```

[Federal Register Volume 75, Number 141 (Friday, July 23, 2010)]
[Notices]
[Pages 43169-43172]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-17796]

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

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.

[[Page 43170]]

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: ``Reduction of Clostridium difficile Infections in a Regional 
Collaborative of Inpatient Healthcare Settings through Implementation 
of Antimicrobial Stewardship.'' 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 September 21, 2010.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports clearance Officer, AHRQ, by e-mail at 
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 
doris.lefkowitz@AHRQ.hhs.gov.

SUPPLEMENTARY INFORMATION:

Proposed Project

Reduction of Clostridium Difficile Infections in a Regional 
Collaborative of Inpatient Healthcare Settings Through Implementation 
of Antimicrobial Stewardship

    Healthcare Acquired Infections (HAIs) caused almost 100,000 deaths 
among the 2.1 million people who acquired infections while hospitalized 
in 2000, and HAI rates have risen relentlessly since then. Alarmingly, 
70% of HAIs are due to bacteria that are resistant to commonly used 
antibiotics (Huang 2007). This project is designed to evaluate the 
implementation of a program to reduce Clostridium difficile Infection 
(CDI) in acute care facilities via Antimicrobial Stewardship Programs 
(ASPs). Working with an already existing collaborative network of acute 
care facilities in New York that currently collect and report mandatory 
data on CDI rates and practice strict environmental controls, this 
project will go beyond environmental strategies in order to attempt to 
reduce rates of CDI. ASPs seek to promote the appropriate use of 
antimicrobials via several methods including selecting the appropriate 
dose, duration and route of administration of antibiotics. Using 
antibiotics appropriately can potentially improve efficacy, reduce 
costs, and keep drug-related adverse events to a minimum. The project 
is a partnership with Boston University School of Public Health 
(BUSPH), Montefiore Medical Center (MMC), and Greater New York Hospital 
Association (GNYHA).
    The overall aims of the research are to evaluate the implementation 
of ASPs specific to CDI at 11 participating hospitals (6 intervention 
sites and 5 control sites) and to create a draft ASP Toolkit. More 
specifically, the pilot study has been designed to provide information 
to meet the following objectives:
    1. Identify the antimicrobial stewardship activities, both 
currently in place and those yet to be identified, specific to each 
site's individual needs, to optimize antimicrobial prescribing 
practices to reduce CDI
    2. Assess prescriber perceptions related to ASP
    3. Assess barriers and facilitators to ASP implementation
    4. Develop a draft ASP Toolkit to help hospitals optimize their 
antimicrobial prescribing practices to reduce CDI.
    New York (NY) State currently requires ongoing reporting of C-
difficile data for both clinical and surveillance purposes. As part of 
an arrangement with NY State, the Greater New York Hospital Association 
(GNYHA) also collects and analyzes these data through their CDI 
collaborative. These data include tracking baseline rates of CDI, 
including pharmacy data, data related to rates of CDI, patient 
outcomes, and data about infection control practices (such as hand-
washing and other environmental controls to prevent spread of 
infection). The data are collected on standardized forms that are 
required by both the state and the Centers for Disease Control and 
Prevention (CDC). The data collected at these participating hospitals 
are also collected at multiple hospitals nationwide as part of routine 
patient care and quality. In addition to new data collections initiated 
specifically for this project, this routine and ongoing mandatory data 
collection will serve as the project's knowledge base to allow the 
assessment of ASP programs.
    From the GNYHA data, a three-month sample from the participating 
hospitals will be analyzed by Montefiore Medical Center (MMC) and GNYHA 
to obtain baseline information. This data will enable a comparison of 
the rates of CDI before and after the implementation of an ASP. The ASP 
will be implemented at 6 hospitals (intervention sites), while 5 other 
hospitals will serve as control sites and continue with their current 
practices, including conducting general infection and environmental 
controls. The specific elements of the ASPs will vary by hospital based 
on priorities and what is possible at each facility as well as by the 
antibiotic(s) targeted and will likely include some of the following:
     Formulary review/changes, restrictions and 
preauthorization of implicated antimicrobials
     Feedback to providers of implicated antimicrobials
     Processes and algorithms for empiric and streamlined 
regimens for specific diagnoses/pathogens
     Antibiotic order form with automatic stop orders
     Novel combinations of approaches to the use of stewardship 
staff or technology for stewardship (e.g., software, text paging, pyxis 
pharmacy machines for tracking and promoting proper antibiotic 
prescribing), and
     Educational efforts for clinicians and patients upon 
diagnosis.
    While the ongoing mandatory reporting will allow the measurement of 
change over time in CDI rates, it does not provide the necessary 
information that hospitals need about the challenges of implementing an 
ASP.

Method of Collection

    The following data collection activities will be implemented to 
achieve the objectives of this project:
    1. Focus Groups with no more than 6 staff members at the 
intervention and control hospitals. The focus groups will be conducted 
one time only, by telephone and approximately 12 months after the 
implementation begins. The focus group guides will differ for the 
intervention and control sites, although there will be a common core of 
questions. The common core of the focus group protocol will address the 
following: issues related to experience with the GNYI-[A] environmental 
and infection control practices they have already been utilizing, 
strategies they have already used to reduce CDI and perceptions of 
those strategies, barriers to the environmental practices, particular 
areas of challenge, facilitators, and factors they think have 
contributed most to their institution's CDI rates. For the intervention 
sites, the goal of the focus group will be to understand in a more in-
depth and qualitative manner, the experience of actually implementing 
the ASP. For the control sites, the goal will be to understand what 
they have learned in being a control site and their plans moving 
forward. In addition to the core questions, questions will be asked 
about their interest in starting an ASP program, goals and priorities, 
expectations of facilitators and barriers

[[Page 43171]]

and if and when they plan to implement an ASP.
    2. ASP Questionnaire will be administered twice, pre and post 
implementation, to a sample of about 70 hospital staff at both the 
intervention and control hospitals. Intervention and control facilities 
will receive the same questionnaire. The purpose of this survey is to 
measure the staff's perception of the scope of CDI at their facility, 
current antibiotic prescribing practices, the perceived need for ASPs 
and how these change over time. The questionnaire also collects some 
background information such as the staff members' primary work area, 
time worked in their profession and time worked in this hospital.
    While the reporting/surveillance data required by the State of NY 
and the CDC can measure rates of CDI and compare how hospitals are 
doing, these data do not capture many important issues. A major reason 
that most hospitals do not have active, robust ASPs is because they can 
be incredibly challenging to develop, administer and manage. They 
require changes in prescribing practices and the active agreement and 
participation of physicians, pharmacists and administrators. Physicians 
and pharmacists may challenge restrictions in formularies and determine 
that a patient may not be given a specific antibiotic. But the severity 
of CDI makes it very important for hospitals to determine optimal 
methods for implementing successful ASPs. This pilot study will collect 
data to allow the comparison of perceptions and experiences between 
hospitals that do and do not attempt to implement an ASP. Reflections 
and feedback directly from prescribers and the ASP team using 
qualitative data collection procedures are needed to fully understand 
what it means or would mean to implement an ASP. The lessons learned 
from this project will be useful to health care facilities considering 
implementing an ASP, and will inform the development of a draft ASP 
Toolkit; this Toolkit will be evaluated in a separate project before 
being disseminated.
    This study is being conducted by AHRQ through its contractor, BUSPH 
and their partners Montefiore Medical Center (MMC), and Greater New 
York Hospital Association (GNYHA), 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).

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the 
respondents' time to participate in this pilot study. Focus Groups will 
be conducted post-intervention with approximately 6 staff members at 
each of the 11 study sites (5 control sites and 6 intervention sites) 
for a total of 66 individuals, approximately 36 at the intervention 
sites and approximately 30 at the control sites. The control site focus 
groups will last approximately 45 minutes. The intervention site focus 
groups will last approximately 60 minutes.
    The ASP questionnaire will be administered twice, pre and post-
intervention, to about 70 staff members at each of the 11 participating 
sites and takes about 7 minutes to complete. The total annualized 
burden is estimated to be 239 hours.
    Exhibit 2 shows the estimated annualized cost burden associated 
with the respondents' time to participate in this study. The total cost 
burden is estimated to be $15,037.

                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
                    Form Name                        Number of     responses per     Hours per     Total burden
                                                     hospitals       hospital        response          hours
----------------------------------------------------------------------------------------------------------------
Focus groups at intervention sites..............               6               6               1              36
Focus groups at control sites...................               5               6           45/60              23
ASP Questionnaire...............................              11             140            7/60             180
                                                 ---------------------------------------------------------------
    Total.......................................              22             n/a             n/a             239
----------------------------------------------------------------------------------------------------------------

                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of     Total burden   Average hourly    Total cost
                    Form Name                        hospitals         hours        wage rate*        burden
----------------------------------------------------------------------------------------------------------------
Focus groups at intervention sites..............               6              36          $57.38          $2,066
Focus groups at control sites...................               5              23           57.38           1,320
ASP Questionnaire...............................              11             180           64.73          11,651
                                                 ---------------------------------------------------------------
    Total.......................................              22             237             n/a          15,037
----------------------------------------------------------------------------------------------------------------
* The hourly wage for the focus groups is based upon the mean of the average wages for physicians ($79.33),
  pharmacists ($50.13), and medical and health services managers ($42.67). The hourly wage for the surveys is
  based upon the average wages for physicians ($79.33) and pharmacists ($50.13). These data come from the May
  2008 National Occupational Employment and Wage Estimates, United States, U.S. Bureau of Labor Statistics
  Division of Occupational Employment Statistics, May 2008, National Occupational Employment and Wage Estimates,
  http://www.bls.gov/oes/2008/may/oes_nat.htm#b11-0000.

Estimated Annual Costs to the Federal Government

    Exhibit 3 shows the annualized and total cost to the federal 
government for this two year research project. Project Management 
includes activities related to coordination between BUSPH staff, 
contracted staff at MMC and GNYHA, and monthly phone calls with the 
task order officer. Project development covers steps taken to revise 
the research plan and begin implementation. The total cost is estimated 
to be $999,995.

[[Page 43172]]

    Exhibit 3--Estimated Total and Annualized Cost to the Government
------------------------------------------------------------------------
         Cost component             Annualized cost       Total cost
------------------------------------------------------------------------
Project Management..............             $28,315             $56,629
Project Development.............              84,944             169,400
Data Collection and Analysis....             169,888             339,776
Technical Assistance and                      60,750             121,500
 Consultation...................
Confirmatory lab testing........              20,000              40,000
Travel..........................               7,500              15,000
Project Supplies and materials..               2,450               4,900
Overhead........................             126,395             252,790
                                 ---------------------------------------
    Total.......................             499,998             999,995
------------------------------------------------------------------------

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: July 9, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010-17796 Filed 7-22-10; 8:45 am]
BILLING CODE 4160-90-M
```