- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00182468
Does Routine Screening for Intimate Partner Violence Against Women in Health Care Settings do More Good Than Harm?
September 8, 2009 updated by: McMaster University
If, When and How to Ask the Question(s): Assessing Screening Approaches to Identifying Woman Abuse in Health Care Settings
The purpose of the research is to evaluate whether routine screening for woman abuse in health care settings, as compared to no screening, does more good than harm.
Recent reviews have identified the need for high quality research to understand 1) the actual impact on all women of instituting mass screening procedures to identify woman abuse and 2) the extent to which early identification through screening is effective in preventing or ameliorating important outcomes.
The main outcomes for the study are reduction in violence, improvement in life quality, and potential harms of screening.
A number of secondary outcomes to help understand the process by which screening and usual care might lead to changes in the primary outcomes will also be assessed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5681
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Brantford, Ontario, Canada, N3T 3C4
- Brantford Aboriginal Health Centre
-
Burlington, Ontario, Canada, L7R 4C4
- Joseph Brant Hospital
-
Grimsby, Ontario, Canada, L3M 1P3
- West Lincoln Memorial Hospital
-
Grimsby, Ontario, Canada, L3M 1P2
- Grimsby Medical Associates
-
Hamilton, Ontario, Canada, L8N 3Z5
- McMaster University Medical Centre
-
Hamilton, Ontario, Canada, L8R 3L5
- City of Hamilton Public Health and Community Services Department
-
Hamilton, Ontario, Canada, L8G 5E4
- St. Joseph's Centre for Ambulatory Health Services
-
Hamilton, Ontario, Canada, L8K 1W2
- Rosedale Medical Group
-
Hamilton, Ontario, Canada, L8L 4S1
- North Hamilton Community Health Centre
-
Hamilton, Ontario, Canada, L8M 1K2
- Aboriginal Health Centre
-
Hamilton, Ontario, Canada, L8R 1B6
- Hamilton Urban Core Community Health Centre
-
Hamilton, Ontario, Canada, L8S 1A4
- West End Clinic
-
Hamilton, Ontario, Canada, L8S 1B7
- HART Clinic
-
London, Ontario, Canada, N6A 5A5
- University Hospital
-
London, Ontario, Canada, N6A 4G5
- Victoria Hospital
-
London, Ontario, Canada, N6A 4V2
- St. Joseph's Health Care - Women's Ambulatory Health Centre
-
London, Ontario, Canada, N6A 4V2
- St. Joseph's Urgent Care
-
London, Ontario, Canada, N6A 5R9
- London Family Practice - Dr. Bhayana
-
London, Ontario, Canada, N6G 1J1
- St. Joseph's Family Medical & Dental Centre
-
Paris, Ontario, Canada, N3L 2N7
- Willett Hospital Urgent Care
-
St. Catharines, Ontario, Canada, L2R 5K2
- Niagara Health Prompt Care
-
Sudbury, Ontario, Canada, P3B 1R6
- Sudbury Family Physicians
-
Sudbury, Ontario, Canada, P3E 1H5
- Sudbury Brady Clinic
-
Sudbury, Ontario, Canada, P3E 3A3
- Sudbury District Health Unit
-
Sudbury, Ontario, Canada, P3E 3B5
- Hopital Regional de Sudbury Regional Hospital, Emergency Services
-
Toronto, Ontario, Canada, M5G 1X5
- Mt. Sinai Hospital
-
Toronto, Ontario, Canada, L8G 5E4
- Mt. Sinai Hospital, Obstetrics & Gynecology Clinic
-
Toronto, Ontario, Canada, M5V 2R4
- Central Toronto Community Health Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women aged 18-64 years
- Patients at the health care site
- Able to participate in English
- Able to separate from accompanying person(s)
Exclusion Criteria:
- Too ill to participate
- Unable to separate from accompanying person(s)
- Unable to speak, read, or write English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Women are screened for intimate partner violence prior to seeing a health care provider.
|
Women are screened for intimate partner violence prior to seeing a health care provider.
|
No Intervention: 2
Women see their health care provider without being asked about intimate partner violence.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Recurrence of intimate partner violence
Time Frame: 18 months
|
18 months
|
Health-specific quality of life
Time Frame: 18 months
|
18 months
|
Harms of screening and/or usual care
Time Frame: 18 months
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mental health (depression, post-traumatic stress disorder [PTSD], anxiety, somatic complaints, substance use)
Time Frame: 18 months
|
18 months
|
Global physical and emotional health and well-being
Time Frame: 18 months
|
18 months
|
Health services utilization
Time Frame: 18 months
|
18 months
|
Safety behaviours
Time Frame: 18 months
|
18 months
|
Use of information and resources
Time Frame: 18 months
|
18 months
|
Child quality of life
Time Frame: 18 months
|
18 months
|
Stage in process of identifying and resolving abuse
Time Frame: 18 months
|
18 months
|
Exposure to maltreatment as a child
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Harriet L MacMillan, MD, MSc, McMaster University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Estimate)
September 9, 2009
Last Update Submitted That Met QC Criteria
September 8, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MacMillan_VAW_RCT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intimate Partner Violence Against Women
-
University of ValenciaMinisterio de Sanidad, Servicios Sociales e IgualdadRecruitingDrug Abuse | Alcohol Abuse | Intimate Partner Violence Against WomenSpain
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedDomestic Violence | Intimate Partner ViolenceUnited States
-
NMP Medical Research InstituteWarwick Research Services; Arsha Vidya Study Centre, Tamilnadu, IndiaCompletedDomestic Violence | Intimate Partner ViolenceIndia
-
Yale UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingIntimate Partner ViolenceUnited States
-
Johns Hopkins UniversityUniversity of Missouri-Columbia; Centers for Disease Control and PreventionCompletedIntimate Partner ViolenceUnited States
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedIntimate Partner ViolenceUnited States
-
Northeastern UniversityRhode Island HospitalCompleted
-
Columbia UniversityNational Institute on Drug Abuse (NIDA)Completed
-
Joanne KlevensUniversity of Michigan; The Community Health and Social Services Center, Inc.Completed
-
University of UtahCompletedDomestic Violence | Intimate Partner ViolenceUnited States
Clinical Trials on Screening for intimate partner violence
-
Medical University of South CarolinaAgency for Healthcare Research and Quality (AHRQ)Completed
-
Centers for Disease Control and PreventionHarvard UniversityCompleted
-
Emory UniversityNational AIDS Research Institute, IndiaCompleted
-
Black Hills Center for American Indian HealthYale UniversityNot yet recruitingSmoking Cessation | Cigarette Smoking
-
Emory UniversityCompletedIntimate Partner Violence | Gender Based ViolenceColombia
-
Johns Hopkins UniversityNational Institute of Nursing Research (NINR)Completed
-
The University of Texas Health Science Center,...Completed
-
VU University of AmsterdamCompletedSubstance Abuse | Domestic ViolenceNetherlands
-
Hamilton Health Sciences CorporationOntario Women's Health CouncilCompleted