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临床试验/NCT06506474
NCT06506474招募中不适用

Low-value Care, and Variation in Practice for Children Hospitalized With Bronchiolitis - a Multicentric Prospective Observational Study

St. Justine's Hospital15 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2024年2月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
3,000
试验地点
15
主要终点
The proportion of eligible patients receiving each of the six low-value health services

研究概览

简要总结

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?
  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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
28 Days 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 24 months

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.

次要结局

  • Use of inhaled corticosteroids(24 months)
  • Transfer to the ICU(24 months)
  • Chest X-ray results(24 months)
  • Complete blood count(24 months)
  • Use of Heated humidified high-flow nasal cannula (HHHFNC)(24 months)
  • Use of CPAP, BiPAP, or mechanical ventilation during admission.(24 months)
  • Use of low-flow supplemental oxygen(24 months)
  • Use of chest physiotherapy(24 months)
  • Antiviral prescription(24 months)
  • Length of stay(24 months)
  • Cardiac arrest(24 months)
  • Nil per os order(24 months)
  • Venous blood gas(24 months)
  • Death(24 months)
  • Fluid supplementation(24 months)
  • Prescription at discharge from hospital(24 months)
  • Care received in the 30 days following discharge.(24 months)
  • Return visits(24 months)
  • Presence of bacterial co-infection(24 months)
  • Electrolyte levels(24 months)
  • Cost of hospitalization(24 months)

研究者

发起方
St. Justine's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

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

研究点 (15)

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