[Federal Register Volume 75, Number 168 (Tuesday, August 31, 2010)]
[Notices]
[Pages 53306-53310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21503]
-----------------------------------------------------------------------
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.
This proposed information collection was previously published in
the Federal Register on June 21st, 2010 and allowed 60 days for public
comment. One comment was received. The purpose of this notice is to
allow an additional 30 days for public comment.
DATES: Comments on this notice must be received by September 30, 2010.
ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk
Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by
e-mail at [email protected] (attention: AHRQ's desk
officer).
Copies of the proposed collection plans, data collection
instruments, and specific details on the estimated burden can be
obtained from the AHRQ Reports Clearance Officer.
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by e-mail at
[email protected].
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
[[Page 53307]]
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 AHRQ's mission by
improving upon the RED Toolkit. This project has the following 2 goals:
(1) 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).
(2) 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 e-mail.
Six selected hospitals will receive intensive TA, which includes:
(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 e-mail.
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' goals, the following data collections and
training will be implemented for the six hospitals that will receive
intensive 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 (see Attachment C). This is not a data collection
but will impose a time burden on the participating hospitals as they
prepare to participate in this project. The purpose of the needs
assessment is for the hospital to become familiar with their discharge
process and what parts of the process are being done well and what
parts of the process need improvement. In order to implement the new
RED discharge process, it is important for a hospital to plan how they
will do this. This information will be shared during the baseline key
contact semi-structured interview.
(2) Baseline key contact semi-structured interviews will be
administered by telephone, approximately two months prior to
implementation, to the key contact at each of the ten study hospitals
(see Attachment D). The purpose of the interview 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
[[Page 53308]]
to establish the baseline readmission rate.
(3) Monthly semi-structured interviews with the key contact or
other implementation team member will be conducted monthly for 12
months after implementation (see Attachment E). 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.
(4) 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 (see
Attachment F). The purpose of this interview is to measure the staff's
opinion of the current discharge process, their perceived need for a
redesigned process, and the perceived barriers and facilitators to
redesigning the discharge process.
(5) 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 (see Attachment G). The purpose of this interview is to
measure the staff's 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.
(6) 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 (see Attachment H). 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.
(7) Medical record review of patient outcomes at all ten study
hospitals (see Attachment I). This data collection will be conducted
both pre- and post-implementation 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.
(8) Master trainer training will be conducted with 3 staff members
from each of the 4 hospitals receiving train-the-trainer TA (see
Attachment J). 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.
(9) Intensive training will be conducted with about 28 staff from
each of the 6 hospitals receiving intensive TA (see Attachment K). 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.
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 conducted by staff at each of the 10
participating hospitals and takes about 8 hours to complete. Baseline
key contact semi-structured interviews will be conducted with the key
contact at each hospital and requires 1 hour 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. The patient survey
will be administered by the hospital staff and will require 10 minutes
of their time to administer. 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 6,126 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 $194,163.
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 8 80
Baseline key contact semi-structured interview.. 10 1 1 10
Monthly semi-structured interview............... 6 12 1 72
Baseline 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
[[Page 53309]]
Administration of patient survey by hospital 6 1,036 10/60 1,036
staff..........................................
Medical record review........................... 10 2 41.6 832
Master trainer training......................... 4 3 16 192
Intensive training.............................. 6 28 16 2,688
---------------------------------------------------------------
Total....................................... 3,172 na na 6,126
----------------------------------------------------------------------------------------------------------------
Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Number of Total burden Average hourly Total cost
Form name respondents hours wage rate* burden
----------------------------------------------------------------------------------------------------------------
Baseline needs assessment....................... 10 80 \a\ $41.94 $3,355
Baseline key contact semi-structured interview.. 10 10 \b\ 51.91 519
Monthly semi-structured interviews.............. 6 72 \c\ 40.91 2,946
Baseline semi-structured interview.............. 6 90 \d\ 38.51 3,466
Post implementation semi-structured interview... 6 90 \e\ 38.51 3,466
Patient survey.................................. 3,108 1,036 \f\ 20.32 21,052
Administration of patient survey by hospital 6 1,036 \b\31.31 32,437
staff..........................................
Medical record review........................... 10 832 \g\ 17.32 14,410
Master trainer training......................... 4 192 \h\ 31.31 6,012
Intensive training.............................. 6 2,688 \i\ 40.91 109,966
---------------------------------------------------------------
Total....................................... 3,172 6,126 na 194,163
----------------------------------------------------------------------------------------------------------------
* 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\ 100% General and Operations Managers (29-1069, $51.91/hr).
\c\ 80% Nurses and 20% Physicians.
\d\ and\e\ 85% Nurses and 15% Physicians.
\f\ 100% General public (00-0000, $20.32/hr).
\g\ 100% Statistical assistants (439111, $17.32/hr).
\h\ 100% Nurses.
\i\ 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
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.
[[Page 53310]]
Dated: August 20, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010-21503 Filed 8-30-10; 8:45 am]
BILLING CODE 4160-90-M