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Trial registered on ANZCTR


Registration number
ACTRN12618001845224
Ethics application status
Approved
Date submitted
16/10/2018
Date registered
13/11/2018
Date last updated
19/07/2022
Date data sharing statement initially provided
13/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
HARMONY - A randomised controlled trial of a GP systems intervention for family violence experienced by South Asian migrant and refugee women and children in Melbourne, Australia..
Scientific title
HARMONY - A cluster randomised controlled trial of a whole of general practice intervention to prevent and reduce domestic violence among migrant and refugee communities.
Secondary ID [1] 295947 0
Nil known.
Universal Trial Number (UTN)
U1111-1219-6571
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Family violence 309506 0
Intimate partner violence 310070 0
Domestic violence 310071 0
Condition category
Condition code
Public Health 308340 308340 0 0
Health service research
Public Health 308902 308902 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Practices in the intervention arm of the study will undergo specialised family violence training co-facilitated by a GP trainer and a bilingual/bicultural South Asian family violence caseworker/advocate, based with and managed by an immigrant women's domestic violence service. The training, developed with University of Melbourne Department of General Practice, will all be delivered online by a GP educator and the caseworker/advocate, for which we have RACGP accreditation, will include 3 sessions of 90 minute training (altered because of COVID) (comprising short lectures, role play simulation and discussions, delivered ~four to eight weeks apart), plus resources (including online modules, information pages and videos accessible during training and after as required), reinforced by 3 opportunities over the intervention year for a teleconference/webinar case discussion. As part of accreditation, training must be delivered in different formats for which self-access resources will be made available on the RACGP website, University of Melbourne and HARMONY websites. This RACGP site requires login to access online resources. The training will teach clinicians cultural competency to: identify family violence symptoms; ask and respond to women with indicators of family violence sensitively; develop women-centred goals appropriate to women's readiness to make changes; motivational interviewing; trauma-informed care; discuss strategies to improve safety; document both ethnicity and family violence accurately on common GP routine software (Best Practice and Medical Director); and to refer women to support services. Training also includes how to refer affected children (and abusive partners) to available services. All intervention administrative staff will be trained about patient safety and confidentiality, supportive responses and culturally safe clinic environments. In addition we train all clinic staff on entering routine ethnicity data depending on software (Medical Director or Best Practice, that covers 80% of all Australian practices) .

The caseworker/advocate will continue to provide support throughout the year long intervention through: (i) weekly or fortnightly visits with intervention GP clinics for consultation and to provide feedback at clinic meetings; (ii) providing casework support (as per inTouch (Multicultural Centre Against Family Violence) standard family violence casework practice for women referred to In Touch; (iii) accurately record and feedback casework data on referral rates to intervention practices; and (iv) providing ad hoc secondary phone consultation with intervention clinicians about patient cases and referral.
The training extends those developed by Kelsey Hegarty at PHCRU, University of Melbourne, in the IRIS trial of Gene Feder and colleagues at Bristol Uni, together with contributions by Angela Taft at La Trobe University and In Touch. HARMONY training however, focuses specifically on cultural safety and competency and has developed new material to this end.
Intervention code [1] 312679 0
Other interventions
Comparator / control treatment
Comparison staff training in recording ethnicity and family violence data (identification, safety planning and referral) will also now be delivered online (approx. 30 minutes). They will still be offered the full training at the end of the intervention period, now estimated to be early in 2022.
Control group
Active

Outcomes
Primary outcome [1] 307323 0
Recorded identification of family violence (violence and abuse from partners and/or other family members) of all women including south Asian women, aged 16 years and over on routine GP software of intervention compared with comparison clinics. (Composite primary outcome)
Timepoint [1] 307323 0
and 15 months after commencement of intervention.
Primary outcome [2] 307325 0
Number of referrals of all affected women including south Asian women, from intervention compared with comparison clinics to inTouch immigrant domestic violence service. (Composite primary outcome). We will also use routine GP software data extracted from clinic databases from referrals, as well as rates of safety planning.
Timepoint [2] 307325 0
Baseline, 6 months into intervention, 12 months post-commencement of intervention and 15 months
Secondary outcome [1] 352950 0
Recorded safety planning by GPs in intervention clinics compared with comparison clinics for all women including south Asian women, experiencing family violence. Anonymised data will collected from medical records using the GrHanite software tool. (Composite secondary outcome)
Timepoint [1] 352950 0
Baseline, 6 months into intervention, 12 months and 15 months post-commencement of intervention
Secondary outcome [2] 352951 0
The cost effectiveness of the intervention compared with comparison arm. This will be calculated by measuring cost of the intervention per case of family violence identified, and the cost of the intervention per woman referred to a family violence caseworker/advocate and will be computed from the provider perspective. The cost of the intervention includes the costs of the GP training, best estimate time required for GP consultation plus program costs associated with provision of advocacy services (staff time, travel and office costs). These costs will be collected using our own study-specific forms. Data on the number of consultations, length and type of consultation will be imputed through extraction via the GrHanite tool,
Timepoint [2] 352951 0
12 months post-commencement of intervention

Eligibility
Key inclusion criteria
The inclusion criteria are: a.the GP practice employs at least 1 South Asian bilingual/bicultural GP; b. the practice uses one of two of the most common software programs in Australia (viz., Medical Director or Best Practice) and agrees to the online software program GrHanite(TM) being installed onto their computers to extract anonymised aggregated outcome data.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
General practices that do not contain GPs of background of interest (South Asian background) and practices that do not have the medical software - Medical Director or Best Practice and do not agree to install GrHanite™ onto their computers

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 will be determined by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be by minimisation, but as well as stratification for region (SE or NW), using clinic size (the numbers of doctors in the practice - small 5 or fewer doctors and large six or more) and SEIFA index for clinic postcode (1- 5 classified as 'lower' and 6 or more as 'higher'), to minimise confounding by these effects.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on our own feasibility study and outcomes achieved in a UK domestic violence intervention study - IRIS - we estimate that the rate of domestic violence identification will be 5 women per 1000 in the control arm. To detect an increase in the identification or referral rate to 20 women per 1000 with 90% power and a significance level of 5%, 873 person-years per arm would be required with individual randomisation. This sample size was inflated to account for the cluster design; assuming an intra-cluster coefficient of 0.01, and any cluster size from 2000-3000 person-years per clinic (based on conservative mean size of the GP female populations in our feasibility study). With these estimations, we require 28 clinics (allowing for a 21% drop out to 22 clusters).

Analysis will be conducted by a statistician blinded to status using an intention-to-treat model. The number of referrals (from clinic and partner inTouch data) and documented identification rate of women 16 years and over, for every cluster will be the independent variables. A Poisson regression model will include the number of women per practice as the exposure variable and GP clinic as the random effect to take account of clustering. Models will adjust for any randomisation imbalance in key factors or confounders.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
15/01/2019
Actual
27/02/2019
Date of last participant enrolment
Anticipated
30/06/2022
Actual
30/10/2020
Date of last data collection
Anticipated
30/09/2022
Actual
Sample size
Target
28
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 23877 0
3029 - Hoppers Crossing
Recruitment postcode(s) [2] 23878 0
3029 - Tarneit
Recruitment postcode(s) [3] 23879 0
3029 - Truganina
Recruitment postcode(s) [4] 23880 0
3030 - Point Cook
Recruitment postcode(s) [5] 23881 0
3024 - Wyndham Vale
Recruitment postcode(s) [6] 23882 0
3976 - Hampton Park
Recruitment postcode(s) [7] 23883 0
3977 - Cranbourne East
Recruitment postcode(s) [8] 23884 0
3977 - Cranbourne North
Recruitment postcode(s) [9] 23885 0
3806 - Berwick
Recruitment postcode(s) [10] 23886 0
3805 - Narre Warren South
Recruitment postcode(s) [11] 23887 0
3174 - Noble Park
Recruitment postcode(s) [12] 23888 0
3175 - Dandenong
Recruitment postcode(s) [13] 23889 0
3175 - Dandenong North
Recruitment postcode(s) [14] 23890 0
3171 - Springvale
Recruitment postcode(s) [15] 23891 0
3173 - Keysborough
Recruitment postcode(s) [16] 23892 0
3075 - Lalor
Recruitment postcode(s) [17] 23893 0
3076 - Epping
Recruitment postcode(s) [18] 23894 0
3750 - Wollert
Recruitment postcode(s) [19] 23895 0
3752 - South Morang
Recruitment postcode(s) [20] 23896 0
3074 - Thomastown
Recruitment postcode(s) [21] 23897 0
3150 - Glen Waverley
Recruitment postcode(s) [22] 23898 0
3150 - Wheelers Hill
Recruitment postcode(s) [23] 23899 0
3168 - Clayton
Recruitment postcode(s) [24] 23900 0
3149 - Mount Waverley
Recruitment postcode(s) [25] 23901 0
3170 - Mulgrave
Recruitment postcode(s) [26] 23902 0
3021 - St Albans
Recruitment postcode(s) [27] 23903 0
3037 - Sydenham
Recruitment postcode(s) [28] 23904 0
3023 - Deer Park
Recruitment postcode(s) [29] 23905 0
3020 - Sunshine
Recruitment postcode(s) [30] 23906 0
3020 - Sunshine West
Recruitment postcode(s) [31] 32295 0
3340 - Bacchus Marsh

Funding & Sponsors
Funding source category [1] 300542 0
Government body
Name [1] 300542 0
NHMRC Partnerships for Health Project
Country [1] 300542 0
Australia
Funding source category [2] 300591 0
Government body
Name [2] 300591 0
Commonwealth Department of Social Services (Family Safety Unit)
Country [2] 300591 0
Australia
Funding source category [3] 300592 0
Government body
Name [3] 300592 0
Multicultural Affairs and Social Cohesion Division, Victorian Department of Premier and Cabinet
Country [3] 300592 0
Australia
Primary sponsor type
Individual
Name
Prof Angela Taft
Address
Judith Lumley Centre, L3, George Singer Building, La Trobe University, Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 300027 0
Individual
Name [1] 300027 0
Prof Kelsey Hegarty
Address [1] 300027 0
Department of General Practice, University of Melbourne, 200 Berkeley Street, Carlton VIC 3053
Country [1] 300027 0
Australia
Secondary sponsor category [2] 300085 0
Individual
Name [2] 300085 0
A/Prof Jane Yelland
Address [2] 300085 0
Murdoch Children's Research Institute, Royal Children's Hospital, Flemington Road, Parkville VIC 3052
Country [2] 300085 0
Australia
Secondary sponsor category [3] 300086 0
Individual
Name [3] 300086 0
Prof Danielle Mazza
Address [3] 300086 0
Department of General Practice, Monash University, Bld 1, 270 Ferntree Gully Road, Notting Hill VIC 3168
Country [3] 300086 0
Australia
Secondary sponsor category [4] 300087 0
Individual
Name [4] 300087 0
Associate Professor Richard Norman
Address [4] 300087 0
School of Public Health, Curtin University, Perth, Western Australia
Country [4] 300087 0
Australia
Secondary sponsor category [5] 300088 0
Individual
Name [5] 300088 0
Prof Gene Feder
Address [5] 300088 0
University of Bristol, 39 Whatley Street, Bristol BS8 2PS
Country [5] 300088 0
United Kingdom
Secondary sponsor category [6] 300089 0
Individual
Name [6] 300089 0
Dr Claudia Garcia-Moreno
Address [6] 300089 0
Department of Reproductive Health and Research, WHO, Avenue Appia 20
1202 Geneva
Country [6] 300089 0
Switzerland
Secondary sponsor category [7] 300090 0
Individual
Name [7] 300090 0
A/Prof Douglas Boyle
Address [7] 300090 0
HaBIC, 200 Berkeley Street, Carlton VIC 3053
Country [7] 300090 0
Australia
Secondary sponsor category [8] 300091 0
Individual
Name [8] 300091 0
Dr Cattram Nguyen
Address [8] 300091 0
Murdoch Children's Research Institute, Royal Children's Hospital, Flemington Road, Parkville VIC 3052
Country [8] 300091 0
Australia
Other collaborator category [1] 280335 0
Individual
Name [1] 280335 0
Ms Ruth Fox
Address [1] 280335 0
in Touch Multicultural Centre Against Family Violence, GPO Box 2905, Melbourne VIC 3001
Country [1] 280335 0
Australia
Other collaborator category [2] 280336 0
Individual
Name [2] 280336 0
Alexis Diamond
Address [2] 280336 0
Family Safety Branch, Commonwealth Department of Social Services, GPO Box 9820, Canberra ACT 2601
Country [2] 280336 0
Australia
Other collaborator category [3] 280337 0
Individual
Name [3] 280337 0
Dana Krause
Address [3] 280337 0
Multicultural Affairs and Social Cohesion Division, Victorian Department of Premier and Cabinet, 1 Spring Street, Melbourne VIC 3000
Country [3] 280337 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301338 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 301338 0
Ethics committee country [1] 301338 0
Australia
Date submitted for ethics approval [1] 301338 0
10/09/2018
Approval date [1] 301338 0
13/12/2018
Ethics approval number [1] 301338 0
HEC18413

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

Contacts
Principal investigator
Name 86662 0
Prof Angela Taft
Address 86662 0
Judith Lumley Centre, L3, George Singer Building, La Trobe University, Bundoora VIC 3086
Country 86662 0
Australia
Phone 86662 0
61 3 9479 8809
Fax 86662 0
Email 86662 0
A.Taft@latrobe.edu.au
Contact person for public queries
Name 86663 0
Angela Taft
Address 86663 0
Judith Lumley Centre, L3, George Singer Building, La Trobe University, Plenty Rd and Kingsbury Dr, Bundoora VIC 3086
Country 86663 0
Australia
Phone 86663 0
61 3 9479 8809
Fax 86663 0
Email 86663 0
A.Taft@latrobe.edu.au
Contact person for scientific queries
Name 86664 0
Angela Taft
Address 86664 0
Judith Lumley Centre, L3, George Singer Building, La Trobe University, Plenty Rd and Kingsbury Dr, Bundoora VIC 3086
Country 86664 0
Australia
Phone 86664 0
61 3 9479 8809
Fax 86664 0
Email 86664 0
A.Taft@latrobe.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
This study will not be collecting individual participant data. This study will be collecting summary data from each participant practice. It is yet to be decided whether this will be shared.


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24380Study protocol    375901-(Uploaded-03-12-2024-17-15-23)-Final BMJ Open HARMONY protocol 2021.pdf
24381Statistical analysis plan    375901-(Uploaded-03-12-2024-17-16-10)-SAP May 2022_FINAL_SIGNED_31.05.22.pdf

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHARMONY: A pragmatic cluster randomised controlled trial of a culturally competent systems intervention to prevent and reduce domestic violence among migrant and refugee families in general practice: Study protocol.2021https://dx.doi.org/10.1136/bmjopen-2020-046431
N.B. These documents automatically identified may not have been verified by the study sponsor.