81_FR_75612 81 FR 75402 - Agency Information Collection Activities: Proposed Collection; Comment Request

81 FR 75402 - 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 210 (October 31, 2016)

Page Range75402-75405
FR Document2016-26143

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. This proposed information collection was previously published in the Federal Register on August 11th, 2016 and allowed 60 days for public comment. AHRQ did not receive any substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.

Federal Register, Volume 81 Issue 210 (Monday, October 31, 2016) 
[Federal Register Volume 81, Number 210 (Monday, October 31, 2016)]
[Notices]
[Pages 75402-75405]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-26143]


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 DEPARTMENT OF HEALTH AND HUMAN SERVICES

 Agency for Healthcare Research and Quality


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Agency for Healthcare Research and Quality, HHS.

ACTION: Notice.

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SUMMARY: This notice announces the intention of the Agency for 
Healthcare Research and Quality (AHRQ) to request that the Office of 
Management and Budget (OMB) approve the proposed information collection 
project: ``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.
    This proposed information collection was previously published in 
the Federal Register on August 11th, 2016 and allowed 60 days for 
public comment. AHRQ did not receive any 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 November 30, 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

Agency for Healthcare Research and Quality's 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: 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 
Agency for Healthcare Research and Quality (AHRQ) has funded the 
development of a Guide to Improving Safety in Primary Care Settings by 
Engaging Patients and Families (hereafter referred to as the Guide). 
The 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, 
result in lack of trust between providers and their organizations, and 
create fissures among members of the clinical care team.
    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.

[[Page 75403]]

    [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 principally, but not exclusively, meet 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 a 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 including guidance for each 
intervention and the Guide as a whole are currently underway. Guide 
field testing will evaluate the implementation challenges faced by 
primary care practices thereby 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, well implemented 
and effective in achieving the goals of improving 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 twelve 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 healthcare 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 twelve primary care 
practice champions, individuals at each practice responsible for 
coordinating Guide activities and responding to inquiries from MedStar 
during Field Testing, 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 6-8 
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

[[Page 75404]]

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 2 or 3 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 6-8 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 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 
30-60 minutes. Patient focus groups will be conducted at the 3- and 6-
month evaluation periods; each lasting between 60-90 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.............................
                                                 ---------------------------------------------------------------
    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

[[Page 75405]]

 
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.............................
                                                 ---------------------------------------------------------------
    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 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. 2016-26143 Filed 10-28-16; 8:45 am]
 BILLING CODE 4160-90-P

75402 Federal Register / Vol. 81, No. 210 / Monday, October 31, 2016 / Notices (301) 427–1111; TTY (toll free): (866) ACTION: Notice. clinical education programs, and 438–7231; TTY (local): (301) 427–1130; welcoming patients and families to Email: pso@ahrq.hhs.gov. SUMMARY: This notice announces the work alongside providers and health intention of the Agency for Healthcare systems employees on transparency, SUPPLEMENTARY INFORMATION: Research and Quality (AHRQ) to request culture change and high reliability Background that the Office of Management and organization initiatives. Budget (OMB) approve the proposed Although the field of PFE in patient The Patient Safety Act authorizes the information collection project: ‘‘Agency listing of PSOs, which are entities or safety for hospitals and health systems for Healthcare Research and Quality’s component organizations whose is maturing, leveraging PFE to improve (AHRQ) Guide to Improving Patient mission and primary activity are to patient safety in non-acute settings is in Safety in Primary Care Settings by conduct activities to improve patient its infancy. Building sustainable Engaging Patients and Families— safety and the quality of health care processes and practice-based Evaluation.’’ In accordance with the delivery. infrastructure are crucial to improving Paperwork Reduction Act, 44 U.S.C. HHS issued the Patient Safety Rule to patient safety through patient and 3501–3521, AHRQ invites the public to implement the Patient Safety Act. family engagement in primary care. comment on this proposed information AHRQ administers the provisions of the collection. In response to the limited guidance Patient Safety Act and Patient Safety This proposed information collection available for primary care practices to Rule relating to the listing and operation was previously published in the Federal improve safety through patient and of PSOs. The Patient Safety Rule Register on August 11th, 2016 and family engagement, the Agency for authorizes AHRQ to list as a PSO an allowed 60 days for public comment. Healthcare Research and Quality entity that attests that it meets the AHRQ did not receive any substantive (AHRQ) has funded the development of statutory and regulatory requirements comments. The purpose of this notice is a Guide to Improving Safety in Primary for listing. A PSO can be ‘‘delisted’’ if to allow an additional 30 days for public Care Settings by Engaging Patients and it is found to no longer meet the comment. Families (hereafter referred to as the requirements of the Patient Safety Act DATES: Comments on this notice must be Guide). The comprehensive guide will and Patient Safety Rule, when a PSO received by November 30, 2016. provide primary care practices with chooses to voluntarily relinquish its interventions that they can use to ADDRESSES: Written comments should status as a PSO for any reason, or when engage patients and families in ways be submitted to: AHRQ’s OMB Desk a PSO’s listing expires. Section 3.108(d) that lead to improved patient safety. It Officer by fax at (202) 395–6974 of the Patient Safety Rule requires will include explicit instructions to help (attention: AHRQ’s desk officer) or by AHRQ to provide public notice when it primary care practices, providers, and email at OIRA_submission@ removes an organization from the list of patients and families adopt new omb.eop.gov (attention: AHRQ’s desk federally approved PSOs. behaviors. The Guide and its officer). AHRQ has accepted a notification development are prefaced on several FOR FURTHER INFORMATION CONTACT: key insights relevant to primary care from the Patient Safety Leadership Council PSO, PSO number P0164, to Doris Lefkowitz, AHRQ Reports including: voluntarily relinquish its status as a Clearance Officer, (301) 427–1477, or by D Active engagement requires PSO. Accordingly, the Patient Safety email at doris.lefkowitz@AHRQ.hhs.gov. organizational commitment to hearing Leadership Council PSO was delisted SUPPLEMENTARY INFORMATION: the patient and family voice and action effective at 12:00 Midnight ET (2400) on Proposed Project by leadership to include them as central September 30, 2016. AHRQ notes that members of the health care team. the Patient Safety Leadership Council Agency for Healthcare Research and D Patients and families expect and PSO submitted this request for Quality’s Guide To Improving Patient increasingly demand meaningful voluntary relinquishment following Safety in Primary Care Settings by engagement in harm prevention efforts. receipt of the Notice of Preliminary Engaging Patients and Families— D Institutional courage is required to Finding of Deficiency sent on Evaluation openly share patient safety September 1, 2016. There is a substantial evidence base vulnerabilities and proactively engage More information on PSOs can be showing that engaging patients and patients in developing solutions that obtained through AHRQ’s PSO Web site families in their care can lead to prevent harm. at http://www.pso.ahrq.gov. improvements in patient safety. Since D Supportive infrastructure is needed the 1999 release of To Err is Human, to hardwire PFE into all facets of care Sharon B. Arnold, delivery across the care continuum. there has been an undeniable focus on Deputy Director. improving patient safety and D When done well, patient [FR Doc. 2016–26144 Filed 10–28–16; 8:45 am] eliminating patient harm within acute engagement yields important and BILLING CODE 4160–90–P care. What is not as well documented is measurable results. When not done how to achieve these improvements in well, PFE activities may disenfranchise primary care settings. patients, contribute to DEPARTMENT OF HEALTH AND Patient and Family Engagement (PFE) misunderstanding about risk, result in HUMAN SERVICES strategies for acute care settings include: lack of trust between providers and their patient and family advisory committees; organizations, and create fissures among Agency for Healthcare Research and membership on patient safety oversight members of the clinical care team. sradovich on DSK3GMQ082PROD with NOTICES Quality bodies at both operations and With these insights as a basis, three Agency Information Collection governance levels; consultation in the precepts undergird our approach to Activities: Proposed Collection; development of patient information development for the Guide. The Guide Comment Request material; engaging patients in process interventions must yield: improvement or redesign projects; D Meaningful relationship-based AGENCY:Agency for Healthcare Research rounding with patients and families; engagement for patients and families and Quality, HHS. patient and family participation in and primary care providers. VerDate Sep<11>2014 17:53 Oct 28, 2016 Jkt 241001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\31OCN1.SGM 31OCN1

Federal Register / Vol. 81, No. 210 / Monday, October 31, 2016 / Notices 75403 D Innovation and enabling recognizes the importance of ensuring activities and responding to inquiries technologies to support engagement, that the Guide will be useful, well from MedStar during Field Testing, shared decision making and patient implemented and effective in achieving immediately following the recruitment safety. the goals of improving patient safety by as part of the Guide Field Test and prior D Workable processes yielding engaging patients and families. Thus, to commencing implementation of the sustainable engagement opportunities the purpose of the Field Testing Guide. Information collected includes: for patients, families, providers, and evaluation is to gain insight on the (i) Practice name and location (e.g., city practice staff. implementation challenges identified by and State); (ii) non-identifying The Guide will principally, but not the twelve primary care practices field demographic information about the exclusively, meet the needs of practices testing the Guide. The Guide materials practice (e.g., number of clinicians by that have not already implemented will be revised in an effort to overcome type, number of patients served by the effective PFE structures or processes. An these implementation challenges prior practice, payer mix of patients served by environmental scan revealed several to broad dissemination. practice, race and ethnicity of patients promising interventions for The specific goals of the proposed served by practice); (iii) general consideration for inclusion in the Guide field testing evaluation are to descriptive information on the practice’s Guide. The four interventions selected examine the following: experience with patient safety and as part of the Guide include: D The feasibility of implementing a quality improvement activities (e.g., D Teach-back minimum of two of the four Guide current experience with Guide D Be Prepared to Be Engaged interventions within twelve medium or interventions, patient safety culture D Medication Management large primary care practices. routinely measured); (iv) information D Warm Handoff D The challenges to implementing the related to the practice’s affiliation with The interventions will be compiled interventions at the patient, clinician, larger health system; and (v) into a Guide for adoption by primary practice staff, and practice level. information related to any competing D The uptake and confidence among priorities or practice improvement care practices. The environmental scan primary care practices to improve initiatives (e.g., patient centered also yielded several important patient safety through patient and medical home designation, etc.). implications for Guide development family engagement. 2. Post-Implementation Focus Groups including: D How the implementation of two of for Patients and Families. Information D Engagement efforts in primary care from patients on their experiences with the four Guide interventions changes to date have focused on the patient as the Guide and its interventions will be the perception of patient safety among the agent of change with limited solicited twice during the Field Test— patients, clinicians, and practice staff. guidance to providers on how to D How the implementation of two of once at 3-months and again at 6-months support patients in these efforts. the four Guide interventions changes post-implementation of the Guide. Each D Many interventions are focused the perception of patient and family patient and family focus group will aim heavily on educational efforts alone, engagement among patients, clinicians, to recruit between 6–8 participants and either for the patient, the provider, or and practice staff. solicit feedback from patients and the practice. D Whether primary care practices will family members on their experiences D Few of the tools and interventions continue to use the Guide (or its with the Guide materials. Information identified are immediately usable interventions) beyond the period of field collected will include: (i) Perceptions of without the need for additional testing and evaluation (i.e. examine patient safety in primary care practices; development or enabling materials to sustainability). (ii) perceptions of patient and family support sustainable adoption. D What changes patients, clinicians, engagement in primary care practices; D Health equity and literacy and practice staff would recommend to (iii) feedback from the patient considerations are limited. Tools for the interventions and the Guide to perspective on the Guide materials and patients are often at a relatively high enhance sustainability. their general use; (iv) feasibility of level of literacy, and/or health literacy This study is being conducted by adopting the patient and family focused is required for use. AHRQ through its contractor, MedStar, intervention materials in practice; (v) D Current interventions, tools, and pursuant to AHRQ’s statutory authority feedback on the patient and family toolkits have a high level of complexity to conduct and support research on experiences of the Guide and its relation that may impede adoption. health care and on systems for the to patient safety. Existing evidence-based interventions delivery of such care, including 3. Baseline Practice Readiness are being refined to reduce complexity activities with respect to the quality, Assessment. Information from primary and enhance the opportunity for effectiveness, efficiency, care practices about their readiness to implementation. Implementation appropriateness and value of healthcare adopt patient and family engagement development activities including services and with respect to quality strategies will be solicited through guidance for each intervention and the measurement and improvement. 42 telephone interviews with practice staff Guide as a whole are currently U.S.C. 299a(a)(1) and (2). champions. Information collected will underway. Guide field testing will include: (i) Descriptive information on evaluate the implementation challenges Method of Collection the person completing the interview faced by primary care practices thereby To achieve the goals of the project, the (e.g., position in the practice, length of offering an opportunity to revise the following data collections will be employment, experience in Guide materials for optimal sradovich on DSK3GMQ082PROD with NOTICES implemented during the Field Testing implementing patient safety implementation success prior to evaluation: improvements); (ii) description of the widespread dissemination. 1. Baseline Practice Assessment of patient safety culture of the primary The Guide will be made publicly Primary Care Practices. This pen and care practice (e.g., teamwork, accessible through the AHRQ Web site paper survey will be administered to the communication, patient safety culture, for easy referral, access, and use by twelve primary care practice etc.,); (iii) perceptions of patient and other health care professionals and champions, individuals at each practice family engagement within the practice; primary care practices. AHRQ responsible for coordinating Guide (iv) perceptions of change management VerDate Sep<11>2014 17:53 Oct 28, 2016 Jkt 241001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\31OCN1.SGM 31OCN1

75404 Federal Register / Vol. 81, No. 210 / Monday, October 31, 2016 / Notices strategies, challenges, and barriers (e.g., during the Field Test—once at 3-months they be amended to work’’, rather than leadership support, competing and again at 6-months post- ‘‘Do they work?’’ Testing will occur at initiatives, other production pressures); implementation of the Guide. Focus up to 12 primary care sites and (v) capacity for ongoing internal groups with between 6–8 primary care feasibility will be assessed at the measurement and assessment of the practice staff will be conducted in each patient, provider, and practice levels. intervention. This process will also practice during Field Testing to solicit The Guide will be revised based on solicit general information the feedback on their experiences with the these findings. interviewee would like to share about Guide materials. Information collected the practice’s readiness to implement will include: (i) Perceptions on patient Estimated Annual Respondent Burden the Guide strategies. safety in primary care practices; (ii) 4. Post-Implementation Interviews of Perceptions of patient and family Exhibit 1 shows the estimated Primary Care Clinicians. Information engagement in primary care practices; annualized burden hours for the from primary care clinicians (e.g., (iii) feedback from the practice staff respondents’ time to participate in this physicians, nurses, nurse practitioners, perspective on the Guide materials and evaluation of the Guide during field social workers, etc.) on their their general use; (iv) feasibility of testing. Two formative evaluations will experiences with the Guide and its adopting the intervention materials in be conducted during field testing in interventions will be solicited twice practice; (v) feedback on the practice twelve primary care practices in at least during the Field Test—once at 3-months staff’s experiences of the Guide and its two geographic regions of the United and again at 6-months post- relation to patient safety. States. Evaluation efforts will include implementation of the Guide. Interviews 6. Monthly Telephone Interviews collection of baseline practice level data with 2 or 3 primary care clinicians per with Practice Champions. This survey prior to Guide implementation and two practice will be conducted during Field will be completed over the phone on a separate rounds of focus groups and Testing to solicit feedback on their monthly basis with the practice interviews conducted 3-months and 6- experiences with the Guide materials. champions from the twelve primary care months after Guide implementation. Information collected will include: (i) practices engaged in the Field Testing of Baseline assessments will be conducted Perceptions on patient safety in primary the Guide. Information collected will on paper via phone consultation care practices; (ii) perceptions of patient include: (i) Current progress towards between the Contractor and the local and family engagement in primary care implementation of the intervention(s); practice champion and will take practices; (iii) feedback from the (ii) movement towards target goals set in between 30–60 minutes. Patient focus clinician perspective on the Guide the prior meeting; (iii) barriers to groups will be conducted at the 3- and materials and their general use; (iv) implementation; (iv) facilitators of feasibility of adopting the intervention implementation; (v) perceived impact 6-month evaluation periods; each materials in practice; (v) feedback on the on patient safety; (vi) perceived impact lasting between 60–90 minutes. Practice clinicians’ experiences of the Guide and on patient and family engagement; vii) staff focus groups will be conducted its relation to patient safety. plans for the coming weeks/months. during each of the site visits, conducted 5. Post-Implementation Focus Groups The Guide will be tested to evaluate outside regular practice hours, and last for Practice Staff Members. Information the feasibility of adopting it in primary between 60–90 minutes. Primary care from practice staff members (e.g., care practices. A mixed-methods clinician interviews will last practice administrators, medical approach will be used to identify approximately 45 minutes. We estimate assistants, schedulers, practice barriers and facilitators to uptake and that approximately 12 individuals will facilitators, other non-clinical staff, etc.) sustainability, and to answer the participate in the monthly telephone on their experiences with the Guide and question ‘‘How and in what contexts do interviews over the 9-month its interventions will be solicited twice the chosen interventions work or can implementation and evaluation 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 sradovich on DSK3GMQ082PROD with NOTICES EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN Average Number of Total burden Total cost Form name hourly wage respondents hours burden rate * Baseline Practice Assessment ........................................................................ 12 12 a $37.40 448.80 VerDate Sep<11>2014 17:53 Oct 28, 2016 Jkt 241001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\31OCN1.SGM 31OCN1

Federal Register / Vol. 81, No. 210 / Monday, October 31, 2016 / Notices 75405 EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued Average Number of Total burden Total cost Form name hourly wage respondents hours burden rate * 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). Request for Comments ACTION: Notice with comment period. Please note: All public comment In accordance with the Paperwork should be submitted through the SUMMARY: The Centers for Disease Federal eRulemaking portal Reduction Act, comments on AHRQ’s Control and Prevention (CDC), as part of (Regulations.gov) or by U.S. mail to the information collection are requested its continuing efforts to reduce public address listed above. with regard to any of the following: (a) burden and maximize the utility of FOR FURTHER INFORMATION CONTACT: To Whether the proposed collection of information is necessary for the proper government information, invites the request more information on the performance of AHRQ health care general public and other Federal proposed project or to obtain a copy of research and health care information agencies to take this opportunity to the information collection plan and dissemination functions, including comment on proposed and/or instruments, contact the Information whether the information will have continuing information collections, as Collection Review Office, Centers for practical utility; (b) the accuracy of required by the Paperwork Reduction Disease Control and Prevention, 1600 AHRQ’s estimate of burden (including Act of 1995. This notice invites Clifton Road NE., MS–D74, Atlanta, hours and costs) of the proposed comment on a proposed information Georgia 30329; phone: 404–639–7570; collection(s) of information; (c) ways to collection entitled ‘‘Understanding the Email: omb@cdc.gov. enhance the quality, utility, and clarity Needs, Challenges, Opportunities, SUPPLEMENTARY INFORMATION: Under the of the information to be collected; and Vision and Emerging Roles in Paperwork Reduction Act of 1995 (PRA) (d) ways to minimize the burden of the Environmental Health (UNCOVER EH).’’ (44 U.S.C. 3501–3520), Federal agencies collection of information upon the The purpose of the data collection is to must obtain approval from the Office of respondents, including the use of collect information from the health Management and Budget (OMB) for each automated collection techniques or department environmental health (EH) collection of information they conduct other forms of information technology. workforce to determine demographics, or sponsor. In addition, the PRA also Comments submitted in response to education/training, experience, areas of requires Federal agencies to provide a this notice will be summarized and practice, and current and future needs 60-day notice in the Federal Register included in the Agency’s subsequent to address emerging environmental concerning each proposed collection of request for OMB approval of the issues. information, including each new proposed information collection. All DATES: Written comments must be proposed collection, each proposed comments will become a matter of received on or before December 30, extension of existing collection of public record. 2016. information, and each reinstatement of previously approved information Sharon B. Arnold, ADDRESSES: You may submit comments, collection before submitting the Deputy Director. identified by Docket No. CDC–2016– collection to OMB for approval. To [FR Doc. 2016–26143 Filed 10–28–16; 8:45 am] 0103 by any of the following methods: comply with this requirement, we are BILLING CODE 4160–90–P • Federal eRulemaking Portal: publishing this notice of a proposed Regulations.gov. Follow the instructions data collection as described below. for submitting comments. Comments are invited on: (a) Whether DEPARTMENT OF HEALTH AND • Mail: Leroy A. Richardson, the proposed collection of information HUMAN SERVICES Information Collection Review Office, is necessary for the proper performance Centers for Disease Control and of the functions of the agency, including Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS– whether the information shall have Prevention D74, Atlanta, Georgia 30329. practical utility; (b) the accuracy of the [60Day–17–17BX; Docket No. CDC–2016– Instructions: All submissions received agency’s estimate of the burden of the 0103] must include the agency name and proposed collection of information; (c) sradovich on DSK3GMQ082PROD with NOTICES Docket Number. All relevant comments ways to enhance the quality, utility, and Proposed Data Collection Submitted received will be posted without change clarity of the information to be for Public Comment and to Regulations.gov, including any collected; (d) ways to minimize the Recommendations personal information provided. For burden of the collection of information AGENCY: Centers for Disease Control and access to the docket to read background on respondents, including through the Prevention (CDC), Department of Health documents or comments received, go to use of automated collection techniques and Human Services (HHS). Regulations.gov. or other forms of information VerDate Sep<11>2014 17:53 Oct 28, 2016 Jkt 241001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\31OCN1.SGM 31OCN1


Document Created: 2018-02-02 12:13:47
Document Modified: 2018-02-02 12:13:47
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 November 30, 2016.
ContactDoris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected]
FR Citation81 FR 75402 
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