Standardizing Antibiotic Use in Long-Term Care Settings (SAUL) Study

Forms and Documents

Document Name	Status
Form Form #8 Physician survey Form and Instruction	New
Form Form #7 Nurse survey Form and Instruction	New
Form Form #5 Final Semi-Structured Interview Form and Instruction	New
Form Form #5 Train-the-physicians training Form and Instruction	New
Form Form #4 Train-the-nurses training Form and Instruction	New
Form Form #3 Train-the-trainer training Form and Instruction	New
Form Form #2 Administrator Interviews Form and Instruction	New
Form Form #1 Pre-implementation semi-structured interviews Form and Instruction	New
AHRQ response to OMB comments for SAUL102210.doc Supplementary Document	2010-10-25
Supporting Statement Part B Standardizing Antibiotic Use in LTC Settings 2010.22.10.doc Supporting Statement B	2010-10-25
ATTACHMENT L STATEMENTS OF INFORMED CONSENT.doc Supplementary Document	2010-07-12
Attachment K -- Federal Register Notice.pdf Supplementary Document	2010-07-12
ATTACHMENT F -- MRR MANUAL AND FORMS.doc Supplementary Document	2010-07-12
ATTACHMENT C -- QI PROGRAM GUIDE.pdf Supplementary Document	2010-07-12
ATTACHMENT B -- RECRUITMENT AND FU LETTERS.doc Supplementary Document	2010-07-12
Supporting Statement Part A Standardizing Antibiotic Use in LTC Settings 2010.17.10.doc Supporting Statement A	2010-10-25

IC Document Collections

IC ID	Document Title	Status
193984	Physician survey Form and Instruction	New
193983	Nurse survey Form and Instruction	New
193982	Final Semi-Structured Interview Form and Instruction	New
193981	Train-the-physicians training Form and Instruction	New
193980	Train-the-nurses training Form and Instruction	New
193979	Train-the-trainer training Form and Instruction	New
193978	Administrator Interviews Form and Instruction	New
193977	Pre-implementation semi-structured interviews Form and Instruction	New

ICR Details

OMB Control No: 0935-0171	ICR Reference No: 201007-0935-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Standardizing Antibiotic Use in Long-Term Care Settings (SAUL) Study
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: 10/29/2010
	Date Received in OIRA: 07/28/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2013	36 Months From Approved
Responses	966	0	0
Time Burden (Hours)	441	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: Inappropriate antibiotic prescribing practices by primary care clinicians caring for residents in long-term care (LTC) communities is becoming a major public health concern as it is a risk factor for morbidity and mortality among LTC residents. Antibiotics are among the most commonly prescribed pharmaceuticals in LTC settings, yet reports indicate that a high proportion of antibiotic prescriptions are inappropriate. The adverse consequences of inappropriate prescribing practices are serious and include drug reactions/interactions, secondary complications, and the emergence of multi-drug resistant organisms. In an effort to reduce antibiotic overprescribing, Loeb and colleagues developed minimum criteria for the initiation of antibiotics in LTC setting (Loeb, M., et al. 2001). The criteria have been tested in several studies, but their implementation and tests of validity have been limited. In particular, though Loeb and colleagues developed distinct minimum criteria for several types of infection (skin and soft-tissue, respiratory, urinary tract, and unexplained fever), a rigorous evaluation has been conducted only for urinary tract infections.

---

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

Citations for New Statutory Requirements: None

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 23266	05/03/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 38104	07/01/2010
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
Nurse survey	Form #7	Nurse survey
Physician survey	Form #8	Physician survey
Pre-implementation semi-structured interviews	Form #1	Pre-Implementation Interview Discussion Guides
Administrator Interviews	Form #2	Administrator Interview Guide & Facility Information Form
Train-the-trainer training	Form #3	QI Program Guide
Train-the-nurses training	Form #4	SAUL QI Program Guide
Train-the-physicians training	Form #5	SAUL QI Program Guide
Final Semi-Structured Interview	Form #5	Final semi-Structured Interview Guide

---

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	966	0	0	966	0	0
Annual Time Burden (Hours)	441	0	0	441	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.

---

Annual Cost to Federal Government: $333,325

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

---

Common Form ICR:  No

---

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: 07/28/2010

---