Making It Easier for Patients to Understand Health Information and Navigate Health Care Systems: Developing Quality Improvement Measures

Forms and Documents

Document	Type	Status	Availability
Form 1 Environmental Scan Semi-Structured Interview Guide	Form and Instruction	New	Available
Supporting Statement Part A responses 9-12-16.docx	Supporting Statement A	Uploaded 2016-09-12	Available
Supporting Statement Part B 12-17-15.docx	Supporting Statement B	Uploaded 2016-04-13	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
221025	Environmental Scan Semi-Structured Interview Guide	Form and Instruction	New

ICR Details

OMB Control No: 0935-0232	ICR Reference No: 201604-0935-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Making It Easier for Patients to Understand Health Information and Navigate Health Care Systems: Developing Quality Improvement Measures
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: 09/20/2016
	Date Received in OIRA: 04/20/2016
Terms of Clearance: This ICR was approved for one-year because it is a one-time data collection.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2017	36 Months From Approved
Responses	50	0	0
Time Burden (Hours)	100	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: A goal of Healthy People 2020 is to increase Americans’ health literacy, defined as “the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions.” 1 The effects of limited health literacy are numerous and serious, including medication non-adherence resulting from patients’ inability to read and comprehend medication labels; under use of preventive measures, such as vaccines; poor self-management of conditions such as asthma and diabetes; and higher utilization of inpatient and emergency department care. 2,3 According to the 2003 National Assessment of Adult Literacy, 88% of US adults have significant difficulties understanding widely used health information. 4 By adopting “health literacy universal precautions,” health care providers and organizations can create an environment in which all patients – regardless of health literacy level – can successfully (1) understand health information, (2) navigate the health care system, (3) engage in medical decision-making, and (4) manage their health. Numerous resources have been developed to support health care organizations in their attempts to address limitations in patient health literacy. 5 However, little work has been done to establish valid quality improvement measures that organizations can use to monitor the impact of initiatives aimed at improving patient understanding, navigation, engagement, and self-management. Absent such measures, organizations may be unable to accurately assess whether their initiatives are effective. This research has the following goals: 1. Identify existing quality improvement measures and gather proposals for additional measures (not generated from patient survey data) that organizations may use to monitor progress related to enhancing patient understanding, navigation, engagement, and self-management; and 2. Identify a set of quality improvement measures that reflect patient priorities, has expert support, and can be recommended for more formal measure development and testing.

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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:
	81 FR 7118	02/10/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 22605	04/18/2016
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Environmental Scan Semi-Structured Interview Guide	1	Environmental Scan Semi-Structured Interview Guide

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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	50	0	0	50	0	0
Annual Time Burden (Hours)	100	0	0	100	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 information collection request.

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Annual Cost to Federal Government: $37,206

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]? No

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: 04/20/2016

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