Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000277741
Ethics application status
Approved
Date submitted
6/11/2021
Date registered
15/02/2022
Date last updated
21/06/2024
Date data sharing statement initially provided
15/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Quantitative assessment of the Pacific gout health burden and treatment need in Auckland
Scientific title
Quantitative assessment of the Pacific gout health burden and treatment need in Auckland
Secondary ID [1] 305684 0
‘Nil known’
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 324161 0
Gout diagnosis and Gout management - allopurinol prescribing and serum urate testing 324162 0
Condition category
Condition code
Musculoskeletal 321634 321634 0 0
Other muscular and skeletal 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 size of the problem related to the low uptake of urate-lowering therapy by Pacific people with gout in comparison to Maori and non-Pacific non-Maori people.

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.

We will use the secondary anonymised dataset from the Health Quality and Safety Commission Atlas of Healthcare Variation – gout national and three Auckland metro DHBs (Waitemata, Auckland, Counties Manukau). In addition, four Primary Health Organisations (PHOs), ProCare, Tamaki Health, Alliance Health Plus (AH+) and National Hauora Coalition), will provide routinely collected clinical data of their de-identified enrolled patient populations. Collectively, these four PHOs have the majority of Pacific and Maori enrolled patients in the three Auckland DHBs. ProCare has 175 practices representing 52.7% of the Auckland DHBs’ population, of whom 22% are Pacific or Maori. Tamaki Health has an enrolled population of 230,000 across 45 Auckland clinics, with 540,700 Pacific patients from South Auckland. AH+ has a network of 40 general practices with a total of approximately 126,000 enrolled patients of all ages, 32% of whom are Pacific and 14% Maori, and the National Hauora Coalition has over 120,000 patients in 26 general practices in Auckland Metro, with 22% Pacific and 33% Maori.

The study denominator will be all people enrolled with all four PHOs, at 1 October 2021, are aged 20 years or older and the numerator is the number of people diagnosed with gout.

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
o 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 2; binary) *excluding Indo-Fijian
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)
o DHB (domicile)
o NZ Deprivation (NZDep) index decile
o A current primary care-coded diagnosis of gout (binary)
o Date of gout diagnosis
o Numbers and dates of prescriptions for urate-lowering therapy (allopurinol) in the period 30 September 2016 to 1 October 2021
o Numbers and dates of serum urate tests requested in the period 30 September 2016 to 1 October 2021
o Numbers and dates of serum urate test done (i.e. have results) in the period 30 September 2016 to 1 October 2021
o Serum urate test results in the period 30 September 2016 to 1 October 2021 (actual value in mmol/L)
o Hospital admission(s) with the primary diagnosis of gout

The duration of observations is between the period of 30 September 2016 to 1 October 2021.
Intervention code [1] 322080 0
Not applicable
Comparator / control treatment
'no control group'
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329400 0
The prevalence of Auckland adult population (20 years and over) with gout by ethnicity. Data will be collected via data-linkage to medical records.
Timepoint [1] 329400 0
Retrospective data will be collected from the participants medical record from 30 September 2016 to 1 October 2021 at a single time point.
Primary outcome [2] 330055 0
The prevalence of Auckland adult population (20 years and over) with gout by sex, Data will be collected via data-linkage to medical records.
Timepoint [2] 330055 0
Retrospective data will be collected from the participants medical record from 30 September 2016 to 1 October 2021 at a single time point.
Primary outcome [3] 330056 0
The prevalence of Auckland adult population (20 years and over) with gout by 10-year age groups, Data will be collected via data-linkage to medical records.
Timepoint [3] 330056 0
Retrospective data will be collected from the participants medical record from 30 September 2016 to 1 October 2021 at a single time point.
Secondary outcome [1] 402464 0
Regular (daily) ULT (allopurinol) use

The frequency of ULT prescribed over the duration of the gout diagnosis (within the study period) will enable calculation of regularity of three-monthly prescriptions, Data will be collected via data-linkage to medical records of prescription data.
Timepoint [1] 402464 0
Retrospective data will be collected from the participants medical record from 30 September 2016 to 1 October 2021 at a single time point.
Secondary outcome [2] 402490 0
Proportion who are hospitalised because of gout. Data will be collected via data-linkage to medical records.
Timepoint [2] 402490 0
Retrospective data will be collected from the participants medical record from 30 September 2016 to 1 October 2021 at a single time point.
Secondary outcome [3] 402724 0
Among participants with gout and who have had a serum test result in the preceding 6 months, the proportion with serum urate of <0.36 mmol/L will be compared by ethnicity. Data will be collected via data-linkage to medical records.
Timepoint [3] 402724 0
Retrospective data will be collected from the participants medical record from 30 September 2016 to 1 October 2021 at a single time point.
Secondary outcome [4] 404763 0
Among participants with gout and who have had a serum test result in the preceding 6 months, the proportion with serum urate of <0.36 mmol/L will be compared by sex.. Data will be collected via data-linkage to medical records.
Timepoint [4] 404763 0
Retrospective data will be collected from the participants medical record from 30 September 2016 to 1 October 2021 at a single time point.
Secondary outcome [5] 405121 0
Among participants with gout and who have had a serum test result in the preceding 6 months, the proportion with serum urate of <0.36 mmol/L will be compared by 10-year age groups. Data will be collected via data-linkage to medical records.
Timepoint [5] 405121 0
Retrospective data will be collected from the participants medical record from 30 September 2016 to 1 October 2021 at a single time point.
Secondary outcome [6] 405122 0
Among participants with gout and who have had a serum test result in the preceding 6 months, the proportion without serum urate of <0.36 mmol/L will be compared by ethnicity. Data will be collected via data-linkage to medical records.
Timepoint [6] 405122 0
Retrospective data will be collected from the participants medical record from 30 September 2016 to 1 October 2021 at a single time point.
Secondary outcome [7] 405123 0
Among participants with gout and who have had a serum test result in the preceding 6 months, the proportion without serum urate of <0.36 mmol/L will be compared by sex. Data will be collected via data-linkage to medical records.
Timepoint [7] 405123 0
Retrospective data will be collected from the participants medical record from 30 September 2016 to 1 October 2021 at a single time point.
Secondary outcome [8] 405124 0
Among participants with gout and who have had a serum test result in the preceding 6 months, the proportion without serum urate of <0.36 mmol/L will be compared by 10-year age groups. Data will be collected via data-linkage to medical records.
Timepoint [8] 405124 0
Retrospective data will be collected from the participants medical record from 30 September 2016 to 1 October 2021 at a single time point.

Eligibility
Key inclusion criteria
All patients aged 20 years or older enrolled with the four Primary Health Organizations (Alliance Health Plus, Pro Care, Tamaki Health and National Hauora Coalition data) from 30 September 2016 to 1 October 2021.
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria
Patients aged less than 20 years

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis
The R software will be utilised to analyse the data. The study denominator will be all people enrolled with the four PHOs aged 20 years or older at 1 October 2021. The numerator is the number of people diagnosed with gout as coded by the primary care practitioner in the health record.

We will use descriptive epidemiology to determine the prevalence of patients aged 20 years and over with a diagnosis of gout 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 gout by ethnicity (Pacific, Maori, non-Pacific non-Maori), and the proportion who have had serum urate monitoring, and hospitalisation for gout. We will conduct sub-group analyses by age, gender and New Zealand Deprivation Index quintile (NZDep) and time series to determine trends.

For the national and DHB samples we will include dispensing of urate lowering therapy (e.g., allopurinol). For the four PHOs we will include prescribing of urate lowering therapy (e.g., allopurinol).

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

The proportion of participants with gout will be compared by ethnicity, for sex and 10-year age groups.

Among participants with gout, the proportion with the following in 2021, 2020, 2019, 2018 and 2017 will be compared by ethnicity, for sex and 10-year age groups:
• prescribed ULT (allopurinol)
• dispensed allopurinol (if available)
• serum urate test requested
• serum urate test result

The frequency of ULT prescribed over the duration of the gout diagnosis (within the study period) will enable calculation of regularity of three-monthly prescriptions, giving an indication of regular (daily) ULT use.

Among participants with gout and who have had a serum test result in the preceding 6 months, the proportion with and without serum urate of <0.36 mmol/L will be compared by ethnicity, for sex and 10-year age groups.

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 AH+ will be transferred via an encrypted USB memory stick and stored on a password-protected University of Auckland drive.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2023
Actual
1/05/2023
Date of last participant enrolment
Anticipated
1/06/2023
Actual
1/07/2023
Date of last data collection
Anticipated
Actual
1/11/2023
Sample size
Target
100000
Accrual to date
Final
18146
Recruitment outside Australia
Country [1] 24285 0
New Zealand
State/province [1] 24285 0
Auckland

Funding & Sponsors
Funding source category [1] 310047 0
Government body
Name [1] 310047 0
Health Research Council of New Zealand
Country [1] 310047 0
New Zealand
Primary sponsor type
Individual
Name
Dr Malakai Ofanoa
Address
The Pacific Health Department, School of Population Health
Faculty of Medical and Health Sciences
The University of Auckland
M&HS Building 507 - Bldg 507
Level B, Room B005
28 Park Avenue
Grafton
Auckland 1023
New Zealand
Country
New Zealand
Secondary sponsor category [1] 311096 0
Individual
Name [1] 311096 0
Professor Felicity Goodyear-Smith
Address [1] 311096 0
Department of General Practice and Primary Healthcare, School of Population Health
Faculty of Medical and Health Sciences
The University of Auckland
M&HS Building 507 - Bldg 507
Level 3, Room 3018
28 Park Avenue
Grafton
Auckland 1023
New Zealand
Country [1] 311096 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309742 0
Auckland Health Research Ethics Committee (AHREC)
Ethics committee address [1] 309742 0
Ethics committee country [1] 309742 0
New Zealand
Date submitted for ethics approval [1] 309742 0
21/08/2021
Approval date [1] 309742 0
16/09/2021
Ethics approval number [1] 309742 0
Reference number: AH22873

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

Contacts
Principal investigator
Name 115234 0
Dr Malakai Ofanoa
Address 115234 0
The Pacific Health Department, School of Population Health
Faculty of Medical and Health Sciences
The University of Auckland
M&HS Building 507 - Bldg 507
Level B, Room B005
28 Park Avenue
Grafton
Auckland 1023
New Zealand
Country 115234 0
New Zealand
Phone 115234 0
+64 9 923 2997
Fax 115234 0
Email 115234 0
[email protected]
Contact person for public queries
Name 115235 0
Malakai Ofanoa
Address 115235 0
The Pacific Health Department, School of Population Health
Faculty of Medical and Health Sciences
The University of Auckland
M&HS Building 507 - Bldg 507
Level B, Room B005
28 Park Avenue
Grafton
Auckland 1023
New Zealand
Country 115235 0
New Zealand
Phone 115235 0
+64 9 923 2997
Fax 115235 0
Email 115235 0
[email protected]
Contact person for scientific queries
Name 115236 0
Felicity Goodyear-Smith
Address 115236 0
Department of General Practice and Primary Healthcare, School of Population Health
Faculty of Medical and Health Sciences
The University of Auckland
M&HS Building 507 - Bldg 507
Level 3, Room 3018
28 Park Avenue
Grafton
Auckland 1023
New Zealand
Country 115236 0
New Zealand
Phone 115236 0
+64 9 923 2357
Fax 115236 0
Email 115236 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
13946Study protocol    383044-(Uploaded-03-11-2021-15-20-27)-Study-related document.docx
13947Ethical approval    383044-(Uploaded-03-11-2021-15-21-29)-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
No additional documents have been identified.