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

NCT04971902 | Unknown

• 1 other identifier: PGX-PACE-2020-001
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pharmacogenetic Testing; Elderly; Opioid Use; Pain; Pain, Acute; Pain, Chronic

Outcome Measures

Primary Outcomes (9)

• 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

Interventions

Pharmacogenetic Test OTHER

Cheek swab sample with PGx results lab analysis

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patient enrolled in a PACE organization during the implementation period; and,
• PACE organization contractually receiving pharmacy services from CareKinesis
• Patient prescribed a CYP2D6 activated opioid, namely codeine, hydrocodone, oxycodone and/or tramadol
• Patients with chronic non-cancer pain (CNCP)
• Patient's prescriber orders a PGx test based upon his/her determination that the patient could potentially benefit from PGx testing
• Patient is able to read, understand, and provide informed consent to participate

You may not qualify if:

• Patient prescribed an opioid that is not metabolized by CYP2D6 including, but not limited to, oxymorphone, morphine, hydromorphone
• Have taken an investigational product in the last 30 days
• Current use of illicit substances
• Immediate family members of site staff, or site staff may not be enrolled in the study without first obtaining IRB authorization
• 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

Sponsors & Collaborators

• Tabula Rasa HealthCare: lead

Study Sites (1)

Tabula Rasa HealthCare Precision Pharmacotherapy Research and Development Institute

Orlando, Florida, 32827, United States

Location

MeSH Terms

Conditions

Pain; Acute Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Veronique Michaud, PhD

  Tabula Rasa HealthCare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: July 22, 2021
• Study Start: July 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: August 31, 2024
• Last Updated: September 2, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)