[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 (http://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