The ImPreSS Trial: Pharmacogenomic Decision Making at Time of Surgery

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03729180
• Other study ID #: IRB17-1422
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2019
• Est. completion date: August 22, 2025

Study information

• Verified date: January 2024
• Source: University of Chicago
• Contact: Cancer Clinical Trials Office
• Phone: 1-855-702-8222
• Email: cancerclinicaltrials[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1900
• Est. completion date: August 22, 2025
• Est. primary completion date: August 22, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
United States	University Of Chicago Medicine Comprehensive Cancer Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The frequency of Genomic Prescribing System (GPS) use by anesthesiologists and pain medicine physicians and associated providers during the perioperative period.	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.	5 years
Primary	Rate of use of high-risk drugs in perioperative setting	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.	5 years
Secondary	Rate of use of favorable drugs in perioperative setting	To determine the occurrence of specific pharmacogenomically-informed adverse drug events in both arms.	5 years
Secondary	Occurrence of specific pharmacogenomically-informed adverse drug events	To determine the occurrence of specific pharmacogenomically-informed adverse drug events in both arms.	5 years
Secondary	Pharmacogenomic result availability on pain management services in both arms using a research database for each patient	To explore the effects of pharmacogenomic result availability on pain management services in both arms.	5 years
Secondary	Comparison of pain scores on a 10 point scale	To compare pain scores between both arms.	5 years
Secondary	Anesthesia and critical care providers knowledge and perceptions of prescribing decisions using a information provided in research database	To determine anesthesia and critical care providers' knowledge and perceptions of prescribing decisions in order to develop better genomic delivery systems in the future	5 years
Secondary	Differences in patient reported satisfaction using research database	To determine whether differences in patient-reported satisfaction and adherence likelihood are observable for patients whose providers access and use pharmacogenomic information.	5 years