Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001658101
Ethics application status
Approved
Date submitted
18/11/2019
Date registered
27/11/2019
Date last updated
15/06/2021
Date data sharing statement initially provided
27/11/2019
Date results provided
15/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
CARE Study- Children's Asthma REadmission Study
Scientific title
Understanding hospital, GP, and family factors associated with paediatric asthma readmissions
Secondary ID [1] 299812 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CARE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 315190 0
Condition category
Condition code
Respiratory 313505 313505 0 0
Asthma

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A multicentre cohort study of all children aged 3 to 18 years admitted to the Royal Children's Hospital, The Northern Hospital and University Hospital Geelong, Victoria between 1st September 2017 and 31st August 2018 with a discharge diagnosis of “Asthma” or “Wheeze”. These children will be followed up for a minimum of 1 year ending on 1st September 2019 using data linkage from the Victorian Admitted Episodes Dataset (VAED) and the Victorian Emergency Minimum Dataset (VEMD) to identify re-admissions to hospitals and/or emergency.

We will compare hospital, GP, and family factors (including environmental exposures) associated with asthma re-admissions between those with the outcome (children with at least 1 re-admission within the observation period) and those without the outcome (children with no re-admission during the observation period). Hospital factors will be obtained from medical record analysis, GP factors from mail surveys, Medicare Benefits Scheme (MBS) and Pharmaceutical Benefits Scheme (PBS) data, family factors from semi-structured phone interviews (30-60 minutes), MBS and PBS, and environmental factors from local pollen and pollution data.
Intervention code [1] 316073 0
Not applicable
Comparator / control treatment
Children within the cohort with no re-admission to hospital for asthma during the observation period.
Control group
Active

Outcomes
Primary outcome [1] 321964 0
Hospital admission(s) for the management of asthma during the follow up period.
Hospital admission data will be assessed through medical records and linked hospital administrative data set (the Victorian Admitted Episode Dataset).
Timepoint [1] 321964 0
These children will be followed up for the period of time following their index admission (between 1st September 2017 and 31st August 2018) until 1st September 2019. All children in the cohort will be followed up for a minimum of 1 year ending on 1st September 2019.
Secondary outcome [1] 376820 0
Emergency presentations for the management of asthma
Emergency presentations will be assessed through medical records and linked administrative dataset (the Victorian Emergency Minimum Dataset).
Timepoint [1] 376820 0
These children will be followed up for the period of time following their index admission (between 1st September 2017 and 31st August 2018) until 1st September 2019. All children in the cohort will be followed up for a minimum of 1 year ending on 1st September 2019.

Eligibility
Key inclusion criteria
1. Admitted to hospital for the inpatient treatment of asthma between 1st September 2017 and 31st August 2018 with a discharge diagnosis of “Asthma” or “Wheeze”.
2. Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant’s behalf.
3. Is aged between 3 and 18 years.
Minimum age
3 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Has a serious comorbid condition such as cystic fibrosis, congenital heart disease (not fully corrected), cerebral palsy, and other suppurative lung diseases.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample Size:
A sample size of 1008 participants will have an 80% power to detect a relative risk of 1.60 of being re-admitted for asthma if the child does not have a regular GP, using chi-squared test for two sample proportions to a significance level of 0.05. A US study has found the relative risk associated with asthma re-admissions from poor quality of primary care to range from 1.06 to 2.32.(1) Other assumptions used in this calculation included an estimated proportion of 20% for re-admission of paediatric asthma in one year,(2) and that 89% of families have a regular GP for their child.(3)

Statistical analysis:
To identify modifiable health system and GP factors associated with asthma re-admissions the research team will analyse associations between each exposure variable and re-admission after adjusting for relevant covariates in a logistic regression model. They will also calculate the risk ratio of key exposure variables using binomial regression model with logged linked function, Sensitivity analysis will be undertaken for early versus late re-admission, multiple versus single re-admission, hospital site and preschool versus school aged children.

1. Auger KA, Kahn RS, Davis MM, Beck AF, Simmons JM. Medical home quality and readmission risk for children hospitalized with asthma exacerbations. Pediatrics. 2013;131(1):64-70.
2. Vicendese D, Abramson MJ, Dharmage SC, Tang ML, Allen KJ, Erbas B. Trends in asthma readmissions among children and adolescents over time by age, gender and season. J Asthma. 2014;51(10):1055-60.
3. Freed GL, Spike N, O'Hara J, Hiscock H, Rhodes AL. National study of parental confidence in general practitioners. J Paediatr Child Health. 2018;54(2):127-31.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/04/2019
Date of last participant enrolment
Anticipated
Actual
4/11/2019
Date of last data collection
Anticipated
31/07/2020
Actual
4/03/2021
Sample size
Target
1008
Accrual to date
Final
767
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15154 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [2] 15155 0
The Northern Hospital - Epping
Recruitment hospital [3] 15156 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment postcode(s) [1] 28449 0
3052 - Parkville
Recruitment postcode(s) [2] 28450 0
3076 - Epping
Recruitment postcode(s) [3] 28451 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 304273 0
Government body
Name [1] 304273 0
Melbourne Academic Centre for Health
Country [1] 304273 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Murdoch Children's Research Institute
Address
Murdoch Children's Research Institute
The Royal Children's Hospital, 50 Flemington Road
Parkville, Victoria 3052 Australia
Country
Australia
Secondary sponsor category [1] 304518 0
None
Name [1] 304518 0
Address [1] 304518 0
Country [1] 304518 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304729 0
Royal Children's Hospital HREC
Ethics committee address [1] 304729 0
Ethics committee country [1] 304729 0
Australia
Date submitted for ethics approval [1] 304729 0
14/02/2019
Approval date [1] 304729 0
26/02/2019
Ethics approval number [1] 304729 0
38295
Ethics committee name [2] 304733 0
Barwon Health HREC
Ethics committee address [2] 304733 0
Ethics committee country [2] 304733 0
Australia
Date submitted for ethics approval [2] 304733 0
07/03/2019
Approval date [2] 304733 0
13/03/2019
Ethics approval number [2] 304733 0
19/10
Ethics committee name [3] 304734 0
Northern Health HREC
Ethics committee address [3] 304734 0
Ethics committee country [3] 304734 0
Australia
Date submitted for ethics approval [3] 304734 0
03/04/2019
Approval date [3] 304734 0
17/04/2019
Ethics approval number [3] 304734 0
50196

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98022 0
Prof Harriet Hiscock
Address 98022 0
Health Services MCRI
The Royal Children's Hospital, 50 Flemington Road
Parkville, Victoria 3052 Australia
Country 98022 0
Australia
Phone 98022 0
+613 9345 6910
Fax 98022 0
Email 98022 0
[email protected]
Contact person for public queries
Name 98023 0
Katherine Chen
Address 98023 0
Health Services MCRI
The Royal Children's Hospital, 50 Flemington Road
Parkville, Victoria 3052 Australia
Country 98023 0
Australia
Phone 98023 0
+613 99366582
Fax 98023 0
Email 98023 0
[email protected]
Contact person for scientific queries
Name 98024 0
Katherine Chen
Address 98024 0
Health Services MCRI
The Royal Children's Hospital, 50 Flemington Road
Parkville, Victoria 3052 Australia
Country 98024 0
Australia
Phone 98024 0
+613 99366582
Fax 98024 0
Email 98024 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to privacy restrictions of health data and the potentially sensitive and identifiable nature of this data no IPD will be publicly available. Furthermore, this project involves a data linkage with the Centre for Victorian Data Linkage (CVDL) and the Australian Institute for Health and Welfare (AIHW), both CVDL and AIHW have restrictions on accessing and sharing data which would make publicly sharing IPD impossible.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5677Ethical approval  [email protected] RCH HREC project reference number: 38295



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseUnderstanding caregiver perspectives on challenges and solutions to pediatric asthma care for children with a previous hospital admission: a multi-site qualitative study.2022https://dx.doi.org/10.1080/02770903.2021.1984528
N.B. These documents automatically identified may not have been verified by the study sponsor.