# Agency Information Collection Activities: Proposed Collection; Comment Request, 10902-10905 [2011-4135]

## Agencies

  * Agency for Healthcare Research and Quality
  * DEPARTMENT OF HEALTH AND HUMAN SERVICES


    
    
    [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]
    
    
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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: ``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
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                                                                         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
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                                       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
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    * 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: https://www.hls.gov/oes/current/naics4_622100.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