Agency Information Collection Activities; Proposed Collection; Comment Request, 25085-25088 [2013-09742]
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Federal Register / Vol. 78, No. 82 / Monday, April 29, 2013 / Notices
B. Federal Reserve Bank of Kansas
City (Dennis Denney, Assistant Vice
President) 1 Memorial Drive, Kansas
City, Missouri 64198–0001:
1. Gene R. Giles, Alliance, Nebraska,
Sally J. Giles, Denver, Colorado, Randall
D. Giles, San Diego, California, Nicholas
G. Giles, and Lucas G. Giles, both of
Lincoln, Nebraska; all of the Giles
family group; the Bradley S. Norden
Irrevocable Trust, and the Brett A.
Norden Irrevocable Trust, Brett A.
Norden and Bradley S. Norden, as cotrustees of both trusts, all of Highlands
Ranch, Colorado, and as members of the
Norden family group; the Michael L.
Ryan 2011 Irrevocable Trust and the
Cheryl L. Ryan 2012 Irrevocable Trust,
both of Minden, Nebraska, Jeffrey M.
Ryan, Heartwell, Nebraska, and Jamie
Johnson, Minden, Nebraska, as cotrustees of both trusts; and Walter D.
Wood Revocable Trust, Walter D. Wood,
trustee, both of Omaha, Nebraska, as
part of the Ryan/Wood family group; to
acquire voting shares of First Central
Nebraska Co., and thereby indirectly
acquire voting shares of Nebraska State
Bank and Trust Company, both in
Broken Bow, Nebraska.
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
conducted throughout the United States.
Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than May 24, 2013.
A. Federal Reserve Bank of Atlanta
(Chapelle Davis, Assistant Vice
President) 1000 Peachtree Street NE.,
Atlanta, Georgia 30309:
1. Oakworth Capital, Inc.,
Birmingham, Alabama; to become a
bank holding company by acquiring 100
percent of the voting shares of Oakworth
Capital Bank, Birmingham, Alabama.
B. Federal Reserve Bank of San
Francisco (Gerald C. Tsai, Director,
Applications and Enforcement) 101
Market Street, San Francisco, California
94105–1579:
1. TFB Bancorp, Inc., Yuma, Arizona;
to become a bank holding company by
acquiring 100 percent of the voting
shares of The Foothills Bank, Yuma,
Arizona.
Board of Governors of the Federal Reserve
System, April 24, 2013.
Michael J. Lewandowski,
Assistant Secretary of the Board.
Board of Governors of the Federal Reserve
System, April 24, 2013.
Michael J. Lewandowski,
Assistant Secretary of the Board.
[FR Doc. 2013–10030 Filed 4–26–13; 8:45 am]
[FR Doc. 2013–10029 Filed 4–26–13; 8:45 am]
BILLING CODE 6210–01–P
BILLING CODE 6210–01–P
FEDERAL RESERVE SYSTEM
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
emcdonald on DSK67QTVN1PROD with NOTICES
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The applications will also be
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
proposal also involves the acquisition of
a nonbanking company, the review also
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Agency for Healthcare Research and
Quality
Agency Information Collection
Activities; Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:
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:
‘‘Improving Sickle Cell Transitions of
Care through Health Information
Technology Phase 1.’’ 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 February 7th, 2013 and
allowed 60 days for public comment. No
SUMMARY:
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25085
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment.
DATES: Comments on this notice must be
received by May 29, 2013.
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).
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
Proposed Project
Improving Sickle Cell Transitions of
Care through Health Information
Technology Phase I
This project is the first phase in
AHRQ’s effort toward the development
of a health information technology (HIT)
enabled tool designed to aid adolescents
and young adults with sickle cell
disease (SCD) during transitions of care.
SCD is a serious, genetic blood disorder
that affects approximately 70,000–
100,000 Americans, including one out
of every 500 African American and one
out of every 36,000 Hispanic American
births. Persons with SCD produce
abnormal, ‘‘sickle-shaped’’ red blood
cells that obstruct blood vessels, leading
to life-long anemia, organ damage,
increased potential for infections,
chronic episodes of pain, and
substantially shortened life spans. SCD
has been noted to be understudied
relative to its prevalence resulting in a
lack of knowledge about the important
variables and domains that determine
health outcomes for patients.
Furthermore, patients with SCD,
typically young, minority, and often of
lower income status, have had few
opportunities to voice their needs and
concerns about their health and health
care.
As recently as 30 years ago, children
with SCD usually did not survive into
adulthood. Now, as a result of advances
in screening and treatment, more than
90 percent of individuals with SCD
reach adulthood, and life expectancy is
typically into the fifth decade. Persons
with SCD experience multiple
transitions of care as a result of the
chronicity of SCD, frequency of both
acute and chronic-events requiring care,
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as well as the advancements in life
expectancy. Transitions of care occur
when either the setting of care changes
(e.g., from home-based to hospital-based
care) or the focus of care changes (e.g.,
from pediatric-focused to adult-focused
care). When transitions of care occur, a
need to share medical history and other
types of health information arises.
Transitions of care are more likely to be
successful when this health information
is accurate, tailored to the type of
transition taking place, and
communicated effectively.
Times of care transitions are
particularly fraught for patients with
SCD and currently, few patients have
access to effective transition programs
for SCD. In a 2010 survey of pediatric
SCD providers, the majority claimed to
have transition programs in place but
they were often newly formed and
without the ability to transfer care to
adult providers with specific expertise
in SCD.
Preliminary evidence suggests that
HIT can be helpful for SCD and similar
conditions. In particular, a technologybased tool has already been used
successfully by patients with SCD to
help with some aspects of disease
management. In one study, a handheld
wireless device was used to implement
a pain management protocol and found
to result in high rates of participation
and satisfaction. Technology-based tools
or applications—‘‘apps’’—have also
been effective in improving care
transitions for other chronic diseases
such as diabetes and HIV, which can
serve as models for this tool.
Improving transitions of care is the
focus of AHRQ’s plans to respond to the
Department of Health and Human
Services’ (HHS’) SCD Initiative
announced in 2011. The overall HHS
SCD initiative, which is aligned with
AHRQ’s mission, aims to improve the
health of persons with SCD through
various activities, including developing
and disseminating evidence-based
guidelines, increasing the availability of
medical homes that provide SCD care,
and supporting research in areas such as
pain and disease management, all of
which could also be supported through
the use of an effective HIT enabled tool.
The goals of this project are to:
(1) Gain the necessary background
knowledge including qualitative
information from key stakeholders, to
establish a set of requirements that
would guide the design and
development of a HIT-enabled tool in
future phases of work that meets
patients’, families’, and providers’ needs
to aid adolescents and young adults
with sickle cell disease during
transitions of care.
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(2) Develop an understanding of the
environmental context, current
facilitators and barriers, health data use
and needs of key stakeholders affected
by sickle cell disease, including
patients, families, and providers.
This study is being conducted by
AHRQ through its contractor, The
Lewin Group in partnership with
Children’s National Medical Center,
Cincinnati Children’s Hospital Medical
Center, Nemours Children’s ClinicJacksonville, and the National Initiative
for Children’s Healthcare Quality,
pursuant to AHRQ’s statutory authority
to conduct and support research on
healthcare 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 this project,
the following activities and data
collections will be implemented:
(1) Environmental Scan—AHRQ will
execute a literature review to identify
potentially relevant scientific literature
and information from other literature
and sources as well as complete a search
for existing tools that aid transitions of
care for persons with SCD or similar
conditions. This will provide contextual
background about the current state of
the field with regards to tooldevelopment and use, identify keyissues of patients with SCD related to
care transitions, and understand the
context of care delivered and health
data information needs to inform the
content, design and functionality of a
tool. This activity does not impose a
burden on the public and is not
included in the burden estimates in
Exhibit 1.
(2) Focus Groups—AHRQ will
facilitate ten focus groups of key
stakeholder groups including: parents/
caregivers of patients with SCD; health
care providers (e.g. SCD specialists,
primary care physicians (PCPs),
hospitalists and emergency room (ER)
physicians); IT developers; SCD patients
ages 9–13; SCD patients ages 14–17;
SCD patients 18 and older; and SCD
patients of mixed ages; to gather
qualitative information on stakeholder
experiences with SCD and care
transitions, barriers to quality care, and
use of technology to inform tool design
and functionality. Each group will
consist of 10 participants and will be
asked to describe their particular
experiences with health care transitions,
communication practices, information
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needs and technology use in order to
develop relevant ‘‘use cases’’ which will
be used by investigators and tool
developers for the later phases of the
project. The in-person nature of focus
groups allows for a more in-depth and
targeted discussion, including
participant experiences, impressions
and priorities in a detailed fashion.
(3) Demographic Questionnaire—
AHRQ will implement a short
demographic questionnaire at the start
of each of the ten focus groups to collect
basic demographic information to allow
the team to contextualize findings from
each focus group. Questionnaires are
tailored to each focus group category:
Parents/caregivers of patients with SCD;
providers, hospitalists and ER
physicians; IT developers; SCD patients
ages 9–13; SCD patients ages 14–17;
SCD patients 18 and older; and SCD
patients of mixed ages.
(4) Key Informant Interviews—AHRQ
will conduct eight key informant
interviews with stakeholders such as
State Medicaid representatives,
attorneys with expertise in privacy and
security issues, representatives from the
Office of the National Coordinator for
Health Information Technology (ONC),
Office of Chief Scientist, and other
relevant policy makers. Qualitative
information gained will contribute to
tool development recommendations
particularly in terms of cost issues
related to reimbursement by payers,
needs for proof of effectiveness,
sustainability, and potential vehicles for
facilitating and funding tool
development and implementation.
The information gained from the
focus groups and key informant
interviews will be used to understand if
and how a patient-centered, HITenabled tool can improve the health of
individuals with SCD during care
transitions.
Focus groups as a form of qualitative
research are an important vehicle for
gathering and explicating insight from
the field, especially if, as in this case,
the important domains are not yet
understood, and need to be outlined by
respondents, rather than suggested by
investigators. Thus active recruitment
and qualitative techniques are a means
to incorporate this necessary and
important perspective into the
derivation of effective interventions.
The primary objective of the focus
groups is to gather more richly nuanced
information from sickle cell disease
stakeholders. The in-person nature of
focus groups allows for a more in-depth
and targeted discussion, including
participant experiences, impressions
and priorities in a detailed fashion.
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Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate in this
research. The demographic
questionnaire will be completed by each
focus group participant and takes 6
minutes to complete. All of the focus
groups and key informant interviews
will last 2 hours except for the IT
developer focus group which will last 4
hours. Each focus group will consist of
10 persons. There will be two focus
groups with providers, three with
parents/caregivers, one group for IT
developers, and one focus group with
each of the four patient groups. Key
informant interviews will be conducted
with eight individuals. The total burden
is estimated to be 246 hours annually.
Exhibit 2 shows the estimated
annualized cost burden associated with
the respondents’ time to participate in
this research. The total cost burden is
estimated to be $8,174 annually.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Hours per
response
Total burden
hours
Demographic Questionnaire ............................................................................
Provider Focus Groups ....................................................................................
Parent/Caregiver Focus Groups ......................................................................
IT Developer Focus Group ..............................................................................
Patients 9–13 Focus Group .............................................................................
Patients 14–17 Focus Group ...........................................................................
Patients 18 & older Focus Group ....................................................................
Patients mixed ages Focus Group ..................................................................
Key Informant Interviews .................................................................................
100
20
30
10
10
10
10
10
8
1
1
1
1
1
1
1
1
1
6/60
2
2
4
2
2
2
2
2
10
40
60
40
20
20
20
20
16
Total ..........................................................................................................
208
na
na
246
EXHIBIT 2—ESTIMATED ANNUALIZE COST BURDEN
Number of
respondents
Form name
Total burden
hours
Average
hourly rate*
Total cost
burden
Demographic Questionnaire ............................................................................
Provider Focus Groups ....................................................................................
Parent/Caregiver Focus Groups ......................................................................
IT Developer Focus Group ..............................................................................
Patients 9–13 Focus Group .............................................................................
Patients 14–17 Focus Group ...........................................................................
Patients 18 & older Focus Group ....................................................................
Patients mixed ages Focus Group ..................................................................
Key Informant Interviews .................................................................................
100
20
30
10
10
10
10
10
8
10
40
60
40
20
20
20
20
16
a $26.89
f 52.72
$269
3,551
1,304
1,771
0
0
435
0
844
Total ..........................................................................................................
208
246
na
8,174
b 88.78
c 21.74
d 44.27
e0
e0
c 21.74
e0
a Based
on the mean wages for Physicians & Surgeons, All other (29–1069), All Occupations (00–0000), Software Developer (15–1132).
Wages for children averaged in as $0.
b Based on the mean wages for Physicians & Surgeons, All other (29–1069).
c Based on the mean wages for All Occupations (00–0000).
d Based on the mean wages for Software Developer (15–1132).
e No wage data for children.
f Based on the mean wages for Lawyers (23–1011), Social and Community Service Managers (11–9151), Medical and Health Services Managers (11–9111), and Computer and Information System Managers (11–3021).
* National Compensation Survey: Occupational wages in the United States May 2011, ‘‘U.S. Department of_Labor, Bureau of Labor Statistics.’’https://www.bls.gov/oes/current/oes_nat.htm#15–0000.
Estimated Annual Costs to the Federal
Government
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Exhibit 3 shows the estimated total
and annualized cost to the federal
government over 18 months. The total
cost to the federal government of this
data collection effort is $264,043. This
figure includes development of draft
and final plans for conducting focus
groups and interviews; development of
materials including moderator guides
for each stakeholders group (seven
guides in total), recruitment materials
for all four sites, consent forms;
facilitating IRB approval processes at
four sites; logistics coordination
including securing facility space;
recruitment of participants; incentives
for participants (as described in section
9 above); and analyzing and
summarizing findings as well as
preparing final reports.
EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST
Cost component
Total cost
Project Development ...................................................................................................................................
Data Collection Activities .............................................................................................................................
Data Processing and Analysis .....................................................................................................................
Publication of Results ..................................................................................................................................
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$23,689
169,586
16,000
33,472
29APN1
Annualized cost
$15,793
113,057
10,667
22,315
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Federal Register / Vol. 78, No. 82 / Monday, April 29, 2013 / Notices
EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST—Continued
Cost component
Total cost
Annualized cost
Project Management ....................................................................................................................................
Overhead .....................................................................................................................................................
18,319
2,977
12,213
1,985
Total ......................................................................................................................................................
264,043
176,029
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.
Dated: April 15, 2013.
Carolyn M Clancy,
Director.
[FR Doc. 2013–09742 Filed 4–26–13; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–13–13RE]
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Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–7570 or send
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comments to Ron Otten, at 1600 Clifton
Road, MS D74, Atlanta, GA 30333 or
send an email to omb@cdc.gov.
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; and (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
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
Public Health Systems, Mental Health
and Community Recovery—New—
Office of Public Health Preparedness
and Response, Division of State and
Local Readiness, Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
This project stems from, and aligns
with, publication of the Office of Public
Health Preparedness and Response’s
(OPHPR) ‘‘National Strategic Plan for
Public Health Preparedness and
Response’’ which provides overall
direction for Centers for Disease Control
and Prevention’s (CDC) preparedness
and response portfolio, including
programmatic direction across OPHPR’s
four divisions. The focus of this project
is to generate findings useful for future
preparedness planning and response in
order to develop strategies and
interventions aimed at mitigating the
impact of adverse events. In April 2011,
one of the largest tornado outbreaks ever
recorded, a ‘‘Super Outbreak,’’ occurred
in the southeastern United States,
resulting in more than 300 deaths and
an estimated $11 million in damages.
This large-scale multistate tragedy offers
a unique opportunity to study how
communities with similar cultural and
geographic features yet different public
health and mental health emergency
response systems could provide access
to care around the same crisis. The
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outcomes of these efforts can inform the
field of what effect these differences had
on the recovery patterns of each of these
communities. By doing so, we can begin
to elucidate best practices for robust
community preparedness and recovery
with attention to types of services that
most effectively promote the natural
resilience of survivors. Two primary
research questions will guide the
proposed study:
1. How did the Alabama and
Mississippi State and local public
health and mental health (PH/MH)
systems prepare for, respond to, and
support recovery after the April 2011
tornados?
2. To what extent have these
communities recovered and what is the
overall health and quality of life of
individuals affected by these events?
CDC requests Office of Management
and Budget (OMB) approval to collect
information for two years.
To address these questions, CDC, in
collaboration with ICF International,
will conduct a mixed method evaluation
utilizing key informant interviews of
public health and mental health agency
staff and other community
representatives at the local, county and
State levels and household survey data
in each of the four regions in
Mississippi and Alabama to assess
community recovery and resilience.
Specifically, the study design includes
two main components (qualitative and
quantitative) designed to
comprehensively examine the PH/MH
system response to and community
recovery and resilience from disasters.
The total estimated burden for the 98
one-time qualitative interviews for
public health/mental health
professionals and community leaders is
98 hours (98 respondents × 1 hour/
response). Interviews will be conducted
during an in-person site-visit to the
region to reduce travel and time burdens
on the respondents. Respondents unable
to participate during the site visit may
participate via telephone. In addition,
the total estimated burden for the
quantitative computer-assisted
interviews are based on 860 respondents
in each of the four tornado effected
regions; each survey will be
approximately 25 minutes (4 counties ×
860 respondents = 3,440 respondents;
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]]>Agencies
[Federal Register Volume 78, Number 82 (Monday, April 29, 2013)]
[Notices]
[Pages 25085-25088]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09742]
=======================================================================
-----------------------------------------------------------------------
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: ``Improving Sickle Cell Transitions of Care through Health
Information Technology Phase 1.'' 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 February 7th, 2013 and allowed 60 days for
public comment. No comments were received. The purpose of this notice
is to allow an additional 30 days for public comment.
DATES: Comments on this notice must be received by May 29, 2013.
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).
Copies of the proposed collection plans, data collection
instruments, and specific details on the estimated burden can be
obtained from the AHRQ Reports Clearance Officer.
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by email at
doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
Proposed Project
Improving Sickle Cell Transitions of Care through Health Information
Technology Phase I
This project is the first phase in AHRQ's effort toward the
development of a health information technology (HIT) enabled tool
designed to aid adolescents and young adults with sickle cell disease
(SCD) during transitions of care. SCD is a serious, genetic blood
disorder that affects approximately 70,000-100,000 Americans, including
one out of every 500 African American and one out of every 36,000
Hispanic American births. Persons with SCD produce abnormal, ``sickle-
shaped'' red blood cells that obstruct blood vessels, leading to life-
long anemia, organ damage, increased potential for infections, chronic
episodes of pain, and substantially shortened life spans. SCD has been
noted to be understudied relative to its prevalence resulting in a lack
of knowledge about the important variables and domains that determine
health outcomes for patients. Furthermore, patients with SCD, typically
young, minority, and often of lower income status, have had few
opportunities to voice their needs and concerns about their health and
health care.
As recently as 30 years ago, children with SCD usually did not
survive into adulthood. Now, as a result of advances in screening and
treatment, more than 90 percent of individuals with SCD reach
adulthood, and life expectancy is typically into the fifth decade.
Persons with SCD experience multiple transitions of care as a result of
the chronicity of SCD, frequency of both acute and chronic-events
requiring care,
[[Page 25086]]
as well as the advancements in life expectancy. Transitions of care
occur when either the setting of care changes (e.g., from home-based to
hospital-based care) or the focus of care changes (e.g., from
pediatric-focused to adult-focused care). When transitions of care
occur, a need to share medical history and other types of health
information arises. Transitions of care are more likely to be
successful when this health information is accurate, tailored to the
type of transition taking place, and communicated effectively.
Times of care transitions are particularly fraught for patients
with SCD and currently, few patients have access to effective
transition programs for SCD. In a 2010 survey of pediatric SCD
providers, the majority claimed to have transition programs in place
but they were often newly formed and without the ability to transfer
care to adult providers with specific expertise in SCD.
Preliminary evidence suggests that HIT can be helpful for SCD and
similar conditions. In particular, a technology-based tool has already
been used successfully by patients with SCD to help with some aspects
of disease management. In one study, a handheld wireless device was
used to implement a pain management protocol and found to result in
high rates of participation and satisfaction. Technology-based tools or
applications--``apps''--have also been effective in improving care
transitions for other chronic diseases such as diabetes and HIV, which
can serve as models for this tool.
Improving transitions of care is the focus of AHRQ's plans to
respond to the Department of Health and Human Services' (HHS') SCD
Initiative announced in 2011. The overall HHS SCD initiative, which is
aligned with AHRQ's mission, aims to improve the health of persons with
SCD through various activities, including developing and disseminating
evidence-based guidelines, increasing the availability of medical homes
that provide SCD care, and supporting research in areas such as pain
and disease management, all of which could also be supported through
the use of an effective HIT enabled tool.
The goals of this project are to:
(1) Gain the necessary background knowledge including qualitative
information from key stakeholders, to establish a set of requirements
that would guide the design and development of a HIT-enabled tool in
future phases of work that meets patients', families', and providers'
needs to aid adolescents and young adults with sickle cell disease
during transitions of care.
(2) Develop an understanding of the environmental context, current
facilitators and barriers, health data use and needs of key
stakeholders affected by sickle cell disease, including patients,
families, and providers.
This study is being conducted by AHRQ through its contractor, The
Lewin Group in partnership with Children's National Medical Center,
Cincinnati Children's Hospital Medical Center, Nemours Children's
Clinic-Jacksonville, and the National Initiative for Children's
Healthcare Quality, pursuant to AHRQ's statutory authority to conduct
and support research on healthcare 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 this project, the following activities and
data collections will be implemented:
(1) Environmental Scan--AHRQ will execute a literature review to
identify potentially relevant scientific literature and information
from other literature and sources as well as complete a search for
existing tools that aid transitions of care for persons with SCD or
similar conditions. This will provide contextual background about the
current state of the field with regards to tool-development and use,
identify key-issues of patients with SCD related to care transitions,
and understand the context of care delivered and health data
information needs to inform the content, design and functionality of a
tool. This activity does not impose a burden on the public and is not
included in the burden estimates in Exhibit 1.
(2) Focus Groups--AHRQ will facilitate ten focus groups of key
stakeholder groups including: parents/caregivers of patients with SCD;
health care providers (e.g. SCD specialists, primary care physicians
(PCPs), hospitalists and emergency room (ER) physicians); IT
developers; SCD patients ages 9-13; SCD patients ages 14-17; SCD
patients 18 and older; and SCD patients of mixed ages; to gather
qualitative information on stakeholder experiences with SCD and care
transitions, barriers to quality care, and use of technology to inform
tool design and functionality. Each group will consist of 10
participants and will be asked to describe their particular experiences
with health care transitions, communication practices, information
needs and technology use in order to develop relevant ``use cases''
which will be used by investigators and tool developers for the later
phases of the project. The in-person nature of focus groups allows for
a more in-depth and targeted discussion, including participant
experiences, impressions and priorities in a detailed fashion.
(3) Demographic Questionnaire--AHRQ will implement a short
demographic questionnaire at the start of each of the ten focus groups
to collect basic demographic information to allow the team to
contextualize findings from each focus group. Questionnaires are
tailored to each focus group category: Parents/caregivers of patients
with SCD; providers, hospitalists and ER physicians; IT developers; SCD
patients ages 9-13; SCD patients ages 14-17; SCD patients 18 and older;
and SCD patients of mixed ages.
(4) Key Informant Interviews--AHRQ will conduct eight key informant
interviews with stakeholders such as State Medicaid representatives,
attorneys with expertise in privacy and security issues,
representatives from the Office of the National Coordinator for Health
Information Technology (ONC), Office of Chief Scientist, and other
relevant policy makers. Qualitative information gained will contribute
to tool development recommendations particularly in terms of cost
issues related to reimbursement by payers, needs for proof of
effectiveness, sustainability, and potential vehicles for facilitating
and funding tool development and implementation.
The information gained from the focus groups and key informant
interviews will be used to understand if and how a patient-centered,
HIT-enabled tool can improve the health of individuals with SCD during
care transitions.
Focus groups as a form of qualitative research are an important
vehicle for gathering and explicating insight from the field,
especially if, as in this case, the important domains are not yet
understood, and need to be outlined by respondents, rather than
suggested by investigators. Thus active recruitment and qualitative
techniques are a means to incorporate this necessary and important
perspective into the derivation of effective interventions. The primary
objective of the focus groups is to gather more richly nuanced
information from sickle cell disease stakeholders. The in-person nature
of focus groups allows for a more in-depth and targeted discussion,
including participant experiences, impressions and priorities in a
detailed fashion.
[[Page 25087]]
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated annualized burden hours for the
respondents' time to participate in this research. The demographic
questionnaire will be completed by each focus group participant and
takes 6 minutes to complete. All of the focus groups and key informant
interviews will last 2 hours except for the IT developer focus group
which will last 4 hours. Each focus group will consist of 10 persons.
There will be two focus groups with providers, three with parents/
caregivers, one group for IT developers, and one focus group with each
of the four patient groups. Key informant interviews will be conducted
with eight individuals. The total burden is estimated to be 246 hours
annually.
Exhibit 2 shows the estimated annualized cost burden associated
with the respondents' time to participate in this research. The total
cost burden is estimated to be $8,174 annually.
Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Form name Number of responses per Hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Demographic Questionnaire....................... 100 1 6/60 10
Provider Focus Groups........................... 20 1 2 40
Parent/Caregiver Focus Groups................... 30 1 2 60
IT Developer Focus Group........................ 10 1 4 40
Patients 9-13 Focus Group....................... 10 1 2 20
Patients 14-17 Focus Group...................... 10 1 2 20
Patients 18 & older Focus Group................. 10 1 2 20
Patients mixed ages Focus Group................. 10 1 2 20
Key Informant Interviews........................ 8 1 2 16
---------------------------------------------------------------
Total....................................... 208 na na 246
----------------------------------------------------------------------------------------------------------------
Exhibit 2--Estimated annualize cost burden
----------------------------------------------------------------------------------------------------------------
Number of Total burden Average Total cost
Form name respondents hours hourly rate* burden
----------------------------------------------------------------------------------------------------------------
Demographic Questionnaire....................... 100 10 \a\ $26.89 $269
Provider Focus Groups........................... 20 40 \b\ 88.78 3,551
Parent/Caregiver Focus Groups................... 30 60 \c\ 21.74 1,304
IT Developer Focus Group........................ 10 40 \d\ 44.27 1,771
Patients 9-13 Focus Group....................... 10 20 \e\ 0 0
Patients 14-17 Focus Group...................... 10 20 \e\ 0 0
Patients 18 & older Focus Group................. 10 20 \c\ 21.74 435
Patients mixed ages Focus Group................. 10 20 \e\ 0 0
Key Informant Interviews........................ 8 16 \f\ 52.72 844
---------------------------------------------------------------
Total....................................... 208 246 na 8,174
----------------------------------------------------------------------------------------------------------------
\a\ Based on the mean wages for Physicians & Surgeons, All other (29-1069), All Occupations (00-0000), Software
Developer (15-1132). Wages for children averaged in as $0.
\b\ Based on the mean wages for Physicians & Surgeons, All other (29-1069).
\c\ Based on the mean wages for All Occupations (00-0000).
\d\ Based on the mean wages for Software Developer (15-1132).
\e\ No wage data for children.
\f\ Based on the mean wages for Lawyers (23-1011), Social and Community Service Managers (11-9151), Medical and
Health Services Managers (11-9111), and Computer and Information System Managers (11-3021).
* National Compensation Survey: Occupational wages in the United States May 2011, ``U.S. Department of--Labor,
Bureau of Labor Statistics.''https://www.bls.gov/oes/current/oes_nat.htm#15-0000.
Estimated Annual Costs to the Federal Government
Exhibit 3 shows the estimated total and annualized cost to the
federal government over 18 months. The total cost to the federal
government of this data collection effort is $264,043. This figure
includes development of draft and final plans for conducting focus
groups and interviews; development of materials including moderator
guides for each stakeholders group (seven guides in total), recruitment
materials for all four sites, consent forms; facilitating IRB approval
processes at four sites; logistics coordination including securing
facility space; recruitment of participants; incentives for
participants (as described in section 9 above); and analyzing and
summarizing findings as well as preparing final reports.
Exhibit 3--Estimated Total and Annualized Cost
------------------------------------------------------------------------
Cost component Total cost Annualized cost
------------------------------------------------------------------------
Project Development............... $23,689 $15,793
Data Collection Activities........ 169,586 113,057
Data Processing and Analysis...... 16,000 10,667
Publication of Results............ 33,472 22,315
[[Page 25088]]
Project Management................ 18,319 12,213
Overhead.......................... 2,977 1,985
-------------------------------------
Total......................... 264,043 176,029
------------------------------------------------------------------------
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.
Dated: April 15, 2013.
Carolyn M Clancy,
Director.
[FR Doc. 2013-09742 Filed 4-26-13; 8:45 am]
BILLING CODE 4160-90-M
