The ImPreSS Trial: Pharmacogenomic Decision Making at Time of Surgery

Официальное название

The ImPreSS Trial: Implementation of Point-of-Care Pharmacogenomic Decision Support in Perioperative Care

Обзор

The study is enrolling adults who are scheduled for either inpatient or outpatient elective surgical procedures at The University of Chicago. At pre-operative visits, 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. Genotyping results will be delivered to participating providers as patient-specific drug-gene clinical decision support summaries using a secured Web portal, the Genomic Prescribing System (GPS). Participating anesthesiologists and critical care and pain management physicians and associated providers from the Department of Anesthesia and Critical Care at the University of Chicago will be invited to receive results for their participating patients. There will be an initial 6- month "run-in" period of the study comprised of approximately 100 enrolled adults in which all patients will have pharmacogenomic results made available to providers. The run-in period will allow for process refinement and GPS delivery to be examined and optimized prior to the randomized phase After the initial run-in period, patients will be randomized to one of two arms - in the pharmacogenomic arm, providers will have access to GPS and pharmacogenomic information, whereas in the control arm, providers will not have access to GPS and patient-specific pharmacogenomic information (current standard of care).

Вмешательства

• Процедура Routine Elective Surgery- In patient or out patient elective surgery
  Participants will be undergoing routine planned surgeries.
• Диагностический тест Blood test for genetic testing
  Blood test to determine differences in genes which may affect how certain medications affect the participant. All patients will consent to collection of a blood sample for preemptive genotyping across a panel of actionable germline variants predicting drug response or toxicity risk.
• Другое Drug-genetic Profile
  Profile describing drugs that may be high-risk, those that should be used with caution, or drugs that are favorable to use based on the participants genes.

Первичные конечные точки

• The frequency of Genomic Prescribing System (GPS) use by anesthesiologists and pain medicine physicians and associated providers during the perioperative period. [Срок оценки: 5 years]
• Rate of use of high-risk drugs in perioperative setting [Срок оценки: 5 years]

Вторичные конечные точки (6)

• Rate of use of favorable drugs in perioperative setting [Срок оценки: 5 years]
• Occurrence of specific pharmacogenomically-informed adverse drug events [Срок оценки: 5 years]
• Pharmacogenomic result availability on pain management services in both arms using a research database for each patient [Срок оценки: 5 years]
• Comparison of pain scores on a 10 point scale [Срок оценки: 5 years]
• Anesthesia and critical care providers knowledge and perceptions of prescribing decisions using a information provided in research database [Срок оценки: 5 years]
• Differences in patient reported satisfaction using research database [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Adult patients who have planned elective surgical procedures at the University of Chicago
• Must be aged 18 years or older

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.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University Of Chicago Medicine Comprehensive Cancer Center — Chicago

Публикации

• Truong TM, Apfelbaum JL, Danahey K, Schierer E, Ludwig J, George D, House L, Karrison T, Shahul S, Anitescu M, Choksi A, Hartman S, Knoebel RW, van Wijk XMR, Yeo KJ, Meltzer DO, Ratain MJ, O'Donnell PH. Pilot Findings of Pharmacogenomics in Perioperative Care: Initial Results From the First Phase of the ImPreSS Trial. Anesth Analg. 2022 Nov 1;135(5):929-940. doi: 10.1213/ANE.0000000000005951. Epub PMID 35213469
• Truong TM, Apfelbaum JL, Schierer E, Danahey K, Borden BA, Karrison T, Shahul S, Anitescu M, Gerlach R, Knoebel RW, Meltzer DO, Ratain MJ, O'Donnell PH. Anesthesia providers as stakeholders to adoption of pharmacogenomic information in perioperative care. Pharmacogenet Genomics. 2022 Apr 1;32(3):79-86. doi: 10.1097/FPC.0000000000000455. PMID 34570085
• Truong TM, Apfelbaum J, Shahul S, Anitescu M, Danahey K, Knoebel RW, Liebovitz D, Karrison T, van Wijk XMR, Yeo KJ, Meltzer D, Ratain MJ, O'Donnell PH. The ImPreSS Trial: Implementation of Point-of-Care Pharmacogenomic Decision Support in Perioperative Care. Clin Pharmacol Ther. 2019 Dec;106(6):1179-1183. doi: 10.1002/cpt.1567. Epub 2019 Aug 21. No abstract available. PMID 31433489

Идентификаторы

NCT: NCT03729180 · IRB17-1422 · 1R01HG009938

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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