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Agency Information Collection Activities: Proposed Collection; Comment Request

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Agency for Healthcare Research and Quality, HHS.




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: “Making It Easier for Patients to Understand Health Information and Navigate Health Care Systems: Developing Quality Improvement Measures.” In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.


Comments on this notice must be received by April 11, 2016.


Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at

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.

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Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at

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Proposed Project

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

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; underuse 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. According to the 2003 National Assessment of Adult Literacy, 88% of U.S. adults have significant difficulties understanding widely used health information. 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. 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.

This project is being conducted by AHRQ through its contractor, Board of Regents of the University of Colorado, pursuant to AHRQ's statutory authority to conduct and support research on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of health care services and with respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1) and (2).

Method of Collection

Environmental Scan Interviews: Representatives from 25 health care organizations engaged in relevant quality improvement efforts will be interviewed to obtain information about the quality improvement measures they use in assessing their work to improve patient understanding, navigation, engagement, and self-care.

The planned environmental scan interviews will provide the information needed to:

  • Identify and document the characteristics of relevant quality improvement measures that are already in use; and
  • identify additional measures that would be useful to stakeholders in the field.

The findings from these interviews will be used, along with the results from other activities (i.e., input from a Technical Expert Panel, literature review, a Request for Information published in the Federal Register, and focus groups with patients), to identify and document a set of quality improvement measures that can be recommended for rigorous testing and validation. Measures that are assessed to be valid and reliable will be eligible to be disseminated by AHRQ to support health care organizations in their efforts to improve patient understanding of health information, navigation of the health care system, engagement in medical decision-making, and management of their health.

Estimated Annual Respondent Burden

Exhibit 1 shows the estimated annualized burden hours for the respondents' time to participate in Environmental Scan Interviews. The Environmental Scan Interviews will be completed by 50 respondents (2 representatives from each of the 25 organizations targeted for participation).

Exhibit 1—Estimated Annualized Burden Hours

Form nameNumber of respondentsNumber of responses per respondentHours per responseTotal burden hours
Environmental Scan Interviews5012100
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Exhibit 2 shows the estimated annual cost burden associated with the respondents' time to participate in this information collection. The annual cost burden for the Environmental Scan Interviews is estimated to be $4,984.

Exhibit 2—Estimated Annualized Cost Burden

Form nameNumber of respondentsTotal burden hoursAverage hourly wage rate *Total cost burden
Environmental Scan Interviews50100a $49.84$4,984
Total50100a 49.844,984
* National Compensation Survey: Occupational wages in the United States May 2014, “U.S. Department of Labor, Bureau of Labor Statistics.”
a Based on the mean wages for Medical and Health Services Managers 11-9111.

Request for Comments

In accordance with the Paperwork Reduction Act, 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.

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Sharon B. Arnold,

Deputy Director.

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[FR Doc. 2016-02678 Filed 2-9-16; 8:45 am]