Information Seeking BehaviorNCT03225820
Implementation of Point-of-Care Pharmacogenomic Decision Support Accounting for Minority Disparities
An observational study of Information Seeking Behavior, run by University of Chicago at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Information Seeking Behavior
- How many people
- 1,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Nov 2017to Mar 2028
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients must be at least 18 years of age.
- Patients must self-identify as African American
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The University of Illinois at Chicago
Chicago, Illinois, 60607
Peter O'Donnell, MD, 773-702-7564
- Not yet recruiting
Northwestern University
Chicago, Illinois, 60611
Kevin O'Leary, MD, (312) 926-2537
About this study
(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.
Read the 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
- Keywords
- pharmacogenomic information
- Medical subject headings
- Information Seeking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 5 years
Secondary outcomes (5)
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.
Measured: 5 years
Number of specific pharmacogenomically-informed adverse drug events
To determine the occurrence of specific pharmacogenomically-informed adverse drug events in both arms.
Measured: 5 years
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.
Measured: After the date of discharge for the patient, not to exceed 5 years.
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.
Measured: After the date of discharge for the patient, not to exceed 5 years.
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.
Measured: Upon patient enrollment, not to exceed 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start9 Nov 2017
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Information Seeking BehaviorStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Peter O'Donnell, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225820
- Sponsor's protocol ID
- IRB17-0890
- Other IDs
- U54MD010723, 3P30AG066619
- Status last verified
- Apr 2026
- First submitted
- 14 Jul 2017
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang Z, O'Leary KJ, Nutescu EA, Jack M, Chen T, Ruhnke GW, Lee JC, George D, House LK, Knoebel R, Rasmussen LV, Hartman S, Choksi A, Yeo KJ, Perera MA, Ratain MJ, Meltzer DO, O'Donnell PH. Results of the ACCOuNT Trial: A Multi-Institutional Prospective Pharmacogenomics Implementation Trial for African American Inpatients. Clin Pharmacol Ther. 2026 Jan;119(1):109-119. doi: 10.1002/cpt.70024. Epub 2025 Aug 22.
PubMed 40847467Huang 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.
PubMed 40259529Saulsberry 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.
PubMed 34945816
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Point-of-Care Pharmacogenomic Decision Support Accounting for Minority Disparities
- ClinicalTrials.gov ID
- NCT03225820
- Acronym / sponsor ID
- IRB17-0890
- Conditions
- Information Seeking Behavior
- Keywords
- pharmacogenomic information
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), National Institute on Aging (NIA)
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
(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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 90 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients must be at least 18 years of age.
- Patients must self-identify as African American
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of Geonomic Prescribing System (GPS) use by physicians and pharmacists
Time frame: Up to 5 years
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.
Number of improved clinical outcomes
Time frame: Up to 5 years
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.
5 secondary outcomes
Rate of use of pharmacogenomically-identified higher-risk drugs (increased pharmacogenomic risk)
Time frame: 5 years
Number of specific pharmacogenomically-informed adverse drug events
Time frame: 5 years
Quantitative survey responses from pharmacists' and physicians'
Time frame: After the date of discharge for the patient, not to exceed 5 years.
Quantitative survey responses from patients
Time frame: After the date of discharge for the patient, not to exceed 5 years.
Measure the frequencies of specific genotyped information on African American patients
Time frame: Upon patient enrollment, not to exceed 5 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Derived from this study: PubMed 40847467Huang Z, O'Leary KJ, Nutescu EA, Jack M, Chen T, Ruhnke GW, Lee JC, George D, House LK, Knoebel R, Rasmussen LV, Hartman S, Choksi A, Yeo KJ, Perera MA, Ratain MJ, Meltzer DO, O'Donnell PH. Results of the ACCOuNT Trial: A Multi-Institutional Prospective Pharmacogenomics Implementation Trial for African American Inpatients. Clin Pharmacol Ther. 2026 Jan;119(1):109-119. doi: 10.1002/cpt.70024. Epub 2025 Aug 22.
- Derived from this study: PubMed 40259529Huang 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.
- Derived from this study: PubMed 34945816Saulsberry 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter O'Donnell, MD principal investigator
University of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Information Seeking Behavior, run by University of Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer Clinical Trials Office (1-855-702-8222, cancerclinicaltrials@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Geonomic Prescribing System (GPS) use by physicians and pharmacists (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03225820, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.