Randomized Controlled Trial for Routine Screening for Intimate Partner Violence

Forms and Documents

Document Name	Status
Pretest Followup Form and Instruction	New
Pretest Baseline Form and Instruction	New
Main Study Followup Form and Instruction	New
Main Study Baseline Form and Instruction	New
Eligibility Screening for Pretest and Main Study Form and Instruction	New
OMB SUPP STMT Part B revised 06-8-07.doc Supporting Statement B	2007-06-19
Attachment M. Public Comments.pdf Supplementary Document	2007-07-17
Attachment C 60-day FRN.pdf Supplementary Document	2007-06-26
Attachment F CDC-IRB Approval Pretest & Main Study.doc Supplementary Document	2007-06-15
Attachment B Privacy Pledge.doc Supplementary Document	2007-06-15
Attachment A Legal Authority.doc Supplementary Document	2007-06-15
OMB SUPP STMT Part A revised 7-17-07.doc Supporting Statement A	2007-07-17

IC Document Collections

IC ID	Document Title	Status
181532	Pretest Followup Form and Instruction	New
181531	Pretest Baseline Form and Instruction	New
181530	Main Study Followup Form and Instruction	New
181529	Main Study Baseline Form and Instruction	New
181528	Eligibility Screening for Pretest and Main Study Form and Instruction	New

ICR Details

OMB Control No: 0920-0761	ICR Reference No: 200708-0920-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Randomized Controlled Trial for Routine Screening for Intimate Partner Violence
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/24/2008
	Date Received in OIRA: 08/09/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2011	36 Months From Approved
Responses	3,814	0	0
Time Burden (Hours)	718	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Intimate partner violence (IPV) occurs frequently and has serious health, economic, and social consequences. Given the seriousness of this problem, numerous professional and health care organizations have recommended routine screening of women for IPV by health care providers in primary care settings. However, recent systematic reviews of the literature have not found evidence for the effectiveness of screening to improve health outcomes for women exposed to IPV. We are proposing to conduct a randomized controlled trial to provide this evidence. The trial will recruit 3680 women in a public obsetrics, 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 of 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 orgniazations, and women's advocate groups in formulating its recommendations and policies regarding routine screening.

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Authorizing Statute(s): US Code: 42 USC 391 Name of Law: Public Health Service Act Prevention and Control of Injuries
   US Code: 42 USC 301 Name of Law: Public Health Service Act Research and Investigation General
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 42644	07/27/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 38837	07/13/2007
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Eligibility Screening for Pretest and Main Study	None	Eligibility Script for Pretest and Main Study
Main Study Baseline	None, None	Supplementary Quality of Life Questions ,   Baseline Questionnaire
Main Study Followup	None, None	Main Study Follow-up Questionnaire ,   Supplementary Quality of Life Questions
Pretest Baseline	None, None	Supplementary Quality of Life Questions ,   Pretest Baseline Questionnaire
Pretest Followup	None, None	Pretest Followup Questionnaire ,   Supplementary Quality of Life Questions

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	3,814	0	0	3,814	0	0
Annual Time Burden (Hours)	718	0	0	718	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new data collection.

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Annual Cost to Federal Government: $482,067

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 08/09/2007

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