Guide to Nursing Home Antimicrobial Stewardship

Forms and Documents

Document Name	Status
Form 5 Attachment E – Draft Guide to Nursing Home Antimicrobial Stewardship Form and Instruction	New
Form 4 Attachment D – Post-Intervention Interview Protocols Form and Instruction	New
Form 3 Attachment C – Proactive TA Discussion Protocol Form and Instruction	New
Form 2 Attachment B – Passive TA Collection Protocol Form and Instruction	New
Form 1 Pre-Intervention Interview Protocol Form and Instruction	New
Attachment_G-Consent_Forms.doc Supplementary Document	2014-09-05
Attachment_F-Resident_and_Family_Information_Sheet_(19Feb14).doc Supplementary Document	2014-09-05
NH_Guide_PRA_Part_B FINAL_v3.doc Supporting Statement B	2014-09-03
NH_Guide_PRA_Part_A_FINAL.doc Supporting Statement A	2014-09-03

IC Document Collections

IC ID	Document Title	Status
212988	Attachment E – Draft Guide to Nursing Home Antimicrobial Stewardship Form and Instruction	New
212986	Attachment D – Post-Intervention Interview Protocols Form and Instruction	New
212984	Attachment C – Proactive TA Discussion Protocol Form and Instruction	New
212981	Attachment B – Passive TA Collection Protocol Form and Instruction	New
212948	Pre-Intervention Interview Protocol Form and Instruction	New

ICR Details

OMB Control No: 0935-0223	ICR Reference No: 201409-0935-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Guide to Nursing Home Antimicrobial Stewardship
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: 10/24/2014
	Date Received in OIRA: 09/18/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2017	36 Months From Approved
Responses	280	0	0
Time Burden (Hours)	200	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This project seeks to contribute to AHRQ's mission by assisting nursing homes to optimize antimicrobial (e.g., antibiotics and antifungals) prescribing practices, also referred to as antimicrobial stewardship. Antimicrobial stewardship programs reduce the development of drug-resistant organisms, enhance patient outcomes, and reduce unnecessary costs. Nursing homes serve as one of our most fertile breeding grounds for antibiotic-resistant strains of bacteria. This stems from high rates of infection in nursing home residents due to the effects of normal aging combined with multiple chronic diseases. The most common infections encountered in nursing home residents are pneumonia, urinary tract infections, and skin and soft tissue infections. In one study by Yoshikawa and Norman, researchers found that these three types of infections accounted for approximately 75 percent of all nursing home-associated infections (NHAIs) . High rates of these infections lead to antimicrobials being among the most commonly prescribed pharmaceuticals in long-term care settings. In nursing homes, where polypharmacy is the rule rather than the exception, as many as 40 percent of all prescriptions are for antimicrobial agents , and depending on the study, 25 percent to 75 percent have been deemed inappropriately prescribed. Such inappropriate prescribing results in negative outcomes, including adverse drug events, hospital admissions, and higher health care costs. Most significantly, inappropriate antimicrobial prescribing gives rise to the development of multi-drug resistant organisms (MDROs), including Methicillin-resistant Staphylococcus aureus, Vancomycin-resistant Enterococci, and fluoroquinolone-resistant strains of a variety of bacteria, and leads to the development of Clostridium difficile infections. In general, determining "appropriateness" of antimicrobial use in healthcare settings is challenging to standardize. This becomes even more complicated in the nursing home setting because most antimicrobial courses are started empirically (without results from labs) due to the limited diagnostics available to many nursing homes. In an effort to address the need for optimizing antibiotic use in the nursing homes, AHRQ is testing a Guide to Nursing Home Antimicrobial Stewardship (the Guide). The Guide is intended to help nursing home staff easily identify toolkits that have been shown to be effective in optimizing antimicrobial use. There are multiple toolkits that could be used by a nursing home, and nursing homes face a potentially time-consuming decision process to choose the most appropriate one. The Guide is intended to help nursing homes make this choice efficiently and effectively.

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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:
	79 FR 29193	05/21/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 53064	09/05/2014
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Attachment E – Draft Guide to Nursing Home Antimicrobial Stewardship	5	Attachment E – Draft Guide to Nursing Home Antimicrobial Stewardship
Pre-Intervention Interview Protocol	1	Attachment A Pre-Intervention Interview Protocol
Attachment D – Post-Intervention Interview Protocols	4	Attachment D – Post-Intervention Interview Protocols
Attachment C – Proactive TA Discussion Protocol	3	Attachment C – Proactive TA Discussion Protocol
Attachment B – Passive TA Collection Protocol	2	Attachment B – Passive TA Collection Protocol

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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	280	0	0	280	0	0
Annual Time Burden (Hours)	200	0	0	200	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: $657,881

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: 09/18/2014

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