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[Federal Register Volume 78, Number 84 (Wednesday, May 1, 2013)]
[Notices]
[Pages 25450-25454]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09741]

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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.

[[Page 25451]]

    This proposed information collection was previously published in 
the Federal Register on February 13th, 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 31, 2013.

ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk 
Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by 
email at OIRA_submission@omb.eop.gov (attention: AHRQ's desk officer).
    Copies of the proposed collection plans, data collection 
instruments, and specific details on the estimated burden can be 
obtained from the AHRQ Reports Clearance Officer.

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports 
Clearance Officer, (301) 427-1477, or by email at 
dorislefkowitz@AHRO.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, filer, 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 portals, sometimes referred to as (electronic) 
personal health records or PHRs, allow patients to view portions of 
their medical records (e.g., laboratory test results), and support 
other health-related tasks such as making appointments or requesting 
medication refills. Some patient portal applications exist as 
standalone Web sites; other portal applications are integrated into an 
existing electronic health record [ERR] system;
     Secure messaging with patients (use of secure email 
between patients and clinicians, typically using the secure messaging 
functionality in the ERR and/or patient portal) (Byrne, Elliott, and 
Firek, 2009; Bergmo, Kummervold, Gammon et al., 2005); and
     E-forms (surveys that are administered using computerized 
media [e.g., tablets, laptops] to collect information from patients 
using pre-formatted forms before or during patient visits).
    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 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 
(1-4 physicians and the other clinicians and office staff in their 
practices) and three medium-sized practices (5-10 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'):

[[Page 25452]]

    (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 8 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 84 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 84 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 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 11 
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 138 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 the 
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 cue 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;

[[Page 25453]]

    (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 114 clinicians and office staff across the six study 
sites, and each interview will last up to one hour. A maximum of 138 
clinicians and office staff combined (up to 11 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 215 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 $10,815.

                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
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.....             114               1               1             114
Survey of Clinicians and Office Staff...........             138               1           15/60              35
Patient Interviews..............................              36               1           30/60              18
Post Visit Follow-up to Review the Workflow                   12               1               1              12
 Process Map(s).................................
                                                 ---------------------------------------------------------------
    Total.......................................             336             N/A             N/A             215
----------------------------------------------------------------------------------------------------------------

                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of     Total burden   Average hourly    Total cost
                    Form name                       respondents        hours        wage rate *       burden
----------------------------------------------------------------------------------------------------------------
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.....             114             114       \c\ 50.97           5,811
Survey of Clinicians and Office Staff...........             138              35           46.89           1,641
Patient Interviews..............................              36              18       \e\ 21.74             391
Review of the Workflow Process Map(s)...........              12              12       \a\ 67.15             806
                                                 ---------------------------------------------------------------
    Total.......................................             336             215             N/A          10,815
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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).

[[Page 25454]]

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: April 15, 2013.
Carolyn M. Clancy,
Director.
[FR Doc. 2013-09741 Filed 4-30-13; 8:45 am]
BILLING CODE 4160-90-M
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