Agency Information Collection Activities: Proposed Collection; Comment Request, 5807-5810 [2013-01345]
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5807
Federal Register / Vol. 78, No. 18 / Monday, January 28, 2013 / Notices
will last about one hour. The student
survey will include 1,800 students and
takes 10 minutes to complete. The total
burden is estimated to be 324 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 $4,790 annually.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Hours per
response
Total
Faculty Interview ..............................................................................................
Student Survey ................................................................................................
24
1,800
1
1
1
10/60
24
300
Total ..........................................................................................................
1,824
Na
Na
324
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Form name
Total burden
hours
Average hourly wage rate *
Total cost
burden
Faculty Interview ..............................................................................................
Student Survey ................................................................................................
24
1,800
24
300
$47.70
12.15
$1,145
3,645
Total ..........................................................................................................
1,824
324
Na
4,790
* Based on the mean wages for Health Specialties Teachers, Postsecondary (25–1071; 47.70/hour) and Teacher Assistants (25–9041; $12.15/
hour. Many of the students will be teaching and research assistants, making this the best occupational code for them), 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#25-0000.
Estimated Annual Costs to the Federal
Government
Exhibit 3 shows the total and
annualized cost to the Federal
Government for conducting this
research. The total cost to the Federal
Government is $683,335. The total
annualized cost is estimated to be
approximately $341,667. The total
annual costs include the questionnaire
development, administration, analysis,
and study management.
EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST
Cost component
Total cost
Annualized
cost
$144,707
283,667
135,523
9,012
65,722
44,704
$72,353
141,833
67,762
4,506
32,861
22,352
Total ..................................................................................................................................................................
tkelley on DSK3SPTVN1PROD with
Project Development ...............................................................................................................................................
Data Collection Activities .........................................................................................................................................
Data Processing and Analysis .................................................................................................................................
Publication of Results ..............................................................................................................................................
Project Management ................................................................................................................................................
Overhead .................................................................................................................................................................
683,335
341,667
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
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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 16, 2013.
Carolyn M. Clancy,
Director.
[FR Doc. 2013–01342 Filed 1–25–13; 8:45 am]
BILLING CODE 4160–90–M
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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 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:
‘‘Applying Novel Methods To Better
SUMMARY:
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Federal Register / Vol. 78, No. 18 / Monday, January 28, 2013 / Notices
Understand the Relationship Between
Health IT and Ambulatory Care
Workflow Redesign.’’ 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 March 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
tkelley on DSK3SPTVN1PROD with
Applying Novel Methods To Better
Understand the Relationship Between
Health IT and Ambulatory Care
Workflow Redesign
The Agency for Healthcare Research
and Quality (AHRQ) requests that the
Office of Management and Budget
(OMB) approve, under the Paperwork
Reduction Act of 1995, AHRQ’s
collection of information for the project
‘‘Applying Novel Methods To Better
Understand the Relationship Between
Health IT and Ambulatory Care
Workflow Redesign.’’ The data to be
collected consists of interviews and
focus groups with clinical, non-clinical,
and management staff about their
experiences with new health
information technology (IT) in an
ambulatory care facility. The overall
goal of this study is to characterize the
relationship between health IT
implementation and health care
workflow in six (6) small and mediumsized ambulatory care practices
implementing patient-centered medical
homes (PCMH), with a focus on the
influence of behavioral and
organizational factors and the effects of
disruptive events.
AHRQ is a lead Federal agency in
developing and disseminating evidence
and evidence-based tools on how health
IT can improve health care quality,
safety, efficiency, and effectiveness.
Health IT has been widely viewed as
holding great promise to improve the
quality of health care in the U.S. Health
IT can improve access to information for
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17:13 Jan 25, 2013
Jkt 229001
both patients and providers,
empowering patients to become
involved in their own self-care.
Increased patient safety can result from
health IT when records are shared,
medications are reconciled, and adverse
event alerts are in place. When health IT
improves efficiency, providers can
spend more time directly caring for
patients, ultimately improving the
quality of care patients receive.
In redesigning an ambulatory office
practice as a patient-centered medical
home (PCMH), health IT is intended to
allow for a seamless and organized flow
of information among providers. The
health IT system is critical, because
under the PCMH model, a team of
clinicians aims to provide continuous
and coordinated care throughout a
patient’s lifetime.
Unfortunately, health IT systems can
fail to generate anticipated results and
even carry unintended consequences
which undermine usability and
usefulness. Directly or indirectly, health
IT may create more work, new work,
excessive system demands, or
inefficient workflow (the sequence of
clinical tasks). Electronic reminders and
alerts may be timed poorly. Software
may require excessive switching
between screens, leading to cognitive
distractions for end users. Providers
may spend more time on health IT
system-related tasks than on direct
patient care.
The literature also suggests that the
ambulatory health care environment is
full of unpredictable yet frequently
occurring events requiring actions that
deviate from normal practice.
Unpredictable events such as
interruptions requiring a provider’s
immediate attention, or disruptions in
the normal functioning of the health IT
system (exceptions) divert health care
workers from the usual course of
workflow. The inability of health IT to
properly accommodate these events
could cause compromises to clinical
work.
Because of adverse, unintended and
disruptive consequences, developing an
understanding of how health IT
implementation alters clinical work
processes and workflow is crucial.
Unfortunately, research is scarce, and
methods of investigation vary widely.
Empirical evidence of health IT’s impact
on clinical workflow has been
‘‘anecdotal, insufficiently supported, or
otherwise deficient in terms of scientific
rigor’’ (Carayon and Karsh, 2010).
This study aims to examine more
systematically the impact of health IT
on workflow in six (6) small and
medium-sized ambulatory care practices
varying in their characteristics but all
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implementing PCMH. All of the
practices will be in the process of
implementing a new health IT system
during the course of the study, but some
may have an existing, baseline system
such as an electronic health record
system. The focus of the study will be
on the new systems being implemented.
It will employ the complementary
quantitative and qualitative methods of
previous research. The combination of
methods produces quantitative results
and allows validation through
observation and solicitation of
qualitative participant opinions.
The specific goals of this study are to
identify (1) the relationship between
health IT implementation and
ambulatory care workflow; (2) the
behavioral and organizational factors
and the role they play in mitigating or
augmenting the impact of health IT on
workflow; and (3) how the impacts of
health IT are magnified through
disruptive events such as interruptions
and exceptions.
This study is being conducted by
AHRQ through its contractor, Billings
Clinic, 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 clinical
practice, including primary care and
practice-oriented research. 42 U.S.C.
299a(a)(1) and (4).
Method of Collection
To achieve the goals of this project the
following data collection will be
implemented:
(1) Mapping of Study Practices. This
activity will detect any changes made to
the physical layout as a result of
implementing PCMH and health IT.
Practices will be mapped at the
beginning of the study and maps will be
updated as needed. Recording this
information will not burden the clinic
staff and is not included in the burden
estimates.
(2) Staff Observation. Clinicians
(physicians, nurse practitioners,
physician assistants, nurses, medical
assistants, pharmacists, and case
managers) and non-clinical office
personnel will be observed to delineate
the overall characteristics of clinical
workflow before, during, and after
health IT implementation. Particular
attention will be paid to interruptions
and exceptions. If necessary and if the
situation allows, observers will as
unobtrusively as possible ask clinic staff
to clarify certain observed actions.
Recording this information will not
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Federal Register / Vol. 78, No. 18 / Monday, January 28, 2013 / Notices
burden the clinic staff and is not
included in the burden estimates.
(3) Before—After Time and Motion
Study. This activity quantifies staffs
time expenditures on different clinical
activities and delineates the sequence of
task execution. It will be conducted
before and after health IT
implementation. This data will be
collected by observation only.
Recording this information will not
burden the clinic staff and is not
included in the burden estimates.
(4) Extraction of Clinical Data. Logs,
audits trails, and time-stamped clinical
data will be extracted from the health IT
system to reconstruct clinical workflow
related to the health IT system. This
information validates and supplements
the data recorded by human observers.
Extracting this data will not burden the
clinic staff and is not included in the
burden estimates.
(5) Semi-Structured Interviews. This
data collection will be conducted posthealth IT implementation to solicit
attitudes and perceptions by health IT
end users including clinical staff, nonclinical personnel, and management
regarding how health IT has changed
their workflow. Particular attention will
be paid to behavioral and organizational
factors.
(6) Focus Group. A focus group will
be conducted post-health IT
implementation with the clinical staff,
non-clinical personnel, and
management team to ensure the research
findings, as well as the interpretation of
the findings, accurately reflect their
experiences using health IT.
On-site data collection will be
conducted over a 5-day period during
each of three phases. Preimplementation data collection
activities will be conducted prior to user
training. During-implementation data
collection will begin when staff are
instructed to start using the health IT
system. Post-implementation data
collection will be conducted
approximately 3 months after
implementation at each study practice.
The qualitative study components of
this project, namely staff observations,
semi-structured interviews, and focus
groups, will generate qualitative data in
the form of observation notes and
interview transcripts. The time-andmotion study and the electronic clinical
data will produce quantitative
information in the form of sequences of
clinical activities and information about
the duration, location, and performer of
each action. Mapping will create
annotated floor plans delineating the
physical layout of each study clinic,
which will be incorporated in the
collection and analysis of the data of the
other study components.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated annual
burden hours for participation in this
study. The semi-structured interview
will be completed by 60 respondents
across the 6 clinics (10 per practice) and
requires one hour. Sixty (60) clinic staff
members will be asked to participate in
the focus group across all 6 clinics (10
per practice). The focus group requires
no more than 45 minutes. The total
annual burden is estimated to be 105
hours.
Exhibit 2 shows the estimated annual
cost burden associated with the
respondents’ time to participate in this
research. The total annual burden is
estimated to be $5,505.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Hours per
response
Total burden
hours
Semi-Structured Interview ...............................................................................
Focus Group ....................................................................................................
60
60
1
1
1
45/60
60
45
Total ..........................................................................................................
120
........................
........................
105
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Form name
Total burden
hours
Average hourly wage rate *
Total cost
burden
Semi-Structured Interview ...............................................................................
Focus Group ....................................................................................................
60
60
60
45
$55
49
$3,300
2,205
Total ..........................................................................................................
120
105
........................
5,505
* Based upon the mean of the average wages, National Compensation Survey. Occupational wages in the United States July 2010, U.S. Department of Labor, Bureau of Labor Statistics, https://www.bls.gov/ncs/ocs/sp/nctb1477.pdf. For the semi-structured interviews, hourly wage is an
average including 2 physicians or surgeons ($85.67), 1 registered nurse ($32.42), 2 non-physician providers (measured here as physician assistants, $43.44), and 1 senior administrator (measured here as ‘‘Medical and health services managers,’’ $42.28). For focus groups, 3.34 physicians or surgeons ($85.67), 1.66 non-physician providers (measured here as physician assistants, $43.44), 3.34 registered nurses ($32.42), and
1.66 medical assistants ($14.46).
Estimated Annual Costs to the Federal
Government
The total cost of this study is
$799,014 over a 36-month time period
from June 1, 2012 through May 31, 2015
for an annualized cost of $266,338.
(Because the project entails gathering
data before, during, and after health IT
implementation, a period of 21 months
is planned for data collection.) Exhibit
3 provides a breakdown of the estimated
total and average annual costs by
category.
tkelley on DSK3SPTVN1PROD with
EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST
Cost component
Total cost
Project Development .......................................................................................................................................
Data Collection Activities .................................................................................................................................
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$135,759
177,460
Annualized cost
$45,253
59,153
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Federal Register / Vol. 78, No. 18 / Monday, January 28, 2013 / Notices
EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST—Continued
Cost component
Total cost
Annualized cost
Data Processing and Analysis .........................................................................................................................
Publication of Results ......................................................................................................................................
Project Management ........................................................................................................................................
Overhead .........................................................................................................................................................
239,426
51,779
67,729
126,861
79,809
17,260
22,576
42,287
Total ..........................................................................................................................................................
799,014
266,338
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 healthcare
research and healthcare 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: January 16, 2013.
Carolyn M. Clancy,
Director.
[FR Doc. 2013–01345 Filed 1–25–13; 8:45 am]
BILLING CODE 4160–90–M
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
AHRQ Standing Workgroup for Quality
Indicator Measure Specification
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Notice of request for
nominations.
AGENCY:
The Agency for Healthcare
Research and Quality (AHRQ) is seeking
nominations for both a time-limited
work group and a standing work group
to be convened by an AHRQ contractor.
The work groups shall be comprised of
individuals with knowledge of the
tkelley on DSK3SPTVN1PROD with
SUMMARY:
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AHRQ Quality Indicators (QIs), their
technical specifications, and associated
methodological issues. The overarching
goals of each group are to provide
feedback to AHRQ regarding
refinements to the Qls. The time-limited
workgroup is more restricted to specific
clinical or methodological issues, while
the standing workgroup addresses
broader issues related to the
measurement cycle.
DATES: Please submit nominations on or
before March 15, 2013. Self-nominations
are welcome. Third-party nominations
must indicate that the individual has
been contacted and is willing to serve
on the workgroup. Selected candidates
will be contacted by AHRQ no later than
April 5, 2013. Please include the
committee of interest. Candidates may
apply for both.
ADDRESSES: Nominations can be sent in
the form of a letter or email, preferably
as an electronic file with an email
attachment, and should specifically
address the submission criteria as noted
below. Electronic submissions are
strongly encouraged. Responses should
be submitted to: ATTN: Pamela Owens,
Agency for Healthcare Research and
Quality, Center for Delivery,
Organization and Markets, 540 Gaither
Road, Rockville, MD 20850, Email:
pam.owens@AHRQ.hhs.gov.
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Pamela Owens, Ph.D., Senior Research
Scientist, Agency for Healthcare
Research and Quality, Center for
Delivery, Organization and Markets, 540
Gaither Road, Rockville, MD 20850,
Email: pam.owens@AHRQ.hhs.gov;
Phone: (301) 427–1412; Fax: (301) 427–
1430.
SUPPLEMENTARY INFORMATION: These
workgroups are being administered by
AHRQ’s contractor as part of a
structured approach to formally and
broadly engage stakeholders, and to
enhance and expand transparency about
the scientific development of the AHRQ
QIs.
Time-Limited Work Group
Time-limited workgroups are
formative in nature, providing feedback
on significant measure improvement
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issues and representing a broad range of
stakeholders. The focus for this
upcoming year will be the Prevention
Quality Indicators (PQI). The role of
time-limited group members is to: (1)
Provide technical guidance on the PQI
specifications and rationales, risk
adjustment strategies, and other quality
measurement issues; (2) provide input
on critical information gaps, as well as
research methods to address them; (3)
provide guidance on draft
recommendations for the PQI measure
refinements; (4) offer scientifically
rigorous recommendations for the
evaluation and validation efforts
required to ensure the accuracy of the
PQIs; and, (5) provide input on and
review of the contractor’s technical
report resulting from the workgroup’s
discussions.
The time-limited workgroup will
consist of 8–12 members consisting of:
• One or more statisticians
specialized in the relevant statistical
methods and applications
• One or more individuals with
expertise in community health care and
prevention, and access to and quality of
care
• One or more individuals with
experience using AHRQ PQI measures
for assessing health system performance
and public reporting
• One or more individuals with
expertise in developing algorithms
using ICD–9–CM codes to construct or
modify quality indicators using
administrative data is desirable, but not
mandatory
In addition, the work group is
expected to include representatives
from impacted provider groups and
their professional organizations, other
stakeholders, consumers and other
users, quality alliances, medical or
specialty societies, measure developers,
accrediting organizations, and public
and private payers.
Standing Work Group
The standing workgroup is part of a
structured approach to bring together
individuals from multiple disciplines
for the purpose of providing technical
feedback on proposed updates to the
AHRQ QIs. The intent is to collect
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]]>Agencies
[Federal Register Volume 78, Number 18 (Monday, January 28, 2013)]
[Notices]
[Pages 5807-5810]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01345]
-----------------------------------------------------------------------
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: ``Applying Novel Methods To Better
[[Page 5808]]
Understand the Relationship Between Health IT and Ambulatory Care
Workflow Redesign.'' 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 March 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
Applying Novel Methods To Better Understand the Relationship Between
Health IT and Ambulatory Care Workflow Redesign
The Agency for Healthcare Research and Quality (AHRQ) requests that
the Office of Management and Budget (OMB) approve, under the Paperwork
Reduction Act of 1995, AHRQ's collection of information for the project
``Applying Novel Methods To Better Understand the Relationship Between
Health IT and Ambulatory Care Workflow Redesign.'' The data to be
collected consists of interviews and focus groups with clinical, non-
clinical, and management staff about their experiences with new health
information technology (IT) in an ambulatory care facility. The overall
goal of this study is to characterize the relationship between health
IT implementation and health care workflow in six (6) small and medium-
sized ambulatory care practices implementing patient-centered medical
homes (PCMH), with a focus on the influence of behavioral and
organizational factors and the effects of disruptive events.
AHRQ is a lead Federal agency in developing and disseminating
evidence and evidence-based tools on how health IT can improve health
care quality, safety, efficiency, and effectiveness. Health IT has been
widely viewed as holding great promise to improve the quality of health
care in the U.S. Health IT can improve access to information for both
patients and providers, empowering patients to become involved in their
own self-care. Increased patient safety can result from health IT when
records are shared, medications are reconciled, and adverse event
alerts are in place. When health IT improves efficiency, providers can
spend more time directly caring for patients, ultimately improving the
quality of care patients receive.
In redesigning an ambulatory office practice as a patient-centered
medical home (PCMH), health IT is intended to allow for a seamless and
organized flow of information among providers. The health IT system is
critical, because under the PCMH model, a team of clinicians aims to
provide continuous and coordinated care throughout a patient's
lifetime.
Unfortunately, health IT systems can fail to generate anticipated
results and even carry unintended consequences which undermine
usability and usefulness. Directly or indirectly, health IT may create
more work, new work, excessive system demands, or inefficient workflow
(the sequence of clinical tasks). Electronic reminders and alerts may
be timed poorly. Software may require excessive switching between
screens, leading to cognitive distractions for end users. Providers may
spend more time on health IT system-related tasks than on direct
patient care.
The literature also suggests that the ambulatory health care
environment is full of unpredictable yet frequently occurring events
requiring actions that deviate from normal practice. Unpredictable
events such as interruptions requiring a provider's immediate
attention, or disruptions in the normal functioning of the health IT
system (exceptions) divert health care workers from the usual course of
workflow. The inability of health IT to properly accommodate these
events could cause compromises to clinical work.
Because of adverse, unintended and disruptive consequences,
developing an understanding of how health IT implementation alters
clinical work processes and workflow is crucial. Unfortunately,
research is scarce, and methods of investigation vary widely. Empirical
evidence of health IT's impact on clinical workflow has been
``anecdotal, insufficiently supported, or otherwise deficient in terms
of scientific rigor'' (Carayon and Karsh, 2010).
This study aims to examine more systematically the impact of health
IT on workflow in six (6) small and medium-sized ambulatory care
practices varying in their characteristics but all implementing PCMH.
All of the practices will be in the process of implementing a new
health IT system during the course of the study, but some may have an
existing, baseline system such as an electronic health record system.
The focus of the study will be on the new systems being implemented. It
will employ the complementary quantitative and qualitative methods of
previous research. The combination of methods produces quantitative
results and allows validation through observation and solicitation of
qualitative participant opinions.
The specific goals of this study are to identify (1) the
relationship between health IT implementation and ambulatory care
workflow; (2) the behavioral and organizational factors and the role
they play in mitigating or augmenting the impact of health IT on
workflow; and (3) how the impacts of health IT are magnified through
disruptive events such as interruptions and exceptions.
This study is being conducted by AHRQ through its contractor,
Billings Clinic, 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 clinical practice, including primary care and practice-
oriented research. 42 U.S.C. 299a(a)(1) and (4).
Method of Collection
To achieve the goals of this project the following data collection
will be implemented:
(1) Mapping of Study Practices. This activity will detect any
changes made to the physical layout as a result of implementing PCMH
and health IT. Practices will be mapped at the beginning of the study
and maps will be updated as needed. Recording this information will not
burden the clinic staff and is not included in the burden estimates.
(2) Staff Observation. Clinicians (physicians, nurse practitioners,
physician assistants, nurses, medical assistants, pharmacists, and case
managers) and non-clinical office personnel will be observed to
delineate the overall characteristics of clinical workflow before,
during, and after health IT implementation. Particular attention will
be paid to interruptions and exceptions. If necessary and if the
situation allows, observers will as unobtrusively as possible ask
clinic staff to clarify certain observed actions. Recording this
information will not
[[Page 5809]]
burden the clinic staff and is not included in the burden estimates.
(3) Before--After Time and Motion Study. This activity quantifies
staffs time expenditures on different clinical activities and
delineates the sequence of task execution. It will be conducted before
and after health IT implementation. This data will be collected by
observation only. Recording this information will not burden the clinic
staff and is not included in the burden estimates.
(4) Extraction of Clinical Data. Logs, audits trails, and time-
stamped clinical data will be extracted from the health IT system to
reconstruct clinical workflow related to the health IT system. This
information validates and supplements the data recorded by human
observers. Extracting this data will not burden the clinic staff and is
not included in the burden estimates.
(5) Semi-Structured Interviews. This data collection will be
conducted post-health IT implementation to solicit attitudes and
perceptions by health IT end users including clinical staff, non-
clinical personnel, and management regarding how health IT has changed
their workflow. Particular attention will be paid to behavioral and
organizational factors.
(6) Focus Group. A focus group will be conducted post-health IT
implementation with the clinical staff, non-clinical personnel, and
management team to ensure the research findings, as well as the
interpretation of the findings, accurately reflect their experiences
using health IT.
On-site data collection will be conducted over a 5-day period
during each of three phases. Pre-implementation data collection
activities will be conducted prior to user training. During-
implementation data collection will begin when staff are instructed to
start using the health IT system. Post-implementation data collection
will be conducted approximately 3 months after implementation at each
study practice.
The qualitative study components of this project, namely staff
observations, semi-structured interviews, and focus groups, will
generate qualitative data in the form of observation notes and
interview transcripts. The time-and-motion study and the electronic
clinical data will produce quantitative information in the form of
sequences of clinical activities and information about the duration,
location, and performer of each action. Mapping will create annotated
floor plans delineating the physical layout of each study clinic, which
will be incorporated in the collection and analysis of the data of the
other study components.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated annual burden hours for participation
in this study. The semi-structured interview will be completed by 60
respondents across the 6 clinics (10 per practice) and requires one
hour. Sixty (60) clinic staff members will be asked to participate in
the focus group across all 6 clinics (10 per practice). The focus group
requires no more than 45 minutes. The total annual burden is estimated
to be 105 hours.
Exhibit 2 shows the estimated annual cost burden associated with
the respondents' time to participate in this research. The total annual
burden is estimated to be $5,505.
Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Form name Number of responses per Hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Semi-Structured Interview....................... 60 1 1 60
Focus Group..................................... 60 1 45/60 45
---------------------------------------------------------------
Total....................................... 120 .............. .............. 105
----------------------------------------------------------------------------------------------------------------
Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Number of Total burden Average hourly Total cost
Form name respondents hours wage rate * burden
----------------------------------------------------------------------------------------------------------------
Semi-Structured Interview....................... 60 60 $55 $3,300
Focus Group..................................... 60 45 49 2,205
---------------------------------------------------------------
Total....................................... 120 105 .............. 5,505
----------------------------------------------------------------------------------------------------------------
* Based upon the mean of the average wages, National Compensation Survey. Occupational wages in the United
States July 2010, U.S. Department of Labor, Bureau of Labor Statistics, https://www.bls.gov/ncs/ocs/sp/nctb1477.pdf. For the semi-structured interviews, hourly wage is an average including 2 physicians or surgeons
($85.67), 1 registered nurse ($32.42), 2 non-physician providers (measured here as physician assistants,
$43.44), and 1 senior administrator (measured here as ``Medical and health services managers,'' $42.28). For
focus groups, 3.34 physicians or surgeons ($85.67), 1.66 non-physician providers (measured here as physician
assistants, $43.44), 3.34 registered nurses ($32.42), and 1.66 medical assistants ($14.46).
Estimated Annual Costs to the Federal Government
The total cost of this study is $799,014 over a 36-month time
period from June 1, 2012 through May 31, 2015 for an annualized cost of
$266,338. (Because the project entails gathering data before, during,
and after health IT implementation, a period of 21 months is planned
for data collection.) Exhibit 3 provides a breakdown of the estimated
total and average annual costs by category.
Exhibit 3--Estimated Total and Annualized Cost
------------------------------------------------------------------------
Cost component Total cost Annualized cost
------------------------------------------------------------------------
Project Development................. $135,759 $45,253
Data Collection Activities.......... 177,460 59,153
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Data Processing and Analysis........ 239,426 79,809
Publication of Results.............. 51,779 17,260
Project Management.................. 67,729 22,576
Overhead............................ 126,861 42,287
-----------------------------------
Total........................... 799,014 266,338
------------------------------------------------------------------------
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 healthcare research and
healthcare 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: January 16, 2013.
Carolyn M. Clancy,
Director.
[FR Doc. 2013-01345 Filed 1-25-13; 8:45 am]
BILLING CODE 4160-90-M
