Clinical trial NCT06506474: Low-value Care, and Variation in Practice for Children Hospitalized With Bronchiolitis
Official title: Low-value Care, and Variation in Practice for Children Hospitalized With Bronchiolitis - a Multicentric Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bronchiolitis
Keywords: infants
hospitalization
bronchiolitis
low-value care
observational study
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Eastern Ontario
name: Maternal Infant Child and Youth Research Network
name: The Hospital for Sick Children
name: Unity Health Toronto
First posted: 2024-07-17
Enrollment: 3000
Sex: ALL
Minimum age (years): 28
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged \>28 days to \<12 months with an admission diagnosis of bronchiolitis.

Brief summary: 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.

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.

Primary outcomes:
measure: The proportion of eligible patients receiving each of the six low-value health services
timeFrame: 24 months
Secondary outcomes:
measure: Transfer to the ICU
timeFrame: 24 months
measure: Use of CPAP, BiPAP, or mechanical ventilation during admission.
timeFrame: 24 months
measure: Cardiac arrest
timeFrame: 24 months
measure: Death
timeFrame: 24 months
measure: Return visits
timeFrame: 24 months
measure: Use of low-flow supplemental oxygen
timeFrame: 24 months
measure: Fluid supplementation
timeFrame: 24 months
measure: Nil per os order
timeFrame: 24 months
measure: Chest X-ray results
timeFrame: 24 months
measure: Presence of bacterial co-infection
timeFrame: 24 months
measure: Use of inhaled corticosteroids
timeFrame: 24 months
measure: Use of chest physiotherapy
timeFrame: 24 months
measure: Complete blood count
timeFrame: 24 months
measure: Electrolyte levels
timeFrame: 24 months
measure: Venous blood gas
timeFrame: 24 months
measure: Antiviral prescription
timeFrame: 24 months
measure: Prescription at discharge from hospital
timeFrame: 24 months
measure: Care received in the 30 days following discharge.
timeFrame: 24 months
measure: Length of stay
timeFrame: 24 months
measure: Cost of hospitalization
timeFrame: 24 months
measure: Use of Heated humidified high-flow nasal cannula (HHHFNC)
timeFrame: 24 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital
state: British Columbia
city: Halifax
country: Canada
facility: IWK Health
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Science Centre
state: Ontario
city: London
country: Canada
facility: Children's Hospital of Western Ontario (London Health Science Centre)
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
city: Laval
country: Canada
facility: Centre hospitalier Cité-de-la-Santé
state: Quebec
city: Montréal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
city: Montréal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
city: Montréal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
city: Québec
country: Canada
facility: Centre Hospitalier Université Laval - Centre Mère-Enfant Soleil
state: Quebec
Study officials:
affiliation: CHU Sainte-Justine Research Centre
name: Olivier Drouin, MD, MSc, MPH
role: PRINCIPAL_INVESTIGATOR
References: