Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000424202
Ethics application status
Approved
Date submitted
7/04/2009
Date registered
10/06/2009
Date last updated
7/10/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The MOVE study: Improving maternal and child health nurse care for vulnerable mothers
Scientific title
Improving maternal and child health (MCH) nurse care through an enhanced model of MCH nurse care for mothers experiencing intimate partner violence (IPV), compared with standard MCH nurse care, in order to improve disclosure, referral to appropriate services, and increased satisfaction with MCH nursing care by MCH clients experiencing partner violence.
Secondary ID [1] 892 0
NA
Universal Trial Number (UTN)
Trial acronym
MOVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intimate Partner Violence 4575 0
Condition category
Condition code
Public Health 4868 4868 0 0
Health service research
Other 237291 237291 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the first six months of the study, results of a systematic review of evidence informing current models of nurse family/intimate partner violence care will be integrated with action research by four nurses within their teams, with the goal of consensus (using AGREE Collaboration (2003) guidelines) of a new recommended model. Informed by Normalisation Process Theory to improve sustainability, this good practice model of screening and care (to be developed) will include training, clinical guidelines and recommended pathways, documentation and standards of care which will be advocated by the nurse scholars into their teams' practice. The intervention will be trialed for twelve months .The model of screening and care refers to family violence (FV) which includes intimate partner violence but is the term used by the Victorian government. Mandated screening questions also asked about the safety of children.
Intervention code [1] 4337 0
Early detection / Screening
Intervention code [2] 236721 0
Other interventions
Comparator / control treatment
Usual care, means that the four comparison nurse teams will screen to identify their clients experiencing family violence and refer to recommended family violence or other community services as necessary.
Control group
Active

Outcomes
Primary outcome [1] 5721 0
Improved family violence (FV) disclosure/safety planning is measured firstly by routine data of nurse reported FV safety planning rates. These are computer data that MCH teams are required to report to government as our assumption was that safety planning would occur after disclosure. We would also examine reported disclosure by survey.
Timepoint [1] 5721 0
15 months after intervention (31st March 2010-April 1 2011) we collected the previous year's FV routine data for all eight teams. We also collected routine data for 24 months (April 2013) after intervention completion to see whether the FV screening and care intervention was sustainable without the involvement of research staff or a trial setting.
Primary outcome [2] 293314 0
FV screening rates measured by routine reported government data
Timepoint [2] 293314 0
15 months (three months after the end of the intervention period. Routine reported government FV data were also then re-examined at 24 months to check sustainability
Secondary outcome [1] 241654 0
Improved referral by MCH nurses of their clients experiencing family violence to appropriate services. This will be assessed by assessing differences in proportions of routinely reported referral rates by arm. As MCH nurses are required to report FV referral data to government, we collected these routine data from all 8 teams, as well as by questions about referral from a survey of women attending MCH centres who have given birth in the preceding twelve months.
Timepoint [1] 241654 0
We collected routine government reporting data at the end of the intervention (April 2011) and again in 2013 (for April 2011-2012 and April 2012-2013).

We sent a survey to over 10,000 women once after the end of the intervention 15 months after the commencement of the intervention.
Secondary outcome [2] 241655 0
Improved client satisfaction with MCH nurse care, which will be assessed by asking women clients in the surveys outlined above.
Timepoint [2] 241655 0
15 months (5000 surveys) and 21 months (second 5000) after commencement of the intervention

Eligibility
Key inclusion criteria
MCH nurse teams in the north west Melbourne suburbs
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
MCH nurse teams previously enrolled in the MOtherS' Advocates In the Community (MOSAIC) trial were invited to participate further in the 'Improving MCH nurse care for Vulnerable mothers (MOVE) study. The eight MCH nurse team clusters had previously been randomised using sealed opaque envelopes selected from a container by an independent person. Nurse teams agreed to a reverse randomisation. That is, MCH nurse intervention teams in MOSAIC would become comparison teams in the MOVE study and vice versa.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation. MCH nurse teams were randomised according to numbers of births in the LGA as outlined in MOSAIC. We have reversed the randomisation outcome for this study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Teams have been allocated to either implement the new 'enhanced' model of care with comparison teams allocated to 'usual care' - that is, identification of clients as usual and referral to community based agencies if necessary.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The target sample size for women clients attending MCH centres in the eight teams was the number seen in each arm over 12 months. This was estimated to be 22,000 in either arm.
Routine data for screening, safety planning and referrals made by MCH nurses targeted the whole population of women with babies=<12 months seeing MCH nurses in the intervention period.
For the postal survey of women clients in the 8 MCH teams, we calculated that for an 8-10% IPV prevalence rate in the previous 12 months we could detect a predicted increase of 15% average disclosure taking into account the numbers of births in participating councils, the likely response fraction (55-65%) and also adjusted for an intra-cluster correlation of 0.02. Analysis using
multivariable logistic regression adjusted for cluster

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/06/2009
Actual
30/06/2009
Date of last participant enrolment
Anticipated
30/06/2009
Actual
30/06/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
44000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1582 0
3018
Recruitment postcode(s) [2] 1583 0
3337
Recruitment postcode(s) [3] 1584 0
3058
Recruitment postcode(s) [4] 1585 0
3011
Recruitment postcode(s) [5] 1586 0
3072
Recruitment postcode(s) [6] 1587 0
3083
Recruitment postcode(s) [7] 1588 0
3121
Recruitment postcode(s) [8] 1589 0
3021

Funding & Sponsors
Funding source category [1] 4761 0
Government body
Name [1] 4761 0
Australian Research Council
Country [1] 4761 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
BUNDOORA VIC 3083
Country
Australia
Secondary sponsor category [1] 4299 0
University
Name [1] 4299 0
Department of Social Work, University of Melbourne
Address [1] 4299 0
MELBOURNE VIC 3010
Country [1] 4299 0
Australia
Other collaborator category [1] 634 0
Individual
Name [1] 634 0
Professor Angela Taft
Address [1] 634 0
Judith Lumley Centre
215 Franklin Street
Melbourne, VIC 3000
Country [1] 634 0
Australia
Other collaborator category [2] 635 0
Individual
Name [2] 635 0
Professor Rhonda Small
Address [2] 635 0
Judith Lumley Centre
215 Franklin Street
Melbourne, VIC 3000
Country [2] 635 0
Australia
Other collaborator category [3] 636 0
Individual
Name [3] 636 0
Professor Cathy Humphreys
Address [3] 636 0
Alfred Felton Chair in Child and Family Welfare Social Work
University of Melbourne
Melbourne Victoria 3010
Country [3] 636 0
Australia
Other collaborator category [4] 637 0
Individual
Name [4] 637 0
Professor Kelsey Hegarty
Address [4] 637 0
Department of General Practice
University of Melbourne
PARKVILLE VIC 3053
Country [4] 637 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6808 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 6808 0
Ethics committee country [1] 6808 0
Australia
Date submitted for ethics approval [1] 6808 0
Approval date [1] 6808 0
30/10/2008
Ethics approval number [1] 6808 0
1/08/0142

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 200 200 0 0
/AnzctrAttachments/83794-Protocol091.pdf

Contacts
Principal investigator
Name 29473 0
Prof Angela Taft
Address 29473 0
Judith Lumley Centre
215 Franklin St , Melbourne
VIC 3000
Country 29473 0
Australia
Phone 29473 0
61 3 9479 8809
Fax 29473 0
Email 29473 0
[email protected]
Contact person for public queries
Name 12720 0
Angela taft
Address 12720 0
Judith Lumley Centre
215 Franklin St , Melbourne
VIC 3000
Country 12720 0
Australia
Phone 12720 0
61 3 9479 8809
Fax 12720 0
NA
Email 12720 0
[email protected]
Contact person for scientific queries
Name 3648 0
Dr Angela Taft
Address 3648 0
Judith Lumley Centre
215 Franklin St , Melbourne
VIC 3000
Country 3648 0
Australia
Phone 3648 0
61 3 9479 8809
Fax 3648 0
+61 3 8341 8555
Email 3648 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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