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 Genders
All
Accepts Healthy Volunteers
No

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

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

ArmDescriptionAssigned 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

Children's National and nearby locations

Children's National Medical Center
Washington, District of Columbia 20010
Contact:
Tina Halley
thalley@childrensnational.org

More Details

NCT ID
NCT05132322
Status
Recruiting
Sponsor
Children's Hospital of Philadelphia

Study Contact

Christopher P Bonafide, MD, MSCE
267-426-2901
bonafide@chop.edu