Recruiting

Observational Study

Sponsor:

St. Justine's Hospital

Code:

NCT06506474

Conditions

Bronchiolitis

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

Provision of any of six different low-value health services for treatment of bronchiolitis

Study Details

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.

Conditions

Bronchiolitis

Study ID

NCT06506474

Start date

Feb 13, 2024

Status verified date

Jul, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

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 Design

Enrollment

3000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Interventions

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 measure

  • The proportion of eligible patients receiving each of the six low-value health services [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Locations

Alberta Children's Hospital

Recruiting

Calgary, Alberta, Canada, T3B 6A8

Contacts

Principal Investigator:

Michelle Bailey, MD

British Columbia Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Contacts

Matthew Carwana, H.BSc, MD

Matthew.Carwana@cw.bc.ca

Principal Investigator:

Matthew Carwana, H.BSc, MD

McMaster Children's Hospital

Recruiting

Hamilton, Ontario, Canada, L8N 3Z5

Contacts

Gita Wahi, MD

wahig@mcmaster.ca

Fariha Chowdhury

chowdf1@mcmaster.ca

Principal Investigator:

Gita Wahi, MD

Lakeridge Health

Recruiting

Oshawa, Ontario, Canada, L1G 8A2

Contacts

Mahmoud Sakran, MD

msakran@lh.ca

Principal Investigator:

Mahmoud Sakran, MD

Centre hospitalier Cité-de-la-Santé

Recruiting

Laval, Quebec, Canada, H7M 3L9

Contacts

Principal Investigator:

Camille Bédard-Gauthier, MD

Hôpital Maisonneuve-Rosemont

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Contacts

Marc-André Turcot, MD

marc-andre.turcot@umontreal.ca

Principal Investigator:

Marc-André Turcot, MD

CHU Sainte-Justine

Recruiting

Montreal, Quebec, Canada, H3T 1C5

Contacts

Principal Investigator:

Olivier Drouin, MD, MSc, MPH

More Information

Sponsor

St. Justine's Hospital

Last update posted

Jul 23, 2025

Last verified

Jul, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Justine's Hospital on 2025-07-23.