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

NCT03225820 | Recruiting

• 3 other identifiers: IRB17-0890U54MD0107233P30AG066619
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Information Seeking Behavior

Keywords

pharmacogenomic information

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Rate of use of pharmacogenomically-identified higher-risk drugs (increased pharmacogenomic risk)

  5 years

• Number of specific pharmacogenomically-informed adverse drug events

  5 years

• Quantitative survey responses from pharmacists' and physicians'

  After the date of discharge for the patient, not to exceed 5 years.

• Quantitative survey responses from patients

  After the date of discharge for the patient, not to exceed 5 years.

• Measure the frequencies of specific genotyped information on African American patients

  Upon patient enrollment, not to exceed 5 years.

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients will comprise the eligible patient population of this study. These patients will be identified through recruitment from the inpatient medicine services at each of the respective institutions, or from relevant clinics or clinical populations that are likely to initiate, or are newly-starting, warfarin therapy.

You may qualify if:

• Patients must be at least 18 years of age.
• Patients must self-identify as African American

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (2)

The University of Illinois at Chicago

Chicago, Illinois, 60607, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

NOT YET RECRUITING

Related Publications (2)

• 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.

  PMID: 40259529 DERIVED

• 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.

  PMID: 34945816 DERIVED

MeSH Terms

Conditions

Information Seeking Behavior

Condition Hierarchy (Ancestors)

Communication; Behavior

Study Officials

• Peter O'Donnell, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer Clinical Trials Office

CONTACT

1-855-702-8222; cancerclinicaltrials@bsd.uchicago.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: July 21, 2017
• Study Start: November 9, 2017
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

US (2)