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[Federal Register Volume 77, Number 98 (Monday, May 21, 2012)]
[Notices]
[Pages 30011-30014]
From the Federal Register Online via the Government Printing 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 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

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

[[Page 30012]]

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

[[Page 30013]]

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
                                                 ---------------------------------------------------------------
    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
----------------------------------------------------------------------------------------------------------------
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
                                                 ---------------------------------------------------------------
    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
------------------------------------------------------------------------
          Cost component                Total cost      Annualized cost
------------------------------------------------------------------------
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
                                   -------------------------------------
    Total.........................            793,456            352,646
------------------------------------------------------------------------
* Costs are fully loaded including overhead and G&A.

[[Page 30014]]

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
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