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Completed

NCT Number: NCT00526994

Randomized Controlled Trial of Routine Screening for IPV

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Fantus Health clinic

Chicago, Illinois, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

screened

Other

Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information

universal education

Behavioral

receives referral information

Primary outcomes

  1. Quality of Life, Physical Health Composite

    Time frame: 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.

  2. Quality of Life, Mental Health Composite

    Time frame: 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 outcomes

  1. Utilization of Health Care

    Time frame: during past year

    number of ambulatory care visits

  2. Disability

    Time frame: one year follow-up

    days lost from housework

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • Cook County Health

Registry information

Official study title

Randomized Controlled Trial of Routine Screening for Intimate Partner Violence

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 10, 2007
Registry last updated
Jul 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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