Agency Information Collection Activities; Proposed Collection; Comment Request, 35038-35041 [2010-14864]
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35038
Federal Register / Vol. 75, No. 118 / Monday, June 21, 2010 / Notices
formulating, monitoring, and evaluating
ASPR budgets and financial plans that
support program activities and ensures
the effective and efficient execution of
ASPR financial resources. OFPA has
administrative oversight of the
Administration & Finance section of the
emergency management group that is
activated under ESF 8 of the NRF during
a public health emergency. On behalf of
the ASPR, OFPA serves as the primary
point of contact with the Office of the
Assistant Secretary for Financial
Resources, the Office of Management
and Budget (OMB) and Congressional
Appropriation Committees. In
compliance with OMB Circular A–123,
FPA ensures accountability and
effectiveness of ASPR’s financial
programs and operations by
establishing, assessing, correcting, and
reporting on internal controls.
The Office of Financial Planning and
Analysis is headed by a Director and
includes the following components:
• Division of Budget Formulation and
Execution (ANF1)
• Division of Requisition Services
(ANF2)
• Division of Management Assurance
(ANF3)
• Division of Administration and
Finance (ANF4)
II. Delegations of Authority. All
delegations and redelegations of
authority made to officials and
employees of affected organizational
components will continue in them or
their successors pending further
redelegation, provided they are
consistent with this reorganization.
Dated: June 14, 2010.
E.J. Holland, Jr.,
Assistant Secretary for Administration.
[FR Doc. 2010–14997 Filed 6–18–10; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities; Proposed Collection;
Comment Request
sroberts on DSKD5P82C1PROD with NOTICES
AGENCY: Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
SUMMARY: This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project:
‘‘Avoiding Readmissions in Hospitals
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15:46 Jun 18, 2010
Jkt 220001
Serving Diverse Patients.’’ 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 August 20, 2010.
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.
SUPPLEMENTARY INFORMATION:
Proposed Project
Avoiding Readmissions in Hospitals
Serving Diverse Patients
An important part of AHRQ’s mission
is to disseminate information and tools
that can support improvement in quality
and safety in the U.S. health care
community. The transition process from
the hospital to the outpatient setting is
nonstandardized and frequently
inadequate in quality. One in five
hospital discharges is complicated by an
adverse event (AE) within 30 days, often
leading to an emergency department
visit and/or rehospitalization. Many
readmissions stem from errors that can
be directly attributed to the
discontinuity and fragmentation of care
at discharge. High rates of low health
literacy, lack of coordination in the
‘‘hand-off’ from the hospital to
community care, gaps in social
supports, and other limitations also
contribute to the risk of
rehospitalization.
Boston University Medical Center
(BUMC), through a grant from AHRQ,
previously defined the discharge
process and determined what
improvements could be made to
improve this care transition for patients.
This new process was called the ‘‘reengineered discharge’’ (RED). The RED
consists of 11 elements, including
educating the patient throughout the
hospital stay, making follow-up
appointments, and giving the patient a
written discharge plan. The RED was
tested in a randomized controlled trial
in an academic safety net hospital at
BUMC with English speaking, general
medical patients being discharged to
home or community settings. Results of
this trial of 749 patients showed a
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reduction in rehospitalizations within
30 days and emergency department
visits following hospital discharge.
Participants also followed up with
primary care providers more often and
reported higher patient satisfaction with
the discharge process. Project RED
researchers created several tools to help
hospitals replicate RED. After AHRQ
and Project RED researchers fielded
many inquiries about how to implement
Project RED at hospitals nationwide,
AHRQ realized that the Project RED
Toolkit did not provide sufficient
guidance to potential replicators.
Various components of the RED were
not documented, and issues regarding
implementing the RED at hospitals
serving linguistically and culturally
diverse patient populations had not
been addressed. AHRQ has therefore
contracted with the RED researchers to
create a revised RED Toolkit that will
address these issues.
This proposed information collection
supports AHRQs mission by improving
upon the RED Toolkit. This project has
the following 3 goals:
(1) To revise the Project RED Toolkit
to comprehensively address all
components of the RED, as well as the
needs of culturally and linguistically
diverse patients;
(2) To pre-test the revised RED Toolkit
in ten varied hospital settings,
evaluating how the RED Toolkit is
implemented in varied hospital settings
by: (a) Documenting the implementation
process; (b) assessing the fidelity of
implementation; and (c) identifying the
factors that affect redesign fidelity,
including intensity of technical
assistance (TA).
(3) To modify the revised RED Toolkit
based on pre-testing and to disseminate
it.
BUMC will provide TA at two varying
levels. Four selected hospitals will
receive ‘‘train-the-trainer’’ TA, which
includes:
(1) Telephone assistance in
conducting a baseline needs assessment;
(2) Master trainer training;
(3) Access to Webinar trainings
specifically designed for each user
(nurse, IT professional, hospital
leadership, and pharmacist);
(4) An electronic template to print an
After Hospital Care Plan (AHCP)
booklet; and
(5) E-mails regarding updates to the
RED Web site and the opportunity to ask
questions about the newly revised and
enhanced RED tools and
implementation via telephone and
email.
Six selected hospitals will receive
intensive TA, which includes:
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sroberts on DSKD5P82C1PROD with NOTICES
Federal Register / Vol. 75, No. 118 / Monday, June 21, 2010 / Notices
(1) Telephone baseline needs
assessment;
(2) On-site training;
(3) Monthly semi-structured
interviews via phone calls with the
implementation team to discuss
implementation efforts and barriers;
(4) Adaptation of the revised RED
Toolkit to include specific details about
the hospital (such as the hospital name
on the cover of the AHCP booklet and
hospital-specific services provided to
patients included in the AHCP booklet);
(5) An assessment and evaluation site
visit by the organizational change
evaluator (a member of the
implementation team), at baseline and
12 months after the start of
implementation efforts to interview
select participating hospital staff;
6) IT support to install and support
the RED Toolkit software to
automatically generate the AHCP
booklet; and
(7) E-mails regarding updates to the
RED Web site and the opportunity to ask
questions about the newly revised and
enhanced RED tools and
implementation via telephone and
email.
A diverse group of hospitals will be
selected to receive each level of TA,
based upon hospital size, location,
readmission rate and patient
population. Implementing the revised
RED Toolkit in diverse settings will
provide a better understanding of
whether and how RED can be best
implemented in different hospital
settings.
The project will be framed within a
model of organizational change and
transformation called the Organizational
Transformation Model (OTM), which is
based on the evaluation of Robert Wood
Johnson Foundation’s Pursuing
Perfection initiative. OTM identifies key
elements that drive dramatic system
change and informs the implementation
process and impact evaluation. Using a
mixed-methods design, the evaluation
tracks change over time and across the
implementation period within each
hospital. The evaluation therefore will
encompass feedback on specific
implementation processes and factors in
microsystems where RED is adopted, in
the larger organizational context, and
interactions between the two.
This research study is being
conducted by AHRQ through its
contractor, BUMC, pursuant to AHRQ’s
statutory authority to conduct and
support research on healthcare and
disseminate information on systems for
the delivery of such care, including
activities with respect to the quality,
effectiveness, efficiency,
appropriateness and value of healthcare
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services and with respect to quality
measurement and improvement. 42
U.S.C. 299(b) and 299a(a)(1) and (2).
Method of Collection
To achieve the projects’ second and
third goals, the following data
collections and training will be
implemented for the six hospitals that
will receive more TA as well as the 4
hospitals receiving train-the-trainer TA,
unless otherwise noted:
(1) Baseline needs assessment to help
each hospital plan and prepare for
implementation of the revised RED
Toolkit and to evaluate it in varied
settings. The baseline needs assessment
will be administered by telephone,
approximately two months prior to
implementation, to the key contact at
each of the ten study hospitals. The
purpose of the assessment is to identify
the implementation team, collect some
basic information about the hospital,
such as the number of beds and if
electronic medical records are used, and
to establish the baseline readmission
rate.
(2) Monthly semi-structured
interviews with the key contact or other
implementation team member will be
conducted monthly for 12 months after
implementation. These interviews will
be conducted by phone with each of the
six hospitals receiving intensive
technical assistance (TA) (the two levels
of TA are described above). The purpose
of these interviews are to allow
hospitals to share their experiences with
implementing the revised RED Toolkit,
their use of specific tools, changes
resulting from using the tools and
problems encountered implementing
the revised RED Toolkit and how they
are being addressed.
(3) Baseline semi-structured
interviews will be conducted prior to
the implementation of the revised RED
Toolkit with 15 hospital staff from each
of the six study hospitals receiving
intensive TA. The purpose of this
interview is to measure the staffs
opinion of the current discharge
process, their perceived need for a
redesigned process, and the perceived
barriers and facilitators to redesigning
the discharge process.
(4) Post implementation semistructured interviews will be conducted
12 months after the implementation of
the revised RED Toolkit with 15
hospital staff from each of the six study
hospitals receiving intensive TA. The
purpose of this interview is to measure
the staffs opinion of the redesigned
discharge process, which tools were
used and their opinion of the tools, and
the observed barriers and facilitators to
redesigning the discharge process.
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35039
(5) Patient surveys will be
administered by telephone to a random
sample of patients 30 days after being
discharged from one of the six intensive
TA study hospitals. The purpose of this
survey is to measure patient outcomes,
including satisfaction with the care they
received, 30-day hospital and
emergency department visits, and
physician appointments, to help
determine the success of the RED
Toolkit implementation in diverse
patient populations. The survey will be
administered by a hospital staff member
to patients during the preimplementation period and again during
the post-implementation period to
compare patient outcomes.
(6) Medical record review of patient
outcomes at all ten study hospitals. This
data collection will be conducted both
pre- and postimplementation of the
revised RED Toolkit and will inform the
success of the revised RED Toolkit
implementation in diverse patient
populations. Outcomes to be collected
include process outcomes, such as
primary care provider appointments
scheduled prior to discharge, and
patient outcomes, such as 30-day
hospital and emergency department
visits.
(7) Master trainer training will be
conducted with 3 staff members from
each of the 4 hospitals receiving trainthe-trainer TA. These people will be
trained to administer the RED Toolkit
and be able to use recorded Webinar
training sessions within their
organization. They will be invited to
travel to BUMC for a 2-day onsite
orientation of the RED intervention.
These people will meet with several
members of the BUMC implementation
team (physician leader, discharge
advocate nurse) and will have the
opportunity to shadow the nurse
discharge advocates in conducting the
RED intervention.
(8) Intensive training will be
conducted with about 28 staff from each
of the 6 hospitals receiving intensive
TA. The training will consist of a twoday on-site orientation and training at
each hospital conducted by the BUMC
implementation team. The BUMC
implementation team will consist of a
physician researcher, a discharge
advocate nurse, an organizational
change champion/evaluator and the
information technology expert. The
BUMC team will spend two days, 8
hours per day, to train the relevant
hospital staff to perform the 11
components of the RED discharge. The
training will include material for senior
hospital management, hospital
physicians, nurses, IT staff, and
pharmacists.
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Federal Register / Vol. 75, No. 118 / Monday, June 21, 2010 / Notices
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours associated
with the respondent’s time to
participate in this research. The baseline
needs assessment will be administered
to the key contact at each of the 10
participating hospitals and takes about 2
hours to complete. Monthly semistructured interviews with the key
contact or other implementation team
member will be conducted monthly for
12 months after implementation. These
interviews will be conducted by phone
with each of the six hospitals receiving
intensive TA and will require 1 hour to
complete. Both the base-line and postimplementation semi-structured
interviews will be conducted with 15
staff members from each of the 6
hospitals receiving intensive TA and
will last about one hour. The patient
survey will be administered twice, pre
and post implementation, to 3,108
patients recently discharged from one of
the 6 hospitals receiving intensive TA
and requires 10 minutes to complete.
Medical record review will be
performed at all 10 participating
hospitals both pre- and postimplementation and will take about 41.6
hours. Master trainer training will be
conducted with 3 staff members from
each of the 4 hospitals receiving train
the trainer TA and will last 16 hours.
Intensive training will be conducted
with about 28 staff members from each
of the 6 hospitals receiving intensive TA
and will also last 16 hours. The total
annualized burden is estimated to be
5,020 hours.
Exhibit 2 shows the estimated
annualized cost burden associated with
the respondent’s time to participate in
this research. The total annualized cost
burden is estimated to be $162,157.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Hours per
response
Total burden
hours
Baseline needs assessment ............................................................................
Monthly semi-structured interviews .................................................................
Base-line semi-structured interview .................................................................
Post implementation semi-structured interview ...............................................
Patient survey ..................................................................................................
Medical record review ......................................................................................
Master trainer training ......................................................................................
Intensive training ..............................................................................................
10
6
6
6
3,108
10
4
6
1
12
15
15
2
2
3
28
2
1
1
1
10/60
41.6
16
16
20
72
90
90
1,036
832
192
2,688
Total ..........................................................................................................
3,156
na
na
5,020
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Form name
Average
hourly wage
rate*
Total burden
hours
Total cost
burden
Baseline needs assessment ............................................................................
Monthly semi-structured interviews .................................................................
Base-line semi-structured interview .................................................................
Post implementation semi-structured interview ...............................................
Patient survey ..................................................................................................
Medical record review ......................................................................................
Master trainer training ......................................................................................
Intensive training ..............................................................................................
10
6
6
6
3,108
10
4
6
20
72
90
90
1,036
832
192
2,688
a $41.94
20.32
17.32
g 31.31
h 40.91
$839
2,946
3,466
3,466
21,052
14,410
6,012
109,966
Total ..........................................................................................................
3,156
5,020
na
162,157
b 40.91
c 38.51
d 38.51
* Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United States May 2008, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
a 75% Nurses (29–1111, $31.31/hr), 20% Physicians (29–1069, $79.33/hr) and 5% General and Operations Managers (29–1069, $51.91/hr);
b 80% Nurses and 20% Physicians; c and d 85% Nurses and 15% Physicians; e 100% General public (00–0000, $20.32/hr); f 100% Statistical assistants (43–9111, $17.32/hr); g 100% Nurses; h 80% Nurses and 20% Physicians.
Estimated Annual Costs to the Federal
Government
this clearance. The total cost is
$449,976.
Exhibit 3 shows the total and
annualized cost over the 18 months of
sroberts on DSKD5P82C1PROD with NOTICES
EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST
Cost component
Total cost
Project RED Toolkit Development ...............................................................................................................
Dissemination Planning and Support ..........................................................................................................
Data Collection Activities .............................................................................................................................
Data Processing and Analysis .....................................................................................................................
Publication of Results ..................................................................................................................................
Project Management ....................................................................................................................................
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E:\FR\FM\21JNN1.SGM
$97,413
98,080
84,563
52,215
3,184
28,892
21JNN1
Annual cost
$64,942
65,387
56,375
34,810
2,123
19,261
35041
Federal Register / Vol. 75, No. 118 / Monday, June 21, 2010 / Notices
EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST—Continued
Cost component
Total cost
Annual cost
Overhead .....................................................................................................................................................
85,629
57,086
Total ......................................................................................................................................................
449,976
299,984
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: June 8, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010–14864 Filed 6–18–10; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day–10–10EG]
sroberts on DSKD5P82C1PROD with NOTICES
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
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15:46 Jun 18, 2010
Jkt 220001
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Maryam I. Daneshvar,
CDC Acting Reports Clearance Officer,
1600 Clifton Road, MS–D74, Atlanta,
GA 30333 or send an e-mail to
omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection 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
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
Audience Analysis for
Biomonitoring—New—National Center
for Environmental Health/Agency for
Toxic Substances and Disease Registry
(NCEH/ATSDR), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
People’s exposure to environmental
chemicals can be a risk to their health.
Scientists at the CDC use biomonitoring,
which is the measurement of
environmental chemicals in human
tissues and fluids, to assess such
exposure. Biomonitoring findings,
however, do not typically provide
information on health risks and toxicity
data often lag behind new
biomonitoring data. The health effects
on humans are, therefore, often
uncertain or unknown, particularly, for
many new or ‘‘emerging’’ chemicals.
Nevertheless, communicating
biomonitoring findings for those
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charged with this task is necessary,
especially due to the growing media
coverage and public concern about
chemicals found in the human body.
The demand for answers and decreasing
patience with uncertainty characterizes
the interpretation of such results. This
poses enormous challenges to those
tasked to communicate such findings to
both scientific and non-scientific
audiences without a biomonitoring
background.
The CDC is, therefore, interested in
developing a framework for
communicating health risk messages,
particularly about emerging
environmental chemicals, to the
attentive public audience such as
selected women who are pregnant or
have very young children. The three
environmental chemicals, Bisphenol A
(BPA), phthalates, and mercury have
been selected for this study. They are of
particular interest to these selected
women as the risks of exposure are
higher for very young children because
of their hand-to-mouth behaviors and
direct oral (mouth) contact with
materials containing these chemicals.
Furthermore, young children eat and
drink more per pound of body weight
than adults.
Focus groups will be conducted in
different parts of the country with
selected women. During phase one,
eight exploratory focus groups will be
conducted to develop messaging
strategies and the results will be used in
the development of preliminary
messages about the emerging chemicals.
The second phase will include six
message testing focus groups to
determine which messages are most
attractive and compelling in terms of
communicating health risk information
about emerging chemicals.
Participants will be recruited via
standard focus group recruitment
methods. Most will come from an
existing database (or list) of potential
participants maintained by the focus
group facility. There is no cost to
respondents.
E:\FR\FM\21JNN1.SGM
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Agencies
[Federal Register Volume 75, Number 118 (Monday, June 21, 2010)]
[Notices]
[Pages 35038-35041]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-14864]
-----------------------------------------------------------------------
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: ``Avoiding Readmissions in Hospitals Serving Diverse
Patients.'' 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 August 20, 2010.
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
Avoiding Readmissions in Hospitals Serving Diverse Patients
An important part of AHRQ's mission is to disseminate information
and tools that can support improvement in quality and safety in the
U.S. health care community. The transition process from the hospital to
the outpatient setting is nonstandardized and frequently inadequate in
quality. One in five hospital discharges is complicated by an adverse
event (AE) within 30 days, often leading to an emergency department
visit and/or rehospitalization. Many readmissions stem from errors that
can be directly attributed to the discontinuity and fragmentation of
care at discharge. High rates of low health literacy, lack of
coordination in the ``hand-off' from the hospital to community care,
gaps in social supports, and other limitations also contribute to the
risk of rehospitalization.
Boston University Medical Center (BUMC), through a grant from AHRQ,
previously defined the discharge process and determined what
improvements could be made to improve this care transition for
patients. This new process was called the ``re-engineered discharge''
(RED). The RED consists of 11 elements, including educating the patient
throughout the hospital stay, making follow-up appointments, and giving
the patient a written discharge plan. The RED was tested in a
randomized controlled trial in an academic safety net hospital at BUMC
with English speaking, general medical patients being discharged to
home or community settings. Results of this trial of 749 patients
showed a reduction in rehospitalizations within 30 days and emergency
department visits following hospital discharge. Participants also
followed up with primary care providers more often and reported higher
patient satisfaction with the discharge process. Project RED
researchers created several tools to help hospitals replicate RED.
After AHRQ and Project RED researchers fielded many inquiries about how
to implement Project RED at hospitals nationwide, AHRQ realized that
the Project RED Toolkit did not provide sufficient guidance to
potential replicators. Various components of the RED were not
documented, and issues regarding implementing the RED at hospitals
serving linguistically and culturally diverse patient populations had
not been addressed. AHRQ has therefore contracted with the RED
researchers to create a revised RED Toolkit that will address these
issues.
This proposed information collection supports AHRQs mission by
improving upon the RED Toolkit. This project has the following 3 goals:
(1) To revise the Project RED Toolkit to comprehensively address
all components of the RED, as well as the needs of culturally and
linguistically diverse patients;
(2) To pre-test the revised RED Toolkit in ten varied hospital
settings, evaluating how the RED Toolkit is implemented in varied
hospital settings by: (a) Documenting the implementation process; (b)
assessing the fidelity of implementation; and (c) identifying the
factors that affect redesign fidelity, including intensity of technical
assistance (TA).
(3) To modify the revised RED Toolkit based on pre-testing and to
disseminate it.
BUMC will provide TA at two varying levels. Four selected hospitals
will receive ``train-the-trainer'' TA, which includes:
(1) Telephone assistance in conducting a baseline needs assessment;
(2) Master trainer training;
(3) Access to Webinar trainings specifically designed for each user
(nurse, IT professional, hospital leadership, and pharmacist);
(4) An electronic template to print an After Hospital Care Plan
(AHCP) booklet; and
(5) E-mails regarding updates to the RED Web site and the
opportunity to ask questions about the newly revised and enhanced RED
tools and implementation via telephone and email.
Six selected hospitals will receive intensive TA, which includes:
[[Page 35039]]
(1) Telephone baseline needs assessment;
(2) On-site training;
(3) Monthly semi-structured interviews via phone calls with the
implementation team to discuss implementation efforts and barriers;
(4) Adaptation of the revised RED Toolkit to include specific
details about the hospital (such as the hospital name on the cover of
the AHCP booklet and hospital-specific services provided to patients
included in the AHCP booklet);
(5) An assessment and evaluation site visit by the organizational
change evaluator (a member of the implementation team), at baseline and
12 months after the start of implementation efforts to interview select
participating hospital staff;
6) IT support to install and support the RED Toolkit software to
automatically generate the AHCP booklet; and
(7) E-mails regarding updates to the RED Web site and the
opportunity to ask questions about the newly revised and enhanced RED
tools and implementation via telephone and email.
A diverse group of hospitals will be selected to receive each level
of TA, based upon hospital size, location, readmission rate and patient
population. Implementing the revised RED Toolkit in diverse settings
will provide a better understanding of whether and how RED can be best
implemented in different hospital settings.
The project will be framed within a model of organizational change
and transformation called the Organizational Transformation Model
(OTM), which is based on the evaluation of Robert Wood Johnson
Foundation's Pursuing Perfection initiative. OTM identifies key
elements that drive dramatic system change and informs the
implementation process and impact evaluation. Using a mixed-methods
design, the evaluation tracks change over time and across the
implementation period within each hospital. The evaluation therefore
will encompass feedback on specific implementation processes and
factors in microsystems where RED is adopted, in the larger
organizational context, and interactions between the two.
This research study is being conducted by AHRQ through its
contractor, BUMC, pursuant to AHRQ's statutory authority to conduct and
support research on healthcare and disseminate information 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. 299(b) and 299a(a)(1) and (2).
Method of Collection
To achieve the projects' second and third goals, the following data
collections and training will be implemented for the six hospitals that
will receive more TA as well as the 4 hospitals receiving train-the-
trainer TA, unless otherwise noted:
(1) Baseline needs assessment to help each hospital plan and
prepare for implementation of the revised RED Toolkit and to evaluate
it in varied settings. The baseline needs assessment will be
administered by telephone, approximately two months prior to
implementation, to the key contact at each of the ten study hospitals.
The purpose of the assessment is to identify the implementation team,
collect some basic information about the hospital, such as the number
of beds and if electronic medical records are used, and to establish
the baseline readmission rate.
(2) Monthly semi-structured interviews with the key contact or
other implementation team member will be conducted monthly for 12
months after implementation. These interviews will be conducted by
phone with each of the six hospitals receiving intensive technical
assistance (TA) (the two levels of TA are described above). The purpose
of these interviews are to allow hospitals to share their experiences
with implementing the revised RED Toolkit, their use of specific tools,
changes resulting from using the tools and problems encountered
implementing the revised RED Toolkit and how they are being addressed.
(3) Baseline semi-structured interviews will be conducted prior to
the implementation of the revised RED Toolkit with 15 hospital staff
from each of the six study hospitals receiving intensive TA. The
purpose of this interview is to measure the staffs opinion of the
current discharge process, their perceived need for a redesigned
process, and the perceived barriers and facilitators to redesigning the
discharge process.
(4) Post implementation semi-structured interviews will be
conducted 12 months after the implementation of the revised RED Toolkit
with 15 hospital staff from each of the six study hospitals receiving
intensive TA. The purpose of this interview is to measure the staffs
opinion of the redesigned discharge process, which tools were used and
their opinion of the tools, and the observed barriers and facilitators
to redesigning the discharge process.
(5) Patient surveys will be administered by telephone to a random
sample of patients 30 days after being discharged from one of the six
intensive TA study hospitals. The purpose of this survey is to measure
patient outcomes, including satisfaction with the care they received,
30-day hospital and emergency department visits, and physician
appointments, to help determine the success of the RED Toolkit
implementation in diverse patient populations. The survey will be
administered by a hospital staff member to patients during the pre-
implementation period and again during the post-implementation period
to compare patient outcomes.
(6) Medical record review of patient outcomes at all ten study
hospitals. This data collection will be conducted both pre- and
postimplementation of the revised RED Toolkit and will inform the
success of the revised RED Toolkit implementation in diverse patient
populations. Outcomes to be collected include process outcomes, such as
primary care provider appointments scheduled prior to discharge, and
patient outcomes, such as 30-day hospital and emergency department
visits.
(7) Master trainer training will be conducted with 3 staff members
from each of the 4 hospitals receiving train-the-trainer TA. These
people will be trained to administer the RED Toolkit and be able to use
recorded Webinar training sessions within their organization. They will
be invited to travel to BUMC for a 2-day onsite orientation of the RED
intervention. These people will meet with several members of the BUMC
implementation team (physician leader, discharge advocate nurse) and
will have the opportunity to shadow the nurse discharge advocates in
conducting the RED intervention.
(8) Intensive training will be conducted with about 28 staff from
each of the 6 hospitals receiving intensive TA. The training will
consist of a two-day on-site orientation and training at each hospital
conducted by the BUMC implementation team. The BUMC implementation team
will consist of a physician researcher, a discharge advocate nurse, an
organizational change champion/evaluator and the information technology
expert. The BUMC team will spend two days, 8 hours per day, to train
the relevant hospital staff to perform the 11 components of the RED
discharge. The training will include material for senior hospital
management, hospital physicians, nurses, IT staff, and pharmacists.
[[Page 35040]]
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated annualized burden hours associated
with the respondent's time to participate in this research. The
baseline needs assessment will be administered to the key contact at
each of the 10 participating hospitals and takes about 2 hours to
complete. Monthly semi-structured interviews with the key contact or
other implementation team member will be conducted monthly for 12
months after implementation. These interviews will be conducted by
phone with each of the six hospitals receiving intensive TA and will
require 1 hour to complete. Both the base-line and post-implementation
semi-structured interviews will be conducted with 15 staff members from
each of the 6 hospitals receiving intensive TA and will last about one
hour. The patient survey will be administered twice, pre and post
implementation, to 3,108 patients recently discharged from one of the 6
hospitals receiving intensive TA and requires 10 minutes to complete.
Medical record review will be performed at all 10 participating
hospitals both pre- and post-implementation and will take about 41.6
hours. Master trainer training will be conducted with 3 staff members
from each of the 4 hospitals receiving train the trainer TA and will
last 16 hours. Intensive training will be conducted with about 28 staff
members from each of the 6 hospitals receiving intensive TA and will
also last 16 hours. The total annualized burden is estimated to be
5,020 hours.
Exhibit 2 shows the estimated annualized cost burden associated
with the respondent's time to participate in this research. The total
annualized cost burden is estimated to be $162,157.
Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Form name Number of responses per Hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Baseline needs assessment....................... 10 1 2 20
Monthly semi-structured interviews.............. 6 12 1 72
Base-line semi-structured interview............. 6 15 1 90
Post implementation semi-structured interview... 6 15 1 90
Patient survey.................................. 3,108 2 10/60 1,036
Medical record review........................... 10 2 41.6 832
Master trainer training......................... 4 3 16 192
Intensive training.............................. 6 28 16 2,688
---------------------------------------------------------------
Total....................................... 3,156 na na 5,020
----------------------------------------------------------------------------------------------------------------
Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Average
Form name Number of Total burden hourly wage Total cost
respondents hours rate* burden
----------------------------------------------------------------------------------------------------------------
Baseline needs assessment....................... 10 20 \a\ $41.94 $839
Monthly semi-structured interviews.............. 6 72 \b\ 40.91 2,946
Base-line semi-structured interview............. 6 90 \c\ 38.51 3,466
Post implementation semi-structured interview... 6 90 \d\ 38.51 3,466
Patient survey.................................. 3,108 1,036 20.32 21,052
Medical record review........................... 10 832 17.32 14,410
Master trainer training......................... 4 192 \g\ 31.31 6,012
Intensive training.............................. 6 2,688 \h\ 40.91 109,966
---------------------------------------------------------------
Total....................................... 3,156 5,020 na 162,157
----------------------------------------------------------------------------------------------------------------
* Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United
States May 2008, ``U.S. Department of Labor, Bureau of Labor Statistics.''
\a\ 75% Nurses (29-1111, $31.31/hr), 20% Physicians (29-1069, $79.33/hr) and 5% General and Operations Managers
(29-1069, $51.91/hr); \b\ 80% Nurses and 20% Physicians; \c\ and \d\ 85% Nurses and 15% Physicians; \e\ 100%
General public (00-0000, $20.32/hr); \f\ 100% Statistical assistants (43-9111, $17.32/hr); \g\ 100% Nurses;
\h\ 80% Nurses and 20% Physicians.
Estimated Annual Costs to the Federal Government
Exhibit 3 shows the total and annualized cost over the 18 months of
this clearance. The total cost is $449,976.
Exhibit 3--Estimated Total and Annualized Cost
------------------------------------------------------------------------
Cost component Total cost Annual cost
------------------------------------------------------------------------
Project RED Toolkit Development... $97,413 $64,942
Dissemination Planning and Support 98,080 65,387
Data Collection Activities........ 84,563 56,375
Data Processing and Analysis...... 52,215 34,810
Publication of Results............ 3,184 2,123
Project Management................ 28,892 19,261
[[Page 35041]]
Overhead.......................... 85,629 57,086
-------------------------------------
Total......................... 449,976 299,984
------------------------------------------------------------------------
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: June 8, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010-14864 Filed 6-18-10; 8:45 am]
BILLING CODE 4160-90-M