Agency Information Collection Activities: Proposed Collection; Comment Request, 16308-16311 [E8-6073]
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16308
Federal Register / Vol. 73, No. 60 / Thursday, March 27, 2008 / Notices
Revised Document
1. The Categories of Individuals
Covered by the System section in the
System of Records Notice (SORN) is
revised to include other HHS personnel
who may treat individuals. The section
is revised as follows:
The individuals covered by the system
are all persons and owners of animals
treated by NDMS and other HHS
medical personnel when the NDMS
Disaster Medical Assistance Teams
(DMATs), National Veterinary Response
Teams (NVRTs), or other HHS medical
personnel are activated to respond to
emergency situations, or as a response
to any other situation for which they are
activated.
2. The Purpose(s) section in the SORN
is revised to include other HHS
personnel who may treat individuals.
The first sentence of that section is
revised to read:
Medical and demographic information
is collected on all patients seen and/or
treated by NDMS or other HHS
personnel.
3. Routine Use No. 1 in the SORN is
revised to clarify that it refers to sharing
information between NDMS partner
agencies, and to include a discussion, at
the end of the routine use, of the
relationship between all of the NDMS
partners regarding the use of medical
records as follows:
NDMS is a coordinated effort between
HHS, the Department of Homeland
Security (DHS), the Department of
Defense (DoD), and the Department of
Veterans Affairs (VA). As such, the
medical treatment and movement of
patients is a shared responsibility
between these partnership agencies. The
medical and demographic information
collected during the treatment of a
patient is shared with the partners to
ensure that patients treated through
NDMS receive the appropriate level of
health care. The health information
disclosed among the partners is limited
to what is needed for continuity of
health care operations.
4. Routine Use No. 4 in the SORN is
revised to include volunteers as follows:
Disclosure to agency contractors,
consultants, grantees, or volunteers who
have been engaged by the agency to
assist in the performance of a service
related to this collection and who have
a need to have access to the records in
order to perform the activity.
5. Routine Use No. 6 in the SORN is
revised to include a discussion, at the
end of the routine use, of the
circumstances when the agency will not
disclose the patient’s location or status
to family members as follows:
Disclosure of a patient’s location or
status is not permitted when there is a
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reasonable belief that disclosing such
information could endanger the life,
safety, health, or well-being of the
patient.
6. In the SORN, in the Policies and
Practices for Storing, Retrieving,
Accessing, Retaining, and Disposing of
Records in the System, in the
Disposition authority subsection, the
first two sentences are revised as
follows:
Patient Care Forms or other Medical
Records created by the Federal Medical
Station(s) (FMS) or by any component of
HHS/ASPR inclusive of NDMS during a
response to an event while caring for
victims of that event are cutoff at the
end of the response activity by the
Federal Medical Station(s) or HHS/
ASPR component for a particular event.
Cutoff refers to breaking, or ending files
at regular intervals, usually at the close
of a fiscal or calendar year, to permit
their disposal or transfer in complete
blocks and, in this case, cutoff is at the
end of the response activity. The cutoff
date marks the beginning of the records
retention period.
Dated: March 3, 2008.
Kevin Yeskey,
Deputy Assistant Secretary, Director, Office
of Preparedness and Emergency Operations.
[FR Doc. E8–6238 Filed 3–26–08; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (0MB) approve the proposed
information collection project: ‘‘Health
Care Systems for Tracking Colorectal
Cancer Screening Tests.’’ In accordance
with the Paperwork Reduction Act of
1995, 44 U.S.C. 3506(c)(2)(A), AHRQ
invites the public to comment on this
proposed information collection.
DATES: Comments on this notice must be
received by May 27, 2008.
ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by email at: doris.lefkowitz@ahrq.hhs.gov.
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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
Health Care Systems for Tracking
Colorectal Cancer Screening Tests
AHRQ proposes to implement and
assess a system redesign intervention to
improve colorectal cancer (CRC)
screening and follow-up among patients
50–79 years-old. Other goals of the
intervention include: (1) Achieving a
high level of satisfaction with the
intervention among patients, providers,
and practice staff, (2) promoting patientcentered care through the intervention,
(3) being a cost-effective intervention,
and (4) demonstrating the benefits to
businesses for implementing the
intervention. The research is sponsored
by AHRQ under its ACTION
(Accelerating Change and
Transformation in Organizations and
Networks) program, and will be
conducted for AHRQ by The CNA
Corporation (CNA) and its partners
Thomas Jefferson University (TJU) and
Lehigh Valley Physician Hospital
Organization (LVPHO).
Colorectal cancer screening is
recommended as routine preventive
care and this intervention, which is
consistent with current CRC screening
guidelines, carries no greater risk than
that which occurs in usual delivery of
healthcare (i.e., screening and follow up
done without benefit of this
intervention).
Nevertheless, as part of standard
research practice, the intervention and
assessment protocol will be submitted
to the Institutional Review Boards (IRB)
at both LVPHO and TJU so that they can
review the protocols to ensure that they
are consistent with the requirements of
human subjects protection as outlined
in federal statute, regulations, and
guidelines. These approvals will be
obtained before the study begins.
Additionally, CNA and LVPHO have a
business associate agreement, and all
parties involved with the study (CNA,
LVPHO, and TJU) will comply with the
Health Insurance Portability and
Accountability Act (HIPAA) Privacy
Rule, 45 CFR Parts 160 and 164. To
further protect patient privacy, neither
CNA nor TJU will have access to any
personally-identifiable data. Only PHO
personnel will have access to
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Federal Register / Vol. 73, No. 60 / Thursday, March 27, 2008 / Notices
identifiable data, which they will deidentify before sending to CNA and TJU
for analysis. Consistent with this
protocol, only LVPHO staff will have
access to patient names and addresses
and will conduct all mailings of letters
and related material to patients.
The intervention will be implemented
in both Family Medicine and General
Internal Medicine practices affiliated
with the LVPHO, and will involve 20
intervention practices and 5 control
practices (25 practices total). The
intervention will consist of inviting and
assisting eligible patients of intervention
practices to be screened for CRC,
providing academic detailing to
intervention practice providers
regarding CRC screening and
appropriate follow-up for positive
screens, and assisting providers to
identify and follow up with their
patients who have positive screens.
Patient eligibility criteria for the
intervention include: being between the
ages of 50–79, having no recent CRC
screening test, not having a previous
diagnosis of CRC, and not having a
family history of CRC before age 60.
Eligible patients will be identified
through a two step process: (1) An
electronic records review to identify
potentially eligible patients; and (2) a
mailed Screening Eligibility Assessment
(SEA) form from their primary care
practice to allow potentially eligible
patients to confirm or refute their
eligibility, and provide selected
additional demographic and perceived
health status information. Patients will
also have the opportunity to opt out of
the study on the SEA form.
Patients who are deemed eligible and
have not opted out of the study through
the SEA form will then receive a
mailing from their practice inviting
them to be screened for colorectal
cancer. The invitation will include a
letter on practice letterhead signed by
the practice’s primary care providers, a
brochure that describes the benefits of
CRC screening and the alternative
screening modalities that are consistent
with American Cancer Society
guidelines, a Stool Blood Test (SBT) kit
with an envelope to return it for
processing for those patients who want
to use that screening modality, and a list
of colonoscopists that the practice refers
patients to for those patients who prefer
colonoscopy to a SBT. In addition to the
list of colonoscopists, the accompanying
letter from the practice will also include
wording to make sure patients are aware
they can select other colonoscopists
who may not be on the list. As this
invitation mailing is part of normal
recommended clinical practice and
requires no response on the part of the
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patient other than participating in the
clinically recommended screening, it is
not considered to be a data collection.
Patient electronic records will be
tracked by LVPHO personnel for
evidence of screening. Patients whose
records do not indicate they have been
screened within a certain amount of
time will be sent a reminder letter. As
with the invitation mailing, this
reminder mailing is part of normal
recommended clinical practice and
requires no response on the part of the
patient other than participating in the
clinically recommended screening, and
is not considered to be a data collection.
There will be no additional cost to
patients for CRC screening beyond that
which occurs in the usual delivery of
health care. Patients insured through a
LVPHO insurance product will be
covered for diagnosis and treatment.
Patients covered through non-LVPHO
plans (public as well as private) will
also likely be covered, and such
coverage will be documented to
determine its impact on the
effectiveness of the intervention.
Patients who are underinsured or
uninsured are eligible to use systems for
charity and discounted care available in
the Lehigh Valley Hospital and
Healthcare Network, including access to
hospital clinics and access to financial
advisors.
Clinicians and staff of intervention
practices will participate in a brief
academic detailing session to review the
current evidence-based guidelines for
CRC screening from the American
Cancer Society, to receive information
regarding appropriate follow-up to
positive screens, and to receive the
operational details of the
implementation that will affect the
practice (including being provided
information about the intervention that
may be necessary for answering
questions from patients). Academic
detailing will not be provided to control
practices. As educational information is
only being provided, this component of
the intervention is not a data collection.
Method of Collection
Data will be collected through six
modes: (1) A SEA form; (2) focus groups
of providers and staff at each
intervention and control practice; (3)
brief informal interviews with selected
providers and staff at each practice; (4)
a survey of all clinicians and staff at
each practice; (5) patient chart audits;
and (6) patient focus groups. The data
will be collected to obtain the following
types of information needed for
determining patient eligibility for the
intervention and for conducting an
assessment of the intervention: patient’s
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16309
screening history and eligibility
information; patient demographics;
patient, provider, and practice
satisfaction with the intervention;
practice attitudes; practice procedures
and systems for screening and tracking
results; and patient-perceived barriers
and facilitators for following screening
and follow-up recommendations.
SEA Form
Potentially eligible patients identified
by electronic records review will receive
a SEA form and accompanying letter.
This form will ask patients to confirm
or refute their eligibility based on all
eligibility criteria. The form will also
ask patients for additional sociodemographic and perceived health
status data, and allow patients to opt out
of participation in the intervention if
they so choose.
Practice Focus Groups
The practice focus groups will be
conducted both prior to the intervention
and following the intervention at each
intervention practice. The preintervention focus groups are designed
to collect information to establish a
baseline. The post-intervention focus
groups will be conducted to assess
satisfaction with the intervention and to
identify changes in attitudes and
behaviors regarding screening and
follow-up and changes in management
of normal and abnormal screening tests
resulting from the intervention. In
addition, focus groups at control
practices will be conducted late in the
intervention period to gather
comparison information similar to the
baseline information gathered from
intervention practices.
Brief Informal Interviews
Brief informal interviews with
selected intervention practice providers
and staff will be conducted as a followup to the focus groups to ascertain
additional baseline information about
procedures and systems for screening
results (pre-intervention), and
additional information about each
practice’s experience with the
intervention and facilitators and barriers
to the intervention’s implementation
(post-intervention). In addition, similar
baseline information will be collected
from control practices late in the
intervention period.
Practice Survey
A pre-intervention practice survey of
providers and staff will be administered
in the intervention practices to provide
a baseline of the current CRC screening
environment at each practice. The
survey will be administered again post-
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Federal Register / Vol. 73, No. 60 / Thursday, March 27, 2008 / Notices
intervention to ascertain changes in
behavior or attitudes resulting from the
intervention. In addition, the survey
will also be administered in the control
practices late in the intervention period
to gather comparison information
similar to the baseline information
gathered from intervention practices.
Patient Chart Audits
Study personnel will track patient
screening rates and outcomes as well as
follow-up rates at intervention and
control practices by conducting chart
audits on patients whose electronic data
are inconclusive, or on patients who are
part of practices without electronic
medical records (EMR) systems. Chart
audits will be performed by study
personnel; however, practice staff will
be required to identify, locate, and make
charts available to study personnel.
Patient Focus Groups
Focus groups of patients will be
conducted to better understand the
intervention from the patient’s
perspective. Focus groups with the
intervention practices will be held at
two sites geographically situated across
the region. At each site, three focus
groups will be conducted for each of the
following types of intervention patients:
(1) Those who did not get the
recommended screening after receiving
the invitation packet, (2) those who did
get the recommended screening and
whose test was negative, and (3) those
who did get screened and whose test
was positive. For purposes of
comparison, two focus groups of
patients from control group practices
will also be conducted. Participants will
be asked about their attitudes and
beliefs regarding colorectal cancer
screening and what they believe would
help them get the screening they need.
Estimated Annual Respondent Burden
Exhibit I shows the estimated
annualized burden hours for the
respondents to participate in this
project. The SEA form will be sent to a
maximum of 7,500 patients across the
20 intervention practices and will
require an average of 10 minutes to
complete each. Practice focus groups
will be conducted with 10 individuals
per practice, and will last approximately
30 minutes each. The pre-intervention
and post-intervention practice focus
groups will be held with intervention
practices only (20 practices). Focus
groups will also be held at each of the
control practices for comparison
purposes (5 practices). Informal
interviews will be conducted with three
individuals per practice, and will last
about 10 minutes each. The pre and
post-intervention informal interviews
will be conducted among the
intervention practices (20 practices).
Informal interviews will also be
conducted in the control practices for
comparison purposes (5 practices). A
survey of providers and staff will be
conducted with 10 individuals at each
practice, and the survey will take
approximately 15 minutes to complete.
The survey will be administered to the
intervention practices during the pre
and post-intervention practice focus
group (20 practices). The survey will
also be administered to the control
practices for comparison purposes (5
practices). Patient chart audits will be
performed post-intervention at both
intervention and control practices as a
supplement to the information available
through electronic records. Among the
25 practices, about 50 patients from
each practice will have their charts
audited, which should take about 10
minutes per chart. Patient focus groups
will be held post-intervention and will
include six groups of 10 patients from
the intervention group practice sites,
and two groups of 10 patients from the
control group practice sites (80 patients
total). These focus groups are expected
to last about 2 hours. The total burden
for all phases of the project is estimated
to be 1,978.33 hours.
Exhibit 2 shows the estimated
annualized cost burden for the
respondents’ time to participate in the
project. The total cost is estimated to be
$29,844.73.
EXHIBIT 1.—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Data collection mode
Number of
responses per
respondent
Est. time per
respondent
in hours
Total burden
hours
Screening Eligibility Assessment (SEA) Form .................................................
Pre-interventlon practice focus groups ............................................................
Post-intervention practice focus groups ..........................................................
Control practice focus groups ..........................................................................
Pre-intervention informal interviews with selected providers and staff ...........
Post-intervention informal interviews with selected providers and staff ..........
Control informal interviews with selected providers and staff .........................
Pre-intervention survey of clinicians and staff .................................................
Post-intervention survey of clinicians and staff ...............................................
Control survey of clinicians and staff ...............................................................
Chart audits .....................................................................................................
Patient Focus Groups (post-intervention) ........................................................
7,500
20
20
5
20
20
5
20
20
5
25
80
1
10
10
10
3
3
3
10
10
10
50
1
10/60
30/60
30/60
30/60
10/60
10/60
10/60
15/60
15/60
15/60
10/60
2
1250
100
100
25
10
10
2.5
50
50
12.5
208.33
160
Total ..........................................................................................................
7,740
........................
........................
1,978.33
EXHIBIT 2.—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
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Data collection mode
Screening Eligibility Assessment (SEA) Form(1) ............................................
Pre-intervention practice focus groups(2) ........................................................
Post-intervention practice focus groups(2) ......................................................
Control practice focus groups(2) .....................................................................
Pre-intervention informal interviews with selected providers and staff(2) .......
Post-intervention informal interviews with selected providers and staff(2) .....
Control informal interviews with selected providers and staff(2) .....................
Pre-intervention survey of clinicians and staff(2) ............................................
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Total burden
hours
7,500
20
20
5
20
20
5
20
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Average hourly wage rate*
1,250
100
100
25
10
10
2.5
50
27MRN1
$12.54
28
28
28
28
28
28
28
Total cost
burden
$15,675
2,800
2,800
700
280
280
70
1,400
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Federal Register / Vol. 73, No. 60 / Thursday, March 27, 2008 / Notices
EXHIBIT 2.—ESTIMATED ANNUALIZED COST BURDEN—Continued
Number of
respondents
Data collection mode
Total burden
hours
Average hourly wage rate*
Total cost
burden
Post-intervention survey of clinicians and staff(2) ...........................................
Control survey of clinicians and staff(2) ..........................................................
Chart audits(3) .................................................................................................
Patient Focus Groups (post-intervention)(1) ...................................................
20
5
25
80
50
12.5
208.33
160
28
28
10
12.54
1,400
350
2,083.33
2,006.40
Total ..........................................................................................................
7,740
1,978.33
........................
29,844.73
(1) Patient average hourly wage based
on the average per capita income of
$26,088 (computed into an hourly wage
rate of $12.54) in Lehigh Valley,
Pennsylvania: ‘‘Demographic
Information for the Lehigh Valley’’ from
the Lehigh Valley Economic
Development Corporation 2006.
(2) Provider and practice hourly wage
based on an average of the following
estimates from LVPHO: physician =
$70/hour; manager = $19/hour; clinical
staff = $13/hour; and clerical staff =
$10/hour.
(3) Practice clerical staff will retrieve
the charts to be audited by study
personnel; therefore only the time of the
practice staff is included in Exhibit 1
and in the Exhibit 2 cost estimate.
Practice clerical staff hourly wage is
estimated by LVPHO to be $10/hour.
Estimated Annual Costs to the Federal
Government
The estimated total cost to the Federal
government is $271,764.68. The average
annualized cost over the two years of
the project is $135,882.34 per year.
Exhibit 3 shows a breakdown of the
costs.
EXHIBIT 3.—ESTIMATED ANNUAL COSTS TO THE FEDERAL GOVERNMENT
Component
Year 1
Year 2
Total
The cost of developing the data collection instruments ..............................................................
The cost of implementing the data collections ............................................................................
The cost of analyzing the data and publishing the results .........................................................
$24,765.38
99,061.52
49,530.76
$0
24,601.75
73,805.26
$24,765.38
123,663.27
123,336.02
Total ......................................................................................................................................
173,357.66
98,407.02
271,764.68
pwalker on PROD1PC71 with NOTICES
Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ 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.
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17:27 Mar 26, 2008
Jkt 214001
Dated: March 20, 2008.
Carolyn M. Clancy,
Director.
[FR Doc. E8–6073 Filed 3–26–08; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0180]
Draft Guidance for Industry on
Coronary Drug Eluting Stents–
Nonclinical and Clinical Studies;
Availability
AGENCY:
Food and Drug Administration,
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Coronary Drug
Eluting Stents—Nonclinical and
Clinical Studies.’’ This draft guidance is
intended to provide recommendations
to sponsors or applicants planning to
develop, or to submit to FDA, a
marketing application for a coronary
drug eluting stent (DES). The draft
guidance discusses the clinical studies
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Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by July 25, 2008.
DATES:
Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. Submit written comments on
the draft guidance to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to
ADDRESSES:
HHS.
ACTION:
that should be performed and the data
that should be submitted to support
such an application. The draft guidance
is being issued in two parts. The
companion document provides
additional and more detailed guidance
on some of the recommendations
included in this document. The
companion document is intended to be
used together with this draft guidance.
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]]>Agencies
[Federal Register Volume 73, Number 60 (Thursday, March 27, 2008)]
[Notices]
[Pages 16308-16311]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-6073]
-----------------------------------------------------------------------
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 (0MB) approve the proposed information collection
project: ``Health Care Systems for Tracking Colorectal Cancer Screening
Tests.'' In accordance with the Paperwork Reduction Act of 1995, 44
U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this
proposed information collection.
DATES: Comments on this notice must be received by May 27, 2008.
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
Health Care Systems for Tracking Colorectal Cancer Screening Tests
AHRQ proposes to implement and assess a system redesign
intervention to improve colorectal cancer (CRC) screening and follow-up
among patients 50-79 years-old. Other goals of the intervention
include: (1) Achieving a high level of satisfaction with the
intervention among patients, providers, and practice staff, (2)
promoting patient-centered care through the intervention, (3) being a
cost-effective intervention, and (4) demonstrating the benefits to
businesses for implementing the intervention. The research is sponsored
by AHRQ under its ACTION (Accelerating Change and Transformation in
Organizations and Networks) program, and will be conducted for AHRQ by
The CNA Corporation (CNA) and its partners Thomas Jefferson University
(TJU) and Lehigh Valley Physician Hospital Organization (LVPHO).
Colorectal cancer screening is recommended as routine preventive
care and this intervention, which is consistent with current CRC
screening guidelines, carries no greater risk than that which occurs in
usual delivery of healthcare (i.e., screening and follow up done
without benefit of this intervention).
Nevertheless, as part of standard research practice, the
intervention and assessment protocol will be submitted to the
Institutional Review Boards (IRB) at both LVPHO and TJU so that they
can review the protocols to ensure that they are consistent with the
requirements of human subjects protection as outlined in federal
statute, regulations, and guidelines. These approvals will be obtained
before the study begins. Additionally, CNA and LVPHO have a business
associate agreement, and all parties involved with the study (CNA,
LVPHO, and TJU) will comply with the Health Insurance Portability and
Accountability Act (HIPAA) Privacy Rule, 45 CFR Parts 160 and 164. To
further protect patient privacy, neither CNA nor TJU will have access
to any personally-identifiable data. Only PHO personnel will have
access to
[[Page 16309]]
identifiable data, which they will de-identify before sending to CNA
and TJU for analysis. Consistent with this protocol, only LVPHO staff
will have access to patient names and addresses and will conduct all
mailings of letters and related material to patients.
The intervention will be implemented in both Family Medicine and
General Internal Medicine practices affiliated with the LVPHO, and will
involve 20 intervention practices and 5 control practices (25 practices
total). The intervention will consist of inviting and assisting
eligible patients of intervention practices to be screened for CRC,
providing academic detailing to intervention practice providers
regarding CRC screening and appropriate follow-up for positive screens,
and assisting providers to identify and follow up with their patients
who have positive screens.
Patient eligibility criteria for the intervention include: being
between the ages of 50-79, having no recent CRC screening test, not
having a previous diagnosis of CRC, and not having a family history of
CRC before age 60. Eligible patients will be identified through a two
step process: (1) An electronic records review to identify potentially
eligible patients; and (2) a mailed Screening Eligibility Assessment
(SEA) form from their primary care practice to allow potentially
eligible patients to confirm or refute their eligibility, and provide
selected additional demographic and perceived health status
information. Patients will also have the opportunity to opt out of the
study on the SEA form.
Patients who are deemed eligible and have not opted out of the
study through the SEA form will then receive a mailing from their
practice inviting them to be screened for colorectal cancer. The
invitation will include a letter on practice letterhead signed by the
practice's primary care providers, a brochure that describes the
benefits of CRC screening and the alternative screening modalities that
are consistent with American Cancer Society guidelines, a Stool Blood
Test (SBT) kit with an envelope to return it for processing for those
patients who want to use that screening modality, and a list of
colonoscopists that the practice refers patients to for those patients
who prefer colonoscopy to a SBT. In addition to the list of
colonoscopists, the accompanying letter from the practice will also
include wording to make sure patients are aware they can select other
colonoscopists who may not be on the list. As this invitation mailing
is part of normal recommended clinical practice and requires no
response on the part of the patient other than participating in the
clinically recommended screening, it is not considered to be a data
collection.
Patient electronic records will be tracked by LVPHO personnel for
evidence of screening. Patients whose records do not indicate they have
been screened within a certain amount of time will be sent a reminder
letter. As with the invitation mailing, this reminder mailing is part
of normal recommended clinical practice and requires no response on the
part of the patient other than participating in the clinically
recommended screening, and is not considered to be a data collection.
There will be no additional cost to patients for CRC screening
beyond that which occurs in the usual delivery of health care. Patients
insured through a LVPHO insurance product will be covered for diagnosis
and treatment. Patients covered through non-LVPHO plans (public as well
as private) will also likely be covered, and such coverage will be
documented to determine its impact on the effectiveness of the
intervention. Patients who are underinsured or uninsured are eligible
to use systems for charity and discounted care available in the Lehigh
Valley Hospital and Healthcare Network, including access to hospital
clinics and access to financial advisors.
Clinicians and staff of intervention practices will participate in
a brief academic detailing session to review the current evidence-based
guidelines for CRC screening from the American Cancer Society, to
receive information regarding appropriate follow-up to positive
screens, and to receive the operational details of the implementation
that will affect the practice (including being provided information
about the intervention that may be necessary for answering questions
from patients). Academic detailing will not be provided to control
practices. As educational information is only being provided, this
component of the intervention is not a data collection.
Method of Collection
Data will be collected through six modes: (1) A SEA form; (2) focus
groups of providers and staff at each intervention and control
practice; (3) brief informal interviews with selected providers and
staff at each practice; (4) a survey of all clinicians and staff at
each practice; (5) patient chart audits; and (6) patient focus groups.
The data will be collected to obtain the following types of information
needed for determining patient eligibility for the intervention and for
conducting an assessment of the intervention: patient's screening
history and eligibility information; patient demographics; patient,
provider, and practice satisfaction with the intervention; practice
attitudes; practice procedures and systems for screening and tracking
results; and patient-perceived barriers and facilitators for following
screening and follow-up recommendations.
SEA Form
Potentially eligible patients identified by electronic records
review will receive a SEA form and accompanying letter. This form will
ask patients to confirm or refute their eligibility based on all
eligibility criteria. The form will also ask patients for additional
socio-demographic and perceived health status data, and allow patients
to opt out of participation in the intervention if they so choose.
Practice Focus Groups
The practice focus groups will be conducted both prior to the
intervention and following the intervention at each intervention
practice. The pre-intervention focus groups are designed to collect
information to establish a baseline. The post-intervention focus groups
will be conducted to assess satisfaction with the intervention and to
identify changes in attitudes and behaviors regarding screening and
follow-up and changes in management of normal and abnormal screening
tests resulting from the intervention. In addition, focus groups at
control practices will be conducted late in the intervention period to
gather comparison information similar to the baseline information
gathered from intervention practices.
Brief Informal Interviews
Brief informal interviews with selected intervention practice
providers and staff will be conducted as a follow-up to the focus
groups to ascertain additional baseline information about procedures
and systems for screening results (pre-intervention), and additional
information about each practice's experience with the intervention and
facilitators and barriers to the intervention's implementation (post-
intervention). In addition, similar baseline information will be
collected from control practices late in the intervention period.
Practice Survey
A pre-intervention practice survey of providers and staff will be
administered in the intervention practices to provide a baseline of the
current CRC screening environment at each practice. The survey will be
administered again post-
[[Page 16310]]
intervention to ascertain changes in behavior or attitudes resulting
from the intervention. In addition, the survey will also be
administered in the control practices late in the intervention period
to gather comparison information similar to the baseline information
gathered from intervention practices.
Patient Chart Audits
Study personnel will track patient screening rates and outcomes as
well as follow-up rates at intervention and control practices by
conducting chart audits on patients whose electronic data are
inconclusive, or on patients who are part of practices without
electronic medical records (EMR) systems. Chart audits will be
performed by study personnel; however, practice staff will be required
to identify, locate, and make charts available to study personnel.
Patient Focus Groups
Focus groups of patients will be conducted to better understand the
intervention from the patient's perspective. Focus groups with the
intervention practices will be held at two sites geographically
situated across the region. At each site, three focus groups will be
conducted for each of the following types of intervention patients: (1)
Those who did not get the recommended screening after receiving the
invitation packet, (2) those who did get the recommended screening and
whose test was negative, and (3) those who did get screened and whose
test was positive. For purposes of comparison, two focus groups of
patients from control group practices will also be conducted.
Participants will be asked about their attitudes and beliefs regarding
colorectal cancer screening and what they believe would help them get
the screening they need.
Estimated Annual Respondent Burden
Exhibit I shows the estimated annualized burden hours for the
respondents to participate in this project. The SEA form will be sent
to a maximum of 7,500 patients across the 20 intervention practices and
will require an average of 10 minutes to complete each. Practice focus
groups will be conducted with 10 individuals per practice, and will
last approximately 30 minutes each. The pre-intervention and post-
intervention practice focus groups will be held with intervention
practices only (20 practices). Focus groups will also be held at each
of the control practices for comparison purposes (5 practices).
Informal interviews will be conducted with three individuals per
practice, and will last about 10 minutes each. The pre and post-
intervention informal interviews will be conducted among the
intervention practices (20 practices). Informal interviews will also be
conducted in the control practices for comparison purposes (5
practices). A survey of providers and staff will be conducted with 10
individuals at each practice, and the survey will take approximately 15
minutes to complete. The survey will be administered to the
intervention practices during the pre and post-intervention practice
focus group (20 practices). The survey will also be administered to the
control practices for comparison purposes (5 practices). Patient chart
audits will be performed post-intervention at both intervention and
control practices as a supplement to the information available through
electronic records. Among the 25 practices, about 50 patients from each
practice will have their charts audited, which should take about 10
minutes per chart. Patient focus groups will be held post-intervention
and will include six groups of 10 patients from the intervention group
practice sites, and two groups of 10 patients from the control group
practice sites (80 patients total). These focus groups are expected to
last about 2 hours. The total burden for all phases of the project is
estimated to be 1,978.33 hours.
Exhibit 2 shows the estimated annualized cost burden for the
respondents' time to participate in the project. The total cost is
estimated to be $29,844.73.
Exhibit 1.--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Est. time per
Data collection mode Number of responses per respondent in Total burden
respondents respondent hours hours
----------------------------------------------------------------------------------------------------------------
Screening Eligibility Assessment (SEA) Form..... 7,500 1 10/60 1250
Pre-interventlon practice focus groups.......... 20 10 30/60 100
Post-intervention practice focus groups......... 20 10 30/60 100
Control practice focus groups................... 5 10 30/60 25
Pre-intervention informal interviews with 20 3 10/60 10
selected providers and staff...................
Post-intervention informal interviews with 20 3 10/60 10
selected providers and staff...................
Control informal interviews with selected 5 3 10/60 2.5
providers and staff............................
Pre-intervention survey of clinicians and staff. 20 10 15/60 50
Post-intervention survey of clinicians and staff 20 10 15/60 50
Control survey of clinicians and staff.......... 5 10 15/60 12.5
Chart audits.................................... 25 50 10/60 208.33
Patient Focus Groups (post-intervention)........ 80 1 2 160
---------------------------------------------------------------
Total....................................... 7,740 .............. .............. 1,978.33
----------------------------------------------------------------------------------------------------------------
Exhibit 2.--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Number of Total burden Average hourly Total cost
Data collection mode respondents hours wage rate* burden
----------------------------------------------------------------------------------------------------------------
Screening Eligibility Assessment (SEA) Form(1).. 7,500 1,250 $12.54 $15,675
Pre-intervention practice focus groups(2)....... 20 100 28 2,800
Post-intervention practice focus groups(2)...... 20 100 28 2,800
Control practice focus groups(2)................ 5 25 28 700
Pre-intervention informal interviews with 20 10 28 280
selected providers and staff(2)................
Post-intervention informal interviews with 20 10 28 280
selected providers and staff(2)................
Control informal interviews with selected 5 2.5 28 70
providers and staff(2).........................
Pre-intervention survey of clinicians and 20 50 28 1,400
staff(2).......................................
[[Page 16311]]
Post-intervention survey of clinicians and 20 50 28 1,400
staff(2).......................................
Control survey of clinicians and staff(2)....... 5 12.5 28 350
Chart audits(3)................................. 25 208.33 10 2,083.33
Patient Focus Groups (post-intervention)(1)..... 80 160 12.54 2,006.40
---------------------------------------------------------------
Total....................................... 7,740 1,978.33 .............. 29,844.73
----------------------------------------------------------------------------------------------------------------
(1) Patient average hourly wage based on the average per capita
income of $26,088 (computed into an hourly wage rate of $12.54) in
Lehigh Valley, Pennsylvania: ``Demographic Information for the Lehigh
Valley'' from the Lehigh Valley Economic Development Corporation 2006.
(2) Provider and practice hourly wage based on an average of the
following estimates from LVPHO: physician = $70/hour; manager = $19/
hour; clinical staff = $13/hour; and clerical staff = $10/hour.
(3) Practice clerical staff will retrieve the charts to be audited
by study personnel; therefore only the time of the practice staff is
included in Exhibit 1 and in the Exhibit 2 cost estimate. Practice
clerical staff hourly wage is estimated by LVPHO to be $10/hour.
Estimated Annual Costs to the Federal Government
The estimated total cost to the Federal government is $271,764.68.
The average annualized cost over the two years of the project is
$135,882.34 per year. Exhibit 3 shows a breakdown of the costs.
Exhibit 3.--Estimated Annual Costs to the Federal Government
----------------------------------------------------------------------------------------------------------------
Component Year 1 Year 2 Total
----------------------------------------------------------------------------------------------------------------
The cost of developing the data collection instruments.......... $24,765.38 $0 $24,765.38
The cost of implementing the data collections................... 99,061.52 24,601.75 123,663.27
The cost of analyzing the data and publishing the results....... 49,530.76 73,805.26 123,336.02
=================
Total....................................................... 173,357.66 98,407.02 271,764.68
----------------------------------------------------------------------------------------------------------------
Request for Comments
In accordance with the above-cited Paperwork Reduction Act
legislation, comments on AHRQ's information collection are requested
with regard to any of the following: (a) Whether the proposed
collection of information is necessary for the proper performance of
AHRQ 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: March 20, 2008.
Carolyn M. Clancy,
Director.
[FR Doc. E8-6073 Filed 3-26-08; 8:45 am]
BILLING CODE 4160-90-M
