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Recruiting NCT06506474

Low-value Care, and Variation in Practice for Children Hospitalized With Bronchiolitis

Observational Bronchiolitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Provision of any of six different low-value health services for treatment of bronchiolitis.
Who it may be relevant to
Registry conditions: Bronchiolitis. Basic parameters: 28 Days — 12 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Low-value Care, and Variation in Practice for Children Hospitalized With Bronchiolitis - a Multicentric Prospective Observational Study

Overview

Low-value care is defined as the use of a health service, such as diagnostics and treatments, for which the harms or costs outweigh the benefits. In pediatrics, investigations or treatments can be unpleasant or traumatizing to the child, can prolong the time spent in hospital, and can create a cascade of further futile investigations and treatments. Several of the commonly used diagnostics and treatments in bronchiolitis are considered low-value, making it a great model to study low-value care in pediatrics. The purpose of CareBEST is to study the use of 6 low-value healthcare services in children aged 1 to 12 months hospitalized with bronchiolitis, their costs, and measure the variability in practice of these services. The main questions this study aims to answer are: 1. How frequently are 6 low-value care health services used in children hospitalized with bronchiolitis? These 6 low-value care health services are: 1) respiratory virus testing; 2) chest x-rays; 3) continuous pulse oximetry; 4) short-acting beta-agonists; 5) systemic corticosteroids; and 6) antibiotics. * Are there factors that predict the use of these services? * What are the costs of the use of these services? 2. How much variability is there between different patients, different doctors, and between hospitals in the use of these 6 low-value health services ? 3. Are differences in use of low-value health services associated with patient and family characteristics (like race and ethnicity, socioeconomic status, language), and do these contribute to disparities in care? Participants will have their infant's medical chart reviewed during their hospitalization. They will also have 2 short questionnaires to complete, once during their child's admission to the hospital, and one 30 days later to ask about whether their child required any additional medical care. They will additionally be asked to complete a questionnaire on their perceptions regarding their child's care while hospitalized, including the use of shared-decision making and their understanding of and involvement in the care decisions made. This analysis will provide a better understanding of treatment of bronchiolitis in Canada and help in the development of effective interventions to reduce low-value care.

Detailed description

Background: Low-value care is defined as the use of a health service, such as diagnostics and treatments, for which the harms or costs outweigh the benefits. Reducing low-value care is important in improving the health of Canadians and achieving a sustainable, high-quality healthcare system. Bronchiolitis is among the most common and most costly causes of hospitalizations in children. Most healthcare costs associated with bronchiolitis are related to hospitalization, and these costs have been increasing. Supportive care is recommended by national guidelines for the treatment of bronchiolitis, and many commonly used diagnostics and treatments in bronchiolitis are considered low-value, making it a great model to study low-value care in pediatrics. To develop effective interventions to reduce low-value care, and ensure the right resources go to the right patient at the right time, it is crucial to develop a better understanding of inpatient management of bronchiolitis in Canada.

The goal of this prospective multi-site observational study is to analyze the use of 6 low-value healthcare services in children diagnosed with bronchiolitis, their costs, and measure the variability in practice of these services.

Specific objectives: Among infants admitted with bronchiolitis at 15 Canadian hospitals with pediatric admissions, to:

1. Measure the incidence, patterns, and predictors of use of 6 low-value care health services and their costs in children hospitalized for bronchiolitis, namely 1) respiratory virus testing; 2) chest x-rays; 3) continuous pulse oximetry; 4) short-acting beta-agonists; 5) systemic corticosteroids; and 6) antibiotics; 2. Estimate the extent of practice variation in the use of 6 low-value health services between hospitals; 3. Determine whether differences in use of low-value health services are associated with patient and family characteristics (e.g., race and ethnicity, socioeconomic status, language), and whether these contribute to disparities in care.

Design: A multi-centre (n=15), prospective observational cohort study of children hospitalized with bronchiolitis. Data will be obtained from medical charts and entered into a central, web-based REDCap database. A health equity questionnaire will be completed by participants once during their child's admission and then again 30 days later to inquire on additional medical care required post-admission. Secondary outcomes and covariates will also be collected which include but are not limited to duration of ICU stay, use of mechanical ventilation, cardiac arrest, length of hospital stay, disease severity, clinician years of experience, and death.

Analysis of the primary outcome will be descriptive for each low-value health service, overall and stratified by sex. Costs of hospitalization will be assessed from a healthcare institution perspective. Cost of each of low-value health service will be described and compared between one another and across sites to identify key differences which may be targets for process change.

This study will provide important data to understand the use of low-value care in bronchiolitis treatment in Canada, and will inform our approach to addressing low-value care in bronchiolitis and in other common conditions.

Interventions

  • Diagnostic test Provision of any of six different low-value health services for treatment of bronchiolitis
    This prospective observational will have six separate primary outcomes acting as exposures, (or interventions).The exposures are the the provision of any of the six low-value health services: 1) respiratory virus testing; 2) chest x-ray; 3) continuous pulse oximetry; 4) short-acting beta-agonists; 5) systemic corticosteroids; and 6) antibiotics.

Primary outcome measures

  • The proportion of eligible patients receiving each of the six low-value health services [Time frame: 24 months]
Secondary outcome measures (12)
  • Transfer to the ICU [Time frame: 24 months]
  • Use of CPAP, BiPAP, or mechanical ventilation during admission. [Time frame: 24 months]
  • Cardiac arrest [Time frame: 24 months]
  • Death [Time frame: 24 months]
  • Return visits [Time frame: 24 months]
  • Use of low-flow supplemental oxygen [Time frame: 24 months]
  • Fluid supplementation [Time frame: 24 months]
  • Nil per os order [Time frame: 24 months]
  • Chest X-ray results [Time frame: 24 months]
  • Presence of bacterial co-infection [Time frame: 24 months]
  • Use of inhaled corticosteroids [Time frame: 24 months]
  • Use of chest physiotherapy [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • Children aged >28 days to <12 months
  • Children admitted to a pediatric inpatient ward with an admission diagnosis of bronchiolitis

Exclusion criteria

\- Children previously recruited for the study, either during a previous bronchiolitis admission or for the same incident of bronchiolitis, while admitted to another study site.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Canada · 15 centers
  • Alberta Children's Hospital — Calgary
  • Stollery Children's Hospital — Edmonton
  • British Columbia Children's Hospital — Vancouver
  • IWK Health — Halifax
  • McMaster Children's Hospital — Hamilton
  • Kingston Health Science Centre — Kingston
  • Children's Hospital of Western Ontario (London Health Science Centre) — London
  • Lakeridge Health — Oshawa
  • … and 7 more centers

Identifiers

NCT: NCT06506474 · 2024-5815

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗