Randomized Controlled Trial of Routine Screening for IPV

Quality of Life Clinical Trial

Official title:

Randomized Controlled Trial of Routine Screening for Intimate Partner Violence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00526994
• Other study ID #: 200-2006-15969/200-2008-28219
• Secondary ID: IRB #4984IRB #49
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 6, 2007
• Last updated: July 29, 2013
• Start date: May 2008
• Est. completion date: June 2011

Study information

• Verified date: July 2013
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 2700
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

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

Behavioral:
• universal education
receives referral information

Locations

Country	Name	City	State
United States	Fantus Health clinic	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Collaborative Research Unit John H. Stroger Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life, Physical Health Composite	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.	at one-year follow-up	No
Primary	Quality of Life, Mental Health Composite	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.	past 30 days	No
Secondary	Utilization of Health Care	number of ambulatory care visits	during past year	No
Secondary	Disability	days lost from housework	one year follow-up	No