Disability, Quality of Life, Utilization of Health Care Services
Conditions
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
Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information
receives referral information
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Utilization of Health Care | during past year | number of ambulatory care visits |
| Disability | one year follow-up | days 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
| Arm | Count |
|---|---|
| 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 |
| Total | 2,700 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 4 | 3 | 3 |
| Overall Study | incarcerated, impaired, incomplete | 4 | 3 | 3 |
| Overall Study | Lost to Follow-up | 98 | 108 | 96 |
| Overall Study | Withdrawal by Subject | 2 | 7 | 5 |
Baseline characteristics
| Characteristic | Screened & Referred | Universal Education (All Referred) | Control | Total |
|---|---|---|---|---|
| Age Continuous | 39 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 Participants | 893 Participants | 898 Participants | 2700 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 801 | 0 / 772 | 0 / 791 |
| serious Total, serious adverse events | 0 / 801 | 0 / 772 | 0 / 791 |
Outcome results
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Screened & Referred | Quality of Life, Mental Health Composite | 48.3 units on a scale |
| Universal Education (All Referred) | Quality of Life, Mental Health Composite | 48.0 units on a scale |
| Control | Quality of Life, Mental Health Composite | 47.8 units on a scale |
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Screened & Referred | Quality of Life, Physical Health Composite | 46.8 units on a scale |
| Universal Education (All Referred) | Quality of Life, Physical Health Composite | 46.4 units on a scale |
| Control | Quality of Life, Physical Health Composite | 47.2 units on a scale |
Disability
days lost from housework
Time frame: one year follow-up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Screened & Referred | Disability | 1.9 days |
| Universal Education (All Referred) | Disability | 2.2 days |
| Control | Disability | 1.9 days |
Utilization of Health Care
number of ambulatory care visits
Time frame: during past year
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Screened & Referred | Utilization of Health Care | 5.4 visits |
| Universal Education (All Referred) | Utilization of Health Care | 5.7 visits |
| Control | Utilization of Health Care | 5.9 visits |