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Trial registered on ANZCTR


Registration number
ACTRN12615001060538
Ethics application status
Approved
Date submitted
22/09/2015
Date registered
12/10/2015
Date last updated
28/11/2018
Date data sharing statement initially provided
28/11/2018
Date results information initially provided
28/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving primary care for Aboriginal mothers and babies in the Kimberley region of Western Australia ‘Nini Helthiwan’: a population and region based cluster randomised trial driven by local health service providers.
Scientific title
Model of enhanced clinical governance and peer led targeted support for antenatal care for improving iron deficiency anaemia rates in Aboriginal infants aged six months in the Kimberley region
Secondary ID [1] 287507 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron deficiency anaemia

296267 0
Child neurodevelopment 296351 0
All cause hospitalisation 296352 0
Condition category
Condition code
Public Health 296536 296536 0 0
Health service research
Reproductive Health and Childbirth 296627 296627 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two midwives will deliver the intervention. The first visit will involve the midwife consulting face-to-face with antenatal primary health care providers to discuss local needs, priorities and protocols; promote the use of best practice protocols and guidelines; and to discuss IT needs, inputs and outputs including key performance indicators reports and recall systems. Following this there will be a weekly scheduled telephone support service between the intervention midwives and primary care staff delivering antenatal care in the primary care services, and ongoing support for services to conduct CQI activities. The intervention midwives will help to solve problems that affect how care is delivered for mothers and babies in the Kimberley. Each service will have direct input into the role of the supporting intervention midwives in their own clinics. This will include offering help with:

1. Improving the coordination of care and information exchange between service providers, both community based services and hospitals in the region and outside the region (e.g. referrals; communication processes; logistics [PATS, transport, accommodation]);

2. Improving and promoting the use of local service protocols and guidelines to support staff with these processes

3. Improving training especially for antenatal and infant health care, nutrition, substance abuse, social and emotional well-being, and prevention and management of maternal anaemia

4. Supporting staff to sort out the complex care sometimes required for specific health problems that mothers and babies may have; and

5. Other problem solving as requested.

As this is a stepped wedge cluster randomised trial the total duration of the intervention provided to each clinic will depend on which cluster the clinic is randomised to. Cluster 1, 2, 3 and 4 will receive 23, 19, 15 and 11 months of intervention, respectively.

Intervention code [1] 292896 0
Prevention
Intervention code [2] 292897 0
Behaviour
Comparator / control treatment
The current care group will be the clinics in the clusters that have not yet received the enhanced model of care. Women who attend the clinics in the current care clusters will still receive standard care according to the usual practices of the primary care clinic.
Control group
Active

Outcomes
Primary outcome [1] 296163 0
Anaemia rates in Aboriginal infants
Timepoint [1] 296163 0
Haemoglobin level (full blood examination at laboratory or point of care test) at age six months
Secondary outcome [1] 317660 0
Satisfaction with care
Timepoint [1] 317660 0
Semi-structured interview with mothers when the infant is aged six months
Secondary outcome [2] 317661 0
Anaemia rates in mothers at six months post-partum
Timepoint [2] 317661 0
Haemoglobin level (full blood examination at laboratory or point of care test) at six months post-partum
Secondary outcome [3] 317662 0
Cost effectiveness of intervention by economic analysis
Timepoint [3] 317662 0
When the infant is aged six months
Secondary outcome [4] 317663 0
Bayley-III child development assessment for cognitive, language and motor skills.
Timepoint [4] 317663 0
When the infant is aged six months
Secondary outcome [5] 317664 0
All cause hospitalisations by data linkage to medical records
Timepoint [5] 317664 0
Infant: From birth to age six months
Mother: From first antenatal visit until six months postpartum

Eligibility
Key inclusion criteria
Target group for the intervention
The target group for the intervention includes all clinics that provide antenatal care in the Kimberley region (this includes both primary care and hospital antenatal clinics). All consenting primary care and hospital antenatal services in the region will be eligible to receive the intervention and will be allocated to a cluster group based on geographical and health service provider boundaries. All pregnant women who are patients of these services will be able to receive the benefits of the intervention.

Inclusion criteria for the intervention
All primary health care clinics that provide antenatal care in the Kimberley will be included in the study

Target group for the outcome data collection
The target group for the six month post-partum data collection are Aboriginal and Torres Strait Islander infants aged six months and their mothers.

Inclusion criteria for the outcome data collection
1. Birth mother or infant is Aboriginal and / or Torres Strait Islander
2. Birth mother aged 16 years or older, or assessed as a mature minor at the time of giving informed consent
3. Birth mother gives informed consent for her baby and herself to participate in outcome data collection.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There will be no additional exclusions.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who are 'off-site' or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by a computer software (i.e., computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Stepped wedge randomisation
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Analysis of the primary outcome (iron deficiency anaemia (IDA) in infants aged six months) will occur at the individual infant level and will use binary logistic regression incorporating generalised estimating equations (GEE) to account for loss of independence due to clustering. The primary independent variable will be whether or not the mother received her first antenatal visit at an intervention clinic. This will give rise to an odds ratio for the effect of the intervention on the probability of IDA. The analysis will adjust for individual covariates, e.g. maternal age, which may differ between groups receiving or not receiving care from the intervention clinics at a given step. Analysis will be on the basis of intention to treat, regardless of movement between clusters. Similar techniques will be used for comparison of IDA in mothers at six months post-partum. Similar techniques will be used for comparison of the other secondary outcomes. We will descriptively assess effects on neurodevelopmental subgroups (i.e. cognitive, neuromotor) but will not perform statistical tests.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 292083 0
Government body
Name [1] 292083 0
National Health and Medical Research Council
Address [1] 292083 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 292083 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
35 Stirling Highway
Crawley
WA 6009
Country: Australia
Country
Australia
Secondary sponsor category [1] 290833 0
None
Name [1] 290833 0
Address [1] 290833 0
Country [1] 290833 0
Other collaborator category [1] 278648 0
Other
Name [1] 278648 0
Kimberley Aboriginal Medical Services Ltd (KAMS)
Address [1] 278648 0
12 Napier Terrace
Broome WA 6725
Country [1] 278648 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293567 0
Western Australian Aboriginal Human Ethics Committee
Ethics committee address [1] 293567 0
450 Beaufort Street
Highgate
WA 6003
Ethics committee country [1] 293567 0
Australia
Date submitted for ethics approval [1] 293567 0
Approval date [1] 293567 0
07/05/2015
Ethics approval number [1] 293567 0
631
Ethics committee name [2] 293568 0
Western Australia Country Health Service
Ethics committee address [2] 293568 0
189 Wellington Street
East Perth WA 6892
Ethics committee country [2] 293568 0
Australia
Date submitted for ethics approval [2] 293568 0
Approval date [2] 293568 0
30/07/2015
Ethics approval number [2] 293568 0
2015:14

Summary
Brief summary
There is increasing concern that over 50% of mothers and 60% of breastfed young infants in disadvantaged areas globally have micronutrient malnutrition and iron deficiency anaemia (IDA), with similar rates found in Aboriginal and Torres Strait Islander communities. Despite a decade of substantial
investments in Continuous Quality Improvement (CQI) programs, many barriers still remain to the provision of antenatal care in remote areas. There have been no studies of the effectiveness of peer led clinical governance to improve antenatal in remote and disadvantaged communities who are likely to benefit most.

We have been funded by the National Health and Medical Research Council (NHMRC) to undertake a study of a new locally driven enhanced support model (clinical governance and peer led targeted support) to reduce anaemia rates and improve the quality of maternal and infant primary care. The study will be based in the Kimberley region of Western Australia. The intervention is clinical governance and peer led targeted support for maternal and early infant care delivered by dedicated local midwife coordinators.

We will evaluate this model of enhanced support using a rigorous stepped wedge design approach. Structured questionnaires and data collection will be used to assess acceptability, feasibility and sustainability. Our primary outcome measure is improved iron deficiency anaemia in infants aged six months. Secondary outcome measures are improved iron deficiency anaemia in mothers at six months post-partum; improved Bayley neurodevelopmental scores in infants aged six months; improved satisfaction of mothers about maternal health care. We will also assess the cost effectiveness of the model of enhanced support. Although we are aiming to measure the primary outcome at six months post-partum we will be accepting measures from 4-8 months due to difficulties in finding all infants at exactly six months post-partum.

This study will be conducted over a five year period in partnership with service providers in the Kimberley. This is the first population and region based study of clinical governance and targeted peer led support in a remote region. The results of our study will be used to develop improved primary care models and to improve health outcomes for all Aboriginal and/or Torres Strait Islander mothers and infants. These are vital steps towards more equitable health service delivery for Aboriginal and Torres Strait Islander peoples in Australia.
Trial website
Trial related presentations / publications
Public notes
For the Min and Max limit - 'We have assumed this refers to the intervention target group i.e. the clinic'

Contacts
Principal investigator
Name 60478 0
Prof Karen Edmond
Address 60478 0
The University of Western Australia
School of Paediatrics and Child Health (M561)
35 Stirling Highway Crawley WA 6009
Country 60478 0
Australia
Phone 60478 0
+61-8-93408142
Fax 60478 0
Email 60478 0
karen.edmond@uwa.edu.au
Contact person for public queries
Name 60479 0
Prof Karen Edmond
Address 60479 0
The University of Western Australia
School of Paediatrics and Child Health (M561)
35 Stirling Highway Crawley WA 6009
Country 60479 0
Australia
Phone 60479 0
+61-8-93408142
Fax 60479 0
Email 60479 0
karen.edmond@uwa.edu.au
Contact person for scientific queries
Name 60480 0
Prof Karen Edmond
Address 60480 0
The University of Western Australia
School of Paediatrics and Child Health (M561)
35 Stirling Highway Crawley WA 6009
Country 60480 0
Australia
Phone 60480 0
+61-8-93408142
Fax 60480 0
Email 60480 0
karen.edmond@uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All needed data
When will data be available (start and end dates)?
1st July 2024 to 1st July 2034
Available to whom?
All persons who apply to the CI team with clear reasons
Available for what types of analyses?
All analyses requested with clear reasons
How or where can data be obtained?
All persons who apply to the CI team with clear reasons
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 88 0
Citation [1] 88 0
Link [1] 88 0
Email [1] 88 0
Other [1] 88 0
Nil
Attachment [1] 88 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary