Agency Information Collection Activities; Proposed Collection; Comment Request, 32209-32212 [2011-13742]

Download as PDF 32209 Federal Register / Vol. 76, No. 107 / Friday, June 3, 2011 / Notices Number of respondents Data collection Number of responses per respondent Hours per response Total burden hours Screening Questionnaire ................................................................................. In-Person Focus Groups EHR Users only ...................................................... Virtual Focus Groups EHR Users only ............................................................ Virtual Focus Groups EHR Non-users only ..................................................... 300 40 29 20 1 1 1 1 12/60 2 2 1.5 60 80 58 30 Total .......................................................................................................... 389 na na 228 Exhibit 2. Estimated Annualized Cost Burden Number of respondents Data collection Total burden hours Average hourly wage rate* Total cost burden Screening Questionnaire ................................................................................. In-Person Focus Groups EHR Users only ...................................................... Virtual Focus Groups EHR Users only ............................................................ Virtual Focus Groups EHR Non-users only ..................................................... 300 40 29 20 60 80 58 30 73.66 73.66 73.66 73.66 $4,420 5,893 4,272 2,210 Total .......................................................................................................... 389 228 na $16,795 *Hourly wage rate is the weighted average of hourly rates of the types of professionals who will complete the screening questionnaire and participate in the focus groups. The weighted average includes the following occupational codes and wage rates: 29–1065 (Pediatricians, General), $78.67; 29–1069 (Physicians and Surgeons, all others), $97.35; 29–1021 (Dentists, General), $76.61; 29–1111 (Registered Nurses, includes Certified Nurse Midwives), $32.35; 29–1071 (Physician Assistants), $41.86. Source: ‘‘National Compensation Survey: Occupational Wages in the United States 2009,’’ U.S. Department of Labor, Bureau of Labor Statistics. Estimated Annual Costs to the Federal Government for conducting this research. The total cost is estimated to be $424,493. Exhibit 3. Estimated Total and Annualized Cost Exhibit 3 shows the estimated total and annualized cost to the government Cost component Total cost Annualized cost $79,313 99,464 49,732 38,415 37,601 119,968 $39,657 49,732 24,866 19,208 18,801 59,984 Total .......................................................................................................................................................................... jlentini on DSK4TPTVN1PROD with NOTICES Project Development ....................................................................................................................................................... Data Collection Activities ................................................................................................................................................. Data Processing and Analysis ......................................................................................................................................... Publication of Results ...................................................................................................................................................... Project Management ........................................................................................................................................................ Overhead ......................................................................................................................................................................... $424,493 $212,247 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. VerDate Mar<15>2010 15:49 Jun 02, 2011 Jkt 223001 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. DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency Information Collection Activities; Proposed Collection; Comment Request Agency for Healthcare Research and Quality, HHS. ACTION: Notice. AGENCY: [FR Doc. 2011–13740 Filed 6–2–11; 8:45 am] BILLING CODE 4160–90–M PO 00000 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 SUMMARY: Frm 00075 Fmt 4703 Sfmt 4703 E:\FR\FM\03JNN1.SGM 03JNN1 32210 Federal Register / Vol. 76, No. 107 / Friday, June 3, 2011 / Notices 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 jlentini on DSK4TPTVN1PROD with NOTICES 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 culturepositive for one or more antimicrobialresistant pathogens, including methicillin-resistant staphylococcus aureas (24 percent), extended-spectrum +-lactamase-producing klebsiella pneumoniae (18 percent) or Escherichia coli (15 percent), and vancomycinresistant enterococci. Inappropriate overprescribing and overuse of broadspectrum 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 VerDate Mar<15>2010 15:49 Jun 02, 2011 Jkt 223001 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 broadspectrum 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 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 (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 postimplementation 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 E:\FR\FM\03JNN1.SGM 03JNN1 32211 Federal Register / Vol. 76, No. 107 / Friday, June 3, 2011 / Notices 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 postimplementation 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 PostImplementation 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 PostImplementation 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 Number of responses per facility Number of facilities Form name Medical Records Extraction ........................................................................... NH Provider Pre-Implementation Questionnaire ........................................... NH Provider Post-Implementation Questionnaire .......................................... ED Physician Post-implementation Questionnaire ........................................ Nurse Pre/Post Implementation Questionnaire ............................................. NH Leadership Post-Implementation Questionnaire ..................................... 2 2 3 1 3 3 Total ........................................................................................................ 7 10 7.67 30 41.67 1 14 Hours per resonse Total burden hours 4 3 6 8 10 1 n/a n/a 15/60 10/60 15/60 15/60 5/60 10/60 32 EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN Number of facilities Form name Total burden hours Average hourly wage rate* Total cost burden jlentini on DSK4TPTVN1PROD with NOTICES Medical Records Extraction ............................................................................. NH Provider Pre-Implementation Questionnaire ............................................. NH Provider Post-Implementation Questionnaire ............................................ ED Physician Post-implementation Questionnaire .......................................... Nurse Pre/Post Implementation Questionnaire ............................................... NH Leadership Post-Implementation Questionnaire ....................................... 2 2 3 1 5 3 4 3 6 8 10 1 $31.99 83.59 83.59 83.59 31.99 51.45 $128 251 502 669 320 51 Total .......................................................................................................... 14 32 n/a 1,921 *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). VerDate Mar<15>2010 15:49 Jun 02, 2011 Jkt 223001 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 E:\FR\FM\03JNN1.SGM 03JNN1 32212 Federal Register / Vol. 76, No. 107 / Friday, June 3, 2011 / Notices Estimated Annual Costs to the Federal Government research. The total budget for this two year study is $458,812. Exhibit 3 shows the total and annualized cost for conducting this EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST Cost component Total Annualized cost Project Administration .................................................................................................................................. Initial Antibiogram Development and Implementation ................................................................................. Expansion of Antibiogram Development and Implementation .................................................................... Toolkit—Development and Refinement ....................................................................................................... Evaluation .................................................................................................................................................... Final Report and Dissemination .................................................................................................................. $60,511 47,618 36,948 92,688 153,978 67,071 $30,256 23,809 18,474 46,344 76,989 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES jlentini on DSK4TPTVN1PROD with NOTICES Centers for Disease Control and Prevention [30Day–11–0106] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) publishes a list of VerDate Mar<15>2010 15:49 Jun 02, 2011 Jkt 223001 information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 395–5806. Written comments should be received within 30 days of this notice. Proposed Project Preventive Health and Health Services Block Grant (OMB No. 0920–0106, exp. 8/31/2011)—Revision—National Center for Chronic Disease Prevention and Health Promotion (NCDDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Preventive Health and Health Services Block Grant program provides awardees with their primary source of flexible funding for health promotion and disease prevention programs. Sixtyone awardees (50 states, the District of Columbia, two American Indian Tribes, and eight U.S. territories) currently receive block grants from CDC in order to address locally-defined public health needs in innovative ways. Block Grants allow awardees to prioritize the use of funds to fill funding gaps in programs that deal with the leading causes of death and disability. Block Grants also improve awardees’ ability to respond rapidly to emerging health issues. CDC currently collects standardized application and performance information from each awardee through a web-based system called the Block Grant Management Information System (BGMIS). As required by the authorizing legislation for the Block Grant program, the BGMIS collects information by the PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 areas described in Healthy People National Health Objectives, and improves adherence to its goals. The BGMIS requires awardees to enter their objectives in SMART (Specific, Measurable, Achievable, Realistic, and Time-based) format, and to use evidence based guidelines and best practices as the basis for public health programs and interventions. Finally, the BGMIS information collection includes a Compliance Review section, which provides feedback to each awardee pertaining to its past reviews. Information will be collected from awardees twice per year, once for the annual Work Plan, and once for the Annual Report. CDC will continue to use the information collected from Block Grant awardees to provide oversight and direction to recipients and to inform CDC management, decision makers, and the general public about PHHS Block Grant allocations, activities, and outcomes. There are no changes to the information being collected during the period of this Revision request, however, there are expected reductions in the estimated burden per response for both the Work Plan and the Annual Report. These reductions are due to changes in the BGMIS, which has been modified to allow pre-population of some fields. Respondents will only need to update information already entered into the system, thus improving the efficiency of reporting and reducing the burden per response. In addition, the guidance documents for both information collections are being revised to improve their usability. All information is collected electronically. There are no costs to respondents other than their time. The estimated annualized burden hours are 2,135. E:\FR\FM\03JNN1.SGM 03JNN1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                    facilities       facility         resonse          hours
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------


                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                    Form name                        Number of     Total burden     hourly wage     Total cost
                                                    facilities         hours           rate*          burden
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
*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
------------------------------------------------------------------------
          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