[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
                                                 ---------------------------------------------------------------

[[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
                                                                 -----------------------------------------------
    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