Randomized Controlled Trial of Routine Screening for IPV

This study has been completed.
Sponsor:
Collaborator:
Collaborative Research Unit John H. Stroger Hospital
Information provided by (Responsible Party):
Joanne Klevens, Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00526994
First received: September 6, 2007
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Quality of Life
Disability
Utilization of Health Care Services
Other: screened
Behavioral: universal education
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of Routine Screening for Intimate Partner Violence

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Quality of Life, Physical Health Composite [ Time Frame: at one-year follow-up ] [ Designated as safety issue: No ]
    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 [ Time Frame: past 30 days ] [ Designated as safety issue: No ]
    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:
  • Utilization of Health Care [ Time Frame: during past year ] [ Designated as safety issue: No ]
    number of ambulatory care visits

  • Disability [ Time Frame: one year follow-up ] [ Designated as safety issue: No ]
    days lost from housework


Enrollment: 2700
Study Start Date: May 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Screened
Screened w/4 questions on intimate partner violence; if positive, receives referral information
Other: screened
Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information
Active Comparator: Universal education
all participants receive partner violence referral information
Behavioral: universal education
receives referral information
No Intervention: Control
no screen and no referral

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00526994

Locations
United States, Illinois
Fantus Health clinic
Chicago, Illinois, United States
Sponsors and Collaborators
Collaborative Research Unit John H. Stroger Hospital
Investigators
Principal Investigator: Joanne Klevens, MD, PhD Centers for Disease Control and Prevention
  More Information

No publications provided by Centers for Disease Control and Prevention

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joanne Klevens, epidemiologist, Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00526994     History of Changes
Other Study ID Numbers: 200-2006-15969/200-2008-28219, IRB #4984, IRB #4985, OMB # 0920-06BM, Contract #200-2008-28219, & 200-2006-15969
Study First Received: September 6, 2007
Results First Received: February 12, 2013
Last Updated: July 29, 2013
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
intimate partner violence
domestic violence
spouse abuse
screening

ClinicalTrials.gov processed this record on April 22, 2014