Clinical trial NCT00526994: Randomized Controlled Trial of Routine Screening for IPV
Official title: Randomized Controlled Trial of Routine Screening for Intimate Partner Violence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Quality of Life
Disability
Utilization of Health Care Services
Keywords: intimate partner violence
domestic violence
spouse abuse
screening
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Cook County Health
First posted: 2007-09-10
Enrollment: 2700
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of Life, Physical Health Composite
timeFrame: at one-year follow-up
measure: Quality of Life, Mental Health Composite
timeFrame: past 30 days
Secondary outcomes:
measure: Utilization of Health Care
timeFrame: during past year
measure: Disability
timeFrame: one year follow-up
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Fantus Health clinic
state: Illinois
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Joanne Klevens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.