[Federal Register Volume 81, Number 163 (Tuesday, August 23, 2016)]
[Notices]
[Pages 57583-57586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20035]


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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: ``Eisenberg Center Voluntary Customer Survey Generic 
Clearance.'' 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 May 27, 2016 and allowed 60 days for public 
comment. AHRQ received no substantive comments. The purpose of this 
notice is to allow an additional 30 days for public comment.

DATES: Comments on this notice must be received by September 22, 2016.

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 [email protected] (attention: AHRQ's desk officer).

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

SUPPLEMENTARY INFORMATION: 

Proposed Project

Eisenberg Center Voluntary Customer Survey Generic Clearance

    The Agency for Healthcare Research and Quality (AHRQ) requests that 
the Office of Management and Budget (OMB) renew under the Paperwork 
Reduction Act of 1995 AHRQ's Generic Clearance to collect information 
from users of work products and services initiated by the John M. 
Eisenberg Center for Clinical Decisions and Communications Science 
(Eisenberg Center). Since September 2008, the Eisenberg Center has been 
operated by Baylor College of Medicine (BCM), located in Houston, 
Texas.
    AHRQ is the lead agency charged with supporting research designed 
to improve the quality of health care, reduce its cost, improve patient 
safety, decrease medical errors, and broaden access to essential 
services (see 42 U.S.C. 299). The Eisenberg Center, funded by AHRQ, is 
an innovative effort aimed at improving communication of findings to a 
variety of audiences (``customers''), including consumers, clinicians, 
and health care policymakers. The Eisenberg Center compiles research 
results into a variety of useful formats for customer stakeholders.
    This research has the following goals:
    (1) Conduct research into effective communication of research 
findings in order to improve the usability and rapid incorporation of 
findings into medical practice and decision making.
    (2) Conduct research into effective strategies for disseminating 
evidence-based products, tools, and resources to consumers, clinicians, 
and other health care professionals, and policymakers.
    (3) Evaluate outcomes reported by clinicians and other health care 
professionals resulting from participation in continuing medical 
education (CME) initiatives and activities.
    (4) Conduct research into factors associated with successful 
collaboration between AHRQ and partnering institutions and 
organizations in synthesizing, translating, and disseminating evidence-
based research.
    Clearance is being requested to cover a three-year period in which 
differing numbers of information collections concerning products and 
research activities may be conducted within each contract year. The 
collections proposed include activities to assist in the development of 
materials to be disseminated through the Eisenberg Center and to 
provide feedback to AHRQ on the extent to which these products meet 
customer needs. These materials include documents that summarize and 
translate the findings of research reports for various decision-making 
audiences, such as consumers, clinicians, or policymakers. The 
summaries are designed to help these decision makers use research 
evidence to maximize the benefits of health care, minimize harm, and 
optimize the use of health care resources. In addition, each year of 
the contract a unique research project will be undertaken to study 
successful approaches to disseminating AHRQ products in various health 
care settings and clinical environments. Also each year the Eisenberg 
Center will develop one interactive decision aid for clinical problems 
identified from selected research reports. The intent is for the 
decision aid to increase the customer's knowledge of the health 
condition, options, and risk/benefits; lead to greater assurance in 
making a decision; increase the congruence between values and choices; 
and enhance involvement in the decision making process. Information 
collections conducted under this generic clearance are not required by 
regulation and will not be used to regulate or sanction customers. Data 
collections will be entirely voluntary, and information provided by 
respondents will be combined and summarized so that no individually 
identifiable information will be released.
    This study is being conducted by AHRQ through its contractor, 
Baylor College of Medicine, 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 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

    The data collections listed below will be implemented to achieve 
project goals. Note: Assessments such as interviews and surveys are 
here denoted formative if conducted prior to product development or 
determination of dissemination channels; usability testing or 
pretesting if conducted while reviewing a draft product, proposed 
dissemination approach, or other proposed content/strategy; and 
evaluation if conducted for summative evaluation or to assess 
satisfaction after the product has been in use or the dissemination 
campaign, learning activity, or other initiative undertaken.

[[Page 57584]]

    Data collections will include the following:
    (1) Interviews for Product and Decision Aid Development, Testing, 
and Use. Individual interviews will be conducted with clinical 
professionals, patients, or other health care consumers, or health 
policymakers. In some cases focus groups may be substituted for patient 
interviews. These formative and pretesting/cognitive interviews will 
allow for (1) collecting input from target audiences regarding the 
development of summary products and decision aids; (2) determining if 
intended information and messages are being delivered effectively 
through products that are developed and disseminated through the 
Eisenberg Center; (3) assessing whether changes in topical knowledge 
levels can be identified following exposure to Eisenberg Center 
informational or instructional products or aids; (4) identifying 
product strengths and weaknesses to facilitate improvements that are 
practical and feasible; and (5) assessing decision support from the 
perspective of each audience. In addition, the Eisenberg Center will 
conduct a new research project annually to inform the enhancement of 
existing health information products, beyond what is currently being 
provided. The accompanying assessments will likely consist of 
interviews conducted with target audience members and may be integrated 
into the existing product interviews discussed above. If new 
assessments are required, the interview scripts and data collection 
particulars will be submitted as addenda.
    (2) Interviews for Dissemination Activities. Interviews will be 
conducted with leadership and staff of health systems, hospitals, and/
or clinics in which dissemination activities are conducted to explore, 
prior to initiating the project, those pathways holding the greatest 
potential for successful uptake of the AHRQ materials. Interviews will 
be conducted again after project conclusion with administrators and 
product users (e.g., consumers, clinicians) to assess success of 
dissemination efforts, perceptions around product access, challenges 
that arose, and strategies to facilitate future successful 
dissemination initiatives. Interview scripts will be developed and 
submitted as addenda.
    (3) Survey for Decision Aids. Following delivery of the decision 
aid, a user survey will be completed to explore subjects' impressions 
of the tool, including ease of use, clarity of presentation, length, 
balance of information, rating of interactive features, and overall 
satisfaction. Both clinicians and patients/consumers will be surveyed. 
For patients, the customer satisfaction survey may include decisional 
outcome measures (e.g., decisional conflict, desire for involvement in 
decision-making), measures of attitudes and self-efficacy, and 
indicators of choice intention or actual choice made. If the aid is 
evaluated within a clinical context, measures of physician-patient 
interaction will also be considered. Additionally, clinicians may be 
interviewed about the impact of the aid on decision making, clinical 
flow, and patient outcomes. A user survey will be developed and 
submitted as an addendum.
    (4) Survey for Summary Products (initial, follow up). Very brief 
surveys will be offered to health care professionals, consumers, and 
policymakers that use the online summaries. Immediately upon accessing 
the summaries, visitors will be asked to complete a brief survey 
assessing for whom they were seeking information, how the product might 
be used, and an email address for a follow-up survey. Respondents will 
subsequently be sent an email asking them to complete a follow-up 
online survey assessing how the information has been used, whether it 
influenced health care practices, and any barriers to use or 
suggestions for improvement.
    (5) Survey of Patient and Consumer Advocacy Organizations. Each 
project year, representatives from consumer and patient advocacy 
organizations will be invited to attend a meeting and participate in 
ongoing activities to facilitate engagement in AHRQ systematic review, 
translation, and dissemination activities. Surveys by phone or online 
questionnaire will be used to assess the quality of the in-person 
meeting and ongoing activities, the impact and value of engaging with 
AHRQ, the value of research and translation products for the target 
audiences, how partners and their constituents are using the products, 
and ways to make the products and partnerships with AHRQ more useful 
for partners and have a broader reach. The survey and any additional 
assessment mechanisms that may be useful in evaluating these 
relationships with advocacy organizations will be developed and 
submitted as an addendum.
    (6) Survey of AHRQ Partners. AHRQ, through the Evidence-based 
Practice Center (EPC) Program and Eisenberg Center, partners with 
organizations when developing, translating, and/or disseminating 
research reports and related products. AHRQ partners include developers 
of clinical practice guidelines, payers, other Government agencies, 
private companies, consumer and patient advocacy groups, and health 
care systems. Surveys by phone or online questionnaire, followed by 
targeted interviews, will be used to assess the impact and value of 
AHRQ research products for the target audiences, determine how partners 
are using the products, and identify ways to make the products and 
partnerships more useful for partners and have a broader reach. Survey 
and interview script will be developed and submitted as addenda.
    (7) CME Outcomes Survey. AHRQ through the Eisenberg Center will 
offer AMA PRA Category 1 continuing medical education (CME) credit for 
certain products that it develops. Clinicians wishing to claim credit 
must complete an outcome assessment survey delivered online two months 
after completing the activity.
    (8) Interviews and Surveys for Dissemination Research Project. Each 
project year the Eisenberg Center will propose and conduct a unique 
research project aimed at disseminating products. As part of that 
project, formative interviews and potentially cognitive testing will be 
conducted with consumers, clinicians, and administrators from 
participating health systems, hospitals, and/or clinics for purposes of 
assessing current dissemination initiatives, similar products available 
to their consumers, ways to optimize dissemination, and other 
indicators as determined by the project aims. These three audiences may 
also be asked to complete follow-up surveys and/or participate in 
interviews to document project outcomes and lessons learned from the 
study. Survey and interview scripts will be developed and submitted as 
addenda.
    The information will be used to develop, improve and/or maintain 
high quality health care informational products and services to lay 
public and health care professionals. Each product previously developed 
by the Eisenberg Center was proposed, drafted, tested, and revised with 
heavy reliance on data collected in a manner similar to those 
approaches described in this clearance. This includes data collected at 
the formative stage when ideas for the product and its information 
parameters are being developed, through draft testing and revisions, 
and finally product implementation and evaluation of its usefulness in 
practice. Work on implementing and evaluating dissemination strategies 
and approaches will complement the development

[[Page 57585]]

activities in optimizing delivery to the targeted audiences.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated total burden for the respondents' 
time to participate in this research. These estimates assume a maximum 
of 141 Summary products over 3 years with separate products developed 
for clinicians, policymakers, and consumers.
    Formative interviews, and in some cases focus groups, will be used 
to conduct needs assessment and will be held with clinicians and 
consumers for development of the products and decision aids, and 
additionally with policymakers for those products in which policy 
recommendations are applicable. Interviews will be conducted with no 
more than 2,115 persons for product development, 180 persons for 
decision aid development, and 180 persons for development of 
dissemination initiatives over 3 years, and each will last about 60 
minutes.
    Once the products are developed they will be subjected to in-person 
or telephone interviews for purposes of usability and product testing 
with clinicians, policymakers and consumers. In-person/telephone 
interviews will be conducted with about 2,115 persons for products and 
180 persons for decision aids over 3 years and will take about 60 
minutes on average. A second round of interviews will be conducted only 
occasionally with one or more of the targeted populations if necessary 
due to substantial product revisions. These interviews may also be used 
to inform product enhancements in relation to the annual enhancement 
study. Because these specifications cannot be determined in advance, 
clearance is being requested for two testing rounds with every product 
and every audience.
    Evaluation surveys will be conducted with approximately 6,000 
representatives across the targeted audiences (i.e., consumer, 
clinician, policymaker) for the health information products and 2,400 
persons who have used the decision aids over the 3-year period. The 
product surveys will take about 5 minutes to complete, and the decision 
aid surveys about 10 minutes. A follow-up survey will be completed for 
the product evaluations, which will also last about 5 minutes, while a 
subset of 180 of those having used the decision aids will be asked to 
participate in a follow-up evaluation interview lasting an hour.
    Those involved in or targeted by the dissemination initiatives will 
be asked to participate in evaluation interviews, which will include up 
to 480 persons completing interviews across the 3 project years. Note: 
Because the timing of interviews with persons at the 6 total partner 
organizations has not yet been finalized, AHRQ is requesting that all 
dissemination-related interviews be approved for the first project 
year. For simplicity, the interviews are presented as annualized in 
Exhibits 1 and 2.
    The unique dissemination research project to be proposed and 
completed annually will include 135 formative interviews with 
consumers, clinicians, and administrators, with each lasting 1 hour. 
Follow-up evaluation surveys and interviews will be conducted with 360 
and 180 persons, respectively.
    AHRQ partners will be asked to complete surveys and interviews in 
relation to their prior or ongoing collaborative work with AHRQ. These 
will include 150 persons completing surveys and 60 follow-up 
interviews. Similar types of surveys designed with the goal of 
improving products and expanding their research will be completed by 90 
representatives of advocacy organizations across the 3 years, with each 
survey lasting about 10 minutes.
    Clinicians that have completed CME accrediting requirements and are 
requesting CME credit will be asked to complete a follow-up outcomes 
survey two months following completion of the online activity. These 
will be completed by no more than 27,000 clinicians over 3 years and 
will require 5 minutes to complete.
    The total burden hours are estimated to be 13,875 annually or 
41,625 over 3 years. The total annual cost burden is $237,604.

                                  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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Product Formative Interviews....................             705               1               1             705
Product Pretesting Interviews...................             705               2               1           1,410
Product Evaluation Surveys......................           2,000               2            5/60             333
Dissemination Formative Interviews..............              40               1               1              40
Dissemination Evaluation Interviews.............             120               1               1             120
Decision Aid Formative Interviews...............              60               1               1              60
Decision Aid Pretesting Interviews..............              60               1               1              60
Decision Aid Evaluation Interviews..............              60               1               1              60
Decision Aid Evaluation Surveys.................             800               1           10/60             133
Research Project Formative Interviews...........              45               1               1              45
Research Project Evaluation Surveys.............             120               1           10/60              20
Research Project Evaluation Interviews..........              60               1               1              60
Partnership Evaluation Surveys..................              50               1           10/60               8
Partnership Evaluation Interviews...............              20               1               1              20
Advocacy Meeting Evaluation Surveys.............              30               1           10/60               5
CME Outcomes Surveys............................           9,000               1            5/60             750
                                                 ---------------------------------------------------------------

[[Page 57586]]

 
    Total.......................................          13,875              NA              NA           3,830
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* For the 3-year contract period, product formative interviews and product testing interviews will each comprise
  300 consumers, 300 clinicians, and 105 policymakers; product evaluation surveys will include 800 consumers,
  800 clinicians, and 400 policymakers; dissemination-related formative interviews will include 40 health system/
  hospital/clinic administrators; dissemination-related evaluation interviews will include 40 consumers, 40
  clinicians, and 40 administrators; formative interviews, pretesting interviews, and evaluation interviews for
  the decision aids will each include 30 consumers and 30 clinicians; evaluation surveys for the decision aids
  will include 400 consumers and 400 clinicians; formative interviews for the annual dissemination research
  project will include 15 consumers, 15 clinicians, and 15 administrators; evaluation surveys for the research
  project will include 50 consumers, 50 clinicians, and 20 administrators; evaluation interviews for the
  research project will include 20 consumers, 20 clinicians, and 20 administrators; the AHRQ partner surveys
  will include 50 partners; the AHRQ partner evaluation interviews will include 20 partners; the health
  advocates surveys will include 30 participants; and CME outcomes surveys will include 500 clinicians for each
  of 18 CME activities.


                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                     Number of     Total burden   Average hourly    Total cost
                    Form name                       respondents        hours        wage rate *       burden
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Product Formative Interviews....................             705             705      \a\ $54.81          38,641
Product Pretesting Interviews...................             705           1,410       \a\ 54.81          77,282
Product Evaluation Surveys......................           2,000             333       \a\ 54.00          17,982
Dissemination Formative Interviews..............              40              40       \a\ 49.84           1,994
Dissemination Evaluation Interviews.............             120             120       \a\ 54.74           6,568
Decision Aid Formative Interviews...............              60              60       \a\ 57.19           3,431
Decision Aid Pretesting Interviews..............              60              60       \a\ 57.19           3,431
Decision Aid Evaluation Interviews..............              60              60       \a\ 57.19           3,431
Decision Aid Evaluation Surveys.................             800             133       \a\ 57.19           7,606
Research Project Formative Interviews...........              45              45       \b\ 54.74           2,463
Research Project Evaluation Surveys.............             120              20       \b\ 55.96           1,119
Research Project Evaluation Interviews..........              60              60       \b\ 54.74           3,284
AHRQ Partner Evaluation Surveys.................              50               8       \c\ 54.50             436
AHRQ Partner Evaluation Interviews..............              20              20       \c\ 54.50           1,090
Advocacy Meeting Evaluation Surveys.............              30               5       \d\ 21.21             106
CME Outcomes Surveys............................           9,000             750       \e\ 91.66          68,745
                                                 ---------------------------------------------------------------
    Total.......................................          13,875           3,830              NA         237,604
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* National Compensation Survey: Occupational wages in the United States May 2014, ``U.S. Department of Labor,
  Bureau of Labor Statistics.''
\a\ Based on the mean and/or weighted mean wages for various combinations of consumers (00-0000 all
  occupations), clinicians (29-1060 physicians and surgeons, 29-1062 family and general practitioners), and
  health policymakers (11-0000 management occupations, 11-3111 compensation & benefits managers, 13-1141
  compensation, benefits & job analysis specialists, 11-9111 medical and health service managers, 13-2053
  insurance underwriters and 15-2011 actuaries).
\b\ Based on the mean and/or weighted mean wages for various combinations of consumers (00-0000 all
  occupations), clinicians (29-1060 physicians and surgeons, 29-1062 family and general practitioners), and
  health system/hospital/clinic administrators (11-9111 medical and health services managers).
\c\ Based on the mean wages for AHRQ partners (25-1071 health specialties teachers, postsecondary, 11-1021
  general and operations managers, 21-0091 health educators, 21-1093 social and human service assistants, 11-
  9111 medical and health services managers).
\d\ Based on the mean wages for health advocacy organizations (21-1093 social and human service assistants
  [social advocacy organizations], 21-0091 health educators).
\e\ Based on the mean wages for clinicians (29-1060 physicians and surgeons, 29-1062 family and general
  practitioners).

    Exhibit 2 depicts the estimated total cost burden associated with 
the respondent's time to participate in this research. The cost burden 
is estimated to be $237,604 annually.

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 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.

Sharon B. Arnold,
Deputy Director.
[FR Doc. 2016-20035 Filed 8-22-16; 8:45 am]
BILLING CODE 4160-90-P