[Federal Register Volume 78, Number 82 (Monday, April 29, 2013)]
[Notices]
[Pages 25085-25088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-09742]
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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: ``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 [email protected] (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
[email protected].
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
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Number of
Form name Number of responses per Hours per Total burden
respondents respondent response hours
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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
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Total....................................... 208 na na 246
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Exhibit 2--Estimated annualize cost burden
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Number of Total burden Average Total cost
Form name respondents hours hourly rate* burden
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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
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Total....................................... 208 246 na 8,174
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\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.''http://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
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Cost component Total cost Annualized cost
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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
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Total......................... 264,043 176,029
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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.
Dated: April 15, 2013.
Carolyn M Clancy,
Director.
[FR Doc. 2013-09742 Filed 4-26-13; 8:45 am]
BILLING CODE 4160-90-M