Randomized Controlled Trial of Routine Screening for Intimate Partner Violence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2,700
- 试验地点
- 1
- 主要终点
- Quality of Life, Physical Health Composite
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women attending obstetrics & gynecology (OB-GYN), family planning, general medicine, family medicine or HIV/Sexually transmitted disease (STD) clinic
排除标准
- •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
结局指标
主要结局
Quality of Life, Physical Health Composite
时间窗: 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
时间窗: 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.
次要结局
- Utilization of Health Care(during past year)
- Disability(one year follow-up)
研究者
Joanne Klevens
epidemiologist
Centers for Disease Control and Prevention