Trial Outcomes & Findings for Randomized Controlled Trial of Routine Screening for IPV (NCT NCT00526994)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

2700 participants

Primary outcome timeframe

at one-year follow-up

Results posted on

2013-07-31

Participant Flow

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

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

Participant milestones

Participant milestones
Measure	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	Universal Education (All Referred) receives referral information universal education : receives referral information	Control no screen and no referral
Overall Study STARTED	909	893	898
Overall Study COMPLETED	801	772	791
Overall Study NOT COMPLETED	108	121	107

Reasons for withdrawal

Reasons for withdrawal
Measure	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	Universal Education (All Referred) receives referral information universal education : receives referral information	Control no screen and no referral
Overall Study Lost to Follow-up	98	108	96
Overall Study Death	4	3	3
Overall Study Withdrawal by Subject	2	7	5
Overall Study incarcerated, impaired, incomplete	4	3	3

Baseline Characteristics

Randomized Controlled Trial of Routine Screening for IPV

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Screened & Referred n=909 Participants 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	Universal Education (All Referred) n=893 Participants receives referral information universal education : receives referral information	Control n=898 Participants no screen and no referral	Total n=2700 Participants Total of all reporting groups
Age Continuous	39 years STANDARD_DEVIATION 15 • n=5 Participants	38.3 years STANDARD_DEVIATION 14.8 • n=7 Participants	38.7 years STANDARD_DEVIATION 15.1 • n=5 Participants	38.7 years STANDARD_DEVIATION 14.9 • n=4 Participants
Sex: Female, Male Female	909 Participants n=5 Participants	893 Participants n=7 Participants	898 Participants n=5 Participants	2700 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Screened & Referred n=801 Participants 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	Universal Education (All Referred) n=772 Participants receives referral information universal education : receives referral information	Control n=791 Participants no screen and no referral
Quality of Life, Physical Health Composite	46.8 units on a scale Interval 46.1 to 47.4	46.4 units on a scale Interval 45.8 to 47.1	47.2 units on a scale Interval 46.5 to 47.8

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Screened & Referred n=801 Participants 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	Universal Education (All Referred) n=772 Participants receives referral information universal education : receives referral information	Control n=791 Participants no screen and no referral
Quality of Life, Mental Health Composite	48.3 units on a scale Interval 47.5 to 49.1	48.0 units on a scale Interval 47.2 to 48.9	47.8 units on a scale Interval 47.0 to 48.6

SECONDARY outcome

Timeframe: during past year

number of ambulatory care visits

Outcome measures

Outcome measures
Measure	Screened & Referred n=801 Participants 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	Universal Education (All Referred) n=772 Participants receives referral information universal education : receives referral information	Control n=791 Participants no screen and no referral
Utilization of Health Care	5.4 visits Interval 3.8 to 7.0	5.7 visits Interval 4.1 to 7.3	5.9 visits Interval 4.3 to 7.4

SECONDARY outcome

Timeframe: one year follow-up

days lost from housework

Outcome measures

Outcome measures
Measure	Screened & Referred n=801 Participants 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	Universal Education (All Referred) n=772 Participants receives referral information universal education : receives referral information	Control n=791 Participants no screen and no referral
Disability	1.9 days Interval 1.6 to 2.3	2.2 days Interval 1.8 to 2.5	1.9 days Interval 1.6 to 2.3

Adverse Events

Screened & Referred

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Universal Education (All Referred)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joanne Klevens

CDC

Phone: 770-488-1386

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place