Agency Information Collection Activities: Proposed Collection; Comment Request, 75402-75405 [2016-26143]
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Federal Register / Vol. 81, No. 210 / Monday, October 31, 2016 / Notices
(301) 427–1111; TTY (toll free): (866)
438–7231; TTY (local): (301) 427–1130;
Email: pso@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION:
Background
The Patient Safety Act authorizes the
listing of PSOs, which are entities or
component organizations whose
mission and primary activity are to
conduct activities to improve patient
safety and the quality of health care
delivery.
HHS issued the Patient Safety Rule to
implement the Patient Safety Act.
AHRQ administers the provisions of the
Patient Safety Act and Patient Safety
Rule relating to the listing and operation
of PSOs. The Patient Safety Rule
authorizes AHRQ to list as a PSO an
entity that attests that it meets the
statutory and regulatory requirements
for listing. A PSO can be ‘‘delisted’’ if
it is found to no longer meet the
requirements of the Patient Safety Act
and Patient Safety Rule, when a PSO
chooses to voluntarily relinquish its
status as a PSO for any reason, or when
a PSO’s listing expires. Section 3.108(d)
of the Patient Safety Rule requires
AHRQ to provide public notice when it
removes an organization from the list of
federally approved PSOs.
AHRQ has accepted a notification
from the Patient Safety Leadership
Council PSO, PSO number P0164, to
voluntarily relinquish its status as a
PSO. Accordingly, the Patient Safety
Leadership Council PSO was delisted
effective at 12:00 Midnight ET (2400) on
September 30, 2016. AHRQ notes that
the Patient Safety Leadership Council
PSO submitted this request for
voluntary relinquishment following
receipt of the Notice of Preliminary
Finding of Deficiency sent on
September 1, 2016.
More information on PSOs can be
obtained through AHRQ’s PSO Web site
at https://www.pso.ahrq.gov.
Sharon B. Arnold,
Deputy Director.
[FR Doc. 2016–26144 Filed 10–28–16; 8:45 am]
BILLING CODE 4160–90–P
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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 for Healthcare Research
and Quality, HHS.
AGENCY:
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ACTION:
Notice.
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 OIRA_submission@
omb.eop.gov (attention: AHRQ’s desk
officer).
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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
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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:
D 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.
D Patients and families expect and
increasingly demand meaningful
engagement in harm prevention efforts.
D Institutional courage is required to
openly share patient safety
vulnerabilities and proactively engage
patients in developing solutions that
prevent harm.
D Supportive infrastructure is needed
to hardwire PFE into all facets of care
delivery across the care continuum.
D 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:
D Meaningful relationship-based
engagement for patients and families
and primary care providers.
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D Innovation and enabling
technologies to support engagement,
shared decision making and patient
safety.
D 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:
D Teach-back
D Be Prepared to Be Engaged
D Medication Management
D 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:
D 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.
D Many interventions are focused
heavily on educational efforts alone,
either for the patient, the provider, or
the practice.
D Few of the tools and interventions
identified are immediately usable
without the need for additional
development or enabling materials to
support sustainable adoption.
D 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.
D 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
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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:
D The feasibility of implementing a
minimum of two of the four Guide
interventions within twelve medium or
large primary care practices.
D The challenges to implementing the
interventions at the patient, clinician,
practice staff, and practice level.
D The uptake and confidence among
primary care practices to improve
patient safety through patient and
family engagement.
D How the implementation of two of
the four Guide interventions changes
the perception of patient safety among
patients, clinicians, and practice staff.
D How the implementation of two of
the four Guide interventions changes
the perception of patient and family
engagement among patients, clinicians,
and practice staff.
D 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).
D 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
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75403
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
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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 postimplementation 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 postimplementation 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 6months 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
respondents
Form name
Number of
responses per
respondent
Hours per
response
Total burden
hours
12
72
12
24
72
12
1
2
1
2
2
6
1
1.5
.75
.75
1.5
.5
12
216
9
36
216
36
Total ..........................................................................................................
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Baseline Practice Assessment ........................................................................
Post-Implementation Focus Group for Patients and Family Members ...........
Interview Guide—Baseline Practice Readiness ..............................................
Post-Implementation Interview Protocol—Providers .......................................
Post-Implementation Focus Group Protocol—Practice Staff ..........................
Topic guide for Telephone Protocol- Guide Practice Champions ...................
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
Number of
respondents
Form name
Baseline Practice Assessment ........................................................................
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Total burden
hours
12
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12
31OCN1
Average
hourly wage
rate *
a $37.40
Total cost
burden
448.80
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Federal Register / Vol. 81, No. 210 / Monday, October 31, 2016 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued
Number of
respondents
Form name
Total burden
hours
Average
hourly wage
rate *
c 23.23
Total cost
burden
Post-Implementation Focus Group for Patients and Family Members ...........
Interview Guide—Baseline Practice Readiness ..............................................
Post-Implementation Interview Protocol—Providers .......................................
Post-Implementation Focus Group Protocol—Practice Staff ..........................
Topic guide for Telephone Protocol—Guide Practice Champions ..................
72
12
24
72
12
216
9
36
216
36
b 94.48
a 37.40
5,017.68
336.60
3,401.28
8,078.40
1,346.40
Total ..........................................................................................................
204
525
........................
18,629.16
a 37.40
a 37.40
* National Compensation Survey: Occupational wages in the United States May 2015, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
https://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.
ACTION:
Sharon B. Arnold,
Deputy Director.
ADDRESSES:
[FR Doc. 2016–26143 Filed 10–28–16; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Centers for Disease Control and
Prevention
[60Day–17–17BX; Docket No. CDC–2016–
0103]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
AGENCY:
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Notice with comment period.
The Centers for Disease
Control and Prevention (CDC), as part of
its continuing efforts to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed information
collection entitled ‘‘Understanding the
Needs, Challenges, Opportunities,
Vision and Emerging Roles in
Environmental Health (UNCOVER EH).’’
The purpose of the data collection is to
collect information from the health
department environmental health (EH)
workforce to determine demographics,
education/training, experience, areas of
practice, and current and future needs
to address emerging environmental
issues.
SUMMARY:
Written comments must be
received on or before December 30,
2016.
DATES:
You may submit comments,
identified by Docket No. CDC–2016–
0103 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Leroy A. Richardson,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE., MS–
D74, Atlanta, Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. All relevant comments
received will be posted without change
to Regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.
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Please note: All public comment
should be submitted through the
Federal eRulemaking portal
(Regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact the Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE., MS–D74, Atlanta,
Georgia 30329; phone: 404–639–7570;
Email: omb@cdc.gov.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
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]]>Agencies
[Federal Register Volume 81, Number 210 (Monday, October 31, 2016)]
[Notices]
[Pages 75402-75405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26143]
-----------------------------------------------------------------------
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.
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 OIRA_submission@omb.eop.gov (attention: AHRQ's desk officer).
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by email at
doris.lefkowitz@AHRQ.hhs.gov.
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.'' https://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
