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Trial registered on ANZCTR


Registration number
ACTRN12615000976583
Ethics application status
Approved
Date submitted
31/08/2015
Date registered
17/09/2015
Date last updated
18/03/2020
Date data sharing statement initially provided
6/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving access to primary care for Aboriginal and Torres Strait Islander babies in Western Australia. The ‘Stork’ stepped wedge randomised controlled trial.
Scientific title
An enhanced model of targeted support and early infant primary care coordination, compared to current practice, for the reduction of all cause hospitalisation in Aboriginal and Torres Strait Islander infants less than 3 months of age.
Secondary ID [1] 287381 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
All cause hospitalisation 296070 0
Child health screening 296071 0
Immunisation coverage 296072 0
Condition category
Condition code
Public Health 296334 296334 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a stepped wedge cluster randomised controlled trial (RCT). The total duration of the intervention, including pilot testing is 3 years. All public WA hospitals where women can give birth (birthing hospitals) and their surrounding primary care clinics have been grouped into 22 distinct geographic clusters and are the unit of randomisation in this study . The clusters will be randomised in a ‘stepped’ (staggered) order to receive our new model of early infant primary care or to continue with current care. The study will consist of a baseline period of six months followed by four steps of six months duration. Five or six new clusters will receive the intervention at each step and all hospitals and primary care clinics will receive the intervention by the end of the third year of the study.

Project staff (Midwife, Aboriginal Liaison Officer, Registered Nurse or health researcher) will be based at the birthing hospitals and will be responsible for administering all aspects of the intervention.

There are three components of the intervention which will be implemented by the dedicated infant health care coordinators:

1) Hospitals – Project staff will work with birthing hospitals to understand the gaps in current infant care coordination and develop project tools that meet the local needs. This will involve one on one meetings with the manager of midwifery, midwives and nursing staff to determine gaps within the current infant care coordination process. If possible small group discussions will be arranged for staff to attend and provide feedback about the current coordination process however it is anticipated that in some hospitals this might be difficult to coordinate.

2) Families – Project staff will approach families as soon possible after birth to invite their participation in the intervention and set up a 30-60 minute meeting. During the meeting project staff will use the locally targeted care coordination process to:

a) Discuss with families about their health care needs: the purpose of this discussion will be to identify any needs that are specific to a family, for example, if a mother is having trouble with breast feeding she may wish to receive some additional information and support. Or a family may live in a very remote area and have concerns about how they will travel to scheduled appointments.

b) Provide information about primary care services available for the first three months of the baby’s life: a postnatal discharge pack will be provided and each piece of information explained. The pack will include information about breast feeding, emotional health and wellbeing, advice for dads, developmental milestones, parenting courses, quitting smoking, coping skills, safe sleeping, child health checks, and immunisations. During this part of the meeting families will have the opportunity to ask questions.

c) Offer assistance with birth and Medicare registration forms: families will be offered the opportunity to have assistance with filling out their birth forms. This may be done at the time of the initial meeting with the family or another time might be arranged.

d) Consult with families about their choice for primary care provider: families will be asked to nominate who they would prefer to see for their baby’s health checks during the first three months of life. If they don’t know or don’t have a regular care provider, suggestions will be made by the project staff member, relevant to their location of intended residence.

e) Offer to notify the chosen primary care provider about the baby’s health needs: project staff will offer to contact the chosen primary care provider on behalf of the family to let them know that the birth has occurred and discuss with the care provider any important health care needs that were raised by the family (as per outlined in a) above).

f) Offer assistance with health care coordination at the time of discharge from hospital: for example, project staff may contact a family’s primary care provider to request a follow up from the clinic in relation to child health check appointments and/or immunisations.

3) Primary care providers – project staff will contact a family’s chosen primary care provider via telephone to:

a) Ensure they receive birth and hospital details: project staff will ask the clinic about their preferred method for receiving information about the birth, for example fax or email containing scanned documents.

b) Offer tools and guidance on early infant primary care: questions will be asked about the services and information that will be available to the family. If the project staff feel that there are any gaps in the services and/or available information, necessary resources will be offered to the clinic.

c) Where necessary, offer additional assistance and contact points with experienced community child health nurses, primary care networks and paediatricians.
Intervention code [1] 292725 0
Prevention
Comparator / control treatment
Current care, which involves transmission of birth notification information to the primary care provider listed on the hospital patient record through facsimile machines or the post. There are no phone calls or direct communication with the primary care provider. Families are not given information about the choices of primary care provider.
Control group
Active

Outcomes
Primary outcome [1] 295985 0
All cause hospitalisations by data linkage to medical records
Timepoint [1] 295985 0
Within 3 months after birth
Secondary outcome [1] 317107 0
Child health checks by data linkage to medicare benefits schedule (MBS) records
Timepoint [1] 317107 0
Within 3 months after birth
Secondary outcome [2] 317108 0
Immunisations by data linkage to the Australian Childhood Immunisation Register (ACIR)
Timepoint [2] 317108 0
Within 3 months after birth
Secondary outcome [3] 317109 0
All cause emergency department presentations by data linkage to medical records
Timepoint [3] 317109 0
Within 3 months after birth
Secondary outcome [4] 317110 0
Satisfaction with care by structured questionnaire specifically designed for our Aboriginal families
Timepoint [4] 317110 0
First 3 months of baby's life
Secondary outcome [5] 317111 0
Cost effectiveness of early infant primary care by economic analysis
Timepoint [5] 317111 0
First 3 months of baby's life

Eligibility
Key inclusion criteria
All mothers who give birth to a live baby at a public hospital in Western Australia and identify as Aboriginal and/or Torres Strait Islander, or identify their baby as Aboriginal and/or Torres Strait Islander, will be invited to participate in the study.
Minimum age
14 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
We will not exclude any women who deliver a preterm baby, develop complications or any unwell babies as these babies are most likely to benefit most from improved skills in their primary care workers.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2016
Actual
1/03/2016
Date of last participant enrolment
Anticipated
31/12/2018
Actual
1/09/2017
Date of last data collection
Anticipated
31/03/2019
Actual
30/06/2019
Sample size
Target
4300
Accrual to date
Final
4300
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 291947 0
Government body
Name [1] 291947 0
National Health and Medical Research Council
Country [1] 291947 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
35 Stirling Highway
Crawley
WA 6009
Country
Australia
Secondary sponsor category [1] 290615 0
None
Name [1] 290615 0
Address [1] 290615 0
Country [1] 290615 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293443 0
Western Australian Aboriginal Human Ethics Committee
Ethics committee address [1] 293443 0
Ethics committee country [1] 293443 0
Australia
Date submitted for ethics approval [1] 293443 0
13/02/2015
Approval date [1] 293443 0
07/05/2015
Ethics approval number [1] 293443 0
607

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

Contacts
Principal investigator
Name 59950 0
Prof Karen Edmond
Address 59950 0
The University of Western Australia
School of Paediatrics and Child Health (M561)
35 Stirling Highway
Crawley
WA 6009
Country 59950 0
Australia
Phone 59950 0
+61-8-93408142
Fax 59950 0
Email 59950 0
[email protected]
Contact person for public queries
Name 59951 0
Karen Edmond
Address 59951 0
The University of Western Australia
School of Paediatrics and Child Health (M561)
35 Stirling Highway
Crawley
WA 6009
Country 59951 0
Australia
Phone 59951 0
+61-8-93408142
Fax 59951 0
Email 59951 0
[email protected]
Contact person for scientific queries
Name 59952 0
Karen Edmond
Address 59952 0
The University of Western Australia
School of Paediatrics and Child Health (M561)
35 Stirling Highway
Crawley
WA 6009
Country 59952 0
Australia
Phone 59952 0
+61-8-93408142
Fax 59952 0
Email 59952 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?

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
EmbaseImproving access to primary care for Aboriginal babies in Western Australia: study protocol for a randomized controlled trial.2016https://dx.doi.org/10.1186/s13063-016-1206-7
N.B. These documents automatically identified may not have been verified by the study sponsor.