NCT04630093

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

May 13, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2022

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 4, 2023

Completed
Last Updated

October 4, 2023

Status Verified

September 1, 2023

Enrollment Period

1.1 years

First QC Date

November 5, 2020

Results QC Date

August 23, 2023

Last Update Submit

September 14, 2023

Conditions

Pharmacogenetic Testing

Keywords

PharmacogeneticsMedically underservedImplementationEffectiveness

Outcome Measures

Primary Outcomes (1)

  • Change in Global Patient Treatment Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)

    The primary feasibility outcome will be change in patient treatment satisfaction between baseline and 6 months after pharmacogenetic testing. This patient reported outcome will be measured via the TSQM. The TSQM is a validated tool that assesses three medication-related domains (effectiveness, side effects, and convenience) to synthesize a global satisfaction score. TSQM domain scores range from 0 to 100 with higher scores representing higher satisfaction for that each domain.

    6 months

Secondary Outcomes (3)

  • Change in Patient Treatment Effectiveness Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)

    6 months

  • Change in Patient Treatment Side Effect Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)

    6 months

  • Change in Patient Treatment Convenience Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)

    6 months

Study Arms (1)

Panel-based pharmacogenetic genotyping

EXPERIMENTAL

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.

Diagnostic Test: Panel-based pharmacogenetic genotyping

Interventions

Panel-based pharmacogenetic genotypingDIAGNOSTIC_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.

Panel-based pharmacogenetic genotyping

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

Location

Results Point of Contact

Title
Dr. Julio Duarte
Organization
University of Florida
juliod@cop.ufl.edu
352-273-8132

Study Officials

  • Julio Duarte, PharmD, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2020

First Posted

November 16, 2020

Study Start

May 13, 2021

Primary Completion

June 22, 2022

Study Completion

June 22, 2022

Last Updated

October 4, 2023

Results First Posted

October 4, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)