[Federal Register Volume 73, Number 138 (Thursday, July 17, 2008)]
[Notices]
[Pages 41081-41084]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-15666]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Agency for Healthcare Research and Quality, HHS.
ACTION: Notice.
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SUMMARY: This notice announces the intention of the Agency for
Healthcare Research and Quality (AHRQ) to request that the Office of
Management and Budget (OMB) approve the proposed information collection
project: ``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.
This proposed information collection was previously published in
the Federal Register on March 27th, 2008 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. Changes were made to
this 30 day notice to account for the electronic patient records review
which were not accounted for in the 60 day notice.
DATES: Comments on this notice must be received by August 18, 2008.
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
e-mail at [email protected] (attention: AHRQ's desk
officer).
Copies of the proposed collection plans, data collection
instruments, and specific details on the estimated burden can be
obtained from the AHRQ Reports Clearance Officer.
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by e-mail at
[email protected].
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 Hospital (LVH).
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 LVH
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 LVH have a business associate agreement, and all parties involved
with the study (CNA, LVH, 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 LVH
personnel will have access to identifiable data, which they will de-
identify before sending to CNA and TJU for analysis. Consistent with
this protocol, only LVH 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 LVH, 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
[[Page 41082]]
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.
Many of the practices within LVH, are part of four large practice
entities--Medical Associates of The Lehigh Valley (MATLV, a large,
private group association), Lehigh Valley Physicians Group (LVPG,
hospital-owned practices), Lehigh Valley Physician Hospital
Organization (LVPHO, a physician hospital organization that provides
physician practice services and health insurance products), and
practices which jointly use Physician Business Services (PBS) for
billing and associated activities. The electronic data used during the
records review (claims and billing records, and electronic medical
records when available) will be centrally extracted by only four
entities (LVPHO, MATLV, LVPG, and PBS). These entities will have access
to their own patients' data. LVH study personnel will then merge these
data to develop the central patient database for this study. This
central patient database will contain information on all intervention
practice patients ages 50-79 identified as being potentially eligible
for the intervention.
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 test
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 stool test. 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 LVH 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 seven modes: (1) Electronic patient
records review; (2) a SEA form; (3) focus groups of providers and staff
at each intervention and control practice; (4) brief informal
interviews with selected providers and staff at each practice; (5) a
survey of all clinicians and staff at each practice; (6) patient chart
audits; and (7) 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.
Electronic Patient Records Review
An electronic records review will be used to identify patients who
are potentially eligible to participate in this study based on the
study's eligibility criteria. The electronic records will be extracted
from only four entities--LVPHO, MATLV, LVPG, and PBS. Electronic
records review will also be used part way through the intervention
period for patients of intervention practices to determine who should
receive a follow up reminder letter, and then again at the conclusion
of the intervention period for patients of both intervention and
control practices to determine which patients have completed a stool
test or colonoscopy and whether patients who screened positive received
appropriate follow up diagnostic evaluation.
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
[[Page 41083]]
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-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 LVH 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 1 shows the estimated annualized burden hours for the
respondents to participate in this project. The electronic patient
records review will be performed by only four entities (LVPHO, MATLV,
LVPG, and PBS) which will each extract approximately 1,875 records,
requiring about 68 hours total. 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 2,046.33 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 $31,446.73.
Exhibit 1.--Estimated Annualized Burden Hours
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Number of Est. time per
Data collection mode Number of responses per respondent (in Total burden
respondents respondent hours) hours
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Electronic patient record review*............... 4 3 5.66 68
Screening Eligibility Assessment (SEA) Form..... 7,500 1 10/60 1250
Pre-intervention 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
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[[Page 41084]]
Total....................................... 7,744 .............. .............. 2,046.33
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*In the intervention practices, electronic records review will be conducted pre-intervention, mid-intervention,
and post-intervention. Mid-intervention electronic records review will be conducted in order to determine
which patients should be sent the Reminder Letter if they have not yet completed a stool test kit or
colonoscopy. In the control practices, electronic records review will be conducted pre-intervention and post-
intervention. The electronic records review will be performed by administrative assistants (16 of 68 burden
hours) and data analysts (52 of 68 burden hours).
Exhibit 2.--Estimated Annualized Cost Burden
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Number of Total burden Average hourly Total cost
Data collection mode respondents hours wage rate* burden
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Electronic patient record review................ 4 68 $23.56 $1,602
Screening Eligibility Assessment (SEA) Form..... 7,500 1,250 12.54 15,675
Pre-intervention practice focus groups.......... 20 100 28 2,800
Post-intervention practice focus groups......... 20 100 28 2,800
Control practice focus groups................... 5 25 28 700
Pre-intervention informal interviews with 20 10 28 280
selected providers and staff...................
Post-intervention informal interviews with 20 10 28 280
selected providers and staff...................
Control informal interviews with selected 5 2.5 28 70
providers and staff............................
Pre-intervention survey of clinicians and staff. 20 50 28 1,400
Post-intervention survey of clinicians and staff 20 50 28 1,400
Control survey of clinicians and staff.......... 5 12.5 28 350
Chart audits.................................... 25 208.33 10 2,083.33
Patient Focus Groups (post-intervention)........ 80 160 12.54 2,006.40
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Total....................................... 7,744 2,046.33 .............. 31,446.73
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* Wage rates were calculated using the following data: (1) For the electronic patient record review the hourly
rate is a weighted average for administrative assistants ($14.00 per hour) and data analysts ($26.50 per
hour); (2) for the SEA form and patient focus groups the patient average hourly wage was 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; (3) for the practice focus groups, informal interviews, and survey the provider and practice hourly wage
was based on an average of the following estimates from LVH--physician = $70/hour; manager = $19/hour;
clinical staff = $13/hour; and clerical staff = $10/hour; (4) for the chart audits the practice clerical staff
hourly wage was estimated by LVH to be $10/hour (note: practice clerical staff will retrieve the charts to be
audited by study personnel; therefore only the time of the practice clerical staff is included in Exhibit 1
and in the Exhibit 2 cost estimate).
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
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Component Year 1 Year 2 Total
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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
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Total....................................................... 173,357.66 98,407.02 271,764.68
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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: June 27, 2008.
Carolyn M. Clancy,
Director.
[FR Doc. E8-15666 Filed 7-16-08; 8:45 am]
BILLING CODE 4160-90-M