Agency Information Collection Activities: Proposed Collection; Comment Request, 16779-16783 [2011-6857]
Download as PDF
16779
Federal Register / Vol. 76, No. 58 / Friday, March 25, 2011 / Notices
via e-mail, and may include a telephone
non-response follow-up. Telephone
non-response follow-up for mailed
surveys is not counted as a telephone
survey in Exhibit 1. Not more than 600
persons, over 3 years, will participate in
telephone surveys that will take about
40 minutes. Web-based surveys will be
conducted with no more than 3,000
persons and will require no more than
10 minutes to complete. About 1,500
persons will participate in focus groups
which may last up to two hours, while
in-person interviews will be conducted
with 600 persons and will take about 1
hour. Automated data collection will be
conducted for about 1,500 persons and
could take up to 1 hour. Cognitive
testing will be conducted with about
600 persons and is estimated to take 1⁄2;
hours to complete. The total burden
over 3 years is estimated to be 8,900
hours (about 2,967 hours per year).
Exhibit 2 shows the estimated cost
burden over 3 years, based on the
respondent’s time to participate in these
research activities. The total cost burden
is estimated to be $298,239.
EXHIBIT 1—ESTIMATED BURDEN HOURS OVER 3 YEARS
Number of
respondents
Type of information collection
Number of
responses per
respondent
Hours per
response
Total burden
hours
Mail/e-mail * ..............................................................................................
Telephone ................................................................................................
Web-based ...............................................................................................
Focus Groups ..........................................................................................
In-person ..................................................................................................
Automated ** ............................................................................................
Cognitive Testing *** ................................................................................
6,000
600
3,000
1,500
600
1,500
600
1
1
1
1
1
1
1
20/60
40/60
10/60
2.0
1.0
1.0
1.5
2,000
400
500
3,000
600
1,500
900
Totals ................................................................................................
13,800
na
na
8,900
* May include telephone non-response follow-up in which case the burden will not change.
** May include testing of database software, CAPI software or other automated technologies.
*** May include cognitive interviews for questionnaire or toolkit development, or ‘‘think aloud’’ testing of prototype Web sites.
EXHIBIT 2—ESTIMATED COST BURDEN OVER 3 YEARS
Number of
respondents
Type of information collection
Total burden
hours
Average wage
rate *
Total cost
burden
Mail/e-mail ................................................................................................
Telephone ................................................................................................
Web-based ...............................................................................................
Focus Groups ..........................................................................................
In-person ..................................................................................................
Automated ................................................................................................
Cognitive Testing .....................................................................................
6,000
600
3,000
1,500
600
1,500
600
2,000
400
500
3,000
600
1,500
900
$33.51
33.51
33.51
33.51
33.51
33.51
33.51
$67,020
13,404
16,755
100,530
20,106
50,265
30,159
Totals ................................................................................................
13,800
8,900
na
298,239
* Based upon the average wages for 29–000 (Healthcare Practitioner and Technical Occupations), ‘‘National Compensation Survey: Occupational Wages in the United States, May 2009,’’ U.S. Department of Labor, Bureau of Labor Statistics.
Estimated Annual Costs to the Federal
Government
Information collections conducted
under this generic clearance will in
some cases be carried out under
contract. Assuming four data collections
per year (either mail/e-mail, telephone,
Web-based or in-person) at an average
cost of $150,000 each, and two focus
groups, automated data collections or
lab experiments at an average cost of
$20,000 each, total contract costs could
be $640,000 per year.
erowe on DSK5CLS3C1PROD with NOTICES
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
necessary for the proper performance of
AHRQ healthcare research and
VerDate Mar<15>2010
15:16 Mar 24, 2011
Jkt 223001
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.
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
Dated: March 15, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011–6855 Filed 3–24–11; 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
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:
This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
SUMMARY:
E:\FR\FM\25MRN1.SGM
25MRN1
16780
Federal Register / Vol. 76, No. 58 / Friday, March 25, 2011 / Notices
that the Office of Management and
Budget (OMB) approve the proposed
information collection project:
‘‘Connecting Primary Care Practices with
Hard-to-Reach Adolescent Populations.’’
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 January 13th, 2011 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 April 25, 2011.
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 0IRA_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
e-mail at
doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
Proposed Project
erowe on DSK5CLS3C1PROD with NOTICES
Connecting Primary Care Practices With
Hard-to-Reach Adolescent Populations
The overall goal of this exploratory
project is to improve the quality of
adolescent health care. The project will
address suboptimal adolescent care with
respect to health risk behaviors, which
can have serious health consequences.
In particular, failure to address health
risk behaviors among adolescents (e.g.,
smoking, substance abuse, poor diets,
physical inactivity, and high-risk sexual
behavior) contributes significantly to
increased morbidity and mortality.
Adolescents (11–17 years of age)
constitute 17% of the population of the
U.S., but they are responsible for only
7% of medical office visits. As a result,
primary care providers have relatively
less opportunity to evaluate and counsel
adolescents in their offices than most
other patients. Even when adolescents
receive routine health care, open
communication with their health care
providers may be problematic. A
national survey found that the majority
of adolescent boys and girls in the
U.S. report at least 1 of 8 potential
health risks, but most (63%) had not
spoken to their doctor about any of
VerDate Mar<15>2010
15:16 Mar 24, 2011
Jkt 223001
these (Klein & Wilson, 2002). Improved
engagement and communication
between adolescents and their primary
care providers could increase the
likelihood that effective preventive
services and health care are provided. It
could also improve the efficiency of
health care services for adolescents, in
terms of appointments kept and
adherence to recommended screening or
treatment recommendations.
Technological interventions to
improve care may be particularly
appropriate for adolescents, since they
are typically the early adopters of new
technology (Skinner, Biscope, Poland, &
Goldberg, 2003). Use of in-office
electronic screeners before
appointments has proven useful (Olson,
Gaffney, Lee, &Starr 2008; Salerno,
2008; Yi, Martyn, Salerno, & DarlingFisher,). Outside of the office, youth
have increasingly turned to the internet
for health-related information, and have
also rapidly adopted mobile technology
(Lenhart. Line, Campbell. & Purcell,
2010) and social media (Lenhart,
Purcell, Smith& Zickuhr, 2010). Health
plans (e.g., Kaiser Permanente) and
practices (Hawn, 2009) have conducted
early work in applying patient-centered
web and mobile technologies. These
projects have included interventions to
decrease patient no-show rates, increase
the use of sunscreen, and engage
adolescents in diabetes management.
Much work remains to be done,
however, in understanding how primary
care practices can best embrace
advances in communications and
information technology to improve
health outcomes for adolescent patients.
This project has the following goals:
(1) Explore the benefits of
supplementing an electronic in-office
pre-visit screener with a set of Web
technologies for adolescent outreach
and engagement outside of office visits.
a. The Rapid Assessment for
Adolescent Preventive Services©
(RAAPS), as described below, will be
used for in-office pre-visit screening.
b. The Web technologies will include
(i) a Web page for more static content
such as information about practices and
health-related commentary from
practice clinicians and staff, (ii) a
Facebook page for social interaction
about health topics including topical
content that will engage adolescents in
conversations about general, not
personal, health behaviors and
encouraging youth to discuss these
issues with their primary care
practitioners at clinic visits, and (iii) a
Twitter site that will allow youth to use
mobile phones with text messaging to
subscribe to Facebook posts.
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
(2) Increase adolescent visits to
primary care and identification of health
risks during visits.
(3) Promote healthier behavior in four
domains: (1) Diet, (2) physical activity,
(3) substance abuse (smoking, alcohol,
and use of other recreational drugs), and
(4) sexual health.
(4) Develop a manual of best practices
for these components in primary care.
This study is being conducted by
AHRQ through its contractor, State
Network of Colorado Ambulatory
Practices and Partners (SNOCAP–USA),
a practice-based research network
(PBRN) based at the University of
Colorado Denver, pursuant to AHRQ’s
statutory authority to conduct and
support research 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 with respect to clinical
practice, including primary care and
practice-oriented research. 42 U.S.C.
299a(a)(1) and (4).
Method of Collection
This project will be conducted in four
primary care practice sites that have a
substantial number of adolescent
patients. The following activities and
data collections will be implemented:
(1) RAAPS questionnaire. Practices
will use the 21-item RAAPS
questionnaire for in-office pre-visit
screening. RAAPS was developed by the
University of Michigan Regional
Alliance for Healthy Schools to elicit
information about risky adolescent
behaviors that should be addressed, but
often are missed, in primary care. It is
available in both paper and online
forms; the latter will be used in this
project. The primary purpose of the
RAAPS questionnaire is to improve
clinical recognition of risky behaviors so
that personal counseling may be
provided.
(2) Process measures for web
technologies. For each of the web
technologies used (the web page,
Facebook page, and Twitter site), data
on the number of unique visitors, the
frequency of their visits, and their
activities (e.g. whether they create a new
post or ‘‘like’’ postings) will be obtained
by the research team. These data will
not include personally identifiable
information (e.g. the user’s username,
birth date, IP address, etc.). OMB
clearance is not required for this data
collection.
(3) Extraction of medical record data.
Staff members at each practice will use
their clinical information systems to
extract medical record data for use by
the research team. Data to be extracted
E:\FR\FM\25MRN1.SGM
25MRN1
16781
Federal Register / Vol. 76, No. 58 / Friday, March 25, 2011 / Notices
erowe on DSK5CLS3C1PROD with NOTICES
consist of (a) Contact information for
patients seen in the 18 months prior to
the start date for implementation of
RAAPS and the web technologies. This
is the sample frame for the adolescent
behavior and communication survey.
These data will be used by the project
staff to prepare the recruitment
mailings. (b) Clinic notes for adolescents
seen in the 12 months prior to
implementation start date and for
adolescents seen in the 12 months
following the implementation start date.
Clinic notes will be made accessible
either by pulling paper charts or
printing notes from electronic medical
records. The notes will be reviewed and
abstracted by the research team to assess
whether the intervention had the
intended effect of increasing adolescent
visits to primary care and the
identification of potential health risks
during visits.
(4) Consent-assent form. This is used
to obtain consent from the parent or
guardian and assent from the adolescent
to participate in the adolescent behavior
and communication survey.
(5) Adolescent behavior and
communication survey. A questionnaire
(by mail, with an online option) will be
administered twice to adolescent
patients for whom consent-assent has
been obtained: Once at baseline and
again six months after the intervention.
The purpose of this survey is to measure
the adolescent’s level of comfort with
discussing their health with their
clinician and their level of satisfaction
with their medical care, and to see how
this changes after the intervention.
(6) Post-visit satisfaction survey.
Practices will provide adolescents with
a brief, post-card sized anonymous
questionnaire at every office visit during
the study period. The purpose is to
assess the perceived utility of the
RAAPS questionnaire, and whether the
visit was related to the project’s web
technologies.
(7) Adolescent focus groups. Eight
adolescents (two from each practice)
will provide feedback on the web page,
Facebook, and Twitter pages. There will
be one in-person group meeting preimplementation, followed by a series of
3 additional asynchronous group
discussions conducted via the web at
three-month intervals. These provide a
process for user-centered design and
refinement of the of web technologies.
(8) Adolescent ‘‘think-aloud’’ sessions.
These sessions, which will be
conducted near the end of the study
period, will involve a set of eight
adolescent patients (two from each
practice) that did not participate in the
focus groups. Subjects will come to the
practice for individual sessions in
which they will be asked to say aloud
what they are thinking about the web
technologies as they navigate them as
they typically would. The purpose is to
assess the perceived utility of the
components of the web, Facebook, and
Twitter pages.
(9) Clinician semi-structured
interviews. At each site, individual
interviews will be conducted with two
clinicians (eight clinicians total). The
purpose is to assess clinician
perceptions of the effects of the RAAPS
questionnaire and the web technologies
on the clinical encounter and the care
they provide.
(10) Administrator-staff semistructured interviews. At each site,
semi-structured interviews will be
conducted with the practice manager
and a front-desk staff member. The
purpose is to assess the effect of the
interventions on the check in process
and other business processes.
(11) Semi-structured interviews for
the draft manual. The draft manual of
best practices in primary care for
adoption of web and assessment
technologies (such as the RAAPS
questionnaire) developed by the
research team will be sent to the
practice manager and the practice
director (lead clinician) of each site.
Their feedback will be solicited by
telephone roughly two weeks later. This
‘‘member checking’’ enhances the
validity of the manual’s conclusions and
recommendations.
The results from this exploratory
project will be used to inform
development of a manual to assist
primary care practices in adopting
interventions to improve the
effectiveness of their outreach to and
interactions with adolescent patients. In
addition, information collected in the
RAAPS questionnaire may be used by
clinicians to improve clinical care.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate in this
research. Among the 776 adolescent
patients across the 4 participating
practices, 310 are expected to complete
the RAAPS questionnaire, which takes
about 12 minutes to complete, at each
office visit (on average there will be an
estimated 1.25 office visits per patient).
Practice staff members will perform the
extraction of medical record data preimplementation, and again postimplementation, for 50 patients. This
task is estimated to require 4 hours per
practice (slightly less than 5 minutes per
patient record).
The consent-assent form for
participation in the adolescent behavior
and communication survey will be sent
to the homes of all adolescents in the
practice’s panels. The estimated average
time for reading and responding to the
form is 15 minutes. The adolescent
behavior and communication survey
will be completed twice, pre and post
intervention, by 186 adolescent patients
and requires 15 minutes to complete.
The post-visit satisfaction survey will be
completed by each of the 310
participating adolescent patients after
each office visit and will take 1 minute
to complete.
A series of four focus groups will be
held with 8 adolescent patients over the
course of the study period with each
session lasting about 1.5 hours. In
addition to the focus groups one ‘‘think
aloud’’ session will be held with a group
of 8 adolescent patients and will also
take 1.5 hours.
Feedback from the practice staff and
the clinicians will be obtained through
3 different semi-structured interviews.
Two staff members from each of the 4
practices will participate in these
interviews. The clinician and
administrator-staff semi-structured
interviews will each last 30 minutes.
Semi-structured interviews for the draft
manual will require about one hour total
(30 minutes to review the manual and
30 minutes to participate in the
interview). The total annualized burden
is estimated to be 479 hours.
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 $7,980.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Activity/data collection
RAAPS questionnaire ......................................................................................
Extraction of medical record data ....................................................................
VerDate Mar<15>2010
15:16 Mar 24, 2011
Jkt 223001
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
310
4
E:\FR\FM\25MRN1.SGM
1.25
2
25MRN1
Hours per
response
12/60
4
Total
burden
hours
78
32
16782
Federal Register / Vol. 76, No. 58 / Friday, March 25, 2011 / Notices
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Activity/data collection
Number of
responses per
respondent
Total
burden
hours
Hours per
response
Consent-assent form .......................................................................................
Adolescent behavior and communication survey ............................................
Post-visit satisfaction survey ............................................................................
Adolescent focus groups .................................................................................
Adolescent ‘‘think-aloud’’ sessions ..................................................................
Clinician semi-structured interviews ................................................................
Administrator-staff semi-structured interviews .................................................
Semi-structured interviews for the draft manual ..............................................
776
186
310
8
8
4
4
4
1
2
1.25
4
1
2
2
2
15/60
15/60
1/60
1.5
1.5
30/60
30/60
1
194
93
6
48
12
4
4
8
Total ..........................................................................................................
1,614
na
na
479
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Activity/data collection cost
Total
burden
hours
Average hourly wage rate 1
Total
burden
RAAPS questionnaire ......................................................................................
Extraction of medical record data ....................................................................
Consent-assent form .......................................................................................
Adolescent behavior and communication survey ............................................
Post-visit satisfaction survey ............................................................................
Adolescent focus groups .................................................................................
Adolescent ‘‘think-aloud’’ sessions ..................................................................
Clinician semi-structured interviews ................................................................
Administrator-staff semi-structured interviews .................................................
Semi-structured interviews for the draft manual ..............................................
310
4
776
186
310
8
8
4
4
4
78
32
194
93
6
48
12
4
4
8
2 $9.01
7 64.75
$703
581
4,289
838
54
432
108
338
119
518
Total ..........................................................................................................
1,614
479
na
7,980
3 18.15
4 22.11
2 9.01
2 9.01
2 9.01
2 9.01
5 84.53
6 29.63
1 Mean
hourly and wage costs for Colorado were derived from the Bureau of Labor and Statistics National Compensation Survey for May 2009
(https://www.bls.gov/oes/current/oes_co.htm).
2 Hourly rate for an entry level worker (occupation code 35–0000) estimates the cost of time for adolescents, although many will not be employed.
3 Hourly rate for medical records and health information technician (29–2071).
3 Hourly rate for medical records and health information technician (29–2071).
4 Hourly rate for the mean for all occupations (00–0000) estimates the cost of time for the parent or guardian of the adolescent.
5 Average of hourly rates for a family medicine practitioner (29–1062) and a general internist (29–1063).
6 Average of (1) the hourly rate for a medical and health services manager (11–9111) and (2) the average of the hourly rates for a receptionist
(43–4171) and a medical assistant (31–9092).
7 Average of (1) the hourly rate for a medical and health services manager (11–9110) and (2) the average of the hourly rates for a family medicine practitioner (29–1062) and a general internist (29–1063).
Estimated Annual Costs to the Federal
Government
Exhibit 3 shows the estimated total
and annualized cost to the Federal
Government for conducting this
research. These estimates include the
costs associated with the project such as
the preparation of survey administration
procedures, labor costs, administrative
expenses, costs associated with copying,
postage, and telephone expenses, data
management and analysis, and
preparation of final reports. The
annualized and total costs are identical
since the data collection period will last
for one year. The total cost is estimated
to be $436,524.
EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST
Cost component
Total cost
Annualized
cost
erowe on DSK5CLS3C1PROD with NOTICES
Project Development ...............................................................................................................................................
Data Collection Activities .........................................................................................................................................
Data Processing and Analysis .................................................................................................................................
Publication of Results ..............................................................................................................................................
Project Management ................................................................................................................................................
Overhead .................................................................................................................................................................
$72,364
48,904
73,937
21,890
75,733
143,696
$72,364
48,904
73 937
21,890
75,733
143,696
Total ..................................................................................................................................................................
436,524
436,524
Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQs
VerDate Mar<15>2010
15:16 Mar 24, 2011
Jkt 223001
information collection are requested
with regard to any of the following:
(a) Whether the proposed collection of
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
information is necessary for the proper
performance of AHRQ healthcare
research and healthcare information
E:\FR\FM\25MRN1.SGM
25MRN1
Federal Register / Vol. 76, No. 58 / Friday, March 25, 2011 / Notices
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: March 15, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011–6857 Filed 3–24–11; 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
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:
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
Nursing Home Antibiograms to Improve
Antibiotic Prescribing and Delivery.’’ 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 May 24, 2011.
ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by
e-mail 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
erowe on DSK5CLS3C1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:16 Mar 24, 2011
Jkt 223001
e-mail at
doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
Proposed Project
Using Nursing Home Antibiograms To
Improve Antibiotic Prescribing and
Delivery
Overuse and inappropriate use of
antibiotics, particularly broad-spectrum
antibiotics, is recognized as a serious
problem in nursing homes (NHs). The
adverse consequences of inappropriate
prescribing practices including drug
reactions/interactions, secondary
complications, and the emergence of
multi-drug resistant organisms, have
become more common. For example, in
one point-prevalence survey of 117 NH
residents, 43 percent were culturepositive for one or more antimicrobialresistant pathogens, including
methicillin-resistant staphylococcus
aureas (24 percent), extended-spectrum
+-lactamase-producing klebsiella
pneumoniae (18 percent) or Escherichia
coli (15 percent), and vancomycinresistant enterococci. Inappropriate
overprescribing and overuse of broadspectrum antibiotics, when narrower
spectrum drugs would suffice, are
believed to be important contributors to
this problem.
Physicians typically begin antibiotics
for suspected infections in NH residents
without waiting for bacteriology
laboratory culture results. If there is a
clinical failure (e.g., patient does not
improve), the physician may request a
bacteriology laboratory test, but will
often try a second antibiotic without
waiting for culture confirmation. If a NH
resident is deteriorating, many NHs do
not try a second antibiotic but will
instead transfer the patient to a hospital
emergency department (ED). In the ED,
physicians must make quick decisions
about whether to continue the first
antibiotic prescribed in the NH or start
another, again often without culture
results.
NH patients are transferred to EDs for
all sorts of medical reasons, including
but not limited to infections. When NH
patients arrive at an ED, physicians may
identify a urinary tract, respiratory, or
other infection that was not the primary
reason for the ED visit. Thus, patients
may not leave the NH with a suspected
bacterial infection or taking any
antibiotics, but an infection is suspected
in the ED and the first antibiotic is
prescribed there.
As a result of the above complexities,
NHs are increasingly recognized as
reservoirs of antibiotic-resistant
bacteria. Antibiograms aggregate
information for an entire institution
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
16783
over a period of several months or a
year. They display the organisms
present in clinical specimens sent for
laboratory testing, and the susceptibility
of each organisms to an array of
antibiotics. Antibiograms are routinely
prepared by hospital laboratories but are
not routine in the NH setting. The
culmination of this project will be a NH
Antibiogram toolkit so that NHs can
create facility-specific antibiograms that
are cost-effective and helpful to
physicians who must make antibiotic
prescription decisions without
bacteriology laboratory test results, for
patients in NHs, and for patients who
are transferred from the NH to the ED.
Outcomes of interest for antibiograms
include reduced reliance on broadspectrum antibiotics as initial therapy,
and fewer clinical failures of antibiotics
that are first prescribed. The
development of a toolkit will be the first
step in this process; future studies are
required to test the toolkit and,
subsequently, the effectiveness of NH
antibiograms.
The objectives of the study are to:
1. Develop a standardized method for
determining antibiotic susceptibility
patterns and developing NH-specific
antibiograms;
2. Extract preliminary data from NH
facilities of various sizes and types to
guide the development of the draft
toolkit; and
3. Develop a draft toolkit to guide a
wide variety of sizes and types of NHs
in developing and sharing antibiogram
information with prescribing providers
(i.e., physicians and physician
extenders) and EDs.
Three NHs and one ED will
participate in this study, which will be
conducted in two phases. The first
phase will include one small NH and
one ED and is intended to test the data
collection instruments and to draft the
initial toolkit, including the creation of
a NH specific antibiogram. The second
phase will expand the study by adding
two larger NHs, while retaining the
same NH and ED as in the first phase
and is intended to further test the data
collection instruments and refine the
draft toolkit. Each phase will use the
same methods and data collections.
This study is being conducted by the
Agency for Healthcare Research and
Quality through its contractors, Abt
Associates and the Brigham and
Women’s Hospital ED, pursuant to the
Agency for Healthcare Research and
Quality’s statutory authority to conduct
and support research 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
E:\FR\FM\25MRN1.SGM
25MRN1
Agencies
[Federal Register Volume 76, Number 58 (Friday, March 25, 2011)]
[Notices]
[Pages 16779-16783]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6857]
-----------------------------------------------------------------------
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
[[Page 16780]]
that the Office of Management and Budget (OMB) approve the proposed
information collection project: ``Connecting Primary Care Practices
with Hard-to-Reach Adolescent Populations.'' 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 January 13th, 2011 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 April 25, 2011.
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
e-mail at 0IRA_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 e-mail at
doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
Proposed Project
Connecting Primary Care Practices With Hard-to-Reach Adolescent
Populations
The overall goal of this exploratory project is to improve the
quality of adolescent health care. The project will address suboptimal
adolescent care with respect to health risk behaviors, which can have
serious health consequences. In particular, failure to address health
risk behaviors among adolescents (e.g., smoking, substance abuse, poor
diets, physical inactivity, and high-risk sexual behavior) contributes
significantly to increased morbidity and mortality. Adolescents (11-17
years of age) constitute 17% of the population of the U.S., but they
are responsible for only 7% of medical office visits. As a result,
primary care providers have relatively less opportunity to evaluate and
counsel adolescents in their offices than most other patients. Even
when adolescents receive routine health care, open communication with
their health care providers may be problematic. A national survey found
that the majority of adolescent boys and girls in the U.S. report at
least 1 of 8 potential health risks, but most (63%) had not spoken to
their doctor about any of these (Klein & Wilson, 2002). Improved
engagement and communication between adolescents and their primary care
providers could increase the likelihood that effective preventive
services and health care are provided. It could also improve the
efficiency of health care services for adolescents, in terms of
appointments kept and adherence to recommended screening or treatment
recommendations.
Technological interventions to improve care may be particularly
appropriate for adolescents, since they are typically the early
adopters of new technology (Skinner, Biscope, Poland, & Goldberg,
2003). Use of in-office electronic screeners before appointments has
proven useful (Olson, Gaffney, Lee, &Starr 2008; Salerno, 2008; Yi,
Martyn, Salerno, & Darling-Fisher,). Outside of the office, youth have
increasingly turned to the internet for health-related information, and
have also rapidly adopted mobile technology (Lenhart. Line, Campbell. &
Purcell, 2010) and social media (Lenhart, Purcell, Smith& Zickuhr,
2010). Health plans (e.g., Kaiser Permanente) and practices (Hawn,
2009) have conducted early work in applying patient-centered web and
mobile technologies. These projects have included interventions to
decrease patient no-show rates, increase the use of sunscreen, and
engage adolescents in diabetes management. Much work remains to be
done, however, in understanding how primary care practices can best
embrace advances in communications and information technology to
improve health outcomes for adolescent patients.
This project has the following goals:
(1) Explore the benefits of supplementing an electronic in-office
pre-visit screener with a set of Web technologies for adolescent
outreach and engagement outside of office visits.
a. The Rapid Assessment for Adolescent Preventive
Services(copyright) (RAAPS), as described below, will be used for in-
office pre-visit screening.
b. The Web technologies will include (i) a Web page for more static
content such as information about practices and health-related
commentary from practice clinicians and staff, (ii) a Facebook page for
social interaction about health topics including topical content that
will engage adolescents in conversations about general, not personal,
health behaviors and encouraging youth to discuss these issues with
their primary care practitioners at clinic visits, and (iii) a Twitter
site that will allow youth to use mobile phones with text messaging to
subscribe to Facebook posts.
(2) Increase adolescent visits to primary care and identification
of health risks during visits.
(3) Promote healthier behavior in four domains: (1) Diet, (2)
physical activity, (3) substance abuse (smoking, alcohol, and use of
other recreational drugs), and (4) sexual health.
(4) Develop a manual of best practices for these components in
primary care.
This study is being conducted by AHRQ through its contractor, State
Network of Colorado Ambulatory Practices and Partners (SNOCAP-USA), a
practice-based research network (PBRN) based at the University of
Colorado Denver, pursuant to AHRQ's statutory authority to conduct and
support research 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 with
respect to clinical practice, including primary care and practice-
oriented research. 42 U.S.C. 299a(a)(1) and (4).
Method of Collection
This project will be conducted in four primary care practice sites
that have a substantial number of adolescent patients. The following
activities and data collections will be implemented:
(1) RAAPS questionnaire. Practices will use the 21-item RAAPS
questionnaire for in-office pre-visit screening. RAAPS was developed by
the University of Michigan Regional Alliance for Healthy Schools to
elicit information about risky adolescent behaviors that should be
addressed, but often are missed, in primary care. It is available in
both paper and online forms; the latter will be used in this project.
The primary purpose of the RAAPS questionnaire is to improve clinical
recognition of risky behaviors so that personal counseling may be
provided.
(2) Process measures for web technologies. For each of the web
technologies used (the web page, Facebook page, and Twitter site), data
on the number of unique visitors, the frequency of their visits, and
their activities (e.g. whether they create a new post or ``like''
postings) will be obtained by the research team. These data will not
include personally identifiable information (e.g. the user's username,
birth date, IP address, etc.). OMB clearance is not required for this
data collection.
(3) Extraction of medical record data. Staff members at each
practice will use their clinical information systems to extract medical
record data for use by the research team. Data to be extracted
[[Page 16781]]
consist of (a) Contact information for patients seen in the 18 months
prior to the start date for implementation of RAAPS and the web
technologies. This is the sample frame for the adolescent behavior and
communication survey. These data will be used by the project staff to
prepare the recruitment mailings. (b) Clinic notes for adolescents seen
in the 12 months prior to implementation start date and for adolescents
seen in the 12 months following the implementation start date. Clinic
notes will be made accessible either by pulling paper charts or
printing notes from electronic medical records. The notes will be
reviewed and abstracted by the research team to assess whether the
intervention had the intended effect of increasing adolescent visits to
primary care and the identification of potential health risks during
visits.
(4) Consent-assent form. This is used to obtain consent from the
parent or guardian and assent from the adolescent to participate in the
adolescent behavior and communication survey.
(5) Adolescent behavior and communication survey. A questionnaire
(by mail, with an online option) will be administered twice to
adolescent patients for whom consent-assent has been obtained: Once at
baseline and again six months after the intervention. The purpose of
this survey is to measure the adolescent's level of comfort with
discussing their health with their clinician and their level of
satisfaction with their medical care, and to see how this changes after
the intervention.
(6) Post-visit satisfaction survey. Practices will provide
adolescents with a brief, post-card sized anonymous questionnaire at
every office visit during the study period. The purpose is to assess
the perceived utility of the RAAPS questionnaire, and whether the visit
was related to the project's web technologies.
(7) Adolescent focus groups. Eight adolescents (two from each
practice) will provide feedback on the web page, Facebook, and Twitter
pages. There will be one in-person group meeting pre-implementation,
followed by a series of 3 additional asynchronous group discussions
conducted via the web at three-month intervals. These provide a process
for user-centered design and refinement of the of web technologies.
(8) Adolescent ``think-aloud'' sessions. These sessions, which will
be conducted near the end of the study period, will involve a set of
eight adolescent patients (two from each practice) that did not
participate in the focus groups. Subjects will come to the practice for
individual sessions in which they will be asked to say aloud what they
are thinking about the web technologies as they navigate them as they
typically would. The purpose is to assess the perceived utility of the
components of the web, Facebook, and Twitter pages.
(9) Clinician semi-structured interviews. At each site, individual
interviews will be conducted with two clinicians (eight clinicians
total). The purpose is to assess clinician perceptions of the effects
of the RAAPS questionnaire and the web technologies on the clinical
encounter and the care they provide.
(10) Administrator-staff semi-structured interviews. At each site,
semi-structured interviews will be conducted with the practice manager
and a front-desk staff member. The purpose is to assess the effect of
the interventions on the check in process and other business processes.
(11) Semi-structured interviews for the draft manual. The draft
manual of best practices in primary care for adoption of web and
assessment technologies (such as the RAAPS questionnaire) developed by
the research team will be sent to the practice manager and the practice
director (lead clinician) of each site. Their feedback will be
solicited by telephone roughly two weeks later. This ``member
checking'' enhances the validity of the manual's conclusions and
recommendations.
The results from this exploratory project will be used to inform
development of a manual to assist primary care practices in adopting
interventions to improve the effectiveness of their outreach to and
interactions with adolescent patients. In addition, information
collected in the RAAPS questionnaire may be used by clinicians to
improve clinical care.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated annualized burden hours for the
respondents' time to participate in this research. Among the 776
adolescent patients across the 4 participating practices, 310 are
expected to complete the RAAPS questionnaire, which takes about 12
minutes to complete, at each office visit (on average there will be an
estimated 1.25 office visits per patient). Practice staff members will
perform the extraction of medical record data pre-implementation, and
again post-implementation, for 50 patients. This task is estimated to
require 4 hours per practice (slightly less than 5 minutes per patient
record).
The consent-assent form for participation in the adolescent
behavior and communication survey will be sent to the homes of all
adolescents in the practice's panels. The estimated average time for
reading and responding to the form is 15 minutes. The adolescent
behavior and communication survey will be completed twice, pre and post
intervention, by 186 adolescent patients and requires 15 minutes to
complete. The post-visit satisfaction survey will be completed by each
of the 310 participating adolescent patients after each office visit
and will take 1 minute to complete.
A series of four focus groups will be held with 8 adolescent
patients over the course of the study period with each session lasting
about 1.5 hours. In addition to the focus groups one ``think aloud''
session will be held with a group of 8 adolescent patients and will
also take 1.5 hours.
Feedback from the practice staff and the clinicians will be
obtained through 3 different semi-structured interviews. Two staff
members from each of the 4 practices will participate in these
interviews. The clinician and administrator-staff semi-structured
interviews will each last 30 minutes. Semi-structured interviews for
the draft manual will require about one hour total (30 minutes to
review the manual and 30 minutes to participate in the interview). The
total annualized burden is estimated to be 479 hours.
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 $7,980.
Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Activity/data collection Number of responses per Hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
RAAPS questionnaire............................. 310 1.25 12/60 78
Extraction of medical record data............... 4 2 4 32
[[Page 16782]]
Consent-assent form............................. 776 1 15/60 194
Adolescent behavior and communication survey.... 186 2 15/60 93
Post-visit satisfaction survey.................. 310 1.25 1/60 6
Adolescent focus groups......................... 8 4 1.5 48
Adolescent ``think-aloud'' sessions............. 8 1 1.5 12
Clinician semi-structured interviews............ 4 2 30/60 4
Administrator-staff semi-structured interviews.. 4 2 30/60 4
Semi-structured interviews for the draft manual. 4 2 1 8
---------------------------------------------------------------
Total....................................... 1,614 na na 479
----------------------------------------------------------------------------------------------------------------
Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Number of Total burden Average hourly
Activity/data collection cost respondents hours wage rate \1\ Total burden
----------------------------------------------------------------------------------------------------------------
RAAPS questionnaire............................. 310 78 \2\ $9.01 $703
Extraction of medical record data............... 4 32 \3\ 18.15 581
Consent-assent form............................. 776 194 \4\ 22.11 4,289
Adolescent behavior and communication survey.... 186 93 \2\ 9.01 838
Post-visit satisfaction survey.................. 310 6 \2\ 9.01 54
Adolescent focus groups......................... 8 48 \2\ 9.01 432
Adolescent ``think-aloud'' sessions............. 8 12 \2\ 9.01 108
Clinician semi-structured interviews............ 4 4 \5\ 84.53 338
Administrator-staff semi-structured interviews.. 4 4 \6\ 29.63 119
Semi-structured interviews for the draft manual. 4 8 \7\ 64.75 518
---------------------------------------------------------------
Total....................................... 1,614 479 na 7,980
----------------------------------------------------------------------------------------------------------------
\1\ Mean hourly and wage costs for Colorado were derived from the Bureau of Labor and Statistics National
Compensation Survey for May 2009 (https://www.bls.gov/oes/current/oes_co.htm).
\2\ Hourly rate for an entry level worker (occupation code 35-0000) estimates the cost of time for adolescents,
although many will not be employed.
\3\ Hourly rate for medical records and health information technician (29-2071).
\4\ Hourly rate for the mean for all occupations (00-0000) estimates the cost of time for the parent or guardian
of the adolescent.
\5\ Average of hourly rates for a family medicine practitioner (29-1062) and a general internist (29-1063).
\6\ Average of (1) the hourly rate for a medical and health services manager (11-9111) and (2) the average of
the hourly rates for a receptionist (43-4171) and a medical assistant (31-9092).
\7\ Average of (1) the hourly rate for a medical and health services manager (11-9110) and (2) the average of
the hourly rates for a family medicine practitioner (29-1062) and a general internist (29-1063).
Estimated Annual Costs to the Federal Government
Exhibit 3 shows the estimated total and annualized cost to the
Federal Government for conducting this research. These estimates
include the costs associated with the project such as the preparation
of survey administration procedures, labor costs, administrative
expenses, costs associated with copying, postage, and telephone
expenses, data management and analysis, and preparation of final
reports. The annualized and total costs are identical since the data
collection period will last for one year. The total cost is estimated
to be $436,524.
Exhibit 3--Estimated Total and Annualized Cost
------------------------------------------------------------------------
Annualized
Cost component Total cost cost
------------------------------------------------------------------------
Project Development..................... $72,364 $72,364
Data Collection Activities.............. 48,904 48,904
Data Processing and Analysis............ 73,937 73 937
Publication of Results.................. 21,890 21,890
Project Management...................... 75,733 75,733
Overhead................................ 143,696 143,696
-------------------------------
Total............................... 436,524 436,524
------------------------------------------------------------------------
Request for Comments
In accordance with the Paperwork Reduction Act, comments on AHRQs
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
[[Page 16783]]
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: March 15, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011-6857 Filed 3-24-11; 8:45 am]
BILLING CODE 4160-90-M