Intimate Partner Violence Against WomenNCT00182468
Does Routine Screening for Intimate Partner Violence Against Women in Health Care Settings do More Good Than Harm?
A study testing Screening for intimate partner violence in people with Intimate Partner Violence Against Women, run by McMaster University at 28 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intimate Partner Violence Against Women
- What is being tested?
- Screening for intimate partner violence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,681 participants
- Where
- 28 sitesCanada
- Study dates
- Apr 2005to Jul 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-64 years
- Patients at the health care site
- Able to participate in English
- Able to separate from accompanying person(s)
Who cannot join
- Too ill to participate
- Unable to separate from accompanying person(s)
- Unable to speak, read, or write English
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
Canada28 sites
Brantford Aboriginal Health Centre
Brantford, Ontario, N3T 3C4
Joseph Brant Hospital
Burlington, Ontario, L7R 4C4
Sudbury Family Physicians
Greater Sudbury, Ontario, P3B 1R6
Sudbury Brady Clinic
Greater Sudbury, Ontario, P3E 1H5
Sudbury District Health Unit
Greater Sudbury, Ontario, P3E 3A3
Hopital Regional de Sudbury Regional Hospital, Emergency Services
Greater Sudbury, Ontario, P3E 3B5
Grimsby Medical Associates
Grimsby, Ontario, L3M 1P2
West Lincoln Memorial Hospital
Grimsby, Ontario, L3M 1P3
St. Joseph's Centre for Ambulatory Health Services
Hamilton, Ontario, L8G 5E4
Rosedale Medical Group
Hamilton, Ontario, L8K 1W2
North Hamilton Community Health Centre
Hamilton, Ontario, L8L 4S1
Aboriginal Health Centre
Hamilton, Ontario, L8M 1K2
McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5
Hamilton Urban Core Community Health Centre
Hamilton, Ontario, L8R 1B6
City of Hamilton Public Health and Community Services Department
Hamilton, Ontario, L8R 3L5
West End Clinic
Hamilton, Ontario, L8S 1A4
HART Clinic
Hamilton, Ontario, L8S 1B7
Victoria Hospital
London, Ontario, N6A 4G5
St. Joseph's Health Care - Women's Ambulatory Health Centre
London, Ontario, N6A 4V2
St. Joseph's Urgent Care
London, Ontario, N6A 4V2
University Hospital
London, Ontario, N6A 5A5
London Family Practice - Dr. Bhayana
London, Ontario, N6A 5R9
St. Joseph's Family Medical & Dental Centre
London, Ontario, N6G 1J1
Willett Hospital Urgent Care
Paris, Ontario, N3L 2N7
Niagara Health Prompt Care
St. Catharines, Ontario, L2R 5K2
Mt. Sinai Hospital, Obstetrics & Gynecology Clinic
Toronto, Ontario, L8G 5E4
Mt. Sinai Hospital
Toronto, Ontario, M5G 1X5
Central Toronto Community Health Centre
Toronto, Ontario, M5V 2R4
About this study
Official title: 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.
- Conditions
- Intimate Partner Violence Against Women
- Being tested
- Screening for intimate partner violence
- Keywords
- Domestic violence, Spouse Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening for intimate partner violenceOther
Women are screened for intimate partner violence prior to seeing a health care provider.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Women are screened for intimate partner violence prior to seeing a health care provider. Receives: Other: Screening for intimate partner violence |
| 2 | No intervention | Women see their health care provider without being asked about intimate partner violence. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of intimate partner violence
Measured: 18 months
Health-specific quality of life
Measured: 18 months
Harms of screening and/or usual care
Measured: 18 months
Secondary outcomes (8)
Mental health (depression, post-traumatic stress disorder [PTSD], anxiety, somatic complaints, substance use)
Measured: 18 months
Global physical and emotional health and well-being
Measured: 18 months
Health services utilization
Measured: 18 months
Safety behaviours
Measured: 18 months
Use of information and resources
Measured: 18 months
Child quality of life
Measured: 18 months
Stage in process of identifying and resolving abuse
Measured: 18 months
Exposure to maltreatment as a child
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intimate Partner Violence Against WomenStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5,681 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Echo: Improving Women's Health in Ontario (formerly Ontario Women's Health Council)
- Investigators
- Harriet L MacMillan, MD, MSc, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182468
- Sponsor's protocol ID
- MacMillan_VAW_RCT
- Status last verified
- Sep 2009
- First submitted
- 13 Sep 2005
- Last updated
- 9 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19654384
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- If, When and How to Ask the Question(s): Assessing Screening Approaches to Identifying Woman Abuse in Health Care Settings
- ClinicalTrials.gov ID
- NCT00182468
- Acronym / sponsor ID
- MacMillan_VAW_RCT
- Conditions
- Intimate Partner Violence Against Women
- Keywords
- Domestic violence, Spouse Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,681 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Echo: Improving Women's Health in Ontario (formerly Ontario Women's Health Council)
- Study start
- Apr 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Screening for intimate partner violenceWomen 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged 18-64 years
- Patients at the health care site
- Able to participate in English
- Able to separate from accompanying person(s)
Key exclusion criteria (3 listed)
- Too ill to participate
- Unable to separate from accompanying person(s)
- Unable to speak, read, or write English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening for intimate partner violenceWomen are screened for intimate partner violence prior to seeing a health care provider. | Other | 1 |
Primary outcome
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
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2009.
- Derived from this study: PubMed 19654384MacMillan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harriet L MacMillan, MD, MSc principal investigator
McMaster University
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening for intimate partner violence in people with Intimate Partner Violence Against Women, run by McMaster University at 28 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of intimate partner violence (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00182468, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2009.