Eliminating Monitor Overuse Trial (EMO Trial)

Eliminating Monitor Overuse (EMO) Hybrid Effectiveness-Deimplementation Trial

The purpose of this study is to identify the optimal deimplementation strategies for an overused practice: continuous pulse oximetry monitoring of children hospitalized with bronchiolitis who are not receiving supplemental oxygen.

Study Overview

• Status: Active, not recruiting
• Conditions: Bronchiolitis Acute Viral
• Intervention / Treatment: Behavioral: Educational Outreach; Behavioral: Audit & Feedback (unit level); Behavioral: Audit & Feedback (real time, individual-level); Behavioral: Clinical Pathway Integrated into Electronic Health Record

• Study Type: Interventional
• Enrollment (Actual): 9265
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Calgary, Canada, AB T3B 6A8
    • Alberta Children's Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Children's of Alabama
  • California
    • Davis, California, United States, 95616
      • University of California Davis
    • Encinitas, California, United States, 92024
      • Rady Children's Hospital/UCSD
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles
    • Madera, California, United States, 93636
      • Valley Children's Hospital
    • Orange, California, United States, 92868
      • Children's Hospital Orange County
    • Stanford, California, United States, 94304
      • Lucile Packard Children's Hospital Stanford
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale-New Haven Children's Hospital
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Children's National Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H. Lurie Children's Hospital of Chicago
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Hospital for Children at IU Health
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48108
      • CS Mott Children's Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Children's Minnesota
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Kansas City
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Children's Hospital at Dartmouth-Hitchcock
  • New Jersey
    • Princeton, New Jersey, United States, 08536
      • CHOP Pediatric Care at Penn Medicine/Princeton Health
    • Voorhees Township, New Jersey, United States, 08043
      • CHOP Care Network at Virtua
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • New Hyde Park, New York, United States, 11040
      • Cohen Children's Medical Center
    • New York, New York, United States, 10032
      • NYP-Morgan Stanley Children's Hospital
    • New York, New York, United States, 10065
      • Komansky Children's Hospital/New York Presbyterian Medical Center /Weill Cornell Medicine
    • Rochester, New York, United States, 14642
      • University of Rochester Golisano Children's Hospital
    • Syracuse, New York, United States, 13210
      • Upstate Golisano Children's Hospital
    • The Bronx, New York, United States, 10467
      • Children's Hospital at Montefiore
  • Ohio
    • Akron, Ohio, United States, 44308
      • Akron Children's Hospital
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Children's Hospital at Oklahoma University Medical Center
  • Pennsylvania
    • King of Prussia, Pennsylvania, United States, 19406
      • CHOP King of Prussia Hospital
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Children's Hospital of Pittsburgh of UPMC
    • Sellersville, Pennsylvania, United States, 18960
      • CHOP Grand View Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Monroe Carell Jr. Children's Hospital at Vanderbilt
  • Texas
    • Dallas, Texas, United States, 75235
      • Children's Medical Center Dallas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital
    • Houston, Texas, United States, 77030
      • Children's Memorial Hermann
    • Houston, Texas, United States, 77094
      • Texas Children's Hospital West Campus
    • The Woodlands, Texas, United States, 77384
      • Texas Children's Hospital The Woodlands
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • Primary Children's Hospital
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont Children's Hospital
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Children's Hospital
    • Norfolk, Virginia, United States, 23507
      • Children's Hospital of The King's Daughters
    • Richmond, Virginia, United States, 23298
      • Children's Hospital of Richmond at VCU
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • Hoops Family Children's Hospital at Marshall University
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Children's Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Population a: Bronchiolitis patients directly observed while not receiving supplemental oxygen ("in room air," for primary trial outcome)

Inclusion Criteria:

• Infants and children 2 months through 23 months old
• Hospitalized on non-ICU wards participating in the trial
• Cared for by generalist inpatient services (e.g. general pediatrics, hospital medicine)
• Primary diagnosis of bronchiolitis in most recent physician progress note
• Not actively receiving supplemental oxygen ("in room air")
• Last documented receipt of supplemental oxygen >1 hour prior to direct observational data collection

Exclusion Criteria:

• Documented apnea or cyanosis during the current illness
• Extreme prematurity (<28 weeks completed gestation)
• Cardiac disease
• Pulmonary hypertension
• Chronic lung disease
• Home oxygen requirement
• Neuromuscular disease
• Immunodeficiency
• Cancer
• Severe Acute Respiratory Syndrome Coronavirus 2 (Covid-19 / SARS-CoV-2)-related illness (known or suspected, including multisystem inflammatory syndrome in children multi-system inflammatory syndrome in children (MIS-C)

Population b: Bronchiolitis patients directly observed while receiving supplemental oxygen (for underuse evaluation).

Inclusion Criteria:

• Infants and children 2 months through 23 months old
• Hospitalized on non-ICU wards participating in the trial
• Cared for by generalist inpatient services (e.g. general pediatrics, hospital medicine)
• Primary diagnosis of bronchiolitis in most recent physician progress note
• Actively receiving ≥2 Liters/minute (2L/min) supplemental oxygen or 21% room air flow

Exclusion Criteria:

• Extreme prematurity (<28 weeks completed gestation)
• Cardiac disease
• Pulmonary hypertension
• Chronic lung disease
• Home oxygen requirement
• Neuromuscular disease
• Immunodeficiency
• Cancer
• Severe Acute Respiratory Syndrome Coronavirus 2 [Covid-19 / SARS-CoV-2 (known or suspected)]

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Unlearning Only; Includes educational outreach and audit & feedback.	Behavioral: Educational Outreach; Educational outreach includes staff-targeted educational materials and outreach sessions summarizing the current evidence and guideline recommendations for pulse oximetry use in bronchiolitis.; Behavioral: Audit & Feedback (unit level); Weekly unit-level feedback of each hospital's guideline-concordant practice will be distributed to sites in the form of a visual dashboard that includes comparisons over time and between hospitals. The dashboard will then be shared locally on a weekly basis with clinicians in person and electronically.; Behavioral: Audit & Feedback (real time, individual-level); Real-time feedback will occur at the individual clinician level. When collecting data on an individual patient, data collectors encountering guideline-discordant continuous monitoring are empowered to briefly ask any available clinician responsible for that patient's care, in a nonjudgmental way, about indications for monitoring that patient. The clinician is ultimately responsible for deciding if any changes are indicated.
Experimental: Unlearning + Substitution; Includes educational outreach, audit & feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry.	Behavioral: Educational Outreach; Educational outreach includes staff-targeted educational materials and outreach sessions summarizing the current evidence and guideline recommendations for pulse oximetry use in bronchiolitis.; Behavioral: Audit & Feedback (unit level); Weekly unit-level feedback of each hospital's guideline-concordant practice will be distributed to sites in the form of a visual dashboard that includes comparisons over time and between hospitals. The dashboard will then be shared locally on a weekly basis with clinicians in person and electronically.; Behavioral: Audit & Feedback (real time, individual-level); Real-time feedback will occur at the individual clinician level. When collecting data on an individual patient, data collectors encountering guideline-discordant continuous monitoring are empowered to briefly ask any available clinician responsible for that patient's care, in a nonjudgmental way, about indications for monitoring that patient. The clinician is ultimately responsible for deciding if any changes are indicated.; Behavioral: Clinical Pathway Integrated into Electronic Health Record; Clinical pathways guide clinicians step-by-step through evidence-based care. Based on the existing guidelines for physiologic monitoring in bronchiolitis, the pathway will clearly specify (a) situations when it is appropriate to initiate intermittent SpO2 measurement instead of continuous SpO2 monitoring, and (b) when it is appropriate to discontinue continuous SpO2 monitoring altogether, and transition to intermittent SpO2 measurement. In order to be visible to clinicians as they perform patient care, the pathway will be integrated into the electronic health record at sites randomized to this intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Deimplementation Sustainment	The primary outcome specified in the protocol is deimplementation sustainment, a "difference in differences" outcome based on statistical comparisons based on pulse oximetry overuse across trial phases and arms. Pulse oximetry overuse is operationally defined as percent of patient observations monitored using continuous pulse oximetry while not receiving supplemental oxygen (measured using direct observation). The least metabolized form of the data for pulse oximetry overuse, raw proportions across trial phases and arms, is reported here. Results of the specific analysis used to report the trial's pre-specified primary outcome of deimplementation sustainment is reported in Statistical Analysis 1.	Data from the baseline phase (approximately 7 months) was compared to data from the sustainment phase (approximately 4 months). Only data from baseline and sustainment phases are used in this calculation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Hospital Stay	The length of hospital stay is the duration of time that elapses between the time a patient is admitted with bronchiolitis to an inpatient unit of the hospital until the time they are discharged from the hospital, using data manually abstracted from the electronic health record chart.	Up to 4 years
Duration of Oxygen Supplementation	The oxygen supplementation duration is the total duration of time during which a patient is documented as receiving supplemental oxygen during hospitalization.	Up to 4 years
Count of Observations During Which the Patient Was Not Receiving Supplemental Oxygen and Yet Was Continuously Monitored Using Pulse Oximetry During the Baseline Phase of the Trial	This measure is assessed as the count of patient observations monitored using continuous pulse oximetry while not receiving supplemental oxygen (measured using direct observation) in the baseline phase. In order to assist in interpretation, this can also be viewed below as a proportion or a percent of the total number of observations. The denominator is the count of observations of patients not receiving supplemental oxygen. The numerator is the count of observations of patients not receiving supplemental oxygen who are also monitored using continuous pulse oximetry. The numerator count is divided by the denominator count to calculate a proportion. The proportion is multiplied by 100 to obtain a percent. This is expressed below as a count with the percentage automatically calculated by the clinicaltrials.gov system.	This measure used data from the baseline phase (approximately 7 months).
Count of Observations During Which the Patient Was Not Receiving Supplemental Oxygen and Yet Was Continuously Monitored Using Pulse Oximetry During the Active Deimplementation Phase of the Trial	This measure is assessed as the count of patient observations monitored using continuous pulse oximetry while not receiving supplemental oxygen (measured using direct observation) in the active deimplementation phase. In order to assist in interpretation, this can also be viewed below as a proportion or a percent of the total number of observations. The denominator is the count of observations of patients not receiving supplemental oxygen. The numerator is the count of observations of patients not receiving supplemental oxygen who are also monitored using continuous pulse oximetry. The numerator count is divided by the denominator count to calculate a proportion. The proportion is multiplied by 100 to obtain a percent. This is expressed below as a count with the percentage automatically calculated by the clinicaltrials.gov system.	Data from the active deimplementation phase (approximately 5 months).
Count of Observations During Which the Patient Was Not Receiving Supplemental Oxygen and Yet Was Continuously Monitored Using Pulse Oximetry During the Sustainment Phase of the Trial	This measure is assessed as the count of patient observations monitored using continuous pulse oximetry while not receiving supplemental oxygen (measured using direct observation) in the sustainment phase. In order to assist in interpretation, this can also be viewed below as a proportion or a percent of the total number of observations. The denominator is the count of observations of patients not receiving supplemental oxygen. The numerator is the count of observations of patients not receiving supplemental oxygen who are also monitored using continuous pulse oximetry. The numerator count is divided by the denominator count to calculate a proportion. The proportion is multiplied by 100 to obtain a percent. This is expressed below as a count with the percentage automatically calculated by the clinicaltrials.gov system.	Data from the sustainment phase (approximately 4 months).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Underuse of Pulse Oximetry Monitoring in High Risk Patients	Underuse is defined as failing to continuously SpO2 -monitor bronchiolitis patients receiving ≥2L/min supplemental oxygen (a marker of more severe disease). It is calculated as the percentage of bronchiolitis patient observations in patients who are receiving ≥2L/min supplemental oxygen, and are not being continuously SpO2-monitored. It is measured using direct observation.	This measure combines data from three sequential study phases: the baseline phase (approximately 7 months), the active deimplementation phase (approximately 5 months), and the sustainment phase (approximately 4 months).
Exploratory Long-term Sustainability	Exploratory long-term sustainability is calculated based on penetration. Penetration is the percentage of bronchiolitis patients who are in room air (not receiving any supplemental oxygen) and are receiving guideline-concordant care (this means they are not being continuously SpO2-monitored). The continuous monitoring status is determined using direct observation on hospital units. In this exploratory outcome investigators are using an alternative definition of sustainability in which, in order to meet criteria for having successfully sustained a practice change, hospitals must first (a) experience a significant increase in penetration between baseline and active deimplementation, and then (b) maintain the increased penetration at ≥90% of the active deimplementation phase level through the end of the sustainability period.	4 years

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: University of Pennsylvania; National Heart, Lung, and Blood Institute (NHLBI); Boston Children's Hospital; Children's Hospital Medical Center, Cincinnati; Pediatric Research in Inpatient Settings (PRIS) Network
• Investigators: Principal Investigator: Rinad S Beidas, PhD, Northwestern University; Principal Investigator: Christopher P Bonafide, MD, MSCE, Children's Hospital of Philadelphia

Publications and helpful links

General Publications

• Bonafide CP, Xiao R, Schondelmeyer AC, Pettit AR, Brady PW, Landrigan CP, Wolk CB, Cidav Z, Ruppel H, Muthu N, Williams NJ, Schisterman E, Brent CR, Albanowski K, Beidas RS; Pediatric Research in Inpatient Settings (PRIS) Network. Sustainable deimplementation of continuous pulse oximetry monitoring in children hospitalized with bronchiolitis: study protocol for the Eliminating Monitor Overuse (EMO) type III effectiveness-deimplementation cluster-randomized trial. Implement Sci. 2022 Oct 21;17(1):72. doi: 10.1186/s13012-022-01246-z.
• Xiao R, Bonafide CP, Williams NJ, Cidav Z, Landrigan CP, Faerber J, Makeneni S, Wolk CB, Schondelmeyer AC, Brady PW, Beidas RS, Schisterman EF. 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.
• Faerber JA, Xiao R, Makeneni S, Schisterman EF, Brady PW, Schondelmeyer AC, Landrigan CP, Lucey K, Lee V, Gregory PF, Prasto J, Parthasarathy P, Greenfield M, Solomon C, Brent CR, Albanowski K, Beidas RS, Bonafide CP; Pediatric Research in Inpatient Settings (PRIS) Network. Sustainment of continuous pulse oximetry deimplementation: Analysis of Eliminating Monitor Overuse study data from six hospitals. J Hosp Med. 2023 Aug;18(8):724-729. doi: 10.1002/jhm.13154. Epub 2023 Jun 28.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): March 31, 2024
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: implementation science; pulse oximetry; cluster-randomized trial; deimplementation; effectiveness-implementation hybrid trial
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: 21-018560; U01HL159880 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Final Research Data (the dataset necessary to document and support the primary research findings).
• IPD Sharing Time Frame: Starting within 6 months after publishing the primary outcome manuscript
• IPD Sharing Access Criteria: We will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) IRB approval; (3) a commitment to securing the data using appropriate computer technology; and (4) a commitment to and an agreed-upon plan for destroying the data after analyses are completed. Once a data sharing agreement is in place, in accordance with the policies determined by the study team, CHOP, PRIS, and NIH/NHLBI, we will provide releasable data to investigators under our own auspices via a secure file transfer mechanism approved by the Research Information Systems Department at CHOP and the receiving institution.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No