Pediatric Bronchiolitis Quality Improvement
Primary Purpose
Bronchiolitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bronchiolitis quality improvement
Sponsored by
About this trial
This is an interventional supportive care trial for Bronchiolitis focused on measuring Bronchiolitis, Children, Hospital
Eligibility Criteria
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
Sites / Locations
- UC David Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Retrospective Controls
Quality Improvement
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Chest x-ray utilization
Percentage of patients meeting inclusion criteria who received a chest x-ray
Antibiotic utilization
Percentage of patients meeting inclusion criteria who received antibiotics
Bronchodilator utilization
Percentage of patients meeting inclusion criteria who received bronchodilators
Steroid utilization
Percentage of patients meeting inclusion criteria who received steroids
Hypertonic saline utilization
Percentage of patients meeting inclusion criteria who received nebulized hypertonic saline.
Chest physiotherapy utilization
Percentage of patients meeting inclusion criteria who received chest physiotherapy
Intravenous fluid utilization
Percentage of patients meeting inclusion criteria who received intravenous fluid
Continuous pulse oximetry utilization
Percentage of patients meeting inclusion criteria who received continuous pulse oximetry
Supplemental oxygen utilization
Percentage of patients meeting inclusion criteria who received supplemental oxygen
Secondary Outcome Measures
Length of stay index
A ratio of observed to expected length of stay for patients admitted with bronchiolitis, as compared to national standards
Readmission rate
Same hospital readmission rate for patients with a diagnosis of bronchiolitis
Emergency room revisit rate
Same hospital emergency room revisit rate for patients with a diagnosis of bronchiolitis
Bronchiolitis specific discharge instructions
Percentage of patients meeting inclusion criteria who received bronchiolitis specific handout containing care instructions on discharge
Timely completion of discharge summary
Percentage of patients meeting inclusion criteria who had a discharge summary completed
Timely routing of discharge summary
Percentage of patients meeting inclusion criteria who had a discharge summary routed to their primary care provider
CC capture rate
The capture rate for comorbid conditions within our charting for patients diagnosed with bronchiolitis
MCC capture rate
The capture rate for major comorbid conditions within our charting for patients diagnosed with bronchiolitis
Full Information
NCT ID
NCT03528083
First Posted
April 9, 2018
Last Updated
May 12, 2022
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT03528083
Brief Title
Pediatric Bronchiolitis Quality Improvement
Official Title
Pediatric Bronchiolitis Quality Improvement to Reduce Unnecessary Use of Diagnostic Testing and Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 31, 2018 (Actual)
Primary Completion Date
May 30, 2020 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
A multidisciplinary team, involving pediatric hospitalists, pediatric emergency physicians, residents, medical students, nurses and nurse managers, and respiratory therapists will be assembled. The investigators will participate in a value stream mapping process, to map out the current pediatric bronchiolitis care process and identify areas for improvement in efficiency and effectiveness. The investigators will then begin the iterative process of implementing improvements to the bronchiolitis care process. Interventions will be evidence-based and designed to improve compliance with bronchiolitis care guidelines, as set forth by the American Academy of Pediatrics. Examples of possible interventions may include creation of a bronchiolitis admission order set, implementation of an evidence-based bronchiolitis clinical pathway, and/or institution of standardized bronchiolitis discharge criteria. Interventions will be implemented in a stepwise fashion, utilizing successive plan-do-study-act cycles, with a minimum 2 month period between interventions to monitor outcomes. The investigators will track utilization of diagnostic testing and treatments within our intervention group, as compared to historical controls who also meet inclusion criteria.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
Bronchiolitis, Children, Hospital
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The investigators will conduct a quality improvement process for all children diagnosed with bronchiolitis at our hospital who meet inclusion criteria. Outcomes for these patients will be compared with retrospective controls.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1321 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Retrospective Controls
Arm Type
No Intervention
Arm Description
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.
Arm Title
Quality Improvement
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Bronchiolitis quality improvement
Intervention Description
Patients in the intervention group will undergo a quality improvement process to improve care quality for bronchiolitis at our hospital.
Primary Outcome Measure Information:
Title
Chest x-ray utilization
Description
Percentage of patients meeting inclusion criteria who received a chest x-ray
Time Frame
Through study completion, an average of 19 months
Title
Antibiotic utilization
Description
Percentage of patients meeting inclusion criteria who received antibiotics
Time Frame
Through study completion, an average of 19 months
Title
Bronchodilator utilization
Description
Percentage of patients meeting inclusion criteria who received bronchodilators
Time Frame
Through study completion, an average of 19 months
Title
Steroid utilization
Description
Percentage of patients meeting inclusion criteria who received steroids
Time Frame
Through study completion, an average of 19 months
Title
Hypertonic saline utilization
Description
Percentage of patients meeting inclusion criteria who received nebulized hypertonic saline.
Time Frame
Through study completion, an average of 19 months
Title
Chest physiotherapy utilization
Description
Percentage of patients meeting inclusion criteria who received chest physiotherapy
Time Frame
Through study completion, an average of 19 months
Title
Intravenous fluid utilization
Description
Percentage of patients meeting inclusion criteria who received intravenous fluid
Time Frame
Through study completion, an average of 19 months
Title
Continuous pulse oximetry utilization
Description
Percentage of patients meeting inclusion criteria who received continuous pulse oximetry
Time Frame
Through study completion, an average of 19 months
Title
Supplemental oxygen utilization
Description
Percentage of patients meeting inclusion criteria who received supplemental oxygen
Time Frame
Through study completion, an average of 19 months
Secondary Outcome Measure Information:
Title
Length of stay index
Description
A ratio of observed to expected length of stay for patients admitted with bronchiolitis, as compared to national standards
Time Frame
Through study completion, an average of 19 months
Title
Readmission rate
Description
Same hospital readmission rate for patients with a diagnosis of bronchiolitis
Time Frame
Within 30 days following the index hospitalization discharge date
Title
Emergency room revisit rate
Description
Same hospital emergency room revisit rate for patients with a diagnosis of bronchiolitis
Time Frame
Within 30 days following the index hospitalization discharge date
Title
Bronchiolitis specific discharge instructions
Description
Percentage of patients meeting inclusion criteria who received bronchiolitis specific handout containing care instructions on discharge
Time Frame
Through study completion, an average of 19 months
Title
Timely completion of discharge summary
Description
Percentage of patients meeting inclusion criteria who had a discharge summary completed
Time Frame
Within 48 hours of discharge from the index hospitalization
Title
Timely routing of discharge summary
Description
Percentage of patients meeting inclusion criteria who had a discharge summary routed to their primary care provider
Time Frame
Within 48 hours of discharge from the index hospitalization
Title
CC capture rate
Description
The capture rate for comorbid conditions within our charting for patients diagnosed with bronchiolitis
Time Frame
Through study completion, an average of 19 months
Title
MCC capture rate
Description
The capture rate for major comorbid conditions within our charting for patients diagnosed with bronchiolitis
Time Frame
Through study completion, an average of 19 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Hamline, MD, PhD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC David Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared, as data will be collected and reported in aggregate.
Learn more about this trial
Pediatric Bronchiolitis Quality Improvement
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