Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
9265 participants
INTERVENTIONAL
2021-12-01
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Unlearning Only
Includes educational outreach and audit \& feedback.
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.
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.
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.
Unlearning + Substitution
Includes educational outreach, audit \& feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry.
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.
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.
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.
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.
Interventions
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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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)-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).
* 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 \[Covid-19 / SARS-CoV-2 (known or suspected)\]
2 Months
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Pennsylvania
OTHER
Boston Children's Hospital
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Pediatric Research in Inpatient Settings (PRIS) Network
UNKNOWN
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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Christopher P Bonafide, MD, MSCE
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Rinad S Beidas, PhD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Children's of Alabama
Birmingham, Alabama, United States
University of California Davis
Davis, California, United States
Rady Children's Hospital/UCSD
Encinitas, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Valley Children's Hospital
Madera, California, United States
Children's Hospital Orange County
Orange, California, United States
Lucile Packard Children's Hospital Stanford
Stanford, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Yale-New Haven Children's Hospital
New Haven, Connecticut, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
Riley Hospital for Children at IU Health
Indianapolis, Indiana, United States
Boston Children's Hospital
Boston, Massachusetts, United States
CS Mott Children's Hospital
Ann Arbor, Michigan, United States
Children's Minnesota
Minneapolis, Minnesota, United States
Children's Mercy Kansas City
Kansas City, Missouri, United States
Children's Hospital at Dartmouth-Hitchcock
Lebanon, New Hampshire, United States
CHOP Pediatric Care at Penn Medicine/Princeton Health
Princeton, New Jersey, United States
CHOP Care Network at Virtua
Voorhees Township, New Jersey, United States
Albany Medical Center
Albany, New York, United States
Cohen Children's Medical Center
New Hyde Park, New York, United States
NYP-Morgan Stanley Children's Hospital
New York, New York, United States
Komansky Children's Hospital/New York Presbyterian Medical Center /Weill Cornell Medicine
New York, New York, United States
University of Rochester Golisano Children's Hospital
Rochester, New York, United States
Upstate Golisano Children's Hospital
Syracuse, New York, United States
Children's Hospital at Montefiore
The Bronx, New York, United States
Akron Children's Hospital
Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital at Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
CHOP King of Prussia Hospital
King of Prussia, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
CHOP Grand View Hospital
Sellersville, Pennsylvania, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Children's Medical Center Dallas
Dallas, Texas, United States
Children's Memorial Hermann
Houston, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Texas Children's Hospital West Campus
Houston, Texas, United States
Texas Children's Hospital The Woodlands
The Woodlands, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
University of Vermont Children's Hospital
Burlington, Vermont, United States
Inova Children's Hospital
Falls Church, Virginia, United States
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States
Children's Hospital of Richmond at VCU
Richmond, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
Hoops Family Children's Hospital at Marshall University
Huntington, West Virginia, United States
Children's Wisconsin
Milwaukee, Wisconsin, United States
Alberta Children's Hospital
Calgary, , Canada
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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21-018560
Identifier Type: -
Identifier Source: org_study_id
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