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[Federal Register Volume 75, Number 219 (Monday, November 15, 2010)]
[Notices]
[Pages 69674-69677]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28368]

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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: ``Development of the Guide to Patient and Family Engagement in 
Health Care Quality and Safety in the Hospital Setting.'' 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 January 14, 2011.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz,

[[Page 69675]]

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

Development of the Guide to Patient and Family Engagement in Health 
Care Quality and Safety in the Hospital Setting

    Improving the quality and safety of health care in the United 
States is one of the most significant challenges facing the American 
health care system. Too many Americans continue to receive health care 
that is not grounded in a reliable evidence base of what is proven 
appropriate, safe, and effective. Extensive studies conducted during 
recent decades demonstrate that the U.S. health care system provides 
continuing unwarranted variation and costly, inefficient, and simply 
unsafe care. Involving patients and families in improving quality and 
safety in hospitals has the potential to improve health care 
experiences, delivery, and outcomes. AHRQ has been at the forefront of 
supporting increased involvement for patients, families, and the public 
in all aspects of health care.
    This project will develop a program to help patients, families, and 
health professionals in the hospital support one another to improve 
quality and safety. To accomplish these goals, patients and families 
must be able to express what they want from their hospital care and how 
they want to be involved and then effectively communicate this 
information with health professionals. Conversely, health professionals 
must be able to understand what patients want to do and what is 
appropriate for them to do and feel that they have the system supports 
and tools to facilitate these actions.
    To address this issue and help fulfill AHRQ's mission of health 
care quality improvement, AHRQ will develop a set of interventions and 
materials, entitled the Guide to Patient and Family Engagement in 
Health Care Quality and Safety in the Hospital Setting (``the Guide''), 
for use by patients, their family members, health care professionals, 
and hospital leaders to foster patient and family engagement around the 
issues of hospital safety and quality.
    The goals of this project are to:
    (1) Identify the barriers and facilitators to implementing the 
Guide, including how barriers were overcome;
    (2) Assess staff satisfaction with the Guide and change in staff 
behavior before and after implementation of the Guide including 
organizational culture with respect to patient- and family engagement 
and patient- and family-centered care;
    (3) Assess patient satisfaction with the Guide and change in 
patient experience of care before and after implementation of the Guide 
including patient/family involvement in their own health care and 
patient/family involvement in quality improvement and patient safety 
activities; and
    (4) Refine the Guide as necessary to improve implementation and 
effectiveness.
    The Guide will be tested in three hospitals which will vary in 
terms of size, location, teaching status, and ownership.
    This study is being conducted by AHRQ through its contractor, the 
American Institutes for Research (AIR), pursuant to AHRQ's statutory 
authority to promote health care quality improvement by conducting and 
supporting research that develops and presents scientific evidence 
regarding all aspects of health care, including the development and 
assessment of methods for enhancing patient participation in their own 
care and for facilitating shared patient-physician decision-making. 42 
U.S.C. 299(b)(1)(A).

Method of Collection

    To achieve the goals of this project the following data collections 
will be implemented:
    (1) Semi-structured interviews will be conducted in-person with 
hospital staff and hospital leaders from each of the participating 
health care facilities. Both pre- and postimplementation interviews 
will be conducted and separate interview guides will be used for staff 
and leaders. Pre-implementation, the interviews will focus on current 
knowledge, attitudes and beliefs around patient and family engagement 
and on the current organizational culture and climate surrounding 
patient and family engagement. Post-implementation, interviews will be 
conducted to understand the hospital's experiences implementing the 
Guide interventions, including how easy or difficult the Guide was to 
implement; the perceived effects of the Guide implementation; and the 
sustainability of the Guide interventions.
    (2) Collection of documentation from each participating facility. 
The purpose of this collection of documentation is to gather 
documentation of the implementation of the Guide and to document 
policies and procedures related to patient and family engagement 
through a review of records and other materials. To the extent that it 
is available, the following types of documentation will be collected:
    [cir] Background on organizational structure and vision.
    [cir] Policies and procedures related to Component 1 and Component 
2 strategies of the Guide.
    [cir] Tools used to foster communication between patients, family 
members and health care team.
    [cir] Policies and procedures related to patient and family 
engagement, patient- and family-centered care, quality and safety.
    This task will consist of forwarding emails and or photocopying and 
sending documents to the project team both pre- and post-
implementation.
    (3) Bi-weekly semi-structured interviews will be conducted by 
telephone with the implementation coordinators from each participating 
facility. At each hospital site, an implementation coordinator will be 
responsible for overseeing implementation activities and serving as a 
primary point-of-contact. Interviews with these individuals will 
provide a complete understanding of the Guide implementation and the 
ability to track the implementation in real time. These interviews will 
occur bi-weekly for 9 months.
    (4) Observation of Guide implementation around different activities 
targeted in the Guide components. The purpose of these observations is 
to directly assess how the Guide is being implemented and to determine 
which follow up questions from the semi-structured interview protocol 
should be prioritized or removed during the in-person semi-structured 
interviews. As such, observations will occur post-implementation only. 
Observations will be conducted by the project staff so this data 
collection does not impose a burden on the participating hospitals; 
therefore it is not included in Exhibit 1.
    (5) Focus groups with patients and family members at each of the 
participating sites. The purpose of these groups is to elicit 
information about patients' and families' experiences of care at the 
hospital along with their reactions to tools in the Guide and their 
implementation. Three focus groups of up to 8 individuals will be 
conducted at each hospital post implementation. One

[[Page 69676]]

focus group will be conducted with patients only, one with family 
members only and one with patients and family members together.
    (6) Staff Survey with hospital staff. The purpose of the pre- and 
post-implementation Staff Survey is to assess changes in organizational 
culture related to patient safety and engagement, and to assess 
significant changes in staff knowledge, attitudes, and behaviors. Items 
from the Medical College of Georgia (MCG) Patient- and Family-Centered 
Care Culture Survey will be used in this data collection activity. The 
survey items will be supplemented with questions from AHRQ's Hospital 
Survey on Patient Safety Culture (HSOPS) and from the Army Medical 
Department Climate Survey. At each of the three hospital sites, it is 
estimated that survey responses will be collected from at least 50 
health professionals. The same questionnaire will be used at pre- and 
post-implementation.
    (7) Patient Survey. The patient survey which will be administered 
pre-implementation and again at post-implementation will be built 
around the CAHPS[reg] Hospital Survey (HCAHPS) domains that assess 
aspects of patient-physician interaction around the hospital stay, 
including Communication with Nurses, Communication with Doctors, 
Communication about Medicines, Responsiveness of Hospital Staff, and 
Discharge Information. These scales directly assess the aspects of the 
hospital stay and encounters that we are hoping the Guide will affect. 
Additional questions to address any aspects of care covered by the 
Guide that are not adequately addressed by the HCAHPS composites will 
also be included in this survey. Additionally, measures from the 
Patient Activation Measures (PAM) Survey will also be included. The 
same questionnaire will be used pre- and post-implementation.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated burden hours for the respondents' 
time to participate in this project. Semi-structured interviews will be 
conducted with about 4 hospital staff members both pre- and post-
implementation and requires one hour to complete. Semi-structured 
interviews will also be conducted with 2 hospital leaders, pre- and 
post-implementation, and will take one hour to complete. Collection of 
documentation will occur twice at each hospital and requires 4 hours to 
complete. Bi-weekly semi-structured interviews will be conducted with 
the implementation coordinator at each hospital. A total of 18 
interviews per hospital over a 9 month period will occur with each 
interview taking about 30 minutes. Focus groups will take place 
separately with patients, their families, and both patients and their 
families and will last for about an hour and a half. The staff survey 
will be completed by approximately SO hospital staff members from each 
hospital, pre- and post-implementation, and requires 15 minutes to 
complete. The patient survey will be conducted twice, pre- and post-
implementation, by about 884 patients across all 3 participating 
hospitals and will take 30 minutes to complete. The total annualized 
burden hours are estimated to be 1,190 hours.
    Exhibit 2 shows the estimated annualized cost burden associated 
with the respondents' time to participate in this project. The total 
cost burden is estimated to be $27,316.

                                  Exhibit 1--Estimated Annualized Burden Hours
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                                                                     Number of
            Data collection activity                 Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
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Semi-structured leader interviews--pre-                        3               4               1              12
 implementation.................................
Semi-structured leader interviews--post-                       3               4               1              12
 implementation.................................
Semi-structured staff interviews--pre-                         3               8               1              24
 implementation.................................
Semi-structured staff interviews--pre-                         3               8               1              24
 implementation.................................
Collection of documentation.....................               3               2               4              24
Bi-weekly semi-structured interviews............               3              18           30/60              27
Focus group with patients.......................              24               1           90/60              36
Focus group with patients' family...............              24               1           90/60              36
Focus group with patients & family..............              24               1           90/60              36
Staff survey....................................               3             100           15/60              75
Patient survey..................................             884               2           30/60             884
                                                 ---------------------------------------------------------------
    Total.......................................             977              na              na           1,190
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                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                     Number of     Total burden   Average hourly    Total cost
                    Form name                       respondents        hours        wage rate*        burden
----------------------------------------------------------------------------------------------------------------
Semi-structured leader interviews--pre-                        3              12          $43.74            $525
 implementation.................................
Semi-structured leader interviews--post-                       3              12           43.74             525
 implementation.................................
Semi-structured staff interviews--pre-                         3              24           33.51             804
 implementation.................................
Semi-structured staff interviews--post-                        3              24           33.51             804
 implementation.................................
Collection of documentation.....................               3              24           21.16             508
Bi-weekly semi-structured interviews............               3              27           33.51             905
Focus group with patients.......................              24              36           20.90             752
Focus group with patients' family...............              24              36           20.90             752
Focus group with patients & family..............              24              36           20.90             752
Staff survey....................................               3              75           33.51           2,513
Patient survey--pre-implementation..............             884             884           20.90          18,476

[[Page 69677]]

 
    Total.......................................             977           1,190             n/a         27,316
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* Based upon the mean of the wages for 11-9111 Medical & Health Services Manager ($43.74), 29-000 Healthcare
  Practitioner and Technical Occupations ($33.51), 43-6011 Executive Secretaries and Administrative Assistants
  ($21.16) and 00-0000 All Occupations ($20.90), May 2009 National Occupational Employment and Wage Estimates.
  United States, ``U.S. Department of Labor, Bureau of Labor Statistics.'' http://www.bls.gov/oes/current/oes_nat.htm#b29-0000.

Estimated Annual Costs to the Federal Government

    Exhibit 3 below breaks down the costs related to this study. Since 
this study will span two years, the costs have been annualized over a 
two year period. The total annualized cost is estimated to be 
$536,396.50.

             Exhibit 3--Estimated Total and Annualized Cost
------------------------------------------------------------------------
                                                            Annualized
             Cost component                 Total cost         cost
------------------------------------------------------------------------
Guide Development.......................        $526,214     $263,107
Data Collection Activities..............         310,006      155,003
Data Processing and Analysis............         110,620       55,310
Project Management......................          20,270       10,135
Overhead................................         105,683       52,842
                                         -------------------------------
    Total...............................       1,072,793      536,396.50
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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: November 1, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010-28368 Filed 11-12-10; 8:45 am]
BILLING CODE 4160-90-M
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