Clinical trial NCT03729180: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgery
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 1900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).


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.

Primary outcomes:
measure: The frequency of Genomic Prescribing System (GPS) use by anesthesiologists and pain medicine physicians and associated providers during the perioperative period.
timeFrame: 5 years
measure: Rate of use of high-risk drugs in perioperative setting
timeFrame: 5 years
Secondary outcomes:
measure: Rate of use of favorable drugs in perioperative setting
timeFrame: 5 years
measure: Occurrence of specific pharmacogenomically-informed adverse drug events
timeFrame: 5 years
measure: Pharmacogenomic result availability on pain management services in both arms using a research database for each patient
timeFrame: 5 years
measure: Comparison of pain scores on a 10 point scale
timeFrame: 5 years
measure: Anesthesia and critical care providers knowledge and perceptions of prescribing decisions using a information provided in research database
timeFrame: 5 years
measure: Differences in patient reported satisfaction using research database
timeFrame: 5 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University Of Chicago Medicine Comprehensive Cancer Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Peter O'Donnell
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 2022 Feb 25.
citation: 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.
citation: 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.