Agency Information Collection Activities: Proposed Collection; Comment Request, 76736-76739 [2010-30902]
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Federal Register / Vol. 75, No. 236 / Thursday, December 9, 2010 / Notices
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FOR FURTHER INFORMATION CONTACT:
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2010–30806 Filed 12–8–10; 8:45 am]
BILLING CODE 6750–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
SUPPLEMENTARY INFORMATION:
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:
‘‘Improving Patient Safety System
Implementation for Patients with
Limited English Proficiency.’’ In
accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3520,
AHRQ invites the public to comment on
this proposed information collection.
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Comments on this notice must be
received by February 7, 2011.
ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by email at doris.lefkowitz@AHRQ.hhs.gov.
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
e-mail at
doris.lefkowitz@AHRQ.hhs.gov.
Proposed Project
Agency for Healthcare Research and
Quality
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B&H Contracting, L.P.
RHMB Capital, LLC.
Blackstone Capital Partners (Cayman) V–NQ L.P.
Mark Buster.
RHMB Capital, LLC.
B&H Contracting, L.P.
SCS Materials, L.P.
RK Hall Construction Limited.
Hall Materials, LTD.
Laboratory Corporation of America Holdings.
Genzyme Corporation.
Genzyme Genetic Counseling, LLC.
General Electric Company.
Clarient, Inc.
Clarient, Inc.
Carlyle Partners V, L.P.
Syniverse Holdings, Inc.
Syniverse Holdings, Inc.
Lion Capital Fund III (USD), L.P.
Bumble Bee Foods, L.P.
Stinson Seafood (2001), Inc.
Athene Group Ltd.
Royal Bank of Canada.
Liberty Life Insurance Company.
DATES:
Sandra M. Peay, Contact Representative,
or Renee Chapman, Contact
Representative, Federal Trade
Commission, Premerger Notification
Office, Bureau of Competition, Room H–
303, Washington, DC 20580, (202) 326–
3100.
SUMMARY:
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Party name
Improving Patient Safety System
Implementation for Patients with
Limited English Proficiency
According to the 2009 American
Community Survey (U.S. Census
Bureau), approximately 57 million
people 20% of the U.S. population—
speak a language other than English at
home. Of that number, approximately
24 million (8.6% of the U.S. population)
are defined as having Limited English
Proficiency (LEP), meaning that they
report speaking English less than ‘‘very
well’’. Recent research suggests that
adverse events affect LEP patients more
severely than they affect Englishspeaking patients. In addition to
linguistic barriers, LEP patients often
face cultural barriers to care and low
health literacy as well.
AHRQ proposes to develop a new
training program to improve patient
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safety system implementation for
patients with limited English
proficiency. The new training program
is designed as a continuing education
module within the TeamSTEPPS
system. TeamSTEPPS is an evidencebased framework to optimize team
performance across the healthcare
delivery system with the goal of
improving patient safety. This system
has been successfully implemented in
numerous hospitals across the United
States. The TeamSTEPPS curriculum is
an easy-to-use comprehensive
multimedia kit that includes modules in
text and presentation format, video
vignettes to illustrate key concepts, and
workshop materials, including a
supporting CD and DVD, on change
management, coaching, and
implementation. Portions of the training
module may also be useful for hospitals
that have not implemented
TeamSTEPPS. The new training module
will show how TeamSTEPPS principles
can be better implemented to improve
the safety of patients with LEP.
AHRQ proposes to field-test this
module by conducting case studies of its
implementation in three hospitals. The
primary goals of this field test are to
identify needed changes in the training
module content or format to increase the
feasibility of implementation and
improve module outcomes including
audience response, learning, adoption of
recommended team behaviors, and
improved outcomes for LEP patients.
Patient outcome measures for this
project include the patient’s access to an
interpreter and how well they
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Federal Register / Vol. 75, No. 236 / Thursday, December 9, 2010 / Notices
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understood instructions from the
hospital staff.
This study is being conducted by
AHRQ through its contractor, Abt
Associates Inc., 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 quality
measurement and improvement. 42
U.S.C. 299a(a)(1) and (2).
Method of Collection
To achieve the goals of this project the
following activities will be
implemented:
(1) Readiness Assessment Survey of
whether a hospital has the right policies
in place to implement the training
module. The readiness assessment will
be completed by the key contact person
(hospital champion) at each site. The
assessment may be completed in
consultation with other members of a
‘‘change team’’ that the hospital
champion may form to support the
initiative.
(2) Pre-work for Master-Training,
including a survey, process map
exercise, and a request to locate the
hospital’s or organization’s policy on
accessing language services. The prework will be completed by one of the
hospital staff persons selected to be a
Master-Trainer at each site.
(3) Master Training session in which
two staff members from each of three
participating hospitals will learn how to
teach the training module. The
TeamSTEPPS system requires at least
two trainers for each hospital because
its implementation is a team endeavor.
Trainers will be selected either by the
hospital champion, or by the ‘‘change
team’’ formed by the hospital champion
to support the intervention. Trainers
will be selected from among natural
leaders working within the hospital unit
where the training will take place.
Ideally the team will include a provider
(e.g., doctor, nurse) and an interpreter.
Hospital staff selected to attend the
training will be required to travel to
Boston for the training session.
(4) Staff Training session using the
training module developed for this
project. Training participants will be
drawn from the interprofessional care
team in one or more hospital units (e.g.,
ob/gyn, surgery, etc.). This team may
include nurses, physicians, technicians,
front desk staff, and interpreters. Since
the training teaches team behaviors, the
entire interprofessional care team in a
given hospital unit will be asked to
attend the training session together. The
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training will be conducted onsite by the
hospital staff members who attended the
Master Training.
(5) Training Participant Satisfaction
Survey to assess trainee satisfaction
with, and perceived adequacy of, the
training module. This questionnaire will
be administered at the end of the
training module.
(6) Learning Outcomes Survey to
assess staff knowledge about the best
way to handle situations with LEP
patients. To measure the change in staff
knowledge resulting from the training
module this questionnaire will be
administered both before and after the
training.
(7) Pre-training Behavior Survey to
assess trainee behavior change resulting
from the training. The behavior
measured by this survey is the hospital
staffs’ use of interpreters when
interacting with LEP patients. To
measure the change in staff behavior
resulting from the training module,
questions from this survey are repeated
in the post-training behavior survey.
Interpreters are exempt from this
questionnaire because the questions
relate to interpreter use.
(8) Post-Training Behavior Survey to
assess trainee use of interpreters when
interacting with LEP patients (repeated
from the Pre-Training Behavior Survey)
and questions to assess the use of team
communication tools demonstrated
during the training.
(9) Patient Outcome Survey to
measure change in patient
communication and safety outcomes
resulting from the training. This
survey’s target audience is all patients
identified as LEP. The purpose of this
survey is to measure intermediate
outcomes related to LEP patients’ access
to language services, comprehension,
and satisfaction with services.
(10) Semi-Structured Follow-Up
Interview to assess hospitals’
experiences implementing the training
module. This semi-structured
interview’s target audience consists of
up to two master-trainers or change
team members in each hospital where
the training module is implemented.
These interviews will be conducted 3
times at the 2-week, 6-week and 10week mark after the training.
(11) Semi-Structured Site Visit
Interview to assess the hospitals’
experiences implementing the training
module. This semi-structured
interview’s target audience consists of
up to 6 persons who may include
master-trainers, change team members,
frontline staff members, or other persons
designated by the ‘‘hospital champion’’
as persons who might provide insight
into module implementation and
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outcomes. These interviews will be
conducted 3 months after the training.
Estimated Annual Respondent Burden
Exhibit 1 presents estimates of the
reporting burden hours for this one-year
data collection process. Time estimates
are based on experience with similar
instruments used with comparable
respondents. The Readiness Assessment
Survey will be completed by the key
contact/project champion at each of the
3 participating hospitals and will take
about 5 minutes. The pre-work for the
Master-Training will be completed by
the two trainers selected for each site
and will take about 30 minutes. The
Master-Training will be conducted with
2 staff members from each hospital and
will last 41⁄2 hours; the burden estimate
of 12.5 hours includes 8 hours of travel
time to and from the training site. Staff
Training will include up to 30 staff
members at each hospital (plus the 2
trainers who are staff members) and will
last 1 hour. The Training Participant
Satisfaction Survey will be completed
by Staff Training participants at the end
of the training and takes 5 minutes to
complete. The Learning Outcomes
Survey will be administered twice,
before and after the training, and will
require 10 minutes. The Pre-Training
Behavior Survey will be administered to
all staff invited to the training except for
interpreters. It will require
approximately 5 minutes. Interpreters
do not complete this questionnaire
because the questions relate to
interpreter use. The Post-training
Behavior survey will be administered
two or more weeks after the training to
all staff who were invited to the
training, and will take approximately
7.5 minutes to complete. The Patient
Outcome Survey will be administered
twice, before and after the intervention,
to a sample of approximately 90 patients
(30 from each of the 3 participating
hospitals) and requires about 10
minutes to complete. Semi-Structured
Follow-up interviews will be conducted
three times over a 12-week period with
two master trainers or change team
members from each hospital. Each semistructured follow-up interview will last
for about an hour. Semi-Structured Site
visit interviews will be conducted with
6 staff members from each hospital and
will take an hour to complete. The total
annualized burden hours are estimated
to be 295 hours.
Exhibit 2 presents the estimated
annualized cost burden associated with
the respondents’ time to participate in
this research. The total cost burden is
estimated to be about $6,980.
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Federal Register / Vol. 75, No. 236 / Thursday, December 9, 2010 / Notices
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Data collection method
Number of
responses per
respondent
Hours per
response
Total burden
hours
Readiness Assessment Survey .......................................................................
Pre-Work for Master-Training ..........................................................................
Train the Trainer Training ................................................................................
Staff Training ...................................................................................................
Training Participant Satisfaction Survey ..........................................................
Learning Outcomes Survey .............................................................................
Pre-Training Behavior Survey .........................................................................
Post-training Behavior Survey .........................................................................
Patient Outcome Survey ..................................................................................
Semi-Structured Follow-Up Interview ..............................................................
Semi-Structured Site Visit Interview ................................................................
3
3
3
3
3
3
3
3
90
3
3
1
2
2
32
30
60
25
30
2
6
6
5/60
30/60
12.5
1
5/60
10/60
5/60
7.5/60
10/60
1
1
0.25
3
75
96
8
30
6
11
30
18
18
Totals ........................................................................................................
117
na
na
295
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Data collection method
Total burden
hours
Average
hourly wage
rate*
Total cost
burden
Readiness Assessment Survey .......................................................................
Pre-Work for Master-Training ..........................................................................
Train the Trainer Training ................................................................................
Staff Training ...................................................................................................
Training Participant Satisfaction Survey ..........................................................
Learning Outcomes Survey .............................................................................
Pre-training Behavior Survey ...........................................................................
Post-training Behavior Survey .........................................................................
Patient Outcome Survey ..................................................................................
Semi-Structured Follow-Up Interview ..............................................................
Semi-Structured Site Visit Interview ................................................................
3
3
3
3
3
3
3
3
90
3
3
0.25
3
75
96
8
30
6
11
30
18
18
$26.50
26.50
26.50
22.02
22.02
22.02
22.04
22.02
20.90
26.50
26.50
$7
80
1,988
2,114
176
661
132
242
627
477
477
Totals ........................................................................................................
117
295
na
6,980
* The
average hourly wage rate for readiness assessments, train-the-trainer trainings, semi-structured site visit interviews, and semi-structured
follow-up interviews was calculated based on the average of the mean hourly wage rate for healthcare practitioners and medical occupations (all
professions), $31.02 and the average hourly wage rate for interpreters and translators, $21.97. The average hourly rate for staff receiving training
was calculated based on the average of the mean hourly wage rate for healthcare practitioners and medical occupations (all professions),
$31.02, mean hourly wage rate for interpreters and translators, $21.97, and mean hourly wage rate for healthcare support occupations, $13.06.
The average hourly wage rate for respondents to the pre-training behavior survey was calculated based on the average of the mean hourly wage
rate for healthcare practitioners and medical occupations (all professions), $31.02, and mean hourly wage rate for healthcare support occupations, $13.06. The average hourly wage rate for patients was calculated on the mean hourly wage rate for all occupations. Average hourly rate
for unit staff, non-interpreter was calculated based on the average of the mean hourly rate for healthcare practitioners and medical occupations
(all professions), $31.02, and occupations (all professions), $31.02, mean hourly wage rate for interpreters and translators, $21.97, and mean
hourly wage rate for healthcare support occupations, $13.06. Mean hourly wage rates for these groups of occupations were obtained from the
Bureau of Labor Statistics on ‘‘Occupational Employment and Wages, May 2009’’ found at the following urls: https://www.bls.gov/oes/current/
naics4_622100.htm, https://www.bls.gov/oes/current/oes273091.htm https://www.bls.gov/oes/current/oes_nat.htm.
Estimated Annual Costs to the Federal
Government
The total cost of this contract to the
government is $499,978. The project
extends over 4 fiscal years, although
data collection will take place over the
course of a single year. Exhibit 3 shows
a breakdown of the total cost as well as
the annualized cost for the data
collection, processing and analysis
activity.
EXHIBIT 3—ESTIMATED COST
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Cost component
Total cost
Annual cost
Project Development .......................................................................................................................................................
Data Collection Activities .................................................................................................................................................
Data Processing and Analysis .........................................................................................................................................
Publication of Results ......................................................................................................................................................
Project Management ........................................................................................................................................................
$301,664
52,629
52,629
51,658
41,399
$75,416
13,157
13,157
12,915
10,350
Total ..........................................................................................................................................................................
499,978
124,995
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E:\FR\FM\09DEN1.SGM
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Federal Register / Vol. 75, No. 236 / Thursday, December 9, 2010 / 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
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: November 30, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010–30902 Filed 12–8–10; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–E–0047]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ILARIS
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for ILARIS
and is publishing this notice of that
determination as required by law. FDA
has made the determination because of
the submission of an application to the
Director of Patents and Trademarks,
Department of Commerce, for the
extension of a patent which claims that
human biological product.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions along with three copies and
written comments to the Division of
Dockets Management (HFA–305), Food
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SUMMARY:
VerDate Mar<15>2010
15:35 Dec 08, 2010
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and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug
Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6222,
Silver Spring, MD 20993–0002 301–
796–3602.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
and the Generic Animal Drug and Patent
Term Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological becomes effective and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the human biological product and
continues until FDA grants permission
to market the biological product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of Patents and Trademarks may
award (for example, half the testing
phase must be subtracted as well as any
time that may have occurred before the
patent was issued), FDA’s determination
of the length of a regulatory review
period for a human biological product
will include all of the testing phase and
approval phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA recently approved for marketing
the human biologic product ILARIS
(canakinumab). ILARIS is indicated for
the treatment of Cryopyrin Associated
Periodic Syndromes in adults and
children 4 years of age and older
including Familial Cold
Autoinflammatory Syndrome and
Muckle-Wells Syndrome. Subsequent to
this approval, the Patent and Trademark
Office received a patent term restoration
application for ILARIS (U.S. Patent No.
7,446,175) from Novartis AG, and the
Patent and Trademark Office requested
FDA’s assistance in determining this
patent’s eligibility for patent term
restoration. In a letter dated March 24,
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76739
2010, FDA advised the Patent and
Trademark Office that this human
biological product had undergone a
regulatory review period and that the
approval of ILARIS represented the first
permitted commercial marketing or use
of the product. Thereafter, the Patent
and Trademark Office requested that
FDA determine the product’s regulatory
review period.
FDA has determined that the
applicable regulatory review period for
ILARIS is 1,072 days. Of this time, 889
days occurred during the testing phase
of the regulatory review period, while
183 days occurred during the approval
phase. These periods of time were
derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: July 13, 2006. The
applicant claims July 12, 2006, as the
date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was July 13, 2006,
which was 30 days after FDA receipt of
the IND.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262: December 17, 2008. The
applicant claims December 15, 2008, as
the date the biologics license
application (BLA) for ILARIS (BLA
125319) was initially submitted.
However, FDA records indicate that
BLA 125319 was submitted on
December 17, 2008.
3. The date the application was
approved: June 17, 2009. FDA has
verified the applicant’s claim that BLA
125319 was approved on June 17, 2009.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 177 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) either
electronic or written comments and ask
for a redetermination by February 7,
2011. Furthermore, any interested
person may petition FDA for a
determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period by June 7, 2011. To meet its
burden, the petition must contain
sufficient facts to merit an FDA
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]]>Agencies
[Federal Register Volume 75, Number 236 (Thursday, December 9, 2010)]
[Notices]
[Pages 76736-76739]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30902]
=======================================================================
-----------------------------------------------------------------------
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: ``Improving Patient Safety System Implementation for Patients
with Limited English Proficiency.'' 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 February 7, 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:
Proposed Project
Improving Patient Safety System Implementation for Patients with
Limited English Proficiency
According to the 2009 American Community Survey (U.S. Census
Bureau), approximately 57 million people 20% of the U.S. population--
speak a language other than English at home. Of that number,
approximately 24 million (8.6% of the U.S. population) are defined as
having Limited English Proficiency (LEP), meaning that they report
speaking English less than ``very well''. Recent research suggests that
adverse events affect LEP patients more severely than they affect
English-speaking patients. In addition to linguistic barriers, LEP
patients often face cultural barriers to care and low health literacy
as well.
AHRQ proposes to develop a new training program to improve patient
safety system implementation for patients with limited English
proficiency. The new training program is designed as a continuing
education module within the TeamSTEPPS system. TeamSTEPPS is an
evidence-based framework to optimize team performance across the
healthcare delivery system with the goal of improving patient safety.
This system has been successfully implemented in numerous hospitals
across the United States. The TeamSTEPPS curriculum is an easy-to-use
comprehensive multimedia kit that includes modules in text and
presentation format, video vignettes to illustrate key concepts, and
workshop materials, including a supporting CD and DVD, on change
management, coaching, and implementation. Portions of the training
module may also be useful for hospitals that have not implemented
TeamSTEPPS. The new training module will show how TeamSTEPPS principles
can be better implemented to improve the safety of patients with LEP.
AHRQ proposes to field-test this module by conducting case studies
of its implementation in three hospitals. The primary goals of this
field test are to identify needed changes in the training module
content or format to increase the feasibility of implementation and
improve module outcomes including audience response, learning, adoption
of recommended team behaviors, and improved outcomes for LEP patients.
Patient outcome measures for this project include the patient's access
to an interpreter and how well they
[[Page 76737]]
understood instructions from the hospital staff.
This study is being conducted by AHRQ through its contractor, Abt
Associates Inc., 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 quality measurement and improvement. 42 U.S.C. 299a(a)(1)
and (2).
Method of Collection
To achieve the goals of this project the following activities will
be implemented:
(1) Readiness Assessment Survey of whether a hospital has the right
policies in place to implement the training module. The readiness
assessment will be completed by the key contact person (hospital
champion) at each site. The assessment may be completed in consultation
with other members of a ``change team'' that the hospital champion may
form to support the initiative.
(2) Pre-work for Master-Training, including a survey, process map
exercise, and a request to locate the hospital's or organization's
policy on accessing language services. The pre-work will be completed
by one of the hospital staff persons selected to be a Master-Trainer at
each site.
(3) Master Training session in which two staff members from each of
three participating hospitals will learn how to teach the training
module. The TeamSTEPPS system requires at least two trainers for each
hospital because its implementation is a team endeavor. Trainers will
be selected either by the hospital champion, or by the ``change team''
formed by the hospital champion to support the intervention. Trainers
will be selected from among natural leaders working within the hospital
unit where the training will take place. Ideally the team will include
a provider (e.g., doctor, nurse) and an interpreter. Hospital staff
selected to attend the training will be required to travel to Boston
for the training session.
(4) Staff Training session using the training module developed for
this project. Training participants will be drawn from the
interprofessional care team in one or more hospital units (e.g., ob/
gyn, surgery, etc.). This team may include nurses, physicians,
technicians, front desk staff, and interpreters. Since the training
teaches team behaviors, the entire interprofessional care team in a
given hospital unit will be asked to attend the training session
together. The training will be conducted onsite by the hospital staff
members who attended the Master Training.
(5) Training Participant Satisfaction Survey to assess trainee
satisfaction with, and perceived adequacy of, the training module. This
questionnaire will be administered at the end of the training module.
(6) Learning Outcomes Survey to assess staff knowledge about the
best way to handle situations with LEP patients. To measure the change
in staff knowledge resulting from the training module this
questionnaire will be administered both before and after the training.
(7) Pre-training Behavior Survey to assess trainee behavior change
resulting from the training. The behavior measured by this survey is
the hospital staffs' use of interpreters when interacting with LEP
patients. To measure the change in staff behavior resulting from the
training module, questions from this survey are repeated in the post-
training behavior survey. Interpreters are exempt from this
questionnaire because the questions relate to interpreter use.
(8) Post-Training Behavior Survey to assess trainee use of
interpreters when interacting with LEP patients (repeated from the Pre-
Training Behavior Survey) and questions to assess the use of team
communication tools demonstrated during the training.
(9) Patient Outcome Survey to measure change in patient
communication and safety outcomes resulting from the training. This
survey's target audience is all patients identified as LEP. The purpose
of this survey is to measure intermediate outcomes related to LEP
patients' access to language services, comprehension, and satisfaction
with services.
(10) Semi-Structured Follow-Up Interview to assess hospitals'
experiences implementing the training module. This semi-structured
interview's target audience consists of up to two master-trainers or
change team members in each hospital where the training module is
implemented. These interviews will be conducted 3 times at the 2-week,
6-week and 10-week mark after the training.
(11) Semi-Structured Site Visit Interview to assess the hospitals'
experiences implementing the training module. This semi-structured
interview's target audience consists of up to 6 persons who may include
master-trainers, change team members, frontline staff members, or other
persons designated by the ``hospital champion'' as persons who might
provide insight into module implementation and outcomes. These
interviews will be conducted 3 months after the training.
Estimated Annual Respondent Burden
Exhibit 1 presents estimates of the reporting burden hours for this
one-year data collection process. Time estimates are based on
experience with similar instruments used with comparable respondents.
The Readiness Assessment Survey will be completed by the key contact/
project champion at each of the 3 participating hospitals and will take
about 5 minutes. The pre-work for the Master-Training will be completed
by the two trainers selected for each site and will take about 30
minutes. The Master-Training will be conducted with 2 staff members
from each hospital and will last 4\1/2\ hours; the burden estimate of
12.5 hours includes 8 hours of travel time to and from the training
site. Staff Training will include up to 30 staff members at each
hospital (plus the 2 trainers who are staff members) and will last 1
hour. The Training Participant Satisfaction Survey will be completed by
Staff Training participants at the end of the training and takes 5
minutes to complete. The Learning Outcomes Survey will be administered
twice, before and after the training, and will require 10 minutes. The
Pre-Training Behavior Survey will be administered to all staff invited
to the training except for interpreters. It will require approximately
5 minutes. Interpreters do not complete this questionnaire because the
questions relate to interpreter use. The Post-training Behavior survey
will be administered two or more weeks after the training to all staff
who were invited to the training, and will take approximately 7.5
minutes to complete. The Patient Outcome Survey will be administered
twice, before and after the intervention, to a sample of approximately
90 patients (30 from each of the 3 participating hospitals) and
requires about 10 minutes to complete. Semi-Structured Follow-up
interviews will be conducted three times over a 12-week period with two
master trainers or change team members from each hospital. Each semi-
structured follow-up interview will last for about an hour. Semi-
Structured Site visit interviews will be conducted with 6 staff members
from each hospital and will take an hour to complete. The total
annualized burden hours are estimated to be 295 hours.
Exhibit 2 presents the estimated annualized cost burden associated
with the respondents' time to participate in this research. The total
cost burden is estimated to be about $6,980.
[[Page 76738]]
Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Data collection method Number of responses per Hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Readiness Assessment Survey..................... 3 1 5/60 0.25
Pre-Work for Master-Training.................... 3 2 30/60 3
Train the Trainer Training...................... 3 2 12.5 75
Staff Training.................................. 3 32 1 96
Training Participant Satisfaction Survey........ 3 30 5/60 8
Learning Outcomes Survey........................ 3 60 10/60 30
Pre-Training Behavior Survey.................... 3 25 5/60 6
Post-training Behavior Survey................... 3 30 7.5/60 11
Patient Outcome Survey.......................... 90 2 10/60 30
Semi-Structured Follow-Up Interview............. 3 6 1 18
Semi-Structured Site Visit Interview............ 3 6 1 18
---------------------------------------------------------------
Totals...................................... 117 na na 295
----------------------------------------------------------------------------------------------------------------
Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Average
Data collection method Number of Total burden hourly wage Total cost
respondents hours rate* burden
----------------------------------------------------------------------------------------------------------------
Readiness Assessment Survey..................... 3 0.25 $26.50 $7
Pre-Work for Master-Training.................... 3 3 26.50 80
Train the Trainer Training...................... 3 75 26.50 1,988
Staff Training.................................. 3 96 22.02 2,114
Training Participant Satisfaction Survey........ 3 8 22.02 176
Learning Outcomes Survey........................ 3 30 22.02 661
Pre-training Behavior Survey.................... 3 6 22.04 132
Post-training Behavior Survey................... 3 11 22.02 242
Patient Outcome Survey.......................... 90 30 20.90 627
Semi-Structured Follow-Up Interview............. 3 18 26.50 477
Semi-Structured Site Visit Interview............ 3 18 26.50 477
---------------------------------------------------------------
Totals...................................... 117 295 na 6,980
----------------------------------------------------------------------------------------------------------------
\*\ The average hourly wage rate for readiness assessments, train-the-trainer trainings, semi-structured site
visit interviews, and semi-structured follow-up interviews was calculated based on the average of the mean
hourly wage rate for healthcare practitioners and medical occupations (all professions), $31.02 and the
average hourly wage rate for interpreters and translators, $21.97. The average hourly rate for staff receiving
training was calculated based on the average of the mean hourly wage rate for healthcare practitioners and
medical occupations (all professions), $31.02, mean hourly wage rate for interpreters and translators, $21.97,
and mean hourly wage rate for healthcare support occupations, $13.06. The average hourly wage rate for
respondents to the pre-training behavior survey was calculated based on the average of the mean hourly wage
rate for healthcare practitioners and medical occupations (all professions), $31.02, and mean hourly wage rate
for healthcare support occupations, $13.06. The average hourly wage rate for patients was calculated on the
mean hourly wage rate for all occupations. Average hourly rate for unit staff, non-interpreter was calculated
based on the average of the mean hourly rate for healthcare practitioners and medical occupations (all
professions), $31.02, and occupations (all professions), $31.02, mean hourly wage rate for interpreters and
translators, $21.97, and mean hourly wage rate for healthcare support occupations, $13.06. Mean hourly wage
rates for these groups of occupations were obtained from the Bureau of Labor Statistics on ``Occupational
Employment and Wages, May 2009'' found at the following urls: https://www.bls.gov/oes/current/naics4_622100.htm, https://www.bls.gov/oes/current/oes273091.htm https://www.bls.gov/oes/current/oes_nat.htm.
Estimated Annual Costs to the Federal Government
The total cost of this contract to the government is $499,978. The
project extends over 4 fiscal years, although data collection will take
place over the course of a single year. Exhibit 3 shows a breakdown of
the total cost as well as the annualized cost for the data collection,
processing and analysis activity.
Exhibit 3--Estimated Cost
------------------------------------------------------------------------
Cost component Total cost Annual cost
------------------------------------------------------------------------
Project Development........................... $301,664 $75,416
Data Collection Activities.................... 52,629 13,157
Data Processing and Analysis.................. 52,629 13,157
Publication of Results........................ 51,658 12,915
Project Management............................ 41,399 10,350
-------------------------
Total..................................... 499,978 124,995
------------------------------------------------------------------------
[[Page 76739]]
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: November 30, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010-30902 Filed 12-8-10; 8:45 am]
BILLING CODE 4160-90-M
