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Randomized Controlled Trial of Routine Screening for Intimate Partner Violence—New—National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Intimate partner violence (IPV) is a prevalent problem with serious health consequences that include death, physical injury, increased rates of physical illness, post-traumatic stress, increased psychological distress, depression, substance abuse, and suicide. Some studies suggest that abuse perpetrated by intimate partners tends to be repetitive and escalates in severity over time. This research has been the basis for promoting early diagnosis and intervention.
Health care providers appear to be well situated to identify IPV. Women come into contact with health care services routinely for a number of reasons such as prenatal care, family planning, cancer screening, and well baby care. Women experiencing IPV make more visits to emergency departments, primary care facilities, and mental health agencies than non-abused women. Considering the magnitude and severity of IPV, and the potential role health care providers could play in reducing its serious consequences, numerous professional and health care organizations have recommended routine screening of women for IPV in primary care settings. However, various systematic reviews of the literature have not found evidence for the effectiveness Start Printed Page 34692of screening to improve outcomes for women exposed to IPV.
Based on the recommendations of a recent expert panel, in order to provide this evidence we are proposing to conduct a randomized controlled trial. The trial will recruit 3680 women in a public obstetrics, gynecology, and family planning clinic. Women attending this clinic tend to be African American and of lower socioeconomic status. For this study (the Main Study), women will be randomly allocated to one of three arms: (1) Screened for IPV, and if disclosing IPV, provided information on available IPV services; (2) not screened and all receiving information on available IPV services; or (3) a control group that will not be screened nor receive information on available IPV services. All three arms will be assessed with a self-report measure for mental health, disability, and quality of life at baseline utilizing an audio-computer-assisted structured interview (A-CASI) and at a 12-month follow-up utilizing a computerized-assisted telephone interview (CATI). A pretest with 196 women in this same clinic will be conducted to test the enrollment, randomization, interview, and follow-up procedures; provide estimates for outcome measures and a potential mediator of outcomes (contact of IPV services); and establish the concordance between measures used at baseline (in the clinic) and at a one-week follow-up over the phone. The study arms of the Pretest, which vary slightly from those of the Main Study, are designed to accomplish these intermediate objectives. The results will be used to refine the measures, procedures, and sample size requirements for the Main Study. The results from the Main Study, the Randomized Controlled Trial, will guide CDC as well as other governmental agencies, professional and health care organizations, and women's advocate groups in formulating its recommendations and policies regarding routine screening.
There are no costs to respondents other than their time to participate in the survey. The total estimated annualized burden hours are 717.7.
|Respondents||Number of respondents||Number of responses per respondents||Average burden per response (in hours)|
|Potential Eligibility for Pretest||210||1||1/60|
|Pretest Baseline Participants||196||1||15/60|
|Pretest Follow-up Participants||176||1||12/60|
|Potential Eligibility for Main Study||4600||1||1/60|
|Main Study Baseline Participants||3680||1||17/60|
|Main Study Follow-up Participants||2580||1||22/60|
Dated: June 19, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. E7-12241 Filed 6-22-07; 8:45 am]
BILLING CODE 4163-18-P