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Randomized Controlled Trial of Routine Screening for IPV

Randomized Controlled Trial of Routine Screening for Intimate Partner Violence

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00526994
Enrollment
2700
Registered
2007-09-10
Start date
2008-05-31
Completion date
2011-06-30
Last updated
2013-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disability, Quality of Life, Utilization of Health Care Services

Keywords

intimate partner violence, domestic violence, spouse abuse, screening

Brief 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.

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.

Interventions

OTHERscreened

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

receives referral information

Sponsors

Cook County Health
CollaboratorOTHER_GOV
Centers for Disease Control and Prevention
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of Life, Physical Health Compositeat one-year follow-upAssessed 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 Compositepast 30 daysAssessed 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

MeasureTime frameDescription
Utilization of Health Careduring past yearnumber of ambulatory care visits
Disabilityone year follow-updays lost from housework

Countries

United States

Participant flow

Recruitment details

May, 2009-April, 2010 at 10 primary health care clinics in Chicago

Pre-assignment details

8 Unenrolled: 7 because computer did not save baseline data & 1 Withdrew

Participants by arm

ArmCount
Screened & Referred
Screened w/4 questions on intimate partner violence; if positive, receives referral information screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information
909
Universal Education (All Referred)
receives referral information universal education : receives referral information
893
Control
no screen and no referral
898
Total2,700

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyDeath433
Overall Studyincarcerated, impaired, incomplete433
Overall StudyLost to Follow-up9810896
Overall StudyWithdrawal by Subject275

Baseline characteristics

CharacteristicScreened & ReferredUniversal Education (All Referred)ControlTotal
Age Continuous39 years
STANDARD_DEVIATION 15
38.3 years
STANDARD_DEVIATION 14.8
38.7 years
STANDARD_DEVIATION 15.1
38.7 years
STANDARD_DEVIATION 14.9
Sex: Female, Male
Female
909 Participants893 Participants898 Participants2700 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 8010 / 7720 / 791
serious
Total, serious adverse events
0 / 8010 / 7720 / 791

Outcome results

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.

Time frame: past 30 days

ArmMeasureValue (MEAN)
Screened & ReferredQuality of Life, Mental Health Composite48.3 units on a scale
Universal Education (All Referred)Quality of Life, Mental Health Composite48.0 units on a scale
ControlQuality of Life, Mental Health Composite47.8 units on a scale
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.

Time frame: at one-year follow-up

ArmMeasureValue (MEAN)
Screened & ReferredQuality of Life, Physical Health Composite46.8 units on a scale
Universal Education (All Referred)Quality of Life, Physical Health Composite46.4 units on a scale
ControlQuality of Life, Physical Health Composite47.2 units on a scale
Secondary

Disability

days lost from housework

Time frame: one year follow-up

ArmMeasureValue (MEAN)
Screened & ReferredDisability1.9 days
Universal Education (All Referred)Disability2.2 days
ControlDisability1.9 days
Secondary

Utilization of Health Care

number of ambulatory care visits

Time frame: during past year

ArmMeasureValue (MEAN)
Screened & ReferredUtilization of Health Care5.4 visits
Universal Education (All Referred)Utilization of Health Care5.7 visits
ControlUtilization of Health Care5.9 visits

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026