The ImPreSS Trial: Pharmacogenomic Decision Making at Time of Surgery

Not Applicable

Recruiting

• Conditions: Surgery
• Interventions: Procedure: Routine Elective Surgery- In patient or out patient elective surgery; Diagnostic Test: Blood test for genetic testing; Other: Drug-genetic Profile

• Registration Number: NCT03729180
• Lead Sponsor: University of Chicago

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 available

Study Timeline

• Study First Submitted: 2018-10-12
• Study First Submitted QC: 2018-10-31
• Study First Posted: 2018-11-02
• Study Start: 2019-01-22
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-29
• Primary Completion: 2025-08-22
• Study Completion: 2025-08-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1900

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Pharmacogenomic (PGx) Arm [Randomization Arm 1]	Blood test for genetic testing	All patients will undergo preemptive genotyping prior to their surgical procedure, and all patients will have pharmacogenomic results made available to providers.
Pain Cohort	Routine Elective Surgery- In patient or out patient elective surgery	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.
Pain Cohort	Blood test for genetic testing	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.
Pain Cohort	Drug-genetic Profile	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.
Pharmacogenomic (PGx) Arm [Randomization Arm 1]	Routine Elective Surgery- In patient or out patient elective surgery	All patients will undergo preemptive genotyping prior to their surgical procedure, and all patients will have pharmacogenomic results made available to providers.
Pharmacogenomic (PGx) Arm [Randomization Arm 1]	Drug-genetic Profile	All patients will undergo preemptive genotyping prior to their surgical procedure, and all patients will have pharmacogenomic results made available to providers.
Control Arm [Randomization Arm 2]	Routine Elective Surgery- In patient or out patient elective surgery	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.
Control Arm [Randomization Arm 2]	Blood test for genetic testing	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.

Primary Outcome Measures

Name	Time	Method
The frequency of Genomic Prescribing System (GPS) use by anesthesiologists and pain medicine physicians and associated providers during the perioperative period.	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	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Of Chicago Medicine Comprehensive Cancer Center; 🇺🇸 Chicago, Illinois, United States