[Federal Register Volume 75, Number 61 (Wednesday, March 31, 2010)]
[Notices]
[Pages 16129-16132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6776]


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

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 
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

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 practice-oriented 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 nine-month 
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

[[Page 16130]]

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 Connections-Readiness 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, problem-solving/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.

[[Page 16131]]



                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
Key informant interviews with practice coaches..               2               2               1               4
Key informant interviews with providers (3 per                10               6               1              60
 practice interviewed twice)....................
Key informant interviews with staff (2 per                    10               4               1              40
 practice interviewed twice)....................
Primary Care Practice Profile (PCPP)............              10               1           30/60               5
Physician Practice Connections--Readiness Survey              10               9             1.5             135
 (PPC-RS) (3 per practice x 3 times)............
Assessment of Chronic Illness Care (ACIC) (8 per              10              24           30/60             120
 practice x 3 times)............................
Change Process Capability Questionnaire (CPCQ)                10              24           15/60              60
 (8 per practice x 3 times).....................
Primary Care Staff Satisfaction Survey (PCSSS)                10              24           15/60              60
 (8 per practice 3 x times).....................
Patient Assessment of Chronic Illness Care                 1,500               1           15/60             375
 (PACIC)........................................
Consumer Assessment of Healthcare Providers and            1,500               1           45/60           1,125
 Systems--Primary Care Adult (CAHPS)............
                                                 ---------------------------------------------------------------
    Total.......................................           3,072              na              na           1,984
----------------------------------------------------------------------------------------------------------------


                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of     Total burden   Average hourly    Total cost
                    Form name                       respondents        hours        wage rate *       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              10             135           77.64          10,481
 (PPC-RS).......................................
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                 1,500             375           20.32           7,620
 (PACIC)........................................
Consumer Assessment of Healthcare Providers and            1,500           1,125           20.32          22.860
 Systems--Primary Care Adult (CAHPS)............
                                                 ---------------------------------------------------------------
    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

[[Page 16132]]

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