[Federal Register Volume 77, Number 211 (Wednesday, October 31, 2012)]
[Notices]
[Pages 65888-65892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-26596]


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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: ``Using Health Information Technology in Practice Redesign: 
Impact of Health Information Technology on Workflow.'' 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 December 31, 2012.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, by email at 
[email protected].
    Copies of the proposed collection plans, data collection 
instruments, and specific details on the estimated burden can be 
obtained from the AHRQ Reports Clearance Officer.

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports 
Clearance Officer, (301) 427-1477, or by email at 
[email protected].

SUPPLEMENTARY INFORMATION: 

Proposed Project

Using Health Information Technology in Practice Redesign: Impact of 
Health Information Technology on Workflow

    The Agency for Healthcare Research and Quality (AHRQ) is a lead 
Federal agency in developing and disseminating evidence and evidence-
based tools on how health information technology (IT) can improve 
health care quality, safety, efficiency, and effectiveness.
    Health IT has the potential to improve the quality, safety, 
efficiency, and effectiveness of care. In particular, health IT can aid 
health care professionals in improving care delivery by redesigning 
care processes to be more effective and efficient (e.g., engaging care 
settings in practice redesign). The use of health IT to support 
practice redesign requires a deep understanding of the interaction 
between health IT and workflow, ideally through a human factors and 
socio-technical framework. Unfortunately, these health IT-workflow 
interactions are poorly understood and the research to date has largely 
focused on large academic medical centers and large health maintenance 
organizations, while the impact of health IT on workflow in smaller, 
ambulatory care practices is not well studied.
    To that end, AHRQ conducted an in-depth study of existing research 
and evidence in the area of the impact of health IT on workflow, its 
linkage to clinician adoption, and its links to the safety, quality, 
efficiency, and effectiveness of care delivery. However, most of the 
articles found were not

[[Page 65889]]

focused directly on workflow, so the quality of evidence related to 
workflow change varied substantially. The majority of studies described 
research completed in large clinics affiliated with academic medical 
centers, health maintenance organizations or national health systems 
outside the U.S., limiting applicability to other settings, 
particularly small and medium-sized primary care and other ambulatory 
care settings. Also, most of the studies did not use a scientifically 
rigorous design. Finally, most of the literature did not include 
descriptions of the socio-technical context of health IT 
implementations and use, making it difficult to understand the role of 
potentially conflating or mediating factors such as training, technical 
support, and organizational culture.
    These gaps and limitations of existing research study designs and 
findings related to health IT and workflow limit the relevance and 
quality of the available evidence for health care organizations wishing 
to effectively implement health IT systems to support current work 
without negatively affecting existing workflow processes. The existing 
evidence is of equally limited utility to those organizations seeking 
to use health IT systems to support redesign of their ambulatory care 
settings.
    The goal of the project is to understand the impact of implementing 
health IT-enabled care coordination on workflow within small community-
based primary care clinics in various stages of practice redesign. The 
focus of this study is the interaction of health IT and care 
coordination workflow in the context of practice redesign. This study 
will focus on clinic staff caring for patients with diabetes within 
small primary care clinics to understand enablers and barriers to care 
coordination workflow through the use of health IT.
    The study will be conducted over a 14-month period in six 
Vanderbilt University Medical Center (VUMC) affiliated-clinics that 
each have an electronic health record (EHR) but are in different phases 
of introducing the health IT component of a care coordination redesign 
program called My Health Team (MHT). MHT was launched at Vanderbilt 
University Medical Center to redesign ambulatory care delivery for 
patients with three chronic conditions (diabetes, hypertension, and 
congestive heart failure) through intensified patient engagement, 
dedicated care coordinators, and specific health IT tools to facilitate 
scalable chronic disease management. The health IT component of MHT, 
layered on a mature EHR, enables (1) diabetes, hypertension and 
congestive heart failure registries, (2) a shared view of the care plan 
for the patient among clinical staff, (3) alerts and reminders to track 
patients' acute care episodes, (4) closed-loop feedback of patient 
self-management through at-home physiological monitoring and two-way 
electronic clinical messaging (via the patient portal), and (5) 
frequent patient contact with coordinators in between physician visits 
by telephone and using a secure patient portal.
    This study is intended to address existing gaps and generate 
findings of particular relevance to health IT and workflow by employing 
a mixed-methods, theoretically-grounded research design that focuses on 
the socio-technical factors in smaller, ambulatory care settings.
    Combining this formal approach with iterative observations and 
analysis across six clinics for 14 months will generate a detailed 
understanding of changes in health IT workflow interaction for each 
clinic over time, and across clinics in various implementation phases 
(pre-MHT, early-MHT, or mature-MHT). Each clinic will be observed at 
two time points: the first (time = 0 months) to capture baseline 
interactions, and the second (time = 12 months) to capture interactions 
later in adoption. Although each clinic will be observed over a period 
of 12 months, the total study period will span 14 months to allow for 
staggered observation windows for the clinics. All clinics are 
anticipated to exhibit changes to health IT-workflow interactions over 
time given that learning and efforts to streamline workflow at each 
practice are ongoing. The early-MHT clinics, engaged actively in 
practice redesign, will be observed at a third time point--midway 
between the first and second observation period--since more changes, 
and possibly more rapid changes in workflow and the use of health IT 
could occur. The 6-month interval between observation periods was 
chosen based on prior experience with MHT implementation in which many 
adoption changes occur during a 3-5 month period during practice 
redesign. Thus, in clinics anticipated to experience slower change, an 
observation period of one year is anticipated to allow capture of 
workflow patterns that have occurred; in fast-changing clinics, a 6-
month observation interval will improve capture of key interactions.
    This study is being conducted by AHRQ through its contractor, RTI 
International, 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 quality measurement and improvement. 42 U.S.C. 299a(a)(1) 
and (2).

Method of Collection

    To achieve the goals of this project the following activities will 
be carried out:
    (1) Project orientation meeting--Researchers will hold an 
orientation meeting for clinic staff to introduce them to the study. Up 
to ten staff members at each clinic will be asked to participate in the 
orientation meetings. During the orientation meeting, research staff 
will explain the purpose of the study, provide an overview of the study 
schedule, explain processes for recruiting individual clinic staff to 
participate, and answer any questions that clinic staff might have.
    (2) Direct observation by researchers of clinic staff performing 
care coordination activities with patients, caregivers, and providers 
to capture their workflow, health IT usage, and work processes. A total 
of 14 observation periods will take place across the six clinics. Each 
site will have an initial observation period that occurs over several 
weeks, with an estimated 60 hours of observation time per site. The two 
sites in the early MHT phase of implementation will also have a middle 
observation period (at 6 months), and all six sites will have a final 
observation period (at 12 months). The middle and final observation 
periods, which build on data gathered during the initial observation 
period, are shorter--approximately 30 hours of observation per site, 
because observations will be more targeted as a result of the 
previously collected contextual data. Observations will be recorded on 
the Direct Observation Field Notes Form. This data collection will not 
burden the clinic staff and is not included in the burden estimates in 
Exhibit 1.
    (3) Artifact and spatial data collection--Artifacts such as paper 
notes or forms, or reminder postcards identified by researchers during 
direct observations as relevant to understanding workflow and health 
IT, will be collected.
    Spatial data, such as still photographs of the workplace and/or 
objects in the workplace, will be collected to augment observation 
data. These will enable the researcher to capture spatial relationships 
and other dimensions, such as the proximity of work stations, exam 
rooms, and technology. For

[[Page 65890]]

example, a health IT tool may include the functionality to print 
information to give to the patient, but if the printer is not 
conveniently located for the user, busy clinic staff may choose not to 
use this function. An image or drawing of this spatial relationship can 
be included in the data and will be coded in the data analysis phase. 
The choice of using a photograph or a drawing will be dependent upon 
the type of information that is needed to better understand the context 
of the workflow. For example, to capture the overall configuration of 
the workspace, photographs will be taken. When other information such 
as process flows are being captured, the observer will draw a sketch of 
that process. This may include the steps that a nurse takes to retrieve 
a patient chart, call the patient from the waiting room, escort the 
patient to a station where vital signs are measured, and escort them to 
an exam room.
    Artifacts and spatial data will be used to enrich the understanding 
of the environment in which care coordination activities and health IT 
interact and will add information that is important for modeling 
workflow. This data collection will not burden the clinic staff and is 
not included in the burden estimates in Exhibit 1.
    (4) Semi-structured individual interviews and surveys with clinic 
staff to further understand their use of health information technology 
and work routines. During each observation period, up to six staff 
members at each clinic will be asked to participate in semi-structured 
interviews and to complete the Technology Assessment Model (TAM) 
survey. The interview will address up to five key topic areas: 
Demographics; general experience with technology; work routines; 
interactions with computers in the work context; and strategies for 
dealing with unanticipated health IT or workflow challenges. The survey 
will be used to consistently assess the staff attitudes that may impact 
their experience of using health IT and adapting workflow to their 
needs.
    (5) Semi-structured interviews and surveys with patients with 
diabetes to gather information from patients as participant-observers 
of clinical workflow and health IT, to understand the impact of work 
processes on their experience of care, and to identify enablers and 
barriers in clinic work processes from their perspective. During the 
initial observation period in each clinic, and during the final 
observation period in two of the clinics (early-MHT), eight patients 
with diabetes will be invited to participate in semi-structured 
interviews and to complete the Patient Activation Measure and Summary 
of Diabetes Self-Care Activities surveys (64 patients total). Since 
fewer changes are anticipated in the pre-MHT and mature-MHT clinics, 
patients will be interviewed at baseline only in these four clinics. 
Since the pre-MHT and mature-MHT clinics will not undergo changes in 
technology during the study period, it is anticipated that saturation 
of patient experiences and observations of workflow, technology use and 
interactions will occur during the initial observation period. Greater 
changes are anticipated at the early-MHT clinics as they adopt MHT, 
therefore, patient interviews will be conducted at these two clinics 
twice. The purpose of the patient interviews is to gather information 
from patients as participant-observers of clinical workflow and health 
IT, to understand the impact on their experience of care, and to 
identify enablers and barriers in work processes from their 
perspective. The interviews will address six key areas related to care 
coordination, including (1) general care experience; (2) patient 
workflow; (3) information needs; (4) barriers; (5) strategies; (6) 
evaluation. The Patient Activation Measure (PAM) and Summary of 
Diabetes Self-Care Activities (SDSCA) surveys will be used to 
understand patient motivation for self-care and the potential impact on 
care processes and workflows.
    The focus of this research is anticipated to be relevant to many 
other settings in which health IT is used to support care coordination 
activities for diabetes and other chronic conditions. This focus is 
especially important given the cost and illness burden of diabetes. 
Information collected by the study will help researchers and 
practitioners better understand the impact of workflow and health IT in 
ambulatory care practices.
    The lessons learned from this research may be used in a variety of 
ways: 1) to identify additional workflow components that ambulatory 
practices should consider when implementing health IT systems; 2) to 
identify issues to address in best practice guidelines health IT 
implementation; and 3) to identify issues for consideration in the 
design and evaluation of other health IT tools.
    The study findings will be widely disseminated to health IT 
researchers and implementers via AHRQ's National Resource Center for 
Health IT Web site, email alerts, and conference presentations.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annual burden hours for each 
respondent's time to participate in this study.
    A total of up to 60 persons will participate in the project 
orientation meeting across the six clinics (up to 10 per clinic), which 
will last up to 30 minutes.
    The staff semi-structured interviews will be completed by a total 
of up to 36 persons across the six clinics (up to 6 per clinic) and 
requires one hour. Those same individuals will also be asked to 
complete Technology Acceptance Model surveys; each survey response is 
estimated to take 30 minutes. Clinic staff interviews and 
administration of surveys will take place at the clinics either two or 
three times. Staff interviews will be conducted twice at each of the 
pre-MHT and mature-MHT clinics, at the initial and final observation 
periods (eight total sets of interviews), for a total of up to 48 staff 
interviews. Staff interviews will be conducted three times at the two 
early-MHT clinics, during the initial, middle, and final observation 
periods, for up to 36 staff interviews across the two early-MHT clinics 
for all observation periods. In total, up to 84 interviews of clinic 
staff will be conducted with up to 36 individual staff for an average 
of 2.33 responses per staff member, as shown in Exhibit 1.
    Up to 64 patients will be asked to participate in the patient-semi 
structured interview, which should take no longer than 1 hour. Those 
same patients will be asked to complete the Patient Activation Measures 
survey, which is estimated to take 12 minutes, and the Summary of 
Diabetes Self Care Activities survey, which should take no longer than 
18 minutes. Patient interviews and surveys will take place at the 
clinics either once or twice. Up to eight patients will be interviewed 
during the initial observation period at each of the clinics for a 
total of 48 patient interviews across all six clinics. Up to 8 patients 
will be interviewed during the final observation period at each of the 
two early-MHT clinics, for a total of 16 patient interviews during the 
final observation period across the two early-MHT clinics. In total, up 
to 64 patient interviews and surveys will be conducted. The total 
annual burden is estimated to be 252 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 $6,670.

[[Page 65891]]



                                  Exhibit 1--Estimated Annualized Burden Hours
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                                                      Maximum        Number of
                    Form Name                        number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
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Project orientation meeting.....................              60               1           30/60              30
Staff Semi-Structured Interviews................              36        \a\ 2.33               1              84
Technology Acceptance Model Survey..............              36        \a\ 2.33           30/60              42
Patient Semi-Structured Interviews..............              64               1               1              64
Patient Activation Measures Survey..............              64               1           12/60              13
Summary of Diabetes Self Care Activities Survey.              64               1           18/60              19
                                                 ---------------------------------------------------------------
    Total.......................................             324              na              na            252
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\a\ This is an average based on the study design and the number of interviews that respondents will complete.
  Two thirds of respondents will participate in two interviews. One third will participate in three interviews.


                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                      Maximum                         Average
                    Form Name                        number of     Total burden     hourly wage     Total cost
                                                    respondents        hours           rate*          burden
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Project orientation meeting.....................              60              30          $34.80          $1,044
Staff Semi-Structured Interviews................              36              84           32.03           2,691
Technology Acceptance Model Survey..............              36              42           32.03           1,345
Patient Semi-Structured Interviews..............              64              64           16.57           1,060
Patient Activation Measures Survey..............              64              13           16.57             215
Summary of Diabetes Self Care Activities Survey.              64              19           16.57             315
                                                 ---------------------------------------------------------------
                                                             324             252              na           6,670
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* Based upon the mean of the average wages, a National Compensation Survey: Occupational wages in the United
  States May 2011, ``U.S. Department of Labor, Bureau of Labor Statistics.'' For the project orientation
  meeting, the hourly rate is a weighted average of two physicians or surgeons, all other ($88.78), two
  registered nurses ($33.32), two licensed practical nurses ($19.79), two medical assistants ($13.99), one
  health care support worker other ($14.80), and one health care practitioners and technician other ($21.61).
  For the interviews and surveys with clinic staff, hourly wage is an average including one physician or
  surgeon, all other ($88.78), one registered nurse ($33.32), one licensed practical nurse ($19.79), one medical
  assistant ($13.99), one health care support worker other ($14.80), and one health care practitioners and
  technician other ($21.61). For patient interviews and surveys, median U.S. hourly wage was used.

Estimated Annual Costs to the Federal Government

    The total cost of this study is $799,929 over a 36-month time 
period for an annualized cost of $266,643. Exhibit 3 provides a 
breakdown of the estimated total and average annual costs by category.

             Exhibit 3--Estimated Total and Annualized Cost*
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                                                            Annualized
             Cost component                 Total  cost        cost
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Development of Research Plan............         $32,520         $10,840
Development of Analysis Plan............          24,028           8,009
Compliance with PRA Requirements........          21,252           7,084
Conduct Research Study..................         271,916          90,639
Conduct Data Analysis...................         279,009          93,003
Develop Final Report of Findings........          62,237          20,746
Develop Presentation of Findings........          28,670           9,557
Project Administration..................          58,976          19,659
Coordination with Other AHRQ Offices and          15,195           5,065
 Contractors............................
Ensure High Quality 508 Compliant                  6,125           2,042
 Deliverables...........................
                                         -------------------------------
    Total...............................         799,929        266,643
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* 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 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 automated collection techniques or 
other forms of information technology.

[[Page 65892]]

    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: October 12, 2012.
Carolyn M. Clancy,
Director.
[FR Doc. 2012-26596 Filed 10-30-12; 8:45 am]
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