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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality

NOTICE: NOTICES

DOCUMENT ACTION: Notice.

SUBJECT CATEGORY: Agency Information Collection Activities: Proposed Collection; Comment Request

DATES: Comments on this notice must be received by August 18, 2008.

DOCUMENT 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.

SUMMARY: Agency Information Collection Activities; Proposals, Submissions, and Approvals,

SUPPLEMENTAL 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 followup among patients 5079 yearsold. 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 costeffective 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 personallyidentifiable 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 followup 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 entitiesMedical Associates of The Lehigh Valley (MATLV, a large, private group association), Lehigh Valley Physicians Group (LVPG, hospitalowned 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 5079 identified as being potentially eligible for the intervention.

Patient eligibility criteria for the intervention include: Being between the ages of 5079, 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 nonLVPHO 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 evidencebased guidelines for CRC screening from the American Cancer Society, to receive information regarding appropriate followup 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 patientperceived barriers and facilitators for following screening and followup 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 entitiesLVPHO, 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 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 postintervention focus groups will be conducted to assess satisfaction with the intervention and to identify changes in attitudes and behaviors regarding screening and [[Page 41083]]
followup 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 (preintervention), 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 preintervention 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 postintervention 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 followup 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 preintervention 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 postintervention 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 postintervention 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 postintervention 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 Number of Est. time per Data collection mode Number of responses per respondent (in Total burden respondents respondent hours) hours Electronic patient record review*............... 4 3 5.66 68 Screening Eligibility Assessment (SEA) Form..... 7,500 1 10/60 1250 Preintervention practice focus groups.......... 20 10 30/60 100 Postintervention practice focus groups......... 20 10 30/60 100 Control practice focus groups................... 5 10 30/60 25 Preintervention informal interviews with 20 3 10/60 10 selected providers and staff...................
Postintervention 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............................
Preintervention survey of clinicians and staff. 20 10 15/60 50 Postintervention 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 (postintervention)........ 80 1 2 160

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Total....................................... 7,744 .............. .............. 2,046.33 *In the intervention practices, electronic records review will be conducted preintervention, midintervention, and postintervention. Midintervention 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 preintervention 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 Number of Total burden Average hourly Total cost Data collection mode respondents hours wage rate* burden Electronic patient record review................ 4 68 $23.56 $1,602 Screening Eligibility Assessment (SEA) Form..... 7,500 1,250 12.54 15,675 Preintervention practice focus groups.......... 20 100 28 2,800 Postintervention practice focus groups......... 20 100 28 2,800 Control practice focus groups................... 5 25 28 700 Preintervention informal interviews with 20 10 28 280 selected providers and staff...................
Postintervention informal interviews with 20 10 28 280 selected providers and staff...................
Control informal interviews with selected 5 2.5 28 70 providers and staff............................
Preintervention survey of clinicians and staff. 20 50 28 1,400 Postintervention 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 (postintervention)........ 80 160 12.54 2,006.40

Total....................................... 7,744 2,046.33 .............. 31,446.73 * 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 LVHphysician = $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 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 abovecited 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. E815666 Filed 71608; 8:45 am]
BILLING CODE 416090M

FOR FURTHER INFORMATION CONTACT Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 4271477, or by email at
doris.lefkowitz@ahrq.hhs.gov.