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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pain; Pain, Acute; Elderly; Opioid Use; Pain, Chronic; Pharmacogenetic Testing
• Intervention / Treatment: Other: Pharmacogenetic Test

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 2500

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32827
      • Tabula Rasa HealthCare Precision Pharmacotherapy Research and Development Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure the feasibility of Clinical Decision Support System (MedWise(TM)) for CYP2D6 opioid prescription and PGx recommendations by usability and acceptability through physician and pharmacist questionnaire.	Quantitative data reported via survey	6 months
Measure the feasibility of Clinical Decision Support System (MedWise(TM)) for PGx recommendations by acceptability through physician and pharmacist questionnaire.	Quantitative data reported via survey	6 months
Measure the feasibility of Clinical Decision Support System (MedWise(TM)) for PGx recommendations by usability through physician and pharmacist questionnaire.	Quantitative data reported via survey	6 months
Analyze patient medication information for PGx- and DDI-guided recommendations using MedWise(TM) a proprietary clinical decision support system by Tabula Rasa HealthCare.	Quantitative (software is proprietary and patented)	6 months
Analyze clinician uptake of PGx- and DDI-guided recommendations using MedWise(TM) a proprietary clinical decision support system by Tabula Rasa HealthCare.	Quantitative (software is proprietary and patented)	6 months
Validate patient QOL questionnaire for disease-related information	Quantitative data measured by percentage of improvement for DDI-guided recommendations based on PGx results	6 months
Validate patient QOL questionnaire for pharmacogenetics information	Quantitative data measured by percentage of improvement for DDI-guided recommendations based on PGx results	6 months
Validate patient QOL questionnaire for medication-related information, and pharmacogenetics information	Quantitative data measured by percentage of improvement for DDI-guided recommendations based on PGx results	6 months
Validate patient QOL questionnaire for socio-demographics	Quantitative data measured by percentage of improvement for DDI-guided recommendations based on PGx results	6 months

Collaborators and Investigators

• Sponsor: Tabula Rasa HealthCare
• Investigators: Principal Investigator: Veronique Michaud, PhD, Tabula Rasa HealthCare

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): August 31, 2024

Study Registration Dates

• First Submitted: February 15, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): September 2, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Acute Pain
• Other Study ID Numbers: PGX-PACE-2020-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No