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Идёт набор NCT03225820

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

Наблюдательное Information Seeking Behavior

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Information Seeking Behavior. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

(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.

Подробное описание

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.

Первичные конечные точки

  • Frequency of Geonomic Prescribing System (GPS) use by physicians and pharmacists [Срок оценки: Up to 5 years]
  • Number of improved clinical outcomes [Срок оценки: Up to 5 years]
Вторичные конечные точки (5)
  • Rate of use of pharmacogenomically-identified higher-risk drugs (increased pharmacogenomic risk) [Срок оценки: 5 years]
  • Number of specific pharmacogenomically-informed adverse drug events [Срок оценки: 5 years]
  • Quantitative survey responses from pharmacists' and physicians' [Срок оценки: After the date of discharge for the patient, not to exceed 5 years.]
  • Quantitative survey responses from patients [Срок оценки: After the date of discharge for the patient, not to exceed 5 years.]
  • Measure the frequencies of specific genotyped information on African American patients [Срок оценки: Upon patient enrollment, not to exceed 5 years.]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 2 центра
  • The University of Illinois at Chicago — Chicago
  • Northwestern University — Chicago

Публикации

  • 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
  • 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: PMID 34945816

Идентификаторы

NCT: NCT03225820 · IRB17-0890 · U54MD010723 · 3P30AG066619

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗