[Federal Register Volume 75, Number 219 (Monday, November 15, 2010)]
[Notices]
[Pages 69677-69679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-28367]


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

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: ``Standardizing Antibiotic Use in Long-term Care Settings.'' 
In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, 
AHRQ invites the public to comment on this proposed information 
collection.

DATES: Comments on this notice must be received by January 14, 2011.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, by e-mail at <a href="/cdn-cgi/l/email-protection#fe9a918c978dd0929b98959189978a84bebfb6acafd0c29fde968c9b98c3" http: hhs.gov">hhs.gov</a>">doris.lefkowitz@AHRQ.hhs.gov</a>.
    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 
<a href="/cdn-cgi/l/email-protection#482c273a213b66242d2e23273f213c320809001a1966742968203a2d2e75" http: hhs.gov">hhs.gov</a>">doris.lefkowitz@AHRQ.hhs.gov</a>.

SUPPLEMENTARY INFORMATION: 

Proposed Project

Standardizing Antibiotic Use in Long-term Care Settings

    This project seeks to contribute to AHRQ's mission by optimizing 
antibiotic prescribing practices in nursing homes. Nursing homes serve 
as one of our most fertile breeding grounds for antibiotic-resistant 
strains of bacteria. Nursing home residents, with their combination of 
the effects of normal aging and multiple chronic diseases, have 
relatively high rates of infection. With high rates of respiratory, 
urinary, skin, and other infection comes a very high rate of antibiotic 
use that gives rise to Methicillin-resistant Staphylococcus aureus 
(MRSA), Vancomycin-resistant Enterococci (VRE), fluoroquinolone-
resistant strains of a variety of bacteria, and multi-drug resistant 
organisms (MDROs). Inappropriate antibiotic prescribing practices by 
primary care clinicians caring for residents in long-term care (LTC) 
communities is becoming a major public health concern. Antibiotics are 
among the most commonly prescribed pharmaceuticals in LTC settings, yet 
reports indicate that a high proportion of antibiotic prescriptions are 
inappropriate.
    In an effort to reduce antibiotic overprescribing, Loeb and 
colleagues

[[Page 69678]]

developed minimum criteria for the initiation of antibiotics in LTC 
setting. The criteria have been tested in several studies, but their 
implementation and tests of validity have been limited. In particular, 
though Loeb and colleagues developed distinct minimum criteria for 
several types of infection (skin and soft-tissue, respiratory, urinary 
tract, and unexplained fever), a rigorous evaluation has been conducted 
only for urinary tract infections.
    This project will assess an approach to using the Loeb criteria 
that requires minimal changes in facility procedures and, therefore, is 
likely to be widely adopted by nursing homes. The intervention makes 
use of a Communication and Order Form (COF), which has been designed by 
the researchers and will be used by the nurses and physicians to guide 
their decisionmaking about whether to order an antibiotic for a 
specific resident experiencing a specific infection. Twelve nursing 
homes will participate in this project with eight assigned to the 
intervention and four serving as controls. The eight intervention sites 
will be divided into two groups of four sites each, with one group 
receiving an additional follow-up training 2 months after the 
intervention.
    The objectives of the study are to:
    1. Implement a quality improvement (01) intervention program to 
optimize antibiotic prescribing practices;
    2. Evaluate the effect of the 01 intervention on antibiotic 
prescribing practices including validation of the Loeb minimum 
criteria; and
    3. Develop and execute a dissemination plan to ensure wide 
dissemination of the findings and recommendations for improving 
antibiotic prescribing behaviors in LTC settings.
    This study is being conducted by AHRQ through its contractor, the 
American Institutes for Research (AIR), 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

    The following data collection activities and trainings will be 
implemented to achieve the first two objectives of this project:
    1. Loeb criteria communication and Order Form--This form will be 
completed by staff in the eight intervention nursing homes to determine 
if the Loeb criteria have been met. The COF provides a logical decision 
model for determining the need for an antibiotic. Facility staff will 
complete the paper form and the data from the forms will be entered 
into a database by the project researchers. Based on a preliminary 
review of the infection logs at 4 nursing homes, we estimate that staff 
nurses will complete an average of 17 COFs per month per nursing home 
at the 8 nursing homes that will use the COF during the 6-month 
intervention period.
    2. Medical record reviews (MMR)--To be conducted by research staff 
to collect outcome data to determine antibiotic prescribing practices 
and their effects and to assess the resident's health and functional 
status, which are potentially important control variables. Outcome and 
control variables will be obtained by monthly chart review and review 
of the Nursing Home Minimum Data Set (MDS) for a period of nine months: 
three months preceding the initiation of the 01 intervention (for which 
the charts of all eligible residents will be abstracted for a 3-month 
period at one time), and every other month during a 6-month period 
following the inception of the intervention (for which the charts of 
all eligible residents will be abstracted for the preceding two months. 
AHRQ's contractor will conduct the data abstraction at all 12 
facilities (treatment and control). Since this data collection will not 
impose a burden on the facility staff, OMB clearance is not required.
    3. Staff training--Prior to implementation, the staff 
(administrators, nurses, and physicians) at all eight intervention 
sites will be trained in the proper use of the Loeb Criteria COF. Staff 
at four of the intervention sites will be trained a second time 2 
months after the initial training. We estimate that an average of 24 
nurses and 2 physicians will be trained at each nursing home.
    4. Pre-implementation semi-structured interview--The purpose of 
this interview is to gain an understanding of: (1) How the staff and 
the department(s) and/or wider facility perceive quality improvement, 
in general; (2) the amount of experience the site has in QI and its 
processes for handling infections; (3) why the facility decided to 
adopt the Loeb Criteria COF; and (4) the facility's goals for the Loeb 
Criteria COF implementation. Four staff members will be interviewed at 
each nursing home: two champions (likely the administrator, director of 
nursing, and/or the assistant director of nursing), one line nurse, and 
one staff physician. Questions vary by respondent type.
    5. Post-training semi-structured interview--The purpose of this 
interview is to measure the staff's: (1) Perceived adequacy of the 
training; (2) their reactions to the training; and (3) their plans for 
implementation. The same four persons at each nursing home who were 
interviewed for the pre-implementation semi-structured interviews will 
participate in this interview. Questions vary by respondent type.
    6. Post-implementation semi-structured interview--The purpose of 
this interview is to identify: (1) Facilitators and barriers to 
implementation; (2) how barriers were overcome; (3) what barriers 
remain; (4) perceived impacts of the Loeb Criteria COF on the use of 
antibiotics within the facility; and (5) the facility's view on the 
business case for Loeb Criteria COF. The same four persons at each 
nursing home who participated in the previous semi-structured 
interviews will participate in this interview. Questions do not vary by 
respondent type.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the 
nursing homes' time to participate in this project. All of the data 
collections and training in Exhibit 1 pertain only to the eight 
intervention nursing homes. The Loeb Criteria COF will be completed 
approximately 17 times a month for 6 months (102 total) by staff at 
each nursing home and will require about 5 minutes to complete. Staff 
training will be attended by all nursing and medical staff members at 
each nursing home (an average of 24 nurses and two physicians per 
facility) and will last 1 hour. All eight intervention facilities will 
receive training once at the start of the intervention and four of the 
eight facilities will receive a second training one month later to see 
if reinforcement results in improved performance. The pre-
implementation, post training and post-implementation semi-structured 
interviews will be completed by the same four staff members at each 
nursing home consisting of two champions (likely the administrator, 
director of nursing, and/or the assistant director of nursing), one 
line nurse, and one staff physician. Each interview will be scheduled 
for 1 hour. The total annual burden is estimated to be 476 hours.
    Exhibit 2 shows the estimated annual cost burden associated with 
the respondents' time to participate in this project. The total annual 
cost burden is estimated to be $17,508.

[[Page 69679]]



                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                   nursing homes   nursing home      response          hours
----------------------------------------------------------------------------------------------------------------
Loeb Criteria COF Staff training................               8             102            5/60              68
Initial Training................................               8              26               1             208
Re-training.....................................               4              26               1             104
Pre-implementation semi-structured interview....               8               4               1              32
Post training semi-structured interview.........               8               4               1              32
Post-implementation semi-structured interview...               8               4               1              32
                                                 ---------------------------------------------------------------
    Total.......................................              44              na              na             476
----------------------------------------------------------------------------------------------------------------


                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of     Total burden   Average hourly
                    Form name                      nursing homes       hours        wage rate*     Total burden
----------------------------------------------------------------------------------------------------------------
Loeb Criteria COF Staff training................               8              68             $33          $2,244
Initial Training................................               8             208              36           7,488
Re-training.....................................               8             104              36           3,744
Pre-implementation semi-structured interview....               8              32              42           1,344
Post training semi-structured interview.........               8              32              42           1,344
Post-implementation semi-structured interview...               8              32              42           1,344
                                                 ---------------------------------------------------------------
    Total.......................................              44             476              na          17,508
                                                 ---------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
* Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United
  States May 2009, ``U.S. Department of Labor, Bureau of Labor Statistics.'' $33 is the average wage for nurses
  who will complete the COF. $36 is the weighted average wage of 24 nurses at $33 per hour and 2 physicians at
  $70 per hour who will be trained. $42 is the weighted average wage of 3 nurses and administrators at $33 per
  hour and 1 physician at $70 per hour who will be interviewed.

Estimated Annual Costs to the Federal Government

    Exhibit 3 shows the estimated total and annual cost to the 
government for funding this project. Although data collection will 
require less than one year, the entire project will span 2 years. The 
total cost of this research is estimated to be $999,554.

             Exhibit 3--Estimated Total and Annualized Cost
------------------------------------------------------------------------
                                                            Annualized
             Cost component                 Total cost         cost
------------------------------------------------------------------------
Project Development.....................        $103,498         $51,749
Data Collection Activities..............         361,178         180,589
Data Processing and Analysis............         193,830          96,915
Publication of Results..................          48,497          24,249
Project Management......................          65,334          32,667
Overhead................................         227,217         113,609
                                         -------------------------------
    Total...............................        $999,554        $499,777
------------------------------------------------------------------------

Request for Comments

    In accordance with the above-cited Paperwork Reduction Act 
legislation, 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: November 4, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010-28367 Filed 11-12-10; 8:45 am]
BILLING CODE 4160-90-M


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>