Does Routine Screening for Intimate Partner Violence Against Women in Health Care Settings do More Good Than Harm? - Full Text View

Sponsor:	McMaster University
Collaborator:	Echo: Improving Women's Health in Ontario (formerly Ontario Women's Health Council)
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00182468

Purpose

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.

Condition	Intervention
Intimate Partner Violence Against Women	Other: Screening for intimate partner violence

Study Type:	Interventional
Study Design:	Screening, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	If, When and How to Ask the Question(s): Assessing Screening Approaches to Identifying Woman Abuse in Health Care Settings

Further study details as provided by McMaster University:

Primary Outcome Measures:

Recurrence of intimate partner violence [ Time Frame: 18 months ]
Health-specific quality of life [ Time Frame: 18 months ]
Harms of screening and/or usual care [ Time Frame: 18 months ]

Secondary Outcome Measures:

Mental health (depression, post-traumatic stress disorder [PTSD], anxiety, somatic complaints, substance use) [ Time Frame: 18 months ]
Global physical and emotional health and well-being [ Time Frame: 18 months ]
Health services utilization [ Time Frame: 18 months ]
Safety behaviours [ Time Frame: 18 months ]
Use of information and resources [ Time Frame: 18 months ]
Child quality of life [ Time Frame: 18 months ]
Stage in process of identifying and resolving abuse [ Time Frame: 18 months ]
Exposure to maltreatment as a child [ Time Frame: 18 months ]

Enrollment:	5681
Study Start Date:	April 2005
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Women are screened for intimate partner violence prior to seeing a health care provider.	Other: Screening for intimate partner violence Women are screened for intimate partner violence prior to seeing a health care provider.
2: No Intervention Women see their health care provider without being asked about intimate partner violence.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182468

Locations

Canada, Ontario
Joseph Brant Hospital
Burlington, Ontario, Canada, L7R 4C4
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
Aboriginal Health Centre
Hamilton, Ontario, Canada, L8M 1K2
West Lincoln Memorial Hospital
Grimsby, Ontario, Canada, L3M 1P3
Sudbury Family Physicians
Sudbury, Ontario, Canada, P3B 1R6
North Hamilton Community Health Centre
Hamilton, Ontario, Canada, L8L 4S1
St. Joseph's Family Medical & Dental Centre
London, Ontario, Canada, N6G 1J1
HART Clinic
Hamilton, Ontario, Canada, L8S 1B7
City of Hamilton Public Health and Community Services Department
Hamilton, Ontario, Canada, L8R 3L5
Sudbury District Health Unit
Sudbury, Ontario, Canada, P3E 3A3
Hopital Regional de Sudbury Regional Hospital, Emergency Services
Sudbury, Ontario, Canada, P3E 3B5
Mt. Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Niagara Health Prompt Care
St. Catharines, Ontario, Canada, L2R 5K2
St. Joseph's Urgent Care
London, Ontario, Canada, N6A 4V2
Willett Hospital Urgent Care
Paris, Ontario, Canada, N3L 2N7
Victoria Hospital
London, Ontario, Canada, N6A 4G5
Brantford Aboriginal Health Centre
Brantford, Ontario, Canada, N3T 3C4
Central Toronto Community Health Centre
Toronto, Ontario, Canada, M5V 2R4
Grimsby Medical Associates
Grimsby, Ontario, Canada, L3M 1P2
Hamilton Urban Core Community Health Centre
Hamilton, Ontario, Canada, L8R 1B6
London Family Practice - Dr. Bhayana
London, Ontario, Canada, N6A 5R9
Rosedale Medical Group
Hamilton, Ontario, Canada, L8K 1W2
Sudbury Brady Clinic
Sudbury, Ontario, Canada, P3E 1H5
West End Clinic
Hamilton, Ontario, Canada, L8S 1A4
St. Joseph's Health Care - Women's Ambulatory Health Centre
London, Ontario, Canada, N6A 4V2
Mt. Sinai Hospital, Obstetrics & Gynecology Clinic
Toronto, Ontario, Canada, L8G 5E4
St. Joseph's Centre for Ambulatory Health Services
Hamilton, Ontario, Canada, L8G 5E4
University Hospital
London, Ontario, Canada, N6A 5A5

Sponsors and Collaborators

McMaster University

Echo: Improving Women's Health in Ontario (formerly Ontario Women's Health Council)

Investigators

Principal Investigator:

Harriet L MacMillan, MD, MSc

McMaster University

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by McMaster University

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

MacMillan HL, Wathen CN, Jamieson E, Boyle MH, Shannon HS, Ford-Gilboe M, Worster A, Lent B, Coben JH, Campbell JC, McNutt LA; McMaster Violence Against Women Research Group. Screening for intimate partner violence in health care settings: a randomized trial. JAMA. 2009 Aug 5;302(5):493-501.

Responsible Party:	McMaster University ( Dr. Harriet L. MacMillan )
Study ID Numbers:	MacMillan_VAW_RCT
Study First Received:	September 13, 2005
Last Updated:	September 8, 2009
ClinicalTrials.gov Identifier:	NCT00182468 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by McMaster University:

Domestic violence
Spouse Abuse

ClinicalTrials.gov processed this record on February 08, 2010