[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]


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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