[Federal Register Volume 76, Number 220 (Tuesday, November 15, 2011)]
[Notices]
[Pages 70726-70728]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29382]


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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: ``Assessing the Feasibility of Disseminating Effective Health 
Care Products through a Shared Electronic Medical Record Serving Member 
Organization of a Health Information Exchange.'' 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 January 17, 2012.

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

    Assessing the Feasibility of Disseminating Effective Health Care 
Products through a Shared Electronic Medical Record Serving Member 
Organization of a Health Information Exchange.
    The Agency for Healthcare Research and Quality (AHRQ) requests that 
the Office of Management and Budget (OMB) approve under the Paperwork 
Reduction Act of 1995 this collection of information from users of work 
products and services initiated by the John M. Eisenberg Clinical 
Decisions and Communications Science Center (Eisenberg Center).
    AHRQ is the lead agency charged with supporting research designed 
to improve the quality of healthcare, reduce its cost, improve patient 
safety, decrease medical errors, and broaden access to essential 
services. AHRQ's Eisenberg Center's mission is improving communication 
of findings to a variety of audiences (``customers''), including 
consumers, clinicians, and health care policy makers. The Eisenberg 
Center compiles research results into useful formats for customer 
stakeholders. The Eisenberg Center also conducts investigations into 
effective communication of research findings in order to improve the 
usability and rapid incorporation of findings into medical practice. 
The Eisenberg Center is one of three components of AHRQ's Effective 
Health Care (EHC) Program. The collections proposed under this 
clearance include activities to assess the feasibility of disseminating 
materials developed by the Eisenberg Center through the use of an 
electronic medical record (EMR) shared by a network of clinical care 
providers that are part of a Health Information Exchange (HIE) 
operating in multiple sites in several states. Our Community Health 
Information Network (OCHIN) members include 30 clinical care 
organizations operating more than 230 primary care clinics in six 
states. Data will be gathered from three different OCHIN-member 
organizations representing a total of 10 primary care clinics. The 
information generated will be provided to AHRQ to guide decision making 
and planning for additional efforts to foster EHC Program product 
distribution via EMR prompting and product linkages.
    This research has the following goals:
    (1) Identify facilitators and barriers to successful efforts to 
implement processes that: (a) Support use of EHC Program products by 
clinicians in practice, and (b) place relevant clinical information in 
the hands of patients and family members in languages and formats that 
are appropriate to patients' information needs;
    (2) Examine ways in which EHC Program products can be used in 
concert with other support programs and products (e.g., 
healthwise[supreg] resources available through the EMR; brief patient 
instructions and letters, including those designed for use with persons 
having very low literacy skills);
    (3) Assess the extent to which EHC Program products are used (e.g., 
accessed by clinicians, provided to patients in relevant formats) in 
settings where use is supported by automated EMR features, such as on-
screen prompts and reminders; and
    (4) Document the perceived value of integrating EHC Program 
products into systems of care supported by an EMR system as self-
reported by clinicians involved in direct care of patients and clinic 
support personnel who interact with patients.
    This study is being conducted by AHRQ through its contractor, the 
Eisenberg Center--Baylor College of Medicine, pursuant to AHRQ's 
statutory

[[Page 70727]]

authority to conduct and support research, and disseminate information, 
on healthcare and on systems for the delivery of such care, including 
activities with respect to the quality, effectiveness, efficiency, 
appropriateness and value of healthcare services and clinical practice. 
42 U.S.C. 299a(a)(1) and (4).

Method of Collection

    To achieve the goals of this project the following data collections 
will be implemented:
    (1) Automated Data Capture from EMR Usage Logs. Electronic usage 
data will be collected to determine the extent to which EHC Program 
guides for clinicians and patients were accessed to support shared 
decision making and patient education. The data will be retrieved from 
the existing EMR-linked database operated by the Kaiser Permanente 
staff in their coordination of activities related to the OCHIN HIE. 
Data will include: (a) Number and frequency of retrieval of EHC 
resource materials; (b) specific types of materials retrieved; and (c) 
health topic or condition targeted in the EHC materials. These data 
will inform the development of follow-up questions to be administered 
to clinicians and patients in the interviews and surveys described 
below. Because the data will be obtained using automated systems 
already in place, no special effort will be needed to generate these 
data, and thus this task is not included in the burden estimates in 
Exhibits 1 and 2.
    (2) Interviews with Clinicians. Interviews will be held with 
clinical service providers for the following purposes: (a) Obtain 
perceptions of the overall value, relevancy, currency and 
appropriateness of EHC Program products in addressing the health 
service needs of patients treated in clinical settings; (b) assess ease 
of use of the materials in terms of access via the EMR; (c) determine 
perceived success of efforts to employ EHC Program products and related 
materials in addressing the needs of patients with limited language 
skills and/or low literacy levels; and (d) describe the relative 
success of efforts to use the EHC Program products in concert with 
other tools (e.g., healthwise[reg] resources) in promoting patient 
engagement in their own health care or in the care of family members.
    (3) Interviews with Support Staff. Interviews will be held with 
non-clinical support staff to characterize perceptions of how the 
introduction of EHC Program products: (a) Affected clinic workflows and 
influenced the work that staff was required to do in supporting 
clinician-patient interactions; and (b) facilitated or impeded efforts 
to inform patients about actions they could take in being more fully 
involved in their own health care.
    (4) Interviews with Patients. Interviews will be held with 
recruited patients to determine if they: (a) Viewed the EHC Program 
products that they were provided as useful to them in understanding 
their health issues; (b) were able to understand the EHC Program-
related information that was provided to them sufficiently to take 
actions in their own health care; and (c) have suggestions about how 
the EHC Program materials could be changed or the delivery of them done 
in a different way to make the materials more useful and/or accessible 
to patients.
    (5) Survey of Clinicians. A questionnaire will be administered to 
clinical care providers near the end of the study to gather 
quantitative data around their assessments of: (a) The relevancy of the 
EHC Program materials to the patients they serve; (b) the 
appropriateness of the products in addressing specific clinical issues; 
(c) the ease of use of the system created to provide access to EHC 
Program products through the EMR; and (d) overall ratings of the 
approach in addressing patient needs with regard to specific conditions 
addressed by the products available.
    The interviews with clinicians, clinical staff, and patients will 
be conducted throughout the project period, approximately every three 
months with different sets of participants, to inform and refine 
delivery mechanisms and monitor progress.
    This information will be used to determine the feasibility of: (a) 
Mounting broader efforts to distribute clinician and consumer guides, 
as well as other EHC products using EMRs as the primary vehicle for 
providing product access at the point of care; and (b) initiating 
additional studies to identify factors that encourage or deter 
effective integration of EHC products into care processes using 
electronic tools and care delivery support systems, like the EMR, that 
are increasingly common in clinical work settings.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden for the 
respondents' time to participate in this research. Three rounds of 
interviews will be conducted during the project period (each round of 
interviews to be held approximately every three months with separate 
sets of participants) to assess progress and adjust methods or refine 
materials as needed. Interviews will be conducted with 100 patients, 50 
clinicians and 50 clinical support staff. Each interview is estimated 
to last no more than 30 minutes. All clinicians in each participating 
clinic will have access to the EMR and will be invited to participate 
in an online questionnaire. Approximately 200 clinicians will complete 
the 10-minute questionnaire.
    Exhibit 2 shows the estimated annualized cost burden associated 
with the respondents' time to participate in this research. The total 
annual cost burden is estimated to be $6,274.

                               Exhibit 1--Estimated Annualized Total Burden Hours
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                                                                     Number of
             Type of data collection                 Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
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Interviews with Clinicians......................              50               1           30/60              25
Interviews with Support Staff...................              50               1           30/60              25
Interviews with Patients........................             100               1           30/60              50
Survey of Clinicians............................             200               1           30/60              33
                                                 ---------------------------------------------------------------
    Total.......................................             400              na              na             133
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[[Page 70728]]


                                Exhibit 2--Estimated Annualized Total Cost Burden
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                                         Number of       Total burden     Average hourly wage      Total cost
      Type of Data Collection           respondents          hours                rate               burden
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Interviews with Clinicians.........                50                25  $83.59...............            $2,090
Interviews with Support Staff......                50                25  14.31................               358
Interviews with Patients...........               100                50  21.35................             1,068
Survey of Clinicians...............               200               -33  83.59................             2,758
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    Total..........................               400               133  na...................            6,274
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Based upon the mean wages for clinicians (29-1062 family and general practitioners), clinical team members (31-
  9092 medical assistants) and patients/consumers (00-0000 all occupations), National Compensation Survey:
  Occupational wages in the United States May 2010, ``U.S. Department of Labor, Bureau of Labor Statistics.''

Estimated Annual Costs to the Federal Government

    The maximum cost to the Federal Government is estimated to be 
$217,451 annually for two years. Exhibit 3 shows the total and 
annualized cost by the major cost components.

             Exhibit 3--Estimated Total and Annualized Cost
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           Cost component                Total cost      Annualized cost
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Project Development.................          $153,750           $76,875
Data Collection Activities..........           162,465            81,233
Data Processing and Analysis........            33,563            16,781
Project Management..................            22,625            11,313
Overhead............................            62,500            31,250
                                     -----------------------------------
    Total...........................           434,903           217,451
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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 healthcare research and 
healthcare 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: November 3, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011-29382 Filed 11-14-11; 8:45 am]
BILLING CODE 4160-90-M