[Federal Register Volume 78, Number 75 (Thursday, April 18, 2013)]
[Notices]
[Pages 23256-23259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-08946]
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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: ``Pilot Test of the Proposed Value and Efficiency Surveys and
Communicating with Patients Checklist.'' In accordance with the
Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public
to comment on this proposed information collection.
This proposed information collection was previously published in
the Federal Register on January 7th, 2013 and allowed 60 days for
public comment. No comments were 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 May 20, 2013.
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
email 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 email at
[email protected].
SUPPLEMENTARY INFORMATION:
Proposed Project
Pilot Test of the Proposed Value and Efficiency Surveys and
Communicating With Patients Checklist
Maximizing value within the American health care system is an
important priority. Value is often viewed as a combination of high
quality, high efficiency care, and there is general agreement by
consumers, policy makers, payers, and providers that it is lacking in
the U.S. A recent report by the Institute of Medicine estimated that 20
to 30 percent ($765 billion a year) of U.S. healthcare spending was
inefficient and could be reduced without lowering quality.
Multiple overlapping initiatives are currently seeking to improve
value using a variety of approaches. Public reporting efforts led by
the Centers for Medicare and Medicaid Services (CMS), other payers and
consumer groups seek to enable consumers to make more informed choices
about the quality, and in some cases, the costs of their care. A
variety of demonstration projects and payment reforms initiated by CMS
and private insurers are attempting to more closely link care quality
with payments to create incentives for higher value care. And national
improvement initiatives led by AHRQ (comprehensive unit-based safety
programs [CUSP] for central line-associated blood stream infection
[CLABSI], catheter-associated urinary tract infections [CUTI], and
surgical units [SUSP]) and CMS (hospital engagement networks, QIO
scopes of work) are seeking to raise care quality and reduce
readmissions. Results from the CUSP-CLABSI project have demonstrated
that central line infections can be reduced and unnecessary costs can
be avoided across the health care system by concerted, unit-based
improvement efforts.
As a systems level example, Denver Health, with initial funding
from AHRQ, has taken major steps towards redesigning clinical and
administrative processes so as to reduce staff time, patient waiting,
and unnecessary costs. These improvements occurred without harm to
quality and in some instances actually improved quality.
In many cases, improving quality improves efficiency naturally.
Reducing the number of hospital errors, for example, will reduce costs
associated with longer length of stay or error-triggered readmissions.
It is more cost-effective to do things right the first time. But higher
value may be more likely if organizations doing quality improvement
link efforts to improve care quality with efforts to reduce unnecessary
costs. AHRQ understands that many of the root causes of inefficiencies
that drive up costs are closely linked to root causes of inefficiencies
that lead to poor quality, uncoordinated care where redundancies and
system failures place patients at risk. Enhancing value in healthcare
[[Page 23257]]
requires understanding the contribution that organizational culture
makes to value and working to foster a culture where high value is a
cultural norm.\1\ AHRQ's development of the Hospital Survey on Patient
Safety Culture (HSOPS) has contributed greatly to efforts to promote
the important role culture plays in providing safe care. HSOPS is used
extensively in national improvement campaigns and many hospitals and
health systems now regularly assess their safety cultures and use
culture scores on organizational dashboards and as parts of variable
compensation programs.
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\1\ (refers to 2nd paragraph in page 3) According to Pronovost
and Sexton (Assessing Safety Culture: Guidelines and
Recommendations, Qual Saf Health Care 2005; 14:231-23),
``Definitions of culture commonly refer to values, attitudes, norms,
beliefs, practices, policies, and behaviors of personnel. In
essence, culture is `the way we do things around here'.''
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If organizations lack cultures committed to value then discrete
efforts to raise dimensions of value are likely to yield limited and
unsustainable results. And if organizational leaders have no plausible
way to know whether their organizational culture is committed to value,
then their ability to make value a higher organizational priority will
be very limited. Thus, developing value and efficiency survey
instruments for hospitals and medical offices fills an important need
for many ongoing and planned efforts to foster greater value within
American health care.
Given the widespread impact of cost and waste in health care, AHRQ
will develop the Value and Efficiency (VE) Surveys for hospitals and
medical offices. These surveys will measure staff perceptions about
what is important in their organization and what attitudes and
behaviors related to value and efficiency are supported, rewarded, and
expected. The surveys will help hospitals and medical offices to
identify and discuss strengths and weaknesses within their individual
organizations. They can then use that knowledge to develop appropriate
action plans to improve their value and efficiency. To develop these
tools AHRQ will recruit medical staff from 42 hospitals and 96 medical
offices to participate in cognitive testing and pretesting.
In addition to the VE surveys, AHRQ also intends to develop and
test the feasibility and utility of a Patient Communication Checklist.
Patients are demanding greater clarity into the costs of health care
and what they can do about affordability problems. While there is
recent interest in making health care prices more transparent for
consumers (e.g., the Health Care Price Transparency Promotion Act of
2013 (H.R. 1326)), physician communication with patients about the cost
of care will be a key component to attaining high-value, high-quality
care from a patient perspective. To aid physicians, this proposal will
develop a consumer value (CV) checklist. Physician checklists have been
instrumental in many quality improvements, such as with AHRQ's
reduction in central line-associated blood stream infections [CLABSI]
(See Atul Gawande's Checklist Manifesto, Metropolitan Books, 2009).
Checklists have also reduced surgical complications by preventing
miscommunication during complex procedures. Similarly, checklists could
potentially facilitate communication between clinicians and patients in
complex discussions about patient preferences, quality, value, and out-
of-pocket costs. The objective of the CV checklist is to facilitate
shared decision-making, and also engage physician and patients in joint
problem solving. For example, if discussions emanating from use of a
checklist show that the patient is not likely to fill a critical
prescription for financial reasons, this could trigger a discussion of
generic substitutes or state or other subsidies available. Since the
proper goal for any health care delivery system is to improve the
quality and value of care delivered to patients, such a tool will bring
the patient perspective on value into the decision-making about their
care.
The CV checklist will address three major topics: who should talk
with patients about preferences and value issues (e.g., nurses,
physicians, etc.), when should these conversations occur (e.g., when
patients may incur costs, when they express financial concerns, etc.),
and how can clinicians prepare for and effectively facilitate such
discussions.
This research has the following goals:
(1) Develop, cognitively test and modify as necessary the VE
surveys (one for hospitals and one for medical offices);
(2) Pretest the VE surveys in hospitals and medical offices and
modify as necessary based on the results;
(3) Develop, cognitively test and modify as necessary the
checklist;
(4) Seek consumer/patient input on the potential value of the
checklist;
(5) Pretest the checklist in hospitals and medical offices and
either drop or modify as necessary based on patient and clinician views
of the results;
(6) Make the final VE surveys and checklist available for use by
the public.
This study is being conducted by AHRQ through its contractor,
Health Research & Educational Trust (HRET), and subcontractor, Westat,
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 these goals the following activities and data
collections will be implemented:
(1) Cognitive interviews for the YE surveys. One round of
interviews on the VE surveys will be conducted by telephone with 9
respondents from hospitals and 9 respondents from medical offices. The
purpose of these interviews is to understand the cognitive processes
the respondent engages in when answering a question on the VE survey
and to refine the survey's items and composites. These interviews will
be conducted with a mix of senior leaders and clinical staff (i.e.,
unit/department managers, practitioners, nurses, technicians, and
medical assistants) from hospitals and medical offices throughout the
U.S. with varying characteristics (e.g., size, geographic location,
type of medical office practice/hospital, and possibly extent of
experience with waste-reduction efforts).
(2) Pretest for the VE surveys. The surveys will be pretested with
senior leaders and clinical staff from 42 hospitals and 96 medical
offices. The purpose of the pretest is to collect data for an
assessment of the reliability and construct validity of the surveys'
items and composites, allowing for their further refinement. A site-
level point-of-contact (POC) will be recruited in each medical office
and hospital to manage the data collection at that organization
(compiles sample information, distribute surveys, promote survey
response, etc.). Exhibit 1 includes a burden estimate for the POC's
time to manage the data collection.
(3) Medical office information form. This form will be completed by
the medical office manager in each of the 96 medical office pretest
sites to provide background characteristics, such as type of
specialty(s) and majority ownership. A hospital information form will
not be needed because characteristics on pretest hospitals will be
obtained from the American Hospital Association's (AHA) data set based
on a hospital's AHA ID number.
(4) Survey to identify items for CV checklist. In order to identify
items to
[[Page 23258]]
put on the checklist, a survey will be developed and sent to 160
representative participants (40 Physicians, 40 Registered Nurses, 20
Social Workers, 20 Health Educators, and 40 Patients). Once the survey
responses have been collected, responses will be analyzed to help
inform the development of the CV checklist. Checklist items will be
chosen based on what is learned. For example, if clinicians strongly
believe that it is inappropriate to discuss costs and value with
patients, the checklist may require different items than if clinicians
recognize the importance of such conversations but believe they lack
required information to facilitate them.
(5) Cognitive Interviews for the CV checklist. Once checklist items
have been identified, cognitive interviews will be conducted with 9
respondents in hospitals and 9 respondents in medical offices to
understand the cognitive processes the respondent engages in when using
the CV checklist. Cognitive interviewing will allow checklist
developers to identify and classify difficulties respondents may have
regarding checklist items. To get different perspectives, interviews
will be conducted with a mix of physicians, nurses, social workers,
health educators, and patients in hospitals and medical offices.
(6) Pretest the CV checklist. The checklist will then be pretested
to solicit feedback from 50 physicians in hospitals and 50 physicians
in medical offices. The pilot testing process will help identify areas
where users of the checklist have trouble understanding, learning, and
using the checklist. It also provides the opportunity to identify
issues that can prevent successful deployment of the checklist.
(7) Dissemination activities. The final VE Surveys and CV checklist
will be made available to the public through the AHRQ Web site. This
activity does not impose a burden on the public and is therefore not
included in the burden estimates in Exhibit 1.
The information collected will be used to test and improve the
draft survey items in the VE Surveys and CV checklist.
The final VE instruments will be made available to the public for
use in hospitals and medical offices to assess value and efficiency
from the perspectives of their staff. The survey can be used by
hospitals and medical offices to identify areas for improvement.
Researchers are also likely to use the surveys to assess the impact of
hospitals' and medical offices' value and efficiency improvement
initiatives.
The final CV checklist will be made available to hospital and
medical office clinicians to aid in having conversations with patients
about value.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated annualized burden hours for the
respondents' time to participate in this research. Cognitive interviews
for the Hospital VE survey will be conducted with 9 hospital staff
(approximately 3 managers, 3 nurses, and 3 technicians) and will take
about one hour and 30 minutes to complete. Cognitive interviews for the
Medical Office VE survey will be conducted with 9 medical office staff
(approximately 4 physicians and 5 medical assistants) and will take
about one hour and 30 minutes to complete. The Hospital VE survey will
be administered to about 4,032 individuals from 42 hospitals (about 96
surveys per hospital) and requires 15 minutes to complete. A site-level
POC will spend approximately 16 hours administering the Hospital VE
survey. The Medical Office VE survey will be administered to about 504
individuals from 96 medical offices (about 5 surveys per medical
office) and requires 15 minutes to complete. A site-level POC will
spend approximately 6 hours administering the Medical Office VE survey.
The medical office information form survey will be completed by a
medical office manager at each of the 96 medical offices participating
in the pretest and takes 10 minutes to complete.
One-hundred and sixty individuals (40 physicians, 40 nurses, 20
social workers, 20 health educators, and 40 patients) will participate
in the survey to identify items for the CV checklist and will take 15
minutes to complete. Cognitive interviews for the CV checklist will be
conducted with 18 individuals (9 in hospitals and 9 in medical offices,
consisting of approximately 4 physicians, 4 nurses, 2 social workers, 2
health educators, and 6 patients) and will take about one hour to
complete. One hundred physicians will participate in the pretest of the
CV checklist (50 in hospitals and 50 in medical offices). The total
burden is estimated to be 2,534 hours annually.
Exhibit 2 shows the estimated annualized cost burden associated
with the respondents' time to participate in this research. The total
cost burden is estimated to be $115,559 annually.
Exhibit 1--Estimated Annualized Burden Hours
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Number of
Form name Number of resonses per Hours per Total burden
respondents resondent response hours
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Cognitive interviews for the Hospital VE survey 9 1 1.5 14
Cognitive interviews for the Medical Office VE 9 1 1.5 14
survey........................................
Pretest for the Hospital VE survey............. 4,032 1 15/60 1,008
Pretest for the Medical Office VE survey....... 504 1 15/60 126
POC Administration of the Hospital VE survey... 42 1 16 672
POC Administration of the Medical Office VE 96 1 6 576
survey........................................
Medical office information form................ 96 1 10/60 16
Survey to identify items for CV checklist...... 160 1 15/60 40
Cognitive interviews for the CV checklist...... 18 1 1 18
Pretest for the CV checklist................... 100 1 30/60 50
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Total...................................... 5,066 na na 2,534
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[[Page 23259]]
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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Cognitive interviews for the Hospital VE survey. 9 14 \a\$36.16 $506
Cognitive interviews for the Medical Office VE 9 14 \b\46.87 656
survey.........................................
Pretest for the Hospital VE survey.............. 4,032 1,008 \c\36.02 36,308
Pretest for the Medical Office VE survey........ 504 126 \d\27.73 3,494
Administration of the Hospital VE survey........ 42 672 \e\55.80 37,498
Administration of the Medical Office VE survey.. 96 576 \f\50.98 29,364
Medical office information form................. 96 16 \f\50.98 816
Survey to identify items for CV checklist....... 160 40 \g\45.02 1,801
Cognitive interviews for the CV checklist....... 18 18 \h\39.84 717
Pretest for the CV checklist.................... 100 50 \i\87.98 399
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Total....................................... 5,066 2,534 na 115,559
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* National Occupational Employment and Wage Estimates in the United States, May 2011, ``U.S. Department of
Labor, Bureau of Labor Statistics'' (available at http://www.bls.gov/oes/current/naics4_621100.htm [for
medical office setting] and http://www.bls.gov/oes/current/naics4_622100.htm [for hospital setting]).
\a\ Based on the weighted average wages for 3 Registered Nurses (29-1111, $33.56), 3 Medical and Clinical
Laboratory Technicians (29-2012, $19.11), and 3 General and Operational Managers (11-1021, $55.80) in the
hospital setting;
\b\ Based on the weighted average wages for 4 Family and General Practitioners (29-1062; $87.18) and 5 Medical
Assistants (31-9092, $14.63) in the medical office setting;
\c\ Based on the weighted average wages for 1,937 Registered Nurses, 1,131 Medical and Clinical Laboratory
Technicians, 526 General and Operational Managers and 446 Physicians (29-1069; $66.23) in the hospital
setting;
\d\ Based on the weighted average wages for 91 Family and General Practitioners and 413 Medical Assistants in
the medical office setting;
\e\ Based on the average wages for General and Operational Managers in the hospital setting;
\f\ Based on the average wages for General and Operational Managers in the medical office setting;
\g\ Based on the weighted average wages for 40 Physician and Surgeons (29-10692; $88.78), 40 Registered Nurses
(29-1111; $33.23), 20 Social Workers (21-1022; $24.28), 20 Health Educators (21-1091, $25.07), and 20 Patients
(00-0000; $21.74);
\h\ Based on the weighted average wages for 4 Physician and Surgeons, 4 Registered Nurses, 2 Social Workers, 2
Health Educators, and 6 Patients;
\i\ Based on the weighted average wages for 50 Physician and Surgeons in the hospital setting and 50 Family and
General Practitioners in the medical office setting;
Estimated Annual Costs to the Federal Government
Exhibit 3 shows the estimated total and annualized cost to the
government for this data collection. Although data collection will last
for less than one year, the entire project will take about 2 years. The
total cost for the three surveys is approximately is $1,001,202.
Exhibit 3--Estimated Total and Annualized Cost
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Annualized
Cost component Total cost cost
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Project Development..................... $273,838 $136,919
Data Collection Activities.............. 153,119 76,560
Data Processing and Analysis............ 171,764 85,882
Publication of Results.................. 14,753 7,377
Project Management...................... 10,032 5,016
Overhead................................ 377,696 188,848
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Total............................... 1,001,202 500,601
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Request for Comments
In accordance with the Paperwork Reduction Act, 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 health care research and
health care 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: April 8, 2013.
Carolyn M. Clancy,
Director.
[FR Doc. 2013-08946 Filed 4-17-13; 8:45 am]
BILLING CODE 4160-90-M