- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03528083
Pediatric Bronchiolitis Quality Improvement
Pediatric Bronchiolitis Quality Improvement to Reduce Unnecessary Use of Diagnostic Testing and Treatment
Bronchiolitis is a respiratory illness characterized by acute inflammation of the airways, typically caused by a virus. By definition, it impacts children between 2 months and 2 years of age and is the most common cause of hospitalization among infants in the first year of life (American Academy of Pediatrics). Children with this illness may exhibit respiratory distress, as well as symptoms of viral respiratory illness, such as sneezing, nasal congestion, and cough. Often, hospitalization is required for respiratory distress and to support hydration needs.
Evidence based guidelines for the treatment of acute viral bronchiolitis primarily involve supportive care, which most often includes supplemental oxygen, hydration, and suctioning of secretions. However, in practice, bronchiolitis care is highly variable, often involving therapies such as inhaled bronchodilators, systemic corticosteroids, inhaled hypertonic saline, continuous pulse oximetry, chest physiotherapy, antibacterial medications, and use of intravenous fluids, all of which have been shown to be unnecessary and costly. Unnecessary care remains although multiple published quality improvement studies centered on acute bronchiolitis have proven successful. Quality improvement interventions have shown reduced use of unnecessary treatments and reduced resource allocation. Therefore, the investigators will conduct a quality improvement process to improve adherence to bronchiolitis treatment guidelines for children with bronchiolitis treated at University of California Davis Children's Hospital.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Sacramento, California, United States, 95817
- UC David Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children less than 2 years of age admitted to UC Davis Children's Hospital with any diagnosis of bronchiolitis
Exclusion Criteria:
- Children or adults greater than 2 years of age
- Children born at less than 35 weeks gestational age
- Children with underlying illnesses, such as chronic lung disease, congenital heart disease, other congenital anomalies including airway anomalies, or immunodeficiencies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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NO_INTERVENTION: Retrospective Controls
A retrospective control group of patients with a diagnosis of bronchiolitis and meeting inclusion criteria will be used as a comparison group.
These patients received usual care for bronchiolitis at our institution.
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EXPERIMENTAL: Quality Improvement
All patients diagnosed with bronchiolitis and meeting inclusion criteria will undergo the intervention of a bronchiolitis quality improvement process to improve bronchiolitis care quality at our institution.
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Patients in the intervention group will undergo a quality improvement process to improve care quality for bronchiolitis at our hospital.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Chest x-ray utilization
Time Frame: Through study completion, an average of 19 months
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Percentage of patients meeting inclusion criteria who received a chest x-ray
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Through study completion, an average of 19 months
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Antibiotic utilization
Time Frame: Through study completion, an average of 19 months
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Percentage of patients meeting inclusion criteria who received antibiotics
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Through study completion, an average of 19 months
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Bronchodilator utilization
Time Frame: Through study completion, an average of 19 months
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Percentage of patients meeting inclusion criteria who received bronchodilators
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Through study completion, an average of 19 months
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Steroid utilization
Time Frame: Through study completion, an average of 19 months
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Percentage of patients meeting inclusion criteria who received steroids
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Through study completion, an average of 19 months
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Hypertonic saline utilization
Time Frame: Through study completion, an average of 19 months
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Percentage of patients meeting inclusion criteria who received nebulized hypertonic saline.
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Through study completion, an average of 19 months
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Chest physiotherapy utilization
Time Frame: Through study completion, an average of 19 months
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Percentage of patients meeting inclusion criteria who received chest physiotherapy
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Through study completion, an average of 19 months
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Intravenous fluid utilization
Time Frame: Through study completion, an average of 19 months
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Percentage of patients meeting inclusion criteria who received intravenous fluid
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Through study completion, an average of 19 months
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Continuous pulse oximetry utilization
Time Frame: Through study completion, an average of 19 months
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Percentage of patients meeting inclusion criteria who received continuous pulse oximetry
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Through study completion, an average of 19 months
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Supplemental oxygen utilization
Time Frame: Through study completion, an average of 19 months
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Percentage of patients meeting inclusion criteria who received supplemental oxygen
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Through study completion, an average of 19 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Length of stay index
Time Frame: Through study completion, an average of 19 months
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A ratio of observed to expected length of stay for patients admitted with bronchiolitis, as compared to national standards
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Through study completion, an average of 19 months
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Readmission rate
Time Frame: Within 30 days following the index hospitalization discharge date
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Same hospital readmission rate for patients with a diagnosis of bronchiolitis
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Within 30 days following the index hospitalization discharge date
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Emergency room revisit rate
Time Frame: Within 30 days following the index hospitalization discharge date
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Same hospital emergency room revisit rate for patients with a diagnosis of bronchiolitis
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Within 30 days following the index hospitalization discharge date
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Bronchiolitis specific discharge instructions
Time Frame: Through study completion, an average of 19 months
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Percentage of patients meeting inclusion criteria who received bronchiolitis specific handout containing care instructions on discharge
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Through study completion, an average of 19 months
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Timely completion of discharge summary
Time Frame: Within 48 hours of discharge from the index hospitalization
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Percentage of patients meeting inclusion criteria who had a discharge summary completed
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Within 48 hours of discharge from the index hospitalization
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Timely routing of discharge summary
Time Frame: Within 48 hours of discharge from the index hospitalization
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Percentage of patients meeting inclusion criteria who had a discharge summary routed to their primary care provider
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Within 48 hours of discharge from the index hospitalization
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CC capture rate
Time Frame: Through study completion, an average of 19 months
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The capture rate for comorbid conditions within our charting for patients diagnosed with bronchiolitis
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Through study completion, an average of 19 months
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MCC capture rate
Time Frame: Through study completion, an average of 19 months
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The capture rate for major comorbid conditions within our charting for patients diagnosed with bronchiolitis
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Through study completion, an average of 19 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michelle Hamline, MD, PhD, University of California, Davis
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1219188
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bronchiolitis
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Regend TherapeuticsShanghai Children's HospitalRecruitingPediatric Bronchiolitis ObliteransChina
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Fondazione IRCCS Policlinico San Matteo di PaviaCompletedBronchiolitis Obliterans Syndrome (BOS)Italy
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National Heart, Lung, and Blood Institute (NHLBI)CompletedBronchiolitis Obliterans | Graft vs Host Disease | Constrictive Bronchiolitis | Bronchiolitis, Exudative | Bronchiolitis, ProliferativeUnited States
-
University Hospital, Basel, SwitzerlandRecruitingBronchiolitis Obliterans Syndrome (BOS) | Bronchiolitis Obliterans (BO)Switzerland, Saudi Arabia
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Hillel Yaffe Medical CenterCompletedReflexology | Bronchiolitis; ChemicalIsrael
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Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker CochinCompletedSevere Viral BronchiolitisFrance
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Hospices Civils de LyonCompleted
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Guy's and St Thomas' NHS Foundation TrustCompletedAcute Viral BronchiolitisUnited Kingdom
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