Eliminating Monitor Overuse Trial (EMO Trial)
- Conditions
- Bronchiolitis Acute Viral
- Interventions
- Behavioral: Educational OutreachBehavioral: Audit & Feedback (unit level)Behavioral: Audit & Feedback (real time, individual-level)Behavioral: Clinical Pathway Integrated into Electronic Health Record
- Registration Number
- NCT05132322
- Lead Sponsor
- Children's Hospital of Philadelphia
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 32357
- 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)
• 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Unlearning Only Educational Outreach Includes educational outreach and audit \& feedback. Unlearning Only Audit & Feedback (real time, individual-level) Includes educational outreach and audit \& feedback. Unlearning + Substitution Audit & Feedback (unit level) Includes educational outreach, audit \& feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry. Unlearning Only Audit & Feedback (unit level) Includes educational outreach and audit \& feedback. Unlearning + Substitution Educational Outreach Includes educational outreach, audit \& feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry. Unlearning + Substitution Clinical Pathway Integrated into Electronic Health Record Includes educational outreach, audit \& feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry. Unlearning + Substitution Audit & Feedback (real time, individual-level) Includes educational outreach, audit \& feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry.
- Primary Outcome Measures
Name Time Method Sustainability of guideline-concordant deimplementation of continuous pulse oximetry monitoring 3 years 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.
- Secondary Outcome Measures
Name Time Method Cost of deimplementation strategies Up to 3 years 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.
Penetration Up to 4 years 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.
Acceptability of deimplementation Up to 3 years 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.
Perceived safety of deimplementation Up to 3 years 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.
Feasibility of deimplementation Up to 3 years 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.
Appropriateness of deimplementation Up to 3 years 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.
Length of Hospital Stay Up to 4 years 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.
Duration of Oxygen Supplementation Up to 4 years The oxygen supplementation duration is the total duration of time during which a patient is documented as receiving supplemental oxygen during hospitalization.
Trial Locations
- Locations (58)
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
CHOP Pediatric Care at Penn Medicine/Princeton Health
🇺🇸Princeton, New Jersey, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Texas Children's Hospital The Woodlands
🇺🇸The Woodlands, Texas, United States
Children's Memorial Hermann
🇺🇸Houston, Texas, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
University of California Davis
🇺🇸Davis, California, United States
Rady Children's Hospital/UCSD
🇺🇸Encinitas, California, United States
Valley Children's Hospital
🇺🇸Madera, California, United States
Lucile Packard Children's Hospital Stanford
🇺🇸Stanford, California, United States
Children's Hospital Orange County
🇺🇸Orange, California, United States
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
Riley Hospital for Children at IU Health
🇺🇸Indianapolis, Indiana, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Children's Mercy Kansas City
🇺🇸Kansas City, Missouri, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Children's Hospital at Montefiore
🇺🇸Bronx, New York, United States
Cohen Children's Medical Center
🇺🇸New Hyde Park, New York, United States
University of Rochester Golisano Children's Hospital
🇺🇸Rochester, New York, United States
NYP-Morgan Stanley Children's Hospital
🇺🇸New York, New York, United States
Komansky Children's Hospital/New York Presbyterian Medical Center /Weill Cornell Medicine
🇺🇸New York, New York, United States
Upstate Golisano Children's Hospital
🇺🇸Syracuse, New York, United States
Akron Children's Hospital
🇺🇸Akron, Ohio, United States
Penn State Hershey Children's Hospital
🇺🇸Hershey, Pennsylvania, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
CHOP King of Prussia Hospital
🇺🇸King Of Prussia, Pennsylvania, United States
Reading Hospital, Tower Health
🇺🇸Reading, Pennsylvania, United States
CHOP Grand View Hospital
🇺🇸Sellersville, Pennsylvania, United States
Children's Medical Center Dallas
🇺🇸Dallas, Texas, United States
Texas Children's Hospital West Campus
🇺🇸Houston, Texas, United States
Utah Valley Hospital
🇺🇸Provo, Utah, United States
Riverton Hospital
🇺🇸Riverton, Utah, United States
Inova Children's Hospital
🇺🇸Falls Church, Virginia, United States
Children's Hospital of The King's Daughters
🇺🇸Norfolk, Virginia, United States
Children's Hospital of Richmond at VCU
🇺🇸Richmond, Virginia, United States
Hoops Family Children's Hospital at Marshall University
🇺🇸Huntington, West Virginia, United States
Alberta Children's Hospital
🇨🇦Calgary, Canada
Children's Minnesota
🇺🇸Minneapolis, Minnesota, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Children's Hospital at Dartmouth-Hitchcock
🇺🇸Lebanon, New Hampshire, United States
Banner University Medical Center- Diamond Children's
🇺🇸Tucson, Arizona, United States
Yale-New Haven Children's Hospital
🇺🇸New Haven, Connecticut, United States
CS Mott Children's Hospital
🇺🇸Ann Arbor, Michigan, United States
CHOP Care Network at Virtua
🇺🇸Voorhees, New Jersey, United States
University of Vermont Children's Hospital
🇺🇸Burlington, Vermont, United States
Children's of Alabama
🇺🇸Birmingham, Alabama, United States
Children's Hospital at Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
🇺🇸Nashville, Tennessee, United States
Primary Children's Hospital
🇺🇸Salt Lake City, Utah, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Children's Wisconsin
🇺🇸Milwaukee, Wisconsin, United States