Key result
As this is a study protocol, no results are available yet; the trial aims to determine if routine postsurgical anesthesia visits reduce 30-day mortality in high-risk surgical patients.
Why the study?
Does a routine postoperative visit by an anesthesia professional reduce 30-day postoperative mortality in high-risk non-cardiac surgical patients?
RCT (n=5,600)
Open-label
Stepped-wedge cluster randomized
Yes
Does a routine postoperative visit by an anesthesia professional reduce 30-day postoperative mortality in high-risk non-cardiac surgical patients?
This study protocol describes a stepped-wedge cluster-randomized trial to evaluate whether routine postoperative anesthesia visits reduce 30-day mortality in high-risk non-cardiac surgical patients.
May support routine postsurgical anesthesia visits to reduce complications; leaves open need for RCTs before practice change.
BACKGROUND: Perioperative 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. METHODS: TRACE 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. DISCUSSION: TRACE 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 REGISTRATION: Nederlands Trial Register/Netherlands Trial Registration, NTR5506 . Registered on 02 December 2015.
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Smit-Fun et al. (2018) conducted an RCT in Non-cardiac surgical patients at high risk of complications (n=5,600). Routine postsurgical anesthesia visits on postoperative days 1 and 3 vs. Standard postoperative care was evaluated on 30-day postoperative mortality. As this is a study protocol, no results are available yet; the trial aims to determine if routine postsurgical anesthesia visits reduce 30-day mortality in high-risk surgical patients.
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