Patient Navigator Outreach and Chronic Disease Prevention Demonstration Program

Forms and Documents

Document Name	Status
Form 13a Client Opinion Form Form and Instruction	New
Form 14 Quarterly Report Form and Instruction	Modified
Form 14 Social Service Provider Focus Group Form and Instruction	Modified
Form 15 Grantee Health Care Provider Focus Group Form and Instruction	Modified
Form 14 Patient Navigator/Health System Administrator Focus Group Form and Instruction	Modified
Form 10 Patient Navigator ultural Competency Checklist Form and Instruction	Modified
Form 9 Annual Clinic-Wide Clinical Performance Mearsures Report Form	Modified
Form 8 Patient Medical Record and Clini Data Form and Instruction	Modified
Form 14 Patient Navigator Focus Group Form and Instruction	Modified
Form 4 Patient Navigator Encounter/Target Services Log Form and Instruction	Modified
Form 3 Patient Navigator Survey Form and Instruction	Modified
Form 2 VR-12 Health Status Form Form and Instruction	Modified
Form 1 Navigated Patient Data Intake Form Form and Instruction	Modified
SupStmt_B_RevBurden_ClientOp2012_08_28_2012_toHRSA - REVISED.doc Supporting Statement B	2012-08-29
SupStmt_A_RevBurdenClientOp2012_08_28_revtoHRSA - REVISED.doc Supporting Statement A	2012-08-29

IC Document Collections

IC ID	Document Title	Status
202876	Client Opinion Form Form and Instruction	New
198114	Quarterly Report Form and Instruction	Modified
198113	Social Service Provider Focus Group Form and Instruction	Modified
198112	Grantee Health Care Provider Focus Group Form and Instruction	Modified
198111	Patient Navigator/Health System Administrator Focus Group Form and Instruction	Modified
198110	Patient Navigator ultural Competency Checklist Form and Instruction	Modified
198109	Annual Clinic-Wide Clinical Performance Mearsures Report Form	Modified
198108	Patient Medical Record and Clini Data Form and Instruction	Modified
198107	Patient Navigator Focus Group Form and Instruction	Modified
198106	Patient Navigator Encounter/Target Services Log Form and Instruction	Modified
198105	Patient Navigator Survey Form and Instruction	Modified
198104	VR-12 Health Status Form Form and Instruction	Modified
198103	Navigated Patient Data Intake Form Form and Instruction	Modified

ICR Details

OMB Control No: 0915-0346	ICR Reference No: 201206-0915-006
Status: Historical Active	Previous ICR Reference No: 201112-0915-005
Agency/Subagency: HHS/HSA	Agency Tracking No:
Title: Patient Navigator Outreach and Chronic Disease Prevention Demonstration Program
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/31/2012
	Date Received in OIRA: 06/26/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2015	36 Months From Approved	01/31/2015
Responses	49,393	0	48,583
Time Burden (Hours)	12,048	0	11,953
Cost Burden (Dollars)	0	0	0

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Abstract: Ten grants have been awarded to eligible entities for the development and operation of demonstration programs to provide patient navigator services to improve health care outcomes. The Patient Navigator Outreach and Chronic Disease Prevention Demonstration Program assesses whether local initiatives can reduce the burden of cancer and other chronic diseases such as obesity, diabetes, asthma and others by reducing the barriers related to accessing high quality health care services. This evaluation consists of two parts of data collection: 1) collection of qualitative information from staff associated with the Patient Navigation Demonstration Program; and 2) quantitative data related to the demographics and care of all patientss entering PNDP, as well as patient navigators.

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Authorizing Statute(s): PL: Pub.L. 109 - 18 0812 Name of Law: Patient Navigator Outreach and hroni Disease Prevention Act of 2005
   PL: Pub.L. 111 - 148 3510 Name of Law: Patient Protection and Affordable Care Act of 2010
   US Code: 42 USC 256A Name of Law: The Public Health Service Act
  

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:
	77 FR 17078	03/23/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 35406	06/13/2012
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Navigated Patient Data Intake Form	1	IntakeAndTarget_20111014
VR-12 Health Status Form	2	VR_12_English_Self20110919v4
Patient Navigator Survey	3	Patient_Navigator_Form
Patient Navigator Encounter/Target Services Log	4, 5	Forms_20110919.v1 ,   Target Services Log
Patient Navigator Focus Group	14, 15, 6	Consent Form ,   Participant Information Form ,   PN_Focus Group
Patient Medical Record and Clini Data	8, 7	Clinical Measures ,   Co-Occuring Disorders
Annual Clinic-Wide Clinical Performance Mearsures Report	9	Clinic-Wide Measures
Patient Navigator ultural Competency Checklist	10	Cultural Competency
Patient Navigator/Health System Administrator Focus Group	14, 15, 11	Consent Form ,   Participant Information Form ,   Health_Administrator_Focus_Gorup
Grantee Health Care Provider Focus Group	15, 14, 12	Participant Information Form ,   Consent Form ,   Focus_Group_Health_Provider
Social Service Provider Focus Group	14, 15, 13	Consent Form ,   Participant Information Form ,   Focus_Group_Social_Service
Quarterly Report	14	Quarterly Report
Client Opinion Form	13a, 13	Clinet Opinon Form Spanish ,   Clinet Opinion Form

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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	49,393	48,583	0	810	0	0
Annual Time Burden (Hours)	12,048	11,953	0	95	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: The initial submission for data collection for the Evaluation of the PNDP focused heavily on the assessment of intermediate health outcomes, and it did not include a client opinion component. However, grant funding for the program was excluded from the 2013 Federal budget, necessitating a greatly shortened period of evaluation. While some clients will participate in the program for long enough for intermediate health outcomes to be affected, many clients will have a more limited experience. Obtaining information about client experience of the program, including whether the navigator was helpful to the client in meeting specific goals related to six duties specified in legislation, will assist in quality improvement efforts by HRSA and the overall assessment of the program by Congress.

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Annual Cost to Federal Government: $473,620

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]? Yes

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

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: 06/26/2012

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