Agency Information Collection Activities: Proposed Collection; Comment Request, 5807-5810 [2013-01345]

Download as PDF 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.’’ http://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 VerDate Mar<15>2010 17:13 Jan 25, 2013 Jkt 229001 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 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 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: E:\FR\FM\28JAN1.SGM 28JAN1 5808 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 VerDate Mar<15>2010 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 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 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 E:\FR\FM\28JAN1.SGM 28JAN1 5809 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, 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. tkelley on DSK3SPTVN1PROD with EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST Cost component Total cost Project Development ....................................................................................................................................... Data Collection Activities ................................................................................................................................. VerDate Mar<15>2010 17:13 Jan 25, 2013 Jkt 229001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\28JAN1.SGM 28JAN1 $135,759 177,460 Annualized cost $45,253 59,153 5810 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: VerDate Mar<15>2010 17:13 Jan 25, 2013 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. Jkt 229001 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 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 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 E:\FR\FM\28JAN1.SGM 28JAN1

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, 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
------------------------------------------------------------------------
           Cost component                Total cost      Annualized cost
------------------------------------------------------------------------
Project Development.................          $135,759           $45,253
Data Collection Activities..........           177,460            59,153

[[Page 5810]]

 
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