NCT00182468

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,681

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

September 9, 2009

Status Verified

September 1, 2009

Enrollment Period

3.3 years

First QC Date

September 13, 2005

Last Update Submit

September 8, 2009

Conditions

Keywords

Domestic violenceSpouse Abuse

Outcome Measures

Primary Outcomes (3)

  • Recurrence of intimate partner violence

    18 months

  • Health-specific quality of life

    18 months

  • Harms of screening and/or usual care

    18 months

Secondary Outcomes (8)

  • Mental health (depression, post-traumatic stress disorder [PTSD], anxiety, somatic complaints, substance use)

    18 months

  • Global physical and emotional health and well-being

    18 months

  • Health services utilization

    18 months

  • Safety behaviours

    18 months

  • Use of information and resources

    18 months

  • +3 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Women are screened for intimate partner violence prior to seeing a health care provider.

Other: Screening for intimate partner violence

2

NO INTERVENTION

Women see their health care provider without being asked about intimate partner violence.

Interventions

Women are screened for intimate partner violence prior to seeing a health care provider.

1

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 18-64 years
  • Patients at the health care site
  • Able to participate in English
  • Able to separate from accompanying person(s)

You may not qualify if:

  • Too ill to participate
  • Unable to separate from accompanying person(s)
  • Unable to speak, read, or write English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Brantford Aboriginal Health Centre

Brantford, Ontario, N3T 3C4, Canada

Location

Joseph Brant Hospital

Burlington, Ontario, L7R 4C4, Canada

Location

Sudbury Family Physicians

Greater Sudbury, Ontario, P3B 1R6, Canada

Location

Sudbury Brady Clinic

Greater Sudbury, Ontario, P3E 1H5, Canada

Location

Sudbury District Health Unit

Greater Sudbury, Ontario, P3E 3A3, Canada

Location

Hopital Regional de Sudbury Regional Hospital, Emergency Services

Greater Sudbury, Ontario, P3E 3B5, Canada

Location

Grimsby Medical Associates

Grimsby, Ontario, L3M 1P2, Canada

Location

West Lincoln Memorial Hospital

Grimsby, Ontario, L3M 1P3, Canada

Location

St. Joseph's Centre for Ambulatory Health Services

Hamilton, Ontario, L8G 5E4, Canada

Location

Rosedale Medical Group

Hamilton, Ontario, L8K 1W2, Canada

Location

North Hamilton Community Health Centre

Hamilton, Ontario, L8L 4S1, Canada

Location

Aboriginal Health Centre

Hamilton, Ontario, L8M 1K2, Canada

Location

McMaster University Medical Centre

Hamilton, Ontario, L8N 3Z5, Canada

Location

Hamilton Urban Core Community Health Centre

Hamilton, Ontario, L8R 1B6, Canada

Location

City of Hamilton Public Health and Community Services Department

Hamilton, Ontario, L8R 3L5, Canada

Location

West End Clinic

Hamilton, Ontario, L8S 1A4, Canada

Location

HART Clinic

Hamilton, Ontario, L8S 1B7, Canada

Location

Victoria Hospital

London, Ontario, N6A 4G5, Canada

Location

St. Joseph's Health Care - Women's Ambulatory Health Centre

London, Ontario, N6A 4V2, Canada

Location

St. Joseph's Urgent Care

London, Ontario, N6A 4V2, Canada

Location

University Hospital

London, Ontario, N6A 5A5, Canada

Location

London Family Practice - Dr. Bhayana

London, Ontario, N6A 5R9, Canada

Location

St. Joseph's Family Medical & Dental Centre

London, Ontario, N6G 1J1, Canada

Location

Willett Hospital Urgent Care

Paris, Ontario, N3L 2N7, Canada

Location

Niagara Health Prompt Care

St. Catharines, Ontario, L2R 5K2, Canada

Location

Mt. Sinai Hospital, Obstetrics & Gynecology Clinic

Toronto, Ontario, L8G 5E4, Canada

Location

Mt. Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Central Toronto Community Health Centre

Toronto, Ontario, M5V 2R4, Canada

Location

Related Publications (1)

  • 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. doi: 10.1001/jama.2009.1089.

MeSH Terms

Interventions

Mass Screening

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • Harriet L MacMillan, MD, MSc

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

April 1, 2005

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

September 9, 2009

Record last verified: 2009-09

Locations