[Federal Register Volume 76, Number 17 (Wednesday, January 26, 2011)]
[Notices]
[Pages 4697-4699]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-1542]
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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.
This proposed information collection was previously published in
the Federal Register on November 15th, 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 February 25, 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 [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
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 post-implementation 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,
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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:
Background on organizational structure and vision.
Policies and procedures related to Component 1 and
Component 2 strategies of the Guide.
Tools used to foster communication between patients,
family members and health care team.
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 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[supreg] 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 50 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--post- 3 8 1 24
implementation.................................
Collection of documentation..................... 3 2 4 24
Bi-weekly semi-structured interviews............ 3 18 30/60 27
[[Page 4699]]
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
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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 Total cost
Form name respondents hours hourly rate * burden
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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
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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
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Annualized
Cost component Total cost cost
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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
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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: January 11, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011-1542 Filed 1-25-11; 8:45 am]
BILLING CODE 4160-90-M