Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT04984538 |
Other study ID # |
PGX-INITIATIVE-TRHC-2020-002 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 1, 2021 |
Est. completion date |
January 30, 2023 |
Study information
Verified date |
January 2023 |
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 (described above). Presently, CareKinesis services more than 35 PACE
organizations, including approximately 100 PACE sites, across the United States. 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. Pharmacist-led PGx clinical services and medication safety reviews are currently
being offered to PACE organizations under the direction of licensed healthcare prescribers by
TRHC (CareKinesis). Our aim is to extend and meticulously study PGx testing for more PACE
patients and conduct a prospective preemptive PGx study to determine feasibility of
implementation and effect on outcomes. After mutual agreement, these services may also be
extended to other organizations where TRHC provides pharmacy services, and data will be
collected with patient consent.
Description:
This project aims to include patients enrolled in PACE organizations or other healthcare
organizations serviced by TRHC. PGx testing will be performed by a vendor contracted by TRHC
(CLIA certified). Genetic testing for CYP450 isoforms like CYP2B6, CYP2C9, CYP2C19, CYP2D6,
and CYP3A5, and transporters like SLCO1B1, ABCB1, and ABCG2 will be conducted, along with
other genes in individual vendors' testing panel. The results will be integrated into TRHC's
proprietary CDSS (Medication Risk Mitigation Matrix, Tabula Rasa Healthcare, Moorestown, NJ).
Phenotypes related to CYP450 isoforms will be used to guide pharmacists to identify drug-drug
interactions (DDIs), drug-gene interactions (DGIs), and drug-drug-gene interactions
(DDGIs).(16) Clinical pharmacists will translate PGx results combined with a comprehensive
DDI review into actionable clinical recommendations. Prescribers will review the pharmacist's
recommendation, and based on their clinical assessment will decide whether or not to
implement the therapy recommendation. Endpoints like number and type of pharmacist
recommendations and uptake by physicians, follow-up drug regimens, and outcomes will be
collected for up to 12 months [baseline (data from the previous year), 3, 6 and 12 months
post-PGx intervention] for each patient to get a longitudinal perspective of implementing PGx
into CDSS systems.