Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001145897
Ethics application status
Approved
Date submitted
26/06/2021
Date registered
25/08/2021
Date last updated
4/08/2023
Date data sharing statement initially provided
25/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding the health care of adults with cerebral palsy
Scientific title
Understanding the health care of adults with cerebral palsy
Secondary ID [1] 304815 0
None
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy 322308 0
Condition category
Condition code
Neurological 319977 319977 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
People with cerebral palsy have significant health issues. We will access National Prescribing Service MedicineWise (NPS) data to provide retrospective baseline information about the use of primary care (General Practitioner) services including specialised Medicare item numbers, medications prescribed and investigations ordered. There will be no active participation such as interviews or surveys. All NPS data related to persons with cerebral palsy will be collected. For some General Practices, they will have only contributed to NPS MedicineWise for a short period, other practices will have contributed for a longer time. NPS MedicineWise commenced data collection in 2013, some practices already had electronic data at that time so data will date back prior to 2013. Some practices joined NPS MedicineWise only recently and for those practices, there may be only 12 months' of data. We hope to collect data from January 2000 to December 2020, where it is available.
Intervention code [1] 320823 0
Not applicable
Comparator / control treatment
People with cerebral palsy will be compared to individuals within the same age range and of the same sex, who do not have cerebral palsy, and whose General Practitioners contribute to NPA.
Control group
Active

Outcomes
Primary outcome [1] 327856 0
The use of health care services provided by general practitioners, in people with cerebral palsy, compared to a control group (from the NPS MedicineWise database) without cerebral palsy.
Timepoint [1] 327856 0
All NPS data related to persons with cerebral palsy will be collected. Some general practices will have only contributed to NPS MedicineWise for a short period whilst other practices will have contributed for a longer time. NPS MedicineWise commenced data collection in 2013, some practices already had electronic data at that time so data will date back prior to 2013. Some practices joined NPS MedicineWise only recently and for those practices, there may be only 12 months' of data. We hope to collect data from January 1st 2000 to December 31st 2020, where it is available.
Secondary outcome [1] 396790 0
Determination of the number, sex and age of people with cerebral palsy whose general practitioners contribute to NPS and comparison of the numbers with the number of individuals within the same age range / sex without cerebral palsy whose general practitioners contribute to NPS. This is a composite secondary outcome. Data will be sourced entirely from the NPS MedicineWise database.
Timepoint [1] 396790 0
All NPS data related to persons with cerebral palsy will be collected. Some general practices will have only contributed to NPS MedicineWise for a short period whilst other practices will have contributed for a longer time. NPS MedicineWise commenced data collection in 2013, some practices already had electronic data at that time so data will date back prior to 2013. Some practices joined NPS MedicineWise only recently and for those practices, there may be only 12 months' of data. We hope to collect data from January 1st 2000 to December 31st 2020, where it is available.
Secondary outcome [2] 396791 0
The frequency with which people with cerebral palsy attend general practitioner consultations compared with individuals within the same age range / sex without cerebral palsy. Data will be accessed from the NPS MedicineWise database.
Timepoint [2] 396791 0
All NPS data related to persons with cerebral palsy will be collected. Some general practices will have only contributed to NPS MedicineWise for a short period whilst other practices will have contributed for a longer time. NPS MedicineWise commenced data collection in 2013, some practices already had electronic data at that time so data will date back prior to 2013. Some practices joined NPS MedicineWise only recently and for those practices, there may be only 12 months' of data. We hope to collect data from January 1st 2000 to December 31st 2020, where it is available.
Secondary outcome [3] 398379 0
The reasons for which individuals attend their general practitioner compared to age and sex-matched controls without cerebral palsy. All information will be accessed from the NPS MedicineWise database.
Timepoint [3] 398379 0
All NPS data related to persons with cerebral palsy will be collected. Some general practices will have only contributed to NPS MedicineWise for a short period whilst other practices will have contributed for a longer time. NPS MedicineWise commenced data collection in 2013, some practices already had electronic data at that time so data will date back prior to 2013. Some practices joined NPS MedicineWise only recently and for those practices, there may be only 12 months' of data. We hope to collect data from January 1st 2000 to December 31st 2020, where it is available.
Secondary outcome [4] 398382 0
The pattern of Medical Benefit Schedule use for people with cerebral palsy compared to an age and sex-matched control group without cerebral palsy. All information will be accessed from the NPS MedicineWise database.
Timepoint [4] 398382 0
All NPS data related to persons with cerebral palsy will be collected. Some general practices will have only contributed to NPS MedicineWise for a short period whilst other practices will have contributed for a longer time. NPS MedicineWise commenced data collection in 2013, some practices already had electronic data at that time so data will date back prior to 2013. Some practices joined NPS MedicineWise only recently and for those practices, there may be only 12 months' of data. We hope to collect data from January 1st 2000 to December 31st 2020, where it is available.
Secondary outcome [5] 398383 0
Medications prescribed to people with cerebral palsy compared with medications prescribed to an age and sex-matched control group of people without cerebral palsy. All information will be accessed from the NPS MedicineWise database.
Timepoint [5] 398383 0
All NPS data related to persons with cerebral palsy will be collected. Some general practices will have only contributed to NPS MedicineWise for a short period whilst other practices will have contributed for a longer time. NPS MedicineWise commenced data collection in 2013, some practices already had electronic data at that time so data will date back prior to 2013. Some practices joined NPS MedicineWise only recently and for those practices, there may be only 12 months' of data. We hope to collect data from January 1st 2000 to December 31st 2020, where it is available.
Secondary outcome [6] 398384 0
The number and type of investigations ordered for people with cerebral palsy compared with an age and sex-matched control group who do not have cerebral palsy. All information will be accessed from the NPS MedicineWise database.
Timepoint [6] 398384 0
All NPS data related to persons with cerebral palsy will be collected. Some general practices will have only contributed to NPS MedicineWise for a short period whilst other practices will have contributed for a longer time. NPS MedicineWise commenced data collection in 2013, some practices already had electronic data at that time so data will date back prior to 2013. Some practices joined NPS MedicineWise only recently and for those practices, there may be only 12 months' of data. We hope to collect data from January 1st 2000 to December 31st 2020, where it is available.

Eligibility
Key inclusion criteria
All individuals with cerebral palsy whose general practitioners contribute data to NPS MedicineWise. These individuals will be matched with an age and sex-matched control group who do not have cerebral palsy.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Descriptive analyses of outcomes and baseline characteristics among the CP and control group (from the NPS MedicineWise database) who do not have CP will be undertaken and presented as:
• Continuous variables: present means and standard deviations for normally distributed variables, present median and interquartile ranges for non-normally distributed variables. Compare unadjusted outcomes using t-tests. Baseline characteristics will be compared descriptively.
• Categorical variables: present frequencies for each level. Compare unadjusted outcomes using chi-squared tests. Baseline characteristics will be compared descriptively.
• Measures of utilisation: present as rates per person-time.
(note: tests are not applicable to match criteria)
Descriptive analysis will also be stratified by age (categorical; broken into age ranges) and sex (M/F) to explore characteristics within these subgroups separately.
Logistic regression will be applied to examine the association between CP and binary outcomes of interest. Poisson regression will be applied to examine the association between CP and rates (event counts per person-time) of interest. For multivariate adjustment, potential confounding variables identified a priori will be included as covariates in the model.
Longitudinal data analysis e.g. GEE or multilevel regression analysis will be used to examine the significant explanatory variables to the MBS and hospitalisation rates and costs. Significance level at p<0.05 will be used.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2021
Actual
18/04/2022
Date of last participant enrolment
Anticipated
1/11/2021
Actual
18/04/2022
Date of last data collection
Anticipated
1/11/2023
Actual
18/04/2022
Sample size
Target
12500
Accrual to date
Final
12500
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 308834 0
Government body
Name [1] 308834 0
NHMRC
Country [1] 308834 0
Australia
Primary sponsor type
Other
Name
Murdoch Children's Research Institute
Address
50 Flemington Road,
Parkville,
Victoria 3052,
Australia
Country
Australia
Secondary sponsor category [1] 309753 0
None
Name [1] 309753 0
Address [1] 309753 0
Country [1] 309753 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308743 0
Royal Children's Hospital HREC
Ethics committee address [1] 308743 0
Ethics committee country [1] 308743 0
Australia
Date submitted for ethics approval [1] 308743 0
17/06/2021
Approval date [1] 308743 0
08/07/2021
Ethics approval number [1] 308743 0
76274

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

Contacts
Principal investigator
Name 111738 0
Prof Dinah Reddihough
Address 111738 0
Murdoch Children's Research Institute
50 Flemington Road
Parkville
VIC 3052
Country 111738 0
Australia
Phone 111738 0
+61 413052367
Fax 111738 0
+61 393455871
Email 111738 0
[email protected]
Contact person for public queries
Name 111739 0
Dinah Reddihough
Address 111739 0
Murdoch Children's Research Institute
50 Flemington Road
Parkville
VIC 3052
Country 111739 0
Australia
Phone 111739 0
+61 393455898
Fax 111739 0
+61 393455871
Email 111739 0
[email protected]
Contact person for scientific queries
Name 111740 0
Dinah Reddihough
Address 111740 0
Murdoch Children's Research Institute
50 Flemington Road
Parkville
VIC 3052
Country 111740 0
Australia
Phone 111740 0
+61 413052367
Fax 111740 0
+61 393455871
Email 111740 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
Secure access, storage and disposal of the data will be managed in SURE, in accordance with Sax Institute policies and procedures. Access will be restricted only to approved users (ie those approved by custodians and ethics); the analyst will only have access to data with personal identifiers removed; only aggregate data will be removed from the analytic environment after being reviewed by SURE staff to ensure that there are no privacy risks.


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.