Eliminating Monitor Overuse Trial (EMO Trial)
a study on Bronchiolitis Acute Viral
Summary
- Eligibility
- for people ages 2 months and up (full criteria)
- Location
- at Encinitas, California and other locations
- Dates
- study startedcompletion around
Description
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.
Official Title
Eliminating Monitor Overuse (EMO) Hybrid Effectiveness-Deimplementation Trial
Keywords
Bronchiolitis Acute Viral, pulse oximetry, deimplementation, cluster-randomized trial, effectiveness-implementation hybrid trial, implementation science, Bronchiolitis, Educational Outreach, Audit & Feedback (unit level), Audit & Feedback (real time, individual-level), Clinical Pathway Integrated into Electronic Health Record, Unlearning + Substitution
Eligibility
For people ages 2 months and up
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
Locations
- Rady Children's Hospital/UCSD
accepting new patients
Encinitas California 92024 United States - Children's Hospital Orange County
accepting new patients
Orange California 92868 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Children's Hospital of Philadelphia
- ID
- NCT05132322
- Study Type
- Interventional
- Participants
- Expecting 32357 study participants
- Last Updated
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