[Federal Register Volume 74, Number 226 (Wednesday, November 25, 2009)]
[Notices]
[Pages 61690-61692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-28211]


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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: ``Spreading Techniques to Radically Reduce Antibiotic 
Resistant Bacteria (Methicillin Resistant Staphylococcus aureus, or 
MRSA).'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 350 
1-3520, AHRQ invites the public to comment on this proposed information 
collection.

DATES: Comments on this notice must be received by January 25, 2010.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, by e-mail at 
[email protected].
    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

Spreading Techniques To Radically Reduce Antibiotic Resistant Bacteria 
(Methicillin Resistant Staphylococcus aureus, or MRSA)

    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 HATs are due to bacteria that are resistant to commonly used 
antibiotics, with Methicillin Resistant Staphylococcus aureus (MRSA) 
being the most rapidly growing, and among the most virulent, pathogens. 
Resistance is increasing rapidly in all types of hospitals (Huang 
2007). Despite evidence that routinely applied, simple interventions do 
work, most hospitals have failed to make notable progress in reducing 
MRSA infections. Hospitals in some European countries and select U.S. 
hospitals, however, have succeeded with impressive results.
    Sites that have already achieved dramatic decreases in their MRSA 
infection rates have done so by implementing precautions to prevent 
transmission, using system redesign approaches. Further, many hospitals 
have successfully instituted isolation procedures for patients 
suspected to be MRSA carriers. In doing so, these hospitals have 
followed the broadly disseminated guidelines for hand hygiene and 
contact isolation precautions. This study is a follow up to a recent 
study implemented in 6 hospital systems in the Indianapolis 
metropolitan area that used a ``MRSA intervention bundle'' composed of 
active surveillance screening, contact isolation precautions, and 
increased hand hygiene. Preliminary data from that initial study 
suggest a 60% decrease in MRSA rates in participating intensive care 
units (ICUs) (Doebbeling, B. Redesigning Hospital Care for Quality and 
Efficiency Applications of Positive Deviance and Lean in Reducing MRSA. 
Presentation at AHRQ Annual Meeting, Rockville, MD, Sept 2009).
    This study is designed to further test this intervention bundle in 
non-ICU settings in hospitals currently using the intervention bundle 
in their ICUs, as well as in additional ICUs in newly recruited 
hospital systems. This project will utilize the same guidelines and 
precautions that were applied in the original study, and will add an 
innovative feature that will use electronic medical record systems to 
improve identifying, communicating and tracking MRSA infections among 
healthcare systems. More specifically, this study has five aims:
    (1) Further test the ``MRSA intervention bundle'' from the original 
Indianapolis MRSA study, and test the intervention in additional units 
in the 4 original Indianapolis hospital systems and an additional 3 
hospital systems beyond Indianapolis;
    (2) Identify and monitor healthcare associated community onset 
(HACO) MRSA cases and controls who receive care in participating 
hospitals and affiliated settings, identify strategies to reduce HACO 
MRSA and demonstrate reduction of HACO MRSA;
    (3) Assess the relative effectiveness of various antibiotics in 
abatement or eradication of MRSA carriage in hospital patients;
    (4) Evaluate the effectiveness of the tested implementation 
strategies and innovations by applying information technology to enable 
consistent collection, sharing, analysis and reporting of data;
    (5) Disseminate findings and promote outreach to target audiences 
and other stakeholders.
    While many secondary data are available for this study, Aims 1 and 
2 involve primary data collection. Use of the intervention bundle 
requires that opinion leaders and front line workers be equipped with 
techniques used in the reorganization of healthcare delivery to improve 
health outcomes (Singhal and Greiner, 2007; IHI, 2005). These 
techniques will assist in identifying goals, implementing the 
interventions to meet local needs and measuring and feeding back 
progress on key processes and outcomes to staff and others.

[[Page 61691]]

    The study also incorporates an additional informatics surveillance 
system to allow participating hospitals to more efficiently 
communicate, share and track MRSA infections. This system will save 
infection control and clinicians' time--for example, by electronically 
identifying patients with a known history of drug-resistant infections 
when they first contact a new institution.
    This study is being conducted by AHRQ through its contractor, 
Indiana University and the Regenstrief Institute, 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)(l) and (2).

Method of Collection

    There will be 3 types of data collection to support the study Aims:
     Electronic medical record data on MRSA infections and 
rates will be collected from an existing and unique healthcare 
information exchange (Indiana Network for Patient Care or INPC) in the 
Indianapolis area, and the CDC's National Healthcare Safety Network 
(Aims 1-5).
     Data on hand washing, swabbing, and isolation rates will 
be collected by observation (Aims 1, 2, and 4).
     Four surveys will be conducted: A brief Social Network 
Analysis (SNA), a Cultural Survey, a Patient Healthcare Use survey, and 
an Implementation Assessment of key informants (Aims 1, 4, and 5).
    The social network analysis questionnaire (SNA) (Wasserman et al., 
1994) will be administered to understand with whom hospital personnel 
work, how hospital networks mature over time and how information is 
shared. Additionally, cultural beliefs, attitudes, and knowledge will 
be captured by surveying staff on intervention units of participating 
hospitals using a cultural questionnaire. To compare changes in the 
network and cultural beliefs, both the SNA and the cultural 
questionnaire will be administered to staff at baseline and again one 
year later. These data will be collected from a sample of staff in the 
intervention units. Project team leaders will select relevant staff 
regularly working and providing patient care or direct patient services 
on the unit in a purposive sample. These staff will receive the paper-
based questionnaires during staff meetings and will return them 
anonymously. A study ID will serve to determine which staff has 
responded and allow linkage of baseline and follow-up surveys.
    The implementation assessment will be an interview obtained 
quarterly to key informants at each organization to assess the 
approaches to implementation of the program (e.g., dose, intensity, 
leadership support, teamwork, etc). This assessment will be a short 
(10-12) item questionnaire.
    Additionally, to better understand the healthcare associated 
community acquired aspect of MRSA transmission, 200 patients will be 
surveyed to gather risk factors and healthcare use statistics that we 
have found in preliminary studies are not otherwise available in 
electronic databases or medical records.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours associated 
with the hospital's time to participate in this research. Electronic 
medical record data will be collected weekly from 7 participating 
hospitals, however only two of these hospitals will use their staff to 
perform this data collection. Over the course of the project electronic 
medical record data will be extracted 52 times and each data extraction 
will take about 10 hours. Observational data will be collected weekly 
from all participating hospitals, however only 3 hospitals will use 
their staff to perform the observations. The project will require 52 
observations per hospital and are estimated to take about 3 hours to 
perform.
    Both the social network analysis questionnaire and the culture 
questionnaire will be administered twice, pretest and posttest, to 
about 75 personnel at each of the 7 hospitals. The social network 
analysis questionnaire will take about 15 minutes to complete while the 
culture questionnaire will take 30 minutes. The implementation 
assessment questionnaire will be administered quarterly to 3 key 
informants at each hospital and will take about one hour.
    The patient healthcare use questionnaire will be completed by 200 
patients sampled from the 7 participating hospitals. Each patient will 
respond once which will require about 15 minutes. The total annualized 
burden hours for all the associated data collections are estimated to 
be 2,430. Exhibit 2 shows the estimated annualized cost burden 
associated with the respondents' time to participate in this research. 
The total annual cost burden is estimated to be $76,118.

                                  Exhibit 1--Estimated Annualized Burden Hours
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                                                                Numer of
                Form name                     Number of       responses per       Hours per       Total burden
                                              hospitals         hospital          response            hours
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Electronic Medical Record Data                           2                52                10             1,040
 Collection.............................
Observational Data Collection...........                 3                52                 3               468
Social Network Analysis Questionnaire...                 7               150             15/60               263
Culture Questionnaire...................                 7               150             30/60               525
Implementation Assessment Questionnaire.                 7                12                 1                84
Patient Healthcare Use Questionnaire....               200                 1             15/60                50
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    Total...............................               226                na                na             2,430
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                                   Exhibit 2--Estimated Annualized Cost Burden
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                                              Number of       Total burden     Average hourly      Total cost
                Form name                     hospitals           hours          wate rate*          burden
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Electronic Medical Record Data                           2              1040            $30.03           $31,231
 Collection.............................
Observational Data Collection...........                 3               468            $20.98             9,819
Social Network Analysis Questionnaire...                 7               263            $38.28            10,068

[[Page 61692]]

 
Culture Questionnaire...................                 7               525            $38.28           $20,097
Implementation Assessment Questionnaire.                 7                84            $45.33            $3,808
Patient Healthcare Use Questionnaire....               200                50            $21.90            $1,095
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    Total...............................               226             2,430                na          $76,118
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*Based upon the mean of the average wages for Nursing Care Providers ($30.03), Primary Care Physicians ($84.97),
  Allied Health Providers ($20.98), Administrators, Chief Executives ($76.23) and All Workers ($21.90); National
  Compensation Survey: Occupational wages in the United States May 2008, ``U.S. Department of Labor, Bureau of
  Labor Statistics.''

Estimated Annual Costs to the Federal Government

    Exhibit 3 shows the total and annualized cost of this project to 
the Federal Government over a two-year period. The total cost of this 
project is $1.8 million dollars which includes $785,000 for project 
development, $70,000 for data collection activities, $235,000 for data 
analysis, $125,000 for publication of the results, $170,000 for project 
management and $415,000 for overhead costs.

             Exhibit 3--Estimated Total and Annualized Cost
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           Cost component                Total cost      Annualized cost
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Project Development.................          $785,000          $262,000
Data Collection Activities..........           $70,000           $35,000
Data Processing and Analysis........          $235,000           $78,000
Publication of Results..............          $125,000          $125,000
Project Management..................          $170,000           $57,000
Overhead............................          $415,000          $138,000
                                     -----------------------------------
    Total...........................        $1,800,000          $900,000
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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: November 16, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9-28211 Filed 11-24-09; 8:45 am]
BILLING CODE 4160-90-M