Funding Opportunity Announcement (FOA) Guidance

This page contains AHRQ policy information and guidance about procedures related to grants.

AHRQ Grants Policy and Guidance | AHRQ Large Research (R01) Project FOA: Research Objectives | AHRQ Large Research Demonstration (R18) FOA: Research Objectives 

AHRQ Grants Policy and Guidance

Human Subjects Protection

Federal regulations at 45 CFR Part 46 require that applications and proposals involving human subjects research must be evaluated in accordance with those regulations, with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained.

Standards for Privacy of Individually Identifiable Health Information

The HIPAA Privacy Rule, 45 CFR Parts 160 and 164, is administered and enforced by the DHHS Office for Civil Rights (OCR). The OCR Web site provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools that may be used to determine whether a researcher is a staff member of a covered entity.

Access to Research Data Through the Freedom of Information Act

OMB Circular A-110 provides access to certain research data developed with Federal support through the Freedom of Information Act (FOIA), 5 U.S.C. 552, in certain circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation or administrative order) may be accessed through FOIA. If no Federal action is taken having the force and effect of law in reliance upon an AHRQ-supported research project, the underlying data are not subject to this disclosure requirement. Furthermore, even if a Federal regulatory action is taken in reliance on AHRQ-supported research data, disclosure of such data is limited in accordance with the AHRQ confidentiality statute, 42 USC 299c-3(c). NIH has provided general related guidance at http://grants.nih.gov/archive/grants/policy/a110/a110_guidance_dec1999.htm which does not include discussion of the exception applicable to confidential identifiable data collected under AHRQ's authorities.

Should applicants wish to place data collected under this FOA in a public archive, which can provide protections for the data (e.g., as required by confidentiality provisions of the statute applicable to AHRQ-supported projects, 42 USC 299c-3(c)) and manage the distribution of non-identifiable data for an indefinite period of time, they may. The application should include a description of any archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should consider how to structure informed consent statements or other human subject protection procedures to permit or restrict disclosures of identifiable data, as warranted.

Healthy People 2020

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2020," a PHS-led national activity for setting health improvement priorities for the United States. AHRQ encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2020" at http://www.health.gov/healthypeople/.

Use of CMS Data

Purchase of Centers for Medicare & Medicaid Services (CMS) public-use data, if required, should be discussed in the application narrative and included in the budget. Projects will ordinarily not use CMS (Medicare or Medicaid) data involving individual identifiers. However, for applications that propose to use Medicare or Medicaid data that are individually identifiable, applicants should state explicitly in the “Research Design and Methods” section of the Research Plan (form 398) the specific files, time periods, and cohorts proposed for the research. The applicant should obtain an estimate for the cost of the requested data, if possible. This estimate will be included in the estimated total cost of the grant at the time funding decisions are made.

Applicants should be aware that for individually identifiable Medicare and Medicaid data, Principal Investigators and their grantee institutions will be required to enter into a Data Use Agreement (DUA) with CMS to protect the confidentiality of data in accordance with the terms of the DUA and applicable law.

In developing research plans, applicants should allow time for refining, obtaining approval, and processing of their CMS data requests. Requests may take six months from the time they are submitted to complete. Applications proposing to contact beneficiaries or their providers require the approval of the CMS Director and may require meeting(s) with CMS staff.

CMS data are provided on IBM mainframe tapes using the record and data formats commonly employed on these computers. Applicants should either have the capability to process these tapes and formats or plan to make arrangements to securely convert them to other media and formats.

Questions regarding CMS data should be directed to the AHRQ program official listed under Agency Contacts.

To avoid double counting, applicants should not include the cost of identifiable CMS data in the budget. In the event the total costs of the project plus the cost of CMS data is greater than the total cost cap of this FOA, the budget for the project will be adjusted so that the total costs awarded to the recipient plus the CMS data costs do not exceed the cost cap.

Publication Transmittal

In keeping with the Agency's efforts to translate the results of AHRQ-funded research into practice and policy, grantees are to inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when articles from their AHRQ-supported activities are accepted for publication in the professional literature. Grantees should also discuss any ideas about other dissemination and marketing efforts with OCKT staff. The goal is to ensure that efforts to disseminate research findings are coordinated with other Agency activities to maximize awareness and application of the research by potential users, including clinicians, patients, health care systems and purchasers and policymakers. This is critical when outreach to the general and trade press is involved. Accordingly, contact with the media will take place with close coordination between OCKT and the press offices of the grantee's institutions. In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees will be asked to submit to OCKT a brief plan describing how the product will be publicized. An OCKT staff person will be assigned to each product and will coordinate the implementation of the plan, especially issues related to printing and electronic dissemination, and outreach to the media.

Assessment of AHRQ Grant Programs

In carrying out its stewardship of research programs, AHRQ may request information essential to an assessment of the effectiveness of Agency research programs. Accordingly, grant recipients are hereby notified that they may be contacted after the completion of awards for periodic updates on publications resulting from AHRQ grant awards, and other information helpful in evaluating the impact of AHRQ-sponsored research.

AHRQ expects grant recipients to keep the Agency informed of publications, as well as the known uses and impact of their Agency-sponsored research. Applicants must agree to notify AHRQ immediately when a manuscript based on research supported by the grant is accepted for publication, and to provide the expected date of publication as soon as it is known, regardless of whether or not the grant award is still active.

Use of HCUP, MEPS, and Other Surveys

Applicants are encouraged to use relevant AHRQ, DHHS, and federal and non-federal public and private data resources to support these research efforts. Examples of such data may be the MEPS (Medical Expenditure Panel Survey), HCUP (Healthcare Cost and Utilization Project), National Health Interview Survey (NHIS), Medicare and Medicaid data resources, and other Departmental data resources http://healthdata.gov/. For the conduct of applicable longitudinal analyses, consideration should also be given to use of linked MEPS-NHIS data.

HCUP

HCUP is a family of health care databases and related software tools and products developed through a Federal-State-Industry partnership. HCUP databases bring together the data collection efforts of State data organizations, hospital associations, private data organizations, and the Federal government to create a national information resource of patient-level health care data. HCUP databases provide data beginning in 1988 and contain encounter-level information for all payers compiled in a uniform format with privacy protections in place. HCUP includes three nationwide databases, the Nationwide Inpatient Sample (NIS) and the Kids' Inpatient Database (KID), and the Nationwide Emergency Department Sample (NEDS), and three types of State databases, the State Inpatient Databases (SID), the State Ambulatory Surgery Databases (SASD), and the State Emergency Department Databases (SEDD). More information on HCUP can be found at http://www.hcup-us.ahrq.gov/home.jsp.

MEPS

The MEPS is conducted to provide nationally representative estimates of health care use, expenditures, sources of payment, and insurance coverage for the U.S. civilian, non-institutionalized population. MEPS is composed of three component surveys: the Household Component (HC), the Medical Provider Component (MPC), and the Insurance Component (IC). The Household Component is the core survey, and it forms the basis for the MPC sample. The MEPS IC collects data on health insurance plans obtained through employers and unions, including the number and types of private insurance plans offered, employer characteristics, premiums, and contributions by employers and employees. More information on the MEPS is available at http://www.meps.ahrq.gov.

Applicants' use of HCUP and/or MEPS data does not preclude the use of secondary data sources or primary data collection.

Health Literacy

AHRQ encourages applicants to write Informed Consent (IC) and HIPAA Authorization documents for research to be understandable to all potential research participants, including those with low levels of literacy and limited English proficiency. AHRQ recommends that IC and Authorization documents be written in accordance with health literacy principles, and that IC and Authorization documents be available in multiple languages if potential research participants include individuals with limited English proficiency. AHRQ also recommends adopting a process to verify potential research participants' understanding.

IC documents must provide information in language understandable to potential participants (45 CFR 46.116. For covered entities under the Privacy Rule, authorization documents must include core elements and required statements in 45 CFR 164.508(c) and must be written in plain language. The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research (http://www.ahrq.gov/funding/grants/policies/informedconsent/index.html) provides sample forms and guidance on adapting them, and also describes an appropriate process for obtaining informed consent and authorization.

Consumer Products

All consumer products produced under an AHRQ-funded grant should be appropriate for the target audience. This includes individuals from diverse cultural, language, and literacy backgrounds. Audience testing should be part of the development process. AHRQ's Talking Quality Web site (https://talkingquality.ahrq.gov/) and AHRQ's guide and checklist for developers and purchasers of health information (IT) that is designed to be accessed and used by consumers (http://healthit.ahrq.gov and select Health IT Tools) are resources applicants can use to ensure appropriateness of consumer products.

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AHRQ Large Research (R01) Project FOA:  Research Objectives

AHRQ seeks a wide range of research projects. However, all grant applications must contain projects that fit within the current AHRQ Research Portfolio areas as articulated below.

Comparative Effectiveness Portfolio

In FY 2013 and FY 2014, AHRQ intends to support research grants focusing on patient-centered outcomes and comparative effectiveness assessment of different clinical treatments and services, as authorized by 42 U.S.C. § 299b—7 and 42 U.S.C. § 299.  In addition, AHRQ aims to enhance and leverage research and electronic data infrastructure and capacity, allowing future studies to address questions where data are currently not sufficient to provide guidance about competing alternatives and to improve the efficiency with which the research and electronic data infrastructure is able to respond to pressing health care questions.  The intent of these grants is to support research focusing on the generation and translation of new scientific evidence and analytic tools in an accelerated format and the integration of evidence into practice and decisionmaking in the health care system.

New applicants are encouraged to build upon a multi-disciplinary research team and partner with institutions well versed in systematic review methodologies or with research centers and integrated health care delivery systems, in particular those with electronic health records and data linkage experience, capable of performing accelerated clinical effectiveness and outcomes research and the translation and dissemination of evidentiary information for health care decisionmaking. Existing examples of such AHRQ networks include, the Evidence-based Practice Centers (EPCs), the Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) network, the Centers for Education & Research on Therapeutics (CERTs), the John M. Eisenberg Clinical Decisions and Communications Science Center, Primary Care-Based Research Network (PBRN), Accelerating Change and Transformation in Organizations and Networks (ACTION), and the HIV Research Network. A listing of these research networks under AHRQ's Effective Health Care program can be found at: http://effectivehealthcare.ahrq.gov/aboutUs/index.cfm.

In addition, applicants are strongly encouraged to collaborate with stakeholders and the target population in an effort to ensure the relevance of the research questions to a broad spectrum of health care decisionmakers, and to facilitate the uptake and implementation of the evidence-based research findings.  An emphasis on the patient-centered outcomes research questions most pertinent to the AHRQ priority populations, and previously understudied populations, is also encouraged.  AHRQ also recognizes the importance of health care delivery and system level issues in comparative effectiveness research.  Research projects that seek to address, in the comparative effectiveness context, how different approaches and strategies of the way care is structured and delivered to improve outcomes, and/or to increase the likelihood of provider and patient uptake and adherence to effective interventions are encouraged as well.

Research projects can have either a clinical or methodological emphasis, but must focus tightly on the study and/or the use of comparative effectiveness research. For applications with methodological emphasis, the goals should be to advance study designs and methods to fill specific knowledge gaps and to enhance the consistency, applicability, and generalizability of the comparative effectiveness studies. For applications with a clinical emphasis, the goals should be to develop new scientific evidence that fills important knowledge gaps and to generate critical insights on the clinical effectiveness and comparative clinical effectiveness of health care interventions. For studies in which randomized controlled trials may not be feasible or timely, or would raise ethical concerns that are difficult to address, novel or alternative study designs may be proposed. Such clinical research projects also need to be informed by the information needs and inputs from various stakeholders (e.g., policymakers, providers, and patients) to ensure the most appropriate outcome measures for assessing the effectiveness of the interventions and outcomes of importance to stakeholders are included in the study.

Specific clinical research projects should also be organized, as appropriate, around a set of priority conditions of importance to the Medicare, Medicaid, and SCHIP programs.  The current list of conditions includes:

  • Arthritis and non-traumatic joint disorders.
  • Cancer.
  • Cardiovascular disease, including stroke and hypertension.
  • Dementia, including Alzheimer's Disease.
  • Depression and other mental health disorders.
  • Developmental delays, attention-deficit hyperactivity disorder and autism.
  • Diabetes Mellitus.
  • Functional limitations and disability.
  • Infectious diseases including HIV/AIDS.
  • Obesity.
  • Peptic ulcer disease and dyspepsia.
  • Pregnancy including pre-term birth.
  • Pulmonary disease/asthma.
  • Substance abuse.

AHRQ interests in research projects focused on the comparative effectiveness of different treatment and practices include, but are not limited, to:

  • Effectiveness/comparative effectiveness of health care treatments and services, including pharmaceuticals, diagnostics, devices, and other types of interventions or combinations of these interventions.
  • Studies of the effectiveness/comparative effectiveness of important new or existing health care technologies.
  • Methodological frameworks and empirical assessments of the effectiveness/comparative effectiveness of complex interventions, including research on how different approaches and strategies of health care delivery and system level issues affect patient outcomes.
  • Assessment of the effectiveness/comparative effectiveness of health care treatments for common, high-cost conditions in elderly and women in various age and racial/ethnic groups.
  • Assessment of the effectiveness/comparative effectiveness of interventions unique to children or treatments that are commonly administered to children but have been evaluated for safety and effectiveness only in adult populations.
  • Effectiveness/comparative effectiveness of interventions and health outcomes in patients with multiple co-morbidities.
  • Studies that explore influences of pharmacogenetics on responses to therapeutic interventions.
  • Studies that aim at better understanding heterogeneity in treatment effects and the development and validation of clinically informative risk stratification and classification models in different clinical domains.
  • Methods for optimal systematic reviews of evidence, including methodological research on meta-analysis, decision analysis, assessing and interpretation of evidence, etc.
  • Methods for study design and/or analysis aimed, for example:
    • To account for patient and provider preferences in health care decisions while minimizing potential selection biases and other sources of confounding.
    • To supplement existing data on patient-centered outcomes for a condition with new data collection to equate different measures of the same domains, or otherwise harmonize outcomes measures within a field.
    • To develop sustainable patient-centered outcome measurement systems usable in routine clinical practice capable of supporting both clinical care and research missions.

Health Information Technology Portfolio

AHRQ's Health Information Technology (IT) Portfolio is part of the Nation's strategy to put information technology to work in health care. AHRQ has invested over $300 million in contracts and grants to over 150 communities, hospitals, providers, and health care systems in 48 States to develop and disseminate evidence and evidence-based tools about health IT's impact on the quality, safety, efficiency, and effectiveness of health care.

Health IT is broadly defined as the use of information and communication technology in health care to support the delivery of patient or population care or to support patient self-management and not administrative functions such as billing or support of health care operations.1  Health IT can support patient care related activities such as order communications, results reporting, care planning, treatment managing (e.g., diagnosis, self-management, monitoring), and clinical or health documentation.  AHRQ funds research on how health IT improves quality, with a focus on health IT that supports care delivery as defined above.  AHRQ does not focus on basic and applied informatics research (e.g., representation, organization, and retrieval of biomedical and biological data and images; development of taxonomies; linguistic analyses for natural language processing and understanding).

AHRQ's Health IT Portfolio has separately published R01 program announcements, available at http://healthit.ahrq.gov/healthitfoas, to solicit applications that address the Portfolio's highest priorities.  Specifically, there are two R01 grant program announcements in the area of health IT that applicants are encouraged to review:

  1. Understanding Clinical Information Needs and Health Care Decision Making Processes in the Context of Health Information Technology (IT) (R01) FOA.  For more information, go to: http://grants.nih.gov/grants/guide/pa-files/PA-11-198.html.
  2. Understanding User Needs and Context to Inform Consumer Health Information Technology (IT) Design (R01) FOA.  For more information, go to: http://grants.nih.gov/grants/guide/pa-files/PA-11-199.html.

Applications that do not address the priorities identified above, but that propose to conduct health IT research to address the following priorities are encouraged to apply to this program announcement:

  1. Making care safer by reducing harm caused in the delivery of care.
  2. Ensuring that each person and family are engaged as partners in their care.
  3. Promoting effective communication and coordination of care.
  4. Promoting the most effective prevention and treatment practices for the leading causes of mortality.
  5. Working with communities to promote wide use of the best practices to enable healthy living.
  6. Making quality care more affordable for individuals, families, employers, and governments by developing and spreading new health care delivery models.

AHRQ's priority is to fund projects that will fill known gaps in the field.  Applicants must demonstrate they are addressing a known gap in health IT research, as evidenced in AHRQ-funded evidence reports available at http://www.ahrq.gov/research/findings/evidence-based-reports/services/health-it/index.html, with regards to how health IT does or does not improve health care quality.

Applications submitted in response to this program announcement must distinguish themselves from those submitted to the AHRQ-wide R18A, available at http://grants.nih.gov/grants/guide/pa-files/PA-13-046.html.  Applications submitted in response to this program announcement are expected to focus on health IT research questions that are not related to the development, testing, and evaluation of new health IT applications or systems, such applications should be directed to the AHRQ-wide R18, available at http://grants.nih.gov/grants/guide/pa-files/PA-13-046.html

Applications focused on the additional evaluation of any new or existing health IT application or system must present preliminary evidence of its effectiveness as found in, for example, a previously funded demonstration project (e.g., such as one that may have been funded under the Utilizing Health Information Technology (IT) to Improve Health Care Quality (R18) FOA, available at http://grants.nih.gov/grants/guide/pa-files/PAR-08-270.html).  In addition, applicants evaluating the effectiveness of a health IT application or system must evaluate the 1) usefulness of the health IT system, 2) the system's usability, 3) the presence and quality of associated care process redesign, and 4) the effectiveness and efficiency of associated care-process management systems as primary outcomes or potential confounders depending on study design.  Applications not responsive to these requirements will not be prioritized for funding.

Since this program announcement encompasses all of AHRQ's portfolios of work, it would be an ideal opportunity to submit applications which address the goals of other portfolios in addition to health IT described in this announcement.

Patient Safety Portfolio

Patient safety is defined as the freedom from accidental or preventable injury produced by health care as well as the practices that create a safe environment of care.

  • Patient safety research initiatives can be considered in three different stages:
    • Identification of risks and hazards.
    • Design, implementation, dissemination and spread, and evaluation of interventions to improve patient safety.
    • Establishment of strategies to sustain patient safety improvements such as just culture, incident/event reporting, measurement, monitoring, and surveillance.

The Patient Safety Portfolio will support research projects to create new knowledge by identifying the risks and hazards encountered by patients as a result of health care.  The Portfolio will also support projects that mitigate those risks and hazards, including the design, implementation and evaluation of strategies (patient safety practices) and the adaptation, refinement, and sustainment of those strategies. These initiatives are part of the Agency's overall mission to improve the quality of health care.

AHRQ encourages an interdisciplinary patient safety approach. In addition to health services research, perspectives from organizational theory, human factors, industrial engineering, facilities design, education, and other disciplines can be incorporated in research plans.

Projects may address important topics such as:  the surveillance, measurement, detection, and reporting of patient safety events; the impact of human performance and working conditions on patient safety; the patients' role and contribution to patient safety; health care safety culture, leadership, communication, teamwork, and simulation; prevention and control of healthcare-associated infections; diagnostic error; the safe use of medical devices and medications; the role of Patient Safety Organizations (PSOs); the relationship between medical liability and patient safety;  and the challenges inherent in transitions of care and handoffs between health care providers. 

The Portfolio supports research in all health care settings including the hospital, long-term care, ambulatory care, home health care, pharmacy, and transitions of care between settings.

Patient safety research involves many stakeholder groups including patients, families, clinicians, non-clinical health care staff, policymakers, payers, and health care organizations including providers and accreditors, local and state governments, and the Federal government, Patient Safety Organizations, and many others. 

Projects in this area may also address patient characteristics that might influence the risk of experiencing a patient safety event.  For example, attributes of AHRQ's Priority Populations that can impact patient safety. 

Please visit the Agency's page to learn more about examples of patient safety research efforts supported by AHRQ.

Prevention and Care Management Portfolio

The mission of the Prevention/Care Management Portfolio is to improve the quality, safety, efficiency, and effectiveness of evidence-based preventive services and chronic care management in ambulatory care settings. AHRQ seeks to support projects that fit within two broad strategic goals.

The first goal focuses on preventive services. Grants awarded in this strategic area should complement the work of the U.S. Preventive Services Task Force in terms of advancing methods for assessing the benefits and harms of preventive services, and improving the implementation of evidence-based recommendations on preventive services. AHRQ is interested in supporting areas that have not traditionally been the focus of funding initiatives, such as:

  • Harms associated with preventive services.
  • Overuse of preventive services.
  • Delivery of preventive services for the patient with multiple co-morbidities.

Examples of grant applications that would be considered under this strategic area include, but are not limited to, research on the:

  • Effectiveness of preventive services in improving health and quality of life in complex patients.
  • Development of new methodologies for assessing the harms of preventive services.
  • Evidence gaps identified by the U.S. Preventive Services Task Force for specific preventive services.

Research questions for R01 projects of interest under this strategic area include, but are not limited to:

  • What are the long-term negative psychological effects of false positive screening tests for cancer? Does having a shared decisionmaking discussion prior to screening mitigate these effects?
  • What are the resource costs of over use or inappropriate use of clinical preventive services, including "downstream" costs related to additional diagnostic testing and workups?
  • Does decreasing the provision of non-recommended "D" preventive services improve outcomes?
  • Does the implementation of individual USPSTF "A" and "B" recommended preventive services or a set of recommended services actually improve overall health outcomes in a particular geographic area or integrated health system or priority population?

The second goal involves improving primary care and clinical outcomes through health care redesign, clinical-community linkages, self management support, and care coordination based on the Care Model.2,3 AHRQ is interested in moving beyond condition-specific research to support grants that are focused on system redesign in ambulatory care, the results of which would be generalizable across health conditions. Examples of grant applications that would be considered under this strategic area include, but are not limited to, research on the effectiveness, efficiency, and/or implementation of:

  • New models of delivering primary care with the potential to improve both preventive services and chronic care management, including, but not limited to, the patient-centered primary care medical home. Potential areas of interest include:
    • Role of clinical teams within the patient-centered, primary care medical home.
    • Costs and benefits of the patient-centered, primary care medical home to patients, clinicians, practices and health systems.
  • Methods of linking primary care practices with community resources to improve the delivery of preventive services and care management.
  • Alternative models of self management support.
  • Care coordination methods, especially during transitions among care settings.
  • System and organizational policy change that support the Care Model.
  • Interventions to stimulate practice change, including practice coaching, training, toolkits, and collaboratives. 

Research questions of interest for R01 applications related to the second strategic goal include, but are not limited to:

  • What bundle of practice redesign changes lead to improved patient access and outcomes and can be successfully implemented and financially sustained in small practices?
  • What combinations of interventions (e.g., improved physician-patient communication; use of ancillary professionals for action planning and/or telephone follow-up; clear, multi-lingual patient education materials, peer-led groups) lead to increased self management capabilities, especially among patients with limited health literacy and/or English proficiency?
  • What payment methods support the establishment of a medical home and the delivery of patient-centered chronic care?
  • What models of connections and collaborations among primary care, and community/public health settings produce improved population level preventive service delivery within a defined community?
  • What are the effects of the implementation of a patient-centered, primary care medical home on health outcomes, costs, and other relevant outcomes such as team functioning?

Value Portfolio

Finding a way to achieve greater value in health care—reducing unnecessary costs and waste while maintaining or improving quality, or improving quality without adding costs—is a critical national need.  AHRQ's Value Portfolio seeks to meet this need by supporting research that health care organizations, systems, insurers, purchasers, and policymakers need to improve the value of health care and reduce disparities in care for ARHQ priority populations, and that will help consumers to choose high-value care. 

Research using quantitative, qualitative and mixed methods, and both basic and more applied research that takes advantage of natural experiments, is encouraged.  Listed below are broad themes describing examples of research that would fit within the value portfolio.  The list is meant to provide examples rather than present an 'all inclusive' list:

  • Payment and markets:
    • When and how do new payment models, such as pay-for -performance, bundled payments, episode-based payments, shared savings and other provider incentives succeed (or not) in improving quality/safety and the affordability of care?
    • When and how do differences or changes in the healthcare marketplace (for example, levels of competition, growth of ACOs, alliances, mergers and acquisitions in the provider or insurance industry) affect prices, quality, accessibility, and disparities in health care?
    • What are the effects of Federal and State regulatory and legal changes on the organization, financing, accessibility, delivery, quality and cost of health care (to include the effects of Medicare, Medicaid, and CHIP benefit provisions)?
    • When and how do consumer financial incentives, such as provider tiering, value-based insurance design, etc. succeed (or not) in improving quality/safety and the affordability of care?
  • Organization and delivery of care:
    • When and how do regional multi-stakeholder quality collaboratives or other aligned strategies succeed (or not) in improving quality/safety, population health and the affordability of care?
    • What are the effects of leadership, management, organizational culture, cultural competence and health literacy interventions on improving organizational performance, efficiency and outcomes, including outcomes for diverse population groups?
    • When and how do organizational redesign activities (e.g., regionalization of trauma or other services, changes in staffing and skill mix) reduce waste and improve quality (or not)—and, what is required to create a business case for a particular aspect of organizational redesign?
    • Which redesign techniques (e.g., Lean, reengineering, etc.) improve the delivery of health care services and under what circumstances?
    • Which redesign techniques and improvement practices are adaptable and scaleable to diverse care settings, delivery systems, and patient populations?  What are the forces affecting the spread and sustainability of these designs and practices?
    • What are successful health care management strategies to improve value?
    • Which strategies are successful (or not) in reducing hospital readmissions, and what circumstances affect the success of these strategies?
  • Reports of provider performance and consumer choice:
    • How can public reports be designed for consumers to successfully engage them in considering quality performance ratings when selecting a physician, hospital or other provider?
    • How can private reports for physicians (i.e., physician performance feedback) be designed to successfully engage physicians in reviewing the quality of their patient care and how to improve it?
    • What are the effects of Federal and State regulatory and legal changes on public reporting of provider quality and resource use?
  • Research to improve measures, data, tools, and implementation strategies to improve the value of health care:
    • How do we improve the clinical robustness and accuracy of administrative or claims data for quality improvement or public reporting? 
    • What are some methodological improvements that could advance our measure development process?
    • Which tools or approaches will enable easier and broader uptake of strategies found to increase the value of health care?

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AHRQ Large Research Demonstration (R18) FOA:  Research Objectives

AHRQ seeks a wide range of research dissemination and demonstration projects. However, all grant applications must contain projects that fit within the current AHRQ Research Portfolio areas as articulated below.

Comparative Effectiveness Portfolio

In FY 2013 and FY 2014, AHRQ intends to support research grants focusing on patient-centered outcomes and comparative effectiveness of different clinical treatments and services, as authorized by 42 U.S.C. § 299b—7 and 42 U.S.C. § 299a.  In addition, AHRQ aims to enhance and leverage research and electronic data infrastructure and capacity, allowing future studies to address questions where data are currently not sufficient to provide guidance about competing alternatives and to improve the efficiency with which the research and electronic data infrastructure is able to respond to pressing health care questions.  The intent of these grants is to support research focusing on the generation and translation of new scientific evidence and analytic tools in an accelerated format and the integration of evidence into practice and decisionmaking in the health care system.

New applicants are encouraged to partner with institutions well versed in systematic review methodologies or with research centers and integrated health care delivery systems, in particular those with electronic health records and data linkage experience, capable of performing accelerated clinical effectiveness and outcomes research and the translation and dissemination of evidentiary information for health care decisionmaking. Existing examples of such AHRQ networks include, the Evidence-based Practice Centers (EPCs), the Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) network, the Centers for Education & Research on Therapeutics (CERTs), and the John M. Eisenberg Clinical Decisions and Communications Science Center. A listing of these research networks under AHRQ's Effective Health Care program can be found at: http://effectivehealthcare.ahrq.gov/aboutUs/index.cfm.

In addition, applicants are strongly encouraged to collaborate with stakeholders and the target population in an effort to ensure the relevance of the research questions to a broad spectrum of health care decisionmakers, and to facilitate the uptake and implementation of the evidence-based research findings.  An emphasis on the patient-centered outcomes research questions most pertinent to the AHRQ priority populations, and previously understudied populations, is also encouraged.  AHRQ also recognizes the importance of health care delivery and system level issues in comparative effectiveness research.  Research projects that seek to address, in the comparative effectiveness context, how different approaches and strategies of the way care is structured and delivered to improve outcomes, and/or to increase the likelihood of provider and patient uptake and adherence to effective interventions are encouraged as well.

The grants can have either a clinical or methodological emphasis, but must focus tightly on the study and/or the use of comparative effectiveness research. For grants with methodological emphasis, the goals should be to advance study designs and methods to fill specific knowledge gaps and to enhance the consistency, applicability, and generalizability of the comparative effectiveness studies. For projects with a clinical emphasis, the goals should be to develop new scientific evidence that fills important knowledge gaps and to generate critical insights on the clinical effectiveness and comparative clinical effectiveness of health care interventions. For studies in which randomized controlled trials may not be feasible or timely, or would raise ethical concerns that are difficult to address, novel or alternative study designs may be proposed. Such clinical research projects also need to be informed by the information needs and inputs from various stakeholders (e.g., policymakers, providers, and patients) to ensure the most appropriate outcome measures for assessing the effectiveness of the interventions and outcomes of importance to stakeholders are included in the study. Research projects should also be organized around a set of priority conditions of importance to the Medicare, Medicaid, and SCHIP programs. The current list of conditions includes:

  • Arthritis and nontraumatic joint disorders.
  • Cancer.
  • Cardiovascular disease, including stroke and hypertension.
  • Dementia, including Alzheimer's Disease.
  • Depression and other mental health disorders.
  • Developmental delays, attention-deficit hyperactivity disorder and autism.
  • Diabetes Mellitus.
  • Functional limitations and disability.
  • Infectious diseases including HIV/AIDS.
  • Obesity.
  • Peptic ulcer disease and dyspepsia.
  • Pregnancy including pre-term birth.
  • Pulmonary disease/asthma.
  • Substance abuse.

In terms of R18 Research Demonstration and Dissemination Projects, AHRQ's interests include, but are not limited to:

  • Effectiveness/comparative effectiveness of health care treatments and services, including pharmaceuticals, diagnostics, devices, and other types of interventions or combinations of these interventions.
  • Studies of the effectiveness/comparative effectiveness of important new or existing health care technologies.
  • Methodological frameworks and empirical assessments of the effectiveness/comparative effectiveness of complex interventions, including research on how different approaches and strategies of health care delivery and system level issues affect patient outcomes.
  • Assessment of the effectiveness/comparative effectiveness of health care treatments for common, high-cost conditions in elderly and women in various age and racial/ethnic groups.
  • Assessment of the effectiveness/comparative effectiveness of interventions unique to children or treatments that are commonly administered to children but have been evaluated for safety and effectiveness only in adult populations.
  • Effectiveness/comparative effectiveness of interventions and health outcomes in patients with multiple co-morbidities.
  • Studies that explore influences of pharmacogenetics on responses to therapeutic interventions.
  • Studies that aim at better understanding heterogeneity in treatment effects and the development and validation of clinically informative risk stratification and classification models in different clinical domains.
  • Methods for optimal systematic reviews of evidence, including methodological research on meta-analysis, decision analysis, assessing and interpretation of evidence, etc.
  • Methods for study design and/or analysis aimed, for example:
    • To account for patient and provider preferences in health care decisions while minimizing potential selection biases and other sources of confounding.
    • To supplement existing data on patient-centered outcomes for a condition with new data collection to equate different measures of the same domains, or otherwise harmonize outcomes measures within a field.
    • To develop sustainable patient-centered outcome measurement systems usable in routine clinical practice capable of supporting both clinical care and research missions.

Health Information Technology Portfolio

AHRQ's Health Information Technology (IT) Portfolio is part of the Nation's strategy to put information technology to work in health care. AHRQ has invested over $300 million in contracts and grants to over 150 communities, hospitals, providers, and health care systems in 48 States to develop and disseminate evidence and evidence-based tools about health IT's impact on the quality, safety, efficiency, and effectiveness of health care.

Health IT is broadly defined as the use of information and communication technology in health care to support the delivery of patient or population care or to support patient self-management and not administrative functions such as billing or support of health care operations.1  Health IT can support patient care related activities such as order communications, results reporting, care planning, treatment managing (e.g., diagnosis, self-management, monitoring), and clinical or health documentation.  AHRQ funds research on how health IT improves quality, with a focus on health IT that supports care delivery as defined above.  AHRQ does not focus on basic and applied informatics research (e.g., representation, organization, and retrieval of biomedical and biological data and images; development of taxonomies; linguistic analyses for natural language processing and understanding).

AHRQ's Health IT Portfolio has separately published program announcements, available at http://healthit.ahrq.gov/healthitfoas, to solicit applications that address the Portfolio's highest priorities. 

Applications that do not address the priorities identified in the health IT program announcements, but that propose to conduct health IT research to address the following priorities are encouraged to apply to this program announcement:

  1. Making care safer by reducing harm caused in the delivery of care.
  2. Ensuring that each person and family are engaged as partners in their care.
  3. Promoting effective communication and coordination of care.
  4. Promoting the most effective prevention and treatment practices for the leading causes of mortality.
  5. Working with communities to promote wide use of the best practices to enable healthy living.
  6. Making quality care more affordable for individuals, families, employers, and governments by developing and spreading new health care delivery models.

AHRQ is particularly interested in supporting projects focused on the sustainability of a health IT intervention or the translation or diffusion of a health IT intervention that has been shown to be effective.  Translation projects could focus on the diffusion of an intervention implemented in one setting, for a health care issue or population, or with one vendor product, to another setting, health care issue, population, or vendor.  Health IT translation projects of interest to AHRQ would either (a) demonstrate the effectiveness of a proven health IT intervention under new conditions or (b) generate guidance to ensure others can easily apply the research findings in their own context of care.  For example, a project could focus on the demonstration that a health IT intervention shown to be effective for the general population will also be effective for underserved populations or those impacted by the digital divide, includingAHRQ priority populations.

AHRQ's priority is to fund projects that will fill known gaps in the field.  Applicants must demonstrate they are addressing a known gap in health IT research, as evidenced in AHRQ-funded evidence reports available at http://www.ahrq.gov/research/findings/evidence-based-reports/services/health-it/index.html, with regards to how health IT does or does not improve health care quality. Applications submitted in response to this FOA must be designed to elucidate what is it about a given health IT application or system and its design and implementation, that may or may not have led to improved quality of care

While not a primary interest of the Health IT Portfolio, applications focused on the development, testing, and evaluation of new health IT applications or systems must demonstrate a unique need for the proposed new application or system or demonstrations of revisions of an existing health IT application or system and how developing or further revising application or system will fill a gap in the field of health IT as discussed above.  Applicants must present a demonstrated need for a new or revised application or system beyond stating that a health IT application or system has not been developed for a particular population, condition, setting, care process (aspect of care), or provider group; and must discuss how the proposed system or significant revision to the system will address deficiencies on previously developed or currently existing health IT applications or systems including those previously funded by AHRQ (available at http://healthit.ahrq.gov/portfolio) or described in the literature. 

In addition, such applications must present evidence of how the health IT application or system was originally developed to ensure the system or application to be evaluated will be useful and effective, as found in, for example, a previously funded pilot or feasibility study (e.g., such as one that may have been funded under the Small Research Grant to Improve Healthcare Quality through Health IT (R03) FOA, available at http://grants.nih.gov/grants/guide/pa-files/PAR-08-268.html; or the Exploratory and Developmental Grant to Improve Health Care Quality through Health IT (R21) FOA, available at http://grants.nih.gov/grants/guide/pa-files/PAR-08-269.html) or that builds on foundational knowledge gleaned from an application funded under one of the two Health IT R01 FOAs (i.e., Understanding Clinical Information Needs and Health Care Decision Making Processes in the Context of Health Information Technology (IT), available at http://grants.nih.gov/grants/guide/pa-files/PA-11-198.html; Understanding User Needs and Context to Inform Consumer Health Information Technology (IT) Design, available at http://grants.nih.gov/grants/guide/pa-files/PA-11-199.html). 

Furthermore, applicants evaluating the effectiveness of a health IT application or system must evaluate the 1) usefulness of the health IT system, 2) the system's usability, 3) the presence and quality of associated care process redesign, and 4) the effectiveness and efficiency of associated care-process management systems as primary outcomes or potential confounders depending on study design.  It is expected that applications submitted in response to this program announcement will be using health IT systems as part of a coordinated effort to improve care practice at a given setting.  Applications not responsive to these requirements will not be prioritized for funding.

Since this program announcement encompasses all of AHRQ's portfolios of work, it would be an ideal opportunity to submit applications which address the goals of other portfolios in addition to health IT described in this announcement.

 Patient Safety Portfolio

Patient safety is defined as the freedom from accidental or preventable injury produced by health care as well as the practices that create a safe environment of care.

Patient safety research initiatives can be considered in three different stages:

  • Identification of risks and hazards.
  • Design, implementation, dissemination and spread, and evaluation of interventions to improve patient safety.
  • Establishment of strategies to sustain patient safety improvements such as just culture, incident/event reporting, measurement, monitoring, and surveillance.

The Patient Safety Portfolio will support research projects to create new knowledge by identifying the risks and hazards encountered by patients as a result of health care.  The Portfolio will also support projects that mitigate those risks and hazards, including the design, implementation and evaluation of strategies (patient safety practices) and the adaptation, refinement, and sustainment of those strategies. These initiatives are part of the Agency's overall mission to improve the quality of health care.

AHRQ encourages an interdisciplinary patient safety approach. In addition to health services research, perspectives from organizational theory, human factors, industrial engineering, facilities design, education, and other disciplines can be incorporated in research plans.

Projects may address important topics such as:  the surveillance, measurement, detection, and reporting of patient safety events; the impact of human performance and working conditions on patient safety; the patients' role and contribution to patient safety; health care safety culture, leadership, communication, teamwork, and simulation; prevention and control of healthcare-associated infections; diagnostic error; the safe use of medical devices and medications; the role of Patient Safety Organizations (PSOs); the relationship between medical liability and patient safety;  and the challenges inherent in transitions of care and handoffs between health care providers. 

The Portfolio supports research in all health care settings including the hospital, long-term care, ambulatory care, home health care, pharmacy, and transitions of care between settings.

Patient safety research involves many stakeholder groups including patients, families, clinicians, non-clinical health care staff, policymakers, payers, and health care organizations including providers and accreditors, local and state governments, and the Federal government, Patient Safety Organizations, and many others. 

Projects in this area may also address patient characteristics that might influence the risk of experiencing a patient safety event.  For example, attributes of AHRQ's Priority Populations that can impact patient safety. 

Please visit the Agency's page to learn more about examples of patient safety research efforts supported by AHRQ.

Prevention and Care Management Portfolio

The mission of the Prevention/Care Management Portfolio is to improve the quality, safety, efficiency, and effectiveness of evidence-based preventive services and chronic care management in ambulatory care settings. We are interested in grants that will support two broad strategic goals. The first goal focuses on preventive services. Grants awarded in this strategic area should complement the work of the U.S. Preventive Services Task Force in terms of advancing methods for assessing the benefits and harms of preventive services, and improving the implementation of evidence-based recommendations on preventive services. AHRQ is interested in funding areas that have not traditionally been the focus of funding initiatives, such as:

  • The harms associated with preventive services.
  • The overuse of preventive services.
  • The delivery of preventive services for the patient with multiple co-morbidities.

Examples of grant applications that would be considered under this strategic area include, but are not limited to, research on:

  • The effectiveness of preventive services in improving health and quality of life in complex patients.
  • The development of new methodologies for assessing the harms of preventive services.
  • Evidence gaps identified by the U.S. Preventive Services Task Force for specific preventive services.

Research questions for R18 projects of interest under this strategic area include, but are not limited to:

  • What common metrics can be developed for harms and benefits of preventive services? How can quality of life issues (e.g., anxiety regarding possible cancer diagnosis) be weighed against "hard" clinical outcomes (e.g., cancer-specific mortality)?

The second strategic area of interest is based on the Care Model.2,3 AHRQ is interested in supporting grants with the aim of improving primary care and clinical outcomes through health care redesign, clinical-community linkages, self management support, and care coordination. We are less interested in funding research on specific conditions, but rather seek to support grants that are focused on system redesign in ambulatory care, the results of which would be generalizable across health conditions. Examples of grant applications that would be considered under this strategic area include, but are not limited to, research on the effectiveness, efficiency, and/or implementation of:

  • New models of delivering primary care, especially for individuals with multiple chronic conditions.
  • Methods of linking primary care practices with community resources to improve the delivery of preventive services and care management.
  • The effectiveness and implementation of models of self management support.
  • Care coordination methods, especially during transitions among care settings.
  • System and organizational policy change that support the Care Model.
  • Interventions to stimulate practice change, including practice coaching, training, toolkits, and collaboratives.

Research questions of interest for R18 applications related to the second strategic area include, but are not limited to:

  • How can the Care Model be spread to diverse settings, especially those serving uninsured, Medicaid, immigrant, geographically or economically disadvantaged, and other vulnerable populations?
  • What is the impact of using a Depression Tool Kit on patients' ability to self manage their other chronic conditions and on patient outcomes? How can use of a Depression Tool Kit be integrated into the delivery of primary care in diverse settings?
  • What are the organizational and workforce needs in primary care, i.e., staffing, training, role descriptions, needed to implement effective self-management support programs?
  • What are the best methods for determining priority processes of self-management support based on health outcomes, treatment effectiveness and cost-effectiveness?

Generally, the portfolio is very interested in research that involves non-traditional ambulatory health care sites that serve the uninsured, Medicaid, and other vulnerable populations. Vulnerable populations, as defined by the IOM in 2002, include the uninsured, low-income, under-insured, Medicaid beneficiaries, minority population, immigrant populations and geographically or economically disadvantaged communities. Partnerships between community-based health care sites and academic institutions are encouraged.

Value Portfolio

Finding a way to achieve greater value in health care—reducing unnecessary costs and waste while maintaining or improving quality, or improving quality without adding costs—is a critical national need.  AHRQ's Value Portfolio seeks to meet this need by supporting research that health care organizations, systems, insurers, purchasers, and policymakers need to improve the value of health care and reduce disparities in care for ARHQ priority populations, and that will help consumers to choose high-value care. 

Public and private decisionmakers in the field have been experimenting with ways to achieve greater value in health care, and AHRQ seeks both to facilitate and quickly learn from this rich body of"natural experiments"—real-world opportunities for rigorous, practical assessments of such experimentation to determine what works best, when, how, and for whom.

AHRQ's value portfolio is interested in demonstrations based on these natural experiments and/or pilots to test, disseminate and implement strategies to improve value in health care.  Listed below are broad themes describing research that would fit within the value portfolio.  The list is meant to provide examples rather than present an 'all inclusive' list:  

  • Payment and markets:
    • When and how do new payment models, such as pay-for-performance, bundled payments, episode-based payments, shared savings and other provider incentives succeed (or not) in improving quality/safety and the affordability of care?
    • When and how do differences or changes in the healthcare marketplace (for example, levels of competition, growth of ACOs, alliances, mergers and acquisitions in the provider or insurance industry) affect prices, quality, accessibility, and disparities in health care?
    • What are the effects of Federal and State regulatory and legal changes on the organization, financing, accessibility, delivery, quality and cost of health care (to include the effects of Medicare, Medicaid, and CHIP benefit provisions)?
    • When and how do consumer financial incentives, such as provider tiering, value-based insurance design, etc. succeed (or not) in improving quality/safety and the affordability of care?
  • Organization and delivery of care:
    • When and how do regional multi-stakeholder quality collaboratives or other aligned strategies succeed (or not) in improving quality/safety, population health and the affordability of care?
    • What are the effects of leadership, management, organizational culture, cultural competence and health literacy interventions on improving organizational performance, efficiency and outcomes, including outcomes for diverse population groups?
    • When and how do organizational redesign activities (e.g., regionalization of trauma or other services, changes in staffing and skill mix) reduce waste and improve quality (or not)—and, what is required to create a business case for a particular aspect of organizational redesign?
    • Which redesign techniques (e.g., Lean, reengineering, etc.) improve the delivery of health care services and under what circumstances?
    • Which redesign techniques and improvement practices are adaptable and scaleable to diverse care settings, delivery systems, and patient populations?  What are the forces affecting the spread and sustainability of these designs and practices?
    • What are successful health care management strategies to improve value?
    • Which strategies are successful (or not) in reducing hospital readmissions, and what circumstances affect the success of these strategies?
  • Reports of provider performance:
    • How can public reports be designed for consumers to successfully engage them in considering quality performance ratings when selecting a physician, hospital or other provider?
    • How can private reports for physicians (i.e., physician performance feedback) be designed to successfully engage physicians in reviewing the quality of their patient care and how to improve it?
    • What are the effects of Federal and State regulatory and legal changes on public reporting of provider quality and resource use?
  • Research to improve measures, data, tools, and implementation strategies to improve the value of health care:
    • How do we improve the clinical robustness and accuracy of administrative or claims data for quality improvement or public reporting? 
    • What are some methodological improvements that could advance our measure development process?
    • Which tools or approaches will enable easier and broader uptake of strategies found to increase the value of health care?
    • How can we advance the science of implementation so that we can more effectively and quickly replicate and spread the essential components of successful strategies while allowing for necessary adaptations to suit local circumstances?

AHRQ is also interested in demonstrations and pilots to test and disseminate measures, data and tools needed by decisionmakers to track, report and improve cost and quality—particularly within and across sites of care.

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References

  1. Shortliffe EH and JJ Cimino, "Biomedical Informatics: Computer Applications in Health Care and Biomedicine." Third Edition. 2006.
  2. Wagner EH. Chronic disease management: What will it take to improve care for chronic illness? Effective Clinical Practice 1998;1(1):2-4.
  3. Barr V, Robinson S, Marin-Link B, et. al.  2002 Adapted from Glasgow R, Orleans CT, Wagner E, Curry S and Solberg L. (2001).  Does the Chronic Care Model also serve as a template for improving prevention?  Milbank Quarterly 2002; 79(4).
Current as of March 2014
Internet Citation: Funding Opportunity Announcement (FOA) Guidance. March 2014. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/funding/policies/foaguidance/index.html