The ImPreSS Trial: Pharmacogenomic Decision Making at Time of Surgery

• ClinicalTrials.gov Identifier: NCT03729180
• Recruitment Status: Recruiting
• First Posted: November 2, 2018
• Last Update Posted: January 29, 2024
• Sponsor: University of Chicago
• Information provided by (Responsible Party): University of Chicago

Tracking Information

• First Submitted Date: October 12, 2018
• First Posted Date: November 2, 2018
• Last Update Posted Date: January 29, 2024
• Actual Study Start Date: January 22, 2019
• Estimated Primary Completion Date: August 22, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 9, 2019)

• 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 ]
  To explore the feasibility and utility of implementing broad preemptive pharmacogenomic testing in the perioperative setting by determining the frequency of Genomic Prescribing System (GPS) use by anesthesiologists and pain medicine physicians and associated providers during the perioperative period.
• Rate of use of high-risk drugs in perioperative setting [ Time Frame: 5 years ]
  To determine the rate of use high-risk drugs (red or yellow pharmacogenomic risk) in the group of patients for whom pharmacogenomic results are available compared to their rate of use (without provider knowledge of pharmacogenomic risk designation) in the control arm.

Original Primary Outcome Measures (submitted: October 31, 2018)

• 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 ]

Current Secondary Outcome Measures (submitted: May 9, 2019)

• Rate of use of favorable drugs in perioperative setting [ Time Frame: 5 years ]
  To determine the occurrence of specific pharmacogenomically-informed adverse drug events in both arms.
• Occurrence of specific pharmacogenomically-informed adverse drug events [ Time Frame: 5 years ]
  To determine the occurrence of specific pharmacogenomically-informed adverse drug events in both arms.
• Pharmacogenomic result availability on pain management services in both arms using a research database for each patient [ Time Frame: 5 years ]
  To explore the effects of pharmacogenomic result availability on pain management services in both arms.
• Comparison of pain scores on a 10 point scale [ Time Frame: 5 years ]
  To compare pain scores between both arms.
• Anesthesia and critical care providers knowledge and perceptions of prescribing decisions using a information provided in research database [ Time Frame: 5 years ]
  To determine anesthesia and critical care providers' knowledge and perceptions of prescribing decisions in order to develop better genomic delivery systems in the future
• Differences in patient reported satisfaction using research database [ Time Frame: 5 years ]
  To determine whether differences in patient-reported satisfaction and adherence likelihood are observable for patients whose providers access and use pharmacogenomic information.

Original Secondary Outcome Measures (submitted: October 31, 2018)

• 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 ]
  Development of a better genomic delivery system by using a research database that will provide Anesthesia and critical care providers knowledge and perceptions of prescribing decisions
• Differences in patient reported satisfaction using research database [ Time Frame: 5 years ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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).

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Surgery

Intervention

• 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.

Study Arms

• Pain Cohort
  Patients with a post-operative pain consult will be included in a pain sub-analysis to assess pain scores, pain therapy administration, and rate of opioid-induced adverse events.
  Interventions:

  • Procedure: Routine Elective Surgery- In patient or out patient elective surgery
  • Diagnostic Test: Blood test for genetic testing
  • Other: Drug-genetic Profile
• Experimental: Pharmacogenomic (PGx) Arm [Randomization Arm 1]
  All patients will undergo preemptive genotyping prior to their surgical procedure, and all patients will have pharmacogenomic results made available to providers.
  Interventions:

  • Procedure: Routine Elective Surgery- In patient or out patient elective surgery
  • Diagnostic Test: Blood test for genetic testing
  • Other: Drug-genetic Profile
• Control Arm [Randomization Arm 2]
  All patients will undergo preemptive genotyping prior to their surgical procedure. Pharmacogenomic test results will not be made available to providers (standard of care). Genotyping results will be released to study providers (and patients) at the 6-month unblinding timepoint for patients in the control group.
  Interventions:

  • Procedure: Routine Elective Surgery- In patient or out patient elective surgery
  • Diagnostic Test: Blood test for genetic testing

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 2022 Feb 25.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 9, 2019): 1900
• Original Estimated Enrollment (submitted: October 31, 2018): 1000
• Estimated Study Completion Date: August 22, 2025
• Estimated Primary Completion Date: August 22, 2025 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Cancer Clinical Trials Office; 1-855-702-8222; cancerclinicaltrials@bsd.uchicago.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03729180
• Other Study ID Numbers: IRB17-1422
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Chicago
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Chicago
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Peter O'Donnell; University of Chicago

• PRS Account: University of Chicago
• Verification Date: January 2024