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[Federal Register Volume 79, Number 172 (Friday, September 5, 2014)]
[Notices]
[Pages 53064-53066]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20422]

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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: ``Guide to Nursing Home Antimicrobial Stewardship.'' In 
accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 
(44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this 
proposed information collection.
    This proposed information collection was previously published in 
the Federal Register on May 21st 2014 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 October 6, 2014.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, by email 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 email at 
doris.lefkowitz@ahrq.hhs.gov.

SUPPLEMENTARY INFORMATION:

Proposed Project

Guide to Nursing Home Antimicrobial Stewardship

    This project seeks to contribute to AHRQ's mission by assisting 
nursing homes to optimize antimicrobial (e.g., antibiotics and 
antifungals) prescribing practices, also referred to as antimicrobial 
stewardship. Antimicrobial stewardship programs reduce the development 
of drug-resistant organisms, enhance patient outcomes, and reduce 
unnecessary costs.
    Nursing homes serve as one of our most fertile breeding grounds for 
antibiotic-resistant strains of bacteria. This stems from high rates of 
infection in nursing home residents due to the effects of normal aging 
combined with multiple chronic diseases. The most common infections 
encountered in nursing home residents are pneumonia, urinary tract 
infections, and skin and soft tissue infections. In one study by 
Yoshikawa and Norman, researchers found that these three types of 
infections accounted for approximately 75 percent of all nursing home-
associated infections (NHAIs). High

[[Page 53065]]

rates of these infections lead to antimicrobials being among the most 
commonly prescribed pharmaceuticals in long-term care settings. In 
nursing homes, where polypharmacy is the rule rather than the 
exception, as many as 40 percent of all prescriptions are for 
antimicrobial agents, and depending on the study, 25 percent to 75 
percent have been deemed inappropriately prescribed. Such inappropriate 
prescribing results in negative outcomes, including adverse drug 
events, hospital admissions, and higher health care costs. Most 
significantly, inappropriate antimicrobial prescribing gives rise to 
the development of multi-drug resistant organisms (MDROs), including 
Methicillin-resistant Staphylococcus aureus, Vancomycin-resistant 
Enterococci, and fluoroquinolone-resistant strains of a variety of 
bacteria, and leads to the development of Clostridium difficile 
infections.
    In general, determining ``appropriateness'' of antimicrobial use in 
healthcare settings is challenging to standardize. This becomes even 
more complicated in the nursing home setting because most antimicrobial 
courses are started empirically (without results from labs) due to the 
limited diagnostics available to many nursing homes. In an effort to 
address the need for optimizing antibiotic use in the nursing homes, 
AHRQ is testing a Guide to Nursing Home Antimicrobial Stewardship (the 
Guide). The Guide is intended to help nursing home staff easily 
identify toolkits that have been shown to be effective in optimizing 
antimicrobial use. There are multiple toolkits that could be used by a 
nursing home, and nursing homes face a potentially time-consuming 
decision process to choose the most appropriate one. The Guide is 
intended to help nursing homes make this choice efficiently and 
effectively.
    The research has the following goals:
     Develop a nursing home-specific antimicrobial stewardship 
guide, containing toolkits to assist nursing homes to optimize 
antimicrobial prescribing practices, monitor microbes and antimicrobial 
use, enhance communication between nursing home staff and attending 
clinicians, and enhance communication and engagement with residents and 
family members regarding optimizing antimicrobial practices.
     Evaluate the ability of nursing homes to use the Guide and 
improve antimicrobial use through better stewardship.
     Develop a plan to ensure wide dissemination of the 
findings and recommendations for antimicrobial stewardship uptake in 
nursing homes.
    This study is being conducted by AHRQ through its contractor, 
American Institutes for Research, pursuant to AHRQ'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

    To achieve the goals of this project the following data collections 
will be implemented:
    (1) Medical Record Review (MRR). The MRR will be used to obtain 
data about antimicrobial prescribing practices, infection prevalence, 
and residents' health and functional statuses. These data will be used 
in the evaluation of the Guide's impact. Members of the research team 
will review the nursing home's medical charts, the Nursing Home Minimum 
Data Set (MDS), and the nursing home's infection control log for an 
evaluation period of at least 12 months (6 months before and 6 months 
after the introduction of the Guide). The MDS is part of the federally 
mandated process for clinical assessment of all residents in Medicare 
and Medicaid certified nursing homes. This process provides a 
comprehensive assessment of each resident's functional capabilities and 
helps nursing home staff identify health problems. Care Area 
Assessments are part of this process, and provide the foundation upon 
which a resident's individual care plan is formulated. MDS assessments 
are completed for all residents in certified nursing homes, regardless 
of source of payment for the individual resident. AHRQ will support 
data abstraction at all nursing homes.
    (2) Cost Data Analysis. AHRQ will use the number and type of 
antimicrobial prescriptions and secondary estimates of the unit cost of 
these prescriptions, obtained from external sources, to compute the 
marginal impact of the Guide on the cost of antimicrobials for nursing 
homes.
    (3) Pre-intervention interviews with nursing home leaders. The 
purpose of these interviews is to gain an understanding of perceptions 
and current activities regarding antimicrobial stewardship and to 
assess the likelihood that the Guide will be used with a reasonable 
degree of fidelity to the implementation plan. This will involve both 
closed and open-ended interviews with nursing home leaders 
(administrator, director of nursing, assistant director of nursing, 
and/or medical director). The open ended interviews will examine (1) 
how the staff perceive antimicrobial stewardship; (2) the amount of 
experience the staff has in antimicrobial stewardship and its processes 
for handling the diagnosis and treatment of infections; and (3) which 
toolkit or toolkits are likely to be adopted and why. This information 
will help us identify interests by nursing homes and potential barriers 
to adopting a toolkit from the Guide. This information also will be 
used to develop dissemination guidance. The closed ended interview 
questions, will be comprised of the Absorptive Capacity for Change 
survey, which asks about (1) leadership culture; (2) clinician culture; 
(3) presence of certified medical directors; and (4) level of 
antimicrobial surveillance. For the Evaluation, two leadership staff at 
each nursing home will be interviewed for a total of 20 interviews 
prior to implementing the intervention.
    (4) Passive Technical Assistance (TA). The purpose of collecting 
these data is to obtain information on the types of TA needed as they 
emerge during the 6-month intervention period. This information will be 
used to improve the Guide. AHRQ projects 60 contacts from nursing home 
staff involved in implementing the Guide (10 sites, one per month at 
each site during the 6-month intervention period).
    (5) Proactive TA discussions. The purpose of collecting these data 
is to obtain information on the facilitators, challenges, and 
unintended consequences of implementing a particular tool or toolkit. 
These informal discussions will be held at each nursing home once a 
month during the 6-month intervention phase. Staff will be asked about 
what activities they are conducting, changes to implementation, any 
facilitators, any challenges, and how they have addressed any 
challenges. This information will be used to improve the Guide. For the 
Evaluation, two individuals from each nursing home are projected to 
attend each of the six conference calls for a total of 20 individuals 
and a total of 120 contacts.
    (6) Post-intervention interviews. The purpose of these interviews 
is to identify (1) facilitators and barriers to implementation; (2) 
perceived impacts of the Guide on the use of antimicrobials within the 
nursing home; (3) the nursing home's views on the business case for the 
Guide; and (4) ways to improve the tools. At a minimum two nursing home 
leaders and two champions (if different from

[[Page 53066]]

leaders) will be interviewed. In addition, depending on the tool or 
toolkit selected, up to two prescribing clinicians, two nurses, or two 
residents or family members might be interviewed after the 6-month 
intervention period is completed. No more than six individuals per 
nursing home will be interviewed for a total of 60 interviewees. 
Interviews may take place together.
    The information described above will be used to evaluate the Guide 
and, if found to be effective, develop a wide-spread dissemination plan 
for the Guide.
Estimated Annual Respondent Burden
    Exhibit 1 shows the estimated annualized burden hours for the 
respondents' time to participate in this information collection.

                                  Exhibit 1--Estimated Annualized Burden Hours
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                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
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Passive TA Collection Protocol..................              20               3           20/60              20
General Review of the Guide.....................              20               1               2              40
Pre-intervention interview protocol.............              20               1               1              20
Proactive TA discussion protocol................              20               6           30/60              60
Post-intervention interview protocols...........              60               1               1              60
                                                 ---------------------------------------------------------------
    Total.......................................             140              na              na             200
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                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                     Number of     Total burden   Average hourly    Total cost
                    Form name                       respondents        hours        wage rate *       burden
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Passive TA Collection Protocol..................              20              20          $30.34            $607
General review of the Guide.....................              20              40           30.34           1,214
Pre-intervention interview protocol.............              20              20           30.34             607
Proactive TA discussion protocol................              20              60           30.34           1,820
Post-intervention interview protocols...........              60              60           30.34           1,820
                                                 ---------------------------------------------------------------
    Total.......................................             140             200              na           6,068
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* National Compensation Survey: Occupational wages in the United States May 2013, ``U.S. Department of Labor,
  Bureau of Labor Statistics.'' We used an average across the following types of staff: Nursing home registered
  nurses ($29.81) 29-1141, nursing home licensed practical/vocational nurses ($21.14) 29-2061, and nursing home
  administrator ($40.07) 11-9111. Our average was created by adding each of these three and dividing by three
  for the average. Sources: http://www.bls.gov/oes/current/oes291141.htm and http://www.bls.gov/oes/current/oes292061.htm; http://www.bls.gov/oes/current/oes119111.htm.

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 health care research and 
health care 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: August 20, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014-20422 Filed 9-4-14; 8:45 am]
BILLING CODE 4160-90-M
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