```

[Federal Register Volume 78, Number 74 (Wednesday, April 17, 2013)]
[Notices]
[Pages 22880-22883]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-08833]

=======================================================================
-----------------------------------------------------------------------

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 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.

[[Page 22881]]

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 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

[[Page 22882]]

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              na              na             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              na           5,505
----------------------------------------------------------------------------------------------------------------
*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
----------------------------------------------------------------------------------------------------------------
                             Cost component                                   Total cost        Annualized cost
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------

[[Page 22883]]

 
    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: April 4, 2013.
Carolyn M. Clancy,
Director.
[FR Doc. 2013-08833 Filed 4-16-13; 8:45 am]
BILLING CODE 4160-90-M
```