TRACE (Routine posTsuRgical Anesthesia visit to improve patient outComE): a prospective, multicenter, stepped-wedge, cluster-randomized interventional study

Abstract

BackgroundPerioperative complications occur in 30–40% of non-cardiac surgical patients and are the leading cause of early postoperative morbidity and mortality. Regular visits by trained health professionals may decrease the incidence of complications and mortality through earlier detection and adequate treatment of complications. Until now, no studies have been performed on the impact of routine postsurgical anesthesia visits on the incidence of postoperative complications and mortality.MethodsTRACE is a prospective, multicenter, stepped-wedge cluster randomized interventional study in academic and peripheral hospitals in the Netherlands. All hospitals start simultaneously with a control phase in which standard care is provided. Sequentially, in a randomized order, hospitals cross over to the intervention phase in which patients at risk are routinely followed up by an anesthesia professional at postoperative days 1 and 3, aiming to detect and prevent or treat postoperative complications. We aim to include 5600 adult patients who are at high risk of developing complications. The primary outcome variable is 30-day postoperative mortality. Secondary outcomes include incidence of postoperative complications and postoperative quality of life up to one year following surgery.Statistical analyses will be performed to compare the control and intervention cohorts with multilevel linear and logistic regression models, adjusted for temporal trends and for clusters (hospitals). The time horizon of the economic (cost-effectiveness) evaluation will be 30 days and one year following surgery.DiscussionTRACE is the first to study the effects of a routine postoperative visit by an anesthesia healthcare professional on mortality and cost-effectiveness of surgical patients. If the intervention proves to be beneficial for the patient and cost-effective, the stepped-wedge design ensures direct implementation in the participating hospitals.Trial registrationNederlands Trial Register/Netherlands Trial Registration, NTR5506. Registered on 02 December 2015.

Validation of the PreOperative Score to predict Post-Operative Mortality (POSPOM) in Dutch non-cardiac surgery patients

“…This study was based on the TRACE (routine posTsuRgical Anesthesia visit to improve patient outComE) study. Details on design and analysis of the TRACE study have been previously reported [ 15 ]. TRACE was a prospective, multicenter, stepped-wedge, cluster-randomized interventional study performed between October 2016 and August 2019 in nine academic and non-academic hospitals in The Netherlands.…”

The changing perspective of clinical trial designs

“…In this, all hospitals start simultaneously with a control phase providing standard care and crossing over sequentially in a randomized order to the intervention phase (routine visits). [ 3 ]…”

Novel Clinical Trial Designs to Improve the Efficiency of Research

“…process continues until all study sites are active, thus producing a growing "wedge" of active sites. [25][26][27] An advantage of the approach is that all trial units eventually convert to the experimental treatment (such as a specialized stroke service) that might even be nationally mandated. In contrast, the experimental treatment is only available to half the units during the trial period with a parallel-group cluster approach.…”

“…For example, the TRACE (routine posTsuRgical Anesthesia visit to improve patient outComE) trial is a prospective, multicenter, stepped-wedge, cluster-randomized trial being conducted in The Netherlands to evaluate routine postoperative visits by an anesthesiologist to reduce the risk of postoperative complications. 25 All hospitals start simultaneously with a control phase in which standard care is provided. Sequentially, in a randomized order, hospitals cross over to the intervention phase (routine visits).…”