The ImPreSS Trial: Implementation of Point-of-Care Pharmacogenomic Decision Support in Perioperative Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,900
- 试验地点
- 2
- 主要终点
- The frequency of Genomic Prescribing System (GPS) use by anesthesiologists and pain medicine physicians and associated providers during the perioperative period.
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients who have planned elective surgical procedures at the University of Chicago
- •Must be aged 18 years or older
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Routine Elective Surgery- In patient or out patient elective surgery (Procedure)
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.
干预措施: Blood test for genetic testing (Diagnostic Test)
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.
干预措施: Drug-genetic Profile (Other)
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.
干预措施: Routine Elective Surgery- In patient or out patient elective surgery (Procedure)
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.
干预措施: Blood test for genetic testing (Diagnostic Test)
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.
干预措施: Drug-genetic Profile (Other)
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.
干预措施: Routine Elective Surgery- In patient or out patient elective surgery (Procedure)
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.
干预措施: Blood test for genetic testing (Diagnostic Test)
结局指标
主要结局
The frequency of Genomic Prescribing System (GPS) use by anesthesiologists and pain medicine physicians and associated providers during the perioperative period.
时间窗: 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.
Rate of use of high-risk drugs in perioperative setting
时间窗: 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.
次要结局
- Rate of use of favorable drugs in perioperative setting(5 years)
- Anesthesia and critical care providers knowledge and perceptions of prescribing decisions using a information provided in research database(5 years)
- Differences in patient reported satisfaction using research database(5 years)
- Occurrence of specific pharmacogenomically-informed adverse drug events(5 years)
- Comparison of pain scores on a 10 point scale(5 years)
- Pharmacogenomic result availability on pain management services in both arms using a research database for each patient(5 years)