[Federal Register Volume 78, Number 30 (Wednesday, February 13, 2013)]
[Notices]
[Pages 10175-10178]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03217]
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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: ``Patient-Reported Health Information Technology and
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 April 15, 2013.
ADDRESSES: Written comments should be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by email at
doris.lefkowitz@AHRQ.hhs.gov.
Copies of the proposed collection plans, data collection
instruments, and specific details on the estimated burden can be
obtained from the AHRQ Reports Clearance Officer.
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by email at
doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
Proposed Project
Patient-Reported Health Information Technology and Workflow
Health IT can improve quality of care by arraying relevant
information, displaying clinical guidelines, highlighting test values
of concern, calculating medication doses, and supporting clinical
decisionmaking in many ways (Chaudhry et al., 2006). Successful health
IT implementation requires careful attention to the workflow of
clinicians and others involved in care delivery. However, few studies
have examined how health IT can change workflow in ambulatory physician
practices. Further, in most studies that address health IT in
ambulatory settings, workflow is not the main focus of the research
(Unertl, Weinger, Johnson et al., 2009, Carayon, Karsh, Cartmill et
al., 2010a). The health IT literature has not focused on sociotechnical
factors, such as patient or provider characteristics, physical
environment and layout; technical training and support; functionality
and usability of health IT; worker roles, staff workload, stress, and
job satisfaction; and communication flows. Important work that does
address such factors comes mainly from inpatient settings, or from
other countries where the health care system is quite different than in
the U.S. (Tjora and Scambler, 2009; Ammenwerth, Iller, and Mahler,
2006; Niazkhani, Pirnejad, de Bont et al., 2008; Niazkhani, Pirnejad,
Berg et al., 2009). Although many of these studies have concluded that
changes in workflow occur when implementing different health IT
applications, few studies have actually examined how workflow changes.
In recent years there has been an increase in the use of health IT
to capture patient reporting of medical histories, symptoms, results of
self-testing (e.g., blood glucose levels, blood pressure), weight
questions and concerns, over-the-counter medication use, and other
information that patients need to share with their care providers.
Health IT can elicit such information from patients, and help
incorporate it into the flow of information within a physician's
practice so that the information is detailed, actionable, timely, and
can be used to meet patients' treatment goals. Gathering and
integrating information from patients using health IT can include
patient surveys and other pre-formatted information collection
mechanisms (e-forms), secure messaging (email) between patients and
their providers (Byrne, Elliott, and Firek, 2009; Bergmo, Kummervold,
Gammon et al., 2005); and patient portals (sometimes referred to as
[electronic] personal health records or PHRs, patient portals allow
patients to view portions of their medical records [e.g., view
laboratory test results] and support other health-related tasks such as
making appointments or requesting medication refills). The use of
patient-reported information is not yet widely integrated into health
IT.
This project will fill the gaps in the current literature by
exploring the influence of sociotechnical factors--for clinicians and
their office staff, and for patients--in capturing and using patient-
reported information in ambulatory health IT systems and associated
workflows. The goal of the project is to answer the following research
questions:
How does the use of health IT to capture and use patient-
reported information support or hinder the workflow from the viewpoints
of clinicians, office staff, and patients?
How does the sociotechnical context influence workflow
related to
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the capture and use of patient-reported information?
How do practices redesign their workflow to incorporate
the capture and use of patient-reported information?
The study will consist of rigorous mixed-methods case studies of
six ambulatory care physician practices including three small practices
(1-3 physicians and the other clinicians and office staff in their
practices) and three medium-sized practices (4-10 physicians, and the
other clinicians and office staff in their practices). These case
studies will be conducted during multiday (3 to 4 days) site visits to
collect information for this exploratory research. The multiple case
study research approach of Eisenhardt and colleagues (Brown &
Eisenhardt, 1997; Eisenhardt, 1989) will guide data collection and data
analysis, to elucidate health IT workflows and important sociotechnical
factors (for patients, clinicians, and office staff) in the capture and
use of patient-reported information.
A focus of the case studies will be to identify current workflows
related to patient-reported information, and determine the work system
factors that influence workflows (barriers and facilitators). In
particular, data collected from the six practices will help identify
bottlenecks and sources of delay, unnecessary steps or duplication,
rework to correct errors or inconsistencies, role ambiguity, missing
information, and lack of data quality controls or reconciliation of
inconsistencies. The focus is not on the content of information
reported by patients, or how it alters clinicians' diagnostic or
treatment decisions. Rather, the focus is on the workflows required to
capture, process, and make use of information that patients report to
their care providers.
This study is being conducted by AHRQ through its contractor, Abt
Associates Inc., and subcontractors University of Wisconsin-Madison and
University of Alabama-Birmingham, 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
health care technologies and the quality, effectiveness, efficiency,
appropriateness and value of health care services including quality
measurement and improvement. 42 U.S.C. 299a(a)(1), (2) and (5).
Method of Collection
To achieve the goal of this project the following activities will
be conducted at each of six participating ambulatory physician
practices (referred to herein as `study sites'):
(1) Preliminary Conference Call: The Practice Manager (the
individual in each practice who manages day-to-day operations) and the
Physician Leader (the physician in each practice who is most
knowledgeable about health IT and health IT implementation) will be
asked to participate in a preliminary conference call to learn about
the study site and what will be expected of their practice as a study
site. This call will last approximately one hour and will be completed
by up to 2 participants per site for a total of up to 12 participants
across sites.
(2) Pre-Visit Questionnaire: The Practice Manager will be asked to
complete a brief questionnaire prior to the site visit, describing the
practice size, health IT installed, patient population served, and
other general contextual information about the practice and use of
health IT. The Pre-Visit Questionnaire will take approximately one hour
to complete and will be completed by up to one respondent per study
site.
(3) Practice Tour: Each of the six site visits will begin with a
one-hour tour of the practice and discussion with the Practice Manager
to observe the physical layout and computer work stations, clarify the
purpose of the study and the site visit, and clarify information from
the Pre-Visit Questionnaire.
(4) Interviews with Practice Manager and Physician Leader:
Following the tour at each study site, the Practice Manager and
Physician Leader will be asked to participate in a one hour interview.
The interview with the Practice Manager will focus on the
sociotechnical context of the practice, with an emphasis on the social
context of the practice. The interview with the Physician Leader will
also focus on the sociotechnical context of the practice, and, in
particular, the technical aspects of clinicians using the health IT
system. The focus will be on the workflow across the practice, not the
workflow of these two individuals. This information will be used to
create the basic outline or structure of a Workflow Process Map(s), a
diagram that shows the temporal sequencing of tasks in relation to
other work system elements (person, organization, environment, and
tools and technologies). It will also be used to begin to identify
potential variation or flexibility in individuals' workflows, and
provide context regarding multiple IT systems that may be in use in the
practice. The information obtained from these interviews will be
augmented by observation of workflows in the practice and interviews
with others in the practice, as described in 5 and 6.
(5) Observations of Clinicians and Office Staff: Researchers will
observe between 7 to 20 clinicians (including physicians, nurse
practitioners, physician assistants, nurses, medical assistants, and
ancillary staff) and between 3 to 7 office staff (including the front
desk receptionist, IT staff, clerks, and other non-clinical staff) per
study site, depending on site size for a total of up to 81 clinicians
and up to 30 office staff observations across the study sites.
Observations will take place as clinicians and office staff work to
elicit, integrate and work with patient-reported information. Each
clinician will be observed for up to two hours and each office staff
person will be observed for up to 30 minutes. These observations
periods are different because clinicians' work is more complex and
varies more from one patient to the next, while office staff work
varies less. Observations will focus on processes, bottlenecks,
facilitators, workarounds, and points in the workflow when paper
information supplements electronic information. Observations of both
clinicians and office staff will be recorded on the Observation Form.
The observations will be used to create a detailed Workflow Process
Map(s). This data collection will not burden the clinic staff and is
not included in the burden estimates in Exhibit 1.
(6) Interviews with Clinicians and Office Staff: Following
observations of the workflow, each clinician and office staff person
who was observed will be interviewed for up to one hour, for a total of
up to 81 clinicians and up to 30 office staff interviews. If there are
more clinicians or office staff than can be interviewed during the site
visit, those with the most extensive experience with patient-reported
information will be selected for interviews. These interviews will
include discussion about the sociotechnical context, the workflow
observed (see above), facilitators and barriers to capturing and using
patient-reported information, and whether there are uncommon workflow
patterns that arise occasionally but were not observed. Unlike the
interviews with the Physician Leader and Practice Manager, these
interviews will focus on the workflow of each individual, not the
workflow across the entire practice. The same interview guide will be
used for both clinician and office staff interviews.
(7) Survey of Clinicians and Office Staff: All clinicians and
office staff in the six study sites will be invited to respond to a
survey. Although there may not be sufficient time on site to
[[Page 10177]]
observe and interview every clinician and office staff person in the
medium-sized practices, all of them will be asked to complete the
survey questionnaire. Therefore, the number of survey respondents is
greater than the number of observed and interviewed individuals. Up to
10 surveys will be completed at each small-sized study site and up to
35 surveys will be completed at each medium-sized study site, for a
total of up to 135 respondents across the six sites. The surveys will
be used to collect data regarding attitudes about and perceptions of
the health IT workflows staff engage in related to patient-reported
information and the impact of health IT on workload, stress, and job
satisfaction, because workflow can impact workload and job satisfaction
which have been shown to impact quality of care. The survey will also
be used to collect data on barriers and facilitators associated with
capturing and using patient-reported information.
(8) Patient Interviews: Patients will be interviewed to understand
the workflow of entering or reporting information from the patient's
perspective; the extent and adequacy of training or instruction
patients received in using the health IT; attitudes about the time it
takes to report information; and whether there are challenges,
barriers, facilitators, or workarounds commonly used by patients as
they report information requested by their care providers. Five
patients will be interviewed at each small practice and up to seven at
each medium-sized practice, for a total of up to 36 across the six
study sites. More patients will be interviewed in the medium-sized
practices because there are more clinicians in these practices, and
each may have different patterns of interacting with their patients.
Interviewing more patients will enhance the ability to capture
information about variation in the clinician-patient information
sharing and interaction. These interviews will help researchers
understand the range of patient experiences.
(9) Post-Visit Follow-up to Review the Workflow Process Map(s):
Following each site visit, researchers will complete the Workflow
Process Map(s) for the study site and send it to the Practice Manager
and Physician Leader, requesting confirmation that the understanding of
their workflows is correct.
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 to capture and
use patient-reported information;
(2) To identify issues relevant to best practice guidelines for
health IT implementation;
(3) To identify issues for consideration in the design and
evaluation of other patient-centered 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. The study will enhance the existing knowledge about
sociotechnical factors that impact health IT workflow, and how small
and medium-sized ambulatory practices employ health IT to capture and
use patient-reported information as they redesign their workflow to
deliver patient-centered care.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated annual burden hours for the
respondents' time to participate in this research. The Preliminary
Conference Call with each site will involve two people, the Practice
Manager and the Physician Leader, and will require up to one hour per
site. A total of 12 people across the six study sites will be involved.
The Pre-Visit Questionnaire and the Practice Tour will be completed by
the Practice Manager at each site and will require up to one hour each.
The Practice Manager and the Physician Leader at each site (12
individuals in total across the 6 sites) will be separately interviewed
to gather in depth information about the sociotechnical context of the
practice. The interviews will each take up to one hour to complete.
Interviews with Clinicians and Office Staff will be completed with a
maximum of 111 clinicians and office staff across the six study sites,
and each interview will last up to one hour. A maximum of 135
clinicians and office staff combined (up to 10 for each of three small-
sized sites and 35 for each of 3 medium-sized sites) will be asked to
complete the clinician and office staff survey, which will take
approximately 15 minutes for each respondent to complete. Up to 36
patients will be interviewed (5 in each of the small sites and up to 7
in each of the medium-sized sites). Each interview will take no more
than 30 minutes to complete. A total of 12 persons (the Practice
Manager and the Physician Leader at each site) will be involved in the
Post-Visit Follow-up to Review the Workflow Process Map(s), which will
take one hour. The total annual burden hours, is estimated to be 211
hours.
Exhibit 2 shows the estimated annual cost burden associated with
the study sites' time to participate in the research. The total annual
cost burden is estimated to be $11,031.
Exhibit 1--Estimated Annualized Burden Hours
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Number of
Form name Number of responses per Hours per Total burden
respondents respondent response hours
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Preliminary Conference Call..................... 12 1 1 12
Pre-Visit Questionnaire......................... 6 1 1 6
Practice Tour................................... 6 1 1 6
Interviews with Practice Manager and Physician 12 1 1 12
Leader.........................................
Interviews with Clinicians and Office Staff..... 111 1 1 111
Survey of Clinicians and Office Staff........... 135 1 15/60 34
Patient Interviews.............................. 36 1 30/60 18
Post Visit Follow-up to Review the Workflow 12 1 1 12
Process Map(s).................................
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Total....................................... 330 N/A N/A 211
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[[Page 10178]]
Exhibit 2--Estimated annualized burden hours
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Average
Form name Number of Total burden hourly wage Total cost
respondents hours rate* burden
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Preliminary Conference Call..................... 12 12 \a\$67.15 $806
Pre-Visit Questionnaire......................... 6 6 \b\46.17 277
Practice Tour................................... 6 6 \b\46.17 277
Interviews with Practice Manager and Physician 12 12 \a\67.15 806
Leader.........................................
Interviews with Clinicians and Office Staff..... 111 111 \c\55.00 6,105
Survey of Clinicians and Office Staff........... 135 34 \d\45.98 1,563
Patient Interviews.............................. 36 18 \e\21.74 391
Review of the Workflow Process Map(s)........... 12 12 \a\67.15 806
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Total....................................... 330 196 N/A 11,031
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\*\ Based upon the mean of the average hourly wages, National Compensation Survey: Occupational wages in the
United States May 2011, ``U.S. Department of Labor, Bureau of Labor Statistics.''
\a\ The average wage for Practice Managers ($46.17 per hour) and Physician Leaders ($88.12 per hour) [$88.12
reflects the average for Family and General Practitioners ($85.26 per hour) and Internists, General ($90.97
per hour)].
\b\ The average U.S. wage for Practice Managers is $46.17 per hour.
\c\ The weighted average wage for physicians ($88.12 per hour) [$88.12 reflects the average for Family and
General Practitioners ($85.26 per hour) and Internists, General ($90.97 per hour)], nurse practitioners and
physician assistants ($41.63 per hour) [$41.63 reflects the average for Physician Assistants ($43.01 per hour)
and Health Diagnosing and Treating Practitioners, All ($40.24 per hour)], nurses ($33.23 per hour), and Office
Staff ($17.94) [reflects the average for Receptionists and Information Clerks ($12.85 per hour), Office and
Administration Support Workers, All Other ($16.07 per hour), and Computer Support Specialists ($24.91 per
hour)].
\d\ The weighted average wage for physicians ($88.12), nurse practitioners and physician assistants ($41.63),
nurses ($33.23) and office staff ($17.94).
\e\ The average U.S. hourly wage ($21.74).
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.
Comments submitted in response to this notice will be summarized
and included in the Agency's subsequent request for OMB approval of the
proposed information collection. All comments will become a matter of
public record.
Dated: February 6, 2012.
Carolyn M. Clancy,
Director.
[FR Doc. 2013-03217 Filed 2-12-13; 8:45 am]
BILLING CODE 4160-90-M