NCT00526994

Randomized Controlled Trial of Routine Screening for IPV

Randomized Controlled Trial of Routine Screening for Intimate Partner Violence

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 2,700 (actual)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Quality of Life
• Disability
• Utilization of Health Care Services

Interventions

Type	Name	Description
OTHER	screened	Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information
BEHAVIORAL	universal education	receives referral information

Timeline

• Start date: 2008-05-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2007-09-10
• Last updated: 2013-07-31
• Results posted: 2013-07-31

Locations

1 site across 1 country: United States