Pharmacogenetic-guided Choice of Post-surgery Analgesics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Feasibility of integrating a PGx panel test in the EMR with a pharmacist consult note for each patient
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Pharmacogenetic testing (Other)
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.
干预措施: Pharmacist note with genotype-guided analgesic recommendations (Other)
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.
干预措施: Pharmacist detailed note with genotype-guided recommendations per CPIC guidelines (Other)
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)
干预措施: Pharmacogenetic testing (Other)
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)
干预措施: Pharmacist detailed note with genotype-guided recommendations per CPIC guidelines (Other)
结局指标
主要结局
Feasibility of integrating a PGx panel test in the EMR with a pharmacist consult note for each patient
时间窗: 14 days
The proportion of PGx test results and pharmacist consult notes returned prior to surgery
Fidelity to genotype-guided pharmacotherapy recommendations
时间窗: 14 days
The proportion of medication selections made in agreement with the genotype-guided dosing recommendations for analgesic medications.
次要结局
- Total opioid consumption in morphine milligram equivalents (MME)(14 days)
- Acute pain - Self-reported numeric pain score(14 days)
研究者
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