Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04971902 |
| Other study ID # |
PGX-PACE-2020-001 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2021 |
| Est. completion date |
August 31, 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
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 PACE organizations with chronic pain and who are prescribed CYP2D6
activated opioids. PGx testing will be performed by contractual PGx vendor with TRHC. PGx
results will be integrated into TRHC's proprietary Clinical Decision Support System
(Medication Risk Mitigation™ Matrix, CareKinesis, Moorestown, NJ) that guides 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 decisions. Clinical pharmacists will
provide medication therapy management recommendation to address medication problems to the
PACE prescriber (physician). PACE prescribers will review the pharmacist's recommendation,
and based on their clinical assessment, the prescriber will decide whether or not to
implement the opioid therapy recommendation.
Description:
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.15 Presently, CareKinesis services
more than 35 PACE organizations, including approximately 75 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 Design 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 PACE organizations with chronic pain and who are prescribed
CYP2D6 activated opioids. PGx testing will be performed by a contractual PGx vendor with
TRHC. PGx results will be integrated into TRHC's proprietary Clinical Decision Support System
(Medication Risk Mitigation™ Matrix, CareKinesis, Moorestown, NJ) that guides 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 decisions. Clinical pharmacists will
provide medication therapy management recommendation to address medication problems to the
PACE prescriber (physician). PACE prescribers will review the pharmacist's recommendation,
and based on their clinical assessment, the prescriber will decide whether or not to
implement the opioid therapy recommendation.
The measurement of health-related quality of life (QoL) and pain assessment using the EQ-5D
survey, and numerical rating scale (NRS) for pain will be performed during the study by PACE
prescribers or the PACE interdisciplinary team (IDT) as follows:
- Health-related quality of life questionnaire (EQ-5D) will be performed at baseline and
at the completion of the study (visits 1 and 3, respectively)
- NRS for pain will be performed at baseline (before the PGx testing), 1-2 and 2-3 weeks
after TRHC's pharmacist recommendations (visits 1, 2 and 3, respectively) All PACE
patients will continue to receive usual medical care throughout the study. Changes to
drug regimens will be at the discretion of the patients' PACE prescribers.
