[Federal Register Volume 78, Number 4 (Monday, January 7, 2013)]
[Notices]
[Pages 946-949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-31592]



[[Page 946]]

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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 About Value 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.

DATES: Comments on this notice must be received by March 8, 2013.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, by email at 
[email protected].
    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 About Value 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 incent 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, QI0 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 removed from 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 is more likely if organizations doing quality improvement link 
efforts to improve care quality with efforts to reduce unnecessary 
costs. Ignoring the financial implications of quality improvement 
efforts will fail in the real world where many providers face acute 
financial challenges and where costs are leading to consumer 
bankruptcies and increased insurance 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. Adding value within healthcare requires understanding 
the contribution that organizational culture makes to value and working 
to foster a culture where high value is a cultural norm. 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.
    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 YE surveys, AHRQ also intends to develop a 
Communicating About Value Checklist (CV checklist). The objective of 
the CV checklist is to aid clinicians in having conversations with 
patients about value. Since the proper goal for any health care 
delivery system is to improve the value delivered to patients, such a 
tool will address the important aspects of health care that are of 
value to patients. Value in health care is typically measured in terms 
of the patient outcomes achieved per dollar expended. But a good 
outcome must be defined in terms of what is meaningful and valuable to 
the individual patient.
    Better identification of patients' preferences is not only the 
right ethical thing to do but it also can reduce the cost of 
healthcare. Studies indicate that engaged and informed patients often 
choose to have less intensive care and become more careful about having 
lots of procedures. In addition, participatory decision making can 
reduce medication non-adherence which has been directly linked to 
increased morbidity, mortality and potentially avoidable healthcare

[[Page 947]]

costs totaling $290 billion annually in the U.S.
    The CV checklist will address three major topics: who should talk 
with patients about 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 CV 
checklist;
    (4) Pretest the CV checklist in hospitals and medical offices and 
modify as necessary based on the results;
    (5) Make the final VE surveys and CV 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 VE 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 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 Section 12.
    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 YE 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.

[[Page 948]]

    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     responses per     Hours per     Total  burden
                                                    respondents     respondent       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
                                                 ---------------------------------------------------------------
    Total.......................................           5,066              na              na           2,534
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                                   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           4,399
                                                 ---------------------------------------------------------------
    Total.......................................           5,066           2,534              na         115,559
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\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;
* 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]).

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.

[[Page 949]]



             Exhibit 3--Estimated Total and Annualized Cost
------------------------------------------------------------------------
                                                            Annualized
             Cost component                 Total  cost        cost
------------------------------------------------------------------------
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
                                         -------------------------------
    Total...............................       1,001,202         500,601
------------------------------------------------------------------------

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: December 20, 2012.
Carolyn M. Clancy,
Director.
[FR Doc. 2012-31592 Filed 1-4-13; 8:45 am]
BILLING CODE 4160-90-M