[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]
-----------------------------------------------------------------------
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: ``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
----------------------------------------------------------------------------------------------------------------
Number of
Type of data collection Number of responses per Hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
[[Page 70728]]
Exhibit 2--Estimated Annualized Total Cost Burden
----------------------------------------------------------------------------------------------------------------
Number of Total burden Average hourly wage Total cost
Type of Data Collection respondents hours rate burden
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------
Total.......................... 400 133 na................... 6,274
----------------------------------------------------------------------------------------------------------------
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
------------------------------------------------------------------------
Cost component Total cost Annualized cost
------------------------------------------------------------------------
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
------------------------------------------------------------------------
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