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RecruitingNCT06506474CareBESTUpdated Jul 23, 2025

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

An observational study in Bronchiolitis, sponsored by St. Justine's Hospital. Recruiting at 15 sites in Canada. Open to participants aged 28 Days to 12 Months. Per ClinicalTrials.gov, last updated 2025-07-23.

Sponsored by St. Justine's Hospital · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Feb 2024; still recruiting 2 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Ages
28 Days to 12 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bronchiolitis

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Keywords

  • infants
  • hospitalization
  • bronchiolitis
  • low-value care
  • observational study
03

In context

Bronchiolitis

289 studies on the registry are indexed under Bronchiolitis; 51 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 200 across 79 observational studies indexed under Bronchiolitis.

Browse Bronchiolitis studies →

Lead sponsor

St. Justine's Hospital is the lead sponsor of 156 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
28 Days to 12 Months
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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.

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Interventions

  • Diagnostic testProvision 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.

06

What researchers measure

Primary outcomes

  1. The proportion of eligible patients receiving each of the six low-value health services

    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.

    Time frame: 24 months

Secondary outcomes

  1. Transfer to the ICU

    Whether the child admitted with bronchiolitis was transferred to the ICU. If so, duration of ICU stay.

    Time frame: 24 months

  2. Use of CPAP, BiPAP, or mechanical ventilation during admission.

    Use of continuous positive airway pressure (CPAP) or biphasic positive airway pressure (BiPAP), mechanical ventilation during admission, as documented in patient's admission record.

    Time frame: 24 months

  3. Cardiac arrest

    Whether the child experienced a cardiac arrest during their admission.

    Time frame: 24 months

  4. Death

    Whether the child died during their admission.

    Time frame: 24 months

  5. Return visits

    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.

    Time frame: 24 months

  6. Use of low-flow supplemental oxygen

    Any use of low-flow supplemental oxygen, and duration of use.

    Time frame: 24 months

  7. Fluid supplementation

    Presence and type (intravenous vs. nasogastric) of fluid supplementation

    Time frame: 24 months

  8. Nil per os order

    Any order for "nil per os" (feeding not permitted) during admission.

    Time frame: 24 months

  9. Chest X-ray results

    Results of chest X-rays ordered. Obtained from medical record.

    Time frame: 24 months

  10. Presence of bacterial co-infection

    Presence and type of bacterial co-infections. Obtained from medical record.

    Time frame: 24 months

  11. Use of inhaled corticosteroids

    Whether inhaled corticosteroids were administered during admission. Obtained from medical record.

    Time frame: 24 months

  12. Use of chest physiotherapy

    Whether chest physiotherapy was performed during admission. Obtained from medical record.

    Time frame: 24 months

  13. Complete blood count

    Results of complete blood count. Obtained from medical record. Numerical

    Time frame: 24 months

  14. Electrolyte levels

    Electrolyte levels in blood. Obtained from medical record. Numerical

    Time frame: 24 months

  15. Venous blood gas

    Results of blood tests ordered; venous blood gas. Obtained from medical record. Numerical

    Time frame: 24 months

  16. Antiviral prescription

    Any prescription for an antiviral effective against influenza during admission.Obtained from medical record.

    Time frame: 24 months

  17. Prescription at discharge from hospital

    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.

    Time frame: 24 months

  18. Care received in the 30 days following discharge.

    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.

    Time frame: 24 months

  19. Length of stay

    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.

    Time frame: 24 months

  20. Cost of hospitalization

    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.

    Time frame: 24 months

  21. Use of Heated humidified high-flow nasal cannula (HHHFNC)

    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.

    Time frame: 24 months

07

Study locations

7 of 15 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2024 (actual). Primary completion is estimated for May 2026, 27 months after the start.

Of 26 observational studies under Bronchiolitis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 87. This study's planned 27 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
May 30, 2024
First posted
Jul 17, 2024
StartActual
Feb 13, 2024
Primary completionEst.
May 2026
CompletionEst.
Jun 2027
Last update
Jul 23, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06506474
Collaborators
Children's Hospital of Eastern Ontario, Maternal Infant Child and Youth Research Network, The Hospital for Sick Children, Unity Health Toronto
Responsible party
Olivier Drouin, M.D., M.Sc M.P.H. (Pediatrician and Clinical Assistant Professor, Departments of Paediatrics and Department of Social and Preventive Medicine, St. Justine's Hospital) — Principal investigator
First posted
Jul 17, 2024
Start date
Feb 13, 2024
Primary completion
May 2026 (estimated)
Completion
Jun 2027 (estimated)
Last update
Jul 23, 2025

Study contacts

Olivier Drouin, MD, MSc, MPH
Contact
olivier.drouin.hsj@ssss.gouv.qc.ca
514 345-4931 ext. 4226
Tamara Perez, MSc
Contact
tamara.perez.hsj@ssss.gouv.qc.ca
Olivier Drouin, MD, MSc, MPH
principal investigator · CHU Sainte-Justine Research Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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