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[Federal Register Volume 76, Number 107 (Friday, June 3, 2011)]
[Notices]
[Pages 32209-32212]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13742]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality

Agency Information Collection Activities; Proposed Collection; 
Comment Request

AGENCY: Agency for Healthcare Research and Quality, HHS.

ACTION: Notice.

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SUMMARY: This notice announces the intention of the Agency for 
Healthcare Research and Quality (AHRQ) to request that the Office of 
Management and Budget (OMB) approve the proposed information collection 
project: ``Using Nursing Home Antibiograms to Improve Antibiotic 
Prescribing and Delivery.'' In accordance with the Paperwork

[[Page 32210]]

Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment 
on this proposed information collection.
    This proposed information collection was previously published in 
the Federal Register on March 25th, 2011 and allowed 60 days for public 
comment. No comments were received. The purpose of this notice is to 
allow an additional 30 days for public comment.

DATES: Comments on this notice must be received by July 5, 2011.

ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk 
Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by 
e-mail at OIRA_submission@omb.eop.gov (attention: AHRQ's desk 
officer).
    Copies of the proposed collection plans, data collection 
instruments, and specific details on the estimated burden can be 
obtained from the AHRQ Reports Clearance Officer.

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports 
Clearance Officer, (301) 427-1477, or by e-mail at 
doris.lefkowitz@AHRQ.hhs.gov.

SUPPLEMENTARY INFORMATION: 

Proposed Project

Using Nursing Home Antibiograms to Improve Antibiotic Prescribing and 
Delivery

    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 [szlig]-
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.
    Physicians typically begin antibiotics for suspected infections in 
NH residents without waiting for bacteriology laboratory culture 
results. If there is a clinical failure (e.g., patient does not 
improve), the physician may request a bacteriology laboratory test, but 
will often try a second antibiotic without waiting for culture 
confirmation. If a NH resident is deteriorating, many NHs do not try a 
second antibiotic but will instead transfer the patient to a hospital 
emergency department (ED). In the ED, physicians must make quick 
decisions about whether to continue the first antibiotic prescribed in 
the NH or start another, again often without culture results.
    NH patients are transferred to EDs for all sorts of medical 
reasons, including but not limited to infections. When NH patients 
arrive at an ED, physicians may identify a urinary tract, respiratory, 
or other infection that was not the primary reason for the ED visit. 
Thus, patients may not leave the NH with a suspected bacterial 
infection or taking any antibiotics, but an infection is suspected in 
the ED and the first antibiotic is prescribed there.
    As a result of the above complexities, NHs are increasingly 
recognized as reservoirs of antibiotic-resistant bacteria. Antibiograms 
aggregate information for an entire institution over a period of 
several months or a year. They display the organisms present in 
clinical specimens sent for laboratory testing, and the susceptibility 
of each organisms to an array of antibiotics. Antibiograms are 
routinely prepared by hospital laboratories but are not routine in the 
NH setting. The culmination of this project will be a NH Antibiogram 
toolkit so that NHs can create facility-specific antibiograms that are 
cost-effective and helpful to physicians who must make antibiotic 
prescription decisions without bacteriology laboratory test results, 
for patients in NHs, and for patients who are transferred from the NH 
to the ED. Outcomes of interest for antibiograms include reduced 
reliance on broad-spectrum antibiotics as initial therapy, and fewer 
clinical failures of antibiotics that are first prescribed. The 
development of a toolkit will be the first step in this process; future 
studies are required to test the toolkit and, subsequently, the 
effectiveness of NH antibiograms.
    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.
    Three NHs and one ED will participate in this study, which will be 
conducted in two phases. The first phase will include one small NH and 
one ED and is intended to test the data collection instruments and to 
draft the initial toolkit, including the creation of a NH specific 
antibiogram. The second phase will expand the study by adding two 
larger NHs, while retaining the same NH and ED as in the first phase 
and is intended to further test the data collection instruments and 
refine the draft toolkit. Each phase will use the same methods and data 
collections.
    This study is being conducted by the Agency for Healthcare Research 
and Quality through its contractors, Abt Associates and the Brigham and 
Women's Hospital ED, pursuant to the Agency for Healthcare Research and 
Quality's statutory authority to conduct and support research on 
healthcare and on systems for the delivery of such care, including 
activities with respect to the quality, effectiveness, efficiency, 
appropriateness and value of healthcare services and with respect to 
quality measurement and improvement. 42 U.S.C. 299a(a)(1) and (2).

Method of Collection

    The following data collection activities will be implemented to 
achieve the objectives of this project:
    (1) Medical Records Extraction. Medical record data related to 
antibiotic use will be extracted by the research team at the three 
participating NHs and one ED. The team will extract the necessary data 
from the infection control log and request access to additional records 
(e.g., medication log and/or patient medical record) as needed to 
collect relevant data. Two months of retrospective NH and ED medical 
records will be reviewed prior to the implementation period, on a 
monthly basis during implementation, and for one month post-
implementation. In the ED medical records will be extracted for only 
those NH residents who have been transferred to the ED from one of the 
participating NHs. The pre-implementation data will be compared to the 
data collected during implementation and post-implementation to see if 
the use of the antibiogram report had an effect on antibiotic use at 
the participating facilities. It is unlikely, but possible, that NH 
staff may be asked to assist the research team with this task in the 
two larger, Expansion Phase Two sites; however, ED staff will not. 
Medical record extraction during Phase One will

[[Page 32211]]

occur prior to OMB clearance and will be limited to 9 or fewer records.
    (2) Provider Pre-Implementation and Post-Implementation 
Questionnaires. These questionnaires will be completed by providers at 
both the NHs and ED one month prior to implementation and again in the 
final month of implementation. NH and ED questions differ somewhat, as 
do pre- and post-implementation surveys. In addition to basic 
background questions such as the providers' title, type of residency 
and length of practice, questions related to their use and opinion of 
antibiograms are included. The post-implementation questionnaire 
contains three additional questions related to the use of antibiograms 
as well as a series of vignettes administered before and after the 
presentation of an antibiogram report. These questionnaires will assess 
change in the providers' use and opinion of antibiograms.
    (3) Nurse Pre/Post-Implementation Questionnaire. This questionnaire 
will be administered one month prior to implementation and again in the 
final month of implementation. In addition to basic background 
questions such as the nurses' title, position at the NH and length of 
employment, questions related to their use and opinion of antibiograms 
are included. The same set of questions are asked at each time period. 
This questionnaire will measure any change in the nurses' use and 
opinion of antibiograms.
    (4) NH Leadership Post-Implementation Questionnaire. This 
questionnaire will be completed by the NH administrator or the director 
of nursing in the final month of the implementation. In addition to 
basic background questions such as their title, position at the NH and 
length of employment, questions are asked about the impact the 
antibiograms had in terms of antibiotic use, the cost associated with 
their use and whether they intend to continue using them once the study 
has been completed.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the 
respondents' time to participate in this research. Although medical 
records extraction using the NH and ED Data Extraction Tools will occur 
at the NHs and ED, the potential information collection burden will be 
limited to staff at each of the Expansion Phase 2 NHs. Medical record 
data extraction will occur monthly for 7 months at the two Expansion 
Phase Two NHs and may require 15 minutes assistance from the NH staff.
    The NH Provider Pre-Implementation Questionnaire will be completed 
by 10 providers at each of the two Expansion Phase Two NHs and will 
take about 10 minutes to complete. The NH Provider Post-Implementation 
Questionnaire will be completed by three providers in the Initial Phase 
One NH and 10 providers at each of the two Expansion Phase Two NHs (23 
total or an average of 7.67 providers per NH as shown in Exhibit 1) and 
takes 15 minutes to complete. The ED Provider Post-Implementation 
Questionnaire will be completed by 30 providers in the ED and requires 
15 minutes to complete. The Nurse Pre/Post Implementation Questionnaire 
will be completed pre-implementation by approximately 25 nurses at each 
of the two Expansion Phase Two NHs and again post-implementation by 25 
nurses at each of the 3 participating NHs (125 total or an average of 
41.67 nurses per NH as shown in Exhibit 1). The Nurse Pre/Post-
Implementation Questionnaire is estimated to take 5 minutes to 
complete. The NH Leadership Post-Implementation Questionnaire will be 
completed by one NH administrator or director of nursing at each of the 
three participating NHs and will require 10 minutes to complete. The 
total annualized burden hours are estimated to be 32 hours.
    Exhibit 2 shows the estimated annual cost burden to the respondent, 
based on their time to participate in this research. The annual cost 
burden is estimated to be $1,921.

                                  Exhibit 1--Estimated Annualized Burden Hours
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                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                    facilities       facility         resonse          hours
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Medical Records Extraction......................               2            7              15/60               4
NH Provider Pre-Implementation Questionnaire....               2           10              10/60               3
NH Provider Post-Implementation Questionnaire...               3            7.67           15/60               6
ED Physician Post-implementation Questionnaire..               1           30              15/60               8
Nurse Pre/Post Implementation Questionnaire.....               3           41.67            5/60              10
NH Leadership Post-Implementation Questionnaire.               3            1              10/60               1
                                                 ---------------------------------------------------------------
    Total.......................................              14          n/a                n/a              32
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                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                                                      Average
                    Form name                        Number of     Total burden     hourly wage     Total cost
                                                    facilities         hours           rate*          burden
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Medical Records Extraction......................               2               4          $31.99            $128
NH Provider Pre-Implementation Questionnaire....               2               3           83.59             251
NH Provider Post-Implementation Questionnaire...               3               6           83.59             502
ED Physician Post-implementation Questionnaire..               1               8           83.59             669
Nurse Pre/Post Implementation Questionnaire.....               5              10           31.99             320
NH Leadership Post-Implementation Questionnaire.               3               1           51.45              51
                                                 ---------------------------------------------------------------
    Total.......................................              14              32             n/a           1,921
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*Based upon the mean of the average wages, National Occupational Employment and Wage Estimates, U.S. Department
  of Labor, Bureau of Labor Statistics. May 2009. Hourly mean wage for registered nurse ($31.99), physician
  ($83.59), and NH administrator ($51.45).

[[Page 32212]]

Estimated Annual Costs to the Federal Government

    Exhibit 3 shows the total and annualized cost for conducting this 
research. The total budget for this two year study is $458,812.

             Exhibit 3--Estimated Total and Annualized Cost
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          Cost component                  Total         Annualized cost
------------------------------------------------------------------------
Project Administration............            $60,511            $30,256
Initial Antibiogram Development                47,618             23,809
 and Implementation...............
Expansion of Antibiogram                       36,948             18,474
 Development and Implementation...
Toolkit--Development and                       92,688             46,344
 Refinement.......................
Evaluation........................            153,978             76,989
Final Report and Dissemination....             67,071             33,536
                                   -------------------------------------
    Total.........................            458,812            229,406
------------------------------------------------------------------------

Request for Comments

    In accordance with the Paperwork Reduction Act, comments on AHRQ's 
information collection are requested with regard to any of the 
following: (a) Whether the proposed collection of information is 
necessary for the proper performance of AHRQ healthcare research and 
healthcare information dissemination functions, including whether the 
information will have practical utility; (b) the accuracy of AHRQ's 
estimate of burden (including hours and costs) of the proposed 
collection(s) of information; (c) ways to enhance the quality, utility, 
and clarity of the information to be collected; and (d) ways to 
minimize the burden of the collection of information upon the 
respondents, including the use of automated collection techniques or 
other forms of information technology.
    Comments submitted in response to this notice will be summarized 
and included in the Agency's subsequent request for OMB approval of the 
proposed information collection. All comments will become a matter of 
public record.

    Dated: May 20, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011-13742 Filed 6-2-11; 8:45 am]
BILLING CODE 4160-90-M
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