[Federal Register Volume 77, Number 47 (Friday, March 9, 2012)]
[Notices]
[Pages 14373-14377]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-5569]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Agency Information Collection Activities; Proposed Collection; 
Comment Request

AGENCY: Agency for Healthcare Research and Quality, HHS.

ACTION: Notice.

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SUMMARY: This notice announces the intention of the Agency for 
Healthcare Research and Quality (AHRQ) to request that the Office of 
Management and Budget (OMB) approve the proposed information collection 
project: ``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.

DATES: Comments on this notice must be received by May 8, 2012.

ADDRESSES: 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.

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

SUPPLEMENTARY INFORMATION: 

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 as Pap smears and vaccines; poor self-
management 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 eight-week 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 
self-management 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 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

    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

[[Page 14374]]

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 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 
literacy-related 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 post-implementation and is designed to obtain patient input on 
health literacy-related performance of providers and staff (e.g., ``did 
your provider use medical words you did not understand''). Each 
practice will recruit 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 will be administered at pre- and post-implementation. 
Surveys will be sent by mail, with phone follow up. Across practices 
and the two time points (pre- and 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 literacy-related practices 
(e.g., staff use of effective communication techniques and confirmation 
of patient comprehension). Surveys will be completed at pre-
implementation and post-implementation, 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 literacy-related 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).
    (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 post-
implementation 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 post-

[[Page 14375]]

implementation. 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 post-implementation 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 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 post-implementation. 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 post-implementation. 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 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 pre-implementation and post-
implementation. 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.
     During the course of the intervention, there will be four 
Check-in 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 post-implementation. The pre-
implementation 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.
    The total annualized burden hours are estimated to be 1,446 hours.

                                  Exhibit 1--Estimated Annualized Burden Hours
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                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
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Practice Screening Calls........................              20               1           20/60               7
Health Literacy Assessment Questions:
    Staff.......................................             120               1           30/60              60
    Staff Administration........................              12              10            5/60              10

[[Page 14376]]

 
Implementation Tracking Form....................              12               6            5/60               6
Webinar/Orientation.............................              48               1               2              96
Patient Survey:
    Patients....................................            1200               1           20/60             400
    Staff Administration........................              12             100           10/60             200
Survey Using Items from the Consumer Assessment             1800               1           12/60             360
 of Healthcare Providers and Systems (CAHPS)....
Medication Review Form..........................              12              10           30/60              60
Practice Staff Survey--Pre-implementation:
    Staff.......................................             216               1           15/60              54
    Staff Administration........................              12              18            5/60              18
Practice Staff Survey--Post-implementation:
    Staff.......................................             216               1           20/60              72
    Staff Administration........................              12              18            5/60              18
Health Literacy Team Leader Survey--Pre-                      12               1           15/60               3
 implementation.................................
Health Literacy Team Leader Survey--Post-                     12               1           20/60               4
 implementation.................................
Check-in Phone Calls............................              12               4           30/60              24
Health Literacy Team Leader Interview--pre-                   12               1           30/60               6
 implementation.................................
Health Literacy Team Leader Interview--post-                  12               1             1.5              18
 implementation.................................
Health Literacy Team Member Interview--post-                  12               1             1.5              18
 implementation.................................
Practice Staff Member Interview--post-                        24               1           30/60              12
 implementation.................................
                                                 ---------------------------------------------------------------
        Total...................................           3,788              na              na           1,446
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Exhibit 2 shows the estimated annual cost burden to respondents, based on their time to participate in this
  research. The annual cost burden is estimated to be $34,329.


                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                     Number of     Total burden   Average hourly    Total cost
                    Form name                       respondents        hours       wage rate \a\      burden
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Practice Screening Calls........................              20               7      \c\ $18.52            $130
Health Literacy Assessment Questions:
    Staff.......................................             120              60       \d\ 29.15           1,749
    Staff Administration........................              12              10       \c\ 18.52             185
Implementation Tracking Form....................              12               6       \c\ 18.52             111
Webinar/Orientation.............................              48              96       \d\ 29.15           2,798
Patient Survey:
    Patients....................................            1200             400       \b\ 22.48           8,992
    Staff Administration........................              12             200       \c\ 18.52           3,704
Survey Using Items from the Consumer Assessment             1800             360       \b\ 22.48           8,093
 of Healthcare Providers and Systems (CAHPS)....
Medication Review Form..........................              12              60       \d\ 29.15           1,749
Practice Staff Survey--Pre-implementation:
    Staff.......................................             216              54       \d\ 29.15           1,574
    Staff Administration........................              12              18       \c\ 18.52             333
Practice Staff Survey--Post-implementation:
    Staff.......................................             216              72       \d\ 29.15           2,099
    Staff Administration........................              12              18       \c\ 18.52             333
Health Literacy Team Leader Survey--Pre-                      12               3       \d\ 29.15              87
 implementation.................................
Health Literacy Team Leader Survey--Post-                     12               4       \d\ 29.15             117
 implementation.................................
Check-in Phone Calls............................              12              24       \d\ 29.15             700
Health Literacy Team Leader Interview--pre-                   12               6       \d\ 29.15             175
 implementation.................................
Health Literacy Team Leader Interview--post-                  12              18       \d\ 29.15             525
 implementation.................................
Health Literacy Team Member Interview--post-                  12              18       \d\ 29.15             525
 implementation.................................
Practice Staff Member Interview--post-                        24              12       \d\ 29.15             350
 implementation.................................
                                                 ---------------------------------------------------------------
        Total...................................           3,788           1,446              na         34,329
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\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/oesco.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).


[[Page 14377]]

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
------------------------------------------------------------------------
                                                             Annualized
               Cost component                     Total         cost
------------------------------------------------------------------------
Administration..............................       $81,654       $81,654
Research Activities.........................       446,201       446,201
Dissemination Activities....................        57,222        57,222
Final Report................................        57,864        57,864
Overhead....................................       141,969       141,969
                                             ---------------------------
    Total...................................       784,910       784,910
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Request for Comments

    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 healthcare research and 
healthcare information dissemination functions, including whether the 
information will have practical utility; (b) the accuracy of AHRQ's 
estimate of burden (including hours and costs) of the proposed 
collection(s) of information; (c) ways to enhance the quality, utility, 
and clarity of the information to be collected; and (d) ways to 
minimize the burden of the collection of information upon the 
respondents, including the use of automated collection techniques or 
other forms of information technology.
    Comments submitted in response to this notice will be summarized 
and included in the Agency's subsequent request for OMB approval of the 
proposed information collection. All comments will become a matter of 
public record.

    Dated: February 29, 2012.
Carolyn M. Clancy,
Director.
[FR Doc. 2012-5569 Filed 3-8-12; 8:45 am]
BILLING CODE 4160-90-M