Pharmacogenetic-guided Choice of Post-surgery Analgesics
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Pain
- Sponsor
- University of Pennsylvania
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Feasibility of integrating a PGx panel test in the EMR with a pharmacist consult note for each patient
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Pharmacogenomics (PGx) is the study of how genes affect a person's response to drugs. PGx testing for certain genes can help predict the risk of side effects or therapeutic failure from analgesics. Testing is not regularly performed in clinical practice due to long wait times for results and challenges with integrating test results in the electronic health record. Investigators leading this study hope to find out if providing surgeons with the ability to order a PGx test and electronically receive results with dosing recommendations will increase the use of these tests to guide analgesic choice and improve patient outcomes.
This is a prospective, two-arm randomized implementation study. Eligible participants will be randomly assigned to receive genotype-guided analgesic selection (intervention arm) or usual care (control arm). Both cohorts will undergo pharmacogenetic testing at the time of consenting. The investigators will primarily measure the feasibility of using this test to guide analgesic selection.
Investigators
Sony Tuteja
Research Assistant Professor of Medicine, Division of Translational Medicine and Human Genetics; Assistant Director, Pharmacogenomics Penn Center for Precision Medicine
University of Pennsylvania
Eligibility Criteria
Inclusion Criteria
- •Able and willing to provide informed consent
- •Assigned female at birth and aged 18 years or older at the time of study initiation
- •Major gynecologic surgery indicated and planned for hysterectomy, myomectomy, exploratory laparotomy, and open abdominal surgery
- •Willing to provide a buccal swab for PGx testing and comply with all study-related procedures
Exclusion Criteria
- •Receiving chronic opioid therapy defined as ≥ 3 consecutive months of 1-month prescriptions for an opioid
- •Breastfeeding
- •Treating physician does not want subject to participate
Outcomes
Primary Outcomes
Feasibility of integrating a PGx panel test in the EMR with a pharmacist consult note for each patient
Time Frame: 14 days
The proportion of PGx test results and pharmacist consult notes returned prior to surgery
Fidelity to genotype-guided pharmacotherapy recommendations
Time Frame: 14 days
The proportion of medication selections made in agreement with the genotype-guided dosing recommendations for analgesic medications.
Secondary Outcomes
- Total opioid consumption in morphine milligram equivalents (MME)(14 days)
- Acute pain - Self-reported numeric pain score(14 days)