Eliminating Monitor Overuse Trial (EMO Trial)
Eliminating Monitor Overuse (EMO) Hybrid Effectiveness-Deimplementation Trial
2 other identifiers
interventional
9,265
2 countries
51
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2021
Longer than P75 for not_applicable
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2021
CompletedFirst Posted
Study publicly available on registry
November 24, 2021
CompletedStudy Start
First participant enrolled
December 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2024
CompletedResults Posted
Study results publicly available
February 13, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
ExpectedFebruary 13, 2026
February 1, 2026
2.3 years
November 10, 2021
June 17, 2025
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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 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
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
Data from the sustainment phase (approximately 4 months).
Duration of Oxygen Supplementation
Up to 4 years
Length of Hospital Stay
Up to 4 years
Other Outcomes (2)
Underuse of Pulse Oximetry Monitoring in High Risk Patients
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
4 years
Study Arms (2)
Unlearning Only
ACTIVE COMPARATORIncludes educational outreach and audit \& feedback.
Unlearning + Substitution
EXPERIMENTALIncludes educational outreach, audit \& feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry.
Interventions
Educational outreach includes staff-targeted educational materials and outreach sessions summarizing the current evidence and guideline recommendations for pulse oximetry use in bronchiolitis.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital of Philadelphialead
- University of Pennsylvaniacollaborator
- Children's Hospital Medical Center, Cincinnaticollaborator
- Pediatric Research in Inpatient Settings (PRIS) Networkcollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Boston Children's Hospitalcollaborator
Study Sites (51)
Children's of Alabama
Birmingham, Alabama, 35233, United States
University of California Davis
Davis, California, 95616, United States
Rady Children's Hospital/UCSD
Encinitas, California, 92024, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Valley Children's Hospital
Madera, California, 93636, United States
Children's Hospital Orange County
Orange, California, 92868, United States
Lucile Packard Children's Hospital Stanford
Stanford, California, 94304, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Yale-New Haven Children's Hospital
New Haven, Connecticut, 06510, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Northwestern University
Chicago, Illinois, 60611, United States
Riley Hospital for Children at IU Health
Indianapolis, Indiana, 46202, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
CS Mott Children's Hospital
Ann Arbor, Michigan, 48108, United States
Children's Minnesota
Minneapolis, Minnesota, 55404, United States
Children's Mercy Kansas City
Kansas City, Missouri, 64108, United States
Children's Hospital at Dartmouth-Hitchcock
Lebanon, New Hampshire, 03756, United States
CHOP Pediatric Care at Penn Medicine/Princeton Health
Princeton, New Jersey, 08536, United States
CHOP Care Network at Virtua
Voorhees Township, New Jersey, 08043, United States
Albany Medical Center
Albany, New York, 12208, United States
Cohen Children's Medical Center
New Hyde Park, New York, 11040, United States
NYP-Morgan Stanley Children's Hospital
New York, New York, 10032, United States
Komansky Children's Hospital/New York Presbyterian Medical Center /Weill Cornell Medicine
New York, New York, 10065, United States
University of Rochester Golisano Children's Hospital
Rochester, New York, 14642, United States
Upstate Golisano Children's Hospital
Syracuse, New York, 13210, United States
Children's Hospital at Montefiore
The Bronx, New York, 10467, United States
Akron Children's Hospital
Akron, Ohio, 44308, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Children's Hospital at Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104, United States
CHOP King of Prussia Hospital
King of Prussia, Pennsylvania, 19406, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
CHOP Grand View Hospital
Sellersville, Pennsylvania, 18960, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232, United States
Children's Medical Center Dallas
Dallas, Texas, 75235, United States
Children's Memorial Hermann
Houston, Texas, 77030, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Texas Children's Hospital West Campus
Houston, Texas, 77094, United States
Texas Children's Hospital The Woodlands
The Woodlands, Texas, 77384, United States
Primary Children's Hospital
Salt Lake City, Utah, 84113, United States
University of Vermont Children's Hospital
Burlington, Vermont, 05401, United States
Inova Children's Hospital
Falls Church, Virginia, 22042, United States
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507, United States
Children's Hospital of Richmond at VCU
Richmond, Virginia, 23298, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Hoops Family Children's Hospital at Marshall University
Huntington, West Virginia, 25701, United States
Children's Wisconsin
Milwaukee, Wisconsin, 53226, United States
Alberta Children's Hospital
Calgary, AB T3B 6A8, Canada
Related Publications (3)
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.
PMID: 37842322DERIVEDFaerber 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.
PMID: 37380625DERIVEDBonafide 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.
PMID: 36271399DERIVED
Results Point of Contact
- Title
- Chris Bonafide
- Organization
- Children's Hospital of Philadelphia
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher P Bonafide, MD, MSCE
Children's Hospital of Philadelphia
- PRINCIPAL INVESTIGATOR
Rinad S Beidas, PhD
Northwestern University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2021
First Posted
November 24, 2021
Study Start
December 1, 2021
Primary Completion
March 31, 2024
Study Completion (Estimated)
August 1, 2026
Last Updated
February 13, 2026
Results First Posted
February 13, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Starting within 6 months after publishing the primary outcome manuscript
- 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.
Final Research Data (the dataset necessary to document and support the primary research findings).