Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000565741
Ethics application status
Approved
Date submitted
30/03/2022
Date registered
13/04/2022
Date last updated
7/04/2024
Date data sharing statement initially provided
13/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Quantitative assessment of Pasifika rheumatic fever burden
Scientific title
Quantitative assessment of Pasifika rheumatic fever burden
Secondary ID [1] 306803 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatic fever 325875 0
Condition category
Condition code
Inflammatory and Immune System 323187 323187 0 0
Autoimmune diseases
Infection 323273 323273 0 0
Other infectious diseases
Inflammatory and Immune System 323274 323274 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The aim of this study is to determine the burden of group A streptococcus infections, acute rheumatic fever, and rheumatic heart disease in Auckland practices, comparing Pacific, Maori, and non-Pacific non-Maori groups.

Routinely collected data stored by electronic health records and provided by the four primary health organisations (PHO): Alliance Health Plus, Pro Care, Tamaki Health and National Hauora Coalition data.

To explore these trends, we will use secondary anonymised data from the National Minimum Dataset, the national collection of hospital discharge information. This will include information of incidence rates for first episode rheumatic fever hospitalisations for each year nationally, by DHB and by prioritised ethnic group. To further explore the burden in Auckland, we will be requesting de-identified, routinely collected clinical data from four PHOs (Alliance Health Plus, National Hauora Coalition, ProCare and Tamaki Health) which comprise the majority of Pasifika and Maori populations in Auckland. Alliance Health Plus is a Pacific-led PHO with approximately 120,000 enrolled patients (28% Pacific, 12% Maori) across 40 general practices while the National Hauora Coalition, a Maori-led PHO, serves around 136,000 patients (14% Pacific, 14% Maori) in 26 clinics. ProCare is a large PHO supporting almost 800,000 patients across Auckland (12.7% Pacific and 9.6% Maori) while Tamaki Health is based in South Auckland and serves 230,000 enrolled patients (33% Pacific and 16% Maori) across 45 general practices.

The following variables will be obtained for individual visit data from the PHO:
• Patient identifier - All four PHOs will de-identify data and apply codes to replace NHI.
• Sex
• Date of birth
• Ethnicity - prioritised Total Pacific (as a binary variable – any Pacific ethnicity reported Y/N)
o Total Tokelauan (ethnicity group Level 2; binary)
o Total Niuean (ethnicity group Level 2; binary)
o Total Tongan (ethnicity group Level 2; binary)
o Total Cook Island Maori (ethnicity group Level 2; binary)
o Total Samoan (ethnicity group Level 2; binary)
o Total Other Pacific Peoples (ethnicity group Level 2; binary)
o Total Pacific Peoples not further defined (ethnicity group Level 2; binary)
o Total Fijian (ethnicity group Level 4; binary)
o Maori (ethnicity group Level 1; binary)
o European (ethnicity group Level 1; binary)
o Asian (ethnicity group Level 1; binary)
o MELAA (ethnicity group Level 1; binary)

• NZ Deprivation (NZDep) index decile
• Overall numbers of patients enrolled (and by ethnicity)

• Numbers of throat swabs positive for Group A strep
• Within cases of positive Group A strep, what was the treatment/management
• All notifications of acute rheumatic fever cases
• Date of rheumatic fever diagnoses
• All cases of rheumatic heart disease
• Numbers and dates of prescriptions for related medications (e.g. amoxicillin, penicillin)
• Hospital admission(s) with the primary diagnosis of rheumatic fever
• Hospital admission(s) with the primary diagnosis of rheumatic heart disease
• Date of death

The duration of observation is between 31 March 2017 to 1 April 2022.
Intervention code [1] 323265 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330939 0
The annual incidence of rheumatic fever by ethnicity among the Auckland population. Data will be collected via data-linkage to medical records.
Timepoint [1] 330939 0
Retrospective data will be collected from patient medical record from 31 March 2017 to 1 April 2022 at a single time point.
Primary outcome [2] 330940 0
The annual incidence of rheumatic fever by 5-year age groups among the Auckland population. Data will be collected via data-linkage to medical records.
Timepoint [2] 330940 0
Retrospective data will be collected from patient medical record from 31 March 2017 to 1 April 2022 at a single time point.
Primary outcome [3] 330941 0
The annual incidence of rheumatic fever by ethnicity among the Auckland population. Data will be collected via data-linkage to medical records.
Timepoint [3] 330941 0
Retrospective data will be collected from patient medical record from 31 March 2017 to 1 April 2022 at a single time point.
Secondary outcome [1] 408149 0
The proportion of patient throat swabs positive for Group A Streptococcus, and compared by ethnicity. Data will be collected via data-linkage to medical records.
Timepoint [1] 408149 0
Retrospective data will be collected from patient medical record from 31 March 2017 to 1 April 2022 at a single time point
Secondary outcome [2] 408150 0
The proportion of patients hospitalised due to rheumatic fever and rheumatic heart disease.
Timepoint [2] 408150 0
Retrospective data will be collected from patient medical record from 31 March 2017 to 1 April 2022 at a single time point.
Secondary outcome [3] 408151 0
Among patients with rheumatic fever, the proportion who receive ongoing monthly treatment/medication such as penicillin injections.
Timepoint [3] 408151 0
Retrospective data will be collected from patient medical record from 31 March 2017 to 1 April 2022 at a single time point.

Eligibility
Key inclusion criteria
All patients enrolled with the following four primary health organisations based in Auckland, New Zealand: Alliance Health Plus, National Hauora Coalition, Pro Care, Tamaki Health, from 31 March 2017 to 1 April 2022.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients not enrolled at one of the four outlined primary health organisations in Auckland.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis
R software will be utilised to analyse data. The study denominator will be all people enrolled with the four Primary Health Organisations at 1 April 2022. The numerator is the number of people diagnosed with rheumatic fever as coded by the primary care practitioner in the health record.

We will use descriptive epidemiology to determine the incidence of patients with a diagnosis of rheumatic fever or rheumatic heart disease by ethnicity (Pacific, Maori, and non-Pacific non-Maori) and gender over the past five years. We will measure the percentage of the adult population diagnosed with rheumatic fever by ethnicity (Pacific, Maori, non-Pacific non-Maori), and the proportion who have had hospitalisations for rheumatic fever. We will conduct sub-group analyses by age, gender and New Zealand Deprivation Index quintile (NZDep) and time series to determine trends.

The study population will be described according to gender, age, ethnicity, NZDep decile and whether they have a primary care-coded diagnosis of rheumatic fever or rheumatic heart disease. Continuous variables (age) will be summarised as means with standard deviations and medians with interquartile ranges, and categorical data (sex, ethnicity, NZDep decile and rheumatic fever) as frequencies and percentages.

The proportion of participants with rheumatic fever will be compared by ethnicity, for sex and 5-year age groups.

Among participants with rheumatic fever, the proportion with the following in 2022, 2021, 2020, 2019 and 2018 will be compared by ethnicity, for sex and 5-year age groups:
• prescribed amoxicillin or penicillin
• dispensed amoxicillin or penicillin (if available)
• throat or skin swab for Group A streptococcus requested
• throat or skin swab result
Differences in proportions between ethnic groups will be assessed using a generalised mixed-methods model with binomial or Poisson distribution.

Data transfer and storage
Deidentified data from the four Primary Health Organisations will be transferred securely via the University’s secure online web drop server or alternatively on an encrypted USB memory stick and stored on a password-protected University of Auckland drive.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100000
Accrual to date
Final
Recruitment outside Australia
Country [1] 24694 0
New Zealand
State/province [1] 24694 0
Auckland

Funding & Sponsors
Funding source category [1] 311140 0
Charities/Societies/Foundations
Name [1] 311140 0
Royal Society Te Aparangi
Country [1] 311140 0
New Zealand
Primary sponsor type
Individual
Name
Dr Siobhan Tu'akoi
Address
Pacific Health section, School of Population Health
Faculty of Medical and Health Sciences
The University of Auckland
Bldg 507, Level 1, Room 1001
28 Park Avenue, Grafton
Auckland 1023
New Zealand
Country
New Zealand
Secondary sponsor category [1] 312486 0
Individual
Name [1] 312486 0
Dr Malakai ' Ofanoa
Address [1] 312486 0
Pacific Health section, School of Population Health
Faculty of Medical and Health Sciences
The University of Auckland
Bldg 507, Level B, Room B005
28 Park Avenue, Grafton
Auckland 1023
New Zealand
Country [1] 312486 0
New Zealand
Secondary sponsor category [2] 312487 0
Individual
Name [2] 312487 0
Professor Felicity Goodyear-Smith
Address [2] 312487 0
Department of General Practice and Primary Healthcare, School of Population Health
Faculty of Medical and Health Sciences
The University of Auckland
Bldg 507, Level 3, Room 3018
28 Park Avenue, Grafton
Auckland 1023
New Zealand
Country [2] 312487 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310665 0
Auckland Health Research Ethics Committee
Ethics committee address [1] 310665 0
The Auckland Health Research Ethics Committee
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Ethics committee country [1] 310665 0
New Zealand
Date submitted for ethics approval [1] 310665 0
10/02/2022
Approval date [1] 310665 0
21/03/2022
Ethics approval number [1] 310665 0
AH23838

Summary
Brief summary
The aim of this study is to determine rheumatic fever incidence and management nationally and across four Primary Health Organisations (PHOs): Alliance Health Plus, National Hauora Coalition, Pro Care and Tamaki Health.

To measure the size of the problem, secondary analysis of the existing anonymised national, and DHB datasets will be conducted via the National Minimum Dataset. De-identified data will be extracted from four PHOs will be transferred via the University's secure web drop where possible or via an encrypted USB memory stick as a backup. All data will be stored on a secure University of Auckland drive to be analysed (see protocol for further details). De-identified PHO data will include patients who have had a throat/skin swab positive for Group A Strep and/or a rheumatic fever/heart disease diagnosis from 2017-2022.

Data will be analysed in R. We will use descriptive epidemiology to determine the incidence of rheumatic fever by ethnicity (Pacific, Maori, and non-Pacific non-Maori) and gender over the past five years. We will also measure the proportion who have had hospitalisations for rheumatic fever and explore the treatment/medication pathways. We will conduct sub-group analyses by age, gender and New Zealand Deprivation Index quintile (NZDep) and time series to determine trends.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118450 0
Dr Siobhan Tu'akoi
Address 118450 0
Pacific Health section, School of Population Health
Faculty of Medical and Health Sciences
The University of Auckland
Bldg 507, Level 1, Room 1001
28 Park Avenue, Grafton
Auckland 1023
New Zealand
Country 118450 0
New Zealand
Phone 118450 0
+64 9 923 2368
Fax 118450 0
Email 118450 0
[email protected]
Contact person for public queries
Name 118451 0
Dr Siobhan Tu'akoi
Address 118451 0
Pacific Health section, School of Population Health
Faculty of Medical and Health Sciences
The University of Auckland
Bldg 507, Level 1, Room 1001
28 Park Avenue, Grafton
Auckland 1023
New Zealand
Country 118451 0
New Zealand
Phone 118451 0
+64 9 923 2368
Fax 118451 0
Email 118451 0
[email protected]
Contact person for scientific queries
Name 118452 0
Prof Felicity Goodyear-Smith
Address 118452 0
Department of General Practice and Primary Healthcare, School of Population Health
Faculty of Medical and Health Sciences
The University of Auckland
Bldg 507, Level 3, Room 3018
28 Park Avenue, Grafton
Auckland 1023
New Zealand
Country 118452 0
New Zealand
Phone 118452 0
+64 9 923 2357
Fax 118452 0
Email 118452 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15622Study protocol    383848-(Uploaded-30-03-2022-08-11-55)-Study-related document.pdf
15623Ethical approval    383848-(Uploaded-30-03-2022-08-12-03)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCo-designing an intervention to prevent rheumatic fever in Pacific People in South Auckland: a study protocol.2022https://dx.doi.org/10.1186/s12939-022-01701-9
N.B. These documents automatically identified may not have been verified by the study sponsor.