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

NCT ID: NCT03225820

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-09
• Study Completion Date: 2026-03-31

Brief 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.

Detailed 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.

Conditions

Information Seeking Behavior

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Overall Pharmacogenomics

All patients who consent to participation will be preemptively genotyped, at no cost to the patient nor provider. A portion of the enrolled patients will be specifically recruited for the usual care arm (no study-specific PGx information available to providers for these patients). Note that patients who are randomized to the Control Arm will be genotyped, but their results will be withheld (not available via GPS) for at least 90 days. For the warfarin sub-study, treating providers caring for patients assigned to both arms are permitted to dose warfarin according to their own discretion and best practices. In either arm of the study, providers may utilize any available other tools or decision-supports for guiding warfarin dosing, including pharmacy assistance.

NOTE: The purpose of the study is to observe if physicians/pharmacists use the genotyped information to determine prescription habits.

No interventions assigned to this group

Warfarin Sub-Study

All patients who consent to participation will be preemptively genotyped, at no cost to the patient nor provider. A portion of the enrolled patients will be specifically recruited for the warfarin sub-study, in which patients will be randomized in 1:1 fashion to the pharmacogenomics arm of the study. Note that patients who are randomized to the Control Arm will be genotyped, but their results will be withheld (not available via GPS) for at least 90 days. For the warfarin sub-study, treating providers caring for patients assigned to both arms are permitted to dose warfarin according to their own discretion and best practices. In either arm of the study, providers may utilize any available other tools or decision-supports for guiding warfarin dosing, including pharmacy assistance.

NOTE: Warfarin is prescribed as a standard of care drug. The purpose of the study is to observe if physicians/pharmacists use the genotyped information to determine prescription habits.

No interventions assigned to this group

Eligibility Criteria

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.

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

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter O'Donnell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

The University of Illinois at Chicago

Chicago, Illinois, United States

Site Status: RECRUITING

Northwestern University

Chicago, Illinois, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Cancer Clinical Trials Office

Role: CONTACT

cancerclinicaltrials@bsd.uchicago.edu

1-855-702-8222

Facility Contacts

Peter O'Donnell, MD

Role: primary

773-702-7564

Kevin O'Leary, MD

Role: primary

312-926-2537

References

Huang Z, Jack M, O'Leary KJ, Nutescu EA, Chen T, Ruhnke GW, George D, House LK, Knoebel R, Hartman S, Choksi A, Yeo KJ, Perera MA, Ratain MJ, Meltzer DO, O'Donnell PH. Care Team Attributes Predict Likelihood of Utilizing Pharmacogenomic Information During Inpatient Prescribing. Clin Transl Sci. 2025 Apr;18(4):e70193. doi: 10.1111/cts.70193.

Reference Type: DERIVED

PMID: 40259529 (View on PubMed)

Saulsberry L, Danahey K, Middlestadt M, O'Leary KJ, Nutescu EA, Chen T, Lee JC, Ruhnke GW, George D, House L, van Wijk XMR, Yeo KJ, Choksi A, Hartman SW, Knoebel RW, Friedman PN, Rasmussen LV, Ratain MJ, Perera MA, Meltzer DO, O'Donnell PH. Applicability of Pharmacogenomically Guided Medication Treatment during Hospitalization of At-Risk Minority Patients. J Pers Med. 2021 Dec 10;11(12):1343. doi: 10.3390/jpm11121343.

Reference Type: DERIVED

PMID: 34945816 (View on PubMed)

Other Identifiers

U54MD010723

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB17-0890

Identifier Type: -

Identifier Source: org_study_id