[Federal Register Volume 76, Number 39 (Monday, February 28, 2011)]
[Notices]
[Pages 10902-10905]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4135]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Agency for Healthcare Research and Quality, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice announces the intention of the Agency for 
Healthcare Research and Quality (AHRQ) to request that the Office of 
Management and Budget (OMB) approve the proposed information collection 
project: ``Improving Patient Safety System Implementation for Patients 
with Limited English Proficiency.'' In accordance with the Paperwork 
Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment 
on this proposed information collection.
    This proposed information collection was previously published in 
the Federal Register on December 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 March 30, 2011.

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 OIRA_submission@omb.eop.gov (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 
doris.lefkowitz@AHRQ.hhs.gov.

SUPPLEMENTARY INFORMATION:

Proposed Project

Improving Patient Safety System Implementation for Patients With 
Limited English Proficiency

    According to the 2009 American Community Survey (U.S. Census 
Bureau), approximately 57 million people--20% of the U.S. population--
speak a language other than English at home. Of that number, 
approximately 24 million (8.6% of the U.S. population) are defined as 
having Limited English Proficiency (LEP), meaning that they report 
speaking English less than ``very well.'' Recent research suggests that 
adverse events affect LEP patients more severely than they affect 
English-speaking patients. In addition to linguistic barriers, LEP 
patients often face cultural barriers to care and low health literacy 
as well.
    AHRQ proposes to develop a new training program to improve patient 
safety system implementation for patients with limited English 
proficiency. The new training program is designed as a continuing 
education module within the TeamSTEPPS system. TeamSTEPPS is an 
evidence-based framework to optimize team performance across the 
healthcare delivery system with the goal of improving patient safety. 
This system has been successfully implemented in numerous hospitals 
across the United States. The TeamSTEPPS curriculum is an easy-to-use 
comprehensive multimedia kit that includes modules in text and 
presentation format, video vignettes to illustrate key concepts, and 
workshop materials, including a supporting CD and DVD, on change 
management, coaching, and implementation. Portions of the training 
module may also be useful for hospitals that have not implemented 
TeamSTEPPS. The new training module will show how TeamSTEPPS principles 
can be better implemented to improve the safety of patients with LEP.
    AHRQ proposes to field-test this module by conducting case studies 
of its implementation in three hospitals. The primary goals of this 
field test are to identify needed changes in the training module 
content or format to increase the feasibility of implementation and 
improve module outcomes including audience response, learning, adoption 
of recommended team behaviors, and improved outcomes for LEP patients. 
Patient outcome measures for this project include the patient's access 
to an interpreter and how well they

[[Page 10903]]

understood instructions from the hospital staff.
    This study is being conducted by AHRQ through its contractor, Abt 
Associates Inc., pursuant to AHRQ's statutory authority to conduct and 
support research on healthcare and on systems for the delivery of such 
care, including activities with respect to the quality, effectiveness, 
efficiency, appropriateness and value of healthcare services and with 
respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1) 
and (2).

Method of Collection

    To achieve the goals of this project the following activities will 
be implemented:
    (1) Readiness Assessment Survey of whether a hospital has the right 
policies in place to implement the training module. The readiness 
assessment will be completed by the key contact person (hospital 
champion) at each site. The assessment may be completed in consultation 
with other members of a ``change team'' that the hospital champion may 
form to support the initiative.
    (2) Pre-work for Master-Training, including a survey, process map 
exercise, and a request to locate the hospital's or organization's 
policy on accessing language services. The pre-work will be completed 
by one of the hospital staff persons selected to be a Master-Trainer at 
each site.
    (3) Master Training session in which two staff members from each of 
three participating hospitals will learn how to teach the training 
module. The TeamSTEPPS system requires at least two trainers for each 
hospital because its implementation is a team endeavor. Trainers will 
be selected either by the hospital champion, or by the ``change team'' 
formed by the hospital champion to support the intervention. Trainers 
will be selected from among natural leaders working within the hospital 
unit where the training will take place. Ideally the team will include 
a provider (e.g., doctor, nurse) and an interpreter. Hospital staff 
selected to attend the training will be required to travel to Boston 
for the training session.
    (4) Staff Training session using the training module developed for 
this project. Training participants will be drawn from the 
interprofessional care team in one or more hospital units (e.g., ob/
gyn, surgery, etc.). This team may include nurses, physicians, 
technicians, front desk staff, and interpreters. Since the training 
teaches team behaviors, the entire interprofessional care team in a 
given hospital unit will be asked to attend the training session 
together. The training will be conducted onsite by the hospital staff 
members who attended the Master Training.
    (5) Training Participant Satisfaction Survey to assess trainee 
satisfaction with, and perceived adequacy of, the training module. This 
questionnaire will be administered at the end of the training module.
    (6) Learning Outcomes Survey to assess staff knowledge about the 
best way to handle situations with LEP patients. To measure the change 
in staff knowledge resulting from the training module this 
questionnaire will be administered both before and after the training.
    (7) Pre-training Behavior Survey to assess trainee behavior change 
resulting from the training. The behavior measured by this survey is 
the hospital staffs' use of interpreters when interacting with LEP 
patients. To measure the change in staff behavior resulting from the 
training module, questions from this survey are repeated in the post-
training behavior survey. Interpreters are exempt from this 
questionnaire because the questions relate to interpreter use.
    (8) Post-Training Behavior Survey to assess trainee use of 
interpreters when interacting with LEP patients (repeated from the Pre-
Training Behavior Survey) and questions to assess the use of team 
communication tools demonstrated during the training.
    (9) Patient Outcome Survey to measure change in patient 
communication and safety outcomes resulting from the training. This 
survey's target audience is all patients identified as LEP. The purpose 
of this survey is to measure intermediate outcomes related to LEP 
patients' access to language services, comprehension, and satisfaction 
with services.
    (10) Semi-Structured Follow-Up Interview to assess hospitals' 
experiences implementing the training module. This semi-structured 
interview's target audience consists of up to two master-trainers or 
change team members in each hospital where the training module is 
implemented. These interviews will be conducted 3 times at the 2-week, 
6-week and 10- week mark after the training.
    (11) Semi-Structured Site Visit Interview to assess the hospitals' 
experiences implementing the training module. This semi-structured 
interview's target audience consists of up to 6 persons who may include 
master-trainers, change team members, frontline staff members, or other 
persons designated by the ``hospital champion'' as persons who might 
provide insight into module implementation and outcomes. These 
interviews will be conducted 3 months after the training.

Estimated Annual Respondent Burden

    Exhibit 1 presents estimates of the reporting burden hours for this 
one-year data collection process. Time estimates are based on 
experience with similar instruments used with comparable respondents. 
The Readiness Assessment Survey will be completed by the key contact/
project champion at each of the 3 participating hospitals and will take 
about 5 minutes. The pre-work for the Master-Training will be completed 
by the two trainers selected for each site and will take about 30 
minutes. The Master-Training will be conducted with 2 staff members 
from each hospital and will last 4.5 hours; the burden estimate of 12.5 
hours includes 8 hours of travel time to and from the training site. 
Staff Training will include up to 30 staff members at each hospital 
(plus the 2 trainers who are staff members) and will last 1 hour. The 
Training Participant Satisfaction Survey will be completed by Staff 
Training participants at the end of the training and takes 5 minutes to 
complete. The Learning Outcomes Survey will be administered twice, 
before and after the training, and will require 10 minutes. The Pre-
Training Behavior Survey will be administered to all staff invited to 
the training except for interpreters. It will require approximately 5 
minutes. Interpreters do not complete this questionnaire because the 
questions relate to interpreter use. The Post-training Behavior survey 
will be administered two or more weeks after the training to all staff 
who were invited to the training, and will take approximately 7.5 
minutes to complete. The Patient Outcome Survey will be administered 
twice, before and after the intervention, to a sample of approximately 
90 patients (30 from each of the 3 participating hospitals) and 
requires about 10 minutes to complete. Semi-Structured Follow-up 
interviews will be conducted three times over a 12-week period with two 
master trainers or change team members from each hospital. Each semi-
structured follow-up interview will last for about an hour. Semi-
Structured Site visit interviews will be conducted with 6 staff members 
from each hospital and will take an hour to complete. The total 
annualized burden hours are estimated to be 295 hours.
    Exhibit 2 presents the estimated annualized cost burden associated 
with the respondents' time to participate in this research. The total 
cost burden is estimated to be about $6,980.

[[Page 10904]]



                                  Exhibit 1--Estimated Annualized burden hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
             Data collection method                  Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
Readiness Assessment Survey.....................               3               1            5/60            0.25
Pre-Work for Master-Training....................               3               2           30/60               3
Train the Trainer Training......................               3               2            12.5              75
Staff Training..................................               3              32               1              96
Training Participant Satisfaction Survey........               3              30            5/60               8
Learning Outcomes Survey........................               3              60           10/60              30
Pre-Training Behavior Survey....................               3              25            5/60               6
Post-Training Behavior Survey...................               3              30          7.5/60              11
Patient Outcome Survey..........................              90               2           10/60              30
Semi-Structured Follow-up interview.............               3               6               1              18
Semi-Structured Site visit interview............               3               6               1              18
                                                 ---------------------------------------------------------------
    Totals......................................             117              na              na             295
----------------------------------------------------------------------------------------------------------------


                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of     Total burden   Average hourly    Totals cost
             Data collection method                 respondents        hours        wage rate *       burden
----------------------------------------------------------------------------------------------------------------
Readiness Assessment Survey.....................               3            0.25          $26.50              $7
Pre-Work for Master-Training....................               3               3           26.50              80
Train the Trainer Training......................               3              75           26.50           1,988
Staff Training..................................               3              96           22.02           2,114
Training Participant Satisfaction Survey........               3               8           22.02             176
Learning Outcomes Survey........................               3              30           22.02             661
Pre-Training Behavior Survey....................               3               6           22.04             132
Post-Training Behavior Survey...................               3              11          $22.02            $242
Patient Outcome Survey..........................              90              30           20.90             627
Semi-Structured Follow-up interview.............               3              18           26.50             477
Semi-Structured Site visit interview............               3              18           26.50             477
                                                 ---------------------------------------------------------------
    Totals......................................             117             295              na           6,980
----------------------------------------------------------------------------------------------------------------
* The average hourly wage rate for readiness assessments, train-the-trainer trainings, semi-structured site
  visit interviews, and semi-structured follow-up interviews was calculated based on the average of the mean
  hourly wage rate for healthcare practitioners and medical occupations (all professions), $31.02 and the
  average hourly wage rate for interpreters and translators, $21.97. The average hourly rate for staff receiving
  training was calculated based on the average of the mean hourly wage rate for healthcare practitioners and
  medical occupations (all professions), $31.02, mean hourly wage rate for interpreters and translators, $21.97,
  and mean hourly wage rate for healthcare support occupations, $13.06. The average hourly wage rate for
  respondents to the pre-training behavior survey was calculated based on the average of the mean hourly wage
  rate for healthcare practitioners and medical occupations (all professions), $31.02, and mean hourly wage rate
  for healthcare support occupations, $13.06. The average hourly wage rate for patients was calculated on the
  mean hourly wage rate for all occupations. Average hourly rate for unit staff, non-interpreter was calculated
  based on the average of the mean hourly rate for healthcare practitioners and medical occupations (all
  professions), $31.02, and occupations (all professions), $31.02, mean hourly wage rate for interpreters and
  translators, $21.97, and mean hourly wage rate for healthcare support occupations, $13.06. Mean hourly wage
  rates for these groups of occupations were obtained from the Bureau of Labor & Statistics on ``Occupational
  Employment and Wages, May 2009'' found at the following urls: http://www.hls.gov/oes/current/naics4_622100.htm, http://www.hls.gov/ocs/current/ocs273091.htm, http://www.hls.gov/oes/current/oes_nat.htm.

Estimated Annual Costs to the Federal Government

    The total cost of this contract to the government is $499,978. The 
project extends over 4 fiscal years, although data collection will take 
place over the course of a single year. Exhibit 3 shows a breakdown of 
the total cost as well as the annualized cost for the data collection, 
processing and analysis activity.

                        Exhibit 3--Estimated Cost
------------------------------------------------------------------------
             Cost component                 Total cost      Annual cost
------------------------------------------------------------------------
Project Development.....................        $301,664         $75,416
Data Collection Activities..............          52,629          13,157
Data Processing and Analysis............          52,629          13,157
Publication of Results..................          51,658          12,915
Project Management......................          41,399          10,350
                                         -------------------------------
    Total...............................         499,978         124,995
------------------------------------------------------------------------


[[Page 10905]]

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: February 15, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011-4135 Filed 2-25-11; 8:45 am]
BILLING CODE 4160-90-M