Attachment I -- Federal Register Notice

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES

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National Committee on Vital and Health
Statistics: Meeting Standards
Subcommittee
Pursuant to the Federal Advisory
Committee Act, the Department of
Health and Human Services (HHS)
announces the following advisory
committee meeting.
Name: National Committee on Vital
and Health Statistics (NCVHS)
Subcommittee on Standards.
Time and Date: February 27, 2013
9:30 a.m.–5:00 p.m. EST
Place: U.S. Department of Health and
Human Services, HHS, 200
Independence Ave, SW., Room 705–A,
Washington, DC 20201, (202) 690–7100.
Status: Open
Purpose: The purpose of the meeting
is to learn about the current state of
standards and operating rules for
electronic claims attachments. In
accordance with the Health Insurance
Portability and Accountability Act of
1996 (HIPAA) and the Affordable Care
Act of 2010 (ACA), the Department of
Health and Human Services (HHS) must
adopt a standard and operating rules for
electronic claims attachments. The
National Committee on Vital Health
Statistics is the public advisory body to
the Secretary of HHS and will make
recommendations based on information
gleaned at the hearing. The SubCommittee is interested in evaluating
the innovations underway in industry as
the convergence occurs between the
clinical and administrative information
exchanges, and industry moves from a
claim-centric, transaction-based
administrative information
infrastructure to quality-oriented and
outcomes-based reporting.
Contact Person for More Information:
Marjorie S. Greenberg, Executive
Secretary, NCVHS, National Center for
Health Statistics, Centers for Disease
Control and Prevention, 3311 Toledo
Road, Room 2402, Hyattsville, Maryland
20782, telephone (301) 458–4245 or
Lorraine Doo, lead staff for the
Standards Subcommittee, NCVHS,
Centers for Medicare and Medicaid
Services, Office of E-Health Standards
and Services, 7500 Security Boulevard,
Baltimore, Maryland, 21244, telephone
(410) 786–6597. Program information as
well as summaries of meetings and a
roster of committee members are
available on the NCVHS home page of
the HHS Web site: http://
www.ncvhs.hhs.gov/, where further
information including an agenda will be
posted when available.

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Should you require reasonable
accommodation, please contact the CDC
Office of Equal Employment
Opportunity on (301) 458–4EEO (4336)
as soon as possible.
Dated: December 21, 2012.
James Scanlon,
Deputy Assistant Secretary for Planning and
Evaluation, Office of the Assistant Secretary
for Planning and Evaluation.
[FR Doc. 2013–00011 Filed 1–4–13; 8:45 am]
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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 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: ‘‘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.
This proposed information collection
was previously published in the Federal
Register on October 31st, 2012 and
allowed 60 days for public comment. No
public 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 February 6, 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
[email protected]
(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 [email protected].
SUPPLEMENTARY INFORMATION:
SUMMARY:

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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 indepth 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
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 sociotechnical 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

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Federal Register / Vol. 78, No. 4 / Monday, January 7, 2013 / Notices
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 communitybased 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
ERR, 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 athome 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 mixedmethods, 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,

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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,

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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
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

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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 matureMHT 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-MI–IT
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 earlyMHT clinics, during the initial, middle,
and final observation periods, for up to
36 staff interviews across the two earlyMHT 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.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Maximum
number of respondents

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Form name
Project orientation meeting ..............................................................................
Staff Semi-Structured Interviews .....................................................................
Technology Acceptance Model Survey ...........................................................
Patient Semi-Structured Interviews .................................................................
Patient Activation Measures Survey ................................................................

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Number of responses per
respondent

60
36
36
64
64

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1
a 2.33
a 2.33

1
1

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Hours per response
30/60
1
30/60
1
12/60

Total burden
hours
30
84
42
64
13

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Federal Register / Vol. 78, No. 4 / Monday, January 7, 2013 / Notices
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Maximum
number of respondents

Form name

Number of responses per
respondent

Hours per response

Total burden
hours

Summary of Diabetes Self Care Activities Survey ..........................................

64

1

18/60

19

Total ..........................................................................................................

324

na

na

252

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
Maximum
number of respondents

Form name
Project orientation meeting ..............................................................................
Staff Semi-Structured Interviews .....................................................................
Technology Acceptance Model Survey ...........................................................
Patient Semi-Structured Interviews .................................................................
Patient Activation Measures Survey ................................................................
Summary of Diabetes Self Care Activities Survey ..........................................

Total burden
hours

60
36
36
64
64
64
324

Average hourly wage rate *

Total cost burden

$34.80
32.03
32.03
16.57
16.57
16.57
na

$1,044
2,691
1,345
1,060
215
315
6,670

30
84
42
64
13
19
252

* Based upon the mean of the average wages, 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 *
Cost component

Total cost

Annualized
cost

Development of Research Plan ...............................................................................................................................
Development of Analysis Plan .................................................................................................................................
Compliance with PRA Requirements ......................................................................................................................
Conduct Research Study .........................................................................................................................................
Conduct Data Analysis ............................................................................................................................................
Develop Final Report of Findings ............................................................................................................................
Develop Presentation of Findings ...........................................................................................................................
Project Administration ..............................................................................................................................................
Coordination with Other AHRQ Offices and Contractors ........................................................................................
Ensure High Quality 508 Compliant Deliverables ...................................................................................................

$32,520
24,028
21,252
271,916
279,009
62,237
28,670
58,976
15,195
6,125

$10,840
8,009
7,084
90,639
93,003
20,746
9,557
19,659
5,065
2,042

Total ..................................................................................................................................................................

799,929

266,643

* Costs are fully loaded including overhead and G&A.

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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

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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

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proposed information collection. All
comments will become a matter of
public record.
Dated: December 20, 2012.
Carolyn M. Clancy,
Director.
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