[Federal Register Volume 78, Number 26 (Thursday, February 7, 2013)]
[Notices]
[Pages 9051-9054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-02549]
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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.
DATES: Comments on this notice must be received by April 8, 2013.
ADDRESSES: Written comments should be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by email at
doris.lefkowitz,AHRQ.hhs.gov.
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
AHRQ.hhs.gov">doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
Proposed Project
Improving Sickle Cell Transitions of Care Through Health Information
Technology Phase 1
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
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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, 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, pursuant to AHRQ's 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 health
care technologies. 42 U.S.C. 299a(a)(1), (2) and (5).
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. Five of these
stakeholders will be Federal government employees and therefore are
excluded from the burden estimates in Exhibit 1 below.
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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.
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 236 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 $7,646 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........................ 3 1 2 6
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Total....................................... 203 na na 236
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* Five interview participants will be Federal government employees and therefore are excluded from the burden
estimates.
Exhibit 2--Estimated Annualized Cost Burden
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Number of Total burden Average hourly Total cost
Form name respondents hours wage rate * burden
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Demographic Questionnaire....................... 100 10 \a\ $26.89 $269
Provider Focus Groups........................... 20 40 \b\ 88.7 3,551
Parent/Caregiver Focus Groups................... 30 60 \a\ 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 \a\ 21.74 435
Patients mixed ages Focus Group................. 10 20 \e\ 0 0
Key Informant Interviews........................ 3 6 \f\ 52.72 316
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Total....................................... 203 236 na 7,646
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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.
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
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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: January 23, 2013.
Carolyn M. Clancy,
Director.
[FR Doc. 2013-02549 Filed 2-6-13; 8:45 am]
BILLING CODE 4160-90-M