942 Federal Register / Vol. 78, No. 4 / Monday, January 7, 2013 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

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. 

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] 

BILLING CODE 4151–05–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Agency for Healthcare Research 

and Quality, HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

intention of the Agency for Healthcare 

Research and Quality (AHRQ) to request 

that the Office of Management and 

Budget (OMB) approve the proposed 

information collection project: ‘‘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 

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 

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 943 

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, 

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 

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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944 Federal Register / Vol. 78, No. 4 / Monday, January 7, 2013 / Notices 

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

Form name 

Maximum 

number of respondents 

Number of responses per 

respondent 

Hours per response Total burden 

hours 

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 


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Federal Register / Vol. 78, No. 4 / Monday, January 7, 2013 / Notices 945 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Form name 

Maximum 

number of respondents 

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 

aThis 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

Form name 

Maximum 

number of respondents 

Total burden 

hours 

Average hourly wage rate * Total cost burden 

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 

* 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 ............................................................................................................................... $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 Contractors ........................................................................................ 15,195 5,065 

Ensure High Quality 508 Compliant Deliverables ................................................................................................... 6,125 2,042 

Total .................................................................................................................................................................. 799,929 266,643 

* 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. 

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: December 20, 2012. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2012–31591 Filed 1–4–13; 8:45 am] 

BILLING CODE 4160–90–M 


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