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Eliminating Monitor Overuse Trial (EMO 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.
Conditions:
🦠 Bronchiolitis Acute Viral
🗓️ Study Start (Actual) 1 December 2021
🗓️ Primary Completion (Estimated) December 2025
✅ Study Completion (Estimated) August 2026
👥 Enrollment (Estimated) 32357
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Birmingham, Alabama, United States
📍 Tucson, Arizona, United States
📍 Davis, California, United States
📍 Encinitas, California, United States
📍 Los Angeles, California, United States
📍 Madera, California, United States
📍 Orange, California, United States
📍 Stanford, California, United States
📍 Aurora, Colorado, United States
📍 Hartford, Connecticut, United States
📍 New Haven, Connecticut, United States
📍 Washington, District of Columbia, United States
📍 Chicago, Illinois, United States
📍 Chicago, Illinois, United States
📍 Indianapolis, Indiana, United States
📍 Boston, Massachusetts, United States
📍 Boston, Massachusetts, United States
📍 Ann Arbor, Michigan, United States
📍 Minneapolis, Minnesota, United States
📍 Kansas City, Missouri, United States
📍 Lebanon, New Hampshire, United States
📍 Princeton, New Jersey, United States
📍 Voorhees, New Jersey, United States
📍 Albany, New York, United States
📍 Bronx, New York, United States
📍 New Hyde Park, New York, United States
📍 New York, New York, United States
📍 New York, New York, United States
📍 Rochester, New York, United States
📍 Syracuse, New York, United States
📍 Akron, Ohio, United States
📍 Cincinnati, Ohio, United States
📍 Columbus, Ohio, United States
📍 Oklahoma City, Oklahoma, United States
📍 Hershey, Pennsylvania, United States
📍 King Of Prussia, Pennsylvania, United States
📍 Philadelphia, Pennsylvania, United States
📍 Philadelphia, Pennsylvania, United States
📍 Pittsburgh, Pennsylvania, United States
📍 Reading, Pennsylvania, United States
📍 Sellersville, Pennsylvania, United States
📍 Nashville, Tennessee, United States
📍 Dallas, Texas, United States
📍 Houston, Texas, United States
📍 Houston, Texas, United States
📍 Houston, Texas, United States
📍 The Woodlands, Texas, United States
📍 Provo, Utah, United States
📍 Riverton, Utah, United States
📍 Salt Lake City, Utah, United States
📍 Burlington, Vermont, United States
📍 Falls Church, Virginia, United States
📍 Norfolk, Virginia, United States
📍 Richmond, Virginia, United States
📍 Seattle, Washington, United States
📍 Huntington, West Virginia, United States
📍 Milwaukee, Wisconsin, United States
📍 Calgary, Canada
More locations available...

📋 Eligibility Criteria

Description

  • Population 1a: Hospital staff who complete study questionnaires.

    • Inclusion Criteria:

    • * Nurse or physician fluent in English and employed full-time by the hospital, affiliated practice, or affiliated university who cared for bronchiolitis patients on a unit participating in the trial during at least 5 days of the most recent bronchiolitis season
    • * Hospital administrator fluent in English who oversaw the care of bronchiolitis on a local level (e.g. nurse manager) or a hospital level (e.g. Chief Quality and Safety Officer)

    Exclusion Criteria:

    • • Under the direct supervision of study or site principal investigator(s)
    • Population 1b: Hospital staff who participate in qualitative interviews
    • In Aim 2, we will conduct semi-structured interviews with physicians and nurses who provide care to bronchiolitis patients in participating units at the 5 hospitals with the highest and 3 hospitals with the lowest sustainability (8 hospitals total; up to maximum of 8 interviews/hospital). Maximum anticipated enrollment 64.

    Inclusion Criteria:

    • * Nurses or Physicians who cared for bronchiolitis patients on a unit participating in the trial during at least 5 days of the most recent bronchiolitis season
    • * Employed full-time by the hospital, affiliated practice, or affiliated university
    • * Fluent in English

    Exclusion Criteria:

    • • No exclusion criteria
    • Population 2a: 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 2b: 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 \[Covid-19 / SARS-CoV-2 (known or suspected)\]
    • Population 3: Parents or guardians of bronchiolitis patients who participate in qualitative interviews.

    Inclusion Criteria:

    • * Their child was hospitalized for bronchiolitis on a unit participating in the trial during the most recent bronchiolitis season
    • * Their child was found to be in room air during Aim 1 data collection
    • * Fluent in English

    Exclusion Criteria:

    • • They are an employee of the hospital or a hospital volunteer
Ages Eligible for Study: 2 Months to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 10 November 2021
  • First Submitted that Met QC Criteria 10 November 2021
  • First Posted 24 November 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 3 June 2024
  • Last Update Posted 4 June 2024
  • Last Verified June 2024
I'm interested ...!!