Federal Register / Vol. 75, No. 61 / Wednesday, March 31, 2010 / Notices 16129 

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. 

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 email at OIRA_submission@omb.eop.gov 

(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 

doris.lefkowitz@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

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 

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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16130 Federal Register / Vol. 75, No. 61 / Wednesday, March 31, 2010 / Notices 

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 

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 10- 

month coaching intervention, and at 3- 

month 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 

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 16131 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of responses per 

respondent 

Hours per 

response 

Total burden 

hours 

Key informant interviews with practice coaches .............................................. 2 2 1 4 

Key informant interviews with providers (3 per practice interviewed twice) ... 10 6 1 60 

Key informant interviews with staff (2 per practice interviewed twice) ........... 10 4 1 40 

Primary Care Practice Profile (PCPP) ............................................................. 10 1 30/60 5 

Physician Practice Connections—Readiness Survey (PPC–RS) (3 per practice × 3 times) ............................................................................................... 10 9 1.5 135 

Assessment of Chronic Illness Care (ACIC) (8 per practice × 3 times) ......... 10 24 30/60 120 

Change Process Capability Questionnaire (CPCQ) (8 per practice × 3 

times) ............................................................................................................ 10 24 15/60 60 

Primary Care Staff Satisfaction Survey (PCSSS) (8 per practice 3 × times) 10 24 15/60 60 

Patient Assessment of Chronic Illness Care (PACIC) .................................... 1,500 1 15/60 375 

Consumer Assessment of Healthcare Providers and Systems—Primary 

Care Adult (CAHPS) .................................................................................... 1,500 1 45/60 1,125 

Total .......................................................................................................... 3,072 na na 1,984 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of 

respondents 

Total burden 

hours 

Average hourly wage rate * Total cost 

burden 

Key informant interviews with practice coaches .............................................. 2 4 $42.00 $168 

Key informant interviews with providers .......................................................... 10 60 77.64 4,658 

Key informant interviews with staff .................................................................. 10 40 32.64 1,306 

Primary Care Practice Profile (PCPP) ............................................................. 10 5 77.64 388 

Physician Practice Connections—Readiness Survey (PPC–RS) ................... 10 135 77.64 10,481 

Assessment of Chronic Illness Care (ACIC) ................................................... 10 120 ** 55.14 6,617 

Change Process Capability Questionnaire (CPCQ) ........................................ 10 60 ** 55.14 3,308 

Primary Care Staff Satisfaction Survey ........................................................... 10 60 ** 55.14 3,308 

Patient Assessment of Chronic Illness Care (PACIC) .................................... 1,500 375 20.32 7,620 

Consumer Assessment of Healthcare Providers and Systems—Primary 

Care Adult (CAHPS) .................................................................................... 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 

Exhibit 3 shows the estimated total 

and annualized cost to conduct this 

research. The total cost over two years 

is estimated to be $600,000. 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST

Cost component Total cost Annualized cost 

Project Development ................................................................................................................................... $162,744 $81,372 

Data Collection Activities ............................................................................................................................. 92,994 46,497 

Data Processing and Analysis (20%) .......................................................................................................... 92,994 46,497 

Publication of Results .................................................................................................................................. 23,248 11,624 

Project Management .................................................................................................................................... 92,994 46,497 

Overhead ..................................................................................................................................................... 135,026 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 

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 


jlentini on DSKJ8SOYB1PROD with NOTICES
16132 Federal Register / Vol. 75, No. 61 / Wednesday, March 31, 2010 / Notices 

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. 

ADDRESSES: Written comments should 

be submitted to: Doris Lefkowitz, 

Reports Clearance Officer, AHRQ, by email 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 

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. 

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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