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. 2018 Oct 26;19(1):586.
doi: 10.1186/s13063-018-2952-5.

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

Valérie M Smit-Fun  1 , Dianne de Korte-de Boer  2 , Linda M Posthuma  3 , Annick Stolze  4 , Carmen D Dirksen  5   6 , Markus W Hollmann  3 , Wolfgang F Buhre  1 , Christa Boer  4
Affiliations

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

Valérie M Smit-Fun et al. Trials. .

Abstract

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.

Keywords: Anesthesiology; Failure-to-rescue; In-hospital mortality; Postsurgical complications; Stepped-wedge cluster randomized trial.

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Conflict of interest statement

Ethics approval and consent to participate

Ethics approval is obtained from the institutional review board of the VUmc Amsterdam (NL56004.029.16; NTR5506). Patients will only be included in the study after written informed consent has been obtained.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Stepped-wedge schedule of the TRACE Study. Hospitals sequentially cross over from control phase to intervention phase. Transistion periods between phases are depicted by ‘x’
Fig. 2
Fig. 2
TRACE study schedule of enrolment, interventions, and assessments
See this image and copyright information in PMC

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