Randomized Controlled Trial of Routine Screening for IPV

Randomized Controlled Trial of Routine Screening for Intimate Partner Violence

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Disability; Utilization of Health Care Services
• Intervention / Treatment: Other: screened; Behavioral: universal education

Detailed Description

Approximately 2675 women* will be enrolled and randomized to one of 3 arms. In the first arm, participants will be screened, and if disclosing IPV, will receive information on available resources in the community. In arms two and three, participants will not be screened, but one group will receive information on available resources in the community and the other will not. All three groups will be assessed for quality of life (SF-12;standardized and validated scale with 12 questions that measure overall health (1 item), physical functioning (2 items), role limitations due to physical health problems (4 items), bodily pain (1 item), energy/fatigue (1 item), social functioning (1 item), psychological distress (1 item), and well being (1 item) in the past 4 weeks; items are summed 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); disability; and utilization of health care and IPV services at baseline and at a 12 month follow-up. A pilot study, also using a randomized controlled trial design, will establish the feasibility, acceptability, and impact on disclosure rates, use of referral resources, and potential harms of three screening and referral strategies.

*sample size calculation based n needed to detect a standardized effect size of 0.3 with an α=.05 (1-tailed)and ß=.20 if there's a 20% IPV (+) rate and 30% lost-to-follow-up rate.

• Study Type: Interventional
• Enrollment (Actual): 2700
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States
      • Fantus Health clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• women attending obstetrics & gynecology (OB-GYN), family planning, general medicine, family medicine or HIV/Sexually transmitted disease (STD) clinic

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Screened; Screened w/4 questions on intimate partner violence; if positive, receives referral information	Other: screened; Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information
Active Comparator: Universal education; all participants receive partner violence referral information	Behavioral: universal education; receives referral information
No Intervention: Control; no screen and no referral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Utilization of Health Care	number of ambulatory care visits	during past year
Disability	days lost from housework	one year follow-up

Collaborators and Investigators

• Sponsor: Centers for Disease Control and Prevention
• Collaborators: John H. Stroger Hospital
• Investigators: Principal Investigator: Joanne Klevens, MD, PhD, Centers for Disease Control and Prevention

Publications and helpful links

General Publications

• 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.
• Klevens 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: September 6, 2007
• First Submitted That Met QC Criteria: September 6, 2007
• First Posted (Estimate): September 10, 2007

Study Record Updates

• Last Update Posted (Estimate): July 31, 2013
• Last Update Submitted That Met QC Criteria: July 29, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: screening; domestic violence; intimate partner violence; spouse abuse
• Other Study ID Numbers: 200-2006-15969/200-2008-28219; IRB #4984; IRB #4985; OMB # 0920-06BM; Contract #200-2008-28219; & 200-2006-15969