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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PGx-guided | Experimental | Pharmacogenetic testing using a 16 gene panel with a pharmacist consult providing genotype-guided recommendations for post-surgery analgesic selection based on CYP2D6 and CYP2C9 results. Pharmacist recommendations for all 16 gene results will also be provided in a detailed note. |
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| Usual care | Other | Pharmacogenetic testing using a 16 gene panel. Post-surgery analgesic selection will be based on usual care (not the PGx results). Pharmacist recommendations for all 16 gene results will be provided in a detailed note with a delayed return of results (30 days post surgery) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacogenetic testing | Other | Genetic testing of CYP2B6, CYP2C19, CYP2C9, CYP2C cluster CYP2D6, CYP3A5, CYP4F2, DPYD, HLA-A, HLA-B, IFNL4, NUDT15, SLCO1B1, TPMT, UGT1A1, and VKORC1. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Integrating a PGx Panel Test in the EMR With a Pharmacist Consult Note for Each Patient | Number of Participants with PGx Test Results and Pharmacist Consult Notes Returned Per Protocol. Before surgery for the PGx-guided arm, and after surgery for the Usual care arm. | 0-30 days |
| Fidelity to Genotype-guided Pharmacotherapy Recommendations | Number of Participants Prescribed Opioids or NSAIDS According to Genotyping | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Pain - Self-reported Numeric Pain Score | Mean patient self-reported numeric pain scores (scale: 0-10, 0 = no pain; 10= worst pain imaginable) assessed on POD 0, 3, 7, 14 in the PGx-guided group vs. the control group | 14 days |
| Total Opioid Consumption in Morphine Milligram Equivalents (MME) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
Data will be made available upon reasonable request.
Study protocol, SAP, ICF will be made available 1 year following enrollment of the last participant. IPD will be made available 6 months after publication of study results
Contact PI, Sony Tuteja, PharmD, sonyt@pennmedicine.upenn.edu with individual requests.
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261 screen failures, 42 missed, 44 declined, and 4 other
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| ID | Title | Description |
|---|---|---|
| FG000 | PGx-guided | Pharmacogenetic testing using a 16 gene panel with a pharmacist consult providing genotype-guided recommendations for post-surgery analgesic selection based on CYP2D6 and CYP2C9 results. Pharmacist recommendations for all 16 gene results will also be provided in a detailed note. Pharmacogenetic testing: Genetic testing of CYP2B6, CYP2C19, CYP2C9, CYP2C cluster CYP2D6, CYP3A5, CYP4F2, DPYD, HLA-A, HLA-B, IFNL4, NUDT15, SLCO1B1, TPMT, UGT1A1, and VKORC1. Pharmacist note with genotype-guided analgesic recommendations: CYP2C9 normal metabolizers will be recommended to receive ibuprofen and intermediate and poor metabolizers will be recommended to receive naproxen. CYP2D6 normal metabolizers will be recommended to receive tramadol and ultrarapid, intermediate and poor metabolizers will be recommended to receive oxycodone. Pharmacist detailed note with genotype-guided recommendations per CPIC guidelines: Genotype-guided recommendations for all actionable phenotypes resulted from the 16-gene PGx panel per CPIC guidelines and FDA labeling |
| FG001 | Usual Care | Pharmacogenetic testing using a 16 gene panel. Post-surgery analgesic selection will be based on usual care (not the PGx results). Pharmacist recommendations for all 16 gene results will be provided in a detailed note with a delayed return of results (30 days post surgery) Pharmacogenetic testing: Genetic testing of CYP2B6, CYP2C19, CYP2C9, CYP2C cluster CYP2D6, CYP3A5, CYP4F2, DPYD, HLA-A, HLA-B, IFNL4, NUDT15, SLCO1B1, TPMT, UGT1A1, and VKORC1. Pharmacist detailed note with genotype-guided recommendations per CPIC guidelines: Genotype-guided recommendations for all actionable phenotypes resulted from the 16-gene PGx panel per CPIC guidelines and FDA labeling |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | PGx-guided | Pharmacogenetic testing using a 16 gene panel with a pharmacist consult providing genotype-guided recommendations for post-surgery analgesic selection based on CYP2D6 and CYP2C9 results. Pharmacist recommendations for all 16 gene results will also be provided in a detailed note. Pharmacogenetic testing: Genetic testing of CYP2B6, CYP2C19, CYP2C9, CYP2C cluster CYP2D6, CYP3A5, CYP4F2, DPYD, HLA-A, HLA-B, IFNL4, NUDT15, SLCO1B1, TPMT, UGT1A1, and VKORC1. Pharmacist note with genotype-guided analgesic recommendations: CYP2C9 normal metabolizers will be recommended to receive ibuprofen and intermediate and poor metabolizers will be recommended to receive naproxen. CYP2D6 normal metabolizers will be recommended to receive tramadol and ultrarapid, intermediate and poor metabolizers will be recommended to receive oxycodone. Pharmacist detailed note with genotype-guided recommendations per CPIC guidelines: Genotype-guided recommendations for all actionable phenotypes resulted from the 16-gene PGx panel per CPIC guidelines and FDA labeling |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Integrating a PGx Panel Test in the EMR With a Pharmacist Consult Note for Each Patient | Number of Participants with PGx Test Results and Pharmacist Consult Notes Returned Per Protocol. Before surgery for the PGx-guided arm, and after surgery for the Usual care arm. | Posted | Count of Participants | Participants | 0-30 days |
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30 days after surgery
Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, plausibly associated with the participant's participation in the research.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PGx-guided | Pharmacogenetic testing using a 16 gene panel with a pharmacist consult providing genotype-guided recommendations for post-surgery analgesic selection based on CYP2D6 and CYP2C9 results. Pharmacist recommendations for all 16 gene results will also be provided in a detailed note. Pharmacogenetic testing: Genetic testing of CYP2B6, CYP2C19, CYP2C9, CYP2C cluster CYP2D6, CYP3A5, CYP4F2, DPYD, HLA-A, HLA-B, IFNL4, NUDT15, SLCO1B1, TPMT, UGT1A1, and VKORC1. Pharmacist note with genotype-guided analgesic recommendations: CYP2C9 normal metabolizers will be recommended to receive ibuprofen and intermediate and poor metabolizers will be recommended to receive naproxen. CYP2D6 normal metabolizers will be recommended to receive tramadol and ultrarapid, intermediate and poor metabolizers will be recommended to receive oxycodone. Pharmacist detailed note with genotype-guided recommendations per CPIC guidelines: Genotype-guided recommendations for all actionable phenotypes resulted from the 16-gene PGx panel per CPIC guidelines and FDA labeling |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sony Tuteja, PI | University of Pennsylvania | 215-573-7834 | Sony.Tuteja@PennMedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 29, 2023 | Jan 20, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000071185 | Pharmacogenomic Testing |
| ID | Term |
|---|---|
| D005820 | Genetic Testing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Post-surgery pharmacogenetic-guided analgesic selection versus usual care analgesia
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| Pharmacist note with genotype-guided analgesic recommendations | Other | CYP2C9 normal metabolizers will be recommended to receive ibuprofen and intermediate and poor metabolizers will be recommended to receive naproxen. CYP2D6 normal metabolizers will be recommended to receive tramadol and ultrarapid, intermediate and poor metabolizers will be recommended to receive oxycodone. |
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| Pharmacist detailed note with genotype-guided recommendations per CPIC guidelines | Other | Genotype-guided recommendations for all actionable phenotypes resulted from the 16-gene PGx panel per CPIC guidelines and FDA labeling |
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Difference in total MME consumption in variant carriers in PGx-guided group vs. control group |
| 14 days |
| BG001 | Usual Care | Pharmacogenetic testing using a 16 gene panel. Post-surgery analgesic selection will be based on usual care (not the PGx results). Pharmacist recommendations for all 16 gene results will be provided in a detailed note with a delayed return of results (30 days post surgery) Pharmacogenetic testing: Genetic testing of CYP2B6, CYP2C19, CYP2C9, CYP2C cluster CYP2D6, CYP3A5, CYP4F2, DPYD, HLA-A, HLA-B, IFNL4, NUDT15, SLCO1B1, TPMT, UGT1A1, and VKORC1. Pharmacist detailed note with genotype-guided recommendations per CPIC guidelines: Genotype-guided recommendations for all actionable phenotypes resulted from the 16-gene PGx panel per CPIC guidelines and FDA labeling |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Usual Care | Pharmacogenetic testing using a 16 gene panel. Post-surgery analgesic selection will be based on usual care (not the PGx results). Pharmacist recommendations for all 16 gene results will be provided in a detailed note with a delayed return of results (30 days post surgery) Pharmacogenetic testing: Genetic testing of CYP2B6, CYP2C19, CYP2C9, CYP2C cluster CYP2D6, CYP3A5, CYP4F2, DPYD, HLA-A, HLA-B, IFNL4, NUDT15, SLCO1B1, TPMT, UGT1A1, and VKORC1. Pharmacist detailed note with genotype-guided recommendations per CPIC guidelines: Genotype-guided recommendations for all actionable phenotypes resulted from the 16-gene PGx panel per CPIC guidelines and FDA labeling |
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| Primary | Fidelity to Genotype-guided Pharmacotherapy Recommendations | Number of Participants Prescribed Opioids or NSAIDS According to Genotyping | For the PGx arm, the outcome was based on the population with results prior to surgery. For the usual care arm, it was based on the whole population. | Posted | Count of Participants | Participants | 14 days |
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| Secondary | Acute Pain - Self-reported Numeric Pain Score | Mean patient self-reported numeric pain scores (scale: 0-10, 0 = no pain; 10= worst pain imaginable) assessed on POD 0, 3, 7, 14 in the PGx-guided group vs. the control group | Eligible participants with at least one survey response. (Please note that outcomes 2 and 3 are unrelated. Outcome 2 relates to if physicians complied with recommended pharmacogenomics pain relief medications. Outcome 3 is for all participants with pain scores unrelated to the PGx results.) | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 14 days |
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| Secondary | Total Opioid Consumption in Morphine Milligram Equivalents (MME) | Difference in total MME consumption in variant carriers in PGx-guided group vs. control group | Not all participants answered all three surveys. Overall participants analyzed notes those who answered at least one. | Posted | Least Squares Mean | 95% Confidence Interval | morphine milligram equivalents | 14 days |
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| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | Usual Care | Pharmacogenetic testing using a 16 gene panel. Post-surgery analgesic selection will be based on usual care (not the PGx results). Pharmacist recommendations for all 16 gene results will be provided in a detailed note with a delayed return of results (30 days post surgery) Pharmacogenetic testing: Genetic testing of CYP2B6, CYP2C19, CYP2C9, CYP2C cluster CYP2D6, CYP3A5, CYP4F2, DPYD, HLA-A, HLA-B, IFNL4, NUDT15, SLCO1B1, TPMT, UGT1A1, and VKORC1. Pharmacist detailed note with genotype-guided recommendations per CPIC guidelines: Genotype-guided recommendations for all actionable phenotypes resulted from the 16-gene PGx panel per CPIC guidelines and FDA labeling | 0 | 53 | 0 | 53 | 0 | 53 |
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| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D008919 | Investigative Techniques |
| D005821 | Genetic Techniques |
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| Day 3 Pain Score among participants prescribed opioids |
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| Day 7 Pain Score among participants prescribed NSAIDs |
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| Day 7 Pain Score among participants prescribed opioids |
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| Day 14 Pain Score among participants prescribed NSAIDs |
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| Day 14 Pain Score among participants prescribed opioids |
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| Postoperative Day 7 |
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| Postoperative Day 14 |
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