[Federal Register Volume 75, Number 126 (Thursday, July 1, 2010)]
[Notices]
[Pages 38104-38107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-15796]


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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: ``Standardizing Antibiotic Use in Long-Term Care Settings 
(SAUL) Study.'' In accordance with the Paperwork Reduction Act, 44 
U.S.C. 3501-3520,

[[Page 38105]]

AHRQ invites the public to comment on this proposed information 
collection.
    This proposed information collection was previously published in 
the Federal Register on May 3rd, 2010 and allowed 60 days for public 
comment. One comment was 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 August 2, 2010.

ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk 
Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by 
e-mail at [email protected] (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 
[email protected].

SUPPLEMENTARY INFORMATION: 

Proposed Project

    Standardizing Antibiotic Use in Long-Term Care Settings (SAUL) 
Study Inappropriate antibiotic prescribing practices by primary care 
clinicians caring for residents in long-term care (LTC) communities is 
becoming a major public health concern as it is a risk factor for 
morbidity and mortality among LTC residents. Antibiotics are among the 
most commonly prescribed pharmaceuticals in LTC settings, yet reports 
indicate that a high proportion of antibiotic prescriptions are 
inappropriate. The adverse consequences of inappropriate prescribing 
practices are serious and include drug reactions/interactions, 
secondary complications, and the emergence of multi-drug resistant 
organisms.
    In an effort to reduce antibiotic overprescribing, Loeb and 
colleagues developed minimum criteria for the initiation of antibiotics 
in LTC setting (Loeb, M., et al. 2001). 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.
    Twelve nursing homes (NH) will participate in this project; six NHs 
will be recruited to serve as treatment sites and six to serve as 
control sites. Once a nursing home community has been selected and 
randomly assigned to the treatment or control group, a facility 
recruitment letter will be sent to the facility Administrator. The 
letter will include a description of the study and inform the 
Administrator that the project manager will be calling in the near 
future to further discuss the project and answers any questions that 
he/she might have regarding the program.
    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.
    To address the first study objective, the research team will 
conduct a six-month QI intervention program in the six treatment sites 
to improve antibiotic prescribing practices. The intervention 
incorporates investigative evidence including the Loeb algorithms. QI 
program procedures are documented in the draft intervention manual, 
including the Loeb algorithms. The protocol recognizes that not all 
factors will need attention in all instances, as (for example) some NHs 
may already be vigilant to advance directive completion. The QI program 
is intended for facilities to self-implement and monitor with guidance 
provided from the research team upon request.
    In order to validate the Loeb Criteria and to test the efficacy of 
the QI intervention, recruited facilities will be matched in pairs with 
respect to bedsize, profit status and location (urban, suburban, rural) 
and within each pair, one facility will be randomized to each study arm 
(treatment and control).
    This study is being conducted by AHRQ through its contractors, Abt 
Associates and the University of North Carolina, 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) Pre-implementation semi-structured interviews will be conducted 
separately with physicians, facility administrators and with the 
director of nursing (DON) or nurse educators (see Attachment D for each 
type of pre-implementation interview) from the six treatment sites. The 
purpose of these interviews is to generate ideas on how best to 
implement the new procedures and what approaches work best across 
facilities. Related risk factors and remedial strategies also will be 
identified. These interviews will take place during the three month 
baseline period and feedback will be used to modify the intervention 
materials as appropriate.
    (2) Administrator interviews will be conducted at the time of 
facility enrollment to collect facility-level data in order to describe 
the sample and to explore linkages to prescribing practices. General 
facility-level descriptors including size (number of beds), profit 
status, location (urban, suburban, rural), and staffing levels (number 
of full and part-time registered nurses, licensed practical nurses, and 
nurse aides) will be collected. Additionally, simple summary (facility-
level) information regarding resident demographics will be collected 
(e.g. age, gender, race/ethnicity, proportion long-stay vs. post-acute/
rehab). Facility data will be collected through interviews with the 
Administrator at all twelve facilities.
    (3) Train-the-trainer training will be conducted during the 
baseline period (prior to the implementation of the intervention). 
Research staff will present information about the Antibiotic Use QI and 
Monitoring Program at one, two-hour in-person meeting held at each 
treatment site. The research team will work with physicians (the 
physician champion at each facility; a physician champion is an expert 
that provides education, champions a cause or product, or gives support 
to staff around the diffusion and implementation of clinical practice 
guidelines, protocols, or research evidence), administrators, directors 
of nursing and nurse educators using a train-the-trainer model to offer 
guidance on educating intervention site staff on how to implement the 
Antibiotic Use QI Program that is based on the Loeb criteria. 
Intervention and training materials include those products and 
strategies used in other successful projects (e.g., written Loeb 
algorithms).
    (4) Train-the-nurses training will be conducted by the nurse 
educator at each of the six treatment sites following the

[[Page 38106]]

train-the-trainer training. The nurse educator will introduce the 
facility nurses to the Antibiotic Use QI and Monitoring Program 
materials and train them on the use of the Loeb minimum criteria. This 
training will be offered two times at regularly scheduled in-service 
meetings; however each nurse will be required to attend only one 
session.
    (5) Train-the-physicians training will be conducted by the 
physician champion at each of the six treatment sites following the 
train-the-trainer training. The project team will be present to address 
any questions regarding the study. The physician champion will 
introduce the facility physicians to the Antibiotic Use QI and 
Monitoring Program materials and discuss with them the use of the Loeb 
minimum criteria. An average of five physicians at each facility will 
be individually contacted by the physician champion to discuss the use 
of the Loeb criteria. Each physician will have received a letter with 
the study description and the Loeb criteria prior to contact by the 
physician champion.
    (6) Medical record reviews (MMR) will be conducted by research 
staff to collect primary outcome data to determine antibiotic 
prescribing. Primary outcomes will be obtained by monthly chart review 
for a period of nine months: three months preceding the initiation of 
the QI intervention (for which the charts of all residents will be 
abstracted), and each month for six months following the inception of 
the program (for which the charts of all residents will be abstracted, 
regardless of whether or not they are discharged from the setting or 
die) at all 12 facilities (treatment and control) by trained research 
staff from current (not archival) records. Since this data collection 
will not impose a burden on the facility staff OMB clearance is not 
required.
    (7) Final semi-structured interviews with QI team members including 
physicians, facility administrators, and other key facility staff will 
be conducted at the completion of the intervention to determine their 
perceptions regarding facilitators and barriers to successful program 
implementation.
    (8) Nurse survey will be administered to nurses in all twelve 
facilities in the month prior to program implementation, and again in 
the final month of implementation. The purpose of this survey is to 
collect secondary outcome data regarding the antibiotic prescribing 
decision-making process and to collect basic information about each 
nurse, such as their title, type of degree and years worked in a LTC 
facility.
    (9) Physician survey will be administered in all twelve facilities 
in the month prior to program implementation, and again in the final 
month of implementation. Similar to the nurse survey, the purpose of 
this survey is to collect secondary outcome data regarding the 
antibiotic prescribing decision-making process and to collect basic 
information about each physician.
    In response to the third study objective, AHRQ will draw upon its 
extensive experience of successfully disseminating information through 
varying strategies. To assist in designing a plan that has ``real 
world'' impact, AHRQ's Dissemination Planning Tool will be utilized.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the 
respondents' time to participate in this research. Pre-implementation 
semi-structured interviews will be conducted with 3 staff members from 
each of the 6 intervention sites and will last about 1 hour. The 
administrator interviews will be completed with one administrator from 
each of the 12 participating NHs and will require 15 minutes. Train-
the-trainer training will include 4 persons from each of the 6 
intervention sites and will last 2 hours. Train-the-nurses training 
will be conducted with 24 nurses from each of the intervention sites; 
the number of responses per NH is 26 since the nurse trainer is an 
employee of the NH and will conduct the training twice, with about 12 
nurses in each training. The nurse training will last about 1 hour. 
Train-the-physician training will be conducted with 5 physicians from 
each of the 6 intervention sites; the number of responses per NH is 6 
since the physician trainer is affiliated with the NH. The physician 
training will last about 30 minutes.
    Final semi-structured interviews will include 4 QI team members 
from each of the 6 intervention sites, at the completion of the 
intervention, and will last one hour. The nurse survey will be 
administered twice to 24 nurses from each of the 12 participating NHs 
and will take about 15 minutes to complete. The physician survey will 
be administered twice to 5 physicians from each of the 12 facilities 
and requires 15 minutes to complete. The total annualized burden hours 
are estimated to be 441 hours.
    Exhibit 2 shows the estimated annual cost burden to the respondent, 
based on their time to participate in this research. The annual cost 
burden is estimated to be $25,204.

                                  Exhibit 1--Estimated Annualized Burden Hours
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                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                   nursing homes   nursing home      response          hours
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Pre-implementation semi-structured interviews...               6               3               1              18
Administrator Interviews........................              12               1           15/60               3
Train-the-trainer training......................               6               4               2              48
Train-the-nurses training.......................               6              26               1             156
Train-the-physicians training...................               6               6           30/60              18
Final Semi-Structured Interview.................               6               4               1              24
Nurse survey....................................              12              48           15/60             144
Physician survey................................              12              10           15/60              30
                                                 ---------------------------------------------------------------
    Total.......................................              66              na              na             441
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[[Page 38107]]


                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                     Number of     Total burden   Average hourly    Total cost
                    Form name                      nursing homes       hours        wage rate*        burden
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Pre-implementation semi-structured interviews...               6              18         **51.68            $930
Administrator Interviews........................              12               3        ***46.59             140
Train-the-trainer training......................               6              48           31.31           1,503
Train-the-nurses training.......................               6             156           77.64          12,112
Train-the-physicians training...................               6              18           31.31             564
Final Semi-Structured Interview.................               6              24           77.64           1,863
Nurse survey....................................              12             144        ***46.59           6,709
Physician survey................................              12              30           46.10           1,383
                                                 ---------------------------------------------------------------
    Total.......................................              66             441             n/a          25,204
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* Based upon the mean of the average wages, National Occupational Employment and Wage Estimates, U.S. Department
  of Labor, Bureau of Labor Statistics. May 2008.
** Average wages for one registered nurse ($31.31), one physician ($77.64), and one Administrator ($46.10).
*** Average wages for two registered nurse ($31.31), one physician ($77.64), and one Administrator ($46.10).

Estimated Annual Costs to the Federal Government

    Exhibit 3 shows the total and annualized cost for conducting this 
research. The total budget for this three year study is $999,976. The 
administration task includes costs associated with the initial kick-off 
conference call with AHRQ and monthly progress reports and ongoing 
conference calls. The research plan task includes costs to finalize the 
research plan; conduct the literature search; prepare and submit the 
IRB applications and OMB package; recruit facilities; collect baseline 
and monthly data from medical record reviews and conduct pre- and post-
intervention provider interviews; implement the intervention; and write 
the final report on the explanatory model. The dissemination costs 
include the writing of a dissemination plan and two manuscripts for 
publication as well as presentations at two national conferences. The 
final report costs include the writing of a draft and final report.

             Exhibit 3--Estimated Total and Annualized Cost
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                                                             Annualized
             Cost component                    Total           cost
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Administration..........................         $24,474          $8,158
Research Plan...........................         591,788         197,263
Dissemination Plan......................          63,397          21,132
Final Report............................          46,501          15,500
Overhead................................         273,816          91,272
                                         -------------------------------
    Total...............................         999,976         333,325
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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: June 22, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010-15796 Filed 6-30-10; 8:45 am]
BILLING CODE 4160-90-M