Pediatric Bronchiolitis Quality Improvement

NCT ID: NCT03528083

Last Updated: 2022-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1321 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-31
• Study Completion Date: 2021-12-31

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.

Conditions

Bronchiolitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Bronchiolitis quality improvement

Intervention Type: OTHER

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

Interventions

Bronchiolitis quality improvement

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Hamline, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

UC David Medical Center

Sacramento, California, United States

Countries

United States

Other Identifiers

1219188

Identifier Type: -

Identifier Source: org_study_id