Pilot of Preemptive Pharmacogenetics in Medically Underserved Patients

NCT ID: NCT04630093

Last Updated: 2023-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-13
• Study Completion Date: 2022-06-22

Brief Summary

This is a pragmatic clinical trial of 100 patients who self-identify as black or Latino. Patients with active prescriptions for at least 3 medications and a medication change within the past 6-months will be recruited from the University of Florida (UF) Health primary care clinics for panel-based pharmacogenetic testing. Participants will be followed for 6 months and will undergo assessments with the Treatment Satisfaction Questionnaire for Medication (TSQM) three times (baseline visit, 3-month visit, and 6-month visit post pharmacogenetic testing). In addition, data on effectiveness outcomes and socioeconomic measures will be collected via the electronic health record (EHR) and patient report. Participation is expected to last approximately 6 months and the study will be open for approximately 12-14 months.

Detailed Description

Little information exists regarding clinical implementation of pharmacogenetics in medically underserved patient populations. Preliminary data indicate that underserved patients are prescribed a higher rate of drugs associated with pharmacogenetic guidelines (pharmacogenetic drugs). Thus, an important knowledge gap exists regarding the use of pharmacogenetic in a patient population that may be the most likely to clinically benefit. The objective of this study is to develop key feasibility data to equitably advance preemptive pharmacogenetic testing within UF Health, and to generate important preliminary data to support future larger studies. This objective will be accomplished by pursuing three specific aims: (1) assess the feasibility of preemptive pharmacogenetic clinical implementation in primary care clinics predominantly serving medically underserved patients; (2) understand perspectives about preemptive pharmacogenetic among key stakeholders in the primary care clinics predominantly serving medically underserved patients; and (3) identify specific socioeconomic characteristics most strongly associated pharmacogenetic drug prescription rate.

One hundred patients who self-identify as black or Latino with active prescriptions for at least 3 medications, one of which can be informed by panel-based pharmacogenetic testing, and a medication change within the past 6-months will be recruited from UF Health primary care clinics for panel-based pharmacogenetic testing. Participants will be followed for 6 months and will undergo assessments with the Treatment Satisfaction Questionnaire for Medication (TSQM) three times (at baseline and then again during the 3and 6-month follow-up post pharmacogenetic testing). In addition, data on effectiveness outcomes and socioeconomic measures will be collected via the EHR and patient report. Records for patients receiving care at UF Health primary care clinics will be screened based on inclusion/exclusion criteria for participation in the study. Those that meet criteria will be offered participation. Participation is expected to last approximately 6 months and the study will be open for approximately 12-14 months.

Conditions

Pharmacogenetic Testing

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Panel-based pharmacogenetic genotyping

All patients will receive clinical preemptive pharmacogenetic testing. Genotype results and consult notes will returned in the EHR pre-emptively. Data on implementation success metrics and PROs via patient report and TSQM measures will be collected. In addition, data on effectiveness outcomes and socioeconomic measures will be collected via the EHR and patient report, respectively.

Group Type: EXPERIMENTAL

Panel-based pharmacogenetic genotyping

Intervention Type: DIAGNOSTIC_TEST

A DNA sample by saliva (via mouthwash swish and expectorate collection) or buccal cell (via buccal brush) will be obtained for pharmacogenetic testing and questionnaires will be administered at baseline and then again at 3 months and 6 months after receiving PGx results.

Interventions

Panel-based pharmacogenetic genotyping

A DNA sample by saliva (via mouthwash swish and expectorate collection) or buccal cell (via buccal brush) will be obtained for pharmacogenetic testing and questionnaires will be administered at baseline and then again at 3 months and 6 months after receiving PGx results.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Adults (18 years or older) with active prescriptions for at least 3 medications documented within the EHR.
• At least 1 drug/drug class that could be informed by the pharmacogenetics test panel available at the UF.
• A medication change within the past 6 months (associated with a healthcare provider encounter).
• Self-identify as black or Latino.

Exclusion Criteria

• Patients with any history of pharmacogenetic testing within the EHR.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julio Duarte, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

UF Health at the University of Florida

Gainesville, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

UL1TR001427

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB202002594-N

Identifier Type: -

Identifier Source: org_study_id