Reducing unnecessary pulse oximetry monitoring in children with bronchiolitis
Eliminating Monitor Overuse (EMO) Hybrid Effectiveness-Deimplementation Trial
This study is testing ways to help hospitals reduce unnecessary pulse oximetry monitoring for children with bronchiolitis who don't need extra oxygen.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32357 (estimated) |
| Ages | 2 Months and up |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Locations | 58 sites (Birmingham, Alabama and 57 other locations) |
| Trial ID | NCT05132322 on ClinicalTrials.gov |
What this trial studies
This trial aims to identify effective strategies to reduce the overuse of continuous pulse oximetry monitoring in children hospitalized with bronchiolitis who do not require supplemental oxygen. The study employs a cluster-randomized design and includes interventions such as educational outreach, real-time audit and feedback, and the integration of clinical pathways into electronic health records. By focusing on hospital staff, the trial seeks to gather insights through questionnaires and qualitative interviews to inform best practices in monitoring. The ultimate goal is to improve patient care by minimizing unnecessary interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are hospital staff, including nurses and physicians, who care for bronchiolitis patients and are fluent in English.
Not a fit: Patients who are not hospitalized for bronchiolitis or those receiving supplemental oxygen will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more appropriate use of monitoring in pediatric patients, reducing unnecessary interventions and healthcare costs.
How similar studies have performed: Other studies have shown success in implementing deimplementation strategies in healthcare settings, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Birmingham, Alabama and 57 other locations
- Children's of Alabama — Birmingham, Alabama, United States (Terminated)
- Banner University Medical Center- Diamond Children's — Tucson, Arizona, United States (Recruiting)
- University of California Davis — Davis, California, United States (Recruiting)
- Rady Children's Hospital/UCSD — Encinitas, California, United States (Recruiting)
- Children's Hospital Los Angeles — Los Angeles, California, United States (Recruiting)
- Valley Children's Hospital — Madera, California, United States (Recruiting)
- Children's Hospital Orange County — Orange, California, United States (Recruiting)
- Lucile Packard Children's Hospital Stanford — Stanford, California, United States (Recruiting)
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
- Connecticut Children's Medical Center — Hartford, Connecticut, United States (Withdrawn)
- Yale-New Haven Children's Hospital — New Haven, Connecticut, United States (Terminated)
- Children's National Medical Center — Washington, District of Columbia, United States (Recruiting)
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Active_not_recruiting)
- Riley Hospital for Children at IU Health — Indianapolis, Indiana, United States (Recruiting)
- Tufts Medical Center — Boston, Massachusetts, United States (Recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- CS Mott Children's Hospital — Ann Arbor, Michigan, United States (Terminated)
- Children's Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- Children's Mercy Kansas City — Kansas City, Missouri, United States (Recruiting)
- Children's Hospital at Dartmouth-Hitchcock — Lebanon, New Hampshire, United States (Recruiting)
- CHOP Pediatric Care at Penn Medicine/Princeton Health — Princeton, New Jersey, United States (Terminated)
- CHOP Care Network at Virtua — Voorhees, New Jersey, United States (Recruiting)
- Albany Medical Center — Albany, New York, United States (Recruiting)
- Children's Hospital at Montefiore — Bronx, New York, United States (Terminated)
- Cohen Children's Medical Center — New Hyde Park, New York, United States (Recruiting)
- NYP-Morgan Stanley Children's Hospital — New York, New York, United States (Recruiting)
- Komansky Children's Hospital/New York Presbyterian Medical Center /Weill Cornell Medicine — New York, New York, United States (Terminated)
- University of Rochester Golisano Children's Hospital — Rochester, New York, United States (Recruiting)
- Upstate Golisano Children's Hospital — Syracuse, New York, United States (Recruiting)
- Akron Children's Hospital — Akron, Ohio, United States (Recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
- Children's Hospital at Oklahoma University Medical Center — Oklahoma City, Oklahoma, United States (Recruiting)
- Penn State Hershey Children's Hospital — Hershey, Pennsylvania, United States (Withdrawn)
- CHOP King of Prussia Hospital — King Of Prussia, Pennsylvania, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States (Terminated)
- Reading Hospital, Tower Health — Reading, Pennsylvania, United States (Withdrawn)
- CHOP Grand View Hospital — Sellersville, Pennsylvania, United States (Terminated)
- Monroe Carell Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee, United States (Recruiting)
- Children's Medical Center Dallas — Dallas, Texas, United States (Recruiting)
- Children's Memorial Hermann — Houston, Texas, United States (Recruiting)
- Texas Children's Hospital — Houston, Texas, United States (Recruiting)
- Texas Children's Hospital West Campus — Houston, Texas, United States (Recruiting)
- Texas Children's Hospital The Woodlands — The Woodlands, Texas, United States (Recruiting)
- Utah Valley Hospital — Provo, Utah, United States (Withdrawn)
- Riverton Hospital — Riverton, Utah, United States (Withdrawn)
- Primary Children's Hospital — Salt Lake City, Utah, United States (Terminated)
+8 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Christopher P Bonafide, MD, MSCE — Children's Hospital of Philadelphia
- Study coordinator: Christopher P Bonafide, MD, MSCE
- Email: bonafide@chop.edu
- Phone: 267-426-2901
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.