Children's National

Eliminating Monitor Overuse Trial (EMO Trial)

Purpose

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.

Condition

Bronchiolitis Acute Viral

Eligibility

Eligible Ages: Over 2 Months
Eligible Sex: All
Accepts Healthy Volunteers: No

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 b: 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)]

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Health Services Research
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator Unlearning Only	Includes educational outreach and audit & feedback.	Behavioral: 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. Behavioral: 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. Behavioral: 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.
Experimental Unlearning + Substitution	Includes educational outreach, audit & feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry.	Behavioral: 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. Behavioral: 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. Behavioral: 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. Behavioral: 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.

Recruiting Locations

More Details

NCT ID: NCT05132322
Status: Active, not recruiting
Sponsor: Children's Hospital of Philadelphia