Implementation of a Pharmacist-led Pharmacogenomic Clinical Service

NCT04984538 | Withdrawn

• 1 other identifier: PGX-INITIATIVE-TRHC-2020-002
• Study Type: observational
• Target: N/A
• 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 (described above). Presently, CareKinesis services more than 35 PACE organizations, including approximately 100 PACE sites, across the United States. 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. Pharmacist-led PGx clinical services and medication safety reviews are currently being offered to PACE organizations under the direction of licensed healthcare prescribers by TRHC (CareKinesis). Our aim is to extend and meticulously study PGx testing for more PACE patients and conduct a prospective preemptive PGx study to determine feasibility of implementation and effect on outcomes. After mutual agreement, these services may also be extended to other organizations where TRHC provides pharmacy services, and data will be collected with patient consent.

Conditions

Adverse Drug Event; Drug Drug Interaction; Pharmacogenomics; Elderly

Outcome Measures

Primary Outcomes (2)

• To measure success of implementation of the PGx consultation process, including TRHC's CDSS (providing patient-specific PGx and phenotypic reviews)

  Quantitative

  1 year

• Assess uptake of recommendations based on PGx is associated with improved outcomes in patients

  Quantitative

  1 year

Secondary Outcomes (2)

• To determine usability of implementation of PGx consult during the process of medication review as measured by clinician response to survey.

  1 year

• To determine the acceptability of recommendations provided on the basis of PGx information as measured by acceptance of the recommendation and changes in prescription made after information provided.

  1 year

Interventions

Pharmacogenomic Testing OTHER

Cheek swab 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: Non-Probability Sample

Study Population

Tabula Rasa Healthcare (TRHC) partners with Programs of All-inclusive Care for the Elderly (PACE) that provides comprehensive medical and supportive services for community-dwelling persons, mostly older adults (\>55 years), as an alternative to institutionalization. The aim of PACE is to improve overall quality of life in four domains (physical, psychological, social, and spiritual) using a multidisciplinary approach.

You may qualify if:

• Patients meeting all the following criteria will be included:
• Patient is enrolled in a healthcare organization where TRHC provides pharmacy services during the implementation period;
• Patient is able to understand, and provide informed consent to participate.

You may not qualify if:

• Patients with one of the following criteria will be excluded:
• Have taken an investigational product in the last 30 days;
• Current use of illicit substances;
• 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 and/or the prescriber.

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

Drug-Related Side Effects and Adverse Reactions

Interventions

Pharmacogenomic Testing

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

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, PhD

  Tabula Rasa HealthCare

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: July 30, 2021
• Study Start: July 1, 2021
• Primary Completion: January 30, 2023
• Study Completion: January 30, 2023
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)