Table 2 Pragmatic design features of the IMPAKT ERAS Trial
PRECIS domain(s) | Assessment |
|---|---|
Eligibility criteria | This study will enroll all eligible major abdominal surgery patients within existing enhanced recovery pathways (colorectal, surgical oncology, & ventral hernia procedures) at a single academic medical center with few exclusions |
Recruitment path | The IRB has approved a modified research consent process for this study, which leverages a shortened consent form. Eligible patients will be recruited and consented by a physician member of the Perioperative Medicine team during the analgesic nerve block consent process |
Setting | Care will occur at a single, tertiary, academic medical center |
Organization intervention | Usual enhanced recovery pathway care will be administered for patients by clinical staff. A blinded study medication containing either ketamine or saline placebo will be initiated as a bolus at the induction of anesthesia and maintained as a postoperative infusion for up to 48 h |
Experimental and comparison interventions – delivery | The OR pharmacy will prepare the blinded study medications and will oversee the randomization schedule in variable week blocks |
Experimental and comparison interventions – adherence | The lead study pharmacist reviews weekly reports of study drug administration to patients. Cross over events are identified by these reports. Adherence to the Enhanced Recovery Pathways is consistently monitored by a clinical dashboard that reports data in real-time. Early discontinuation of a study drug order requires providers to indicate a reason for cessation, which is captured in the EMR (e.g. side effects, early discharge anticipated) |
Follow-up | In-hospital outcomes, including side effects and adverse outcomes, are monitored every 6 months by an independent Data Safety and Monitoring Board |
Primary trial outcome | All outcomes of this study are pragmatically designed to be readily obtained within the clinical EMR. The primary outcome is the hospital length of stay, defined as the time from start of surgery until hospital discharge. Secondary outcomes, including adverse perioperative events, opioid requirements, frequency of antiemetic administrations, and postoperative nasogastric tube placement are also pragmatically available through the EMR |
Analysis of primary outcome | All participants who are randomized will be included in the intention-to-treat statistical analysis, according to group assignment |