81_FR_57746 81 FR 57583 - Agency Information Collection Activities: Proposed Collection; Comment Request

81 FR 57583 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality

Federal Register Volume 81, Issue 163 (August 23, 2016)

Page Range57583-57586
FR Document2016-20035

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.

Federal Register, Volume 81 Issue 163 (Tuesday, August 23, 2016)
[Federal Register Volume 81, Number 163 (Tuesday, August 23, 2016)]
[Notices]
[Pages 57583-57586]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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

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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
* 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
----------------------------------------------------------------------------------------------------------------
                                                     Number of     Total burden   Average hourly    Total cost
                    Form name                       respondents        hours        wage rate *       burden
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
* 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



                                                                             Federal Register / Vol. 81, No. 163 / Tuesday, August 23, 2016 / Notices                                           57583

                                                Public and Tribal Meetings on the Draft                 SUPPLEMENTARY INFORMATION:                            AHRQ on the extent to which these
                                                Plan Update                                                                                                   products meet customer needs. These
                                                                                                        Proposed Project
                                                  In addition to the comment                                                                                  materials include documents that
                                                opportunities discussed above, the                      Eisenberg Center Voluntary Customer                   summarize and translate the findings of
                                                Council will also hold a number of                      Survey Generic Clearance                              research reports for various decision-
                                                public and Tribal meetings across the                      The Agency for Healthcare Research                 making audiences, such as consumers,
                                                Gulf to hear from the public and Tribes                 and Quality (AHRQ) requests that the                  clinicians, or policymakers. The
                                                regarding this draft Plan update. The                   Office of Management and Budget                       summaries are designed to help these
                                                locations, dates, and times for the public              (OMB) renew under the Paperwork                       decision makers use research evidence
                                                meetings can be found at                                Reduction Act of 1995 AHRQ’s Generic                  to maximize the benefits of health care,
                                                www.RestoreTheGulf.gov.                                 Clearance to collect information from                 minimize harm, and optimize the use of
                                                  Legal Authority: The statutory                        users of work products and services                   health care resources. In addition, each
                                                program authority for the draft Plan                    initiated by the John M. Eisenberg                    year of the contract a unique research
                                                update is found at 33 U.S.C. 1321(t).                   Center for Clinical Decisions and                     project will be undertaken to study
                                                                                                        Communications Science (Eisenberg                     successful approaches to disseminating
                                                Will D. Spoon,                                                                                                AHRQ products in various health care
                                                                                                        Center). Since September 2008, the
                                                Program Analyst, Gulf Coast Ecosystem                   Eisenberg Center has been operated by                 settings and clinical environments. Also
                                                Restoration Council.                                                                                          each year the Eisenberg Center will
                                                                                                        Baylor College of Medicine (BCM),
                                                [FR Doc. 2016–19986 Filed 8–22–16; 8:45 am]
                                                                                                        located in Houston, Texas.                            develop one interactive decision aid for
                                                BILLING CODE 6560–58–P                                     AHRQ is the lead agency charged                    clinical problems identified from
                                                                                                        with supporting research designed to                  selected research reports. The intent is
                                                                                                        improve the quality of health care,                   for the decision aid to increase the
                                                DEPARTMENT OF HEALTH AND                                reduce its cost, improve patient safety,              customer’s knowledge of the health
                                                HUMAN SERVICES                                          decrease medical errors, and broaden                  condition, options, and risk/benefits;
                                                                                                        access to essential services (see 42                  lead to greater assurance in making a
                                                Agency for Healthcare Research and                      U.S.C. 299). The Eisenberg Center,                    decision; increase the congruence
                                                Quality                                                 funded by AHRQ, is an innovative effort               between values and choices; and
                                                                                                        aimed at improving communication of                   enhance involvement in the decision
                                                Agency Information Collection                                                                                 making process. Information collections
                                                                                                        findings to a variety of audiences
                                                Activities: Proposed Collection;                                                                              conducted under this generic clearance
                                                                                                        (‘‘customers’’), including consumers,
                                                Comment Request                                                                                               are not required by regulation and will
                                                                                                        clinicians, and health care
                                                                                                        policymakers. The Eisenberg Center                    not be used to regulate or sanction
                                                AGENCY: Agency for Healthcare Research
                                                                                                        compiles research results into a variety              customers. Data collections will be
                                                and Quality, HHS.
                                                                                                        of useful formats for customer                        entirely voluntary, and information
                                                ACTION: Notice.                                                                                               provided by respondents will be
                                                                                                        stakeholders.
                                                SUMMARY:   This notice announces the                       This research has the following goals:             combined and summarized so that no
                                                intention of the Agency for Healthcare                     (1) Conduct research into effective                individually identifiable information
                                                Research and Quality (AHRQ) to request                  communication of research findings in                 will be released.
                                                that the Office of Management and                       order to improve the usability and rapid                 This study is being conducted by
                                                Budget (OMB) approve the proposed                       incorporation of findings into medical                AHRQ through its contractor, Baylor
                                                information collection project:                         practice and decision making.                         College of Medicine, pursuant to
                                                ‘‘Eisenberg Center Voluntary Customer                      (2) Conduct research into effective                AHRQ’s statutory authority to conduct
                                                Survey Generic Clearance.’’ In                          strategies for disseminating evidence-                and support research on health care and
                                                accordance with the Paperwork                           based products, tools, and resources to               on systems for the delivery of such care,
                                                Reduction Act, 44 U.S.C. 3501–3521,                     consumers, clinicians, and other health               including activities with respect to the
                                                AHRQ invites the public to comment on                   care professionals, and policymakers.                 quality, effectiveness, efficiency,
                                                this proposed information collection.                      (3) Evaluate outcomes reported by                  appropriateness and value of health care
                                                   This proposed information collection                 clinicians and other health care                      services and with respect to quality
                                                was previously published in the Federal                 professionals resulting from                          measurement and improvement. 42
                                                Register on May 27, 2016 and allowed                    participation in continuing medical                   U.S.C. 299a(a)(1) and (2).
                                                60 days for public comment. AHRQ                        education (CME) initiatives and                       Method of Collection
                                                received no substantive comments. The                   activities.
                                                purpose of this notice is to allow an                      (4) Conduct research into factors                    The data collections listed below will
                                                additional 30 days for public comment.                  associated with successful collaboration              be implemented to achieve project
                                                DATES: Comments on this notice must be
                                                                                                        between AHRQ and partnering                           goals. Note: Assessments such as
                                                received by September 22, 2016.                         institutions and organizations in                     interviews and surveys are here denoted
                                                                                                        synthesizing, translating, and                        formative if conducted prior to product
                                                ADDRESSES: Written comments should
                                                                                                        disseminating evidence-based research.                development or determination of
                                                be submitted to: AHRQ’s OMB Desk                           Clearance is being requested to cover              dissemination channels; usability
                                                Officer by fax at (202) 395–6974                        a three-year period in which differing                testing or pretesting if conducted while
                                                (attention: AHRQ’s desk officer) or by                  numbers of information collections                    reviewing a draft product, proposed
sradovich on DSK3GMQ082PROD with NOTICES




                                                email at OIRA_submission@                               concerning products and research                      dissemination approach, or other
                                                omb.eop.gov (attention: AHRQ’s desk                     activities may be conducted within each               proposed content/strategy; and
                                                officer).                                               contract year. The collections proposed               evaluation if conducted for summative
                                                FOR FURTHER INFORMATION CONTACT:                        include activities to assist in the                   evaluation or to assess satisfaction after
                                                Doris Lefkowitz, AHRQ Reports                           development of materials to be                        the product has been in use or the
                                                Clearance Officer, (301) 427–1477, or by                disseminated through the Eisenberg                    dissemination campaign, learning
                                                email at doris.lefkowitz@AHRQ.hhs.gov.                  Center and to provide feedback to                     activity, or other initiative undertaken.


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                                                57584                        Federal Register / Vol. 81, No. 163 / Tuesday, August 23, 2016 / Notices

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


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                                                                                   Federal Register / Vol. 81, No. 163 / Tuesday, August 23, 2016 / Notices                                                        57585

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

                                                                                                        EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                              Number of
                                                                                                                                                            Number of                           Hours per         Total
                                                                                            Form name                                                                       responses per
                                                                                                                                                           respondents                          response      burden hours
                                                                                                                                                                              respondent

                                                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
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                                                57586                                  Federal Register / Vol. 81, No. 163 / Tuesday, August 23, 2016 / Notices

                                                                                                   EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS—Continued
                                                                                                                                                                                            Number of
                                                                                                                                                                          Number of                            Hours per           Total
                                                                                                 Form name                                                                                responses per
                                                                                                                                                                         respondents                           response        burden hours
                                                                                                                                                                                            respondent

                                                      Total ..........................................................................................................          13,875                 NA               NA                3,830
                                                   * 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 form-
                                                ative 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
                                                                                                                                                                                                                Average
                                                                                                                                                                          Number of           Total                             Total cost
                                                                                                 Form name                                                                                                    hourly wage
                                                                                                                                                                         respondents      burden hours                           burden
                                                                                                                                                                                                                 rate *

                                                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
                                                   * 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 phy-
                                                sicians and surgeons, 29–1062 family and general practitioners), and health policymakers (11–0000 management occupations, 11–3111 com-
                                                pensation & 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 phy-
                                                sicians 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 man-
                                                agers, 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                                     AHRQ’s estimate of burden (including                            comments will become a matter of
                                                cost burden associated with the                                             hours and costs) of the proposed                                public record.
                                                respondent’s time to participate in this                                    collection(s) of information; (c) ways to
                                                research. The cost burden is estimated                                                                                                      Sharon B. Arnold,
                                                                                                                            enhance the quality, utility, and clarity
                                                to be $237,604 annually.                                                    of the information to be collected; and                         Deputy Director.
                                                                                                                            (d) ways to minimize the burden of the                          [FR Doc. 2016–20035 Filed 8–22–16; 8:45 am]
                                                Request for Comments
                                                                                                                            collection of information upon the                              BILLING CODE 4160–90–P
                                                  In accordance with the Paperwork                                          respondents, including the use of
                                                Reduction Act, comments on AHRQ’s                                           automated collection techniques or
                                                information collection are requested
                                                                                                                            other forms of information technology.
                                                with regard to any of the following: (a)
sradovich on DSK3GMQ082PROD with NOTICES




                                                Whether the proposed collection of                                            Comments submitted in response to
                                                information is necessary for the proper                                     this notice will be summarized and
                                                performance of AHRQ health care                                             included in the Agency’s subsequent
                                                research and health care information                                        request for OMB approval of the
                                                dissemination functions, including                                          proposed information collection. All
                                                whether the information will have
                                                practical utility; (b) the accuracy of


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Document Created: 2018-02-09 11:40:17
Document Modified: 2018-02-09 11:40:17
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesComments on this notice must be received by September 22, 2016.
ContactDoris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected]
FR Citation81 FR 57583 

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