Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000032358
Ethics application status
Approved
Date submitted
11/01/2008
Date registered
21/01/2008
Date last updated
20/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Women's Evaluation of Abuse and Violence Care in General Practice: a Cluster Randomised Controlled Trial (weave)
Scientific title
weave: a trial of a general practice intervention involving screening with feedback, education for health practitioners and counselling for patients to increase safety planning and behaviour, quality of life, and mental health in women who experience partner abuse, compared to usual care.
Secondary ID [1] 252529 0
None
Universal Trial Number (UTN)
Trial acronym
weave
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intimate partner abuse (IPA) 2703 0
Condition category
Condition code
Mental Health 2825 2825 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
20000 women (16-50 years) from 40 general practices (500 per practice) in Victoria, Australia, will be mailed a screening survey. Women who screen positive to being ‘afraid’ of their partner or ex-partner in the last 12 months will be invited to the next [intervention] stage of the project. The intervention will be multifacted and practice-based involving a professional, patient-oriented and organisational component. For GPs there will be 8 hour training program involving feedback based on the screening of their patients, training in guidelines for IPA management, long-distance education as well as interactive training sessions using simulated patients to improve counselling skills. The patients will subsequently receive 3-6 sessions of brief counselling from their GP. Each session will be 30 minutes in duration and conducted over the phone or on a one-to-one basis. Patients will be surveyed at baseline and then followed for one year after the invitation for counselling from the GP with surveys at 6 and 12 months. The final element of the intervention involves organisational change to promote awareness about IPA throughout the practice through pamphlets and posters.
Intervention code [1] 2440 0
Treatment: Other
Intervention code [2] 2441 0
Behaviour
Comparator / control treatment
A basic IPA education kit is provided to GPs and women attend their GP as usual (no intervention) - GPs will not be aware of which women are participating in the trial. The comparator observation period is 12 months in duration, commencing from when the invitation to GP counselling is sent to women in the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 3707 0
Safety planning and behaviour measured using the Safety-Promoting Behaviours Checklist (McFarlane et al., 2002)
Timepoint [1] 3707 0
Baseline and 6 and 12 months post-intervention
Primary outcome [2] 3708 0
Quality of life (WHO QOL Bref; Skevington, Lofty, O'Connell, 2004)
Timepoint [2] 3708 0
Baseline; 6 months; 12 months; 24 months
Primary outcome [3] 3709 0
Mental health status (SF-12; Ware et al, 1996)
Timepoint [3] 3709 0
Baseline; 6 months; 12 months; 24 months
Secondary outcome [1] 6251 0
Practitioner inquiry about safety of women and children (Yes/No)
Timepoint [1] 6251 0
Baseline; 6 months; 12 months
Secondary outcome [2] 6252 0
Preparedness to change with regard to abuse (Domestic Violence Survivor Assessment; Dienmann et al., 2002)
Timepoint [2] 6252 0
Baseline; 6 months; 12 months
Secondary outcome [3] 6253 0
Women's comfort to discuss abuse with practitioner (Item about comfort to discuss abuse using 5-point likert scale)
Timepoint [3] 6253 0
Baseline; 6 months; 12 months
Secondary outcome [4] 6254 0
Cost effectiveness (Number of visits to health professionals; hospital admissions; days out of role due to physical/emotional problems and SF-12(Ware et al., 1996)
Timepoint [4] 6254 0
Baseline; 6 months; 12 months; 24 months
Secondary outcome [5] 6265 0
Psychological distress (Hospital Anxiety and Depression Scale; Zigmond & Snaith, 1983)
Timepoint [5] 6265 0
Baseline; 6 months; 12 months; 24 months
Secondary outcome [6] 298419 0
PTSD, substance use and other mental disorders (PRIME-MD; Spitzer, Kroenke, Williams, 1999)
Timepoint [6] 298419 0
24 month
Secondary outcome [7] 298420 0
Intimate partner violence (Composite Abuse Scale, Hegarty, Bush, Sheehan, 2005)
Timepoint [7] 298420 0
24 month
Secondary outcome [8] 298421 0
Harm (Consequences of Screening Tool; Lock, 2008)
Timepoint [8] 298421 0
24 months
Secondary outcome [9] 298422 0
Physical health (SF-12)
Timepoint [9] 298422 0
24 month
Secondary outcome [10] 298423 0
Physical symptoms (>5 in the last month; adapted from Web Study, Hegarty, Gunn, Chondros, Taft, 2008)
Timepoint [10] 298423 0
24 month

Eligibility
Key inclusion criteria
GP participants must practice in urban or rural areas Victoria, Australia within 150km of Melbourne; have at least 200 women aged 16-50 years that they saw in the last 12 months; use computerised patient registers. To be eligible for screening, patient participants must be female; aged 16-50 years; and have seen the participating GP in the previous 12 months. Women who indicate in the screening survey that they have been afraid of their partner/ex-partner in the previous 12 months and who would like to hear more about the weave project will be eligible for the intervention stage of the study. These women will be contacted by phone based on the information they provided in the survey and invited to participate.
Minimum age
16 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
GPs: GPs who have a majority of non-English speaking patients or who have not worked at the practice in the last year are excluded. Patients with severe mental or physical health problems, severe learning disabilities or poor comprehension of English language compromising capacity to provide informed consent are excluded or where women are no longer attending that GP/have moved away from the locality.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
GPs will be recruited through a letter of invite followed up by a phone call. For each participating practitioner, a list of patients who meet inclusion criteria will be randomly generated. In conjunction with the GP, research staff will identify women on that list who meet exclusion criteria. Between 200 and 600 women per GP will be mailed the screening survey. At the end of the screening survey respondents will be asked if they would like to participate further in a study to explore “the care that women receive from GPs when they are experiencing depression, domestic violence or stress and worry.” Women eligible for the intervention stage based on the screen will be contacted by phone. Those willing to participate in the project will be sent the baseline survey. Allocation of GPs to the intervention or comparison group will be concealed and achieved by contacting the holder of the allocation schedule at a central administration site. GPs will subsequently be informed of their allocation. The allocation of the GP will dictate whether women participants are in the intervention or comparison arm of the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
To help ensure comparability of the intervention and comparison clusters with respect to cluster characteristics, the GPs will be stratified according to whether they are i) solo or group and ii) based in urban or rural location and iii) a PN or GP delivering the intervention. This stratified allocation will create six strata to be incorporated in generating the randomisation schedule. Randomisation will be performed by a statistician not directly involved in the study and who is blind to the identity of the practitioners.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
21/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2957 0
Government body
Name [1] 2957 0
National Health & Medical Research Council
Country [1] 2957 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Kelsey Hegarty
Address
Dept of General Practice
University of Melbourne
200 Berkeley Street
Carlton Vic 3053
Country
Australia
Secondary sponsor category [1] 2670 0
Individual
Name [1] 2670 0
Professor Jane Gunn
Address [1] 2670 0
Dept of General Practice
University of Melbourne
200 Berkeley Street
Carlton Vic 3053
Country [1] 2670 0
Australia
Secondary sponsor category [2] 2696 0
Individual
Name [2] 2696 0
Dr Lorna Jane O'Doherty
Address [2] 2696 0
Dept of General Practice
University of Melbourne
200 Berkeley Street
Carlton Vic 3053
Country [2] 2696 0
Australia
Other collaborator category [1] 135 0
Individual
Name [1] 135 0
Associate Professor
Address [1] 135 0
School of Public Health, Latrobe University
Country [1] 135 0
Australia
Other collaborator category [2] 136 0
Individual
Name [2] 136 0
Professor Gene Feder
Address [2] 136 0
Bristol University
Country [2] 136 0
United Kingdom
Other collaborator category [3] 137 0
Individual
Name [3] 137 0
Professor Jill Astbury
Address [3] 137 0
Monash University
Country [3] 137 0
Australia
Other collaborator category [4] 138 0
Individual
Name [4] 138 0
Associate Professor Stephanie Brown
Address [4] 138 0
Murdoch Children's Research Institute, University of Melbourne
Country [4] 138 0
Australia
Other collaborator category [5] 139 0
Individual
Name [5] 139 0
Dr Lisa Gold
Address [5] 139 0
Deakin Health Economics Unit, Deakin University
Country [5] 139 0
Australia
Other collaborator category [6] 140 0
Individual
Name [6] 140 0
Dr Patty Chondros
Address [6] 140 0
Primary Care Research Unit, Dept. of General Practice, University of Melbourne
Country [6] 140 0
Australia
Other collaborator category [7] 141 0
Individual
Name [7] 141 0
Prof Ann Taket
Address [7] 141 0
School of Health and Social Development, Deakin University
Country [7] 141 0
Australia
Other collaborator category [8] 142 0
Individual
Name [8] 142 0
Dr David Pierce
Address [8] 142 0
Primary care research unit, University of Melbourne
Country [8] 142 0
Australia
Other collaborator category [9] 143 0
Individual
Name [9] 143 0
Assoc Professor Rhian Parker
Address [9] 143 0
Australia National University
Country [9] 143 0
Australia
Other collaborator category [10] 144 0
Individual
Name [10] 144 0
Professor Sandra Eldridge
Address [10] 144 0
Centre for Health Sciences, Queen Marys, University of London
Country [10] 144 0
United Kingdom
Other collaborator category [11] 276958 0
Individual
Name [11] 276958 0
Associate Professor Angela Taft
Address [11] 276958 0
Mother and Child Health Research, La Trobe University, 215 Franklin St, Melbourne, VIC 3000
Country [11] 276958 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4898 0
Human Research Ethics Committee, University of Melbourne
Ethics committee address [1] 4898 0
Ethics committee country [1] 4898 0
Australia
Date submitted for ethics approval [1] 4898 0
Approval date [1] 4898 0
04/09/2007
Ethics approval number [1] 4898 0
0717042

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

Contacts
Principal investigator
Name 28290 0
Address 28290 0
Country 28290 0
Phone 28290 0
Fax 28290 0
Email 28290 0
Contact person for public queries
Name 11447 0
Dr Lorna Jane O'Doherty
Address 11447 0
Dept of General Practice
University of Melbourne
200 Berkeley Street
Carlton Vic 3053
Country 11447 0
Australia
Phone 11447 0
03-8344 3369
Fax 11447 0
03-9347 6136
Email 11447 0
[email protected]
Contact person for scientific queries
Name 2375 0
Dr Lorna Jane O'Doherty
Address 2375 0
Dept of General Practice
University of Melbourne
200 Berkeley Street
Carlton Vic 3053
Country 2375 0
Australia
Phone 2375 0
03-8344 3369
Fax 2375 0
03-9347 6136
Email 2375 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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTwo-year follow up of a cluster randomised controlled trial for women experiencing intimate partner violence: Effect of screening and family doctor-delivered counselling on quality of life, mental and physical health and abuse exposure.2020https://dx.doi.org/10.1136/bmjopen-2019-034295
N.B. These documents automatically identified may not have been verified by the study sponsor.