Summary

Eligibility
for people ages 2 months and up (full criteria)
Location
at Encinitas, California and other locations
Dates
study started
completion 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:

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