```

[Federal Register Volume 78, Number 75 (Thursday, April 18, 2013)]
[Notices]
[Pages 23256-23259]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-08946]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 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 email at 
doris.lefkowitz@AHRQ.hhs.gov.

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.
---------------------------------------------------------------------------

    \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'.''
---------------------------------------------------------------------------

    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
----------------------------------------------------------------------------------------------------------------
                                                                    Number of
                   Form name                        Number of     resonses per      Hours per      Total burden
                                                   respondents      resondent        response          hours
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------

[[Page 23259]]

                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                    Form name                        Number of     Total burden     hourly wage     Total cost
                                                    respondents        hours           rate*          burden
----------------------------------------------------------------------------------------------------------------
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
                                                 ---------------------------------------------------------------
    Total.......................................           5,066           2,534              na         115,559
----------------------------------------------------------------------------------------------------------------
* 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
------------------------------------------------------------------------
                                                            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: April 8, 2013.
Carolyn M. Clancy,
Director.
[FR Doc. 2013-08946 Filed 4-17-13; 8:45 am]
BILLING CODE 4160-90-M
```