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BronchiolitisCareBESTNCT06506474

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

An observational study of Bronchiolitis, run by St. Justine's Hospital at 15 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 28 days to 12 months
Conditions the study is for
Bronchiolitis
What is being tested?
Provision of any of six different low-value health services for treatment of bronchiolitis
How many people
3,000 participants
Where
15 sitesCanada
Study dates
13 Feb 2024to Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 28 days to 12 months
  • All sexes
  • Child

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

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Tamara Perez, MSc contact

tamara.perez.hsj@ssss.gouv.qc.ca

15 sites in 1 country

Canada15 sites, 13 recruiting
  • Alberta Children's Hospital

    Calgary, Alberta, T3B 6A8

    Michelle Bailey, MD, Michelle.Bailey@albertahealthservices.ca

    Michelle Bailey, MD

    Recruiting
  • Stollery Children's Hospital

    Edmonton, Alberta, T6G 2B7

    Karen Forbes, MD MEd, Karen.Forbes@albertahealthservices.ca

    Karen Forbes, MD MEd

    Not yet recruiting
  • IWK Health

    Halifax, Nova Scotia, B3K 6R8

    Active, not recruiting
  • McMaster Children's Hospital

    Hamilton, Ontario, L8N 3Z5

    Gita Wahi, MD, wahig@mcmaster.ca

    Fariha Chowdhury, chowdf1@mcmaster.ca

    Recruiting
  • Kingston Health Science Centre

    Kingston, Ontario, K7L 2V7

    Anupam Sehgal, MD

    Anupam Sehgal, MD

    Not yet recruiting
  • Centre hospitalier Cité-de-la-Santé

    Laval, Quebec, H7M 3L9

    Camille Bédard-Gauthier, MD, camille.bedard-gauthier.med@ssss.gouv.qc.ca

    Camille Bédard-Gauthier, MD

    Recruiting
  • Children's Hospital of Western Ontario (London Health Science Centre)

    London, Ontario, N6C 0B2

    Breanna Chen, MD, BreannaAshley.Chen@lhsc.on.ca

    Breanna Chen, MD

    Not yet recruiting
  • Hôpital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

    Marc-André Turcot, MD, marc-andre.turcot@umontreal.ca

    Marc-André Turcot, MD

    Recruiting
  • CHU Sainte-Justine

    Montreal, Quebec, H3T 1C5

    Tamara Perez, MSc, tamara.perez.hsj@ssss.gouv.qc.ca

    Isabelle Lahaie, MSc, isabelle.lahaie.hsj@ssss.gouv.qc.ca

    Recruiting
  • Montreal Children's Hospital

    Montreal, Quebec, H4A 3J1

    Patricia Li, MD, MSc, patricia.li@mcgill.ca

    Evelyn Constantin, MD, MSc, evelyn.constantin@mcgill.ca

    Not yet recruiting
  • Lakeridge Health

    Oshawa, Ontario, L1G 8A2

    Mahmoud Sakran, MD, msakran@lh.ca

    Mahmoud Sakran, MD

    Recruiting
  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

    Melanie Buba, mbuba@cheo.on.ca

    Melanie Buba, MD

    Not yet recruiting
  • Centre Hospitalier Université Laval - Centre Mère-Enfant Soleil

    Québec, Quebec, G1V 4G2

    Active, not recruiting
  • Hospital for Sick Children

    Toronto, Ontario, M5G 1E8

    Peter Gill, MD DPhil MSc

    Shamama Raza, shamama.raza@sickkids.ca

    Not yet recruiting
  • British Columbia Children's Hospital

    Vancouver, British Columbia, V6H 3N1

    Matthew Carwana, H.BSc, MD, Matthew.Carwana@cw.bc.ca

    Candice Wiedman, Candice.Wiedman@bcchr.ca

    Recruiting

Other trials in Canada

About this study

Official title: 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.

Read more

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?
  1. How much variability is there between different patients, different doctors, and between hospitals in the use of these 6 low-value health services ?
  2. 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.

Conditions
Bronchiolitis
Being tested
Provision of any of six different low-value health services for treatment of bronchiolitis
Keywords
infants, hospitalization, bronchiolitis, low-value care, observational study
Medical subject headings
Bronchiolitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Provision of any of six different low-value health services for treatment of bronchiolitisDiagnostic test

    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.

Study groups in NCT06506474
Study groupRoleWhat they receive
Children admitted to CHU Sainte-JustineChildren 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.
Receives: Diagnostic Test: Provision of any of six different low-value health services for treatment of bronchiolitis
Children admitted to McMaster Children's HospitalChildren 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.
Receives: Diagnostic Test: Provision of any of six different low-value health services for treatment of bronchiolitis
Children admitted to British Columbia Children's HospitalChildren 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.
Receives: Diagnostic Test: Provision of any of six different low-value health services for treatment of bronchiolitis
Children admitted to IWK Children's HospitalChildren 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.
Receives: Diagnostic Test: Provision of any of six different low-value health services for treatment of bronchiolitis
Children admitted to CHU de Quebec University Laval HospitalChildren 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.
Receives: Diagnostic Test: Provision of any of six different low-value health services for treatment of bronchiolitis
Children admitted to Montreal Children's HospitalChildren 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.
Receives: Diagnostic Test: Provision of any of six different low-value health services for treatment of bronchiolitis
Children admitted to Children's Hospital of Eastern OntarioChildren 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.
Receives: Diagnostic Test: Provision of any of six different low-value health services for treatment of bronchiolitis
Children admitted to Kingston Health Sciences CentreChildren 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.
Receives: Diagnostic Test: Provision of any of six different low-value health services for treatment of bronchiolitis
Children admitted to The Hospital for Sick ChildrenChildren 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 OntarioChildren 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.
Receives: Diagnostic Test: Provision of any of six different low-value health services for treatment of bronchiolitis
Children admitted to Alberta Children's HospitalChildren 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.
Receives: Diagnostic Test: Provision of any of six different low-value health services for treatment of bronchiolitis
Children admitted to Stollery Children's HospitalChildren 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.
Receives: Diagnostic Test: Provision of any of six different low-value health services for treatment of bronchiolitis
Children Admitted to Hôpital Maisonneuve-RosemontChildren 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.
Receives: Diagnostic Test: Provision of any of six different low-value health services for treatment of bronchiolitis
Children admitted to Cité-de-la-SantéChildren 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.
Receives: Diagnostic Test: Provision of any of six different low-value health services for treatment of bronchiolitis
Children admitted to Lakeridge HealthChildren 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.
Receives: Diagnostic Test: Provision of any of six different low-value health services for treatment of bronchiolitis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 months

Secondary outcomes (21)
  1. Transfer to the ICU

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

    Measured: 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.

    Measured: 24 months

  3. Cardiac arrest

    Whether the child experienced a cardiac arrest during their admission.

    Measured: 24 months

  4. Death

    Whether the child died during their admission.

    Measured: 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.

    Measured: 24 months

  6. Use of low-flow supplemental oxygen

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

    Measured: 24 months

  7. Fluid supplementation

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

    Measured: 24 months

  8. Nil per os order

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

    Measured: 24 months

  9. Chest X-ray results

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

    Measured: 24 months

  10. Presence of bacterial co-infection

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

    Measured: 24 months

  11. Use of inhaled corticosteroids

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

    Measured: 24 months

  12. Use of chest physiotherapy

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

    Measured: 24 months

  13. Complete blood count

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

    Measured: 24 months

  14. Electrolyte levels

    Electrolyte levels in blood. Obtained from medical record. Numerical

    Measured: 24 months

  15. Venous blood gas

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

    Measured: 24 months

  16. Antiviral prescription

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2024
  2. Study start13 Feb 2024
  3. Primary completionMay 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06506474
Sponsor's protocol ID
2024-5815
Acronym
CareBEST
Status last verified
Jul 2025
First submitted
30 May 2024
Last updated
23 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Bronchiolitis, run by St. Justine's Hospital at 15 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Olivier Drouin, MD, MSc, MPH (514 345-4931 ext. 4226, olivier.drouin.hsj@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of eligible patients receiving each of the six low-value health services (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.

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