[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 hhs.gov">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
hhs.gov">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
[[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