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Educational and Feedback Interventions for Bronchiolitis
N/A
Recruiting
Led By Christopher P Bonafide, MD, MSCE
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Select...
I am currently hospitalized but not in the ICU.
Select...
My latest doctor's note says I have bronchiolitis.
Select...
I need at least 2 liters per minute of extra oxygen to breathe.
Select...
I do not need extra oxygen to breathe normally.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Sustainability of guideline-concordant deimplementation of continuous pulse oximetry monitoring
Secondary outcome measures
Acceptability of deimplementation
Appropriateness of deimplementation
Cost of deimplementation strategies
+5 moreOther outcome measures
Exploratory long-term sustainability
Implementation Climate
Implementation Leadership
+6 moreTrial 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
709 Previous Clinical Trials
8,550,685 Total Patients Enrolled
3 Trials studying Bronchiolitis
2,558 Patients Enrolled for Bronchiolitis
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,841 Previous Clinical Trials
47,781,748 Total Patients Enrolled
7 Trials studying Bronchiolitis
19,086 Patients Enrolled for Bronchiolitis
University of PennsylvaniaOTHER
2,006 Previous Clinical Trials
42,850,695 Total Patients Enrolled
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this clinical trial open and ongoing?
"Affirmative. According to clinicaltrials.gov, this clinical study is still in search of participants and was first publicized on December 1st 2021 with a recent update occurring July 12th 2022. The trial requires the participation of 6480 individuals between 54 sites around the world."
Answered by AI
What is the current enrollment number for this clinical experiment?
"Yes, the details found on clinicaltrials.gov demonstrate that this medical research is actively recruiting participants. The project was initially advertised on December 1st 2021 and has since been updated to July 12th 2022. In total, 6480 people need to be recruited from 54 different sites."
Answered by AI
How many venues is this investigation taking place in?
"Currently, 54 medical centres are offering this study. Examples of these include the Rady Children’s Hospital/UCSD in Encinitas, University of Rochester Golisano Children's Hospital in Rochester and CHOP King Of Prussia Hospital in King Of Prussia amongst many others."
Answered by AI
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