Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000210471
Ethics application status
Approved
Date submitted
11/04/2007
Date registered
16/04/2007
Date last updated
30/01/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
WISE Study: Women in Safe Environments
Scientific title
The efficacy of partner violence screening and brief intervention compared to usual care in reducing violence in the three months following a healthcare visit.
Universal Trial Number (UTN)
Trial acronym
WISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Partner Violence 1737 0
Condition category
Condition code
Injuries and Accidents 1829 1829 0 0
Other injuries and accidents
Public Health 2856 2856 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive the intervention or usual care during a health care visit.

Intervention: 3-item partner violence screen (physical abuse; sexual abuse; feeling unsafe) followed by high risk assessment, brief supportive messages, partner violence information, community referral. The screen items include: Within the last year, have you been hit, slapped, kicked, or otherwise physically hurt by someone? (if so, by whom); Within the last year, has anyone forced you to have, watch or participate in any sexual activities against your will (if so, by whom); and Is there a current or past partner that is making you feel unsafe?
Intervention code [1] 1696 0
Early detection / Screening
Comparator / control treatment
Comparator: Usual care (study sites do not have a partner violence inquiry policy)
Control group
Active

Outcomes
Primary outcome [1] 2560 0
Partner violence (Composite Abuse Scale)
Timepoint [1] 2560 0
Three months post-intervention
Secondary outcome [1] 4407 0
General Health and Well-Being (Short Form Survey; IQOLA SF-12v2 Standard, English New Zealand)
Timepoint [1] 4407 0
Three months post-intervention
Secondary outcome [2] 4408 0
General Health change from Baseline (SF-12v2)
Timepoint [2] 4408 0
Three months post-intervention
Secondary outcome [3] 4409 0
Informal and Formal Resource Use (Community Resources Checklist)
Timepoint [3] 4409 0
Three months post-intervention
Secondary outcome [4] 4410 0
Safety Behaviours (Safety Behaviours Checklist)
Timepoint [4] 4410 0
Three months post-intervention
Secondary outcome [5] 4411 0
Satisfaction with healthcare services (Primary Care Satisfaction Survey for Women)
Timepoint [5] 4411 0
Three months post-intervention
Secondary outcome [6] 4412 0
Parental stress (Parental Stress Index Short Form)
Timepoint [6] 4412 0
Three months post-intervention

Eligibility
Key inclusion criteria
There are two sites in the study: an emergency department and a general practice clinic. Emergency Department: Potential participants include women registered for care during 100 randomly selected 4 hour time blocks over a 12 week study recruitment period. General Practice Clinic (Hauora): Potential participants include all women crossing the threshold of the hauora. Includes women there for their own health care appointment, accompanying someone else for a health visit, or just stopping in (e.g. to make an appointment, pick up materials, etc). Recruitment will continue until the day in which 400 women are enrolled.
Inclusion Criteria:Non-acute (where immediate health care delivery is not a priority; in the emergency department setting triage >=3); English Speaking (able to converse and comprehend every day English); Non-impaired (able to participate in and comprehend informed consent.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclude functional or organic impairment based on self-report, chart review, or clinician assessment; Examples: acute psychosis, alcohol intoxication).

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)
Trained research assistants enrol participants, collect baseline data (demographics, potential co-variates), then opens the next sequentially numbered sealed opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A set of random treatment allocations was computer-generated separately for each study site (emergency department, general practice clinics).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Assessor of outcomes blinded to group allocation
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
16/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment outside Australia
Country [1] 511 0
New Zealand
State/province [1] 511 0

Funding & Sponsors
Funding source category [1] 1978 0
Government body
Name [1] 1978 0
Health Research Council of New Zealand (#05/283)
Country [1] 1978 0
New Zealand
Primary sponsor type
University
Name
Interdisciplinary Trauma Research Unit, Faculty of Health and Environmental Sciences, Auckland University of Technology
Address
Private Bag 92006
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 1791 0
None
Name [1] 1791 0
Nil
Address [1] 1791 0
Country [1] 1791 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3674 0
Northern X Regional Ethics Committee-Whangarei Hospital
Ethics committee address [1] 3674 0
Ethics committee country [1] 3674 0
New Zealand
Date submitted for ethics approval [1] 3674 0
Approval date [1] 3674 0
06/03/2007
Ethics approval number [1] 3674 0
NTX/07/02/013
Ethics committee name [2] 3675 0
Northern X Regional Ethics Committee-South Auckland Raukura Hauora O Tainui clinics
Ethics committee address [2] 3675 0
Ethics committee country [2] 3675 0
New Zealand
Date submitted for ethics approval [2] 3675 0
Approval date [2] 3675 0
06/03/2007
Ethics approval number [2] 3675 0
NTX/07/02/013

Summary
Brief summary
Recognizing that partner violence poses a significant health risk for women and children, professional and government organizations recommend that clients be screened for violence. Whether healthcare site-based partner violence early detection (screening) and intervention can reduce morbidity and mortality, however, remains untested.

In this study we will invite women and young persons who are healthcare clients at selected study sites to participate in a clinical randomised controlled trial (RCT) to test the efficacy of a healthcare site-based partner violence screening and intervention protocol.

Hypotheses include:
Compared to women in the usual care group, women in the screening and intervention group will, in the follow-up period, have significantly:
Less violence
More use of safety behaviours
More use of community resources
Higher self-reported general health
Higher satisfaction with healthcare services
Less parental stress

The effect of screening and intervention on violence in the follow-up period will be mediated by:
Acknowledgement of partner violence during the initial baseline healthcare visit (included in their diagnoses list)
Socioeconomic status
Problem drinking or drug use
Depression
Self-care measures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27799 0
Address 27799 0
Country 27799 0
Phone 27799 0
Fax 27799 0
Email 27799 0
Contact person for public queries
Name 10885 0
Vivien Lovell
Address 10885 0
Auckland University of Technology Faculty of Health and Environmental Sciences
Interdisciplinary Trauma Research Unit
Private Bag 92006
Auckland 1142
Country 10885 0
New Zealand
Phone 10885 0
+64 0508 AUT WISE (+64 0508 2889473)
Fax 10885 0
+64 9 9219796
Email 10885 0
vlovell@aut.ac.nz
Contact person for scientific queries
Name 1813 0
Associate Professor Jane Koziol-McLain
Address 1813 0
Auckland University of Technology Faculty of Health and Environmental Sciences
Interdisciplinary Trauma Research Unit
Private Bag 92006
Auckland 1142
Country 1813 0
New Zealand
Phone 1813 0
+64 9 9219796
Fax 1813 0
+64 9 9219796
Email 1813 0
jkoziolm@aut.ac.nz

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
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