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

NCT ID: NCT06506474

Last Updated: 2025-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-13

Study Completion Date

2027-06-30

Brief Summary

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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

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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

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Bronchiolitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

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

Intervention Type DIAGNOSTIC_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.

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.

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

Intervention Type DIAGNOSTIC_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.

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.

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

Intervention Type DIAGNOSTIC_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.

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.

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

Intervention Type DIAGNOSTIC_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.

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.

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

Intervention Type DIAGNOSTIC_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.

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.

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

Intervention Type DIAGNOSTIC_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.

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.

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

Intervention Type DIAGNOSTIC_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.

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.

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

Intervention Type DIAGNOSTIC_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.

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.

No interventions assigned to this group

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.

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

Intervention Type DIAGNOSTIC_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.

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.

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

Intervention Type DIAGNOSTIC_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.

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.

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

Intervention Type DIAGNOSTIC_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.

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.

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

Intervention Type DIAGNOSTIC_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.

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.

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

Intervention Type DIAGNOSTIC_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.

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.

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

Intervention Type DIAGNOSTIC_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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

28 Days

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Eastern Ontario

OTHER

Sponsor Role collaborator

Maternal Infant Child and Youth Research Network

UNKNOWN

Sponsor Role collaborator

The Hospital for Sick Children

OTHER

Sponsor Role collaborator

Unity Health Toronto

OTHER

Sponsor Role collaborator

St. Justine's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Olivier Drouin, M.D., M.Sc M.P.H.

Pediatrician and Clinical Assistant Professor, Departments of Paediatrics and Department of Social and Preventive Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Olivier Drouin, MD, MSc, MPH

Role: PRINCIPAL_INVESTIGATOR

CHU Sainte-Justine Research Centre

Locations

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Alberta Children's Hospital

Calgary, Alberta, Canada

Site Status RECRUITING

Stollery Children's Hospital

Edmonton, Alberta, Canada

Site Status NOT_YET_RECRUITING

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

Site Status RECRUITING

IWK Health

Halifax, Nova Scotia, Canada

Site Status ACTIVE_NOT_RECRUITING

McMaster Children's Hospital

Hamilton, Ontario, Canada

Site Status RECRUITING

Kingston Health Science Centre

Kingston, Ontario, Canada

Site Status NOT_YET_RECRUITING

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

London, Ontario, Canada

Site Status NOT_YET_RECRUITING

Lakeridge Health

Oshawa, Ontario, Canada

Site Status RECRUITING

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Site Status NOT_YET_RECRUITING

Hospital for Sick Children

Toronto, Ontario, Canada

Site Status NOT_YET_RECRUITING

Centre hospitalier Cité-de-la-Santé

Laval, Quebec, Canada

Site Status RECRUITING

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Site Status RECRUITING

CHU Sainte-Justine

Montreal, Quebec, Canada

Site Status RECRUITING

Montreal Children's Hospital

Montreal, Quebec, Canada

Site Status NOT_YET_RECRUITING

Centre Hospitalier Université Laval - Centre Mère-Enfant Soleil

Québec, Quebec, Canada

Site Status ACTIVE_NOT_RECRUITING

Countries

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Canada

Central Contacts

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Olivier Drouin, MD, MSc, MPH

Role: CONTACT

514 345-4931 ext. 4226

Tamara Perez, MSc

Role: CONTACT

Facility Contacts

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Michelle Bailey, MD

Role: primary

Karen Forbes, MD MEd

Role: primary

Matthew Carwana, H.BSc, MD

Role: primary

Candice Wiedman

Role: backup

Gita Wahi, MD

Role: primary

Fariha Chowdhury

Role: backup

Anupam Sehgal, MD

Role: primary

Breanna Chen, MD

Role: primary

Mahmoud Sakran, MD

Role: primary

Melanie Buba

Role: primary

Peter Gill, MD DPhil MSc

Role: primary

Shamama Raza

Role: backup

Camille Bédard-Gauthier, MD

Role: primary

Marc-André Turcot, MD

Role: primary

Tamara Perez, MSc

Role: primary

Isabelle Lahaie, MSc

Role: backup

Patricia Li, MD, MSc

Role: primary

Evelyn Constantin, MD, MSc

Role: backup

Other Identifiers

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2024-5815

Identifier Type: -

Identifier Source: org_study_id

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