis d/b/a Tabula Rasa HealthCare. This project aims to include
patients enrolled in the PACE organization who received PGx testing. PGx testing was
performed by one of several contracted PGx vendors with TRHC (e.g., Corriel, CQuentia,
OneOme) at the time. Upon return from the laboratory, PGx results were integrated into TRHC's
proprietary Clinical Decision Support System (Medication Risk Mitigation™ Matrix,
CareKinesis, Moorestown, NJ) that guides pharmacists to identify DDIs, DGIs, and DDGIs. As
part of this workflow, clinical pharmacists utilized PGx results combined with a
comprehensive DDI review (via PGx consult, medication safety review, and/or polypharmacy
call) to inform their recommendations to PACE prescribers to address medication problems,
including those related to DDIs, DGIs, and/or DDGIs (drug-induced phenoconversion). Upon
reviewing the pharmacist's recommendation(s) and based on their clinical assessment, PACE
prescribers decided whether to implement the recommended changes. This current study plans to
collect data retrospectively from the past six years (2016-2021) on specific PGx test
results, genotype-guided and interacting drugs, and recommendations, in order to look for any
patterns that may help optimize the process of PGx consultation and/or PGx-guided
recommendations, with the ultimate goal of reducing adverse drug events and improving patient
outcomes.