Current Environment:

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.

Conditions

Bronchiolitis Acute Viral

Recruitment Status

Recruiting

Eligibility Criteria

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 continuously SpO2-monitored while in room air during Aim 1 data collection
Fluent in English

Exclusion criteria:

Does not recall being present while child was continuously SpO2-monitored
They are an employee of the hospital or a hospital volunteer

Intervention

Intervention Type

Intervention Name

Behavioral

Educational Outreach

Behavioral

Audit & Feedback (unit level)

Behavioral

Audit & Feedback (real time, individual-level)

Behavioral

Clinical Pathway Integrated into Electronic Health Record

Phase

Not Applicable

Gender

All

Min Age

2 Months

Max Age

N/A

Download Date

June 22, 2023

Principal Investigator

Patty Stoeck, MD

This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.

Primary Contact Information

Patty Stoeck, MD
patricia.stoeck@childrens.harvard.edu

This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team:

Eliminating Monitor Overuse Trial (EMO Trial) NCT05132322 Patty Stoeck, MD patricia.stoeck@childrens.harvard.edu