Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-01-03 @ 3:14 AM
Study NCT ID:
NCT00182468
Status:
COMPLETED
Last Update Posted:
2009-09-09
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Routine Screening for Intimate Partner Violence Against Women in Health Care Settings do More Good Than Harm?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008403', 'term': 'Mass Screening'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015980', 'term': 'Public Health Practice'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5681}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-08', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2009-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of intimate partner violence', 'timeFrame': '18 months'}, {'measure': 'Health-specific quality of life', 'timeFrame': '18 months'}, {'measure': 'Harms of screening and/or usual care', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'Mental health (depression, post-traumatic stress disorder [PTSD], anxiety, somatic complaints, substance use)', 'timeFrame': '18 months'}, {'measure': 'Global physical and emotional health and well-being', 'timeFrame': '18 months'}, {'measure': 'Health services utilization', 'timeFrame': '18 months'}, {'measure': 'Safety behaviours', 'timeFrame': '18 months'}, {'measure': 'Use of information and resources', 'timeFrame': '18 months'}, {'measure': 'Child quality of life', 'timeFrame': '18 months'}, {'measure': 'Stage in process of identifying and resolving abuse', 'timeFrame': '18 months'}, {'measure': 'Exposure to maltreatment as a child', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Domestic violence', 'Spouse Abuse'], 'conditions': ['Intimate Partner Violence Against Women']}, 'referencesModule': {'references': [{'pmid': '19654384', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18-64 years\n* Patients at the health care site\n* Able to participate in English\n* Able to separate from accompanying person(s)\n\nExclusion Criteria:\n\n* Too ill to participate\n* Unable to separate from accompanying person(s)\n* Unable to speak, read, or write English'}, 'identificationModule': {'nctId': 'NCT00182468', 'briefTitle': 'Does Routine Screening for Intimate Partner Violence Against Women in Health Care Settings do More Good Than Harm?', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'If, When and How to Ask the Question(s): Assessing Screening Approaches to Identifying Woman Abuse in Health Care Settings', 'orgStudyIdInfo': {'id': 'MacMillan_VAW_RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Women are screened for intimate partner violence prior to seeing a health care provider.', 'interventionNames': ['Other: Screening for intimate partner violence']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Women see their health care provider without being asked about intimate partner violence.'}], 'interventions': [{'name': 'Screening for intimate partner violence', 'type': 'OTHER', 'description': 'Women are screened for intimate partner violence prior to seeing a health care provider.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N3T 3C4', 'city': 'Brantford', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Brantford Aboriginal Health Centre', 'geoPoint': {'lat': 43.1334, 'lon': -80.26636}}, {'zip': 'L7R 4C4', 'city': 'Burlington', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Joseph Brant Hospital', 'geoPoint': {'lat': 43.38621, 'lon': -79.83713}}, {'zip': 'P3B 1R6', 'city': 'Greater Sudbury', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sudbury Family Physicians', 'geoPoint': {'lat': 46.49, 'lon': -80.99001}}, {'zip': 'P3E 1H5', 'city': 'Greater Sudbury', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sudbury Brady Clinic', 'geoPoint': {'lat': 46.49, 'lon': -80.99001}}, {'zip': 'P3E 3A3', 'city': 'Greater Sudbury', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sudbury District Health Unit', 'geoPoint': {'lat': 46.49, 'lon': -80.99001}}, {'zip': 'P3E 3B5', 'city': 'Greater Sudbury', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hopital Regional de Sudbury Regional Hospital, Emergency Services', 'geoPoint': {'lat': 46.49, 'lon': -80.99001}}, {'zip': 'L3M 1P2', 'city': 'Grimsby', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Grimsby Medical Associates', 'geoPoint': {'lat': 43.20011, 'lon': -79.56631}}, {'zip': 'L3M 1P3', 'city': 'Grimsby', 'state': 'Ontario', 'country': 'Canada', 'facility': 'West Lincoln Memorial Hospital', 'geoPoint': {'lat': 43.20011, 'lon': -79.56631}}, {'zip': 'L8G 5E4', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Centre for Ambulatory Health Services", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8K 1W2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Rosedale Medical Group', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8L 4S1', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'North Hamilton Community Health Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8M 1K2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Aboriginal Health Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster University Medical Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8R 1B6', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Urban Core Community Health Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8R 3L5', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'City of Hamilton Public Health and Community Services Department', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8S 1A4', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'West End Clinic', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8S 1B7', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'HART Clinic', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A 4G5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Victoria Hospital', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'N6A 4V2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Health Care - Women's Ambulatory Health Centre", 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'N6A 4V2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Urgent Care", 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Hospital', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'N6A 5R9', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Family Practice - Dr. Bhayana', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'N6G 1J1', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Family Medical & Dental Centre", 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'N3L 2N7', 'city': 'Paris', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Willett Hospital Urgent Care', 'geoPoint': {'lat': 43.2, 'lon': -80.38333}}, {'zip': 'L2R 5K2', 'city': 'St. Catharines', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Niagara Health Prompt Care', 'geoPoint': {'lat': 43.17126, 'lon': -79.24267}}, {'zip': 'L8G 5E4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mt. Sinai Hospital, Obstetrics & Gynecology Clinic', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mt. Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5V 2R4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Central Toronto Community Health Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Harriet L MacMillan, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'collaborators': [{'name': "Echo: Improving Women's Health in Ontario (formerly Ontario Women's Health Council)", 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Dr. Harriet L. MacMillan', 'oldOrganization': 'McMaster University'}}}}