Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000870752
Ethics application status
Approved
Date submitted
10/06/2022
Date registered
20/06/2022
Date last updated
6/06/2023
Date data sharing statement initially provided
20/06/2022
Date results provided
6/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A 40-Year Prospective Study of Adversity Over the Early Life Course Predicting Hospital Morbidity Using Linked Administrative Health Data
Scientific title
A 40-Year Prospective Study of Adversity Over the Early Life Course Predicting Hospital Morbidity Using Linked Administrative Health Data
Secondary ID [1] 307327 0
RSS_2022_002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health consequences of childhood adversity and behavioural problems 326613 0
Condition category
Condition code
Public Health 323856 323856 0 0
Epidemiology
Mental Health 323857 323857 0 0
Depression
Mental Health 323858 323858 0 0
Other mental health disorders
Public Health 323859 323859 0 0
Health service research
Injuries and Accidents 323860 323860 0 0
Fractures
Injuries and Accidents 323861 323861 0 0
Other injuries and accidents
Emergency medicine 323862 323862 0 0
Other emergency care
Metabolic and Endocrine 323863 323863 0 0
Diabetes
Metabolic and Endocrine 323864 323864 0 0
Metabolic disorders
Diet and Nutrition 323865 323865 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To link the following Queensland-wide administrative health databases to a longitudinal, population-based birth cohort recruited in Brisbane between 1983 & 84 to assess the health outcomes of early maternal/childhood adversity:
1. The Queensland Hospital Admitted Patients’ Data Collection (QHAPDC) of all admissions for all diagnoses to public and private hospitals in Queensland from 1 January 2000 for public hospitals and 1 July 2007 for private hospitals up till 31 December 2019.
2. The Consumer Integrated Mental Health Application (CIMHA) of all contacts with state-run community-based or outpatient mental health services in the State from 1 January 2010 till 31 December 2019
3. The Emergency Data Collection (EDC) of all Emergency Department presentations state-wide from 1 July 2008 till 31 December 2019.

The birth cohort is from the Mater-University of Queensland Study of Pregnancy (MUSP), a 40-year longitudinal study from Brisbane that examined a variety of environmental risk factors for cognitive, psychological, and behavioural health outcomes for over 7000 women and their children. Between 1981 and 1983, 8556 consecutive pregnant women attending the Mater Misericordiae Mothers’ Hospital for their first prenatal visit were invited to participate. The final cohort numbered 7223 mother and infant pairs, which included only consenting participants who delivered live, singleton infants at the study hospital.

A major limitation of the existing cohort study has been the possibility of attrition bias with differential and high rates of loss to follow-up of participants with markers of greater socio-economic disadvantage. Use of Queensland—wide administrative health data will mean that we can capture all health service contacts throughout the state in case cohort participants have moved from the South Metropolitan area. The cohort are now aged 40 years of age. All data will be directly collected from existing health databases and participants will not be actively involved.

The data custodians of each database (MUSP, EDC, QHAPDC and CIMHA) will send patient identifiers stripped of any other information. Linkages will be done by the Statistical Services Branch (SSB) of Queensland Health Within the SSB, probabilistic and deterministic matching is used to link within and between the datasets based on identifying information (ID), including name, date of birth (DOB), aliases, and gender. Each person will be assigned a unique project ID that will be returned to the data custodians. The data custodian will attach the relevant clinical or service information to the unique project ID, but no identifying information. These anonymized data extracts are then released to the third-party researchers analyst (in this case the researchers at PA Hospital). The third-party analyst will use the project IDs from the anonymized data to link the four datasets. No identifying data will be released to the researchers conducting the analysis.

Exposures include childhood poverty, behavioural disorders in childhood and adolescence, as well as notifications to child protection services.
Intervention code [1] 323768 0
Diagnosis / Prognosis
Comparator / control treatment
Cohort members who were not exposed to childhood adversity
Control group
Active

Outcomes
Primary outcome [1] 331672 0
All discharge diagnoses from public hospitals & private hospitals in Queensland as captured by the Queensland Hospital Admitted Patients’ Data Collection (QHAPDC) and linked to the MUSP birth cohort .
Timepoint [1] 331672 0
All separations from 1 January 2010 for public hospitals and 1 July 2007 for private hospitals up till 31 December 2019
Primary outcome [2] 331673 0
All community contacts with Queensland Health mental health services as captured by Consumer Integrated Mental Health Application (CIMHA) database of attendances at state-run community-based or outpatient mental health services in the State and linked to the MUSP birth cohort .
Timepoint [2] 331673 0
All episodes and provisions of service for the identified cohort from 1 January 2010 till 31 December 2019
Primary outcome [3] 331674 0
Diagnoses from all Emergency Department presentations as captured by the Emergency Data Collection (EDC) of all Emergency Department visits state-wide and linked to the MUSP birth cohort .
Timepoint [3] 331674 0
From 1 July 2008 till 31 December 2019
Secondary outcome [1] 410749 0
Lengths of stay for each admission as captured by the Queensland Hospital Admitted Patients’ Data Collection (QHAPDC) and linked to the MUSP birth cohort .
Timepoint [1] 410749 0
From 1 January 2010 for public hospitals and 1 July 2007 for private hospitals up till 31 December 2019
Secondary outcome [2] 410750 0
All diagnoses from community contacts with Queensland Health mental health services as captured by Consumer Integrated Mental Health Application (CIMHA) database of attendances at state-run community-based or outpatient mental health services in the State and linked to the MUSP birth cohort .
Timepoint [2] 410750 0
From 1 January 2010 till 31 December 2019

Eligibility
Key inclusion criteria
All participants in the Mater-University of Queensland Study of Pregnancy (MUSP), a 30-year longitudinal birth cohort study from Brisbane, which examined a variety of environmental risk factors for cognitive, psychological and behavioural health outcomes for 7223 participants born from 1983 -1984 at the Mater Hospital
Minimum age
0 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
We will measure the association between the following predictors and health service outcomes:

1. Pregnancy-related characteristics of both the mothers of the original MUSP participants and when they, in turn, had children. These include the following: prenatal intention of pregnancy, number of previous pregnancies, number of previous live births, number of previous pregnancies/live births, maternal dyad during pregnancy, feelings on becoming pregnant, symptoms during pregnancy, perceptions of pregnancy (easy/hard), problems with delivery, attitudes towards new-born & social support during or after pregnancy.
2. Socio-demographic variables on entry to the study: gender of the child, parental racial origin, maternal age, parental relationship status, family income at the time of study entry (first prenatal visit), maternal smoking and maternal education status
3. Behavioural disorders in childhood and adolescence, as well as notifications to child protection services
4. Socio-demographic variables at the 30-year-old follow-up: the offspring’s employment status, their educational achievement, marital status. Administrative data will give employment & marital status at 40 years.

We will adjust for potential confounders with a series of multiple and logistic regressions depending on whether the outcome is continuous or categorical. These would include relevant demographic and clinical variables. Odds ratios (ORs) with 95% confidence intervals (95% CIs) will be used to present the findings for the logistic regression models. Other supplementary analyses will be done as deemed necessary.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/09/2022
Actual
23/06/2022
Date of last participant enrolment
Anticipated
Actual
23/06/2022
Date of last data collection
Anticipated
Actual
23/06/2022
Sample size
Target
7223
Accrual to date
Final
6087
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 311619 0
Hospital
Name [1] 311619 0
Metro South Health Research Support Scheme (MSH RSS)
Country [1] 311619 0
Australia
Primary sponsor type
Hospital
Name
Metro South Addiction & Mental Health Services
Address
Addiction & Mental Health Services | Metro South Health
P.O. Box 6046 Upper Mt Gravatt QLD 4122
Country
Australia
Secondary sponsor category [1] 313058 0
None
Name [1] 313058 0
Address [1] 313058 0
Country [1] 313058 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311074 0
University of Queensland Human Research Ethics Committee B EC00457
Ethics committee address [1] 311074 0
Ethics committee country [1] 311074 0
Australia
Date submitted for ethics approval [1] 311074 0
19/08/2021
Approval date [1] 311074 0
18/10/2021
Ethics approval number [1] 311074 0
2021/HE001925
Ethics committee name [2] 311078 0
Metro South Research Ethics
Ethics committee address [2] 311078 0
Ethics committee country [2] 311078 0
Australia
Date submitted for ethics approval [2] 311078 0
28/01/2022
Approval date [2] 311078 0
02/03/2022
Ethics approval number [2] 311078 0
HREC/2022/QMS/83690

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

Contacts
Principal investigator
Name 119854 0
Prof Steve Kisely
Address 119854 0
Level 4, Building 1, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, QLD 4102
Country 119854 0
Australia
Phone 119854 0
+61 7 3176 9568
Fax 119854 0
Email 119854 0
[email protected]
Contact person for public queries
Name 119855 0
Steve Kisely
Address 119855 0
Level 4, Building 1, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, QLD 4102
Country 119855 0
Australia
Phone 119855 0
+61 7 3176 9568
Fax 119855 0
Email 119855 0
[email protected]
Contact person for scientific queries
Name 119856 0
Steve Kisely
Address 119856 0
Level 4, Building 1, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, QLD 4102
Country 119856 0
Australia
Phone 119856 0
+61 7 3176 9568
Fax 119856 0
Email 119856 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
This is a data linkage study using large datasets with de-identified data under the jurisdiction of the Data Custodians and Public Health Act.


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
SourceTitleYear of PublicationDOI
EmbaseA 40-year study of child maltreatment over the early life course predicting psychiatric morbidity, using linked birth cohort and administrative health data: Protocol for the Childhood Adversity and Lifetime Morbidity (CALM) study.2023https://dx.doi.org/10.1192/bjo.2023.29
N.B. These documents automatically identified may not have been verified by the study sponsor.