[Federal Register Volume 78, Number 74 (Wednesday, April 17, 2013)]
[Notices]
[Pages 22880-22883]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-08833]
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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: ``Applying Novel Methods to Better 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.
This proposed information collection was previously published in
the Federal Register on January 28th, 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 17, 2013.
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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
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 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
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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
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Number of
Form name Number of responses per Hours per Total burden
respondents respondent response hours
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Semi-Structured Interview....................... 60 1 1 60
Focus Group..................................... 60 1 45/60 45
Total....................................... 120 na na 105
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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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Semi-Structured Interview....................... 60 60 $55 $3,300
Focus Group..................................... 60 45 49 2,205
Total....................................... 120 105 na 5,505
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*Based upon the mean of the average wages, National Compensation Survey: wages in the United States July 2010,
U.S. Department of Labor, Bureau of Labor Statistics, http://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
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Cost component Total cost Annualized cost
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Project Development..................................................... $135,759 $45,253
Data Collection Activities.............................................. 177,460 59,153
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
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Total............................................................... 799,014 266,338
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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 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: April 4, 2013.
Carolyn M. Clancy,
Director.
[FR Doc. 2013-08833 Filed 4-16-13; 8:45 am]
BILLING CODE 4160-90-M