ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

All cause hospitalisation

Child health screening

Immunisation coverage

Condition category

Condition code

Public Health

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]

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]

All cause hospitalisations by data linkage to medical records

Timepoint [1]

Within 3 months after birth

Secondary outcome [1]

Child health checks by data linkage to medicare benefits schedule (MBS) records

Timepoint [1]

Within 3 months after birth

Secondary outcome [2]

Immunisations by data linkage to the Australian Childhood Immunisation Register (ACIR)

Timepoint [2]

Within 3 months after birth

Secondary outcome [3]

All cause emergency department presentations by data linkage to medical records

Timepoint [3]

Within 3 months after birth

Secondary outcome [4]

Satisfaction with care by structured questionnaire specifically designed for our Aboriginal families

Timepoint [4]

First 3 months of baby's life

Secondary outcome [5]

Cost effectiveness of early infant primary care by economic analysis

Timepoint [5]

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)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Level 1
16 Marcus Clarke Street
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

The University of Western Australia

Address

35 Stirling Highway
Crawley
WA 6009

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western Australian Aboriginal Human Ethics Committee

Ethics committee address [1]

450 Beaufort Street
Highgate
WA 6003

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/02/2015

Approval date [1]

07/05/2015

Ethics approval number [1]

607

Summary

Brief summary

Despite a decade of substantial investments in programs to improve access to primary care for Aboriginal mothers and infants, over 50% of Western Australian Aboriginal babies are still not receiving primary and preventative care in the early months of life.  Western Australian hospitals now input birth data into the Western Australian ‘Stork’ electronic birth registration system within 24 hours of birth. However, there have been difficulties in ensuring that the appropriate primary care providers receive birth notification and clinical information by the time babies are discharged from hospital. There is no consistent process for ensuring that choices about primary care are discussed with Aboriginal families. 

We will undertake a population based stepped wedge cluster randomised controlled trial of an enhanced model of early infant primary care.  The intervention is targeted support and care coordination for Aboriginal families with new babies starting as soon as possible during the antenatal period or after birth. Dedicated health professionals and research staff will: consult with families about their health care needs; provide information about health care in the first three months of life; offer assistance with birth and Medicare forms; consult with families about their choice for primary care provider; offer to notify the chosen primary care provider about their baby’s health needs; and offer assistance with health care coordination at the time of discharge from hospital. 

We will evaluate this model of care using rigorous stepped wedge approaches. Our primary outcome measure is reduced hospitalisation rates in infants aged under 3 months. Secondary outcome measures include emergency department presentations, completed Aboriginal and Torres Strait Islander child health screening assessments, immunisation coverage and satisfaction of families about early infant primary care. We will also assess the cost effectiveness of the model of care. 

This study will be conducted over a four year period in partnership with birthing hospitals and primary care providers including Western Australian Aboriginal Community Controlled Health Services and the new Primary Health Networks. The results of our trial will be used to develop improved primary care models and to improve health outcomes for all Aboriginal infants. These are vital steps towards more equitable health service delivery for Aboriginal and Torres Strait Islander children in Australia.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Karen Edmond

Address

The University of Western Australia
School of Paediatrics and Child Health (M561)
35 Stirling Highway
Crawley
WA 6009

Country

Australia

Phone

+61-8-93408142

Fax

karen.edmond@uwa.edu.au

Contact person for public queries

Name

Karen Edmond

Address

The University of Western Australia
School of Paediatrics and Child Health (M561)
35 Stirling Highway
Crawley
WA 6009

Country

Australia

Phone

+61-8-93408142

Fax

karen.edmond@uwa.edu.au

Contact person for scientific queries

Name

Karen Edmond

Address

The University of Western Australia
School of Paediatrics and Child Health (M561)
35 Stirling Highway
Crawley
WA 6009

Country

Australia

Phone

+61-8-93408142

Fax

karen.edmond@uwa.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Improving access to primary care for Aboriginal babies in Western Australia: study protocol for a randomized controlled trial.	2016	https://dx.doi.org/10.1186/s13063-016-1206-7

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically