[Federal Register Volume 77, Number 98 (Monday, May 21, 2012)]
[Notices]
[Pages 30011-30014]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-12168]
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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: ``Workflow Assessment for Health IT Toolkit Evaluation.'' 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 March 9th, 2012 and allowed 60 days for public
comment. One comment was 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 June 20, 2012.
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
Workflow Assessment for Health IT Toolkit Evaluation
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. Understanding
clinical work practices and how they will be affected by practice
innovations such as implementing health IT has become a central focus
of health IT research. While much of the attention of health IT
research and development had been directed at the technical issues of
building and deploying health IT
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systems, there is growing consensus that deployment of health IT has
often had disappointing results, and while technical challenges remain,
there is a need for greater attention to sociotechnical issues and the
problems of modeling workflow.
The implementation of health IT in practice is costly in time and
effort and less is known about these issues in small- and medium-sized
practices where the impact, of improved or disrupted workflows may have
especially significant consequences because of limited resources.
Practices would derive great benefit from effective tools for assessing
workflow during many types of health IT implementation, such as
creating disease registries, collecting quality measures, using patient
portals, or implementing a new electronic health record system. To that
end, in 2008, AHRQ funded the development of the Workflow Assessment
for Health IT toolkit (Workflow toolkit). Through this toolkit, end
users should obtain a better understanding of the impact of health IT
on workflow in ambulatory care for each of the following stages of
health IT implementation: (1) Determining system requirements, (2)
selecting a vendor, (3) preparing for implementation, or (4) using the
system post implementation. They should also be able to effectively
utilize the publicly available workflow tools and methods before,
during, and after health IT implementation while recognizing commonly
encountered issues in health IT implementation. In the current project
AHRQ is conducting an evaluation to ensure that the newly developed
Workflow toolkit is useful to small- and medium-sized ambulatory care
clinic managers, clinicians, and staff.
The evaluation will consist of field assessments of use of the
Workflow toolkit in 18 small- and medium-sized practices and gathering
feedback from two Health IT Regional Extension Centers (RECs) who are
providing support to some of these practices. The evaluation will
address the issues of system validation as classically defined in
software engineering: Determining whether the software or system
actually meets the requirements of the user to perform the relevant
tasks. The evaluation will answer the following questions:
Are results correct? Are individual tools included in the
Workflow toolkit accurate? Does workflow assessment with the Workflow
toolkit provide accurate information the practice can act upon?
Does knowledge change? Does user knowledge and capacity
change? Does user knowledge of workflow in their own practice change?
Do decisions change? Do user decisions about workflow
assessment change? Do user decisions about health information
technology (health IT) implementation change?
Do outcomes change? Are changes in workflow favorable? Are
changes in clinical practices favorable? Are changes to the practice
favorable? Are changes for patients favorable?
To answer these questions the proposed evaluation will be conducted
to examine usefulness of the Workflow toolkit in small- and medium-
sized practices. The evaluation will be conducted with 18 practices
affiliated with one of two Practice-based Research Networks (PBRNs) in
Oregon and Wisconsin, and with the Health IT Regional Extension Centers
(RECs) in those States. Participants will be recruited who agree to use
the Workflow toolkit in their specific health IT project for a minimum
of 10 weeks. This will provide an opportunity to observe use of the
Workflow toolkit amongst its intended end users, who are best
positioned to provide critical feedback to improve the functionality of
the Workflow toolkit.
This study is being conducted by AHRQ through its contractors, the
Oregon Rural Practice-based Research Network (ORPRN) and the Wisconsin
Research & Education Network (WREN), pursuant to AHRQ's statutory
authority to conduct and support research on health care and on systems
for the delivery of such care, including activities with respect to the
quality, effectiveness, efficiency, appropriateness and value of health
care services and with respect to health care technologies, facilities,
and equipment. 42 U.S.C. 299a(a)(1) and (5).
Method of Collection
To achieve the goals of this project the following activities and
data collections will be implemented:
(1) Creation of Clinic Study Team: Each participating practice will
form small teams, referred to as Clinic Study Teams, who will
participate in the Pre-Workflow Toolkit Interview, use the Workflow
toolkit and participate in Observations, and participate in the Post-
Workflow Toolkit Interview. Each team will include a maximum of 14
individuals and may represent the following types of respondents:
clinicians, office managers, front office staff, medical assistant or
nurse, nurse care manager, social worker, health educator, information
technology specialist, and/or quality improvement director.
(2) Pre-Workflow Toolkit Interview: these will consist of semi-
structured interviews with practice staff and with three specialists
from each Health IT Regional Extension Center. These interviews are
designed to examine the knowledge, attitudes, and barriers to and
facilitators of workflow assessment for implementation of health IT.
Respondents will be asked to define workflow, to rate its importance to
the practice or REC and to health IT implementation, to describe
factors motivating use of the Workflow toolkit, to describe previous
experience with assessing or redesigning workflow, and to describe
previous experience with health IT implementation and the effect of
this implementation on work processes in their practice (practices) or
for their clients (RECs).
(3) Observations: Participating practices will form small teams
(Clinic Study Teams) who will use the Workflow toolkit. A member of the
project staff will join each Clinic Study Team or the three specialists
at each of the two RECs, as participant-observer and will meet with the
team at times to be determined by the teams, but at least every two
weeks after the Pre-Workflow Toolkit Interview for at least four
visits. During these visits project staff will participate in and keep
field notes regarding the practice's or REC's workflow assessment
activities.
(4) Usage Logs: As part of their workflow assessment process,
Clinic Study Teams, and REC staff, will be asked to meet weekly. For
weekly meetings at which a project staff member is not present, Clinic
Study Teams and REC staff will keep a record of workflow assessment
activities including use of the workflow assessment toolkit, recording
in a free-form journal the purpose and results of the activity as well
as issues that arose in the process.
(5) Post-Workflow Toolkit Interview: This final interview will
consist of individual semi-structured interviews of practice staff and
three specialists from each Health IT Regional Extension Center. These
interviews will (a) Re-examine their knowledge and attitudes about
workflow assessment; (b) revisit the barriers to and facilitators of
workflow assessment; (c) discuss changes that have taken place as a
result of the process; (d) explore outcomes in terms of: (d.1) for
practices, the perceived impacts on clinicians, the practice staff, the
practice, and the patients; and (d.2) for RECs, technician confidence
in guiding affiliated clinics in understanding workflow; and finally
(e) assess the overall impressions about
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the usefulness of the Workflow toolkit as well as any suggested
changes.
The outcome of the evaluation will be a report including
recommendations for enhancing and improving the Workflow toolkit. The
report will provide results about the perceived usefulness of the
Workflow toolkit. Results will be produced separately for practices and
RECs as well as for both user groups as a whole. The report will also
include specific suggestions on how to revise Workflow toolkit to make
it more useful to its intended audiences.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated annual burden hours for each
respondent's time to participate in this evaluation. Each practice will
convene a ``Clinic Study Team'' consisting of no more than 14
individuals; this process will take approximately 8 hours per practice,
or about 35 minutes per person. The Pre-Workflow interview will be
completed by a total of up to 258 persons (about 14 per practice and 3
per REC) and requires one hour. Up to four observations will be
conducted for up to 258 persons and they are each estimated to take two
hours. Ten usage logs will be completed by a total of up to 258 persons
(one per week of study activity) and completion of a single usage log
should take no longer than 15 minutes. The Post-Workflow interview will
be completed by a total of up to 258 persons and requires one hour.
The total annual burden is estimated to be 3,372.
Exhibit 2 shows the estimated annual cost burden associated with
the organizations' time to participate in this research. The total
annual burden is estimated to be $104,813.
Exhibit 1--Estimated Annualized Burden Hours
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Maximum number Number of
Data collection of responses per Hours per Total burden
respondents respondent response hours
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Creation of Clinic Study Team................... 252 1 35/60 147
Pre-Workflow Toolkit Interview.................. 258 1 1 258
Observations.................................... 258 4 2 2,064
Usage Logs...................................... 258 10 15/60 645
Post-Workflow Toolkit Interview................. 258 1 1 258
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Total....................................... 1,284 NA NA 3,372
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Exhibit 2--Estimated Annualized Cost Burden
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Maximum number
Data collection of Total burden Average Total cost
respondents hours hourly rate * burden
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Creation of Clinic Study Team................... 252 147 32.28 4,745
Pre-Workflow Toolkit Interview.................. 258 258 32.28 8,005
Observations.................................... 258 2,064 32.28 64,044
Usage Logs...................................... 258 645 32.28 20,014
Post-Workflow Toolkit Interview................. 258 258 32.28 8,005
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Total....................................... 1,284 3,372 NA 104,813
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* The hourly wage for the participants across the four data collections (pre-workflow toolkit interviews,
observations, usage logs, and post-workflow toolkit interview) is based upon a weighted mean of the average
hourly wages for Family and General Practitioners (1.5; $87.84 per hour); office managers (1.0; $35.18 per
hour); front office staff (1.0; $15.15 per hour); medical assistants or nurses (2.5; $24.36 per hour); nurse
care managers (0.5; $33.57); social workers (0.1; $24.44 per hour); health educators (0.1; $25.12 per hour);
information technology specialists (0.25; $23.43 per hour); quality improvement directors (0.25; 25.12 per
hour); and technical staff (1.0; $33.14 per hour) for Oregon and Wisconsin from the U.S. Department of Labor,
Bureau of Labor Statistics, May 2010 National Occupational Employment and Wage Estimates for the United
States, Occupational Employment Statistics (OES), Washington, DC (Feb. 2009), http://bls.gov/oes/2010/may/www.bls.govoessrcst.htm (accessed November, 2011).
Estimated Annual Costs to the Federal Government
The estimated total cost to the Federal Government for this project
is $793,456 over a 27-month period from September 23, 2011 to December
22, 2013. The estimated average annual cost is $352,646. Exhibit 3
provides a breakdown of the estimated total and average annual costs by
category.
Exhibit 3--Estimated Total and Annual Cost * to the Federal Government
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Cost component Total cost Annualized cost
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Project Management and $96,449 $42,866
Coordination Activities..........
Develop Research and Recruitment 78,383 34,837
Plans............................
Compliance with PRA............... 12,267 5,452
Obtaining IRB approval............ 10,254 4,557
Develop Data Analysis Plan........ 18,246 8,109
Conduct Evaluation................ 534,401 237,512
Data analysis and Final Report.... 23,554 10,468
Ensure 508-compliant deliverables. 19,902 8,845
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Total......................... 793,456 352,646
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* Costs are fully loaded including overhead and G&A.
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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: May 3, 2012.
Carolyn M. Clancy,
Director.
[FR Doc. 2012-12168 Filed 5-18-12; 8:45 am]
BILLING CODE 4160-90-M