Randomized Controlled Trial of Routine Screening for IPV
6 other identifiers
interventional
2,700
1 country
1
Brief Summary
This is a randomized controlled trial with three arms to establish the impact of screening and referral to services for women disclosing exposure to IPV.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 quality-of-life
Started May 2008
Typical duration for phase_2 quality-of-life
1 active site
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
First Submitted
Initial submission to the registry
September 6, 2007
CompletedFirst Posted
Study publicly available on registry
September 10, 2007
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
July 31, 2013
CompletedJuly 31, 2013
July 1, 2013
3.1 years
September 6, 2007
February 12, 2013
July 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Quality of Life, Physical Health Composite
Assessed with Quality of Life SF-12 V.2 (Ware, Kosinski,Turner-Bowker, \& Gandek, 2002). This instrument has 12 items measuring eight subscales of mental and physical health-general health, physical functioning, role limitations due to physical health problems, role limitations due to emotional problems, bodily pain, vitality (energy/fatigue), social functioning, and mental health (psychological distress)-during the past 4 weeks. These subscales are combined to form a physical health composite scale and a mental health composite scale. Each scale is standardized to have a mean of 50 and a standard deviation of 10 for the U.S. population with a possible range from 0 to 100; higher scores represent a better health state.
at one-year follow-up
Quality of Life, Mental Health Composite
Assessed with the Quality of Life SF-12 v.2 (Ware, Kosinski, Turner-Bowker, \& Gandek, 2002). This instrument has 12 items measuring eight subscales of mental and physical health-general health, physical functioning, role limitations due to physical health problems, role limitations due to emotional problems, bodily pain, vitality (energy/fatigue), social functioning, and mental health (psychological distress)-during the past 4 weeks. These subscales are combined to form a physical health composite scale and a mental health composite scale. Each scale is standardized to have a mean of 50 and a standard deviation of 10 for the U.S. population with a possible range from 0 to 100; higher scores represent a better health state.
past 30 days
Secondary Outcomes (2)
Utilization of Health Care
during past year
Disability
one year follow-up
Study Arms (3)
Screened
EXPERIMENTALScreened w/4 questions on intimate partner violence; if positive, receives referral information
Universal education
ACTIVE COMPARATORall participants receive partner violence referral information
Control
NO INTERVENTIONno screen and no referral
Interventions
Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information
Eligibility Criteria
You may qualify if:
- women attending obstetrics \& gynecology (OB-GYN), family planning, general medicine, family medicine or HIV/Sexually transmitted disease (STD) clinic
You may not qualify if:
- non-English speaking other than Spanish speakers
- accompanied by a child \>3 years of age without adequate provision for child care;
- Visually- or hearing-impaired women;
- without access to a telephone;
- Severe Mental impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centers for Disease Control and Preventionlead
- Cook County Healthcollaborator
Study Sites (1)
Fantus Health clinic
Chicago, Illinois, United States
Related Publications (2)
Klevens J, Sadowski LS, Kee R, Garcia D, Lokey C. Effect of Screening for Partner Violence on Use of Health Services at 3-Year Follow-up of a Randomized Clinical Trial. JAMA. 2015 Aug 4;314(5):515-6. doi: 10.1001/jama.2015.6755. No abstract available.
PMID: 26241603DERIVEDKlevens J, Kee R, Trick W, Garcia D, Angulo FR, Jones R, Sadowski LS. Effect of screening for partner violence on women's quality of life: a randomized controlled trial. JAMA. 2012 Aug 15;308(7):681-9. doi: 10.1001/jama.2012.6434.
PMID: 22893165DERIVED
Limitations and Caveats
12% lost to follow-up differed in age, education, and insurance status from those retained. Generalizability of the findings is limited by the urban setting; exclusion of some participants.
Results Point of Contact
- Title
- Joanne Klevens
- Organization
- CDC
Study Officials
- PRINCIPAL INVESTIGATOR
Joanne Klevens, MD, PhD
Centers for Disease Control and Prevention
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- epidemiologist
Study Record Dates
First Submitted
September 6, 2007
First Posted
September 10, 2007
Study Start
May 1, 2008
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
July 31, 2013
Results First Posted
July 31, 2013
Record last verified: 2013-07