Attachment M -- Federal Register Notice

Federal Register / Vol. 75, No. 61 / Wednesday, March 31, 2010 / Notices
Dated: March 22, 2010.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2010–7171 Filed 3–30–10; 8:45 am]
BILLING CODE 4163–18–P

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:
‘‘Studying the Implementation of a
Chronic Care Toolkit and Practice
Coaching In Practices Serving
Vulnerable Populations.’’ 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 February 1, 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 April 30, 2010.

Written comments should
be submitted to: AHRQ’s OMB Desk
Officer by fax at (202) 395–6974
(attention: AHRQ’s desk officer) or by email 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.
jlentini on DSKJ8SOYB1PROD with NOTICES

ADDRESSES:

FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
e-mail at
[email protected].
SUPPLEMENTARY INFORMATION:

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Proposed Project
Studying the Implementation of a
Chronic Care Toolkit and Practice
Coaching In Practices Serving
Vulnerable Populations
An important part of AHRQ’s mission
is to disseminate information and tools
that can support improvement in quality
and safety in the U.S. health care
community. This proposed information
collection supports that part of AHRQ’s
mission by further refining the practice
coaching delivered in conjunction with
a previously developed toolkit,
Implementing Integrating Chronic Care
and Business Strategies in the Safety
Net: A Toolkit for Primary Care
Practices and Clinics. AHRQ requests
that the Office of Management and
Budget approve, under the Paperwork
Reduction Act of 1995, AHRQ’s
intention to collect information needed
to determine whether practice coaching
is effective in facilitating adoption of the
Chronic Care Model (CCM) for
improving treatment and management
of chronic medical conditions by
primary care physicians, especially
those who care for underserved
populations. This project is being
conducted pursuant to AHRQ’s
statutory authority to conduct and
support research on health care and on
systems for the delivery of such care,
including activities with respect to
quality measurement and improvement
and with respect to clinical practice,
including primary care and practiceoriented research. 42 U.S.C. 299a(a)(2)
and (4). This project will be conducted
by AHRQ through a contract with the
University of Minnesota.
Although 1,500 physician practices in
the U.S. and internationally have been
involved in CCM quality improvement
efforts, most patients still do not receive
their chronic care in accordance with
CCM. One factor affecting CCM
implementation has been that having
teams attend collaborative meetings
(three two-day meetings over a ninemonth period) is burdensome,
especially for under-resourced
providers. An attempt to use the
Internet as a virtual collaborative met
with disappointing results. Another
barrier to adoption of the CCM in
settings that serve vulnerable
populations is the scarcity of resources
to implement and sustain the CCM. In
2006 AHRQ contracted with the RAND
Corporation, Group Health’s MacColl
Institute, and the California Health Care
Safety Net Institute (SNI) to develop a
toolkit that informs safety net providers
on how to redesign their systems of care
along the lines of the Chronic Care
Model while attending to their financial

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realities. The result was Implementing
Integrating Chronic Care and Business
Strategies in the Safety Net: A Toolkit
for Primary Care Practices and Clinics.
The Toolkit was piloted in two
California safety net clinics.
Recognizing that merely distributing the
Toolkit was unlikely to foster adoption
of CCM, the intervention included six
months of practice coaching delivered
by the MacColl Institute. Practice
Coaches (PC) are health care or related
professionals who help primary care
practices in a variety of quality
improvement and research activities.
PCs made two site visits to each site and
participated in weekly team meetings by
phone. They also interacted with the
sites through e-mail and phone contact.
The lack of documentation available
on coaching led to the development of
a practice coaching manual, which was
funded by AHRQ through a contract
with the RAND Corporation.
Development of the Coaching Manual
entailed conducting a literature review,
interviewing practice coaching experts,
and incorporating evaluation results
from the coaching provided in
conjunction with the Toolkit. The
Coaching Manual was published in the
winter of 2009. The literature review
and interviews revealed that there are a
number of different models of practice
coaching. However, knowledge is scant
about how practice coaching is best
performed, under what conditions
practice coaching is most successful,
and the costs of coaching and being
coached. Pilot testing the Toolkit with a
low-intensity practice coaching strategy
proved insufficient to encourage
practices to use the Toolkit
independently. The Toolkit was
subsequently streamlined based on pilot
sites’ reports that the initial Toolkit was
not easy to use. This project will explore
the implementation of the revised
Toolkit along with a more intensive
practice coaching strategy, providing
lessons on methods to improve chronic
care in clinical practices that serve
vulnerable populations.
Method of Collection
This project will include the
following data collections:
(1) Key Informant Interviews with
providers, staff and practice coaches
from 20 safety net practices that
participate in the practice coaching
intervention. These will be used to
describe the process and content of
practice coaching, perceived changes
from the coaching intervention at the
practice, provider and patient levels,
factors that impeded or facilitated the
coaching intervention and
implementation of practice changes

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through the coaching process, overall
satisfaction with practice coaching, and
recommendations for improvement.
(2) Primary Care Practice Profile
(PCPP). This questionnaire will be
completed by a single individual at each
site, either the medical director or chief
administrator, and will provide an
overview of each replication site that
will help place intervention activities
and outcomes in context for each site.
It covers demographics of patients
served, patient flow, disease health
outcomes, most frequent diagnoses,
most frequent referrals, number of staff
by discipline, staff and patient
satisfaction, processes of care, and
organizational processes.
(3) Physician Practice ConnectionsReadiness Survey (PPC–RS)—This
questionnaire asks about the presence of
53 practice systems in 5 of the 6
domains of the Chronic Care Model:
Clinical information systems
(information systems, presence of
registry or organized database, and
systematic monitoring of patient
population); decision support (clinician
reminders and alerts for lab tests, and
visits or guidelines related to individual
patient care), delivery system redesign
(services for managing patients with
chronic illness involving multiple
clinicians and care between visits),
health care organization (performance
tracking and feedback, process of using
clinical information systems to
aggregate and report on key indicators,
and use of data for benchmarking
performance and informing QI
activities), and clinical quality
improvement (presence of formal
processes to assess care, develop
interventions, and use data to monitor
the effects).
(4) Assessment of Chronic Illness Care
(ACIC)—The ACIC is contained in the
Toolkit and yields subscale scores and
a total score. Subscale scores reflect
CCM components and include:
Community linkages, self-management
support, decision support, delivery
system design, information systems, and
organization of care.
(5) Change Process Capability
Questionnaire (CPCQ)—The CPCQ
assesses 30 factors and strategies that
experienced quality improvement
leaders ranked as most important for
successful implementation. A recent
validation study found good predictive
validity. Items correlating with the PPC–
RS were eliminated after the initial
validation study so there is little to no
overlap across the two measures. In
addition to changes in the content of

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care (CCM components), these also
include organizational will for change
(Priority) and capacity and skill in the
conduct of the actual change processes
and strategies.
(6) Patient Assessment of Chronic
Illness Care (PACIC)—The 20-item
PACIC consists of five subscales which
assess components of the CCM: Patient
activation, delivery system design/
decision support, goal setting, problemsolving/contextual counseling, and
followup and coordination.
(7) Consumer Assessment of
Healthcare Providers and Systems—
Primary Care Adult—This questionnaire
assesses patient experiences in three
areas: Getting appointments and
healthcare when needed; how well
doctors communicate, and courteous
and helpful office staff.
(8) Primary Care Staff Satisfaction
Survey—This questionnaire assesses
staff satisfaction with their work
environment. It consists of 8 4-point
likert scale items and 2 open-ended
questions, and was developed by the
Institute for Healthcare Improvement.
(9) Chart Audits—Chart audits will be
conducted at baseline, the end of the 10month coaching intervention, and at 3month follow-up to assess changes in
patient care quality over the course of
the intervention. A chart abstraction
form will be developed to collect these
data. This data collection will be
performed by the project staff and will
not impose a burden on the
participating sites. Therefore, OMB
clearance is not required for this data
collection.
Clinic staff will be provided with a
paper version of the surveys as well as
the option to complete the surveys on
line using a secure on-line survey
program. With the exception of the staff
surveys, no special information
technology will be used to collect
information, since many of the data
collection forms are standardized
instruments available in hard-copy
form, and special permission from the
developers would be required to create
electronic versions of these forms. The
information collection is a one-time
only project; thus, there would be little
benefit in reduced burden from
automated information collection tools
for the other instruments.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate in this
two-year study. Key informant
interviews will be conducted with
practice coaches at midpoint in the

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intervention and again at the end of the
intervention. Key informant interviews
will also be conducted with up to 3
primary care providers and 2 other staff
members from each of the 20 practices
(10 per year) prior to start of the
intervention, and again at 3-month
follow-up after the intervention is
completed. Each interview takes about 1
hour.
The Primary Care Practice Profile will
be administered once and will be
completed by one staff person from each
practice and takes 30 minutes to
complete. The Physician Practice
Connections-Readiness Survey (PPC–
RS) will be completed pre, post and at
3-month follow-up by three individuals
from each of the 20 practices
(individuals with the appropriate
knowledge to complete the survey will
be identified by the medical director of
each site). It takes 90 minutes to
complete. The Assessment of Chronic
Illness Care (ACIC) will be completed by
4 staff and 4 primary care providers per
practice at pre, post and 3-month
follow-up and takes 30 minutes to
complete. The Change Process
Capability Questionnaire (CPCQ) will be
completed by 4 staff and 4 primary care
providers per practice at pre, post and
3-month follow-up and takes 15 minutes
to complete. The Primary Care Staff
Satisfaction Survey (PCSSS) will be
completed by 4 staff and 4 primary care
providers per practice at pre, post and
3-month follow-up and takes 15 minutes
to complete. The Patient Assessment of
Chronic Illness Care (PACIC) will be
completed by 3,000 adult patients
(1,500 annually) with chronic illness
and requires 15 minutes to complete.
The Consumer Assessment of
Healthcare Providers and Systems—
Primary Care Adult (CAHPS) will be
completed by 3,000 adult patients
(1,500 annually) with chronic illness
and requires 45 minutes to complete.
Both patient surveys will be
administered to adult patients with a
chronic disease who receive care at the
practices during a 2-day data collection
period immediately before, immediately
after, and at 3-month follow-up. The
surveys will be administered during the
post visit period in the wait room, by a
bi-lingual Spanish-English research
assistant. The total annualized burden
hours are estimated to be 1,984 hours.
Exhibit 2 shows the estimated
annualized cost burden associated with
the respondent’s time to participate in
this study. The total annualized cost
burden is estimated to be $60,714.

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Federal Register / Vol. 75, No. 61 / Wednesday, March 31, 2010 / Notices
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Form name
Key informant interviews with practice coaches ..............................................
Key informant interviews with providers (3 per practice interviewed twice) ...
Key informant interviews with staff (2 per practice interviewed twice) ...........
Primary Care Practice Profile (PCPP) .............................................................
Physician Practice Connections—Readiness Survey (PPC–RS) (3 per practice × 3 times) ...............................................................................................
Assessment of Chronic Illness Care (ACIC) (8 per practice × 3 times) .........
Change Process Capability Questionnaire (CPCQ) (8 per practice × 3
times) ............................................................................................................
Primary Care Staff Satisfaction Survey (PCSSS) (8 per practice 3 × times)
Patient Assessment of Chronic Illness Care (PACIC) ....................................
Consumer Assessment of Healthcare Providers and Systems—Primary
Care Adult (CAHPS) ....................................................................................
Total ..........................................................................................................

Number of responses per
respondent

Hours per
response

Total burden
hours

2
10
10
10

2
6
4
1

1
1
1
30/60

4
60
40
5

10
10

9
24

1.5
30/60

135
120

10
10
1,500

24
24
1

15/60
15/60
15/60

60
60
375

1,500

1

45/60

1,125

3,072

na

na

1,984

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents

Form name

Total burden
hours

Average hourly wage rate *

Total cost
burden

Key informant interviews with practice coaches ..............................................
Key informant interviews with providers ..........................................................
Key informant interviews with staff ..................................................................
Primary Care Practice Profile (PCPP) .............................................................
Physician Practice Connections—Readiness Survey (PPC–RS) ...................
Assessment of Chronic Illness Care (ACIC) ...................................................
Change Process Capability Questionnaire (CPCQ) ........................................
Primary Care Staff Satisfaction Survey ...........................................................
Patient Assessment of Chronic Illness Care (PACIC) ....................................
Consumer Assessment of Healthcare Providers and Systems—Primary
Care Adult (CAHPS) ....................................................................................

2
10
10
10
10
10
10
10
1,500

4
60
40
5
135
120
60
60
375

$42.00
77.64
32.64
77.64
77.64
** 55.14
** 55.14
** 55.14
20.32

$168
4,658
1,306
388
10,481
6,617
3,308
3,308
7,620

1,500

1,125

20.32

22.860

Total ..........................................................................................................

3,072

1,984

na

60,714

* Based upon the mean of the average wages, May 2008 National Occupational and Wage Estimates accessed on December 14, 2009 at:
http://www.bls.gov/oes/current/oes_nat.htm#b29–0000.
National Compensation Survey:
** Average for 4 staff ($32.64/hr) and 4 physician clinicians ($77.64/hr).

Estimated Annual Costs to the Federal
Government

research. The total cost over two years
is estimated to be $600,000.

Exhibit 3 shows the estimated total
and annualized cost to conduct this

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST

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Cost component

Total cost

Annualized cost

Project Development ...................................................................................................................................
Data Collection Activities .............................................................................................................................
Data Processing and Analysis (20%) ..........................................................................................................
Publication of Results ..................................................................................................................................
Project Management ....................................................................................................................................
Overhead .....................................................................................................................................................

$162,744
92,994
92,994
23,248
92,994
135,026

$81,372
46,497
46,497
11,624
46,497
67,513

Total ......................................................................................................................................................

600,000

300,000

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

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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

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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

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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: March 19, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010–6776 Filed 3–30–10; 8:45 am]
BILLING CODE 4160–90–M

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:
‘‘Reductions of Infection Caused by
Carbapenem Resistant
Enterobacteriaceae (KPC) Producing
Organisms through the Application of
Recently Developed CDC/HICPAC
Recommendations.’’ 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 June 1, 2010.

Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by email 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.
jlentini on DSKJ8SOYB1PROD with NOTICES

ADDRESSES:

FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
e-mail at
[email protected].
SUPPLEMENTARY INFORMATION:

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Proposed Project
Reductions of Infection Caused by
Carbapenem Resistant
Enterobacteriaceae (KPC) Producing
Organisms Through the Application of
Recently Developed CDC/HICPAC
Recommendations
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. On March 20, 2009, the
Centers for Disease Control (CDC) and
the Healthcare Infections Control
Practices Advisory Committee (HICPAC)
developed infection control (IC)
guidance for Klebsiella pneumonia
carbapenemase-producing (KPC)
isolates, as they have been rapidly
emerging as a significant challenge in
healthcare settings. The danger of these
bacteria is that they are resistant to
carbapenem (a class of beta-lactam
antibiotics with a broad spectrum of
antibacterial activity) and cannot be
treated by the most commonly
prescribed antibiotics. Limited
treatment options mean that infections
caused by carbapenem resistant bacteria
result in substantial mortality and
morbidity.
The CDC and HICPAC
recommendations draw on infection
control strategies which have been
applied to these pathogens in other
settings, and other evidence based
strategies in infection control. There has
been little research, however, on the
implementation of control strategies to
prevent the spread of these KPC
infections. The goal of this project is to
understand how these recommendations
can best be implemented and how
effective these recommendations will be
in practice. This research will advance
private and public efforts to improve
health care quality by improving
measures to control the spread of a
dangerous organism. This research will
also provide data for the development of
an implementation toolkit that hospitals
can use to prevent the spread of
carbapenem resistant bacteria. The
toolkit may include the following types
of resources: General information about
the implementation of evidenced-based
clinical practices, resource materials,
and tools and methods that users can
adopt to conduct point prevalence
surveys, protocols and tools that users
can adopt to specify when active KPC
surveillance is needed, and resources
for approaching the problem as a teambased quality-improvement effort.
OMB clearance will be sought for this
toolkit once it is developed.

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This study is being conducted by
AHRQ through its contractor, Boston
University, 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
This project will include the
following data collections from the
intensive care unit (ICU) staff within
each of three participating hospitals:
(1) Pre-intervention focus groups will
be conducted separately with managers
and staff. The purpose of these focus
groups is to identify potential problems
in the implementation that can be
addressed through various means (e.g.,
additional education, other changes in
process). Another purpose is to
understand the existing approach to
quality improvement, the connection(s)
between overall approach to quality
improvement and to KPC infection
control practices, current practices at
the hospital of quality reporting and
accountability, and constraints and
obstacles to quality improvement as
seen in their roles. Staff members
identified for the focus groups will be
those with the most first-hand
knowledge of existing quality
improvement efforts, and KPC infection
control practices.
(2) Clinical staff survey. Factors
identified in the pre-intervention focus
groups will be used to inform the
development of a self-administered
survey of staff knowledge of and
attitudes toward KPC surveillance and
infection control procedures.
Respondents will be health care workers
on the units where these new guidelines
have been implemented. Findings from
the survey will be used to assess barriers
perceived by the staff, potential
differences across units, and potential
differences by employee/occupational
group.
(3) Post-intervention focus groups (6
months after implementation of new
KPC IC guidelines) will be conducted
separately with managers and staff. The
purpose of these focus groups is to
identify actual problems experienced in
the initial implementation and possible
measures to address, and to identify
successful practices to include in a
toolkit that hospitals can use to
implement the CDC and HICPAC
recommendations.
In addition to developing a toolkit,
AHRQ plans to disseminate the lessons

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