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Federal Register / Vol. 74, No. 139 / Wednesday, July 22, 2009 / Notices
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
Annual Frequency
per
Recordkeeping
Total Annual
Records
Hours per
Record
203.23(a) and (b)
31,676
5
158,380
.25
39,595
203.23(c)
31,676
5
158,380
.08
12,670
203.30(a)(2) and 203.31(a)(2)
2,208
100
220,800
.50
110,400
203.31(d)(1) and (d)(2)
2,208
1
2,208
40
88,320
442
1
442
24
10,608
2,208
1
2,208
1
2,208
203.34
90
1
90
40
3,600
203.37(a)
50
4
200
6
1,200
203.37(b)
50
40
2,000
6
12,000
203.39(d)
65
1
65
1
65
203.39(e)
3,221
1
3,221
.50
1,610
203.39(f)
3,221
1
3,221
8
25,768
203.39(g)
3,221
1
3,221
8
25,768
203.50(a)
125
100
12,500
.17
2,125
203.50(b)
125
100
12,500
.50
6,250
203.50(d)
691
1
691
2.0
1,382
203.31(d)(4)
203.31(e)
Total
1 There
332,769
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 15, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–17394 Filed 7–21–09; 8:45 am]
BILLING CODE 4160–01–S
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.
jlentini on DSKJ8SOYB1PROD with NOTICES
Total Hours
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: ‘‘Study
of Factors Influencing Consumer
Choices Among Health Plans and
Clinicians.’’ In accordance with the
Paperwork Reduction Act of 1995,
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Public Law 104–13 (44 U.S.C.
3506(c)(2)(A)), AHRQ invites the public
to comment on this proposed
information collection. This proposed
information collection was previously
published in the Federal Register on
September 3rd, 2008 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. This notice differs
from the 60 day notice in the following
ways: (1) The number of responses has
been decreased from 6,000 to 4,950, (2)
the burden hours are decreased from
838 to 709, and (3) the descriptions of
each experimental arm in the sections:
Clinician Choice Experimental Design
and Health Plan Choice Experimental
Design were removed.
DATES: Comments on this notice must be
received by August 21, 2009.
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 [email protected]
(attention: AHRQ’s desk officer).
Copies of the proposed collection
plans, data collection instruments, and
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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
e-mail at [email protected].
SUPPLEMENTARY INFORMATION:
Proposed Project
‘‘Study of Factors Influencing Consumer
Choices Among Health Plans and
Clinicians’’
AHRQ proposes to use an
experimental design to determine
factors that influence consumers’
understanding and use of performance
information to select among health
plans and clinicians. The experimental
design will include two parallel
experiments, one designed to assess
factors influencing choice of health
plans and one designed to assess factors
influencing choice of individual
doctors. For both the health plan and
clinician choice experiments
respondents will be randomly assigned
to one of six experimental arms that
vary according to the type and
complexity of performance information
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Federal Register / Vol. 74, No. 139 / Wednesday, July 22, 2009 / Notices
and the size of the choice set (number
of plans or doctors) included in the
Web-based report. Respondents will
complete the experiment through a
secure online connection from their
homes. Data will be derived from pre
and post-test questionnaires and from
server logs that record the web pages
visited and viewing times.
The results of this study will be used
to develop recommendations for helping
consumers to better understand and
more effectively use complex
information to select health plans and
providers, with the aim of making
performance information less
burdensome and more accessible,
useful, and transparent to the public.
This study, funded through cooperative
agreements with the RAND Corporation
and Harvard University, is being
conducted pursuant to AHRQ’s
statutory mandate to promote health
care quality improvement by conducting
and supporting research that develops
and presents scientific evidence
regarding all aspects of health care, 42
U.S.C. 299(b)(l), and to conduct research
on health care and on systems for the
delivery of such health care, 42 U.S.C.
299a.
Method of Collection
Participants in this study will be
recruited through the Knowledge
Networks national online panel of
consumers. The experimental designs of
the clinician choice experiment and of
the health plan choice experiment are
discussed separately below.
Clinician Choice Experimental Design
Participants will see a web page
labeled ‘‘Performance Overview’’ that
presents performance information for a
set of primary care doctors in a way that
allows them to compare doctor ratings.
Performance is summarized by
assigning one to five stars to show how
each doctor compares with others in the
same geographic area. Participants can
click on hyperlinks or a tab to see more
detailed results. The six experimental
arms differ in the type and amount of
performance information presented and
the number of doctors listed.
The goals of the experiment are to
assess the process of consumer choice
and the extent to which the Consumer
Assessment of Healthcare Providers and
Systems (CAHPS)-type measures are
consulted, and to examine how
consumers respond to different types of
information about doctor quality,
including quantitative patient
experience measures, anecdotal reports
from individual patients, and clinical
performance indicators. The post-test
questionnaire will elicit participants’
understanding and impressions of the
material they saw on the Web site and
inquire about how they made their
choice. Therefore, the post-test
questions will differ across
experimental arms.
Health Plan Choice Experimental
Design
The basic design of the health plan
choice experiment is similar to that
used for the clinician choice
experiment. The key difference in the
choice set is that as is true in real-world
choices health plan choice is made
complex in the experiment by
introducing a larger number of measures
of performance, compared to those
available to inform clinician choice.
Even the simplest experimental arm has
twice as many component measures for
health plans as for clinicians. Reports
from consumers include both anecdotes
and a count of aggregate complaints that
have been filed against the plan.
Potentially offsetting the cognitive
burdens caused by additional measures,
health plan choices typically involve
fewer options than do clinician choices;
in this choice experiment participants
will face choice sets involving either 4
or 8 health plans.
A second substantial difference exists
between the health plan and clinician
choice experiments: the former assesses
in an explicit manner the ways in which
emotionality affects how consumers
make use of information. It will do so
in two ways. First, the counts of
complaints mentioned above as an
additional measure of plan performance
represent a quantitative score with a
stronger emotional valence than the
other measures. Second, two of the
experimental arms will ‘‘prime’’
respondents to think about health
outcomes in a more emotionally laden
manner, to see if this alters the way in
which they process this information.
The goals of the experiment are to
assess the process of consumer choice
and the extent to which CAHPS-type
measures are consulted, and to examine
how consumers respond to different
types of information about health plan
quality, including customer services and
accessibility of care issues, selected
Healthcare Effectiveness Data and
Information Set (HEDIS) measures for
preventive care and treatment of chronic
conditions, and selected reports on
enrollee complaint rates and other
issues. The post-test questionnaire will
elicit participants’ understanding and
impressions of the material they saw on
the Web site and inquire about how they
made their choice. Therefore, the posttest questions will differ across
experimental arms.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate in this
one year experiment. All participants
will complete the pre-test, which is
estimated to require 5 minutes. As
explained above, the experimental
website varies by experimental arm;
however, based on preliminary testing,
each participant will require an average
of 10 minutes to review the information
on the site. The post-test questionnaires
will require between 7 to 14 minutes to
complete, depending on the
experimental arm. The total burden
hours are estimated to be 709 hours.
Exhibit 2 shows the respondents’ cost
burden associated with their time to
participate in this experiment. The total
cost burden is estimated to be $13,887.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses
jlentini on DSKJ8SOYB1PROD with NOTICES
Experimental group
Clinician Choice Experiment: Pretest
Experimental Web site .............................................................................
Baseline/Control Arm Post-test ................................................................
Experimental Arm #1 Post-test .................................................................
Experimental Arm #2 Post-test .................................................................
Experimental Arm #3 Post-test .................................................................
Experimental Arm #4 Post-test .................................................................
Experimental Arm #5 Post-test .................................................................
Health Plan Choice Experiment: Pretest
Experimental Web site .............................................................................
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Number of
responses per
respondent
750
750
125
125
125
125
125
125
900
900
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1
1
1
1
1
1
1
1
1
1
22JYN1
Hours per
response
5/60
10/60
7/60
8/60
8/60
12/60
12/60
14/60
5/60
10/60
Total burden
hours
63
125
15
17
17
25
25
29
75
150
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Federal Register / Vol. 74, No. 139 / Wednesday, July 22, 2009 / Notices
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
responses
Experimental group
Number of
responses per
respondent
Hours per
response
Total burden
hours
Baseline/Control Arm Post-test ................................................................
Experimental Arm #1 Post-test .................................................................
Experimental Arm #2 Post-test .................................................................
Experimental Arm #3 Post-test .................................................................
Experimental Arm #4 Post-test .................................................................
Experimental Arm #5 Post-test .................................................................
150
150
150
150
150
150
1
1
1
1
1
1
7/60
8/60
12/60
12/60
14/60
14/60
18
20
30
30
35
35
Total ...................................................................................................
4,950
na
na
709
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Experimental group
Total burden
hours
Average hourly wage rate*
Total cost
burden
Clinician Choice Experiment: Pretest
Experimental Web site .............................................................................
Baseline/Control Arm Post-test ................................................................
Experimental Arm #1 Post-test .................................................................
Experimental Arm #2 Post-test .................................................................
Experimental Arm #3 Post-test .................................................................
Experimental Arm #4 Post-test .................................................................
Experimental Arm #5 Post-test .................................................................
Health Plan Choice Experiment: Pretest
Experimental Web site .............................................................................
Baseline/Control Arm Post-test ................................................................
Experimental Arm #1 Post-test .................................................................
Experimental Arm #2 Post-test .................................................................
Experimental Arm #3 Post-test .................................................................
Experimental Arm #4 Post-test .................................................................
Experimental Arm #5 Post-test .................................................................
750
750
125
125
125
125
125
125
900
900
150
150
150
150
150
150
63
125
15
17
17
25
25
29
75
150
18
20
30
30
35
35
$19.56
19.56
19.56
19.56
19.56
19.56
19.56
19.56
19.56
19.56
19.56
19.56
19.56
19.56
19.56
19.56
$1,232
2,445
293
333
333
489
489
567
1,467
2,934
352
391
587
587
685
685
Total ...................................................................................................
4,950
709
na
13,887
*Based upon the mean of the average wages, ‘‘National Compensation Survey: Occupational Wages in the United States, May 2007,’’ U.S.
Department of Labor, Bureau of Labor Statistics.
Estimated Annual Costs to the Federal
Government
Exhibit 3 shows the total and
annualized cost for developing and
conducting both the health plan and
clinician choice components of this
study, including the cost of designing
the experiments, developing the
simulated Web-based reports,
conducting usability testing of the Web
reports, pilot testing the experiment,
collecting the data, analyzing the data,
preparing reports and papers for journal
submission, and the cost for AHRQ staff
to oversee the project. The total and
annual costs are identical since data
collection will not exceed one year. The
total cost is estimated to be $844,000.
EXHIBIT 3—TOTAL AND ANNUALIZED COSTS
jlentini on DSKJ8SOYB1PROD with NOTICES
Cost components
Total cost
Annual cost
Experimental design ................................................................................................................................................
Development of simulated Web-based reports .......................................................................................................
Pilot testing ..............................................................................................................................................................
Usability testing of Web-based reports ...................................................................................................................
Data collection via Knowledge Networks ................................................................................................................
Data analysis ...........................................................................................................................................................
Preparation of reports and journal papers ..............................................................................................................
AHRQ project management ....................................................................................................................................
$168,900
157,900
56,000
56,300
126,000
56,300
112,600
110,000
$168,900
157,900
56,000
56,300
126,000
56,300
112,600
110,000
Total ..................................................................................................................................................................
844,000
844,000
Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
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16:04 Jul 21, 2009
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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
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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
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Federal Register / Vol. 74, No. 139 / Wednesday, July 22, 2009 / Notices
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: July 8, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9–17203 Filed 7–21–09; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
jlentini on DSKJ8SOYB1PROD with NOTICES
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: ‘‘Health
Literacy Item Set Supplemental to
CAHPS Hospital Survey—Pretest of
Proposed Questions and Methodology.’’
In accordance with the Paperwork
Reduction Act of 1995, Public Law 104–
13 (44 U.S.C. 3506(c)(2)(A)), AHRQ
invites the public to comment on this
proposed information collection.
This proposed information collection
was previously published in the Federal
Register on May 13th, 2009 and allowed
60 days for public comment. The
purpose of this notice is to allow an
additional 30 days for public comment.
This notice differs from the 60 day
notice in the following ways: (1) The
burden hours are increased from 200 to
250, and (2) an incentive experiment
has been added.
DATES: Comments on this notice must be
received by August 21, 2009.
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 [email protected]
(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.
VerDate Nov<24>2008
16:04 Jul 21, 2009
Jkt 217001
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
e-mail at [email protected].
SUPPLEMENTARY INFORMATION:
Proposed Project
‘‘Health Literacy Item Set Supplemental
to CAHPS Hospital Survey—Pretest of
Proposed Questions and Methodology’’
AHRQ proposes to conduct a pretest
of the Consumer Assessment of
Healthcare Providers and Systems
(CAHPS®) Hospital Survey health
literacy module. The CAHPS program is
a multi-year initiative of the Agency for
Healthcare Research and Quality. AHRQ
first launched the program in October
1995 in response to concerns about the
lack of good information about the
quality of health plans from the
enrollees’ perspective. Numerous public
and private organizations collected
information on enrollee and patient
satisfaction, but the surveys varied from
sponsor to sponsor and often changed
from year to year. The CAHPS®
program was designed to make it
possible to compare survey results
across sponsors and over time, and to
generate tools and resources that
sponsors can use to produce
understandable and usable comparative
information for consumers.
Over time, the program has expanded
beyond its original focus on health
plans to address a range of health care
services to meet the various needs of
health care consumers, purchasers,
health plans, providers, and
policymakers. Based on a literature
review and an assessment of currently
available questionnaires, AHRQ
identified the need to develop a health
literacy module for the CAHPS®
Hospital Survey. The intent of the
planned module is to examine patients’
perspectives on how well health
information is communicated to them
by healthcare professionals in the
hospital setting. The objective of the
new module is to provide information to
health plans, hospitals, clinicians, group
practices, and other interested parties
regarding the quality of health
information delivered to patients. The
set of questions about health literacy
will be evaluated as a supplement to the
CAHPS® Hospital Survey.
This study will be conducted for
AHRQ by its contractor, RAND
Corporation. It is being conducted
pursuant to AHRQ’s statutory authority
to conduct research and evaluations on
health care and systems for the delivery
of such care, including activities with
respect to (1) the quality, effectiveness,
efficiency, appropriateness and value of
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36235
health care services. See 42 U.S.C.
299a(a)(1).
This study is a one-time field test to
be completed in the calendar years 2009
and 2010. The field test to be conducted
under this request will be done for the
following purposes:
a. Analysis of item wording—Assess
candidate wordings for items.
b. Analysis of participation rate—
Evaluate the overall response rate and
the proportion of that obtained from
mail versus telephone modes of data
collection.
c. Case mix adjustment analysis—
Evaluate variables that need to be
considered for case mix adjustment of
scores.
d. Psychometric analysis—Provide
information for the revision of the
health literacy item set based on the
assessment of the reliability and
validity.
e. Incentive experiment—Provide
information on the effectiveness of a
post-paid, $5 incentive as a mechanism
to enhance response by randomizing
half the sample at one site to an
experiment in which a post-paid
incentive of $5 is provided for
completing the survey.
The end result will be collection of
the data related to the assessment of
patients’ perspective on how well health
information is communicated to them
by health care professionals in a
hospital setting. The field testing will
ensure that future data collections yield
high quality data and minimize
respondent burden, increase agency
efficiency, and improve responsiveness
to the public. The survey items will be
added to currently available CAHPS®
surveys and will enhance the ability of
hospitals to assess the quality of their
services.
Method of Collection
The potential respondent universe is
persons who had at least one overnight
stay at a hospital within the previous
five months. Excluded from the study
will be those who were less than 18
years old at the time of their admission,
had a psychiatric diagnosis, were
discharged to a hospice facility or died
during the hospitalization. Testing sites
will be selected purposively based on
several considerations, including ability
to execute the activities necessary to
participate in the pilot, number of beds,
number of discharges for medical,
surgical, and obstetric patients, average
length of stay, location (urban versus
rural), profit status, and academic
medical center status.
The draw will be a sample large
enough to yield approximately 600
completes. It is assumed that
E:\FR\FM\22JYN1.SGM
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File Type | application/pdf |
File Title | Document |
Subject | Extracted Pages |
Author | U.S. Government Printing Office |
File Modified | 2009-07-21 |
File Created | 2009-07-21 |