Eliminating Monitor Overuse (EMO) type III effectiveness-deimplementation cluster-randomized trial: Statistical analysis plan

Rui Xiao; Christopher P Bonafide; Nathaniel J Williams; Zuleyha Cidav; Christopher P Landrigan; Jennifer Faerber; Spandana Makeneni; Courtney Benjamin Wolk; Amanda C Schondelmeyer; Patrick W Brady; Rinad S Beidas; Enrique F Schisterman

doi:10.1016/j.conctc.2023.101219

Eliminating Monitor Overuse (EMO) type III effectiveness-deimplementation cluster-randomized trial: Statistical analysis plan

Contemp Clin Trials Commun. 2023 Oct 2:36:101219. doi: 10.1016/j.conctc.2023.101219. eCollection 2023 Dec.

Authors

Rui Xiao¹, Christopher P Bonafide^{2

3

4}, Nathaniel J Williams⁵, Zuleyha Cidav^{6

7}, Christopher P Landrigan^{8

9}, Jennifer Faerber¹⁰, Spandana Makeneni¹⁰, Courtney Benjamin Wolk¹¹, Amanda C Schondelmeyer^{12

13}, Patrick W Brady^{12

13}, Rinad S Beidas¹⁴, Enrique F Schisterman¹

Affiliations

¹ Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, Blockley Hall, 423 Guardian Drive, Philadelphia, PA, 19104-6021, USA.
² Section of Hospital Medicine and Clinical Futures, Children's Hospital of Philadelphia, 3500 Civic Center Blvd, The Hub, Philadelphia, PA, 19104, USA.
³ Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
⁴ Penn Implementation Science Center at the Leonard Davis Institute of Health Economics (PISCE@LDI), University of Pennsylvania, Philadelphia, PA, USA.
⁵ School of Social Work, Boise State University, 1910 W. University Drive, Boise, ID, 83725, USA.
⁶ Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market St, Philadelphia, Pennsylvania, 19104, USA.
⁷ Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA.
⁸ Division of General Pediatrics, Boston Children's Hospital, Enders 1, 300 Longwood Ave, Boston, MA, 02115, USA.
⁹ Department of Pediatrics, Harvard Medical School, Boston, MA, USA.
¹⁰ Data Science and Biostatistics Unit, Roberts Center for Pediatric Research, Children's Hospital of Philadelphia, 2716 South Street, Philadelphia, PA, 19146, USA.
¹¹ Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3553 Market Street, 3rd Floor, Philadelphia, PA, 19104, USA.
¹² Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
¹³ Division of Hospital Medicine, James M. Anderson Center for Health Systems Excellence, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave ML 9016, Cincinnati, OH, 45229, USA.
¹⁴ Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, 625 North Michigan Avenue, Chicago, IL, 60661, USA.

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.

Keywords: Bronchiolitis; Cluster randomized trial; Deimplementation sustainment; Overuse; Pulse oximetry.

Associated data

ClinicalTrials.gov/NCT05132322

Grants and funding

U01 HL159880/HL/NHLBI NIH HHS/United States