Using Nursing Home Antibiograms to Improve Antibiotic Prescribing and Delivery

Forms and Documents

Document Name	Status
Form Form #8 NH Leadership Post-Implementation Questionnaire Form and Instruction	New
Form Form #7 Nurse Pre/Post Implementation Questionnaire Form and Instruction	New
Form Form #6 ED Physician Post-implementation Questionnaire Form and Instruction	New
Form Form #5 ED Physician Pre-implementation Questionnaire Form and Instruction	New
Form Form #4 NH Provider Post-Implementation Questionnaire Form and Instruction	New
Form Form #3 NH Provider Pre-Implementation Questionnaire Form and Instruction	New
Form Form #1 Medical Records Extraction Form and Instruction	New
Supporting Statement Part B -- Using NH Antibiograms to Improve Antibiotic 1-4-2011.doc Supporting Statement B	2011-06-14
Attachment S--Federal Register Notice.pdf Supplementary Document	2011-06-14
Attachment R -- Fact Sheet.docx Supplementary Document	2011-06-14
Attachment Q -- Nurse Statement of Informed Consent.docx Supplementary Document	2011-06-14
Attachment P -- ED Provider Web-Based Statement of Informed Consent.docx Supplementary Document	2011-06-14
Attachment O -- ED Provider Paper Statement of Informed Consent.docx Supplementary Document	2011-06-14
Attachment N -- NH Provider Web-Based Statement of Informed Consent.docx Supplementary Document	2011-06-14
Attachment M -- NH Provider Paper Statement of Informed Consent.docx Supplementary Document	2011-06-14
Attachment L -- Nurse Recruitment Letter.docx Supplementary Document	2011-06-14
Attachment K -- ED Provider Recruitment Letter.docx Supplementary Document	2011-06-14
Attachment J -- NH Provider Recruitment Letter.docx Supplementary Document	2011-06-14
Attachment A -- Healthcare Research and Quality Act of 1999.pdf Supplementary Document	2011-06-14
Supporting Statement Part A -- Using NH Antibiograms to Improve Antibiotic 9-26-2011-1.doc Supporting Statement A	2011-09-26

IC Document Collections

IC ID	Document Title	Status
198172	NH Leadership Post-Implementation Questionnaire Form and Instruction	New
198171	Nurse Pre/Post Implementation Questionnaire Form and Instruction	New
198170	ED Physician Post-implementation Questionnaire Form and Instruction	New
198169	ED Physician Pre-implementation Questionnaire Form and Instruction	New
198168	NH Provider Post-Implementation Questionnaire Form and Instruction	New
198167	NH Provider Pre-Implementation Questionnaire Form and Instruction	New
198166	Medical Records Extraction Form and Instruction	New

ICR Details

OMB Control No: 0935-0185	ICR Reference No: 201106-0935-005
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Using Nursing Home Antibiograms to Improve Antibiotic Prescribing and Delivery
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 with change	Conclusion Date: 09/27/2011
	Date Received in OIRA: 06/20/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2013	24 Months From Approved
Responses	218	0	0
Time Burden (Hours)	33	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Overuse and inappropriate use of antibiotics, particularly broad-spectrum antibiotics, is recognized as a serious problem in nursing homes (NHs). The adverse consequences of inappropriate prescribing practices including drug reactions/interactions, secondary complications, and the emergence of multi-drug resistant organisms have become more common. For example, in one point-prevalence survey of 117 NH residents, 43 percent were culture-positive for one or more antimicrobial-resistant pathogens, including methicillin-resistant staphylococcus aureas (24 percent), extended-spectrum β-lactamase-producing klebsiella pneumoniae (18 percent) or Escherichia coli (15 percent), and vancomycin-resistant enterococci. Inappropriate overprescribing and overuse of broad-spectrum antibiotics, when narrower spectrum drugs would suffice, are believed to be important contributors to this problem. The objectives of the study are to: 1.Develop a standardized method for determining antibiotic susceptibility patterns and developing NH-specific antibiograms; 2.Extract preliminary data from NH facilities of various sizes and types to guide the development of the draft toolkit; and 3.Develop a draft toolkit to guide a wide variety of sizes and types of NHs in developing and sharing antibiogram information with prescribing providers (i.e., physicians and physician extenders) and EDs.

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Authorizing Statute(s): US Code: 42 USC 299 Name of Law: Healthcare Research and Quality Act of 1999
  

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:
	76 FR 16783	03/25/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 32209	06/03/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Nurse Pre/Post Implementation Questionnaire	Form #7	Nurse Pre/Post Implementation Questionnaire
NH Leadership Post-Implementation Questionnaire	Form #8	NH Leadership Post-Implementation Questionnaire
ED Physician Pre-implementation Questionnaire	Form #5	ED Physician Pre-implementation Questionnaire
ED Physician Post-implementation Questionnaire	Form #6	ED Physician Post-implementation Questionnaire
NH Provider Post-Implementation Questionnaire	Form #4	NH Provider Post-Implementation Questionnaire
NH Provider Pre-Implementation Questionnaire	Form #3	NH Provider Pre-Implementation Questionnaire
Medical Records Extraction	Form #2, Form #1	NH Data Extraction Tool ,   ED Data Extraction Tool

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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	218	0	0	218	0	0
Annual Time Burden (Hours)	33	0	0	33	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 information collection request.

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Annual Cost to Federal Government: $229,406

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]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

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: 06/20/2011

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