Request for Measures Assessing Health Care Organization Quality Improvement Activities To Improve Patient Understanding, Navigation, Engagement, and Self-Management, 7116-7118 [2016-02679]

Download as PDF 7116 Federal Register / Vol. 81, No. 27 / Wednesday, February 10, 2016 / Notices agency or other federal entity that furnished the record or information for the purpose of permitting that agency or entity to make a decision regarding access to or correction of the record or information, or to a federal agency or entity for purposes of providing guidance or advice regarding the handling of a particular request. 3. A record from this system of records may be disclosed to the Department of Justice (DOJ) to obtain advice regarding statutory and other requirements under the FOIA. 4. A record from this system of records may be disclosed to the National Archives and Records Administration, Office of Government Information Services (OGIS), to the extent necessary to fulfill its responsibilities in 5 U.S.C. 552(h) to review administrative agency policies, procedures, and compliance with the FOIA, and to facilitate OGIS’s offering of mediation services to resolve disputes between persons making FOIA requests and administrative agencies. DISCLOSURE TO CONSUMER REPORTING AGENCIES: None. POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM: STORAGE: Records are maintained in paper and electronic form, including on computer databases, all of which are stored in a secure location. RETRIEVABILITY: Records are retrieved by any one or more of the following: The name of the requestor; the number assigned to the request or appeal; and in some instances, the name of the attorney representing the requestor or appellant, and/or the name of an individual who is the subject of such a request or appeal. asabaliauskas on DSK9F6TC42PROD with NOTICES2 SAFEGUARDS: FRTIB has adopted appropriate administrative, technical, and physical controls in accordance with FRTIB’s security program to protect the security, confidentiality, availability, and integrity of the information, and to ensure that records are not disclosed to or accessed by unauthorized individuals. Paper records are stored in locked file cabinets in areas of restricted access that are locked after office hours. Electronic records are stored on computer networks and protected by assigning usernames to individuals needing access to the records and by passwords set by unauthorized users that must be changed periodically. VerDate Sep<11>2014 17:22 Feb 09, 2016 Jkt 238001 RETENTION AND DISPOSAL: Records are retained and disposed of in accordance with the General Records Schedule 4.2, item 020, issued by the National Archives and Records Administration (NARA). DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Chief FOIA Officer, 77 K Street NE., Washington, DC 20002. Request for Measures Assessing Health Care Organization Quality Improvement Activities To Improve Patient Understanding, Navigation, Engagement, and Self-Management NOTIFICATION PROCEDURE: AGENCY: SYSTEM MANAGER(S) AND ADDRESS: Individuals seeking to determine whether this system of records contains information about themselves must submit a written request to the FOIA Officer, FRTIB, 77 K Street NE., Washington, DC 20002, and provide the following information: a. Full name; b. Any available information regarding the type of record involved; c. The address to which the record information should be sent; and d. You must sign your request. Attorneys or other persons acting on behalf of an individual must provide written authorization from that individual, such as a Power of Attorney, in order for the representative to act on their behalf. Individuals requesting access must also comply with FRTIB’s Privacy Act regulations regarding verification of identity and access to such records, available at 5 CFR part 1630. RECORD ACCESS PROCEDURE: Same as Notification Procedures. CONTESTING RECORDS PROCEDURE: Same as Notification Procedures. RECORD SOURCE CATEGORIES: Records are obtained from those individuals who submit requests and administrative appeals pursuant to the FOIA or who file litigation regarding such requests and appeals; the agency record keeping systems searched in the process of responding to such requests and appeals; FRTIB employees assigned to handle such requests, appeals, and/or litigation; other agencies or entities that have referred to FRTIB requests concerning FRTIB records, or that have consulted with FRTIB regarding handling of particular requests; and submitters or subjects of records or information that have provided assistance to FRTIB in making access or amendment determinations. EXEMPTIONS CLAIMED FOR SYSTEM: None. [FR Doc. 2016–02673 Filed 2–9–16; 8:45 am] BILLING CODE 6760–01–P PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 Agency for Healthcare Research and Quality (AHRQ), DHHS. ACTION: Notice of request for measures. The Agency for Healthcare Research and Quality (AHRQ) requests information from the public (including health care delivery organizations, health information developers, payers, quality measure developers, clinicians, and health care consumers) about quality improvement measures designed to help health care organizations monitor initiatives aimed at: • Improving patient understanding of health information, • simplifying navigation of health care systems and facilities, and • enhancing patients’ ability to manage their health. Specifically, AHRQ seeks quality improvement measures in four domains: 1. Communication, 2. Ease of Navigation, 3. Patient Engagement and SelfManagement, and 4. Organizational Structure, Policy, and Leadership. AHRQ is interested in measures that do not require patient survey data and that health care organizations are currently using, or have used in the past, to guide quality improvement activities designed to address these domains. AHRQ is also interested in information about relevant measures that are under development or are suggested for future development. DATES: Please submit one or more quality improvement measures and supporting information on or before March 4, 2016. AHRQ will not respond individually to submitters, but will consider all submitted measures and publicly report the results of the review of the submissions in aggregate. ADDRESSES: Submissions should follow the Submission Instructions below. Electronic responses are preferred and should be addressed to HealthLiteracy@ AHRQ.HHS.gov. Non-electronic responses will also be accepted. Please send these by mail to: Cindy Brach, Center for Delivery, Organization, and Markets, Agency for Healthcare Research and Quality, 5600 Fisher Lane, Rockville, MD 20857, Mailstop: 07W25B. SUMMARY: E:\FR\FM\10FEN1.SGM 10FEN1 Federal Register / Vol. 81, No. 27 / Wednesday, February 10, 2016 / Notices FOR FURTHER INFORMATION CONTACT: asabaliauskas on DSK9F6TC42PROD with NOTICES2 HealthLiteracy@AHRQ.HHS.gov or Cindy Brach at the address above. SUPPLEMENTARY INFORMATION: Background Information The health care system is complex and demanding. Health care organizations can help patients to succeed in the health care environment by ensuring that patients and caregivers are able to understand health information, navigate the health care system, engage in the health care process, and take an active and effective role in the management of their health. This Request for Measures is part of a project that aims to: • Identify existing measures that organizations use or could use to monitor progress related to the four domains described above; and, • Refine and cull identified measures to establish a set of measures that reflects patient priorities, has expert support, and will be recommended for more formal measure development and testing. The project focuses on identifying measures that are not generated from patient survey data. The project is guided by a conceptual framework that builds on the concept of organizational health literacy. As described in the Institute of Medicine’s Roundtable on Health Literacy, organizational health literacy is the ‘‘implementation and monitoring of organizational policies, practices, and structures that support patients in understanding health information, navigating the health care system, and managing their health’’ (Brach et al. 2012). The conceptual framework identifies four domains as key components of organizational health literacy. 1. Communication (e.g., the quality of verbal and written communication with patients, families, caregivers) 2. Ease of Navigation (e.g., the degree to which an organization’s physical environment and systems of care are designed in a manner that simplifies navigation and use of services) 3. Patient Engagement and SelfManagement (e.g., the degree to which an organization encourages patient engagement and provides support to enhance the ability of patients to manage their health) 4. Organizational Structure, Policy, and Leadership (e.g., leadership support for organizational health literacy; implementation of policies, procedures, and structures that serve to improve communication with patients, simplify patient navigation, and enhance patient engagement and self-management) VerDate Sep<11>2014 17:22 Feb 09, 2016 Jkt 238001 Quality improvement measures selected for further measure development and testing will assess key features of one or more of these domains. This project is being conducted by AHRQ pursuant to its statutory authority to conduct and support research on healthcare and on systems for the delivery of such care, including activities with respect to quality measurement and improvement. 42 U.S.C. 299a(a)(2). Submission Guidance Submit a measure(s) that is currently in use, in development, or for which a need has been identified, in one or more of the four domains (i.e., Communication; Ease of Navigation; Patient Engagement and SelfManagement; and Organizational Structure, Policy, and Leadership). For this Request for Measures, AHRQ is specifically interested in measures that do not require or use patient reported data obtained using a patient survey. Your contribution will be very beneficial to AHRQ. The contents of all submissions will be made available to the public upon request. Materials submitted must be publicly available or can be made public. Materials that are considered confidential and marketing materials cannot be used by AHRQ. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter. AHRQ and its contractor, will evaluate all submitted measures and supporting documentation. As a set of measures is identified and evaluated for further refinement and testing, submissions may be included in whole or in part or may be modified for inclusion in the measurement set. AHRQ will assume responsibility for the final measurement sets as well as any future modifications. Submission Instructions To facilitate handling of submissions, please include the name and email address of the measure developer or contact. The responses most helpful to the Agency will include all or most of the following: 1. A brief cover letter, 2. a description of the measure and how it is calculated (e.g., who/what is included in the numerator, who/what is included in the denominator, who/what is excluded in calculating the measure), 3. the source of the measure (e.g., publications, organizations where measure has been used to guide quality improvement activities), PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 7117 4. the domain best aligned with the measure (i.e., Communication; Ease of Navigation; Patient Engagement and Self-Management; and Organizational Structure, Policy, and Leadership), 5. the source of data used to calculate the measure (e.g., electronic health records, internal monitoring and reporting systems), 6. a description of data collection strategies (e.g., who is responsible for data collection, how is the information needed to calculate the measure collected), 7. a list of health care settings in which the measure has been or would be used and characteristics of the patient populations in these health care settings, 8. a description of how the measure has been used to support performance improvement (e.g., to whom is the measure reported, what actions have been taken based on the measure), 9. a summary of unintended negative consequences resulting from use of the measure (e.g., evidence that implementation of the measure has negatively impacted patients, staff, clinical process, or other features of the implementing organization), and 10. evidence that the measure is: a. Valid and reliable, b. associated with important outcomes, c. meaningful to patients, families, clinicians, and/or administrators, d. feasible to compute with accuracy and without undue cost, burden, or delay, and e. generalizable across health care settings. 11. title, author(s), publication year, journal name, volume, issue, and page numbers of cited articles. 12. a statement of willingness to grant to AHRQ the right to use and disseminate submitted measures and their documentation to the public as part of a set of organizational health literacy measures. Submission of copies of existing documentation or reports describing the measure and its properties, existing data sources, etc. is highly desirable but not required. Reference Material Brach, C., Keller, D., Hernandez, L.M., et al. (2012). Ten attributes of a health literate health care organization. Washington DC: Institute of Medicine. Kripalani, S., Wallston, K., Cavanaugh, K.L., Osborn, C., Mulvaney, S., Scott, A.M., & Rothman, R.L. (2014). Measures to assess a health-literate organization. E:\FR\FM\10FEN1.SGM 10FEN1 7118 Federal Register / Vol. 81, No. 27 / Wednesday, February 10, 2016 / Notices Washington DC: Institute of Medicine. Sharon B. Arnold, Deputy Director. [FR Doc. 2016–02679 Filed 2–9–16; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request Agency for Healthcare Research and Quality, HHS. ACTION: Notice. AGENCY: 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. DATES: Comments on this notice must be received by April 11, 2016. ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at doris.lefkowitz@AHRQ.hhs.gov. 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. FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427–1477, or by email at doris.lefkowitz@AHRQ.hhs.gov. SUPPLEMENTARY INFORMATION: SUMMARY: asabaliauskas on DSK9F6TC42PROD with NOTICES2 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 Number of respondents Form name Environmental Scan Interviews ....................................................................... VerDate Sep<11>2014 17:22 Feb 09, 2016 Jkt 238001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 Number of responses per respondent 50 E:\FR\FM\10FEN1.SGM 1 10FEN1 Hours per response Total burden hours 2 100

Agencies

[Federal Register Volume 81, Number 27 (Wednesday, February 10, 2016)]
[Notices]
[Pages 7116-7118]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02679]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Request for Measures Assessing Health Care Organization Quality 
Improvement Activities To Improve Patient Understanding, Navigation, 
Engagement, and Self-Management

AGENCY: Agency for Healthcare Research and Quality (AHRQ), DHHS.

ACTION: Notice of request for measures.

-----------------------------------------------------------------------

SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) requests 
information from the public (including health care delivery 
organizations, health information developers, payers, quality measure 
developers, clinicians, and health care consumers) about quality 
improvement measures designed to help health care organizations monitor 
initiatives aimed at:
     Improving patient understanding of health information,
     simplifying navigation of health care systems and 
facilities, and
     enhancing patients' ability to manage their health.
    Specifically, AHRQ seeks quality improvement measures in four 
domains:
    1. Communication,
    2. Ease of Navigation,
    3. Patient Engagement and Self-Management, and
    4. Organizational Structure, Policy, and Leadership.
    AHRQ is interested in measures that do not require patient survey 
data and that health care organizations are currently using, or have 
used in the past, to guide quality improvement activities designed to 
address these domains. AHRQ is also interested in information about 
relevant measures that are under development or are suggested for 
future development.

DATES: Please submit one or more quality improvement measures and 
supporting information on or before March 4, 2016. AHRQ will not 
respond individually to submitters, but will consider all submitted 
measures and publicly report the results of the review of the 
submissions in aggregate.

ADDRESSES: Submissions should follow the Submission Instructions below. 
Electronic responses are preferred and should be addressed to 
HealthLiteracy@AHRQ.HHS.gov. Non-electronic responses will also be 
accepted. Please send these by mail to: Cindy Brach, Center for 
Delivery, Organization, and Markets, Agency for Healthcare Research and 
Quality, 5600 Fisher Lane, Rockville, MD 20857, Mailstop: 07W25B.

[[Page 7117]]


FOR FURTHER INFORMATION CONTACT: HealthLiteracy@AHRQ.HHS.gov or Cindy 
Brach at the address above.

SUPPLEMENTARY INFORMATION:

Background Information

    The health care system is complex and demanding. Health care 
organizations can help patients to succeed in the health care 
environment by ensuring that patients and caregivers are able to 
understand health information, navigate the health care system, engage 
in the health care process, and take an active and effective role in 
the management of their health.
    This Request for Measures is part of a project that aims to:
     Identify existing measures that organizations use or could 
use to monitor progress related to the four domains described above; 
and,
     Refine and cull identified measures to establish a set of 
measures that reflects patient priorities, has expert support, and will 
be recommended for more formal measure development and testing.
    The project focuses on identifying measures that are not generated 
from patient survey data.
    The project is guided by a conceptual framework that builds on the 
concept of organizational health literacy. As described in the 
Institute of Medicine's Roundtable on Health Literacy, organizational 
health literacy is the ``implementation and monitoring of 
organizational policies, practices, and structures that support 
patients in understanding health information, navigating the health 
care system, and managing their health'' (Brach et al. 2012). The 
conceptual framework identifies four domains as key components of 
organizational health literacy.
    1. Communication (e.g., the quality of verbal and written 
communication with patients, families, caregivers)
    2. Ease of Navigation (e.g., the degree to which an organization's 
physical environment and systems of care are designed in a manner that 
simplifies navigation and use of services)
    3. Patient Engagement and Self-Management (e.g., the degree to 
which an organization encourages patient engagement and provides 
support to enhance the ability of patients to manage their health)
    4. Organizational Structure, Policy, and Leadership (e.g., 
leadership support for organizational health literacy; implementation 
of policies, procedures, and structures that serve to improve 
communication with patients, simplify patient navigation, and enhance 
patient engagement and self-management)
    Quality improvement measures selected for further measure 
development and testing will assess key features of one or more of 
these domains.
    This project is being conducted by AHRQ pursuant to its statutory 
authority to conduct and support research on healthcare and on systems 
for the delivery of such care, including activities with respect to 
quality measurement and improvement. 42 U.S.C. 299a(a)(2).

Submission Guidance

    Submit a measure(s) that is currently in use, in development, or 
for which a need has been identified, in one or more of the four 
domains (i.e., Communication; Ease of Navigation; Patient Engagement 
and Self-Management; and Organizational Structure, Policy, and 
Leadership). For this Request for Measures, AHRQ is specifically 
interested in measures that do not require or use patient reported data 
obtained using a patient survey.
    Your contribution will be very beneficial to AHRQ. The contents of 
all submissions will be made available to the public upon request. 
Materials submitted must be publicly available or can be made public. 
Materials that are considered confidential and marketing materials 
cannot be used by AHRQ. This is a voluntary request for information, 
and all costs for complying with this request must be borne by the 
submitter.
    AHRQ and its contractor, will evaluate all submitted measures and 
supporting documentation. As a set of measures is identified and 
evaluated for further refinement and testing, submissions may be 
included in whole or in part or may be modified for inclusion in the 
measurement set. AHRQ will assume responsibility for the final 
measurement sets as well as any future modifications.

Submission Instructions

    To facilitate handling of submissions, please include the name and 
email address of the measure developer or contact.
    The responses most helpful to the Agency will include all or most 
of the following:
    1. A brief cover letter,
    2. a description of the measure and how it is calculated (e.g., 
who/what is included in the numerator, who/what is included in the 
denominator, who/what is excluded in calculating the measure),
    3. the source of the measure (e.g., publications, organizations 
where measure has been used to guide quality improvement activities),
    4. the domain best aligned with the measure (i.e., Communication; 
Ease of Navigation; Patient Engagement and Self-Management; and 
Organizational Structure, Policy, and Leadership),
    5. the source of data used to calculate the measure (e.g., 
electronic health records, internal monitoring and reporting systems),
    6. a description of data collection strategies (e.g., who is 
responsible for data collection, how is the information needed to 
calculate the measure collected),
    7. a list of health care settings in which the measure has been or 
would be used and characteristics of the patient populations in these 
health care settings,
    8. a description of how the measure has been used to support 
performance improvement (e.g., to whom is the measure reported, what 
actions have been taken based on the measure),
    9. a summary of unintended negative consequences resulting from use 
of the measure (e.g., evidence that implementation of the measure has 
negatively impacted patients, staff, clinical process, or other 
features of the implementing organization), and
    10. evidence that the measure is:
    a. Valid and reliable,
    b. associated with important outcomes,
    c. meaningful to patients, families, clinicians, and/or 
administrators,
    d. feasible to compute with accuracy and without undue cost, 
burden, or delay, and
    e. generalizable across health care settings.
    11. title, author(s), publication year, journal name, volume, 
issue, and page numbers of cited articles.
    12. a statement of willingness to grant to AHRQ the right to use 
and disseminate submitted measures and their documentation to the 
public as part of a set of organizational health literacy measures.
    Submission of copies of existing documentation or reports 
describing the measure and its properties, existing data sources, etc. 
is highly desirable but not required.

Reference Material

Brach, C., Keller, D., Hernandez, L.M., et al. (2012). Ten 
attributes of a health literate health care organization. Washington 
DC: Institute of Medicine.
Kripalani, S., Wallston, K., Cavanaugh, K.L., Osborn, C., Mulvaney, 
S., Scott, A.M., & Rothman, R.L. (2014). Measures to assess a 
health-literate organization.

[[Page 7118]]

Washington DC: Institute of Medicine.

Sharon B. Arnold,
Deputy Director.
[FR Doc. 2016-02679 Filed 2-9-16; 8:45 am]
 BILLING CODE P