Attachment V -- Federal Register Notice

Attachment V -- Federal Register Notice.pdf

Demonstration of Health Literacy Universal Precautions Toolkit

Attachment V -- Federal Register Notice

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Federal Register / Vol. 77, No. 98 / Monday, May 21, 2012 / Notices

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and sustain the Medical Reserve Corps
(MRC) units nationwide; (3) Maintains
close liaison with the Assistant
Secretary for Preparedness and
Response (ASPR) regarding MRC policy,
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capacity of MRC units to achieve their
missions, through technical assistance
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Supports efforts to utilize willing, able
and approved MRC members, as needed
in a Federal Response.
(e) Division of Systems Integration
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Direct Access system and TRICARE);
and (3) Assures that system migration
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C. Under Section AC.20, Functions,
delete Section ’’L. Office of
Commissioned Corps Force
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II. Delegations of Authority. Pending
further re-delegation, Directives or
orders made by the Secretary, ASH, or
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officials and employees of the affected
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in effect pending further re-delegations,
provided they are consistent with this
reorganization.
Dated: December 27, 2011.
Kathleen Sebelius,
Secretary.
Editorial Note: This document was
received at the Office of the Federal Register
on May 15, 2012.
[FR Doc. 2012–12173 Filed 5–18–12; 8:45 am]
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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 for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:

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:
‘‘Demonstration of a Health Literacy
Universal Precautions Toolkit.’’ In
accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3521,
AHRQ invites the public to comment on
this proposed information collection.
This proposed information collection
was previously published in the Federal
Register on March 9th, 2012 and
allowed 60 days for public comment. No
substantive comments were 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 June 20, 2012.
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
email at doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:

Proposed Project
Demonstration of Health Literacy
Universal Precautions Toolkit
A goal of Healthy People 2020 is to
increase Americans’ health literacy,
defined as, ‘‘the degree to which
individuals have the capacity to obtain,
process, and understand basic health
information and services needed to
make appropriate health decisions.’’
The effects of limited literacy are
numerous and serious, including
medication errors resulting from
patients’ inability to read labels;
underuse of preventive measures such

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as Pap smears and vaccines; poor selfmanagement of conditions such as
asthma and diabetes; and higher rates of
hospitalization and longer hospital
stays.
According to the 2003 National
Assessment of Adult Literacy (NAAL),
more than one-third of Americans—77
million people—have limited health
literacy. Although some adults are more
likely than others to have difficulty
understanding and acting upon health
information (e.g., minority Americans,
elderly), providers cannot tell by
looking which patients have limited
health literacy. Experts recommend that
providers assume all patients may have
difficulty understanding health-related
information. Known as adopting ‘‘health
literacy universal precautions,’’
providers create an environment in
which all patients benefit from clear
communication.
AHRQ contracted with the University
of North Carolina at Chapel Hill to
develop the Health Literacy Universal
Precautions Toolkit to help primary care
practices ensure that systems are in
place to promote better understanding
of health-related information by all
patients. As part of Toolkit
development, testing of a ‘‘prototype
Toolkit’’ was conducted in eight
primary care practices over an eightweek period. Testing provided
important information about
implementation and resulted in
refinement of the Toolkit, which AHRQ
made publically available in Spring
2010. At this time, the Toolkit includes
20 tools to prepare practices for health
literacy-related quality improvement
activities and to guide them in
improving their performance related to
four domains: (1) Improving spoken
communication with patients, (2)
improving written communication with
patients, (3) enhancing patient selfmanagement and empowerment, and (4)
linking patients to supportive systems
in the community. The tools included in
the Health Literacy Universal
Precautions Toolkit are listed below:
Tools to Start on the Path to Improvement
Tool 1: Form a Team
Tool 2: Assess Your Practice
Tool 3: Raise Awareness
Tools to Improve Spoken Communication
Tool 4: Tips for Communicating Clearly
Tool 5: The Teach-Back Method
Tool 6: Follow up with Patients
Tool 7: Telephone Considerations
Tool 8: Brown Bag Medication Review
Tool 9: How to Address Language Differences
Tool 10: Culture and Other Considerations
Tools to Improve Written Communication
Tool 11: Design Easy-to-Read Material
Tool 12: Use Health Education Material

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Effectively
Tool 13: Welcome Patients: Helpful Attitude,
Signs, and More
Tools to Improve Self-Management and
Empowerment
Tool 14: Encourage Questions
Tool 15: Make Action Plans
Tool 16: Improve Medication Adherence and
Accuracy
Tool 17: Get Patient Feedback
Tools to Improve Supportive Systems
Tool 18: Link Patients to Non-Medical
Support
Tool 19: Medication Resources
Tool 20: Use Health and Literacy Resources
in the Community

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AHRQ will now conduct a
demonstration of the Health Literacy
Universal Precautions Toolkit. The
purpose of this demonstration project is
to explore whether the Toolkit helps
motivated practices to make changes
intended to improve communication
with and support for patients of all
literacy levels.
Twelve primary care practices will be
recruited to implement at least four
tools from the Health Literacy Universal
Precautions Toolkit. The project team
will provide participating practices with
limited technical assistance throughout
the implementation period. Data
regarding the assistance provided will
contribute to the team’s assessment of
the ease with which specific tools can
be implemented and will provide
insight into additional resources and
guidance that might be valuable to add
to the Toolkit.
This study is being conducted by
AHRQ through its contractors, the
University of Colorado, the American
Academy of Family Physicians National
Research Network and Synovate, Inc.,
under its statutory authority to conduct
and support research on health care and
on systems for the delivery of such care,
including activities with respect to the
quality, effectiveness, efficiency,
appropriateness, and value of health
care services and with respect to quality
measurement and improvement (42
U.S.C. 299a(a)(1) and (2)).
Method of Collection
To achieve the goals of this project the
following activities and data collections
will be implemented:
(1) Practice Screening Calls: To
recruit practices into the project, the
project team will conduct screening
calls with all interested practices,
typically with the lead physician or
practice administrator. The introductory
script presents an overview of the
project. For those practices that agree to
participate, some basic data about the
practice will be collected, such as the
type of practice, the number of full and

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part time clinicians, the number of
patients seen in a typical week and the
percentage of patients enrolled in
Medicaid.
(2) Health Literacy Assessment
Questions: In implementing Tool 2,
which guides practices in conducting a
self-assessment of their health literacyrelated systems and procedures,
practices will complete the Health
Literacy Assessment Questions at the
beginning of the project. We will request
that they complete the same items again
following implementation so that we
may examine whether these items
suggest change over time. Practices will
collect responses from staff members
representing different components of
the practice (e.g., clinicians, front desk
staff). A member of the practice staff,
who will be designated the project
coordinator, will oversee collection of
survey data.
(3) Implementation Tracking Form:
The Implementation Tracking Form will
be completed by the leader of the Health
Literacy Team at the beginning of the
project period and updated prior to each
check-in phone call with project staff
(see item 13 below). (As part of
implementation of Tool 1, participating
practices will establish a Health Literacy
Team to oversee Toolkit
implementation.) This form elicits
information about the timing with
which different steps in the
implementation process were completed
(e.g., when was the first training
conducted).
(4) Webinar/Orientation: Prior to
beginning data collection, we will
conduct a Webinar with all practices to
review the pre-implementation data
collection requirements and provide an
overview of Tools 1 and 2, which
practices are to complete prior to our
conducting site visits. Up to four
members of the Health Literacy Team or
other practice members will attend.
(5) On-site Observation: At pre- and
post-implementation, the project team
will conduct an observational review of
the practice environment to assess
health literacy-related features, such as
readability of patient materials in the
waiting room and ease of patient
navigation. This data collection activity
involves no burden to participating
practices and their patients and,
therefore, is not included in the burden
estimates in Section 12.
(6) Patient Survey: The Patient Survey
will be collected at pre- and postimplementation and is designed to
obtain patient input on health literacyrelated performance of providers and
staff (e.g., ‘‘did your provider use
medical words you did not
understand’’). Each practice will recruit

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50 patients at each time point to
complete the survey. The survey will
include the same items at the two time
points. The on-site project coordinator
will oversee recruitment and collection
of survey data.
(7) Survey Using Items from the
Consumer Assessment of Healthcare
Providers and Systems (CAHPS®): In
two of the participating practices,
selected health literacy-related items
from the CAHPS Clinician and Group
Survey and CAHPS Item Set for
Addressing Health Literacy will be
administered at pre- and postimplementation. Surveys will be sent by
mail, with phone follow up. Across
practices and the two time points (preand post-implementation), we will
collect surveys for 1800 patients.
(8) Medication Review Form: Each
practice that chooses to implement Tool
8 (Brown Bag Medication Review) will
conduct medication reviews with 20
patients at pre-implementation and 20
at post-implementation, completing the
Medication Review Form for each
review. (We estimate that 3 of the 12
participating practices will choose to
implement Tool 8.) During these
reviews, the Medication Review Form
will be completed to record errors found
in the medication regimen (e.g., expired
medications, incorrect dosing, patient
misunderstanding of regimen). So that
this data collection activity will be of
value to practices and patients, reviews
will be conducted with patients
identified through routine clinical
practice (e.g., the prescription refill
process, regular follow-up visits) to
require a full review of current
medications.
(9) Practice Staff Survey: We will
request that all staff members of
participating practices complete the
Practice Staff Survey, which elicits staff
perceptions regarding health literacyrelated practices (e.g., staff use of
effective communication techniques and
confirmation of patient comprehension).
Surveys will be completed at preimplementation and postimplementation, with items varying
slightly at the two time points. The
project coordinator for each practice
will oversee collection of survey data.
(10) Health Literacy Team Leader
Survey: The leader of the Health
Literacy Team will complete this survey
at pre- and post-implementation to
provide data regarding health literacyrelated policies and details regarding
Toolkit implementation (e.g., has the
reading level of written patient
materials been assessed, how does the
practice remind patients to bring in
medication bottles to facilitate
medication reviews).

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(11) Health Literacy Team Leader
Interview: The leader of the Health
Literacy Team will be interviewed in
person at pre- and post-implementation.
At the beginning of the project, this
qualitative interview will focus on
expectations regarding implementation
(e.g., expected barriers) and technical
assistance needs. The postimplementation interview is designed to
elicit detailed information about the
implementation process, suggested
revisions to the Toolkit, and an
assessment of the technical assistance
provided.
(12) Check-in Phone Calls: To ensure
that practices stay on track, the project
team will contact practices on a regular
schedule to assess progress and provide
facilitation that might be needed to help
practices address barriers they may be
experiencing. Calls will take place two
weeks, one month, two months, and
four months into implementation and
will involve the leader of the Health
Literacy Team.
(13) Health Literacy Team Member
Interview: So that we may obtain
information about the implementation
process as well as functioning of the
Health Literacy Team (e.g., how difficult
was it to reach decisions about which
tools to implement), we also will
interview a member of the Team other
than the Team leader at postimplementation. Interviews will be
conducted on site at the practice.
(14) Practice Staff Member Interview:
So that we can obtain input about
Toolkit implementation and project
participation from someone outside of
the Health Literacy Team, we will
conduct on-site interviews at postimplementation with one or two staff
members who were not involved in the
Health Literacy Team.
Data collected will be used for the
following purposes:
• To explore whether/how the
Toolkit assists motivated practices to
take a systematic approach to reducing
the complexity of health care and
ensuring that patients can succeed in
the health care environment. Based on
the data collected, AHRQ will issue a
Technical Assistance Guide for use by
practice facilitators that work with
Toolkit implementers and Case Studies
that highlight lessons learned.
• To improve the Health Literacy
Universal Precautions Toolkit, AHRQ
will issue a new edition of the Toolkit
based on insights from this study.
• To see whether items from the
CAHPS Item Set for Addressing Health
Literacy are sensitive to quality
improvement activities. AHRQ will use
the findings to modify the document
entitled ‘‘About the CAHPS Item Set for

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Addressing Health Literacy,’’ which
discusses use of the items for quality
improvement.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate in this
research.
• Practice Screening Calls will be
conducted with one person from 20
different practices, with 12 practices
expected to ‘‘screen-in’’ and be included
in this project. The screening calls will
take 20 minutes.
• The Health Literacy Assessment
Questions will be completed twice; once
at pre-implementation and again at postimplementation. We estimate that five
staff members from each of the 12
practices will complete the
questionnaire at each time point, for a
total of 120 respondents, and will
require 30 minutes to complete. (The
same staff members will not be targeted
to complete the survey at both time
points.) A staff member will distribute
and collect the survey, which we
estimate will take approximately five
minutes per survey.
• The Implementation Tracking Form
will be completed at the beginning of
the project and updated before each of
the four Check-in Phone Calls and again
at the end of the intervention.
The form will be completed by the
Leader of each practice’s Health Literacy
Team and will take approximately 5
minutes to complete each time.
• The Webinar/Orientation will take
place at the beginning of the
intervention and will include, on
average, 4 staff members from each of
the 12 practices and may take up to 2
hours.
• The Patient Survey will be
completed at each of the 12 practices at
pre-implementation and postimplementation. Fifty patients from
each time period will be surveyed at
each of the practices for a total of 1200
patients. The same patients will not be
targeted to complete both surveys. The
two surveys are identical and will take
20 minutes to complete. These will be
administered by a practice staff member
(recruiting patients, distributing
surveys, collecting surveys). It is
estimated that it will take 10 minutes of
the staff member’s time to administer
each survey.
• The Survey Using Items from the
Consumer Assessment of Healthcare
Providers and Systems (CAHPS) will be
completed by mail or phone and will
take approximately 12 minutes to
complete. It will be completed by a total
of about 1800 patients total at two of the
participating practices; 900 will

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30009

complete it at pre-implementation and
900 at post-implementation. The same
patients will not be targeted to complete
both surveys.
• The Medication Review Form will
not be used by all of the participating
practices. We estimate that 3 of the 12
practices will choose to implement Tool
8 from the Toolkit (Brown Bag
Medication Review), and only practices
implementing Tool 8 will collect these
data. For practices that do complete the
Medication Review Form, we expect
that about four clinic staff per practice
will complete this form and each will
complete it approximately five times at
each time point (pre-implementation
and post-implementation). Therefore, a
total of 12 clinical staff will complete a
total of 120 Medication Review Forms
and each form will take about 30
minutes to complete.
• The Practice Staff Survey will be
completed twice by each staff member;
about 18 staff at each of the 12 practices.
The pre-implementation version of the
survey will take 15 minutes to complete,
whereas the post-implementation
version of the survey will take 20
minutes to complete. The surveys will
be disseminated and collected by a
member of the practice, a role which we
expect to take about five minutes for
each survey.
• The Health Literacy Team Leader
Survey is completed by the Team
Leader at each of the practices at preimplementation and postimplementation. The preimplementation version of the survey
will take 15 minutes to complete,
whereas the post-implementation
version of the survey will take 20
minutes to complete.
• During the course of the
intervention, there will be four Checkin Phone Calls with the Health Literacy
Team Leader at each practice. Each call
will last approximately 30 minutes.
• The Health Literacy Team Leader
from each practice will be interviewed
at pre-implementation and postimplementation. The preimplementation version of the interview
will take about 30 minutes, whereas the
post-implementation interview will take
90 minutes.
• The Health Literacy Team Member
interview will target one member of the
Health Literacy Team from each practice
(other than the Team Leader) and will
be conducted at the post-intervention
time period. The interview is expected
to last 90 minutes.
• For the Practice Staff Member
Interview, two other staff members per
practice (24 total) will be interviewed
post-implementation and these will take
30 minutes to complete.

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Federal Register / Vol. 77, No. 98 / Monday, May 21, 2012 / Notices

The total annualized burden hours are
estimated to be 1,446 hours.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Form name
Practice Screening Calls .................................................................................
Health Literacy Assessment Questions:
Staff ..........................................................................................................
Staff Administration ..................................................................................
Implementation Tracking Form .................................................................
Webinar/Orientation ..................................................................................
Patient Survey:
Patients .....................................................................................................
Staff Administration ..................................................................................
Survey Using Items from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) ......................................................................
Medication Review Form .................................................................................
Practice Staff Survey—Pre-implementation:
Staff ..........................................................................................................
Staff Administration ..................................................................................
Practice Staff Survey—Post-implementation:
Staff ..........................................................................................................
Staff Administration ..................................................................................
Health Literacy Team Leader Survey-Pre-implementation .............................
Health Literacy Team Leader Survey-Post-implementation ............................
Check-in Phone Calls ......................................................................................
Health Literacy Team Leader Interview—pre-implementation ........................
Health Literacy Team Leader Interview—post-implementation .......................
Health Literacy Team Member Interview—post-implementation .....................
Practice Staff Member Interview—post-implementation ..................................
Total ..........................................................................................................

Exhibit 2 shows the estimated annual
cost burden to respondents, based on
their time to participate in this research.

Number of
responses per
respondent

Hours per
response

Total burden
hours

20/60

120
12
12
48

1
10
6
1

30/60
5/60
5/60
2

60
10
6
96

1,200
12

1
100

20/60
10/60

400
200

1,800
12

1
10

12/60
30/60

360
60

216
12

1
18

15/60
5/60

54
18

216
12
12
12
12
12
12
12
24

1
18
1
1
4
1
1
1
1

20/60
5/60
15/60
20/60
30/60
30/60
1.5
1.5
30/60

72
18
3
4
24
6
18
18
12

3,788

1,446

The annual cost burden is estimated to
be $34,329.

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents

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Form name
Practice Screening Calls .................................................................................
Health Literacy Assessment Questions:
Staff ..........................................................................................................
Staff Administration ..................................................................................
Implementation Tracking Form .................................................................
Webinar/Orientation ..................................................................................
Patient Survey:
Patients .....................................................................................................
Staff Administration ..................................................................................
Survey Using Items from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) ......................................................................
Medication Review Form .................................................................................
Practice Staff Survey—Pre-implementation:
Staff ..........................................................................................................
Staff Administration ..................................................................................
Practice Staff Survey—Post-implementation:
Staff ..........................................................................................................
Staff Administration ..................................................................................
Health Literacy Team Leader Survey-Pre-implementation .............................
Health Literacy Team Leader Survey-Post-implementation ............................
Check-in Phone Calls Health Literacy Team Leader ......................................
Interview—pre-implementation Health Literacy Team Leader ........................
Interview—post-implementation Health Literacy Team Member .....................
Interview—post-implementation Practice Staff Member ..................................
Interview—post-implementation .......................................................................

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Total burden
hours

Average
hourly wage
rate a

Total cost
burden

$18.52 c

$130

120
12
12
48

60
10
6
96

$29.15 d
$18.52 c
$18.52 c
$29.15 d

$1,749
$185
$111
$2,798

1,200
12

400
200

$22.48 b
$18.52 c

$8,992
$3,704

1,800
12

360
60

$22.48 b
$29.15 d

$8,093
$1,749

216
12

54
18

$29.15 d
$18.52 c

$1,574
$333

216
12
12
12
12
12
12
12
24

72
18
3 $29.15 d
4
24
6
18
18
12

$29.15 d
$18.52 c
$87
$29.15 d
$29.15 d
$29.15 d
$29.15 d
$29.15 d
$29.15 d

$2,099
$333

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$117
$700
$175
$525
$525
$350

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Federal Register / Vol. 77, No. 98 / Monday, May 21, 2012 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued
Number of
respondents

Form name
Total ...................................................................................................

Total burden
hours

3,788

Average
hourly wage
rate a

1,446

Total cost
burden
$34,329

a Mean

hourly and wage costs for Colorado were derived from the Bureau of Labor and Statistics National Compensation Survey for May 2010
(http://www.bls.gov/oes/current/oes_co.htm).
b Hourly rate for all workers (occupation code 00–0000) estimates the cost of time for patients.
c Hourly rate for medical records and health information technician (29–2071).
d Hourly rate for Healthcare Practitioners and Technical Workers, All Other (29–9799).

Estimated Annual Costs to the Federal
Government
Exhibit 3 shows the estimated total
and annualized cost to the Federal
Government for conducting this
research. These estimates include the

costs associated with the project such as
the preparation of survey administration
procedures, labor costs, administrative
expenses, costs associated with copying,
postage, and telephone expenses, data
management and analysis, preparation

of final reports, and dissemination of
findings/results/products. The
annualized and total costs are identical
since the data collection period will last
for one year. The total cost is estimated
to be $784,910.

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST
Cost component

Annualized
cost

Administration ..........................................................................................................................................................
Research Activities ..................................................................................................................................................
Dissemination Activities ...........................................................................................................................................
Final Report .............................................................................................................................................................
Overhead .................................................................................................................................................................

$81,654
446,201
57,222
57,864
141,969

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

784,910

Request for Comments

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Total

In accordance with the Paperwork
Reduction Act, 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 health care
research and health care 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.

AGENCY:
ACTION:

Notice.

Dated: May 3, 2012.
Carolyn M. Clancy,
Director.

[FR Doc. 2012–12171 Filed 5–18–12; 8:45 am]

DATES:

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SUMMARY:

Comments on this notice must be
received by June 20, 2012.

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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
email at doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:

Proposed Project
Workflow Assessment for Health IT
Toolkit Evaluation
AHRQ is a lead Federal agency in
developing and disseminating evidence
and evidence-based tools on how health
IT can improve health care quality,
safety, efficiency, and effectiveness.
Understanding clinical work practices
and how they will be affected by
practice innovations such as
implementing health IT has become a
central focus of health IT research.
While much of the attention of health IT
research and development had been
directed at the technical issues of
building and deploying health IT

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