ImPreSS Trial: Implementation of Point‐of‐Care Pharmacogenomic Decision Support in Perioperative Care
The goal of the ImPreSS Trial is to develop a model of implementing point-of-care pharmacogenomic decision support in the perioperative care setting. Anesthesiologists and critical care and pain management physicians and associated providers (nurse anesthetists, physician assistants, and pharmacists) within the Department of Anesthesia and Critical Care (DACC) will be targeted for enrollment through a process of direct stakeholder engagement and informed consent. Adult patients with planned elective inpatient or outpatient surgeries will be eligible for the study. Enrolled patients provide a blood sample during their pre-operative clinic at the Anesthesia Perioperative Medicine Clinic (APMC), which is sent to our CLIA-certified laboratory for genotyping, and results will be available before the patient’s surgical admission. Patients’ genotyping results will be delivered to providers through our online web portal, the Genomic Prescribing System (GPS), which is currently integrated into our institutional electronic medical record.
There will be an initial 6 month run-in period in which a small cohort of 100 will all have their pharmacogenomics results made available to participating treating providers. The purpose of the run-in period is to allow for process evaluation and refinement of pharmacogenomic information delivery. After the initial run-in period, genotyped patients will be prospectively randomized in a 1:1 ratio at the time of surgical admission to one of two treatment arms. In the pharmacogenomics arm (n=900), treating providers who care for the patient during the course of the surgical admission will have access to GPS and the patients’ pharmacogenomic information, whereas in the control arm (n=900), GPS and patient-specific pharmacogenomic information will be withheld from the providers, approximating current standard of care. All medications administered/prescribed will be tracked for both arms. Providers and patients will be asked to complete a survey after each surgical admission. Providers will also be asked to complete a questionnaire every 6 months during the study to assess general knowledge and understanding of, in addition to attitudes towards, pharmacogenomics. The primary outcome is to compare the rate of use of high pharmacogenomic risk drugs between the two groups.
Our institutional Data and Analytics Core will be utilized for a key sub-analysis to collect pain care quality data and assess pain management services for both arms, including pain assessment (patient reported pain scores using a 11-point numeric scale; determined from EMR), pain therapy administration, and rate of opioid-induced adverse drug events (ADEs). Reported ADEs will be reviewed to determine whether they were due to prescribed or administered medications during the admission, and whether these medication choices were potentially the result of pharmacogenomics related decision-support delivered to providers in the context of this study.
The link to the clinicaltrials.gov website for this study can be found here.
Truong TM, Apfelbaum J, Shahul S, et al. The ImPreSS Trial: Implementation of Point-of-Care Pharmacogenomic Decision Support in Perioperative Care. Clin Pharmacol Ther. 2019;106(6):1179‐1183. doi:10.1002/cpt.1567