Eliminating Monitor Overuse Trial (EMO Trial)

Study Overview
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Brief Summary
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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
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Eliminating Monitor Overuse (EMO) Hybrid Effectiveness-Deimplementation Trial

Conditions
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Bronchiolitis Acute Viral

Intervention / Treatment
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* Behavioral: Educational Outreach
* Behavioral: Audit & Feedback (unit level)
* Behavioral: Audit & Feedback (real time, individual-level)
* Behavioral: Clinical Pathway Integrated into Electronic Health Record


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Unlearning Only<br>Includes educational outreach and audit & feedback. | Behavioral: Educational Outreach<br>* Educational outreach includes staff-targeted educational materials and outreach sessions summarizing the current evidence and guideline recommendations for pulse oximetry use in bronchiolitis.<br>Behavioral: Audit & Feedback (unit level)<br>* 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.<br>Behavioral: Audit & Feedback (real time, individual-level)<br>* 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.<br>|
| Experimental: Unlearning + Substitution<br>Includes educational outreach, audit & feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry. | Behavioral: Educational Outreach<br>* Educational outreach includes staff-targeted educational materials and outreach sessions summarizing the current evidence and guideline recommendations for pulse oximetry use in bronchiolitis.<br>Behavioral: Audit & Feedback (unit level)<br>* 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.<br>Behavioral: Audit & Feedback (real time, individual-level)<br>* 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.<br>Behavioral: Clinical Pathway Integrated into Electronic Health Record<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustainability of guideline-concordant deimplementation of continuous pulse oximetry monitoring | Sustainability of guideline-concordant deimplementation of continuous pulse oximetry (SpO2) monitoring is the primary trial outcome. It is calculated based on penetration (outcome 2). Sustainability will be measured longitudinally based on calculating the differences in the penetration of guideline-concordant practice at baseline, compared to the penetration during the sustainability phase. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Penetration | Penetration is calculated as the percentage of bronchiolitis patients who are in room air (not receiving any supplemental oxygen) and are receiving guideline-concordant care (this means they are not being continuously SpO2-monitored). The continuous monitoring status is determined using direct observation on hospital units. | Up to 4 years | 
| Acceptability of deimplementation | Acceptability of deimplementation among staff measured by questionnaire. Items are adapted from the validated Acceptability of Implementation Measure (AIM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating Completely disagree and 5 indicating Completely agree. Higher scores indicate better acceptability. The items are analyzed individually and not summed to a total score. | Up to 3 years | 
| Feasibility of deimplementation | Feasibility of deimplementation among staff measured by questionnaire. Items are adapted from the validated Feasibility of Implementation Measure (FIM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating Completely disagree and 5 indicating Completely agree. Higher scores indicate better feasibility. The items are analyzed individually and not summed to a total score. | Up to 3 years | 
| Appropriateness of deimplementation | Appropriateness of deimplementation among staff measured by questionnaire. Items are adapted from the validated Implementation Appropriateness Measure (IAM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating Completely disagree and 5 indicating Completely agree. Higher scores indicate better appropriateness. The items are analyzed individually and not summed to a total score. | Up to 3 years | 
| Perceived safety of deimplementation | Perceived safety of deimplementation among staff measured by questionnaire. Items are adapted from those used in the pilot study preceding this trial and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating Completely disagree and 5 indicating Completely agree. Higher scores indicate better agreement with each question. | Up to 3 years | 
| Cost of deimplementation strategies | Cost of delivering each of the strategies will be assessed using a pragmatic Time-Driven Activity Based Costing method developed specifically for economic analysis of implementation strategies. | Up to 3 years | 
| Length of Hospital Stay | The length of hospital stay is the duration of time that elapses between the time a patient is admitted with bronchiolitis to an inpatient unit of the hospital until the time they are discharged from the hospital, using data manually abstracted from the electronic health record chart. | Up to 4 years | 
| Duration of Oxygen Supplementation | The oxygen supplementation duration is the total duration of time during which a patient is documented as receiving supplemental oxygen during hospitalization. | Up to 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulse oximetry, deimplementation, cluster-randomized trial, effectiveness-implementation hybrid trial, implementation science