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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03528083
Other study ID # 1219188
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 31, 2018
Est. completion date December 31, 2021

Study information

Verified date May 2022
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1321
Est. completion date December 31, 2021
Est. primary completion date May 30, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Bronchiolitis quality improvement
Patients in the intervention group will undergo a quality improvement process to improve care quality for bronchiolitis at our hospital.

Locations

Country Name City State
United States UC David Medical Center Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Chest x-ray utilization Percentage of patients meeting inclusion criteria who received a chest x-ray Through study completion, an average of 19 months
Primary Antibiotic utilization Percentage of patients meeting inclusion criteria who received antibiotics Through study completion, an average of 19 months
Primary Bronchodilator utilization Percentage of patients meeting inclusion criteria who received bronchodilators Through study completion, an average of 19 months
Primary Steroid utilization Percentage of patients meeting inclusion criteria who received steroids Through study completion, an average of 19 months
Primary Hypertonic saline utilization Percentage of patients meeting inclusion criteria who received nebulized hypertonic saline. Through study completion, an average of 19 months
Primary Chest physiotherapy utilization Percentage of patients meeting inclusion criteria who received chest physiotherapy Through study completion, an average of 19 months
Primary Intravenous fluid utilization Percentage of patients meeting inclusion criteria who received intravenous fluid Through study completion, an average of 19 months
Primary Continuous pulse oximetry utilization Percentage of patients meeting inclusion criteria who received continuous pulse oximetry Through study completion, an average of 19 months
Primary Supplemental oxygen utilization Percentage of patients meeting inclusion criteria who received supplemental oxygen Through study completion, an average of 19 months
Secondary Length of stay index A ratio of observed to expected length of stay for patients admitted with bronchiolitis, as compared to national standards Through study completion, an average of 19 months
Secondary Readmission rate Same hospital readmission rate for patients with a diagnosis of bronchiolitis Within 30 days following the index hospitalization discharge date
Secondary Emergency room revisit rate Same hospital emergency room revisit rate for patients with a diagnosis of bronchiolitis Within 30 days following the index hospitalization discharge date
Secondary Bronchiolitis specific discharge instructions Percentage of patients meeting inclusion criteria who received bronchiolitis specific handout containing care instructions on discharge Through study completion, an average of 19 months
Secondary Timely completion of discharge summary Percentage of patients meeting inclusion criteria who had a discharge summary completed Within 48 hours of discharge from the index hospitalization
Secondary Timely routing of discharge summary Percentage of patients meeting inclusion criteria who had a discharge summary routed to their primary care provider Within 48 hours of discharge from the index hospitalization
Secondary CC capture rate The capture rate for comorbid conditions within our charting for patients diagnosed with bronchiolitis Through study completion, an average of 19 months
Secondary MCC capture rate The capture rate for major comorbid conditions within our charting for patients diagnosed with bronchiolitis Through study completion, an average of 19 months
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