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Pharmacogenetic Testing
+5

Pharmacist-led Pharmacogenomic Clinical Service Within the Program of All-inclusive Care for the Elderly

Sponsored by Tabula Rasa HealthCare

About this trial

Last updated 3 years ago

Study ID

PGX-PACE-2020-001

Status

Enrolling by invitation

Type

Observational

Placebo

No

Accepting

18-75 Years
55+ Years
All
All

Trial Timing

Ended a year ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

1. Patient enrolled in a PACE organization during the implementation period; and,

2. PACE organization contractually receiving pharmacy services from CareKinesis

3. Patient prescribed a CYP2D6 activated opioid, namely codeine, hydrocodone, oxycodone and/or tramadol

4. Patients with chronic non-cancer pain (CNCP)

5. Patient's prescriber orders a PGx test based upon his/her determination that the patient could potentially benefit from PGx testing

6. Patient is able to read, understand, and provide informed consent to participate

No

Exclusion Criteria

1. Patient prescribed an opioid that is not metabolized by CYP2D6 including, but not limited to, oxymorphone, morphine, hydromorphone

2. Have taken an investigational product in the last 30 days

3. Current use of illicit substances

4. Immediate family members of site staff, or site staff may not be enrolled in the study without first obtaining IRB authorization

5. Any other medical, cognitive or physical abnormality, disease, or disorder that would prohibit the patient from completing study procedures in the judgement of the investigator

Locations

Location

Status