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 Department of Health and Human Services Agency for Healthcare Research and Quality
 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 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 ß-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 
                    ( print 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
Form name
Number of 
                             facilities
Number of 
                             responses per facility
Hours per 
                             response
Total burden hoursMedical Records Extraction
2
7
15/60
4NH Provider Pre-Implementation Questionnaire
2
10
10/60
3NH Provider Post-Implementation Questionnaire
3
7.67
15/60
6ED Physician Post-implementation Questionnaire
1
30
15/60
8Nurse Pre/Post Implementation Questionnaire
3
41.67
5/60
10NH Leadership Post-Implementation Questionnaire
3
1
10/60
1Total
14
n/a
n/a
32
 
 
 Exhibit 2—Estimated Annualized Cost Burden
Form name
Number of 
                             facilities
Total burden hours
Average 
                             hourly wage rate *
Total cost 
                             burdenMedical Records Extraction
2
4
$31.99
$128NH Provider Pre-Implementation Questionnaire
2
3
83.59
251NH Provider Post-Implementation Questionnaire
3
6
83.59
502ED Physician Post-implementation Questionnaire
1
8
83.59
669Nurse Pre/Post Implementation Questionnaire
5
10
31.99
320NH Leadership Post-Implementation Questionnaire
3
1
51.45
51 1Total
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).
 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 costProject Administration
$60, 511
$30,256Initial Antibiogram Development and Implementation
47,618
23,809Expansion of Antibiogram Development and Implementation
36,948
18,474Toolkit—Development and Refinement
92,688
46,344Evaluation
153,978
76,989Final Report and Dissemination
67,071
33,536Total
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: March 15, 2011. Carolyn M. Clancy, Director.


[FR Doc. 2011-6848 Filed 3-24-11; 8:45 am] BILLING CODE 4160-90-M