Implementation of Point-of-Care Pharmacogenomic Decision Support Accounting for Minority Disparities

Information Seeking Behavior Clinical Trial

Official title:

Implementation of Point-of-Care Pharmacogenomic Decision Support Accounting for Minority Disparities

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03225820
• Other study ID #: IRB17-0890
• Secondary ID: U54MD010723
• Status: Recruiting
• Start date: November 9, 2017
• Est. completion date: September 2024

Study information

• Verified date: April 2023
• Source: University of Chicago
• Contact: Cancer Clinical Trials Office
• Phone: 1-855-702-8222
• Email: cancerclinicaltrials[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

(a) To explore the feasibility and utility of implementing broad preemptive pharmacogenomic result delivery in the inpatient setting across multiple institutions specifically with the goal of incorporating minority-specific pharmacogenomic information; (b) To determine whether clinical outcomes for the drug warfarin are improved in African Americans through the availability of pharmacogenomics-based dosing guidance at the point-of-care.

Description:

This study aims to determine whether preemptively obtained pharmacogenomic information can be delivered and utilized at the point-of-care across multiple institutions specifically in African American patients at risk for minority health disparities. The investigators have chosen the high-stakes, rapid-paced setting of inpatient medicine for this implementation study. The investigators seek to examine whether the availability of pharmacogenomic information improves prescribing.

The investigators will enroll adults at one of three institutions, The University of Chicago, University of Illinois at Chicago, and Northwestern University. During an initial (enrollment) hospital inpatient encounter, patients will be consented and a blood sample will be obtained for preemptive genotyping across a panel of actionable germline variants predicting drug response or toxicity risk. Patients will also be targeted for enrollment who are highly likely to initiate future warfarin therapy. Patients will be recruited to two primary cohorts. In the feasibility cohort, all patients will have their actionable pharmacogenomic results (with decision support) available to inpatient treating physicians for the duration of the study, once genotyping is completed, via the Genomic Prescribing System (GPS). Physicians and pharmacists will be individually approached for enrollment through a process of direct stakeholder engagement and informed consent. Participating providers will give permission for their medication decisions to be analyzed. Providers will never be instructed how to practice nor how to prescribe, and it is their choice whether or not to use GPS. GPS accession, use, and all medications prescribed throughout the admission will be passively recorded by the research team, for all patients, and an analysis of the impact of GPS results and decision-supports will be performed.

For the African American warfarin cohort, patients newly-starting warfarin will be enrolled at the time of new warfarin initiation and then randomized such that their treating physicians and pharmacists either have access to African American-specific warfarin dosing guidance via GPS, or not. The frequency of unfavorable (high-risk) scenarios related to warfarin-related clinical outcomes will be examined in each group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must be at least 18 years of age.

• Patients must self-identify as African American

Exclusion Criteria:

• Patients who have undergone, or are being actively considered for, liver or kidney transplantation.

• Patients with known active or prior leukemia.

• Inability to understand and give informed consent to participate.

• For patients being recruited to the warfarin sub-study, those with a glomerular filtration rate or creatinine clearance <30 mL/min34.

Related Conditions & MeSH terms

• Information Seeking Behavior

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	The University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Geonomic Prescribing System (GPS) use by physicians and pharmacists	To explore the feasibility and utility of implementing broad preemptive pharmacogenomic result delivery for African Americans in the inpatient setting across multiple institutions by determining the frequency of Genomic Prescribing System (GPS) use by physicians and pharmacists caring for self-identified African American patients.	Up to 5 years
Primary	Number of improved clinical outcomes	To determine whether African-American-specific pharmacogenomic and clinical dosing guidance results in improved clinical outcomes related to warfarin compared to dosing without such guidance.	Up to 5 years
Secondary	Rate of use of pharmacogenomically-identified higher-risk drugs (increased pharmacogenomic risk)	To determine the rate of use of pharmacogenomically-identified higher-risk drugs (increased pharmacogenomic risk) in patients for whom pharmacogenomic results are available, comparing specifically patients whose providers access GPS during an admission versus when their providers do not.	5 years
Secondary	Number of specific pharmacogenomically-informed adverse drug events	To determine the occurrence of specific pharmacogenomically-informed adverse drug events in both arms.	5 years
Secondary	Quantitative survey responses from pharmacists' and physicians'	To determine pharmacists' and physicians' knowledge, attitudes and perceptions of prescribing including pharmacogenomic-informed prescribing by providing a survey for the appropriate individuals to complete.	After the date of discharge for the patient, not to exceed 5 years.
Secondary	Quantitative survey responses from patients	To determine whether differences in patient-reported satisfaction and adherence likelihood are observable for patients whose providers access and use pharmacogenomic information by providing a survey for the appropriate individuals to complete.	After the date of discharge for the patient, not to exceed 5 years.
Secondary	Measure the frequencies of specific genotyped information on African American patients	To develop a repository of information on genotyped African American patients receiving care by a preemptive genotype.	Upon patient enrollment, not to exceed 5 years.