[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]
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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.
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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
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Number of
Form name Number of responses per Hours per Total burden
respondents respondent response hours
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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
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Total....................................... 3,156 na na 5,020
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Exhibit 2--Estimated Annualized Cost Burden
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Average
Form name Number of Total burden hourly wage Total cost
respondents hours rate* burden
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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
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Total....................................... 3,156 5,020 na 162,157
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* 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
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Cost component Total cost Annual cost
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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
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Total......................... 449,976 299,984
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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]
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