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 Department of Health and Human Services Agency for Healthcare Research and Quality
 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: “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.
 DATES: Comments on this notice must be received by May 8, 2012.
 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 
                        *doris.lefkowitz@AHRQ.hhs.gov.*


SUPPLEMENTARY INFORMATION:
                    ( print page 14371) 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 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 AFIRQ 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 data collections will be implemented: (1) 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). (2) 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. (3) 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. (4) 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 
                    ( print page 14372)
                    patients; and (d.2) for RECs, technician confidence in guiding affiliated clinics in understanding workflow; and finally (e) assess the overall impressions about 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. The Pre-Workflow interview will be completed by a total of up to 248 persons (about 12 per practice) and requires one hour. Up to four observations will be conducted for up to 248 persons and they are each estimated to take two hours. Ten usage logs will be completed by a total of up to 248 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 248 persons and requires one hour. The total annual burden is estimated to be 3,100 hours or 155 hours per practice or Regional Extension Center. 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 $96,100. Exhibit 1—Estimated Annualized Burden Hours
Data collection
Number of 
                             respondents
Number of respoonses per 
                             respondent
Hours per 
                             response
Total burden hoursPre-Workflow Toolkit Interview
248
1
1
248Observations
248
4
2
1,984Usage Logs
248
10
15/60
620Post-Workflow Toolkit Interview
248
1
1
248Total
992
NA
NA
3,100
 Exhibit 2—Estimated Annualized Cost Burden
Data collection
Number of
                             respondents
Total burden hours
Average
                             hourly wage 
                             rate*
Total cost
                             burdenPre-Workflow Toolkit Interview
248
248
$31.00
$7,688Observations
248
1,984
31.00
61,504Usage Logs
248
620
31.00
19,220Post-Workflow Toolkit Interview
248
248
31.00
7,688Total
992
147
NA
96,100* 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 costProject Management and Coordination Activities
$96,449
$42,866Develop Research and Recruitment Plans
78,383
34,837Compliance with PRA
12,267
5,452Obtaining IRB approval
10,254
4,557Develop Data Analysis Plan
18,246
8,109Conduct Evaluation
534,401
237,512Data analysis and Final Report
23,554
10,468Ensure 508-compliant deliverables
19,902
8,845Total
793,456
352,646* Costs are fully loaded including overhead and G&A.
 
 
 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: February 29, 2012. Carolyn M. Clancy, Director.


[FR Doc. 2012-5574 Filed 3-8-12; 8:45 am] BILLING CODE 4160-90-M