Eliminating Monitor Overuse Trial (EMO Trial)

Children's Hospital of Philadelphia (CHOP)

Status: Enrolling

Conditions: Bronchiolitis Acute Viral

Treatments: Behavioral: Clinical Pathway Integrated into Electronic Health Record; Behavioral: Audit & Feedback (unit level); Behavioral: Educational Outreach; Behavioral: Audit & Feedback (real time, individual-level)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05132322

21-018560

U01HL159880 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 32,357 estimated patients

Sex: All

Ages: 2+ months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 in room air during Aim 1 data collection
• Fluent in English

Exclusion criteria:

• They are an employee of the hospital or a hospital volunteer

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

32,357 participants in 2 patient groups

Unlearning Only

Active Comparator group

Description:

Includes educational outreach and audit \& feedback.

Treatment:

Behavioral: Audit & Feedback (real time, individual-level)

Behavioral: Educational Outreach

Behavioral: Audit & Feedback (unit level)

Unlearning + Substitution

Experimental group

Description:

Includes educational outreach, audit \& feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry.

Treatment:

Behavioral: Audit & Feedback (real time, individual-level)

Behavioral: Educational Outreach

Behavioral: Audit & Feedback (unit level)

Behavioral: Clinical Pathway Integrated into Electronic Health Record