Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000678796
Ethics application status
Approved
Date submitted
21/04/2022
Date registered
10/05/2022
Date last updated
12/04/2023
Date data sharing statement initially provided
10/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Pathways of care for children with cerebral palsy and medical complexity
Scientific title
Examining the impact of a complex care hub for children with cerebral palsy and complex medical needs: a mixed methods study
Secondary ID [1] 306983 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy 326097 0
Medical complexity 326098 0
Condition category
Condition code
Neurological 323411 323411 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A state-wide multidisciplinary Complex Care Hub (CCH) at The Royal Children's Hospital which was implemented as part of standard treatment in 2017.
Phase 1. The medical records of participants will be viewed and quantitative data collected on: number of emergency department presentations and inpatient admissions, length of inpatient admissions, number and length of ICU admissions, number and profile of hospital department appointments, number and profile of community referrals, socio-demographic characteristics (e.g., living situation, need for interpreter, social work involvement) of children with and their families, functioning/disability profile (movement disorder type, functional status including Gross Motor Function Classification System level (GMFCS ), Manual Ability Classification System level (MACS), Communication Function Classification System level (CFCS), Eating and Drinking Classification System level (EDACS), associated impairments related to intellectual impairment, vision, hearing and behaviour)
This information will be collected for the 3 year period January 2019 to December 2021.
Phase 2. A smaller group of parents and clinicians from the RCH will also be involved in qualitative focus groups or interviews to explore their experiences and perspective. These will occur within 6 weeks of enrolment pending participant availability
Intervention code [1] 323419 0
Not applicable
Comparator / control treatment
Medical records of a matched group of children with cerebral palsy who accessed the Royal Children's Hospital between January 2019 and December 2021 but who did not access the complex care hub will be reviewed for the comparator group.
Control group
Historical

Outcomes
Primary outcome [1] 331149 0
Service usage: number and profile of different hospital departments accessed and community referrals
This will be collected from the hospital medical records
Timepoint [1] 331149 0
Medical records from January 2019 to December 2021 will be reviewed at a single timepoint
Primary outcome [2] 331192 0
Number and length of intensive care unit admissions,
This will be collected from the hospital medical records
Timepoint [2] 331192 0
Medical records from January 2019 to December 2021 will be reviewed at a single timepoint
Primary outcome [3] 331259 0
Number and length of emergency department admissions
Timepoint [3] 331259 0
Medical records from January 2019 to December 2019 will be reviewed at a single timepoint
Secondary outcome [1] 409008 0
Health characteristics collected from the hospital medical records. For example treatment for respiratory or gastrointestinal issues, continence.
Timepoint [1] 409008 0
At the time of enrolment
Secondary outcome [2] 409009 0
Sociodemographic characteristics collected from the hospital medical records
Timepoint [2] 409009 0
At the time of enrolment
Secondary outcome [3] 409132 0
Movement disorder type. Collected from the hospital medical record
Timepoint [3] 409132 0
At the time of enrolment
Secondary outcome [4] 409133 0
Experiences and perspectives of caregivers and health care professionals will be examined qualitatively using focus groups facilitated by a member of the research team and semi-structured one on one interviews with a member of the research team.
This is a composite outcome and will be analysed together using thematic analysis.
Timepoint [4] 409133 0
Within 6 weeks of enrolment into the study
Secondary outcome [5] 409335 0
Number and length of inpatient admissions. This is a primary outcome
This will be collected from the hospital medical records
Timepoint [5] 409335 0
Medical records from January 2019 to December 2021 will be reviewed at a single timepoint
Secondary outcome [6] 409336 0
Gross Motor Function Classification System (GMFCS) level will be ascertained from the hospital medical records
Timepoint [6] 409336 0
At the time of enrolment
Secondary outcome [7] 409337 0
Manual Ability Classification System (MACS) level. From the hospital medical records
Timepoint [7] 409337 0
At the time of enrolment
Secondary outcome [8] 409338 0
Communication Function Classification System (CFCS) level from the hospital medical records
Timepoint [8] 409338 0
At the time of enrolment
Secondary outcome [9] 409339 0
Eating and Drinking Ability Classification System (EDACS) level from the hospital medical records
Timepoint [9] 409339 0
At the time of enrolment
Secondary outcome [10] 409340 0
Associated impairments (for example, intellectual impairment, vision and hearing) from the hospital medical records
Timepoint [10] 409340 0
At the time of enrolment

Eligibility
Key inclusion criteria
1. The child has a diagnosis of cerebral palsy and has either received services within the CCH between 1 January 2019 and 31 December 2021 or the RCH without CCH services and has been matched to a clinically similar child (as above).
2. Parents of children (and where possible children) with a diagnosis of cerebral palsy who are recruited to the study and healthcare professionals working with children with cerebral palsy at the RCH during the three-year period January 2019 to December 2021,
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability or unwillingness of participant or legally acceptable representative to give written informed consent.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Descriptive statistics for and comparison between the 2 groups using relevant parametric and non-parametric testing for quantitative data
Thematic analysis for qualitative data

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
7/06/2022
Actual
21/09/2022
Date of last participant enrolment
Anticipated
30/09/2022
Actual
8/02/2023
Date of last data collection
Anticipated
30/04/2023
Actual
Sample size
Target
150
Accrual to date
Final
170
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22226 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 37389 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 311294 0
University
Name [1] 311294 0
The University of Melbourne
Country [1] 311294 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Murdoch Children's research Institute
Address
50 Flemington Road Parkville Victoria 3052
Country
Australia
Secondary sponsor category [1] 312657 0
None
Name [1] 312657 0
Address [1] 312657 0
Country [1] 312657 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310797 0
The Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 310797 0
Ethics committee country [1] 310797 0
Australia
Date submitted for ethics approval [1] 310797 0
30/05/2022
Approval date [1] 310797 0
09/08/2022
Ethics approval number [1] 310797 0
HREC/87242/RCHM-2022

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

Contacts
Principal investigator
Name 118902 0
A/Prof Adrienne Harvey
Address 118902 0
Murdoch Children's research Institute
50 Flemington Road
Parkville Victoria 3052
Country 118902 0
Australia
Phone 118902 0
+61 438186522
Fax 118902 0
Email 118902 0
[email protected]
Contact person for public queries
Name 118903 0
Adrienne Harvey
Address 118903 0
Murdoch Children's research Institute
50 Flemington Road
Parkville Victoria 3052
Country 118903 0
Australia
Phone 118903 0
+61 438186522
Fax 118903 0
Email 118903 0
[email protected]
Contact person for scientific queries
Name 118904 0
Adrienne Harvey
Address 118904 0
Murdoch Children's research Institute
50 Flemington Road
Parkville Victoria 3052
Country 118904 0
Australia
Phone 118904 0
+61 438186522
Fax 118904 0
Email 118904 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
Data will be collated and presented as group data


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.