Randomized Controlled Trial of Routine Screening for IPV

Phase 2

Completed

Conditions: Quality of Life
Disability
Utilization of Health Care Services

Interventions: Other: screened
Behavioral: universal education

Registration Number: NCT00526994

Lead Sponsor: Centers for Disease Control and 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 2700

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Screened	screened	Screened w/4 questions on intimate partner violence; if positive, receives referral information
Universal education	universal education	all participants receive partner violence referral information

Primary Outcome Measures

Name	Time	Method
Quality of Life, Physical Health Composite	at one-year follow-up	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.
Quality of Life, Mental Health Composite	past 30 days	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.

Secondary Outcome Measures