[Federal Register Volume 76, Number 17 (Wednesday, January 26, 2011)]
[Notices]
[Pages 4700-4702]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1540]



[[Page 4700]]

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

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.
    This proposed information collection was previously published in 
the Federal Register on November 15th, 2010 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 February 25, 2011.

ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk 
Officer by fax at (202) 395-6974 (attention: AHRQs 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

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 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 decision-making 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 (QI) intervention program to 
optimize antibiotic prescribing practices;
    2. Evaluate the effect of the QI 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 9 months: 
Three months preceding the initiation of the QI 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

[[Page 4701]]

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 COP 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 COP on the use of 
antibiotics within the facility; and (5) the facility's view on the 
business case for Loeb Criteria COP. 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 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.

                                  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...............................               8             102            5/60              68
Staff training..................................  ..............
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    Total cost
                    Form name                      nursing homes       hours        wage rate *       burden
----------------------------------------------------------------------------------------------------------------
Loeb Criteria COF...............................               8              68             $33          $2,244
Staff training..................................  ..............
Initial Training................................               8             208              36           7,488
Re-training.....................................               4             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.

[[Page 4702]]



             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: January 11, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011-1540 Filed 1-25-11; 8:45 am]
BILLING CODE 4160-90-M