[Federal Register Volume 79, Number 172 (Friday, September 5, 2014)]
[Notices]
[Pages 53064-53066]
From the Federal Register Online via the Government Publishing 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
[email protected].
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
[email protected].
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
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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
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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
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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
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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