[Federal Register Volume 75, Number 118 (Monday, June 21, 2010)]
[Notices]
[Pages 35038-35041]
From the Federal Register Online via the Government Publishing 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 
[email protected].
    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 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
                                                 ---------------------------------------------------------------
    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
                                                 ---------------------------------------------------------------
    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
                                   -------------------------------------
    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]
BILLING CODE 4160-90-M