Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506474
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-30
Brief Title:
Low-value Care and Variation in Practice for Children Hospitalized with Bronchiolitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Low-value Care and Variation in Practice for Children Hospitalized with Bronchiolitis - a Multicentric Prospective Observational Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CareBEST
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 infants medical chart reviewed during their hospitalization They will also have 2 short questionnaires to complete once during their childs admission to the hospital and one 30 days later to ask about whether their child required any additional medical care
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
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 infants medical chart reviewed during their hospitalization They will also have 2 short questionnaires to complete once during their childs admission to the hospital and one 30 days later to ask about whether their child required any additional medical care
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:
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 18 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 eg race and ethnicity socioeconomic status language and whether these contribute to disparities in care
Design A multi-centre n18 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 childs 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
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 18 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 eg race and ethnicity socioeconomic status language and whether these contribute to disparities in care
Design A multi-centre n18 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 childs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None