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

July 18, 2025 updated by: Olivier Drouin, M.D., M.Sc M.P.H., St. Justine's Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
      • Edmonton, Alberta, Canada, T6G 2B7
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • Active, not recruiting
        • IWK Health
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Recruiting
        • McMaster Children's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gita Wahi, MD
      • Kingston, Ontario, Canada, K7L 2V7
        • Not yet recruiting
        • Kingston Health Science Centre
        • Contact:
          • Anupam Sehgal, MD
        • Principal Investigator:
          • Anupam Sehgal, MD
      • London, Ontario, Canada, N6C 0B2
        • Not yet recruiting
        • Children's Hospital of Western Ontario (London Health Science Centre)
        • Contact:
        • Principal Investigator:
          • Breanna Chen, MD
      • Oshawa, Ontario, Canada, L1G 8A2
        • Recruiting
        • Lakeridge Health
        • Contact:
        • Principal Investigator:
          • Mahmoud Sakran, MD
      • Ottawa, Ontario, Canada, K1H 8L1
        • Not yet recruiting
        • Children's Hospital of Eastern Ontario
        • Contact:
        • Principal Investigator:
          • Melanie Buba, MD
      • Toronto, Ontario, Canada, M5G 1E8
        • Not yet recruiting
        • Hospital for Sick Children
        • Contact:
          • Peter Gill, MD DPhil MSc
        • Contact:
        • Principal Investigator:
          • Peter Gill, MD DPhil MSc
        • Principal Investigator:
          • Sanjay Mahant, MD MSc
    • Quebec
      • Laval, Quebec, Canada, H7M 3L9
      • Montréal, Quebec, Canada, H1T 2M4
        • Recruiting
        • Hôpital Maisonneuve-Rosemont
        • Contact:
        • Principal Investigator:
          • Marc-André Turcot, MD
      • Montréal, Quebec, Canada, H3T 1C5
      • Montréal, Quebec, Canada, H4A 3J1
        • Not yet recruiting
        • Montreal Children's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patricia Li, MD, MSc
        • Sub-Investigator:
          • Evelyn Constantin, MD, MSC
      • Québec, Quebec, Canada, G1V 4G2
        • Active, not recruiting
        • Centre Hospitalier Université Laval - Centre Mère-Enfant Soleil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children aged >28 days to <12 months with an admission diagnosis of bronchiolitis.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children admitted to CHU Sainte-Justine
Children aged >28 days to <12 months with an admission diagnosis of bronchiolitis, admitted to a general pediatric inpatient unit, not previously recruited for the study.
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.
Children admitted to McMaster Children's Hospital
Children aged >28 days to <12 months with an admission diagnosis of bronchiolitis, admitted to a general pediatric inpatient unit, not previously recruited for the study.
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.
Children admitted to British Columbia Children's Hospital
Children aged >28 days to <12 months with an admission diagnosis of bronchiolitis, admitted to a general pediatric inpatient unit, not previously recruited for the study.
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.
Children admitted to IWK Children's Hospital
Children aged >28 days to <12 months with an admission diagnosis of bronchiolitis, admitted to a general pediatric inpatient unit, not previously recruited for the study.
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.
Children admitted to CHU de Quebec University Laval Hospital
Children aged >28 days to <12 months with an admission diagnosis of bronchiolitis, admitted to a general pediatric inpatient unit, not previously recruited for the study.
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.
Children admitted to Montreal Children's Hospital
Children aged >28 days to <12 months with an admission diagnosis of bronchiolitis, admitted to a general pediatric inpatient unit, not previously recruited for the study.
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.
Children admitted to Children's Hospital of Eastern Ontario
Children aged >28 days to <12 months with an admission diagnosis of bronchiolitis, admitted to a general pediatric inpatient unit, not previously recruited for the study.
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.
Children admitted to Kingston Health Sciences Centre
Children aged >28 days to <12 months with an admission diagnosis of bronchiolitis, admitted to a general pediatric inpatient unit, not previously recruited for the study.
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.
Children admitted to Children's Hospital of Western Ontario
Children aged >28 days to <12 months with an admission diagnosis of bronchiolitis, admitted to a general pediatric inpatient unit, not previously recruited for the study.
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.
Children admitted to Alberta Children's Hospital
Children aged >28 days to <12 months with an admission diagnosis of bronchiolitis, admitted to a general pediatric inpatient unit, not previously recruited for the study.
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.
Children admitted to Stollery Children's Hospital
Children aged >28 days to <12 months with an admission diagnosis of bronchiolitis, admitted to a general pediatric inpatient unit, not previously recruited for the study.
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.
Children Admitted to Hôpital Maisonneuve-Rosemont
Children aged >28 days to <12 months with an admission diagnosis of bronchiolitis, admitted to a general pediatric inpatient unit, not previously recruited for the study.
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.
Children admitted to Cité-de-la-Santé
Children aged >28 days to <12 months with an admission diagnosis of bronchiolitis, admitted to a general pediatric inpatient unit, not previously recruited for the study.
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.
Children admitted to Lakeridge Health
Children aged >28 days to <12 months with an admission diagnosis of bronchiolitis, admitted to a general pediatric inpatient unit, not previously recruited for the study.
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.
Children admitted to The Hospital for Sick Children
Children aged >28 days to <12 months with an admission diagnosis of bronchiolitis, admitted to a general pediatric inpatient unit, not previously recruited for the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of eligible patients receiving each of the six low-value health services
Time Frame: 24 months
The primary outcome of the study is the proportion of patients receiving each of the six low-value health services during their hospitalization for bronchiolitis: 1) respiratory virus testing; 2) chest x-ray; 3) continuous pulse oximetry; 4) short-acting beta-agonists; 5) systemic corticosteroids; and 6) antibiotics.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transfer to the ICU
Time Frame: 24 months
Whether the child admitted with bronchiolitis was transferred to the ICU. If so, duration of ICU stay.
24 months
Use of CPAP, BiPAP, or mechanical ventilation during admission.
Time Frame: 24 months
Use of continuous positive airway pressure (CPAP) or biphasic positive airway pressure (BiPAP), mechanical ventilation during admission, as documented in patient's admission record.
24 months
Cardiac arrest
Time Frame: 24 months
Whether the child experienced a cardiac arrest during their admission.
24 months
Death
Time Frame: 24 months
Whether the child died during their admission.
24 months
Return visits
Time Frame: 24 months
Using administrative data and parent surveys, we will measure return visits to the Emergency Department, and hospitalizations within 30 days following the initial bronchiolitis admission, overall and for respiratory illness.
24 months
Use of low-flow supplemental oxygen
Time Frame: 24 months
Any use of low-flow supplemental oxygen, and duration of use.
24 months
Fluid supplementation
Time Frame: 24 months
Presence and type (intravenous vs. nasogastric) of fluid supplementation
24 months
Nil per os order
Time Frame: 24 months
Any order for "nil per os" (feeding not permitted) during admission.
24 months
Chest X-ray results
Time Frame: 24 months
Results of chest X-rays ordered. Obtained from medical record.
24 months
Presence of bacterial co-infection
Time Frame: 24 months
Presence and type of bacterial co-infections. Obtained from medical record.
24 months
Use of inhaled corticosteroids
Time Frame: 24 months
Whether inhaled corticosteroids were administered during admission. Obtained from medical record.
24 months
Use of chest physiotherapy
Time Frame: 24 months
Whether chest physiotherapy was performed during admission. Obtained from medical record.
24 months
Complete blood count
Time Frame: 24 months
Results of complete blood count. Obtained from medical record. Numerical
24 months
Electrolyte levels
Time Frame: 24 months
Electrolyte levels in blood. Obtained from medical record. Numerical
24 months
Venous blood gas
Time Frame: 24 months
Results of blood tests ordered; venous blood gas. Obtained from medical record. Numerical
24 months
Antiviral prescription
Time Frame: 24 months
Any prescription for an antiviral effective against influenza during admission.Obtained from medical record.
24 months
Prescription at discharge from hospital
Time Frame: 24 months
Data collection on prescription at discharge from the hospital including the following: 1) repeat chest x-ray; 2) prescription for short-acting beta-agonists (SABA); 3) inhaled corticosteroids; 4) systemic corticosteroids; 5) antibiotics; and 6) antivirals.
24 months
Care received in the 30 days following discharge.
Time Frame: 24 months
Care received in the 30 days following the patient's discharge from the hospital, including outpatient follow-up appointments in the following 30 days, follow-up chest x-rays, as well as prescription for antibiotics, short-acting beta-agonists, and inhaled corticosteroids.
24 months
Length of stay
Time Frame: 24 months
Length of hospital stay in hours, both in the ED and inpatient unit, measured using recorded time of arrival and departure to and from the ED and inpatient unit.
24 months
Cost of hospitalization
Time Frame: 24 months
Cost of hospitalization will be evaluated from a healthcare institution perspective with data from hospital decision support. More detailed costs data (micro-costing) will also be obtained whenever possible, allowing differentiation between services not readily discerned by traditional case costing methods typically based on resource intensity weights.
24 months
Use of Heated humidified high-flow nasal cannula (HHHFNC)
Time Frame: 24 months
Heated humidified high-flow nasal cannula (HHHFNC) help reduce work of breathing and can be beneficial in severe bronchiolitis cases. We will measure proportion of HHHFNC use in hospitalized children with bronchiolitis stratified by disease severity. Obtained from medical record.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Justine's Hospital

Collaborators

The Hospital for Sick Children
Unity Health Toronto
Children's Hospital of Eastern Ontario
Maternal Infant Child and Youth Research Network

Investigators

  • Principal Investigator: Olivier Drouin, MD, MSc, MPH, CHU Sainte-Justine Research Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

May 30, 2024

First Submitted That Met QC Criteria

July 11, 2024

First Posted (Actual)

July 17, 2024

Study Record Updates

Last Update Posted (Actual)

July 23, 2025

Last Update Submitted That Met QC Criteria

July 18, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-5815

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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