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Trial registered on ANZCTR


Registration number
ACTRN12618000945224
Ethics application status
Approved
Date submitted
30/05/2018
Date registered
5/06/2018
Date last updated
2/03/2021
Date data sharing statement initially provided
6/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Women's action for Mums and Bubs (WOMB): a trial of participatory women's groups to improve Indigenous maternal and child health.
Scientific title
Women's action for Mums and Bubs (WOMB): a non-randomised stepped wedge implementation trial of participatory women’s groups to improve the health of Aboriginal and Torres Strait Islander mothers and children in Australia.
Secondary ID [1] 294924 0
NHMRC GNT1146013
Universal Trial Number (UTN)
U1111-1214-2400
Trial acronym
WOMB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antenatal care 307887 0
Condition category
Condition code
Reproductive Health and Childbirth 306936 306936 0 0
Antenatal care
Reproductive Health and Childbirth 307154 307154 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Complex intervention involving Participatory Women's Groups (PWGs) being supported to engage with Maternal and Child Health audit data from their community/PHC service and suggesting interventions to improve quality of care. These groups will use the Remote Services Futures methodology to engage with MCH audit data; collect information about strengths and limitations of MCH care in that context, co-produce a MCH quality improvement plan for that site, co-implementation of that plan and monitoring.

PWGs will be formed for each community in the study and supported by local facilitators with remote support from the project team.. Two facilitators for each group will be identified from within the community with the assistance of the health service and community women and trained. Training will occur during a one week training program in the first year of the project (probably held in Cairns), covering group facilitation skills, familiarisation with MCH audit data and the RSF process as a framework for supporting the initiatiation and conduct of PWGs, with the aim of engaging with MCH audit data and facilitating action to promote quality of MCH care. This training will also help facilitators form relationships with the research team members and other facilitators to enable ongoing remote support for the process. Comprehensive refresher training will be done on site just prior to implementation of the intervention.

PWGs will be supported by the PWG facilitators (with significant support from the project team include remote reminders and prompts and a project team member attending each participating health service during the first cycle of workshops) to meet for a series of four planning workshops (held at approximately monthly intervals over the first six months of the intervention at each site). Three initiatives from the community MCH improvement plan developed will be prioritised for implementation, and a series of four implementation workshops will be held over the following 8 months at approximately bi-monthly intervals.
Annual meetings to bring facilitators together and disseminate their experiences will share learning and enhance the knowledge base to respond to local priorities.
Adherence and fidelity of the intervention will be assessed using detailed process evaluation, including facilitator structured field journals, interviews (with PWG facilitators and PWG participatants) and direct observation .
Intervention code [1] 301241 0
Treatment: Other
Comparator / control treatment
Stepped- wedge intervention so the comparator is the same service prior to commencement of the Participatory Women's Group intervention. This is important from our partners' points of view to ensure that all communities are able to receive the intervention.
Cross sectional MCH audit data to calculate a MCH QCI index will be collected from all participating services at the beginning of the project and on an annual basis.
Under the stepped wedge design, it is expected that at least 4 -five data points will be available for each service. These will cover the period from at least 6 months preceding the intervention commencement to at least 18 months after the intervention.
Control group
Historical

Outcomes
Primary outcome [1] 305919 0
Maternal and child health quality of care index (MCH-QCI) - indicates overall adherence to delivering recommended services (total number of services provided)/(total number of recommended services)*100. Previously validated and published methodology.
This outcome measure is assessed through annual cross-sectional chart audit data using the usual mechanisms used by the service. Some of these involve automatic data extraction using PENCAT tools and some involve direct paper auditing of records. Patients attending the service whose charts may be audited are women with an infant aged between 2 and 14 months, resident in the community for at least 6 months of the pregnancy and using the PHC service as her usual source of care.
Timepoint [1] 305919 0
Annual measures - five measures for each service.
Using the stepped wedge design, the primary outcome measure will be assessed at yearly intervals, for five measurements throughout the trial, with the intervention occurring in an additional 2 services at 3 month intervals.
Each service will be supported to ensure that they have two - three high quality sets of baseline (pre-intervention) MCH audit data and two- three sets of post-intervention MCH audit data.
Secondary outcome [1] 347029 0
Mean birthweight.
This measure will be assessed from chart audits within the service.
Timepoint [1] 347029 0
Annual measures pre and post intervention.
Using the stepped wedge design, the secondary outcome measures will also be assessed at yearly intervals, for five measurements throughout the trial, with the intervention occurring in an additional 2 services at 3 month intervals.
Each service will be supported to ensure that they have two - three high quality sets of baseline (pre-intervention) data and two- three sets of post-intervention data.
Secondary outcome [2] 347028 0
Percentage of pregnant women having their first antenatal visit before 13 weeks gestation. This measure will be assessed from chart audits within the service.
Timepoint [2] 347028 0
Annual measures pre and post intervention
Using the stepped wedge design, the secondary outcome measures will also be assessed at yearly intervals, for five measurements throughout the trial, with the intervention occurring in an additional 2 services at 3 month intervals.
Each service will be supported to ensure that they have two - three high quality sets of baseline (pre-intervention) data and two- three sets of post-intervention data.
Secondary outcome [3] 347031 0
Cost-effectiveness and cost-consequence analysis of the intervention. Costs for the CCA and CEA will be obtained from trial data, and include all training, staff time, and resource use costs to the health systems for a hypothetical national roll-out of the program. The outcomes for the CCA will be all the primary and secondary outcomes for the study. The outcome for the CEA will be 100g increase in mean birthweight. The number of women needed to be treated (NNT) to achieve this increase will be calculated based upon change in birthweights over the intervention period adjusting for confounding factors (maternal age, parity). Incremental cost-effectiveness ratio will then be estimated from the additional costs of providing the intervention multiplied by the NNT.
Timepoint [3] 347031 0
In the last year of the trial - this will be between 2 1/2 years to 1 year after intervention completion, depending on which step the service is in to receive the intervention.
Secondary outcome [4] 347030 0
Women's empowerment using Global Growth and Empowerment Scale (GEM) with PWG members and facilitators.
Timepoint [4] 347030 0
Immediately pre and post intervention. This GEM scale will be administered at the start of the first PWG planning workshop and at the end of the last PWG implementation workshop.
The GEM scale will also be administered again in the last year of the study, which will be between 2 1/2 years and 1 year post intervention depending on the step at which that service receives the intervention.

Eligibility
Key inclusion criteria
Indigenous primary health care services are eligible to take part if they:
1. are engaged in MCH auditing using a recognised tool.
2. are willing to support staff member participation in facilitator training
3. have agreement from CEO, Board and key staff to participate.

Participatory women's group facilitators and PWG participants are any local community women with an interest in the health of mums and bubs - may include mothers, Elders, other community women (ideally linking in with other community initiatives).

Women whose charts are audited in terms of the primary and secondary outcomes are any woman in the community with an infant aged between 2 and 14 months at the time of the audit, resident in the community for at least 6 months of her pregnancy and using the PHC service as her usual source of care.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Does not meet inclusion criteria. Unwilling to take part or has a physical or mental health condition that makes participation in a women's group impossible.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Cluster non-randomised stepped-wedge intervention trial . Two health services will each commence the intervention at 3-monthly steps, with the four services with pre-existing women's groups commencing on the early steps and the others commencing on the later steps. Service pairing has been finalised based on proximity for practical reasons to minimise costs and facilitate travel.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For primary analyses for primary and secondary outcomes, it will be assumed that the PWG will have its full effect on outcomes after 12 months from the start of the intervention at each step. The sample size of 200 specified in step 7 is 200 mother/baby diads, based on an approximation of 20 diads to audit for each of 10 communities in each audit.
Outcomes will be assessed using linear mixed effects modelling with a random effect for community, and fixed effects for the effects of time. Estimates of the full effect of PWGs will be reported along with 95% confidence intervals. Secondary analyses may adjust for rurality, service size, governance models and sensitivity analyses may be undertaken. Statistical signficance will be set at p<0.05 level.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2018
Actual
15/10/2018
Date of last participant enrolment
Anticipated
30/06/2021
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
200
Accrual to date
170
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,WA

Funding & Sponsors
Funding source category [1] 299506 0
Government body
Name [1] 299506 0
National Health and Medical Research Council
Country [1] 299506 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
1 James Cook Drive
Douglas QLD 4811
Country
Australia
Secondary sponsor category [1] 298808 0
University
Name [1] 298808 0
University Centre for Rural Health, Lismore, University of Sydney
Address [1] 298808 0
61 Uralba St, Lismore NSW 2740
PO Box: 3074, Lismore NSW 2740
Country [1] 298808 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303307 0
Aboriginal Health and Medical Research Council (NSW)
Ethics committee address [1] 303307 0
Ethics committee country [1] 303307 0
Australia
Date submitted for ethics approval [1] 303307 0
Approval date [1] 303307 0
06/11/2018
Ethics approval number [1] 303307 0
1439/18
Ethics committee name [2] 300525 0
James Cook University Human Research Ethics Committee
Ethics committee address [2] 300525 0
Ethics committee country [2] 300525 0
Australia
Date submitted for ethics approval [2] 300525 0
07/06/2018
Approval date [2] 300525 0
Ethics approval number [2] 300525 0
H7441
Ethics committee name [3] 300407 0
Human Research Committee of the Northern Territory Department of Health and Menzies School of Health Research
Ethics committee address [3] 300407 0
Ethics committee country [3] 300407 0
Australia
Date submitted for ethics approval [3] 300407 0
06/04/2018
Approval date [3] 300407 0
30/04/2018
Ethics approval number [3] 300407 0
HREC 2018-3076
Ethics committee name [4] 303308 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [4] 303308 0
Ethics committee country [4] 303308 0
Australia
Date submitted for ethics approval [4] 303308 0
Approval date [4] 303308 0
21/11/2018
Ethics approval number [4] 303308 0
890

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

Contacts
Principal investigator
Name 83566 0
Prof Sarah Larkins
Address 83566 0
Project Co-Principal Investigator,
College of Medicine and Dentistry
James Cook University
1 James Cook Drive,
Douglas QLD 4811
Country 83566 0
Australia
Phone 83566 0
+61 7 47813139
Fax 83566 0
Email 83566 0
sarah.larkins@jcu.edu.au
Contact person for public queries
Name 83567 0
Catrina Felton-Busch
Address 83567 0
Project Co-Principal Investigator
Mt Isa Centre for Rural and Remote Health
James Cook University
1oo Joan Street
Mount Isa QLD 4825.
Country 83567 0
Australia
Phone 83567 0
+61 7 47454514
Fax 83567 0
Email 83567 0
catrina.feltonbusch@jcu.edu.au
Contact person for scientific queries
Name 83568 0
Sarah Larkins
Address 83568 0
College of Medicine and Dentistry
James Cook University
1 James Cook Drive
Douglas QLD 4811
Country 83568 0
Australia
Phone 83568 0
+61 7 47813139
Fax 83568 0
Email 83568 0
sarah.larkins@jcu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Our service partners are not comfortable with sharing data at individual level, as the detailed qualitative information requires detailed contextual interpretation and identification of individuals within small communities may be possible. Aggregated and analysed information (both quantitative and qualitative will be published).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1999Study protocolWOmen's Action for Mums and Bubs (WOMB) Trial Protocol: A Non-randomized Stepped Wedge Implementation Trial of Participatory Women's Groups to Improve the Health of Aboriginal and Torres Strait Islander Mothers and Children in Australia K Carlisle, C Felton-Busch, Y Cadet-James, J Taylor… - Frontiers in Public Health, 2020 n8:73 https://doi.org/10.3389/fpubh.2020.00073https://www.frontiersin.org/articles/10.3389/fpubh.2020.00073/full?report=reader  Study protocol is published and uploaded.
10847Informed consent form    375127-(Uploaded-15-06-2020-10-20-32)-Study-related document.docx


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.