Pharmacogenomic Testing in a Program of All-inclusive Care for the Elderly (PACE) Setting

NCT05053815 | Unknown

• 1 other identifier: TRHC-PACE-PGX-2021-001
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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. 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. Presently, CareKinesis services approximately 140 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.

Conditions

Pharmacogenomics; Polypharmacy

Outcome Measures

Primary Outcomes (3)

• Evaluate the value of PGx testing for pharmacogenes and subsequent CDSS-informed, pharmacist-led PGx consultation and its impact on recommendations and prescribing decisions.

  Quantitative

  1 year

• Measure PGx-guided interventions on improvement of therapy response.

  Quantitative

  1 year

• Measure PGx-guided interventions on improvement of adverse drug events.

  Quantitative

  1 year

Interventions

Pharmacogenomic Testing OTHER

Pharmacogenomic testing is done via buccal swab. As this study is retrospective, data from PGx testing has already been collected as a part of routine care.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients enrolled in PACE are 55 years of age and older and are eligible for Medicare and Medicaid.

You may qualify if:

• Patient received PGx testing; and
• Patient enrolled in a PACE organization when PGx test results were returned; and
• PACE organization contractually received pharmacy services from CareKinesis upon PGx return of results.

You may not qualify if:

• a) Patient did not receive PGx test results.

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

Interventions

Pharmacogenomic Testing

Intervention Hierarchy (Ancestors)

Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Veronique Michaud

  Tabula Rasa HealthCare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 23, 2021
• Study Start: November 2, 2021
• Primary Completion: November 1, 2023
• Study Completion: March 1, 2024
• Last Updated: September 2, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)