Randomized Controlled Trial of Routine Screening for IPV

• Sponsor: Centers for Disease Control and Prevention (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00526994
• Collaborator: John H. Stroger Hospital (Other)
• Enrollment: 2,700
• Location: 1
• Arms: 3
• Duration (Months): 37
• Patients Per Site Per Month: 73

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Quality of Life; Disability; Utilization of Health Care Services	Other: screened; Behavioral: universal education	Phase 2/Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2700 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Randomized Controlled Trial of Routine Screening for Intimate Partner Violence
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Quality of Life, Physical Health Composite [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.

2. Quality of Life, Mental Health Composite [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.

Secondary Outcome Measures

1. Utilization of Health Care [during past year]

   number of ambulatory care visits

2. Disability [one year follow-up]

   days lost from housework

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fantus Health clinic	Chicago	Illinois	United States

Sponsors and Collaborators

• Centers for Disease Control and Prevention
• John H. Stroger Hospital

Investigators

• Principal Investigator: Joanne Klevens, MD, PhD, Centers for Disease Control and Prevention

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joanne Klevens, epidemiologist, Centers for Disease Control and Prevention
• ClinicalTrials.gov Identifier: NCT00526994
• Other Study ID Numbers: 200-2006-15969/200-2008-28219; IRB #4984; IRB #4985; OMB # 0920-06BM; Contract #200-2008-28219; & 200-2006-15969
• First Posted: Sep 10, 2007
• Last Update Posted: Jul 31, 2013
• Last Verified: Jul 1, 2013

• Keywords provided by Joanne Klevens, epidemiologist, Centers for Disease Control and Prevention: intimate partner violence; domestic violence; spouse abuse; screening

Study Results

Participant Flow

Recruitment Details	May, 2009-April, 2010 at 10 primary health care clinics in Chicago
Pre-assignment Detail	8 Unenrolled: 7 because computer did not save baseline data & 1 Withdrew

Arm/Group Title	Screened & Referred	Universal Education (All Referred)	Control
Arm/Group Description	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	receives referral information universal education : receives referral information	no screen and no referral
Period Title: Overall Study
STARTED	909	893	898
COMPLETED	801	772	791
NOT COMPLETED	108	121	107

Baseline Characteristics

Arm/Group Title	Screened & Referred	Universal Education (All Referred)	Control	Total
Arm/Group Description	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	receives referral information universal education : receives referral information	no screen and no referral	Total of all reporting groups
Overall Participants	909	893	898	2700
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39 (15)	38.3 (14.8)	38.7 (15.1)	38.7 (14.9)
Sex: Female, Male (Count of Participants)
Female	909 100%	893 100%	898 100%	2700 100%
Male	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Quality of Life, Physical Health Composite
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Screened & Referred	Universal Education (All Referred)	Control
Arm/Group Description	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	receives referral information universal education : receives referral information	no screen and no referral
Measure Participants	801	772	791
Mean (95% Confidence Interval) [units on a scale]	46.8	46.4	47.2

2. Secondary Outcome

Title	Utilization of Health Care
Description	number of ambulatory care visits
Time Frame	during past year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Screened & Referred	Universal Education (All Referred)	Control
Arm/Group Description	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	receives referral information universal education : receives referral information	no screen and no referral
Measure Participants	801	772	791
Mean (95% Confidence Interval) [visits]	5.4	5.7	5.9

3. Secondary Outcome

Title	Disability
Description	days lost from housework
Time Frame	one year follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Screened & Referred	Universal Education (All Referred)	Control
Arm/Group Description	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	receives referral information universal education : receives referral information	no screen and no referral
Measure Participants	801	772	791
Mean (95% Confidence Interval) [days]	1.9	2.2	1.9

4. Primary Outcome

Title	Quality of Life, Mental Health Composite
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Screened & Referred	Universal Education (All Referred)	Control
Arm/Group Description	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	receives referral information universal education : receives referral information	no screen and no referral
Measure Participants	801	772	791
Mean (95% Confidence Interval) [units on a scale]	48.3	48.0	47.8

Adverse Events

Time Frame	1 year
Arm/Group Title	Screened & Referred		Universal Education (All Referred)		Control
Arm/Group Description	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		receives referral information universal education : receives referral information		no screen and no referral
All Cause Mortality
	Screened & Referred		Universal Education (All Referred)		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Screened & Referred		Universal Education (All Referred)		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/801 (0%)		0/772 (0%)		0/791 (0%)
Other (Not Including Serious) Adverse Events
	Screened & Referred		Universal Education (All Referred)		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/801 (0%)		0/772 (0%)		0/791 (0%)

Limitations/Caveats

12% lost to follow-up differed in age, education, and insurance status from those retained. Generalizability of the findings is limited by the urban setting; exclusion of some participants.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.