Health Care Systems for Tracking Colorectal Cancer Screening Tests

Forms and Documents

Document	Type	Status	Availability
Form Form #13 Patient Focus Groups (post-intervention)	Form and Instruction	New	Available
Form Form #12 Chart audits	Form and Instruction	New	Available
Form Form #11 Control survey of clinicians and staff	Form and Instruction	New	Available
Form Form #10 Post-intervention survey of clinicians and staff	Form and Instruction	New	Available
Form Form #9 Pre-intervention survey of clinicians and staff	Form and Instruction	New	Available
Form Form #8 Control informal interviews with selected providers and staff	Form and Instruction	New	Available
Form Form #7 Post-intervention informal interviews with selected providers and staff	Form and Instruction	New	Available
Form Form #6 Pre-intervention informal interviews with selected providers and staff	Form and Instruction	New	Available
Form Form #5 Control practice focus groups	Form and Instruction	New	Available
Form Form #4 Post-intervention practice focus groups	Form and Instruction	New	Available
Form Form #3 Pre-intervention practice focus groups	Form and Instruction	New	Repair queued
Form Form #2 Screening Eligibility Assessment (SEA) Form	Form and Instruction	New	Available
Form Form #1 Electronic patient record review	Form and Instruction	New	Available
CRC omb passback.doc	Supplementary Document	Uploaded 2008-11-26	Available
Attachment C3_Brief Informal Interviews with Selected Providers and Staff at Each Practice.doc	Supplementary Document	Uploaded 2008-11-26	Available
Attachment C2_Focus group of providers and staff at each intervention and control practice.doc	Supplementary Document	Uploaded 2008-11-26	Available
Attachment C6_Patient Focus Groups.doc	Supplementary Document	Uploaded 2008-11-26	Available
Attachment C5_Patient Chart Audits.doc	Supplementary Document	Uploaded 2008-11-26	Available
Attachment C7_Electronic Records Review Eligibility Criteria.xls	Supplementary Document	Uploaded 2008-11-26	Available
Attachment C4_A survey of all clinicians and staff at each practice - FINALv2.doc	Supplementary Document	Uploaded 2008-11-26	Available
Attachment C1_A Screening Eligibility (SEA) Form - FINALv2.doc	Supplementary Document	Uploaded 2008-11-26	Available
Supporting Statement Part B - FINAL Resubmit - 10-28-2008.doc	Supporting Statement B	Uploaded 2008-11-26	Available
Attachment A -- Healthcare Research and Quality Act of 1999.pdf	Supplementary Document	Uploaded 2008-07-25	Available
Attachment B_60 Day FRN -- Healthcare Systems for Tracking Colorectal Cancer Screening Tests.pdf	Supplementary Document	Uploaded 2008-11-26	Available
Attachment D5_Patient Consent.doc	Supplementary Document	Uploaded 2008-11-26	Available
Attachment D4_ Practice consent.doc	Supplementary Document	Uploaded 2008-11-26	Available
Attachment D3_ Patient Reminder Letter.doc	Supplementary Document	Uploaded 2008-11-26	Available
Attachment D2_ Patient Invitation Letter.doc	Supplementary Document	Uploaded 2008-11-26	Available
Attachment D1_Screening Elibility Letter.doc	Supplementary Document	Uploaded 2008-11-26	Available
Supporting Statement Part A - FINAL Resubmit - 10-28-2008.doc	Supporting Statement A	Uploaded 2008-11-26	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
185946	Patient Focus Groups (post-intervention)	Form and Instruction	New
185945	Chart audits	Form and Instruction	New
185944	Control survey of clinicians and staff	Form and Instruction	New
185943	Post-intervention survey of clinicians and staff	Form and Instruction	New
185942	Pre-intervention survey of clinicians and staff	Form and Instruction	New
185941	Control informal interviews with selected providers and staff	Form and Instruction	New
185940	Post-intervention informal interviews with selected providers and staff	Form and Instruction	New
185939	Pre-intervention informal interviews with selected providers and staff	Form and Instruction	New
185938	Control practice focus groups	Form and Instruction	New
185937	Post-intervention practice focus groups	Form and Instruction	New
185936	Pre-intervention practice focus groups	Form and Instruction	New
185935	Screening Eligibility Assessment (SEA) Form	Form and Instruction	New
185934	Electronic patient record review	Form and Instruction	New

ICR Details

OMB Control No: 0935-0146	ICR Reference No: 200807-0935-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Health Care Systems for Tracking Colorectal Cancer Screening Tests
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 12/05/2008
	Date Received in OIRA: 07/30/2008
Terms of Clearance: Clearance is provided consistent with the understanding that the results of this study will not be represented as generalizable. The population served by the study site is not representative of the US population and the single health care system studied cannot be assumed to be representative of any particular provider model. Furthermore, as noted in the supporting statement, the internal(practice-based) sampling approach used is not suitable for drawing statistically rigorous comparisons. Rather, qualitative analysis will be used to gain insights into how, how well, and how easily different types of practices incorporate the system redesign intervention.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2010	24 Months From Approved
Responses	9,877	0	0
Time Burden (Hours)	2,047	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The proposed study, Health Care Systems for Tracking Colorectal Cancer Screening Tests (contract number: HHSA290200600014, task order #1; task order number: 290-06-0014-1) is consistent with AHRQ's mission, as it will implement and assess a system redesign intervention to improve colorectal cancer (CRC) screening and follow-up among patients 50 - 79 years-old. The primary purpose of this study is to determine whether a system redesign intervention previously shown to be effective for increasing CRC screening and follow up rates in one setting can be successfully disseminated to other settings and to identify conditions and attributes associated with successful dissemination and uptake. This study will synthesize and disseminate information about appropriate CRC screening recommendations (that are consistent with 2008 American Cancer Society Guidelines) to both providers and patients at selected primary care practices. It will also provide a mechanism for facilitating CRC screening tests, monitoring the test results, informing providers of the results, and facilitating appropriate follow up through feedback to providers and subsequently patients. This in turn, is expected to help improve the quality of health care and its delivery. The study's analysis will determine to what extent this intervention was disseminated effectively and successfully and identify facilitators and barriers to effective and successful dissemination. It will also provide valuable information and "lessons learned" to other health care practices, delivery networks, and insurers that are interested in increasing CRC screening and follow up rates.

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Authorizing Statute(s): US Code: 42 USC 299 Name of Law: Healthcare Research and Quality Act of 1999
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 16308	03/27/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 41081	07/17/2008
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 13

IC Title	Form No.	Form Name
Electronic patient record review	Form #1	Electronic patient record review
Screening Eligibility Assessment (SEA) Form	Form #2	Screening Eligibility Assessment (SEA) Form
Pre-intervention practice focus groups	Form #3	Pre-intervention practice focus groups
Post-intervention practice focus groups	Form #4	Post-intervention practice focus groups
Control practice focus groups	Form #5	Control practice focus groups
Pre-intervention informal interviews with selected providers and staff	Form #6	Pre-intervention informal interviews with selected providers and staff
Post-intervention informal interviews with selected providers and staff	Form #7	Post-intervention informal interviews with selected providers and staff
Control informal interviews with selected providers and staff	Form #8	Control informal interviews with selected providers and staff
Pre-intervention survey of clinicians and staff	Form #9	Pre-intervention survey of clinicians and staff
Post-intervention survey of clinicians and staff	Form #10	Post-intervention survey of clinicians and staff
Control survey of clinicians and staff	Form #11	Control survey of clinicians and staff
Chart audits	Form #12	Chart audits
Patient Focus Groups (post-intervention)	Form #13	Patient Focus Groups (post-intervention)

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	9,877	0	0	9,877	0	0
Annual Time Burden (Hours)	2,047	0	0	2,047	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new proposed information collection.

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Annual Cost to Federal Government: $135,882

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 07/30/2008

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