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Educational and Feedback Interventions for Bronchiolitis
N/A
Recruiting
Led By Rinad S Beidas, PhD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Infants and children 2 months through 23 months old
Hospitalized on non-ICU wards participating in the trial
Must not have
Neuromuscular disease
Immunodeficiency
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will help find the best way to stop using continuous pulse oximetry for children with bronchiolitis who don't need extra oxygen.
Who is the study for?
The EMO Trial is for English-speaking nurses, physicians, and hospital administrators who have cared for bronchiolitis patients. It includes infants and children aged 2-23 months hospitalized with a primary diagnosis of bronchiolitis on non-ICU wards. Exclusions are extreme prematurity, cardiac disease, chronic lung conditions, immunodeficiency or current severe illness like COVID-19.
What is being tested?
This study tests strategies to reduce unnecessary continuous pulse oximetry monitoring in children with bronchiolitis not needing supplemental oxygen. Interventions include educational outreach, audit & feedback at unit and individual levels, and integrating clinical pathways into electronic health records.
What are the potential side effects?
Since the interventions involve process changes rather than medications or medical procedures, traditional side effects are not applicable. However, there may be indirect effects on patient care routines or outcomes which will be monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is between 2 and 23 months old.
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I am currently hospitalized but not in the ICU.
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My latest doctor's note says I have bronchiolitis.
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I need at least 2 liters per minute of extra oxygen to breathe.
Select...
I do not need extra oxygen to breathe normally.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a neuromuscular disease.
Select...
I have a weakened immune system.
Select...
I have or might have COVID-19 or its related severe complications.
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I have a heart condition.
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I have high blood pressure in the lungs.
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I have a long-term lung condition.
Select...
I have or might have COVID-19.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Sustainability of guideline-concordant deimplementation of continuous pulse oximetry monitoring
Secondary study objectives
Acceptability of deimplementation
Appropriateness of deimplementation
Cost of deimplementation strategies
+5 moreOther study objectives
Exploratory long-term sustainability
Implementation Climate
Implementation Leadership
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Unlearning + SubstitutionExperimental Treatment4 Interventions
Includes educational outreach, audit \& feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry.
Group II: Unlearning OnlyActive Control3 Interventions
Includes educational outreach and audit \& feedback.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Educational Outreach
2015
N/A
~210
Find a Location
Who is running the clinical trial?
Children's Hospital of PhiladelphiaLead Sponsor
731 Previous Clinical Trials
8,440,477 Total Patients Enrolled
3 Trials studying Bronchiolitis
2,558 Patients Enrolled for Bronchiolitis
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,765,536 Total Patients Enrolled
7 Trials studying Bronchiolitis
19,086 Patients Enrolled for Bronchiolitis
University of PennsylvaniaOTHER
2,084 Previous Clinical Trials
42,694,691 Total Patients Enrolled
Boston Children's HospitalOTHER
789 Previous Clinical Trials
5,550,584 Total Patients Enrolled
2 Trials studying Bronchiolitis
658 Patients Enrolled for Bronchiolitis
Children's Hospital Medical Center, CincinnatiOTHER
839 Previous Clinical Trials
6,533,246 Total Patients Enrolled
7 Trials studying Bronchiolitis
2,929 Patients Enrolled for Bronchiolitis
Pediatric Research in Inpatient Settings (PRIS) NetworkUNKNOWN
1 Previous Clinical Trials
630 Total Patients Enrolled
Rinad S Beidas, PhDPrincipal InvestigatorNorthwestern University
1 Previous Clinical Trials
126 Total Patients Enrolled
Christopher P Bonafide, MD, MSCEPrincipal InvestigatorChildren's Hospital of Philadelphia
2 Previous Clinical Trials
79,178 Total Patients Enrolled
1 Trials studying Bronchiolitis
1,898 Patients Enrolled for Bronchiolitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a neuromuscular disease.I last used supplemental oxygen more than an hour ago.I have a weakened immune system.Their child had their oxygen levels monitored while breathing normal air during Aim 1 data collection.I have or might have COVID-19 or its related severe complications.I am a hospital administrator fluent in English and have managed bronchiolitis care.Nurses or doctors who worked with bronchiolitis patients on a unit involved in the trial for at least 5 days during the most recent bronchiolitis season.You have experienced periods of not breathing or turning blue during your current illness.I have a heart condition.I have high blood pressure in the lungs.I am a nurse or doctor who speaks English and worked with bronchiolitis patients for at least 5 days last season.Your child was in the hospital for bronchiolitis during the last bronchiolitis season.My child is between 2 and 23 months old.I am currently hospitalized but not in the ICU.My latest doctor's note says I have bronchiolitis.You were born very early, before 28 weeks of pregnancy were completed.I need at least 2 liters per minute of extra oxygen to breathe.I have cancer.You need to use oxygen at home.I have a long-term lung condition.You cannot remember being with the child while their oxygen levels were constantly monitored.I have or might have COVID-19.I do not need extra oxygen to breathe normally.
Research Study Groups:
This trial has the following groups:- Group 1: Unlearning Only
- Group 2: Unlearning + Substitution
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.