Randomized Controlled Trial of Routine Screening for IPV

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

2700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2011-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Quality of Life Disability Utilization of Health Care Services

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Screened

Screened w/4 questions on intimate partner violence; if positive, receives referral information

Group Type EXPERIMENTAL

screened

Intervention Type OTHER

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

Universal education

all participants receive partner violence referral information

Group Type ACTIVE_COMPARATOR

universal education

Intervention Type BEHAVIORAL

receives referral information

Control

no screen and no referral

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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screened

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

Intervention Type OTHER

universal education

receives referral information

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes