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| ID | Type | Description | Link |
|---|---|---|---|
| IRB #4984 | |||
| IRB #4985 | |||
| OMB # 0920-06BM | |||
| Contract #200-2008-28219 | |||
| & 200-2006-15969 |
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| Name | Class |
|---|---|
| Cook County Health | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screened | Experimental | Screened w/4 questions on intimate partner violence; if positive, receives referral information |
|
| Universal education | Active Comparator | all participants receive partner violence referral information |
|
| Control | No Intervention | no screen and no referral |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| screened | Other | Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at one-year follow-up |
| 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. | past 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Utilization of Health Care | number of ambulatory care visits | during past year |
| Disability | days lost from housework | one year follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne Klevens, MD, PhD | Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fantus Health clinic | Chicago | Illinois | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26241603 | Derived | Klevens J, Sadowski LS, Kee R, Garcia D, Lokey C. Effect of Screening for Partner Violence on Use of Health Services at 3-Year Follow-up of a Randomized Clinical Trial. JAMA. 2015 Aug 4;314(5):515-6. doi: 10.1001/jama.2015.6755. No abstract available. | |
| 22893165 | Derived | Klevens J, Kee R, Trick W, Garcia D, Angulo FR, Jones R, Sadowski LS. Effect of screening for partner violence on women's quality of life: a randomized controlled trial. JAMA. 2012 Aug 15;308(7):681-9. doi: 10.1001/jama.2012.6434. |
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8 Unenrolled: 7 because computer did not save baseline data & 1 Withdrew
May, 2009-April, 2010 at 10 primary health care clinics in Chicago
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Universal Education (All Referred) | receives referral information universal education : receives referral information |
| FG002 | Control | no screen and no referral |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Universal Education (All Referred) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | at one-year follow-up |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joanne Klevens | CDC | 770-488-1386 | dzk8@cdc.gov |
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| universal education | Behavioral | receives referral information |
|
| Withdrawal by Subject |
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| incarcerated, impaired, incomplete |
|
receives referral information universal education : receives referral information |
| BG002 | Control | no screen and no referral |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Universal Education (All Referred) | receives referral information universal education : receives referral information |
| OG002 | Control | no screen and no referral |
|
|
| Secondary | Utilization of Health Care | number of ambulatory care visits | Posted | Mean | 95% Confidence Interval | visits | during past year |
|
|
|
| Secondary | Disability | days lost from housework | Posted | Mean | 95% Confidence Interval | days | one year follow-up |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | past 30 days |
|
|
|
| 0 |
| 801 |
| 0 |
| 801 |
| EG001 | Universal Education (All Referred) | receives referral information universal education : receives referral information | 0 | 772 | 0 | 772 |
| EG002 | Control | no screen and no referral | 0 | 791 | 0 | 791 |
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