[Federal Register Volume 76, Number 58 (Friday, March 25, 2011)]
[Notices]
[Pages 16783-16785]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6848]
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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 Reduction
Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this
proposed information collection.
DATES: Comments on this notice must be received by May 24, 2011.
ADDRESSES: Written comments should be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by e-mail at
doris.lefkowitz@AHRQ.hhs.gov.
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
[[Page 16784]]
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 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 is 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 response 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
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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 51.45 511
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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).
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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Annualized
Cost component Total cost
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Project Administration.................. $60, 511 $30,256
Initial Antibiogram Development and 47,618 23,809
Implementation.........................
Expansion of Antibiogram Development and 36,948 18,474
Implementation.........................
Toolkit--Development and Refinement..... 92,688 46,344
Evaluation.............................. 153,978 76,989
Final Report and Dissemination.......... 67,071 33,536
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Total............................... 458,812 229,406
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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: March 15, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011-6848 Filed 3-24-11; 8:45 am]
BILLING CODE 4160-90-M