The ImPreSS Trial: Pharmacogenomic Decision Making at Time of Surgery

Official title

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

Overview

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).

Interventions

• Procedure Routine Elective Surgery- In patient or out patient elective surgery
  Participants will be undergoing routine planned surgeries.
• Diagnostic test 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.
• Other 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.

Primary outcome measures

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

Secondary outcome measures (6)

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

Eligibility criteria

Inclusion criteria

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Sequential

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• University Of Chicago Medicine Comprehensive Cancer Center — Chicago

Publications

• 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

Identifiers

NCT: NCT03729180 · IRB17-1422 · 1R01HG009938

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗