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Pediatric Bronchiolitis Quality Improvement

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ClinicalTrials.gov Identifier: NCT03528083
Recruitment Status : Recruiting
First Posted : May 17, 2018
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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.


Condition or disease Intervention/treatment Phase
Bronchiolitis Other: Bronchiolitis quality improvement Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: Pediatric Bronchiolitis Quality Improvement to Reduce Unnecessary Use of Diagnostic Testing and Treatment
Actual Study Start Date : May 31, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

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




Primary Outcome Measures :
  1. Chest x-ray utilization [ Time Frame: Through study completion, an average of 19 months ]
    Percentage of patients meeting inclusion criteria who received a chest x-ray

  2. Antibiotic utilization [ Time Frame: Through study completion, an average of 19 months ]
    Percentage of patients meeting inclusion criteria who received antibiotics

  3. Bronchodilator utilization [ Time Frame: Through study completion, an average of 19 months ]
    Percentage of patients meeting inclusion criteria who received bronchodilators

  4. Steroid utilization [ Time Frame: Through study completion, an average of 19 months ]
    Percentage of patients meeting inclusion criteria who received steroids

  5. Hypertonic saline utilization [ Time Frame: Through study completion, an average of 19 months ]
    Percentage of patients meeting inclusion criteria who received nebulized hypertonic saline.

  6. Chest physiotherapy utilization [ Time Frame: Through study completion, an average of 19 months ]
    Percentage of patients meeting inclusion criteria who received chest physiotherapy

  7. Intravenous fluid utilization [ Time Frame: Through study completion, an average of 19 months ]
    Percentage of patients meeting inclusion criteria who received intravenous fluid

  8. Continuous pulse oximetry utilization [ Time Frame: Through study completion, an average of 19 months ]
    Percentage of patients meeting inclusion criteria who received continuous pulse oximetry

  9. Supplemental oxygen utilization [ Time Frame: Through study completion, an average of 19 months ]
    Percentage of patients meeting inclusion criteria who received supplemental oxygen


Secondary Outcome Measures :
  1. Length of stay index [ Time Frame: Through study completion, an average of 19 months ]
    A ratio of observed to expected length of stay for patients admitted with bronchiolitis, as compared to national standards

  2. Readmission rate [ Time Frame: Within 30 days following the index hospitalization discharge date ]
    Same hospital readmission rate for patients with a diagnosis of bronchiolitis

  3. Emergency room revisit rate [ Time Frame: Within 30 days following the index hospitalization discharge date ]
    Same hospital emergency room revisit rate for patients with a diagnosis of bronchiolitis

  4. Bronchiolitis specific discharge instructions [ Time Frame: Through study completion, an average of 19 months ]
    Percentage of patients meeting inclusion criteria who received bronchiolitis specific handout containing care instructions on discharge

  5. Timely completion of discharge summary [ Time Frame: Within 48 hours of discharge from the index hospitalization ]
    Percentage of patients meeting inclusion criteria who had a discharge summary completed

  6. Timely routing of discharge summary [ Time Frame: Within 48 hours of discharge from the index hospitalization ]
    Percentage of patients meeting inclusion criteria who had a discharge summary routed to their primary care provider

  7. CC capture rate [ Time Frame: Through study completion, an average of 19 months ]
    The capture rate for comorbid conditions within our charting for patients diagnosed with bronchiolitis

  8. MCC capture rate [ Time Frame: Through study completion, an average of 19 months ]
    The capture rate for major comorbid conditions within our charting for patients diagnosed with bronchiolitis



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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528083


Contacts
Contact: Michelle Hamline, MD, PhD 916-734-5387 mhamline@ucdavis.edu

Locations
United States, California
UC David Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Ramsey Batawi, PhD    916-734-7940    ramsey.badawi@ucdmc.ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Michelle Hamline, MD, PhD University of California, Davis

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03528083     History of Changes
Other Study ID Numbers: 1219188
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared, as data will be collected and reported in aggregate.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, Davis:
Bronchiolitis
Children
Hospital

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections