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

被引：0

作者：

Xiao, Rui ^{[1
,15
]}

Bonafide, Christopher P. ^{[2
,3
,4
]}

Williams, Nathaniel J. ^{[5
]}

Cidav, Zuleyha ^{[6
,7
]}

Landrigan, Christopher P. ^{[8
,9
]}

Faerber, Jennifer ^{[10
]}

Makeneni, Spandana ^{[10
]}

Wolk, Courtney Benjamin ^{[11
]}

Schondelmeyer, Amanda C. ^{[12
,13
]}

Brady, Patrick W. ^{[12
,13
]}

Beidas, Rinad S. ^{[14
]}

Schisterman, Enrique F. ^{[1
]}

机构：

[1] Perelman Sch Med, Dept Biostat Epidemiol & Informat, Blockley Hall,423 Guardian Dr, Philadelphia, PA 19104 USA

[2] Childrens Hosp Philadelphia, Sect Hosp Med & Clin Futures, 3500 Civ Ctr Blvd, Hub, Philadelphia, PA 19104 USA

[3] Univ Penn, Perelman Sch Med, Dept Pediat, Philadelphia, PA USA

[4] Univ Penn, Penn Implementat Sci Ctr, Leonard Davis Inst Hlth Econ PISCELDI, Philadelphia, PA USA

[5] Boise State Univ, Sch Social Work, 1910 W Univ Dr, Boise, ID 83725 USA

[6] Univ Penn, Perelman Sch Med, Dept Psychiat, 3535 Market St, Philadelphia, PA 19104 USA

[7] Univ Penn, Leonard Davis Inst Hlth Econ, Philadelphia, PA USA

[8] Boston Childrens Hosp, Div Gen Pediat, Dept Med, Enders 1, 300 Longwood Ave, Boston, MA 02115 USA

[9] Harvard Med Sch, Dept Pediat, Boston, MA USA

[10] Childrens Hosp Philadelphia, Roberts Ctr Pediat Res, Data Sci & Biostat Unit, 2716 South St, Philadelphia, PA 19146 USA

[11] Univ Penn, Perelman Sch Med, Dept Psychiat, 3553 Market St, 3rd Floor, Philadelphia, PA 19104 USA

[12] Univ Cincinnati, Dept Pediat, Coll Med, Cincinnati, OH USA

[13] Cincinnati Childrens Hosp Med Ctr, Div Hosp Med, James M Anderson Ctr Hlth Syst Excellence, 3333 Burnet Ave ML 9016, Cincinnati, OH 45229 USA

[14] Northwestern Univ, Feinberg Sch Med, Dept Med Social Sci, 625 North Michigan Ave, Chicago, IL 60661 USA

[15] 206 Blockley Hall, 423 Guardian Dr, Philadelphia, PA 19104 USA

来源：

CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS | 2023年 / 36卷

基金：

美国国家卫生研究院;

关键词：

Bronchiolitis; Deimplementation sustainment; Overuse; Pulse oximetry; Cluster randomized trial; PEDIATRIC HOSPITAL MEDICINE; BRONCHIOLITIS; REACTANCE; CHILDREN;

D O I：

10.1016/j.conctc.2023.101219

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

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 (SpO(2)) 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) SpO(2) trial, which compares the effect of two competing deimplementation strategies (unlearning only vs. unlearning plus substitution) on the sustainment of deimplementation of SpO(2) 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.

引用

页数：6

共 36 条

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