81_FR_53018 81 FR 52864 - Agency Information Collection Activities: Proposed Collection; Comment Request

81 FR 52864 - 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 154 (August 10, 2016)

Page Range52864-52867
FR Document2016-18995

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: ``Agency for Healthcare Research and Quality's (AHRQ) Guide To Improving Patient Safety in Primary Care Settings by Engaging Patients and Families--Evaluation.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

Federal Register, Volume 81 Issue 154 (Wednesday, August 10, 2016)
[Federal Register Volume 81, Number 154 (Wednesday, August 10, 2016)]
[Notices]
[Pages 52864-52867]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-18995]


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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: ``Agency for Healthcare Research and Quality's (AHRQ) Guide To 
Improving Patient Safety in Primary Care Settings by Engaging Patients 
and Families--Evaluation.'' In accordance with the Paperwork Reduction 
Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this 
proposed information collection.

DATES: Comments on this notice must be received by October 11, 2016.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, by email at 
[email protected].
    Copies of the proposed collection plans, data collection 
instruments, and specific details on the estimated burden can be 
obtained from the AHRQ Reports Clearance Officer.

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

SUPPLEMENTARY INFORMATION: 

Proposed Project

Agency for Healthcare Research and Quality's (AHRQ) Guide To Improving 
Patient Safety in Primary Care Settings by Engaging Patients and 
Families--Evaluation

    There is a substantial evidence base showing that engaging patients 
and families in their care can lead to improvements in patient safety. 
Since the 1999 release of To Err is Human, there has been an undeniable 
focus on improving patient safety and eliminating patient harm within 
acute care. What is not as well documented is how to achieve these 
improvements in primary care settings.
    Patient and Family Engagement (PFE) strategies for acute care 
settings include, among others: Patient and family advisory committees; 
membership on patient safety oversight bodies at both operations and 
governance levels; consultation in the development of patient 
information material; engaging patients in process improvement or 
redesign projects; rounding with patients and families; patient and 
family participation in clinical education programs, and welcoming 
patients and families to work alongside providers and health systems 
employees on transparency, culture change and high reliability 
organization initiatives.
    Although the field of PFE in patient safety for hospitals and 
health systems is maturing, leveraging PFE to improve patient safety in 
non-acute settings is in its infancy. Building sustainable processes 
and practice-based infrastructure are crucial to improving patient 
safety through patient and family engagement in primary care.
    In response to the limited guidance available for primary care 
practices to improve safety through patient and family engagement, the 
AHRQ has funded the development of a Guide To Improving Patient Safety 
in Primary Care Settings by Engaging Patients and Families (hereafter 
referred to as the Guide). This comprehensive Guide will provide 
primary care practices with interventions that they can use to engage 
patients and families in ways that lead to improved patient safety. It 
will include explicit instructions to help primary care practices, 
providers, and patients and families adopt new behaviors. The Guide and 
its development are prefaced on several key insights relevant to 
primary care including:
    [ssquf] Active engagement requires organizational commitment to 
hearing the patient and family voice and action by leadership to 
include them as central members of the health care team.
    [ssquf] Patients and families expect and increasingly demand 
meaningful engagement in harm prevention efforts.
    [ssquf] Institutional courage is required to openly share patient 
safety vulnerabilities and proactively engage patients in developing 
solutions that prevent harm.
    [ssquf] Supportive infrastructure is needed to hardwire PFE into 
all facets of care delivery across the care continuum.
    [ssquf] When done well, patient engagement yields important and 
measurable results. When not done well, PFE activities may 
disenfranchise patients, contribute to misunderstanding about risk, 
create fissures among members of the clinical care team, and result in 
lack of trust between patients and providers.
    With these insights as a basis, three precepts undergird our 
approach to development for the Guide. The Guide interventions must 
yield:
    [ssquf] Meaningful relationship-based engagement for patients and 
families and primary care providers.
    [ssquf] Innovation and enabling technologies to support engagement, 
shared decision making and patient safety.
    [ssquf] Workable processes yielding sustainable engagement 
opportunities for patients, families, providers, and practice staff.
    The Guide will be principally (but not exclusively) meeting the 
needs of practices that have not already implemented effective PFE 
structures or processes. An environmental scan revealed several 
promising interventions for consideration for inclusion in the Guide. 
The four interventions selected as part of the Guide include:
    [ssquf] Teach-back.
    [ssquf] Be Prepared to Be Engaged.
    [ssquf] Medication Management.
    [ssquf] Warm Handoff.
    The interventions will be compiled into the Guide for adoption by 
primary care practices. The environmental scan also yielded several 
important implications for Guide development including:
    [ssquf] Engagement efforts in primary care to date have focused on 
the patient as the agent of change with limited guidance to providers 
on how to support patients in these efforts.
    [ssquf] Many interventions are focused heavily on educational 
efforts alone, either for the patient, the provider, or the practice.
    [ssquf] Few of the tools and interventions identified are 
immediately usable without the need for additional development or 
enabling materials to support sustainable adoption.
    [ssquf] Health equity and literacy considerations are limited. 
Tools for patients are often at a relatively high level of literacy, 
and/or health literacy is required for use.
    [ssquf] Current interventions, tools, and toolkits have a high 
level of complexity that may impede adoption.
    Existing evidence-based interventions are being refined to reduce 
complexity and enhance the opportunity for implementation. 
Implementation development activities are currently underway. Field 
testing of the Guide will evaluate the implementation challenges faced 
by primary care

[[Page 52865]]

practices whereby offering an opportunity to revise the Guide materials 
for optimal implementation success prior to widespread dissemination.
    The Guide will be made publicly accessible through the AHRQ Web 
site for easy referral, access, and use by other health care 
professionals and primary care practices. AHRQ recognizes the 
importance of ensuring that the Guide will be useful and feasible to 
implement and ultimately able to improve patient safety by engaging 
patients and families. Thus, the purpose of the Field Testing 
evaluation is to gain insight on the implementation challenges 
identified by the twelve primary care practices field testing the 
Guide. The Guide materials will be revised in an effort to overcome 
these implementation challenges prior to broad dissemination.
    The specific goals of the proposed Guide field testing evaluation 
are to examine the following:
    [ssquf] The feasibility of implementing a minimum of two of the 
four Guide interventions within 12 medium or large primary care 
practices.
    [ssquf] The challenges to implementing the interventions at the 
patient, clinician, practice staff, and practice level.
    [ssquf] The uptake and confidence among primary care practices to 
improve patient safety through patient and family engagement.
    [ssquf] How the implementation of two of the four Guide 
interventions changes the perception of patient safety among patients, 
clinicians, and practice staff.
    [ssquf] How the implementation of two of the four Guide 
interventions changes the perception of patient and family engagement 
among patients, clinicians, and practice staff.
    [ssquf] Whether primary care practices will continue to use the 
Guide (or its interventions) beyond the period of field testing and 
evaluation (i.e. examine sustainability).
    [ssquf] What changes patients, clinicians, and practice staff would 
recommend to the interventions and the Guide to enhance sustainability.
    This study is being conducted by AHRQ through its contractor, 
MedStar, 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

    To achieve the goals of the project, the following data collections 
will be implemented during the Field Testing evaluation:
    1. Baseline Practice Assessment of Primary Care Practices. This pen 
and paper survey will be administered to the 12 primary care practice 
champions immediately following the recruitment as part of the Guide 
Field Test and prior to commencing implementation of the Guide. 
Information collected includes: (i) Practice name and location (e.g., 
city and State); (ii) non-identifying demographic information about the 
practice (e.g., number of clinicians by type, number of patients served 
by the practice, payer mix of patients served by practice, race and 
ethnicity of patients served by practice); (iii) general descriptive 
information on the practice's experience with patient safety and 
quality improvement activities (e.g., current experience with Guide 
interventions, patient safety culture routinely measured); (iv) 
information related to the practice's affiliation with larger health 
system; and (v) information related to any competing priorities or 
practice improvement initiatives (e.g., patient centered medical home 
designation, etc.).
    2. Post-Implementation Focus Groups for Patients and Families. 
Information from patients on their experiences with the Guide and its 
interventions will be solicited twice during the Field test--once at 3-
months and again at 6-months post-implementation of the Guide. Each 
patient and family focus group will aim to recruit between six to eight 
participants and solicit feedback from patients and family members on 
their experiences with the Guide materials. Information collected will 
include: (i) Perceptions of patient safety in primary care practices; 
(ii) perceptions of patient and family engagement in primary care 
practices; (iii) feedback from the patient perspective on the Guide 
materials and their general use; (iv) feasibility of adopting the 
patient and family focused intervention materials in practice; (v) 
feedback on the patient and family experiences of the Guide and its 
relation to patient safety.
    3. Baseline Practice Readiness Assessment. Information from primary 
care practices about their readiness to adopt patient and family 
engagement strategies will be solicited through telephone interviews 
with practice staff champions. Information collected will include: (i) 
Descriptive information on the person completing the interview (e.g., 
position in the practice, length of employment, experience in 
implementing patient safety improvements); (ii) description of the 
patient safety culture of the primary care practice (e.g., teamwork, 
communication, patient safety culture, etc.,); (iii) perceptions of 
patient and family engagement within the practice; (iv) perceptions of 
change management strategies, challenges, and barriers (e.g., 
leadership support, competing initiatives, other production pressures); 
(v) capacity for ongoing internal measurement and assessment of the 
intervention. This process will also solicit general information the 
interviewee would like to share about the practice's readiness to 
implement the Guide strategies.
    4. Post-Implementation Interviews of Primary Care Clinicians. 
Information from primary care clinicians (e.g., physicians, nurses, 
nurse practitioners, social workers, etc.) on their experiences with 
the Guide and its interventions will be solicited twice during the 
Field test--once at 3-months and again at 6-months post-implementation 
of the Guide. Interviews with two or three primary care clinicians per 
practice will be conducted during Field Testing to solicit feedback on 
their experiences with the Guide materials. Information collected will 
include: (i) Perceptions on patient safety in primary care practices; 
(ii) perceptions of patient and family engagement in primary care 
practices; (iii) feedback from the clinician perspective on the Guide 
materials and their general use; (iv) feasibility of adopting the 
intervention materials in practice; (v) feedback on the clinicians' 
experiences of the Guide and its relation to patient safety.
    5. Post-Implementation Focus Groups for Practice Staff Members. 
Information from practice staff members (e.g., practice administrators, 
medical assistants, schedulers, practice facilitators, other non-
clinical staff, etc.) on their experiences with the Guide and its 
interventions will be solicited twice during the Field test--once at 3-
months and again at 6-months post-implementation of the Guide. Focus 
groups with between six to eight primary care practice staff will be 
conducted in each practice during Field Testing to solicit feedback on 
their experiences with the Guide materials. Information collected will 
include: (i) Perceptions on patient safety in primary care practices; 
(ii) perceptions of patient and family engagement in primary care 
practices; (iii) feedback from the practice staff perspective on the 
Guide materials and their general use; (iv) feasibility of adopting the 
intervention materials in practice; (v) feedback on the

[[Page 52866]]

practice staff's experiences of the Guide and its relation to patient 
safety.
    6. Monthly Telephone Interviews with Practice Champions. This 
survey will be completed over the phone on a monthly basis with the 
practice champions from the twelve primary care practices engaged in 
the Field Testing of the Guide. Information collected will include: (i) 
Current progress towards implementation of the intervention(s); (ii) 
movement towards target goals set in the prior meeting; (iii) barriers 
to implementation; (iv) facilitators of implementation; (v) perceived 
impact on patient safety; (vi) perceived impact on patient and family 
engagement; (vii) plans for the coming weeks/months.
    The Guide will be tested to evaluate the feasibility of adopting it 
in primary care practices. A mixed-methods approach will be used to 
identify barriers and facilitators to uptake and sustainability, and to 
answer the question ``How and in what contexts do the chosen 
interventions work or can they be amended to work'', rather than ``Do 
they work?'' Testing will occur at up to 12 primary care sites and 
feasibility will be assessed at the patient, provider, and practice 
levels. The Guide will be revised based on these findings.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the 
respondents' time to participate in this evaluation of the Guide during 
field testing. Two formative evaluations will be conducted during field 
testing in twelve primary care practices in at least two geographic 
regions of the United States. Evaluation efforts will include 
collection of baseline practice level data prior to Guide 
implementation and two separate rounds of focus groups and interviews 
conducted 3 months and 6 months after Guide implementation. Baseline 
assessments will be conducted on paper via phone consultation between 
the Contractor and the local practice champion and will take between 30 
to 60 minutes. Patient focus groups will be conducted at the 3- and 6-
month evaluation periods; each lasting between 60 to 90 minutes. 
Practice staff focus groups will be conducted during each of the site 
visits, conducted outside regular practice hours, and last between 60-
90 minutes. Primary care clinician interviews will last approximately 
45 minutes. We estimate that approximately 12 individuals will 
participate in the monthly telephone interviews over the 9-month 
implementation and evaluation period.

                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
Baseline Practice Assessment....................              12               1               1              12
Post-Implementation Focus Group for Patients and              72               2             1.5             216
 Family Members.................................
Interview Guide--Baseline Practice Readiness....              12               1             .75               9
Post-Implementation Interview Protocol--                      24               2             .75              36
 Providers......................................
Post-Implementation Focus Group Protocol--                    72               2             1.5             216
 Practice Staff.................................
Topic guide for Telephone Protocol--Guide                     12               6              .5              36
 Practice Champions.............................
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total.......................................             204              NA              NA             525
----------------------------------------------------------------------------------------------------------------

    Exhibit 2 shows the estimated annualized cost burden based on the 
respondents' time to participate in this project. The total cost burden 
is estimated to be $18,629.16.

                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                    Form name                        Number of     Total  burden    hourly wage     Total cost
                                                    respondents        hours          rate *          burden
----------------------------------------------------------------------------------------------------------------
Baseline Practice Assessment....................              12              12       \a\ 37.40          448.80
Post-Implementation Focus Group for Patients and              72             216       \c\ 23.23        5,017.68
 Family Members.................................
Interview Guide--Baseline Practice Readiness....              12               9       \a\ 37.40          336.60
Post-Implementation Interview Protocol--                      24              36       \b\ 94.48        3,401.28
 Providers......................................
Post-Implementation Focus Group Protocol--                    72             216       \a\ 37.40        8,078.40
 Practice Staff.................................
Topic guide for Telephone Protocol--Guide                     12              36       \a\ 37.40        1,346.40
 Practice Champions.............................
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total.......................................             204             525  ..............       18,629.16
----------------------------------------------------------------------------------------------------------------
* National Compensation Survey: Occupational wages in the United States May 2015, ``U.S. Department of Labor,
  Bureau of Labor Statistics.'' http://www.bls.gov/oes/current/oes_nat.htm.
\a\ Based on the mean wages for Miscellaneous Health care Worker (Code 29-9090).
\b\ Based on the mean wages for Internists, General (Code 29-1063).
\c\ Based on the mean wages for All Occupations (Code 00-0000).

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

[[Page 52867]]

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. 2016-18995 Filed 8-9-16; 8:45 am]
 BILLING CODE 4160-90-P



                                                  52864                      Federal Register / Vol. 81, No. 154 / Wednesday, August 10, 2016 / Notices

                                                    By direction of the Commission.                       how to achieve these improvements in                  misunderstanding about risk, create
                                                  Donald S. Clark,                                        primary care settings.                                fissures among members of the clinical
                                                  Secretary.                                                 Patient and Family Engagement (PFE)                care team, and result in lack of trust
                                                  [FR Doc. 2016–18915 Filed 8–9–16; 8:45 am]              strategies for acute care settings include,           between patients and providers.
                                                  BILLING CODE 6750–01–P
                                                                                                          among others: Patient and family                         With these insights as a basis, three
                                                                                                          advisory committees; membership on                    precepts undergird our approach to
                                                                                                          patient safety oversight bodies at both               development for the Guide. The Guide
                                                                                                          operations and governance levels;                     interventions must yield:
                                                  DEPARTMENT OF HEALTH AND
                                                                                                          consultation in the development of                       D Meaningful relationship-based
                                                  HUMAN SERVICES                                          patient information material; engaging                engagement for patients and families
                                                  Agency for Healthcare Research and                      patients in process improvement or                    and primary care providers.
                                                  Quality                                                 redesign projects; rounding with                         D Innovation and enabling
                                                                                                          patients and families; patient and family             technologies to support engagement,
                                                  Agency Information Collection                           participation in clinical education                   shared decision making and patient
                                                  Activities: Proposed Collection;                        programs, and welcoming patients and                  safety.
                                                  Comment Request                                         families to work alongside providers                     D Workable processes yielding
                                                                                                          and health systems employees on                       sustainable engagement opportunities
                                                  AGENCY: Agency for Healthcare Research                  transparency, culture change and high                 for patients, families, providers, and
                                                  and Quality, HHS.                                       reliability organization initiatives.                 practice staff.
                                                  ACTION: Notice.                                            Although the field of PFE in patient                  The Guide will be principally (but not
                                                                                                          safety for hospitals and health systems               exclusively) meeting the needs of
                                                  SUMMARY:   This notice announces the                    is maturing, leveraging PFE to improve                practices that have not already
                                                  intention of the Agency for Healthcare                  patient safety in non-acute settings is in            implemented effective PFE structures or
                                                  Research and Quality (AHRQ) to request                  its infancy. Building sustainable                     processes. An environmental scan
                                                  that the Office of Management and                       processes and practice-based                          revealed several promising
                                                  Budget (OMB) approve the proposed                       infrastructure are crucial to improving               interventions for consideration for
                                                  information collection project: ‘‘Agency                patient safety through patient and                    inclusion in the Guide. The four
                                                  for Healthcare Research and Quality’s                   family engagement in primary care.                    interventions selected as part of the
                                                  (AHRQ) Guide To Improving Patient                          In response to the limited guidance                Guide include:
                                                  Safety in Primary Care Settings by                      available for primary care practices to                  D Teach-back.
                                                  Engaging Patients and Families—                         improve safety through patient and                       D Be Prepared to Be Engaged.
                                                  Evaluation.’’ In accordance with the                    family engagement, the AHRQ has                          D Medication Management.
                                                  Paperwork Reduction Act, 44 U.S.C.                      funded the development of a Guide To                     D Warm Handoff.
                                                  3501–3521, AHRQ invites the public to                   Improving Patient Safety in Primary                      The interventions will be compiled
                                                  comment on this proposed information                    Care Settings by Engaging Patients and                into the Guide for adoption by primary
                                                  collection.                                             Families (hereafter referred to as the                care practices. The environmental scan
                                                  DATES: Comments on this notice must be                  Guide). This comprehensive Guide will                 also yielded several important
                                                  received by October 11, 2016.                           provide primary care practices with                   implications for Guide development
                                                  ADDRESSES: Written comments should                      interventions that they can use to                    including:
                                                  be submitted to: Doris Lefkowitz,                       engage patients and families in ways                     D Engagement efforts in primary care
                                                  Reports Clearance Officer, AHRQ, by                     that lead to improved patient safety. It              to date have focused on the patient as
                                                  email at doris.lefkowitz@AHRQ.hhs.gov.                  will include explicit instructions to help            the agent of change with limited
                                                    Copies of the proposed collection                     primary care practices, providers, and                guidance to providers on how to
                                                  plans, data collection instruments, and                 patients and families adopt new                       support patients in these efforts.
                                                  specific details on the estimated burden                behaviors. The Guide and its                             D Many interventions are focused
                                                  can be obtained from the AHRQ Reports                   development are prefaced on several                   heavily on educational efforts alone,
                                                  Clearance Officer.                                      key insights relevant to primary care                 either for the patient, the provider, or
                                                  FOR FURTHER INFORMATION CONTACT:                        including:                                            the practice.
                                                  Doris Lefkowitz, AHRQ Reports                              D Active engagement requires                          D Few of the tools and interventions
                                                  Clearance Officer, (301) 427–1477, or by                organizational commitment to hearing                  identified are immediately usable
                                                  email at doris.lefkowitz@AHRQ.hhs.gov.                  the patient and family voice and action               without the need for additional
                                                                                                          by leadership to include them as central              development or enabling materials to
                                                  SUPPLEMENTARY INFORMATION:
                                                                                                          members of the health care team.                      support sustainable adoption.
                                                  Proposed Project                                           D Patients and families expect and                    D Health equity and literacy
                                                                                                          increasingly demand meaningful                        considerations are limited. Tools for
                                                  Agency for Healthcare Research and                                                                            patients are often at a relatively high
                                                  Quality’s (AHRQ) Guide To Improving                     engagement in harm prevention efforts.
                                                                                                             D Institutional courage is required to             level of literacy, and/or health literacy
                                                  Patient Safety in Primary Care Settings                                                                       is required for use.
                                                                                                          openly share patient safety
                                                  by Engaging Patients and Families—                                                                               D Current interventions, tools, and
                                                                                                          vulnerabilities and proactively engage
                                                  Evaluation                                                                                                    toolkits have a high level of complexity
                                                                                                          patients in developing solutions that
                                                     There is a substantial evidence base                 prevent harm.                                         that may impede adoption.
                                                  showing that engaging patients and                         D Supportive infrastructure is needed                 Existing evidence-based interventions
mstockstill on DSK3G9T082PROD with NOTICES




                                                  families in their care can lead to                      to hardwire PFE into all facets of care               are being refined to reduce complexity
                                                  improvements in patient safety. Since                   delivery across the care continuum.                   and enhance the opportunity for
                                                  the 1999 release of To Err is Human,                       D When done well, patient                          implementation. Implementation
                                                  there has been an undeniable focus on                   engagement yields important and                       development activities are currently
                                                  improving patient safety and                            measurable results. When not done                     underway. Field testing of the Guide
                                                  eliminating patient harm within acute                   well, PFE activities may disenfranchise               will evaluate the implementation
                                                  care. What is not as well documented is                 patients, contribute to                               challenges faced by primary care


                                             VerDate Sep<11>2014   17:34 Aug 09, 2016   Jkt 238001   PO 00000   Frm 00055   Fmt 4703   Sfmt 4703   E:\FR\FM\10AUN1.SGM   10AUN1


                                                                             Federal Register / Vol. 81, No. 154 / Wednesday, August 10, 2016 / Notices                                             52865

                                                  practices whereby offering an                           Method of Collection                                  implementing patient safety
                                                  opportunity to revise the Guide                            To achieve the goals of the project, the           improvements); (ii) description of the
                                                  materials for optimal implementation                    following data collections will be                    patient safety culture of the primary
                                                  success prior to widespread                             implemented during the Field Testing                  care practice (e.g., teamwork,
                                                  dissemination.                                          evaluation:                                           communication, patient safety culture,
                                                     The Guide will be made publicly                         1. Baseline Practice Assessment of                 etc.,); (iii) perceptions of patient and
                                                  accessible through the AHRQ Web site                    Primary Care Practices. This pen and                  family engagement within the practice;
                                                  for easy referral, access, and use by                   paper survey will be administered to the              (iv) perceptions of change management
                                                  other health care professionals and                     12 primary care practice champions                    strategies, challenges, and barriers (e.g.,
                                                  primary care practices. AHRQ                            immediately following the recruitment                 leadership support, competing
                                                  recognizes the importance of ensuring                   as part of the Guide Field Test and prior             initiatives, other production pressures);
                                                  that the Guide will be useful and                       to commencing implementation of the                   (v) capacity for ongoing internal
                                                  feasible to implement and ultimately                    Guide. Information collected includes:                measurement and assessment of the
                                                  able to improve patient safety by                       (i) Practice name and location (e.g., city            intervention. This process will also
                                                  engaging patients and families. Thus,                   and State); (ii) non-identifying                      solicit general information the
                                                  the purpose of the Field Testing                                                                              interviewee would like to share about
                                                                                                          demographic information about the
                                                  evaluation is to gain insight on the                                                                          the practice’s readiness to implement
                                                                                                          practice (e.g., number of clinicians by
                                                  implementation challenges identified by                                                                       the Guide strategies.
                                                                                                          type, number of patients served by the                   4. Post-Implementation Interviews of
                                                  the twelve primary care practices field                 practice, payer mix of patients served by
                                                  testing the Guide. The Guide materials                                                                        Primary Care Clinicians. Information
                                                                                                          practice, race and ethnicity of patients              from primary care clinicians (e.g.,
                                                  will be revised in an effort to overcome                served by practice); (iii) general
                                                  these implementation challenges prior                                                                         physicians, nurses, nurse practitioners,
                                                                                                          descriptive information on the practice’s             social workers, etc.) on their
                                                  to broad dissemination.                                 experience with patient safety and                    experiences with the Guide and its
                                                     The specific goals of the proposed                   quality improvement activities (e.g.,                 interventions will be solicited twice
                                                  Guide field testing evaluation are to                   current experience with Guide                         during the Field test—once at 3-months
                                                  examine the following:                                  interventions, patient safety culture                 and again at 6-months post-
                                                     D The feasibility of implementing a                  routinely measured); (iv) information                 implementation of the Guide. Interviews
                                                  minimum of two of the four Guide                        related to the practice’s affiliation with            with two or three primary care
                                                  interventions within 12 medium or large                 larger health system; and (v)                         clinicians per practice will be
                                                  primary care practices.                                 information related to any competing                  conducted during Field Testing to
                                                     D The challenges to implementing the                 priorities or practice improvement                    solicit feedback on their experiences
                                                  interventions at the patient, clinician,                initiatives (e.g., patient centered                   with the Guide materials. Information
                                                  practice staff, and practice level.                     medical home designation, etc.).                      collected will include: (i) Perceptions
                                                     D The uptake and confidence among                       2. Post-Implementation Focus Groups                on patient safety in primary care
                                                  primary care practices to improve                       for Patients and Families. Information                practices; (ii) perceptions of patient and
                                                  patient safety through patient and                      from patients on their experiences with               family engagement in primary care
                                                  family engagement.                                      the Guide and its interventions will be               practices; (iii) feedback from the
                                                                                                          solicited twice during the Field test—
                                                     D How the implementation of two of                                                                         clinician perspective on the Guide
                                                                                                          once at 3-months and again at 6-months                materials and their general use; (iv)
                                                  the four Guide interventions changes
                                                                                                          post-implementation of the Guide. Each                feasibility of adopting the intervention
                                                  the perception of patient safety among
                                                                                                          patient and family focus group will aim               materials in practice; (v) feedback on the
                                                  patients, clinicians, and practice staff.
                                                                                                          to recruit between six to eight                       clinicians’ experiences of the Guide and
                                                     D How the implementation of two of                   participants and solicit feedback from
                                                  the four Guide interventions changes                                                                          its relation to patient safety.
                                                                                                          patients and family members on their                     5. Post-Implementation Focus Groups
                                                  the perception of patient and family                    experiences with the Guide materials.
                                                  engagement among patients, clinicians,                                                                        for Practice Staff Members. Information
                                                                                                          Information collected will include: (i)               from practice staff members (e.g.,
                                                  and practice staff.                                     Perceptions of patient safety in primary              practice administrators, medical
                                                     D Whether primary care practices will                care practices; (ii) perceptions of patient           assistants, schedulers, practice
                                                  continue to use the Guide (or its                       and family engagement in primary care                 facilitators, other non-clinical staff, etc.)
                                                  interventions) beyond the period of field               practices; (iii) feedback from the patient            on their experiences with the Guide and
                                                  testing and evaluation (i.e. examine                    perspective on the Guide materials and                its interventions will be solicited twice
                                                  sustainability).                                        their general use; (iv) feasibility of                during the Field test—once at 3-months
                                                     D What changes patients, clinicians,                 adopting the patient and family focused               and again at 6-months post-
                                                  and practice staff would recommend to                   intervention materials in practice; (v)               implementation of the Guide. Focus
                                                  the interventions and the Guide to                      feedback on the patient and family                    groups with between six to eight
                                                  enhance sustainability.                                 experiences of the Guide and its relation             primary care practice staff will be
                                                     This study is being conducted by                     to patient safety.                                    conducted in each practice during Field
                                                  AHRQ through its contractor, MedStar,                      3. Baseline Practice Readiness                     Testing to solicit feedback on their
                                                  pursuant to AHRQ’s statutory authority                  Assessment. Information from primary                  experiences with the Guide materials.
                                                  to conduct and support research on                      care practices about their readiness to               Information collected will include: (i)
                                                  health care and on systems for the                      adopt patient and family engagement                   Perceptions on patient safety in primary
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                                                  delivery of such care, including                        strategies will be solicited through                  care practices; (ii) perceptions of patient
                                                  activities with respect to the quality,                 telephone interviews with practice staff              and family engagement in primary care
                                                  effectiveness, efficiency,                              champions. Information collected will                 practices; (iii) feedback from the
                                                  appropriateness and value of health care                include: (i) Descriptive information on               practice staff perspective on the Guide
                                                  services and with respect to quality                    the person completing the interview                   materials and their general use; (iv)
                                                  measurement and improvement. 42                         (e.g., position in the practice, length of            feasibility of adopting the intervention
                                                  U.S.C. 299a(a)(1) and (2).                              employment, experience in                             materials in practice; (v) feedback on the


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                                                  52866                              Federal Register / Vol. 81, No. 154 / Wednesday, August 10, 2016 / Notices

                                                  practice staff’s experiences of the Guide                                  sustainability, and to answer the                               separate rounds of focus groups and
                                                  and its relation to patient safety.                                        question ‘‘How and in what contexts do                          interviews conducted 3 months and 6
                                                     6. Monthly Telephone Interviews                                         the chosen interventions work or can                            months after Guide implementation.
                                                  with Practice Champions. This survey                                       they be amended to work’’, rather than                          Baseline assessments will be conducted
                                                  will be completed over the phone on a                                      ‘‘Do they work?’’ Testing will occur at                         on paper via phone consultation
                                                  monthly basis with the practice                                            up to 12 primary care sites and                                 between the Contractor and the local
                                                  champions from the twelve primary care                                     feasibility will be assessed at the                             practice champion and will take
                                                  practices engaged in the Field Testing of                                  patient, provider, and practice levels.                         between 30 to 60 minutes. Patient focus
                                                  the Guide. Information collected will                                      The Guide will be revised based on                              groups will be conducted at the 3- and
                                                  include: (i) Current progress towards                                      these findings.                                                 6-month evaluation periods; each
                                                  implementation of the intervention(s);
                                                                                                                             Estimated Annual Respondent Burden                              lasting between 60 to 90 minutes.
                                                  (ii) movement towards target goals set in
                                                  the prior meeting; (iii) barriers to                                         Exhibit 1 shows the estimated                                 Practice staff focus groups will be
                                                  implementation; (iv) facilitators of                                       annualized burden hours for the                                 conducted during each of the site visits,
                                                  implementation; (v) perceived impact                                       respondents’ time to participate in this                        conducted outside regular practice
                                                  on patient safety; (vi) perceived impact                                   evaluation of the Guide during field                            hours, and last between 60–90 minutes.
                                                  on patient and family engagement; (vii)                                    testing. Two formative evaluations will                         Primary care clinician interviews will
                                                  plans for the coming weeks/months.                                         be conducted during field testing in                            last approximately 45 minutes. We
                                                     The Guide will be tested to evaluate                                    twelve primary care practices in at least                       estimate that approximately 12
                                                  the feasibility of adopting it in primary                                  two geographic regions of the United                            individuals will participate in the
                                                  care practices. A mixed-methods                                            States. Evaluation efforts will include                         monthly telephone interviews over the
                                                  approach will be used to identify                                          collection of baseline practice level data                      9-month implementation and evaluation
                                                  barriers and facilitators to uptake and                                    prior to Guide implementation and two                           period.

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

                                                  Baseline Practice Assessment ........................................................................                               12                1                           1               12
                                                  Post-Implementation Focus Group for Patients and Family Members ...........                                                         72                2                         1.5              216
                                                  Interview Guide—Baseline Practice Readiness ..............................................                                          12                1                         .75                9
                                                  Post-Implementation Interview Protocol—Providers .......................................                                            24                2                         .75               36
                                                  Post-Implementation Focus Group Protocol—Practice Staff ..........................                                                  72                2                         1.5              216
                                                  Topic guide for Telephone Protocol—Guide Practice Champions ..................                                                      12                6                          .5               36

                                                       Total ..........................................................................................................             204                NA                         NA               525



                                                    Exhibit 2 shows the estimated                                            project. The total cost burden is
                                                  annualized cost burden based on the                                        estimated to be $18,629.16.
                                                  respondents’ time to participate in this

                                                                                                                 EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
                                                                                                                                                                                                                   Average
                                                                                                                                                                           Number of           Total                                       Total cost
                                                                                                  Form name                                                                                                      hourly wage
                                                                                                                                                                          respondents      burden hours                                     burden
                                                                                                                                                                                                                    rate *

                                                  Baseline Practice Assessment ........................................................................                               12               12                  a 37.40              448.80
                                                  Post-Implementation Focus Group for Patients and Family Members ...........                                                         72              216                  c 23.23            5,017.68
                                                  Interview Guide—Baseline Practice Readiness ..............................................                                          12                9                  a 37.40              336.60
                                                  Post-Implementation Interview Protocol—Providers .......................................                                            24               36                  b 94.48            3,401.28
                                                  Post-Implementation Focus Group Protocol—Practice Staff ..........................                                                  72              216                  a 37.40            8,078.40
                                                  Topic guide for Telephone Protocol—Guide Practice Champions ..................                                                      12               36                  a 37.40            1,346.40

                                                       Total ..........................................................................................................             204               525      ........................      18,629.16
                                                     * National Compensation Survey: Occupational wages in the United States May 2015, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
                                                  http://www.bls.gov/oes/current/oes_nat.htm.
                                                     a Based on the mean wages for Miscellaneous Health care Worker (Code 29–9090).
                                                     b Based on the mean wages for Internists, General (Code 29–1063).
                                                     c Based on the mean wages for All Occupations (Code 00–0000).
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                                                  Request for Comments                                                       information is necessary for the proper                         hours and costs) of the proposed
                                                                                                                             performance of AHRQ health care                                 collection(s) of information; (c) ways to
                                                    In accordance with the Paperwork                                         research and health care information                            enhance the quality, utility, and clarity
                                                  Reduction Act, comments on AHRQ’s                                          dissemination functions, including                              of the information to be collected; and
                                                  information collection are requested                                       whether the information will have                               (d) ways to minimize the burden of the
                                                  with regard to any of the following: (a)                                   practical utility; (b) the accuracy of                          collection of information upon the
                                                  Whether the proposed collection of                                         AHRQ’s estimate of burden (including                            respondents, including the use of


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                                                                             Federal Register / Vol. 81, No. 154 / Wednesday, August 10, 2016 / Notices                                           52867

                                                  automated collection techniques or                      Disease Control and Prevention, 1600                  generate, maintain, retain, disclose or
                                                  other forms of information technology.                  Clifton Road NE., MS–D74, Atlanta,                    provide information to or for a Federal
                                                    Comments submitted in response to                     Georgia 30329.                                        agency. This includes the time needed
                                                  this notice will be summarized and                         Instructions: All submissions received             to review instructions; to develop,
                                                  included in the Agency’s subsequent                     must include the agency name and                      acquire, install and utilize technology
                                                  request for OMB approval of the                         Docket Number. All relevant comments                  and systems for the purpose of
                                                  proposed information collection. All                    received will be posted without change                collecting, validating and verifying
                                                  comments will become a matter of                        to Regulations.gov, including any                     information, processing and
                                                  public record.                                          personal information provided. For                    maintaining information, and disclosing
                                                                                                          access to the docket to read background               and providing information; to train
                                                  Sharon B. Arnold,
                                                                                                          documents or comments received, go to                 personnel and to be able to respond to
                                                  Deputy Director.                                        Regulations.gov.                                      a collection of information, to search
                                                  [FR Doc. 2016–18995 Filed 8–9–16; 8:45 am]                 Please note: All public comment                    data sources, to complete and review
                                                  BILLING CODE 4160–90–P                                  should be submitted through the                       the collection of information; and to
                                                                                                          Federal eRulemaking portal                            transmit or otherwise disclose the
                                                                                                          (Regulations.gov) or by U.S. mail to the              information.
                                                  DEPARTMENT OF HEALTH AND                                address listed above.
                                                  HUMAN SERVICES                                                                                                Proposed Project
                                                                                                          FOR FURTHER INFORMATION CONTACT: To
                                                  Centers for Disease Control and                         request more information on the                         Women’s Preventive Health Services
                                                  Prevention                                              proposed project or to obtain a copy of               Study—New—National Center for
                                                                                                          the information collection plan and                   Chronic Disease Prevention and Health
                                                  [60Day–16–16AWP; Docket No. CDC–2016–                   instruments, contact the Information                  Promotion (NCCDPHP), Centers for
                                                  0075]                                                   Collection Review Office, Centers for                 Disease Control and Prevention (CDC).
                                                                                                          Disease Control and Prevention, 1600
                                                  Proposed Data Collection Submitted                                                                            Background and Brief Description
                                                                                                          Clifton Road NE., MS–D74, Atlanta,
                                                  for Public Comment and
                                                                                                          Georgia 30329; phone: 404–639–7570;                      The National Breast and Cervical
                                                  Recommendations
                                                                                                          Email: omb@cdc.gov.                                   Cancer Early Detection Program
                                                  AGENCY: Centers for Disease Control and                 SUPPLEMENTARY INFORMATION: Under the                  (NBCCEDP) provides free or low-cost
                                                  Prevention (CDC), Department of Health                  Paperwork Reduction Act of 1995 (PRA)                 breast and cervical cancer screening and
                                                  and Human Services (HHS).                               (44 U.S.C. 3501–3520), Federal agencies               diagnostic services to low-income,
                                                  ACTION: Notice with comment period.                     must obtain approval from the Office of               uninsured, and underserved women.
                                                                                                          Management and Budget (OMB) for each                  The NBCCEDP is an organized screening
                                                  SUMMARY:   The Centers for Disease                      collection of information they conduct                program with a full complement of
                                                  Control and Prevention (CDC), as part of                or sponsor. In addition, the PRA also                 services including outreach and patient
                                                  its continuing efforts to reduce public                 requires Federal agencies to provide a                education, patient navigation, case
                                                  burden and maximize the utility of                      60-day notice in the Federal Register                 management, professional development,
                                                  government information, invites the                     concerning each proposed collection of                and tracking and follow-up that
                                                  general public and other Federal                        information, including each new                       contribute to the program’s success.
                                                  agencies to take this opportunity to                    proposed collection, each proposed                    Compared to when the NBCCEDP was
                                                  comment on proposed and/or                              extension of existing collection of                   established, more women are eligible for
                                                  continuing information collections, as                  information, and each reinstatement of                insurance coverage but there are still
                                                  required by the Paperwork Reduction                     previously approved information                       many women who are not insured and
                                                  Act of 1995. This notice invites                        collection before submitting the                      many insured women not obtaining
                                                  comment on a proposed study to                          collection to OMB for approval. To                    preventive services that they are eligible
                                                  examine the facilitators and barriers to                comply with this requirement, we are                  to receive. Currently, the NBCCEDP not
                                                  receiving clinical preventive services                  publishing this notice of a proposed                  only provides screening services to
                                                  among newly insured medically                           data collection as described below.                   uninsured and underinsured, but has
                                                  underserved women who had                                  Comments are invited on: (a) Whether               expanded its services to include
                                                  previously been served by the National                  the proposed collection of information                population-based activities that prevent
                                                  Breast and Cervical Cancer Early                        is necessary for the proper performance               missed opportunities and ensure that all
                                                  Detection Program (NBCCEDP). The                        of the functions of the agency, including             women receive appropriate breast and
                                                  purpose of this survey is to assess if                  whether the information shall have                    cervical cancer screening.
                                                  newly insured women receive                             practical utility; (b) the accuracy of the               Previous research suggests that access
                                                  appropriate clinical preventive health                  agency’s estimate of the burden of the                to health care through insurance alone
                                                  services, what barriers and facilitators                proposed collection of information; (c)               does not ensure adherence to cancer
                                                  these women experience, and if they are                 ways to enhance the quality, utility, and             screening, as many individual, cultural,
                                                  able to maintain consistent health                      clarity of the information to be                      and community factors serve as barriers
                                                  insurance coverage.                                     collected; (d) ways to minimize the                   to preventive service use. With recent
                                                  DATES: Written comments must be                         burden of the collection of information               increases in the numbers of women who
                                                  received on or before October 11, 2016.                 on respondents, including through the                 are insured, there is a need to
                                                  ADDRESSES: You may submit comments,                     use of automated collection techniques                understand the experiences of women
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                                                  identified by Docket No. CDC–2016–                      or other forms of information                         who had been served by the NBCCEDP
                                                  0075 by any of the following methods:                   technology; and (e) estimates of capital              and become newly insured. This project
                                                     • Federal eRulemaking Portal:                        or start-up costs and costs of operation,             will inform the development of future
                                                  Regulations.gov. Follow the instructions                maintenance, and purchase of services                 activities of the NBCCEDP so that all
                                                  for submitting comments.                                to provide information. Burden means                  women receive the information and
                                                     • Mail: Jeffrey M. Zirger, Information               the total time, effort, or financial                  support services needed for obtaining
                                                  Collection Review Office, Centers for                   resources expended by persons to                      clinical preventive services.


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Document Created: 2016-08-10 01:59:54
Document Modified: 2016-08-10 01:59:54
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 October 11, 2016.
ContactDoris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected]
FR Citation81 FR 52864 

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