Agency Information Collection Activities: Proposed Collection; Comment Request, 2390-2393 [2011-408]
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Background Information on ICCVAM
and NICEATM
ICCVAM is an interagency committee
composed of representatives from 15
Federal regulatory and research agencies
that require, use, generate, or
disseminate toxicological and safety
testing information. ICCVAM conducts
technical evaluations of new, revised,
and alternative methods with regulatory
applicability and promotes the scientific
validation and regulatory acceptance of
toxicological and safety-testing methods
that more accurately assess the safety
and hazards of chemicals and products
and that reduce, refine (decrease or
eliminate pain and distress), or replace
animal use. The ICCVAM Authorization
Act of 2000 established ICCVAM as a
permanent interagency committee of the
NIEHS under NICEATM (42 U.S.C.
285l–3(a)). NICEATM administers
ICCVAM, provides scientific and
operational support for ICCVAM-related
activities, and conducts independent
validation studies to assess the
usefulness and limitation of new,
revised, and alternative test methods.
NICEATM and ICCVAM work
collaboratively to evaluate new and
improved test methods applicable to the
needs of U.S. Federal agencies.
NICEATM and ICCVAM welcome the
public nomination of new, revised, and
alternative test methods for validation
studies and technical evaluations.
Additional information about ICCVAM
and NICEATM can be found on the
NICEATM–ICCVAM Web site (https://
iccvam.niehs.nih.gov).
srobinson on DSKHWCL6B1PROD with NOTICES
References
EPA. 2003. Health Effects Test
Guidelines: OPPTS 870.2600—Skin
Sensitization. EPA 712–C–03–197.
Washington, DC: U.S.
Environmental Protection Agency.
Available: https://www.epa.gov/
ocspp/pubs/frs/publications/
Test_Guidelines/series870.htm.
ICCVAM 2010 ICCVAM Test Method
Evaluation Report. The Murine
Local Lymph Node Assay: BrdUELISA, a Nonradioactive
Alternative Test Method to Assess
the Allergic Contact Dermatitis
Potential of Chemicals and
Products. NIH Publication No. 10–
7552. Research Triangle Park, NC:
National Institute of Environmental
Health Sciences. Available at:
https://iccvam.niehs.nih.gov/
methods/immunotox/llna-ELISA/
TMER.htm.
ICCVAM. 2010. ICCVAM Test Method
Evaluation Report. The Murine
Local Lymph Node Assay: DA, a
Nonradioactive Alternative Test
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Method to Assess the Allergic
Contact Dermatitis Potential of
Chemicals and Products. NIH
Publication No. 10–7551. Research
Triangle Park, NC: National
Institute of Environmental Health
Sciences. Available at: https://
iccvam.niehs.nih.gov/methods/
immunotox/llna-D/TMER.htm.
ICCVAM. 2010. ICCVAM Test Method
Evaluation Report on Using the
LLNA for Testing Pesticide
Formulations, Metals, Substances in
Aqueous Solutions, and Other
Products. NIH Publication No. 10–
7512. Research Triangle Park, NC:
National Institute of Environmental
Health Sciences. Available at:
https://iccvam.niehs.nih.gov/
methods/immunotox/LLNA-app/
TMER.htm.
ICCVAM. 2009. Recommended
Performance Standards: Murine
Local Lymph Node Assay. NIH
Publication No. 09–7357. Research
Triangle Park, NC: National
Institute of Environmental Health
Sciences. Available at: https://
iccvam.niehs.nih.gov/methods/
immunotox/llna_PerfStds.htm.
ICCVAM. 1999. The Murine Local
Lymph Node Assay: A Test Method
for Assessing the Allergic Contact
Dermatitis Potential of Chemicals/
Compounds. The Results of an
Independent Peer Review
Evaluation Coordinated by ICCVAM
and NICEATM. NIH Publication No.
99–4494. Research Triangle Park,
NC: National Institute of
Environmental Health Sciences.
Available at: https://
iccvam.niehs.nih.gov/methods/
immunotox/llna_PeerPanel98.htm.
ISO. 2002. Biological evaluation of
medical devices—10993 Part 10:
Tests for irritation and delayed-type
hypersensitivity. Available for
purchase at: https://www.iso.org/iso/
home.htm.
ISO. 2010. Biological evaluation of
medical devices—10993 Part 10:
Tests for irritation and skin
sensitization. Available for
purchase at: https://www.iso.org/iso/
home.htm.
OECD. 2002. Test Guideline 429. Skin
Sensitization: Local Lymph Node
Assay, adopted April 24, 2002. In:
OECD Guidelines for Testing of
Chemicals. Paris: OECD.
OECD. 2010a. Test Guideline 429. Skin
Sensitization: Local Lymph Node
Assay, adopted July 22, 2010. In:
OECD Guidelines for Testing of
Chemicals. Paris: OECD. Available
at: https://dx.doi.org/10.1787/
9789264071100-en.
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OECD. 2010b. Test Guideline 442B.
Skin Sensitization: Local Lymph
Node Assay: BrdU-ELISA, adopted
July 22, 2010. In: OECD Guidelines
for Testing of Chemicals. Paris:
OECD. Available at: https://
dx.doi.org/10.1787/9789264090996en.
OECD. 2010c. Test Guideline 442A.
Skin Sensitization: Local Lymph
Node Assay: DA, adopted July 22,
2010. In: OECD Guidelines for
Testing of Chemicals. Paris: OECD.
Available at: https://dx.doi.org/
10.1787/9789264090972-en.
Dated: January 5, 2011.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. 2011–669 Filed 1–12–11; 8:45 am]
BILLING CODE 4140–01–P
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:
‘‘Connecting Primary Care Practices with
Hard-to-Reach Adolescent Populations.’’
In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3520,
AHRQ invites the public to comment on
this proposed information collection.
DATES: Comments on this notice must be
received by March 14, 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
e-mail at
doris.lefkowitz@AHRQ.hhs.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
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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, & Star 2008; Salerno, 2008;
Yi, Martyn, Salerno, & Darling-Fisher,
2009). Outside of the office, youth have
increasingly turned to the internet for
health-related information, and have
also rapidly adopted mobile technology
(Lenhart, Ling, 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,
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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.
(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)(l) 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
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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
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
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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 15 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 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 postintervention, by 233 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 5 minutes
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 ‘‘thinkaloud’’ 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 548 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 $8,601.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
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Activity/data collection
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
233
310
8
8
4
4
4
Total ..........................................................................................................
Number of
responses per
respondent
1,661
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1.25
2
1
2
1.25
4
1
2
2
2
na
13JAN1
Hours per
response
Total burden
hours
15/60
4
15/60
15/60
5/60
1.5
1.5
30/60
30/60
1
97
32
194
117
32
48
12
4
4
8
na
548
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Federal Register / Vol. 76, No. 9 / Thursday, January 13, 2011 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of respondents
Activity/data collection
Total burden
hours
Average hourly wage rate 1
Total cost
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
233
310
8
8
4
4
4
97
32
194
117
32
48
12
4
4
8
$9.01 2
18.15 3
22.11 4
9.01 2
9.01 2
9.01 2
9.01 2
84.53 5
29.63 6
64.75 7
$874
581
4,289
1,054
288
432
108
338
119
518
Total ..........................................................................................................
1,661
548
na
8,601
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.htrn).
2 Hourly rate for an entry level worker (occupation code 3 5–0000) 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
Cost component
Total cost
Annualized cost
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
srobinson on DSKHWCL6B1PROD 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
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
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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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: January 4, 2011.
Carolyn M. Clancy,
Director.
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
[FR Doc. 2011–408 Filed 1–12–11; 8:45 am]
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Centers for Disease Control and
Prevention
[30Day–11–0338]
Agency Forms Undergoing Paperwork
Reduction Act Review
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]]>Agencies
[Federal Register Volume 76, Number 9 (Thursday, January 13, 2011)]
[Notices]
[Pages 2390-2393]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-408]
-----------------------------------------------------------------------
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: ``Connecting Primary Care Practices with Hard-to-Reach
Adolescent Populations.'' In accordance with the Paperwork Reduction
Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this
proposed information collection.
DATES: Comments on this notice must be received by March 14, 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 e-mail at
doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
[[Page 2391]]
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, & Star 2008; Salerno, 2008; Yi,
Martyn, Salerno, & Darling-Fisher, 2009). Outside of the office, youth
have increasingly turned to the internet for health-related
information, and have also rapidly adopted mobile technology (Lenhart,
Ling, 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)(l) 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 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
[[Page 2392]]
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 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 15
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 233 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 5 minutes 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 548 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 $8,601.
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 15/60 97
Extraction of medical record data................. 4 2 4 32
Consent-assent form............................... 776 1 15/60 194
Adolescent behavior and communication survey...... 233 2 15/60 117
Post-visit satisfaction survey.................... 310 1.25 5/60 32
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......................................... 1,661 na na 548
----------------------------------------------------------------------------------------------------------------
[[Page 2393]]
Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Number of Total burden Average hourly Total cost
Activity/data collection respondents hours wage rate \1\ burden
----------------------------------------------------------------------------------------------------------------
RAAPS questionnaire............................. 310 97 $9.01 \2\ $874
Extraction of medical record data............... 4 32 18.15 \3\ 581
Consent-assent form............................. 776 194 22.11 \4\ 4,289
Adolescent behavior and communication survey.... 233 117 9.01 \2\ 1,054
Post-visit satisfaction survey.................. 310 32 9.01 \2\ 288
Adolescent focus groups......................... 8 48 9.01 \2\ 432
Adolescent ``think-aloud'' sessions............. 8 12 9.01 \2\ 108
Clinician semi-structured interviews............ 4 4 84.53 \5\ 338
Administrator-staff semi-structured interviews.. 4 4 29.63 \6\ 119
Semi-structured interviews for the draft manual. 4 8 64.75 \7\ 518
---------------------------------------------------------------
Total....................................... 1,661 548 na 8,601
----------------------------------------------------------------------------------------------------------------
\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.htrn).
\2\ Hourly rate for an entry level worker (occupation code 3 5-0000) 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
------------------------------------------------------------------------
Cost component Total cost Annualized 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 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 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: January 4, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011-408 Filed 1-12-11; 8:45 am]
BILLING CODE 4160-90-M
