[Federal Register Volume 82, Number 86 (Friday, May 5, 2017)]
[Notices]
[Pages 21235-21238]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-09097]


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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 ``The Re-engineered Visit for Primary Care.''
    This proposed information collection was previously published in 
the Federal Register on February 13, 2017 and allowed 60 days for 
public comment. AHRQ received one comment from the public. The purpose 
of this notice is to allow an additional 30 days for public comment.

DATES: Comments on this notice must be received by June 5, 2017.

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

The Re-Engineered Visit for Primary Care

    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 project, The Re-engineered Visit for Primary Care, 
directly addresses the agency's goal to conduct research to enhance the 
quality of health care and reduce avoidable readmissions, which are a 
major indicator of poor quality and patient safety.
    Research from AHRQ's Healthcare Cost and Utilization Project (HCUP) 
indicates that in 2011 there were approximately 3.3 million adult 
hospital readmissions in the United States. Adults covered by Medicare 
have the highest readmission rate (17.2 per 100 admissions), followed 
by adults covered by Medicaid (14.6 per 100 admissions) and privately 
insured adults (8.7 per

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100 admissions). High rates of readmissions are a major patient safety 
problem and are associated with a range of adverse events, such as 
prescribing errors and misdiagnoses of conditions in the hospital and 
ambulatory care settings. Collectively these readmissions are 
associated with $41.3 billion in annual hospital costs, many of which 
potentially could be avoided.
    In recent years, payer and provider efforts to reduce readmissions 
have proliferated. Many of these national programs have been informed 
or guided by evidence-based research, toolkits and guides, such as 
AHRQ's RED (Re-Engineered Discharge), STAAR (STate Action on Avoidable 
Readmission), AHRQ's Project BOOST (Better Outcomes by Optimizing Safe 
Transitions), the Hospital Guide to Reducing Medicaid Readmissions, and 
Eric Coleman's Care Transitions Intervention. These efforts have 
largely focused on enhancing practices occurring within the hospital 
setting, including the discharge process transitions among providers 
and between settings of care. While many of these efforts have 
recognized the critical role of primary care in managing care 
transitions, they have not had an explicit focus on enhancing primary 
care with the aim of reducing avoidable readmissions.
    Evidence-based guidance to reduce readmissions and improve patient 
safety are comparatively lacking for the primary care setting. This gap 
in the literature is becoming more pronounced as primary care is 
increasingly serving as the key integrator across the health system as 
part of payment and delivery system reforms. This research project aims 
to address the important and unfulfilled need to improve patient safety 
and reduce avoidable readmissions within the primary care context.
    AHRQ's goals in supporting this 30-month project are to build on 
the knowledge base from the inpatient settings, add to the expanding 
evidence base on preventing readmissions by focusing on the primary 
care setting, and provide insight on the components and themes that 
should be part of a re-engineered visit in primary care. This work will 
ultimately inform an effective intervention that can be tested in a 
diverse set of primary care clinics.
    To meet AHRQ's goals and objectives, the agency awarded a task 
order to John Snow, Inc. (JSI) to conduct qualitative research using 
quality improvement to investigate the primary care-based transitional 
care workflow from the primary care staff, patient, and community 
agency perspective.
    This research has the following goals:
    1. Analyze current processes in the primary care visit associated 
with hospital discharge; and
    2. Identify components of the re-engineered visit.
    This study is being conducted by AHRQ through its contractor 
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 vale of health care services and with respect to 
quality measurement and improvement. 42 U.S.C 299a(a)(1) and (2).

Method of Collection

    To analyze current processes in the primary care visit associated 
with hospital discharge, the data collection is separated into seven 
smaller data collection activities to minimize research participant 
burden while still allowing for the collection of necessary data. Each 
of these tasks will be conducted at nine primary care sites:
    1. Primary care site organizational characteristics survey: The 
purpose of this background information on the primary care site's 
organizational characteristics is to offer context for the work flow 
mapping. It will help make the work flow mapping process more efficient 
and reduce burden by only requesting information that is already known 
by each site contact. One person per primary care site will be engaged 
for this task.
    2. Primary care site patient characteristics survey: The purpose of 
this background information on the primary care site's patients is to 
offer context for the work flow mapping. It will help make the work 
flow mapping process more efficient and reduce burden by only 
requesting information that is already known in the primary care 
practices' billing or clinical information systems. One person per 
primary care site will be engaged for this task.
    3. Work flow mapping preliminary interviews: The purpose of this 
flow mapping ``pre-work'' is to engage individual primary care staff 
members to think about the current work flow map in order to set a 
foundation for the actual work flow mapping process. It is anticipated 
that eight individuals per primary care site will participate, for a 
total of 72 participants.
    4. Work flow mapping: This collection will take place in a group 
meeting that brings together staff from various role types to 
collaborate in identifying their workflow processes involved in 
planning for and executing post-hospital follow up services for their 
patients. Based on feasibility, these may be smaller or larger group 
meetings, but the total burden on each role type participant is the 
same. The end goal of this meeting is to have enough information to 
develop an initial process flow map on paper. It is anticipated that 10 
individuals per primary care site will participate, for a total of 90 
participants.
    5. Work flow mapping follow-up interviews: Once the initial process 
flow map is on paper, each role type will be asked to review to 
correct, add, or confirm detail to the document. Once the flow map has 
been edited and ratified by the primary care site staff, each role type 
will be asked specific questions regarding the flaws identified in the 
process flow for the failure mode effects analysis. It is anticipated 
that eight individuals per primary care site will participate, for a 
total of 72 participants.
    6. Patient Interviews: As a complement to the work flow mapping, 
there will also be a process flow map developed from the patient's 
perspective. The purpose of the patient interviews is to capture 
patient perspectives on potential breakdowns in making the transition 
from the hospital to care in the primary care settings and to get, in 
their own words, information about the initial hospitalization and 
barriers to accessing follow-up care. One of the widely acknowledged 
limitations of the existing evidence based toolkits is that they are 
not designed with input from patients.
    This has occurred despite the fact that clinical experience 
suggests that providers often fail to identify patient needs and 
concerns. Research has shown that there are cultural, social, and 
behavioral factors that may contribute to readmissions and assessing 
the patient's perspective can help to better understand the barriers to 
receiving appropriate follow-up care.
    Patient and family interviews are increasingly common practices in 
efforts to improve care transitions and reduce readmissions, endorsed 
by CMS, the Institute for Healthcare Improvement, Kaiser Permanente, 
and others. This patient interview will collect unique information on 
the barriers to effective care transitions in the post-discharge period 
care, information which cannot be collected in other ways. It is 
anticipated that ten post-discharge patients per primary care site will 
be interviewed for a total of 90 patients.
    7. Community agency interviews: As a complement to the work flow 
mapping, the process flow map developed will reflect the perspective of 
community

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agencies affiliated with the primary care sites to assist patients. It 
is anticipated that five community agency representatives per primary 
care site will be interviewed.
    The purpose of this data collection is to understand the key 
components that should be included in the re-engineered visit in 
primary care. The project team will examine the diverse settings, 
staff, and transitional care activities across a variety of primary 
care practices to identify key transitional care processes that impact 
patient outcomes, the challenges to implementing those processes, and 
ways to improve those processes.
    The project team will distill the themes and principles that should 
be a part of the re-engineered visit and develop an outline and summary 
of its components, with a comparison/contrast of the components across 
sites and discussion of the generalizability of these components to 
different settings.
    The results of this research will add to the expanding evidence 
base on preventing readmissions by focusing on the primary care 
setting, and provide insight on the components and themes that should 
be part of a re-engineered visit. This information will ultimately 
inform an effective intervention that can be tested in a diverse set of 
primary care clinics.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated burden hours to the respondents for 
providing all of the data needed to meet the project's objectives. The 
hours estimated per responses are based on the pilot project results.
    For the primary care site organizational characteristics survey and 
patient characteristics survey, one person per each of the nine primary 
care sites will participate. Both surveys are anticipated to take 1.5 
hours to complete.
    For the work flow mapping preliminary interviews, we estimate that 
eight primary care staff per primary care site will participate, with 
each individual spending 0.5 hours in these interviews. For the work 
flow mapping group interview, we estimate that 10 primary care staff 
per primary care site will participate, with each individual spending 
1.5 hours in these interviews. Finally, we estimate that eight primary 
care staff per primary care site will participate in the work flow 
mapping follow-up interviews, with each individual spending 0.5 hours 
in this data collection activity.
    There will be 10 patients interviewed in association with each 
primary care site. These patient interviews are expected to take 0.5 
hours per individual research participant.
    Lastly, there will be five community agency staff members 
interviewed in association with each primary care site. These 
interviews are expected to take 1 hour per individual research 
participant.
    Exhibit 2 shows the estimated cost burden for the respondents' time 
to participate in the project. The total annualized cost burden is 
estimated at $11,500.30.

                                  Exhibit 1--Estimated Annualized Burden Hours
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                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
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Primary care site organizational characteristics               9               1             1.5            13.5
 survey.........................................
Primary care site patient characteristics survey               9               1             1.5            13.5
Workflow mapping preliminary interview..........              72               1             0.5              36
Workflow mapping group interview................              90               1             1.5             135
Workflow mapping follow-up interview............              72               1             0.5              36
Patient interview...............................              90               1             0.5              45
Community agency interview......................              45               1               1              45
                                                 ---------------------------------------------------------------
    Total.......................................             387             n/a             n/a           2,628
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                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                                                      Average
                    Form name                        Number of     Total burden    hourly  wage     Total cost
                                                    respondents        hours          rate *          burden
----------------------------------------------------------------------------------------------------------------
Primary care site organizational characteristics               9            13.5      \a\ $40.41         $545.54
 survey.........................................
Primary care site patient characteristics survey               9            13.5       \a\ 40.41          545.54
Workflow mapping preliminary interview..........              72              36       \a\ 40.41        1,454.76
Workflow mapping group interview................              90             135       \a\ 40.41        5,455.35
Workflow mapping follow-up interview............              72              36       \a\ 40.41        1,454.76
Patient interview...............................              90              45       \b\ 23.23        1,045.35
Community agency interview......................              45              45       \c\ 22.20          999.00
                                                 ---------------------------------------------------------------
    Total.......................................             387             n/a             n/a       11,500.30
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* For hourly average wage rates, mean hourly wages from the Bureau of Labor Statistics (BLS) May 2015 national
  occupational employment wage estimates were used. http://www.bls.gov/oes/current/oes_nat.htm#00-0000.
\a\ Participants will include a mix of providers and front desk staff; therefore a blended rate for these tasks
  are used including Nurse ($33.55), Medical Assistant ($15.01 \1\), Front Desk Staff ($13.38 \2\), Program
  Director ($32.56), Pharmacist ($56.96), Physician ($91.60), Behavioral health provider ($22.03).
\b\ Based upon the mean wages for consumers (all occupations).
\c\ Based upon the mean wages for Social Workers.
\1\ http://www.bls.gov/oes/current/oes319092.htm.
\2\ http://www.bls.gov/oes/current/oes434171.htm.


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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,
Acting Director.
[FR Doc. 2017-09097 Filed 5-4-17; 8:45 am]
 BILLING CODE 4160-90-P