Expired PAR-13-131: Understanding and Promoting Health Literacy (R03)

Part 1. Overview Information

Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	Office of Behavioral and Social Sciences Research (OBSSR) National Cancer Institute (NCI) National Institute of Biomedical Imaging and Bioengineering (NIBIB) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute on Deafness and Other Communication Disorders (NIDCD) National Institute of Dental and Craniofacial Research (NIDCR) National Institute of Environmental Health Sciences (NIEHS) National Institute of Mental Health (NIMH)
Funding Opportunity Title	Understanding and Promoting Health Literacy (R03)
Activity Code	R03 Small Grant Program
Announcement Type	Reissue of PAR-10-134
Related Notices	NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015) NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015) July 8, 2014 - NIMH Focus for Intervention Studies Submitted Under the Stigma and Health Literacy Announcements. See Notice NOT-MH-14-016. June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications. May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013. May 17, 2013 - Notice to correct sections of PAR-13-131 related to funding. See Notice NOT-OD-13-066.
Funding Opportunity Announcement (FOA) Number	PAR-13-131
Companion Funding Opportunity	PAR-13-130, R01 Research Project Grant PAR-13-132, R21 Exploratory/Developmental Grant
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.399; 93.286; 93.865; 93.173 ; 93.121;93.113;93.242
Funding Opportunity Purpose	The goal of this program announcement is to encourage methodological, intervention and dissemination research for understanding and promoting health literacy. Health literacy is 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 (Ratzan and Parker, 2000).

Key Dates

Posted Date	March 1, 2013
Open Date (Earliest Submission Date)	May 16, 2013
Letter of Intent Due Date(s)	Not Applicable
Application Due Date(s)	Standard dates apply , by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Standard AIDS dates apply by 5:00 PM local time of applicant organization.
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date	Standard dates apply
Expiration Date	May 8, 2016
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

Health literacy is 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 (Ratzan & Parker, 2000). Health literacy includes not only the ability to read, interpret and write prose (print literacy), but also the ability to use quantitative information (numeracy), and to speak and listen effectively (oral literacy). Together these skills are needed to understand and act appropriately on health information and in health care interactions. Limited health literacy is a wide spread problem. Over a third of adults in the United States 77 million people would have difficulty with common health tasks, such as following directions on a prescription drug label or adhering to a childhood immunization schedule using a standard chart (U.S. Department of Health and Human Services 2009). A growing body of evidence links low health literacy with poor health outcomes, including limited ability to take medications appropriately, poor ability to interpret labels and health messages, greater use of emergency care and higher hospitalization rates (AHRQ, 2004; 2011). In the past, the onus of these poor health outcomes was largely attributed to patients and consumers, but more current thinking recognizes that health literacy is a dynamic systems issue that involves both the health information being presented and the health care system being navigated (Koh, Berwick, Clancey, Baur, Brach, Harris & Zerhusen, 2012).

Health literacy is a complex concept that involves individuals, families, health professionals, communities and health care systems. For instance, individuals may vary with respect to:

Access to information and resources (e.g., audience-appropriate health information, media, technologies, health care providers health insurance, support networks, transportation);
Skills (e.g., to gather and comprehend health information, including numerical information; to share personal information about health history and symptoms; to act on information by initiating appropriate follow-up visits and conveying understanding back to the information source; to make decisions about basic healthy behaviors, such as healthy eating and exercise; to engage in self-care and chronic disease management);
Knowledge (e.g., of health and medical concepts such as risk , the organization and functioning of healthcare systems, understandings of the body, meaning of symptoms, illness and health);
Abilities (e.g., sensory, communication, cognitive or physical challenges or limitations);
Life span and socio-cultural context (e.g., developmental or life stage, cultural, linguistic or educational differences that affect health, knowledge, communication and action).

In addition to personal/individual differences in health literacy, health care systems, including clinic/practice and community settings, vary in their readiness and ability to engage and effectively communicate with patients from diverse health literacy levels. Addressing health literacy requires active involvement of multiple sectors in and outside the health care system including the health care team, media, information technologies and policies addressing access to and delivery of services.

The Institute of Medicine has described health literacy as the result of multiple, complex social and individual factors (2004). These include complicated, cumbersome and unfamiliar ways health information is communicated to different audiences. For instance, informed-consent-for-treatment or shared decision-making processes are difficult when health care providers neglect to use clear, accessible language to explain biological processes, treatment procedures, or medical concepts. In communicating public health recommendations, the lack of clear and actionable information and multi-level social and cultural contextual factors (e.g., mistrust, language access, gender), often hamper the effectiveness of health interventions and limit many individuals opportunities to make important and appropriate decisions regarding prevention and/or treatment.

Specific Objectives

Several NIH institutes and offices support this initiative. Applications should be relevant to both the general objectives of the FOA and to the specific research interests of at least one of the participating organizations. Applications that address generic health literacy issues, but do not delineate clear relationships to the specific interests of at least one of the sponsoring organizations may not secure funding.

Researchers are strongly encouraged to review the illustrative examples of topics relevant to health literacy provided below, as well as the specific research interests of the participating organizations supporting this announcement. Applications should address health promotion, injury or disease prevention, environmental exposure reduction; treatment or management of injuries, diseases or health conditions, and/or the improvement of health or health care outcomes within specific populations (e.g., children, older adults, lower income or vulnerable and underserved populations).

Prospective applicants are strongly encouraged to contact the relevant program administrator for this health literacy FOA as listed in Section VII, the Agency Contacts section of this announcement prior to preparing an application.

Research appropriate for this funding announcement includes:

A wide variety of research approaches are encouraged under this Funding Opportunity Announcement:
Basic research to elucidate the mechanisms underlying health literacy and to determine the causal pathways that link health literacy to a behavioral outcome or to identify the underlying components of health literacy, such as cognitive ability or other constructs/skills integral to health literacy.
Applied research addressing issues pertinent to health literacy practices (e.g., systems level interventions) and research-in-practice (e.g., active potential end users participate as research partners).
Intervention research to develop and test the effectiveness of strategies to improve care (e.g., decision making, patient-centered care, self management) and health outcomes for individuals with limited health literacy.
Intervention research to develop and test the effectiveness of strategies to reduce potentially harmful exposures by improving understanding of the link between environmental exposures and health outcomes for individuals with limited health literacy.
Methodological and measurement research to refine constructs and to develop, validate and improve innovative methods and measures of health literacy of individuals, providers and health systems. Testing of measures that allow comparison across contexts, culture and settings are particularly encouraged.
Public health research to improve population health literacy and elucidate and measure the role of health literacy as a contributor to health disparities.
Implementation and dissemination research to adapt and test evidence-based practices and interventions in health care systems, communities, and diverse populations.

Multilevel, multidisciplinary, interdisciplinary, and transdisciplinary research is encouraged. Studies that incorporate state-of-the-science health communication theory and knowledge are particularly encouraged.

Research not appropriate for this funding announcement includes:

Studies to develop or evaluate the readability or utility of specific materials intended for single uses or single audiences are not appropriate for this funding opportunity announcement unless these investigations are integral to testing a significant research hypothesis related to health literacy.
Studies with a sole focus of describing the association between health literacy and other factors (i.e., purely descriptive studies) will not be considered appropriate for this program announcement unless they also include one or more of the research approaches listed below. For example, cross-sectional research merely documenting levels of health literacy in a defined population, or the association between health literacy and a given behavior or disease is not responsive to the intent of this funding opportunity announcement.

Priority Program Areas

Researchers are encouraged to address health literacy as it pertains to health care, prevention, healthy living, chronic disease management, community health, cultural competence, and health disparities. Research questions can focus on consumers, patients, providers, health care teams, educators, communities and organizations or systems.

This Funding Opportunity Announcement (FOA) invites applications to develop research on health literacy in general areas that include, but are not limited to, the following:

Nature and Scope

Analyze and measure the mix of abilities and skills required to be functionally health literate (e.g., including health care system navigation skills, numeracy, oral literacy, etc.), and specify cutpoints for distinguishing different levels of health literacy.

Examine the problems and factors involved in the presentation and interpretation of health information (e.g., graphic interpretation, probability statistics, information formats, communication technologies, etc.) and investigate how specific health concepts (e.g., basic genetics and/or environmental risks) are best understood and conveyed.

Evaluate the different strategies and channels, including information technologies and Web 2.0/social media, that enable consumers to seek, access, and interpret relevant health information effectively, and how these may differ by cultural and health literacy backgrounds (e.g., research on the information seeking or service utilization characteristics among health consumers with different levels of health literacy and basic literacy) and/or evaluation of different strategies needed for access and utilization of health information among individuals with disabilities, such as deafness or blindness.

Analyze and evaluate alternate approaches to the design of medical and public health systems to facilitate consumer and patient access to and use of health information and services.

Lifespan and Cultural Differences

Explore the developmental precursors of limited health literacy and the age-related changes in skills throughout the life course that may contribute to these difficulties.
Identify the linguistic ability and skills (including written and oral communication) crucial for the acquisition and understanding of basic health information by children, adolescents, and adults of various age groups (e.g., young adults, retirees, etc.).
Examine how social and cultural factors influence the development of health literacy. For example, how do children and teens acquire health-related knowledge (e.g., through media, family socialization, peers) as they age?
Explore English as a Second Language in health literacy, including first-generation immigrant populations as they navigate the health care systems.
Explore cross-cultural and global differences in the determinants and consequences of health literacy, including the impact of transmigration and acculturation on health-related outcomes, cultural beliefs about the value of science and evidence-based information, and the role of community vis-a-vis individual needs for literacy and individual health choices.

Education and Training

Develop or evaluate approaches to increasing health literacy in community and clinical settings
Evaluate the role of K-12 education systems as well as community settings (serving children and/or adults) in increasing levels of health literacy.
Implement and evaluate skill-based training programs for health care providers and public health professionals, both to effectively communicate with individuals with diverse literacy levels and to improve health literacy and health outcomes.
Identify, develop, and test the effectiveness of policies, training, and technologies to train providers and community leaders to better address the health literacy of their patients and community members.

Health Systems Interventions

Evaluate the effectiveness of health literacy interventions, directed at the general public, and selected audience segments (e.g., patients, providers, health care or public health systems) that seek to improve health literacy and patient outcomes (e.g., What health care systems designs support the information needs of consumers with different levels of health literacy? What are the characteristics/elements of effective systems-level interventions? How effective are interventions intended to increase the access of intended audiences to relevant health information and appropriate materials, such as print or audiovisual materials, Internet-based information, interpreters and translated materials, library information resources and services, and patient advocates?).
Determine the best methods of developing and disseminating effective information sources and materials for audiences with different levels of health literacy and from different cultural backgrounds (e.g., How should prevention campaigns be designed to communicate effectively with audiences with differing levels of health literacy?).
Design and evaluate health literacy diagnostic and/or communication tools to help health care professionals and community leaders identify, and communicate more effectively with, patients and consumers and community members with different levels of health literacy (e.g., develop and assess tools and/or strategies to help make complex quantitative health information more understandable, such as technology tools for automatically converting health information to a variety of appropriate levels).
Design, implement and evaluate context-based intervention research to examine interventions that fit within existing health care and community settings to facilitate program adoption and sustainability in the real world .
Evaluate the effectiveness practices and policies currently in use and their potential to be disseminated immediately to promote health literacy across the various participants in the health care systems.
Evaluate adaptation strategies used by providers and consumers to minimize health literacy problems, including systemic and cultural barriers, during provider-patient communication.
Investigate the ability of consumers to understand and navigate health insurance options and benefits and how this impacts use of health services and health outcomes.
Test methods for disseminating, adapting and implementing effective health literacy interventions in diverse settings and locations.
Examine the effect of implementation of electronic medical records and other communication technologies on the delivery of care and communication with individuals and groups with limited health literacy.
Conduct research on improving access and quality of health care services for health literacy among vulnerable populations, including women, adolescents, racial/ethnic minorities, and those with other co-occurring disorders (such as mental health, substance abuse, infectious disease).
Develop and evaluate interventions for prevention and treatment of comorbidities associated with poor health literacy.

Methodology and Research Technology Development

Assess the efficacy of current methods of health literacy assessment.
Quantify the contribution of limited health literacy to healthcare costs and health outcomes.
Identify innovative and effective approaches that combine and integrate qualitative and quantitative methods to further knowledge of health literacy.
Identify patterns of how populations with varying health literacy access and use health information technology.
Develop, pilot, and evaluate technologies and media to identify and overcome health literacy barriers (e.g., eHealth or mHealth tools to support those with communication disorders, smartphone use to collect health data and/or explain diagnoses/treatments or record self-care practices).
Develop technologies related to data reduction, data mining, natural language processing (NLP)-based computational text analyses, and knowledge extraction; develop tools for integrative services and data; develop methods or technologies for timely, effective communication of pertinent health information and knowledge.
Methodological research on poor literacy and chronic conditions to develop new study designs, standardized assessment and measurement instruments (including ecologic validity) and data analytic methods.

Examination of mediators and moderators of health literacy in all studies is highly encouraged, particularly in the following areas:

Examine how patients information-seeking abilities and health information interpretation mediates or moderates the effects of patient-provider communication and provider practices (e.g., how does patients use of print and electronic health information mediate or moderate their communication with providers?).
Examine the influence of social, contextual, and environmental factors (e.g., urban versus rural, housing types, workplace features, social support and social network members, etc.) on health literacy outcomes.
Examine how media (including broadcast media and Internet/social media) affect health literacy. How can different media be used to target communications most effectively with specific sub-groups of consumers varying in health literacy levels, age, race, ethnicity, disease, exposure etc.?
Examine the factors that influence the preference for, or processing of, health information and health behavior (e.g., self-efficacy in decision making and/or financial planning, ease of cognitive access via intuitive and reasoning processes, coping and anxiety reduction behaviors).
Examine how the design and structure of a health care system can support the information needs of consumers with different levels of health literacy.
Study the effects of technological innovations (e.g., eHealth and mHealth tools and systems, smartphone applications, social media, health related Internet use, EMR/EHR) on the access, understanding, retention, and/or retrieval of health information and whether these technologies create technologically-based disparities.
Examine how health professionals in- and outside clinical settings (e.g. community health workers and promotoras) and family members as interpreters affect health literacy.
Examine the role of community leaders/elders or tribal authorities in decision-making, health promotion, and as sources of local information and how local authority is incorporated or disenfranchised from health professional literacy efforts.
Research on the relationship between health literacy and co-occurrence of chronic diseases (including, but not limited to, HIV/AIDS, diabetes, mental illness, obesity, hypertension, cardiovascular disease, chronic respiratory disease, cancer or stroke) and how this affects patient outcomes.

Research Interests and Examples of the Participating Institutes and Centers

Several NIH Institutes and Offices have joined together to support this Funding Opportunity Announcement (FOA). Applications should be relevant to both the objectives of the FOA and to at least one of the participating organization's research interests. Researchers are strongly encouraged to review the general research interests of the participating organizations and the examples of topics of interest specific to health literacy, which are posted at http://obssr.od.nih.gov/scientific_areas/social_culture_factors_in_health/health_literacy/r01.aspx and to contact the designated Program Official.

For health literacy research related to oral health, note that the NIDCR does not accept applications that include clinical trials in response to trans-NIH FOAs. Applicants proposing a clinical trial should refer to the following NIDCR websites: http://www.nidcr.nih.gov/clinicaltrials/ and http://grants.nih.gov/grants/guide/pa-files/PAR-11-338.html.

Section II. Award Information

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New Resubmission Revision The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award Budget	Project period is limited to $50,000 per year with a maximum of two years and $100,000. Budget needs to reflect actual needs of the proposed project.
Award Project Period	Scope of the proposed project should not exceed 2 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

Small Businesses
For-Profit Organizations (Other than Small Businesses)

Governments

State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
Eligible Agencies of the Federal Government
U.S. Territory or Possession

Other

Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American Tribal Organizations (other than Federally recognized tribal governments)
Faith-based or Community-based Organizations
Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions)

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

SF424(R&R) Cover