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Eliminating Monitor Overuse (EMO) Type III Effectiveness-Deimplementation Cluster-Randomized Trial: Statistical Analysis Plan
Contemporary Clinical Trials Communications
  • Rui Xiao, University of Pennsylvania
  • Christopher P. Bonafide, Children’s Hospital of Philadelphia
  • Nathaniel J. Williams, Boise State University
  • Zuleyha Cidav, University of Pennsylvania
  • Christopher P. Landrigan, Boston Children's Hospital
  • Jennifer Faerber, Children's Hospital of Philadelphia
  • Spandana Makeneni, Children's Hospital of Philadelphia
  • Courtney Benjamin Wolk, University of Pennsylvania
  • Amanda C. Schondelmeyer, University of Cincinnati College of Medicine
  • Patrick W. Brady, University of Cincinnati College of Medicine
  • Rinad S. Beidas, Northwestern University
  • Enrique F. Schisterman, University of Pennsylvania
Document Type
Article
Publication Date
12-1-2023
Disciplines
Abstract

Background: Deimplementing overused health interventions is essential to maximizing quality and value while minimizing harm, waste, and inefficiencies. Three national guidelines discourage continuous pulse oximetry (SpO2) monitoring in children who are not receiving supplemental oxygen, but the guideline-discordant practice remains prevalent, making it a prime target for deimplementation. This paper details the statistical analysis plan for the Eliminating Monitor Overuse (EMO) SpO2 trial, which compares the effect of two competing deimplementation strategies (unlearning only vs. unlearning plus substitution) on the sustainment of deimplementation of SpO2 monitoring in children with bronchiolitis who are in room air.

Methods: The EMO Trial is a hybrid type 3 effectiveness-deimplementation trial with a longitudinal cluster-randomized design, conducted in Pediatric Research in Inpatient Settings Network hospitals. The primary outcome is deimplementation sustainment, analyzed as a longitudinal difference-in-differences comparison between study arms. This analysis will use generalized hierarchical mixed-effects models for longitudinal clustering outcomes. Secondary outcomes include the length of hospital stay and oxygen supplementation duration, modeled using linear mixed-effects regressions. Using the well-established counterfactual approach, we will also perform a mediation analysis of hospital-level mechanistic measures on the association between the deimplementation strategy and the sustainment outcome.

Discussion: We anticipate that the EMO Trial will advance the science of deimplementation by providing new insights into the processes, mechanisms, and likelihood of sustained practice change using rigorously designed deimplementation strategies. This pre-specified statistical analysis plan will mitigate reporting bias and support data-driven approaches.

Trial registration: ClinicalTrials.gov NCT05132322. Registered on 24 November 2021.

Creative Commons License
Creative Commons Attribution-NonCommercial-No Derivative Works 4.0 International
Citation Information
Xiao, Rui; Bonafide, Christopher P.; Williams, Nathaniel J.; Cidav, Zuleyha; Landrigan, Christopher P.; Faerber, Jennifer; Makeneni, Spandana; Wolk, Courtney Benjamin; Schondelmeyer, Amanda C.; Brady, Patrick W.; Beidas, Rinad S.; and Schisterman, Enrique F. (2023). "Eliminating Monitor Overuse (EMO) Type III Effectiveness-Deimplementation Cluster-Randomized Trial: Statistical Analysis Plan". Elsevier Contemporary Clinical Trials Communications, 36, 101219. https://doi.org/10.1016/j.conctc.2023.101219