[Federal Register Volume 76, Number 144 (Wednesday, July 27, 2011)]
[Notices]
[Pages 44929-44932]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18790]
-----------------------------------------------------------------------
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: ``Evaluation of ARRA Comparative Effectiveness Research
Dissemination Contractor Efforts.'' 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 September 26, 2011.
ADDRESSES: Written comments should be submitted to: Doris Lefkowitz,
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
Evaluation of ARRA Comparative Effectiveness Research Dissemination
Contractor Efforts
Today, both patients and their health care providers have many
options when deciding on a treatment plan. Information available to
patients and their health care providers offers great opportunities for
informed decision making. However, the volume of information that needs
to be reviewed and synthesized can be daunting. To complicate matters,
studies may offer conflicting information or have a conflict of
interest (e.g., research sponsored by pharmaceutical companies that
make drugs). Sorting through conflicting information requires a
background in research that most patients do not have, and physicians
have limited time to conduct these reviews. Having a neutral third
party review research, draw conclusions, and disseminate findings is
necessary to ensure effective health care delivery and consumption of
quality care.
AHRQ recognizes the need to fill this gap and has taken a lead role
in developing mechanisms for reviewing and disseminating Comparative
Effectiveness Research (CER) and findings to clinicians, health care
decision makers, purchasers/business decision makers, and consumers
through its Effective Healthcare Program (EHCP). CER directly compares
the benefits, potential risks, and costs of two or more health care
interventions. These direct comparisons allow assessments of how well a
health care treatment or intervention works under real-world
conditions. AHRQ has paid careful attention not only to how studies are
conducted but also to how results are communicated to its audiences.
To augment AHRQ's existing CER dissemination efforts performed by
the Eisenberg Center and other initiatives, AHRQ is conducting four
one-time projects to test other ways to disseminate CER results. These
four related projects will test new approaches to CER dissemination and
promote awareness of the EHCP. Collectively, dissemination efforts will
reach AHRQ's priority audiences of: clinical decision makers, health
care system decision makers, purchasers/business decision makers,
public policy decision makers, and consumers/patients.
Through these four projects AHRQ aims to: (1) Educate professional
and consumer audiences about CER; (2) inform professional and consumer
audiences about AHRQ's EHCP; (3) and inform a wide range of audiences
about new EHCP research findings.
This project will evaluate the effectiveness of these four new
dissemination efforts. The evaluation has four main goals:
1. Assess the effectiveness of the four dissemination strategies in
creating awareness of CER, specific CER topics, and the EHCP.
2. Assess the effectiveness of the four dissemination strategies in
fostering knowledge and understanding of CER finding, specific CER
topics, and the EHCP.
3. Assess the effectiveness of the four dissemination strategies in
promoting utilization, including use of the EHCP materials by consumers
and by clinicians in patient care and if usage by clinicians is
increasing across time.
4. Assess the effectiveness of the four dissemination strategies in
supporting the benefits of using CER, and specific CER topics, for both
patients and health care providers.
This study is being conducted by AHRQ through its contractor, IMPAQ
[[Page 44930]]
International, LLC and its subcontractor, Battelle Memorial Institute,
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
clinical practice, including primary care and practice-oriented
research. 42 U.S.C. 299a(a)(1) and (4).
Method of Collection
To achieve project goals the following data collections will be
implemented, each of which apply to all of the above-stated goals:
1. Clinician Survey--Conduct three cross-sectional mail surveys
with clinicians to measure awareness, understanding, use of the EHCP
materials, and benefits of CER. Collecting survey data at multiple time
points is critical to assess trends in the outcomes of interest among
clinicians and the impact of ongoing and increased dissemination
contractor activities. Three data points for the survey will allow us
to test if the proportion of clinicians aware of CER and the Effective
Healthcare Program is changing over time and if the rate of change is
changing. The Survey will be administered at the end of years 1, 3 and
4; the burden for the year 4 data collection is not included in the
estimates in Exhibits 1 and 2 since it will be included in a second OMB
clearance package to be submitted after year 3.
2. Consumer/Patient Survey--Conduct two cross-sectional telephone
surveys with consumers/patients to measure awareness, understanding,
use of the EHCP materials, and benefits of CER. Collecting survey data
at multiple time points is critical to assess trends in the outcomes of
interest among consumers/patients and the impact of ongoing and
increased dissemination contractor activities. Two data points for the
survey will allow us to test if the proportion of consumers/patients
aware of CER and the Effective Healthcare Program is changing over
time. The Survey will be administered at the end of years 1 and 3. A
short screener questionnaire will be used to identify eligible
respondents.
3. Health System Decision Maker Survey--Conduct one cross-sectional
telephone survey with health care system decision makers to measure
awareness, understanding, use of the EHCP materials, and benefits of
CER. The questionnaire and respondent materials for this data
collection are not included in this submission since it occurs in year
4 of the project and have not yet been developed. These materials will
be submitted in another OMB clearance package in year 3 of this
project. This data collection is mentioned here in order to provide an
overview of the entire 5 years of the project; it is not included in
the burden estimates in Exhibits 1 and 2.
4. Clinician Focus Groups--Conduct six follow-up focus groups with
clinicians after the first and third cross-sectional surveys of this
audience, The focus groups will be conducted with three clinician
segments: (1) Those who report awareness of CER and have self-reported
use of CER in their clinical practice; (2) those who report awareness
of CER and have self-reported non-use of CER in their clinical
practice; and (3) those who report no awareness of CER. One moderator
guide will be used for each focus group. By asking the same questions
to each clinician segment, who will have been targeted by all four
dissemination contractors, differences among answers are more likely to
be attributed to the segmentation criteria and eliminate bias through
different questions. Two focus groups will be conducted for each of the
three segments. The clinician focus groups will be conducted by
telephone. The focus groups will be administered at the end of year 2
and during year 5; the burden for the year 5 data collection is not
included in the estimates in Exhibits 1 and 2 since it will be included
in a second OMB clearance package to be submitted after year 3.
5. Consumer/Patients Focus Groups--Conduct twelve follow-up focus
groups with consumers/patients after the first cross-sectional survey
of this audience, at the end of year 2 of the project. The focus groups
will be conducted with three consumer/patient segments: (1) Those who
report awareness of CER and have self-reported use of CER in medical
decision making; (2) those who report awareness of CER and have self-
reported non-use of CER in medical decision making; and (3) those who
report no awareness of CER. Four focus groups will be conducted for
each of the three segments. A single screening questionnaire will be
used to recruit participants. The consumer/patient focus groups will be
conducted by telephone.
6. Health System Decision Maker Focus Groups--Conduct twelve
follow-up focus groups with health care system decision makers, after
the cross-sectional survey of this audience. The focus groups will be
conducted with three decision maker segments: (1) Those who reported
awareness of CER and have self-reported use of CER in business decision
making; (2) those who reported awareness of CER and have self-reported
non-use of CER in business decision making; and (3) those who report no
awareness of CER. Four focus groups will be conducted for each of the
three segments. The focus groups will be conducted by telephone. The
screener, moderator guides, and respondent materials for this data
collection are not included in this submission since it occurs in year
5 of the project and have not yet been developed. These materials will
be submitted in another OMB clearance package in year 3 of this
project. This data collection is mentioned here in order to provide an
overview of the entire 5 years of the project; it is not included in
the burden estimates in Exhibits 1 and 2.
7. Semi-structured Interviews--Conduct semi-structured interviews,
in year 3 of the project, with 20 individuals in each of the following
groups: health care system decision makers, purchasers, and
policymakers for a total of 60 interviews. In-depth interviews will be
used to determine how people receive and interpret CER-related
materials and verbal information, and adopt new behaviors based on
information they receive.
AHRQ will use the survey, focus group, and in-depth interview data
to assess trends and the effectiveness of the four complementary and
different dissemination methods to inform current and future
dissemination of the EHCP. Specific attention will be given to changes
in audience awareness, understanding, behavior change/use, and benefits
of CER. Collecting data at multiple times will enable AHRQ to determine
whether increased dissemination contractors' activities over time is
associated with any change in CER awareness, knowledge, use, or
benefit. Finally, collecting data from five audiences (i.e.,
clinicians, consumers/patients, health system decision makers,
purchasers, and policy makers) will enable AHRQ to assess the
effectiveness of its CER-related dissemination efforts among its target
populations.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated annualized burden hours for the
respondent's time to participate in this evaluation. The total burden
hours are estimated to be 3,760.
Clinician Surveys: The design for the clinician survey consists of
three cross sectional waves (only 2 of which are included in the
estimates here, as explained in section 1), each wave having 1,926
respondents for a total of
[[Page 44931]]
3,852 across the two waves included in this information collection
request. The survey will take no longer than 20 minutes to complete.
Consumer/Patient Surveys: The design for the consumer/patient
survey consists of two cross-sectional waves, each wave having 1,000
respondents for a total of 2,000 across both waves. The screener will
take no longer than 5 minutes to complete. The survey will take no
longer than 20 minutes to complete.
Clinician Focus Groups: Six follow-up focus groups with clinicians
will be conducted by telephone twice; once after the first and again
after the third cross-sectional surveys of this audience (only one of
which is included in the estimates here, as explained in section 1).
Focus group participants will have completed the survey and will have
expressed interest in participating in a telephone focus group. For
each of the two rounds of focus groups, twelve clinicians will be
recruited for each of six focus groups.
Focus groups will last one hour.
Consumer/Patient Focus Groups: Twelve follow-up focus groups with
consumer/patients will be conducted by telephone after the first cross-
sectional survey of this audience. Focus group participants will have
completed the survey and will have expressed interest in participating
in a telephone focus group. Eight people will be in each focus group.
The screener will take no longer than 5 minutes to complete. Focus
group will last approximately 90 minutes.
In-Depth Interviews with Other Key Audiences: In-depth interviews
will be conducted with up to 20 representatives in each of three key
audiences: (1) Health care system decision makers, (2) purchasers, and
(3) policy makers. Respondents located in the metropolitan Washington,
DC/Baltimore area will be interviewed in person, and respondents
located outside the local area will be interviewed by telephone.
Participant recruitment should take no longer than five minutes. The
interviews will last one hour.
The estimated annualized cost burden associated with the
respondent's time to participate in this evaluation is shown in Exhibit
2. The total cost burden is estimated to be $144,266.
Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Data Collection Activity Number of responses per Hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Clinician Survey................................ 3,852 1 20/60 1,284
Consumer/Patient Survey Screener................ 2560 1 5/60 214
Survey.......................................... 2000 1 20/60 667
Clinician Focus Groups.......................... 72 1 60/60 72
Consumer/Patient Focus Groups Screener.......... 120 1 5/60 10
Focus Group..................................... 96 1 90/60 144
Semi-structured Interviews with Health System 20 1 60/60 20
Decision Makers................................
Semi-structured Interviews with Purchasers...... 20 1 60/60 20
Semi-structured Interviews with Policymakers.... 20 1 60/60 20
---------------------------------------------------------------
Total....................................... 8,760 n/a n/a 2,451
----------------------------------------------------------------------------------------------------------------
Exhibit 2: Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Average
Data Collection Activity Number of Total burden hourly wage Total cost
respondents hours rate* burden
----------------------------------------------------------------------------------------------------------------
Clinician Survey................................ 3,852 1,284 $88.46 $113,583
Consumer/Patient Survey Screener................ 2560 214 20.90 4,473
Survey.......................................... 2000 667 20.90 13,940
Clinician Focus Groups.......................... 72 72 88.46 6,369
Consumer/Patient Focus Groups Screener.......... 120 10 20.90 209
Focus Groups.................................... 96 144 20.90 3,010
Semi-structured Interviews with Health System 20 20 43.74 875
Decision Makers................................
Semi-structured Interviews with Purchasers...... 20 20 46.59 932
Semi-structured Interviews with Policymakers.... 20 20 43.74 875
---------------------------------------------------------------
Total....................................... 8,760 2,451 n/a 144,266
----------------------------------------------------------------------------------------------------------------
* Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United
States May 2009, ``U.S. Department of Labor, Bureau of Labor Statistics.'' Hourly wage rates for clinicians
were estimated using the mean wage for internists (occupation code 29-1063). Hourly wage rates for consumers/
patients were estimated using the mean wage for all occupations (occupation code 00-0000) since participants
in the consumer groups may have a wide range of jobs and occupations. Hourly wage rates for health system
decision makers and policymakers were estimated using the mean wage for medical and health services managers
(occupation code 11-9111). Hourly wage rates for purchasers were estimated using the mean wage for purchasing
managers (occupation code 11-3061). These rates were obtained in January 2011 at the following Web site: http://www.bls.gov/oes/current/oes_nat.htm#b29-0000.
Estimated Annual Costs to the Federal Government
The total cost to the Government for this information collection is
$2,719,272 over the five years of the project. Exhibit 3 provides a
breakdown of these costs.
[[Page 44932]]
Exhibit 3--Estimated Total and Annualized Cost
------------------------------------------------------------------------
Annualized
Cost Component Total cost cost
------------------------------------------------------------------------
Project Development........................... $420,055 $84,011
Data Collection Activities.................... 1,452,290 290,458
Data Processing and Analysis, and Reports to 141,637 28,327
AHRQ.........................................
Project Management............................ 291,706 58,341
Overhead...................................... 413,584 82,717
-------------------------
Total..................................... 2,719,272 543,854
------------------------------------------------------------------------
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 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: July 6, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011-18790 Filed 7-26-11; 8:45 am]
BILLING CODE 4160-90-M