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The ImPreSS Trial: Pharmacogenomic Decision Making at Time of Surgery

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ClinicalTrials.gov Identifier: NCT03729180
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease Intervention/treatment Phase
Surgery Procedure: Routine Elective Surgery- In patient or out patient elective surgery Diagnostic Test: Blood test for genetic testing Other: Drug-genetic Profile Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1900 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The ImPreSS Trial: Implementation of Point-of-Care Pharmacogenomic Decision Support in Perioperative Care
Actual Study Start Date : January 22, 2019
Estimated Primary Completion Date : August 22, 2023
Estimated Study Completion Date : August 22, 2025

Arm Intervention/treatment
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.
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.

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.
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.

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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Comparison of pain scores on a 10 point scale [ Time Frame: 5 years ]
    To compare pain scores between both arms.

  5. 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

  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729180


Contacts
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Contact: Tien M Truong 773-834-3717 truongtm@medicine.bsd.uchicago.edu

Locations
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United States, Illinois
University Of Chicago Medicine Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Emily Schierer    773-753-1200    theimpresstrial@uchicago.edu   
Principal Investigator: Peter O'Donnell, MD         
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Peter O'Donnell University of Chicago

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03729180     History of Changes
Other Study ID Numbers: IRB17-1422
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019

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