DEMONSTRATING THE VALUE OF HEALTH INFORMATION TECHNOLOGY RELEASE DATE: November 21, 2003 RFA Number: RFA-HS-04-012 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: Agency for Healthcare Research and Quality (AHRQ) (http://www.ahrq.gov) National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATIONS: National Library of Medicine (NLM) (http://www.nlm.nih.gov) NOTE: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by NIH. CFDA NUMBER: 93.226 (AHRQ) and 93.879 (NLM) LETTER OF INTENT RECEIPT DATE: February 6, 2004 APPLICATION RECEIPT DATE: April 22, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION: o Purpose of the RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations o References PURPOSE OF THE RFA The Agency for Healthcare Research and Quality (AHRQ) announces the availability of research grants to assess the value derived from the adoption, diffusion, and utilization of health information technology (HIT) to improve patient safety and quality of care. AHRQ is seeking proposals that elucidate the value of HIT from a variety of perspectives, including patients, providers, purchasers, payers, policymakers, or other important stakeholders and decision makers. The main objective of this RFA is to support projects that will increase our knowledge and understanding of the value of HIT, which includes clinical, safety, quality, financial, organizational, effectiveness, efficiency, or other direct or indirect benefits that may be derived from the use of HIT in the delivery of health care. The findings from this initiative should provide these stakeholders with information needed to make better and more informed clinical, purchasing, and other important health care decisions regarding the use of HIT in their environment. The other objective of this RFA is to support the development of models or other tools that can be used to help demonstrate the value of HIT or to advance the adoption of HIT. For the purpose of this RFA, value is defined as clinical, organizational, financial, or other benefits derived from the adoption, utilization, and diffusion of HIT less the costs of achieving these benefits. Specific aspects of value may include things such as: reduction in medical errors; improved use of effective and recommended interventions; decreased use of inappropriate or ineffective interventions; increased use of clinical guidelines and evidence-based clinical decisions; improvements in access to care and quality of care; improvements in provider productivity; more efficient use of personnel; reductions in costs (total costs or costs related to specific activities and functions); enhanced revenues; better coordination of care among providers; improved patient involvement and satisfaction; and greater transparency and accountability of provider operations. These potential benefits must be weighed against the costs and potentially detrimental consequences of HIT adoption. Applicants are encouraged to submit proposals that examine the value of HIT in diverse health care settings (e.g., inpatient hospitals, outpatient clinics, nursing homes, home health, and community care), consider the perspective of various stakeholders (e.g., patients, providers and health care organizations), and include priority populations (e.g., low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care). AHRQ is also specifically interested in applications that will examine the value of new and emerging HIT, as well as applications that explore the unique barriers faced by rural and small community providers in adopting HIT and opportunities for overcoming these barriers. The National Library of Medicine (NLM) supports research in biomedical informatics, bioinformatics, computational biology and health information sciences in such areas as : representation of medical knowledge in computers; organization and retrieval issues for image databases; enhancement of human intellectual capacities through virtual reality, dynamic modeling, artificial intelligence, and machine learning; medical decision-making; linguistic analyses of medical languages and nomenclatures; management of information in disasters; and approaches to linking genome and phenome data. In the area of clinical informatics, NLM is particularly interested in ways computers and networks bring value to the delivery of health care, the management of health information, and the support of informed decisionmaking by consumers, patients, health care providers, and health care administrators. Other fundamental areas of interest include context-appropriate information to guide learning and decisions; standards based information management that employs standard vocabularies and information exchange protocols; and digital libraries. This RFA is one in a series of solicitations to be issued by AHRQ in FY 2004 on the use of HIT to improve patient safety and quality of care. The solicitations form an integrated set of activities designed to explore strategies for successful organizational and community-wide planning and implementation of HIT solutions and to demonstrate the value of HIT in patient safety and quality of care. The FY 04 HIT initiative will place particular emphasis on the challenges facing rural and small communities in integrating HIT into their health care delivery systems. In addition to this RFA, other grants and contracts to be released as part of this program include: 1. Transforming Healthcare Quality through Information Technology (THQIT) Planning Grants - planning grants to provide organizations and communities with the resources needed to develop their capacity to compete for AHRQ (and other funding agencies) implementation grants and further develop their HIT capabilities for improving patient safety and quality of care. Planning grants will enable these entities to begin planning and developing their HIT infrastructure and data sharing capacity among clinical provider organizations in their communities. 2. Transforming Healthcare Quality Through Information Technology (THQIT) Implementation Grants - implementation grants aimed at providing resources to community partners who have successfully completed the planning process and plan to implement HIT in their practice setting. These projects must also include an evaluation of the effects of HIT on important patient safety and quality measures. The objective of this RFA is to support implementation and diffusion of HIT and to assess the extent to which HIT contributes to measurable and sustainable improvements in patient safety and quality of care. Research resulting from this RFA should inform AHRQ, providers, patients, payers, policymakers, and the public about how HIT can be successfully implemented in diverse health care settings and lead to safer and better health care. 3. Health Information Technology Resource Center (HITRC) - The center will provide technical assistance to grantees; serve as a repository for best practice assimilation and diffusion; help develop, maintain and export executable knowledge for clinicians and patients; offer expert HIT support for providers and communities; perform and sponsor educational activities; and develop and disseminate tools to help providers and organizations utilize HIT to improve patient safety and quality of care. In July 2003, AHRQ convened a diverse group of approximately 50 experts who helped the Agency to identify gaps in knowledge relating to the use of HIT and provided recommendations on important thematic areas for AHRQ’s HIT initiatives in FY 2004. Among the panel’s many recommendations were the need for more research on the impact of HIT on important health-related outcomes; more research on HIT in diverse healthcare settings; the need to support local and regional HIT collaborative projects that would lead to standards-based data sharing across healthcare delivery sites; the need to demonstrate the value of HIT in improving patient safety and quality of care, including direct/indirect and tangible/intangible benefits; the need to study incentives and disincentives to the adoption and use of HIT; the need for technical assistance to providers, organizations, and communities in order to implement HIT successfully in their environment; and the need to develop evidence-based, executable knowledge content and decision-support tools to support clinical decision-making. The panel also encouraged collaboration between AHRQ and other Federal agencies, such as the Office for Rural Health Programs (OHRP) at the Health Resources and Services Administration (HRSA) and the Center for Medicare and Medicaid Services, to leverage the resources, expertise, and experiences of these diverse Federal agencies and increase the program’s chances of success. Finally, the panel stressed the need for developing collaborative partnerships and HIT programs that are viable and sustainable. A summary of the proceedings is available on the AHRQ website at http://www.ahrq.gov/data/hitmeet.htm. RESEARCH OBJECTIVES Definitions For purposes of this RFA, the following definitions will apply: 1. Health Information Technology is broadly defined as the use of information and communication technology in healthcare and includes, but is not limited to, electronic health records, personal health records, e-mail communication, clinical alerts and reminders, computerized provider order entry, computerized decision support systems, hand-held computers, electronic information resources technology, and electronic monitoring systems. 2. Value of Health Information Technology is defined as clinical, organizational, financial, or other benefits derived from the adoption, diffusion, and utilization of HIT less the costs of achieving these benefits. o Financial benefits include cost reduction, revenue enhancement and productivity gains. o Clinical benefits include advances in care processes, improved patient outcomes, improvements in safety and quality, and better monitoring of diseases and other health risks. o Organizational benefits include improvements in organizational effectiveness as evidenced in work and quality improvement processes; communication among individuals, groups and organizations; satisfaction of needs and expectations of patients, providers, and other stakeholders; capacity to adapt to changing technical and operating conditions, such as fluctuations in patient load, acuity, and emergency conditions; and organizational risk mitigation. o Costs include equipment, personnel, training, hardware, software, modeling, networks, configuration, linking, or other costs incurred to achieve HIT implementation and interoperability. Changes that adversely affect organizational or individual revenue or resources such as lost productivity, decreased revenue, or reduced clinical efficiency can also be considered to be a cost to the system. 3. Electronic Health Record Systems are defined by the Institute of Medicine’s Letter Report on the Key Capabilities of an Electronic Health Record System (http://www.iom.edu/report.asp?id=14391). EHR systems include the ability to collect longitudinal data for and about a person in an electronic format; immediate electronic access to person and population level information by authorized users; provision of knowledge and decision-support tools that enhance the safety, quality and efficiency of health care; and support of efficient processes for health care delivery. 4. Clinical decision support systems (CDSS) are defined as computer applications that assist clinicians in the management of their patients at the point-of-care by integrating medical knowledge with patient characteristics and generating patient-specific recommendations. CDSS can take the form of computerized reminders, alerts, guidelines, order sets or other similar tools. 5. Patient Safety refers to the absence of the potential for, or occurrence of, healthcare associated injury to patients. Patient safety can result from the avoidance of medical errors as well as taking action to prevent errors from causing injury. AHRQ patient safety activities involve four major components: identifying threats; identifying and evaluating effective practices; education dissemination, and implementation interventions that enhance patient safety; and maintaining vigilance. o Medical Errors are defined as mistakes made in the process of care that result in, or have the potential to, result in harm to patients. Mistakes include the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. Medical errors can result from an action that is taken (error of commission) or an action that is not taken (error of omission). o Medication Error is defined as preventable inappropriate use of medication including inappropriate prescribing, dispensing, or administering. o Adverse Event is defined as an untoward, unintended (usually), and unanticipated (usually) outcome that occurs in association with health care. Preventable adverse events are a subset of adverse events that are judged to have been avoidable if appropriate and reasonable steps had been taken. For example, an anaphylactic reaction to penicillin is an adverse event. It is a preventable adverse event if the patient’s allergy to penicillin is noted in his or her chart or if the patient knows of his or her history of penicillin reactions and is capable to communicating it to the clinician. o Preventable Injury is defined as harm that could be avoided through reasonable planning or proper execution of an action. o Quality, with respect to health care, is defined as doing the right thing, at the right time, in the right way, for the right person, and having the best possible results. It means striking the right balance in the provision of health services by avoiding overuse (e.g., getting unnecessary tests or procedures), under use (e.g., not being screened for high blood pressure or not being treated with a beta-blocker when clinically indicated), or misuse (e.g., being prescribed drugs that have dangerous interactions or being given the wrong dose of a medication). o Healthcare Environment is defined as the structures and processes employed to provide health care. They reflect the characteristics of the facility (e.g., size, location, specialty, licensure, certification, equipment, working conditions) and the organization (e.g., personnel mix and experience, lines of authority, leadership, policies and procedures, governance, culture). o Rural Hospitals are defined as acute care hospitals physically located in a rural or non-metropolitan area within the borders and confines of any state or U.S. territory. o Rural and/or non-metropolitan areas are defined as geographic regions that either: Reside within a county or area not designated by the Office of Management and Budget as a Metropolitan Statistical Area (MSA) or Metropolitan New England City or Town Area (MNECTA). http://www.census.gov/population/estimates/metro-city/03msa.txt or Reside within a non-metropolitan region of an MSA or MNECTA designated county or area as defined by the Economic Research Service (ERS) of the United States Department of Agriculture (USDA) Rural-Urban Commuting Area codes (RUCA). Non-metropolitan areas will be defined by a RUCA code of between 4 and 10. http://www.ers.usda.gov/briefing/Rurality/RuralUrbanCommutingAreas/ o Small Hospitals are defined as acute care hospitals containing no more than 100 licensed beds or fewer than 6,000 inpatient admissions in the most recent 12-month period. Partnerships are defined as a collaborative working relationship between three or more organizations formalized through one or more written agreements that contain at a minimum the following elements: 1) substantial and meaningful contributions of personnel, expertise, money, equipment, facilities or other important resources to and from each of the partners; and 2) sharing of clinical and research data across healthcare delivery sites. Background In 1998 the Committee on the Quality of Health Care in America, established within the Institute of Medicine (IOM), was appointed to identify strategies for achieving substantial improvement in the quality of health care in America. The committee’s first report, To Err is Human: Building a Safer Health System, was released in November 1999 and focused on issues relating to patient safety [1]. The study found that 44,000 to 98,000 people die in U.S. hospitals each year as a result of medical errors. In March 2001, the Committee released a follow-up report, Crossing the Quality Chasm: A New Health System for the 21st Century, which addressed a broader range of quality issues and provided a strategic direction for redesigning the health care delivery system [2]. They reported that the U.S. health care system is plagued by serious quality problems resulting from an outmoded and inadequate delivery system, which is incapable of providing high-quality care to its population in a consistent manner. The Committee went so far as to state: In its current form, habits, and environment, American health care is incapable of providing the public with the quality health care it expects and deserves. In particular, HIT was identified as one of the four critical forces that could significantly improve health care quality. There must be a renewed national commitment to building an information infrastructure to support health care delivery, consumer health, quality measurement and improvement, public accountability, clinical and health services research, and clinical education. In addition, the National Committee on Vital and Health Statistics (NCVHS) and the President’s Information Technology Advisory Committee have recommended the development of a National Health Information Infrastructure (NHII) to improve safety, reduce costs and enhance the quality of healthcare. Over the past 30 years, research has demonstrated that HIT can improve patient safety and quality of care. For example, at LDS Hospital in Salt Lake City, a computerized physician order entry (CPOE) system with decision support reduced the incidence of adverse drug events related to antibiotic administration by 75% [3]. It also significantly reduced orders for drugs for which patients reported allergies and adverse effects that were caused by antibiotics [4]. At the Regenstrief Institute for Health Care in Indianapolis, researchers demonstrated that automated computerized reminders increased orders for recommended interventions from 22% to 46% [5]. At the Brigham and Women’s Hospital in Boston, use of a CPOE system with decision support led to increased use of appropriate medications for high-risk clinical situations, such as an increase in the use of subcutaneous heparin to prevent venous thromboembolism, from 24% to 47%. Medication errors were also reduced by 19% to 84% [6]. A 1998 systematic review of the literature that assessed the effects of 68 computer-based clinical decision support systems demonstrated a beneficial, though variable impact on physician performance in 43/65 studies (66%) and a beneficial effect on patient outcomes in 6/14 studies (43%) [7]. In a more recent study, the Center for Information Technology Leadership (CITL) at Harvard recently projected that the adoption of advanced computerized physician order entry systems in ambulatory care settings could eliminate more than two-million adverse drug events and prevent more than 190,000 hospitalizations per year; this improvement in quality and safety could also generate billions of dollars in savings in the healthcare systems [8]. Despite this evidence, physicians, hospitals and other healthcare facilities have lagged behind most industries in their adoption of HIT systems. Although accurate data are not available, it is estimated that less than 10% of facilities across the United States have comprehensive HIT systems in place and use them to provide clinical care. Reasons for this paucity of investment in HIT include misaligned financial incentives, high cost of investing in HIT systems, current evidence on HIT is limited to a few sites with home grown legacy systems, limited data that HIT improves important outcomes, potentially disruptive effects on clinical workflow, cultural barriers, and competing priorities. In addition, little is known about the relationship between HIT and financial or other economic aspects of healthcare. Healthcare providers, consumers, and decision makers do not often have the knowledge or resources needed to make major HIT purchasing or utilization decisions. Key information that is needed to make informed decisions, such as improvements in various aspects of safety and quality of care, direct and indirect return on investment, effects on clinical workflow, and effects on individual or system efficiency are currently missing or incomplete. Although information is often available on the upfront costs for purchase and implementation of various HIT components, data on indirect costs and other important cost components are often not available. Further, information on the short- and long-term benefits of HIT investment and utilization is scant or nonexistent. Finally, health care purchasers are reluctant to provide incentives for the use of HIT without more evidence that HIT substantially improves safety and quality or that it provides a significant return on investment. The lack of financial incentives for HIT investment, lack of high-quality evidence that HIT improves important outcomes in diverse health care settings, lack of widespread industry experience, and the limited number of useful and generalizable models create formidable barriers to the adoption and use of HIT. Fortunately, efforts are currently underway in both the private and public sector to accelerate the rate of HIT adoption. Many health care systems have already implemented, or are planning to implement, electronic health records (EHRs), computerized provider order entry (CPOE) systems with clinical decision support, bar coding systems, automated medication dispensing systems, personal health records, or other HIT tools to improve patient safety and quality of care. Some of the more recent efforts are even being spearheaded by the payers. For example, the Bridges to Excellence program was launched by three large employer groups and will reward participating providers who use EHRs in the care of patients with diabetes and heart disease and who achieve certain levels of high-quality care. Another initiative, which is being developed by the Leapfrog Group in partnership with AHRQ and the Center for Medicare and Medicaid Services (CMS), will promote the use of e-prescribing, e-lab management and e-reminders in the ambulatory care setting. Additionally, CMS recently announced the Physician Group Practice Demonstration and the Premier Hospital Demonstration, two large demonstration projects that involve the use of HIT to improve quality of care, reduce costs, and support the reporting of quality, administrative, and systems data to CMS. While these efforts are encouraging, there is still a tremendous need for more information on the value of HIT to assist providers, patients, payers, policymakers, and other health care decision makers. Providers and patients in rural, small, and other underserved communities are struggling with similar issues as those described above. In addition, these communities face other challenges such as a poor or non-existent IT infrastructure, lack of available capital for HIT investment, poor payer mix, lack of providers and specialty care, and patients who must often seek care across long distances, which create an even greater challenge in demonstrating the value of HIT in these communities. Objectives and Scope AHRQ announces the availability of research grants to assess the value derived from the diffusion, adoption and utilization of HIT to improve patient safety and quality of care. Specifically, AHRQ is seeking proposals that elucidate the value of HIT from a variety of perspectives, including patients, providers, purchasers, payers, policymakers, or other important stakeholders and decision makers. The main objective of this RFA is to support projects that will increase our knowledge and understanding of the value of HIT, which includes clinical, safety, quality, financial, organizational, effectiveness, efficiency, or other direct or indirect benefits that may be derived from the use of HIT in the delivery of health care. The findings from this initiative should provide these stakeholders with information needed to make better and more informed clinical, purchasing, and other important health care decisions regarding the use of HIT in their environment. The other objective of this RFA is to support the development of models or other tools that can be used to help demonstrate the value of HIT or to advance the adoption of HIT. The agency is specifically seeking the following types of projects: Projects that will increase our knowledge and understanding of the value of HIT. Value can include clinical, organizational, financial, or other benefits of HIT. These may take the form of research projects that examine direct and indirect, tangible and intangible, and quantitative or qualitative aspects of the value proposition of HIT. They may also take the form of demonstration projects that help define, assess, and illustrate various components of HIT value. AHRQ is interested in projects that explore the value of current or emerging HIT. Clarifying the costs and benefits of community-wide efforts to promote interoperability of clinical data exchange is a priority for this solicitation. Models and other tools that address clinical, financial, economic, organizational, effectiveness, efficiency or other aspects of HIT value and lead to a better understanding of how HIT provides value to patients, providers, payers, or other components of the healthcare system. For example, an applicant may propose to develop and test a simulation model that demonstrates return on investment (ROI), economic impact, effect on safety and quality, or other important aspects of HIT value in different health care settings and under variable conditions. AHRQ anticipates that tools developed under this initiative would be made available to health care decision-makers and provide them with the ability to utilize current and emerging evidence to delineate the value of HIT and guide HIT investment and implementation decisions in their own health care environment. AHRQ is interested in supporting local and regional collaborative partnerships that include a diverse array of health care settings (e.g., primary care, outpatient clinics, inpatient hospital, nursing home, home health, and community care) and account for the needs, objectives, and perspectives of patients, providers, healthcare organizations, and other stakeholder groups. AHRQ is also especially interested in projects that include priority populations. It is important that research projects, models, tools, and other activities that are funded through AHRQ’s HIT portfolio are generalizable across various types of populations, geographic areas, and health care settings. Research areas that are of particular interest to AHRQ include but are not limited to: 1. What are the economic implications of HIT adoption, diffusion, and utilization at the individual, local, regional, national, health system, or organizational level? - Does HIT positively affect local, state, national, community, provider, payer, or organizational health expenditures through improvements in safety, quality, effectiveness or efficiency? - Can HIT mitigate risk and liabilities and improve the medical malpractice environment through improved data collection, documentation, communication, decision support, safety, quality of care, or other means? - What is the business case for HIT? Can HIT provide a meaningful return on investment (ROI)? Should ROI be the driver for HIT investment or should investment in HIT be part of the cost of doing business (e.g., part of the cost of providing safe, high-quality health care)? - Can HIT result in cost savings through improvements in safety, quality, organizational improvements, workflow re-engineering, system efficiencies, and more effective provision of health care services and interventions? What are the different types of savings that can be realized through the use of HIT? Do different savings accrue to different stakeholders, and, if so, can the benefits be quantified across the various stakeholders? - Does HIT facilitate revenue enhancements through such mechanisms as increased productivity, more appropriate use of personnel and resources, improved documentation and billing, etc.? - What are the financial and economic barriers to HIT implementation and use? What are the incentives and disincentives for investing in HIT? What are some methods or strategies for creating incentives and overcoming the disincentives? - What are the financial and organizational impacts of improving patient safety and quality of care through HIT? - Is HIT cost effective? Do the safety, quality, and financial benefits justify the costs of implementation and maintenance and the impact on the organization and stakeholders affected by the adoption of HIT? - What are the advantages and disadvantages of HIT adoption and use among various stakeholders and across different health care settings? 2. What is the value proposition for investing in HIT for rural and small communities? - Are there unique aspects of rural and small communities, providers, patients, etc. that facilitate or hinder the adoption of HIT in these settings? - What are the clinical, safety, quality, financial, organizational or other benefits of HIT adoption in rural and small communities? - Are there specific aspects of HIT that provide more value than others in these settings? - Are there certain business models for HIT adoption that would lead to successful implementation and use of HIT in these settings? - What are the financial and economic barriers to HIT implementation and use in rural and small communities? What are the incentives and disincentives for investing in HIT? What are some methods or strategies for creating incentives and overcoming the disincentives? 3. What is known about best practices in the use of HIT? What has been successful, what has failed, and why have some initiatives succeeded and others failed? Are there factors that predict success or failure? What are the lessons learned over the past 30 years of HIT adoption? Can lessons learned from these successes and failures be applied to other care settings? 4. What are the tangible and intangible benefits of uniform standards for health information exchange, system interoperability, and data sharing? What are the potential problems and what are ways to address these concerns? - Among the various types of health care settings (e.g., inpatient hospitals, outpatient clinics, nursing homes, home health, etc.); among the various stakeholders (providers, patients, payers, etc.); or among different geographic locations or service areas (e.g., rural areas, small communities, metropolitan areas, cities, states, etc.) 5. Creation and diffusion of knowledge regarding the value of HIT - Creating new knowledge and evidence regarding the benefits of HIT in various health care settings. - Development and evaluation of methods, tools, and strategies to disseminate information about the current state of the health care delivery system (e.g., safety, quality, efficiency, appropriateness of care, and other attributes) to consumers, providers, purchasers, payers, policymakers, or other decision- makers. - Development and evaluation of methods, tools, and strategies to disseminate information about the evidence for HIT in improving safety and quality to consumers, providers, purchasers, payers, policymakers, or other decision-makers. - Development and evaluation of toolkits and other resources that can be used by consumers, providers, purchasers, payers, policymakers, or other decision-makers to help them understand the value of HIT and assist them to make HIT purchasing and implementation decisions. Overall, AHRQ is looking to support research, demonstration projects, tools, or other activities that will improve our knowledge and understanding of the value of HIT in health care and advance the use of HIT to improve patient safety and quality of care. MECHANISM OF SUPPORT This RFA will use the R01 award mechanism, in which the Principal Investigator will be solely responsibility for planning, directing, and executing the proposed project. The total project period for an application submitted in response to this RFA may not exceed three years. This RFA is a one-time solicitation. Future unsolicited, competing continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review process. The anticipated award date is September 30, 2004. At this time, it is not known if this RFA will be reissued. Applications that are not funded in the competition described in this RFA may be resubmitted as new investigator- initiated applications (R01) using the standard receipt dates for new applications described in the instructions of the PHS 398 application. AHRQ is not using the Modular Grant Application and Award Process. Applications submitted in modular format will be returned without review. FUNDS AVAILABLE AHRQ intends to commit up to $10,000,000 (ten million dollars) in FY 2004 to fund a minimum of 20 new grants in response to this RFA. An applicant may request a project period of up to three years and a budget of up to $500,000 per year in total costs. Applications that request budgets greater than $500,000 per year in total costs will be returned without review. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will vary. Although the financial plans of AHRQ currently provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of scientifically meritorious applications. Cost sharing and matching are not required of applications submitted in response to this RFA. ELIGIBLE INSTITUTIONS Your institution may submit (an) application (s) if it has one or more of the following characteristics: o Non-profit organization o Domestic organization o Public and private non-profit institution, such as a university, clinic, college, or hospital o Unit of State and local government o Tribe or Tribal Organization o Faith-based or community-based organizations Because this RFA is principally intended to support the adoption and diffusion of HIT in the U.S., no awards will be made to foreign institutions. Foreign organizations may participate in projects as members of consortia or as subcontractors. Organizations described in sections 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible. Institutions and partnerships that are considered safety net providers are encouraged to apply. Practice-based research networks, such as Integrated Delivery Systems Research Networks (IDSRNs) and Primary Care Practice-Based Research Networks (PBRNs) are eligible and encouraged to apply. The ISDRNs are a model of field-based research that links experienced health services researchers with large health care delivery systems to conduct user-driven research on an accelerated timetable. A PBRN is a group of clinical practices devoted to the primary care of patients and with the research capacity to conduct health services research related to community-based practice. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop and submit an application. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ programs. The principal investigator should be an experienced senior level person and should devote a considerable and meaningful portion of his/her time to this project (at least 25%). SPECIAL REQUIREMENTS Studies and projects under this RFA are expected to produce evidence, tools, models, and other information or resources that can be utilized by public and private entities to improve the safety, quality, effectiveness and efficiency of health care. AHRQ recognizes that rural and small community hospitals, clinics, and other components of these health care settings often face unique challenges in terms of knowledge, experience, personnel, infrastructure, resources and other needs that are not addressed by traditional health services research funding opportunities. Therefore, AHRQ strongly encourages researchers with experience in working with rural or small underserved communities to submit proposals focusing on issues applicable to these settings. For proposals that are not focused on rural or small community settings, AHRQ encourages proposals that will generate knowledge, tools, or other end-products that are applicable across multiple health care settings. Strategies for the dissemination of knowledge, tools, or other end-products that may result from the research should be discussed in the proposal and not simply limited to presentations at academic meetings or publications in peer- reviewed journals. AHRQ is interested in broader mechanisms of disseminating research findings, tools, or other end-products to a wide range of potential end-users. The Principal Investigator and at least one key program staff member from the project are required to attend two annual grantee meetings in the Washington D.C. area. Travel to these annual meetings should be included in the project’s budget. AHRQ is committed to supporting public-private partnerships that will result in interoperable, standards-based data sharing across multiple care sites and lead to measurable, generalizable and sustainable improvements in patient safety and quality of care. Where applicable, investigators are encouraged to comply with Federal health information interoperability standards that have been adopted by the Federal Government’s Consolidated Health Informatics (CHI) Initiative. CHI is a collaborative effort between the Department of Health and Human Services, the Veterans Affairs/Veterans Health Administration, the Department of Defense, and other Federal agencies to adopt government-wide health information standards. The first set of CHI standards were announced on March 21, 2003 and include: Health Level 7 (HL7) messaging standards; Logical Observation Identifier Name Codes (LOINC) to standardize the electronic exchange of clinical laboratory results; National Council on Prescription Drug Programs (NCDCP) standards for retail pharmacy transactions; Institute of Electrical and Electronics Engineers 1073 (IEEE1073) standards that allow for health care providers to plug medical devices into information and computer systems; Digital Imaging Communications in Medicine (DICOM) standards that enable retrieval and transfer of images and associated diagnostic information. More information on CHI can be found at: http://www.whitehouse.gov/omb/egov/gtob/health_informatics.htm Projects funded under this RFA are considered part of the AHRQ HIT portfolio. As part of its FY 2004 HIT initiatives, AHRQ intends to establish a Health Information Technology Resource Center (HITRC). The HITRC will provide a variety of services, including coordinating the activities of awardees across all of the HIT patient safety RFAs. All awardees under this RFA are expected to participate in the activities of the HITRC, including participation in periodic conference calls and an annual meeting of all awardees in the Washington, D.C. area. When appropriate and feasible, AHRQ expects awardees to work with each other to identify collaborative opportunities that can contribute to the overall success of their projects and the overall success of AHRQ’s HIT and patient safety initiatives. These collaborative relationships may be facilitated through the HITRC, initiated by the awardees through self-identified opportunities, or developed via other mechanisms during the life of the project. RAND is under contract to AHRQ to serve as its Patient Safety Evaluation Center. RAND’s evaluation contract activity is not intended to evaluate the specific performance of individual patient safety projects but rather to provide an objective, comprehensive, and longitudinal view of AHRQ’s patient safety initiatives. This work is being accomplished by characterizing AHRQ’s (1) progress in achieving its goals, (2) effects of patient safety interventions undertaken within the patient safety initiative on important health-related outcomes, and (3) diffusion of new knowledge and practices beyond patient safety initiative participants. The RAND team will conduct interviews with the principal investigators and other key personnel that are responsible for each of the patient safety grants and will conduct occasional site visits to learn more about new interventions and tools being developed and implemented. Agreeing to full cooperation with the RAND evaluation team is a requirement (prerequisite) for receiving AHRQ patient safety grant support. PRIORITY POPULATIONS The Healthcare Research and Quality Act of 1999 (http://www.ahrq.gov/hrqa99a.htm) reauthorized AHRQ and directed the Agency, in carrying out its mission, to conduct and support research and evaluations, and to support demonstration projects, with respect to the delivery of health care in inner-city and rural areas (including frontier areas); and health care for priority populations, which include low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. To implement this directive, AHRQ published a notice in the NIH Guide on February 28, 2003, establishing a new Agency policy on the Inclusion of Priority Populations in health services research (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). Applicants under this RFA who seek funding from AHRQ should address the requirements of including priority populations as specified in the Notice. PUBLICATION TRANSMITTAL: GENERAL AHRQ REQUIREMENTS In keeping with the Agency’s efforts to translate the results of AHRQ-funded research into practice and policy, grantees and/or contractors are to inform the Office of Communications and Knowledge Transfer (OCKT) when articles from their studies are accepted for publication in the professional literature. Grantees and contractors 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, healthcare systems, purchasers and policymakers. This is critical when outreach to the general and trade press is involved. Contact with the media will take place in close coordination with OCKT and the press offices of the grantee’s or contractor’s institutions. In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees and contractors 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, electronic dissemination, and outreach to the media. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions regarding scientific/research issues, including information on the inclusion of women, minorities, and children in study populations to: Eduardo Ortiz, M.D., M.P.H. Senior Advisor for Clinical Informatics Center for Primary Care, Prevention, and Clinical Partnerships Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Telephone: (301) 427-1585 FAX: (301) 427-1597 Email: EORTIZ@AHRQ.GOV Valerie Florance, Ph.D. Program Officer Program Management Branch National Library of Medicine 6705 Rockledge Drive, Suite 301 Bethesda, MD 20892 Telephone: (301) 594-4882 FAX: (301) 402-2952 EMAIL: floranv@mail.nlm.nih.gov o Direct your questions about peer review issues to: Patricia Thompson Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Telephone: (301) 427-1556 FAX: (301) 427-1562 Email: pthompso@ahrq.gov o Direct your questions about financial or grant management matters to: George Gardner Grants Management Specialist Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Telephone: (301) 427-1453 FAX: (301) 427-1462 Email: ggardner@AHRQ.gov Dwight Mowery Extramural Programs National Library of Medicine Rockledge 1, Suite 301, 6705 Rockledge Drive Bethesda, MD 20892 Telephone: (301) 496-4221 FAX: (301) 402-0421 moweryd@mail.nlm.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows AHRQ staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Eduardo Ortiz, M.D., M.P.H. Center for Primary Care, Prevention, and Clinical Partnerships Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Telephone: (301) 427-1585 FAX: (301) 427-1597 Email: EORTIZ@AHRQ.GOV SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. To ensure equity among applicants, however, applicants using the Form PHS 398 must observe page number and font size requirements specified in the form. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SUPPLEMENTARY INSTRUCTIONS: Application Preparation The following supplemental instructions to the form PHS 398 should be used to guide the preparation of the application: In the Description (page 2) indicate which specific Area (s) of Interest, as listed in the Objectives and Scope section, the proposed project intends to concentrate on. Detailed Budget. In general, allowable budget items for these projects are limited to a portion of the salaries of the project staff including the PI, consultation fees, key administrative and clerical support personnel, as allowable under the appropriate cost principles, telephone and IT costs, copying, mailing and other justifiable operating expenses directly related to conducting the project, travel and per diem expenses for outside consultants/advisors, and supplies. The travel and lodging expenses for up to two study representatives (PI and one other) to attend two yearly meetings in the Washington, D.C. area should be included in the budget request. Project Plan. This narrative part of the application should not exceed 25 pages and must contain the following elements: Section I. Area of Interest 1. Describe the proposed area of interest as referenced in the Objectives and Scope section of this RFA. 2. Describe the PI’s previous experience in this area. 3. Describe the importance and potential use of the knowledge, evidence, model, tool or other products that will result from this effort. 4. Discuss how this project will add to current knowledge/understanding in this area. 5. Provide a set of long-term outcome goals and explicitly state how the project will support the achievement of these goals. For example, AHRQ’s long-term goals for the FY2004 HIT initiative include the following: - Support the successful deployment of hospital HIT practices that reduce medical errors and improve patient safety. - Increase the identification and reporting of medical errors and adverse events. - Decrease the number of actual errors and adverse events. - Increase the number of hospitals utilizing EHRs and CPOE with CDSS to reduce medication errors. - Increase the number of non-hospital providers utilizing EHRs and CPOE with CDSS. 6. The application must also address how the applicant will monitor their progress toward the goal(s) they specify and how those goals further the accomplishment of the agency’s goals. Section II. Proposed Study 1. Detailed description of the project design and methodology. 2. Description of the project’s objectives and outcomes. 3. Description of how the project’s success will be evaluated, including specific measures to determine success. 4. Describe the stakeholders and health care settings that will be involved, including the rationale for their selection. 5. Describe the project’s timelines, including critical milestones. 6. Description of the PI’s involvement and responsibility with the study, along with other key co-investigators. 7. Description of institutional support for the project, including support from key partners. Letters of support or memorandums of understanding, if applicable, should be referenced. 8. If the project involves collaboration with a vendor or other commercial company, the relationship should be described, including a letter from the commercial partner indicating the partner’s level of commitment to the project. Applicants are encouraged to make use of AHRQ’s Healthcare Cost and Utilization Program (HCUP). The HCUP includes databases covering 1988-1999. These databases were created through a Federal and State industry partnership to build a multi-State healthcare data system. The main HCUP databases contain discharge-level information for inpatient hospital stays in a uniform format with privacy protections. The Nationwide Inpatient Sample (NIS) is a nationwide probability sample of about 1000 hospitals. The State Inpatient Databases (SID) contain inpatient records for all community hospitals in 22 States. Other HCUP databases contain ambulatory surgery data from nine States. These databases can be directly linked to county-level data from the Health Resources and Services Administration’s Area Resource File and to hospital- level data from the Annual Survey of the American Hospital Association. This does not preclude the use of secondary data sources or primary data collection. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS AHRQ is not using the Modular Grant Application and Award Process. Applicants for funding from AHRQ should ignore application instructions concerning the Modular Grant Application and Award Process and prepare applications according to instructions provided in form PHS 398. Applications submitted in the Modular format will be returned without review. SENDING AN APPLICATION TO THE NIH and AHRQ: Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 (20817 for express/courier service) At the time of submission, two additional copies of the application must also be sent to: Eduardo Ortiz, M.D., M.P.H. Center for Primary Care, Prevention, and Clinical Partnerships Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Telephone: (301) 427-1585 FAX: (301) 427-1597 Email: EORTIZ@AHRQ.GOV APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. However, when a previously unfunded application, which was originally submitted as an investigator-initiated application, is submitted in response to an RFA, it must be prepared and submitted as a NEW application. That is, the application for the RFA must not include an Introduction section describing the changes and improvements made to the previously unfunded application, and the text must not be marked to indicate changes in response to the reviewers. While the investigator may obviously still benefit from the previous review, the RFA application must be submitted as a NEW application and should not discuss the reviewers comments or changes made by the Principal Investigator to address the reviewers concerns. Although there is no immediate acknowledgment of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. Applicants are encouraged to read all PHS Forms 398 instructions prior to preparing an application in response to this RFA. The PHS 398 type size requirements (p.6) will be enforced rigorously and non-compliant applications will be returned. It is very important to note that limitations on number of pages and size of font must be observed; applications violating these requirements will be returned without review. Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an AHRQ application. The AHRQ Revised Policy for IRB Review of Human Subjects Protocols in Grant Applications was published in the NIH Guide on September 27, 2000 (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). The RFA is also available on AHRQ’s Web site at: http://www.AHRQ.gov, (click on Funding Opportunities) Application Preparation (for Using CMS Data) Purchase of 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. In consultation with the Center for Medicare and Medicaid Services (CMS), previously called the Health Care Financing Administration (HCFA), AHRQ will use this information to develop a cost estimate for obtaining the data. 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 AHRQ’s confidentiality statue, 42 USC 299c-3(c), the Privacy rules at 45 CFR Parts 160 and 164, if applicable, and standards set out in OMB Circular A-130, Appendix III Security of Federal Automated Information Systems. The use of the data will be restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee will be required to return the data to CMS or certify that the data have been destroyed. Unless AHRQ is able to negotiate exceptional arrangements included in the DUA, the User is required to submit a copy of all findings within 30 days of making such findings to CMS, for the sole purpose of assuring CMS that data confidentiality is maintained. The User further agrees not to submit these findings to any third party (including, but not limited to, any manuscript to be submitted for publication) until receiving CMS’s approval to do so. In developing research plans, applicants should allow time for refining, obtaining approval, and processing of their CMS data requests. Requests may take 6 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 INQUIRIES. 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 are to 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. To receive an award, applicants must agree to submit an original and 2 copies of an abstract, executive summary, and full report of the research results in the format prescribed by AHRQ no later than 90 days after the end of the project period. The executive summary should be sent at the same time on a computer disk which specifies on the label the format used (Word Perfect, or Word, or ASCII format). The past cooperation of applicants with regard to the submissions described in this section may be considered by AHRQ to assess applicants potential for responsible stewardship of awarded funds. TECHNICAL ASSISTANCE AHRQ encourages applicants to take advantage of a technical assistance conference call sponsored by AHRQ program staff. This conference call will provide interested potential applicants with background information and response to questions about the preparation of an application in response to this RFA. Participants are encouraged to submit questions via email prior to the conference call. Please submit up to five questions with your name and the name of your institution to HITValueRFA@AHRQ.gov by January 13, 2004. Questions of a similar topic and nature may be grouped at the sole discretion of AHRQ staff. The conference call is open to any individual or organization intending to apply. Participation is not a prerequisite to applying. The conference call will take place on January 15, 2004 at 1:00 Eastern Standard Time. To register to participate in the call, please send your request to: HITValueRFA@AHRQ.gov by January 13, 2004. Transcripts of the conference call will be available seven business days after the call. Please send your request for a copy of the transcripts to HITValueRFA@AHRQ.gov. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness and responsiveness to the RFA. Incomplete and/or non-responsive applications or applications not following instructions given in this RFA will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an AHRQ Special Emphasis Panel (SEP) in accordance with standard AHRQ peer review procedures. As part of the merit review, all applications will: o Undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score o Receive a written critique o Receive a second level review from an appropriate national advisory council or board. REVIEW CRITERIA In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment o Budget The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. The application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does the study address an important problem outlined in this RFA? If the aims of your application are achieved, is the proposed work likely to result in accelerated adoption, diffusion and utilization of HIT? Will it improve the safety and quality of health care? Will the project provide clinicians, patients, payers, policymakers, or other important stakeholders with evidence, models, or other tools that will add to the understanding of the value of HIT? (2) APPROACH: Are the conceptual framework, design, methods, interventions, measures, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the application acknowledge and address potential problem areas and consider alternative strategies and tactics? Where applicable, are the needs of rural and small communities being addressed? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or propose to develop new methodologies, technologies, models, or tools? Where applicable, will the proposed work increase knowledge and facilitate the advancement of HIT in rural and small communities? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your level of experience as the principal investigator and to that of the other researchers? Does the proposed study team reflect an appropriate array of knowledge and skills needed to successfully accomplish the aims of the project? Is the time commitment of the principal investigator and co-investigators reasonable and sufficient to accomplish the aims of the project? Are roles of the investigators clearly delineated? (5) ENVIRONMENT: Does the environment in which the work will be conducted contribute to the likelihood of success? Is there evidence of institutional support? Are there any plans for working collaboratively with other provider organizations, health care purchasing groups, HIT developers/vendors, State or local governments, professional organizations, advocacy groups, or other entities that can enhance the probability of success? (6) BUDGET: Is the proposed budget and the requested period of support reasonable in relation to the proposed research? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to address the need of both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the aims of the project. Adequacy of attention to other populations of special priority to AHRQ (see discussion on Priority Populations in the section on Special Requirements, above, and Inclusion Criteria included in the section on Agency Policies and Requirements, below.) Finally, peer reviewers will be asked to specifically comment in these two areas: 1) technical merit of the proposed project; and 2) potential for any knowledge, models, tools or other end-products resulting from the project to be useful to health care decision makers and stakeholders. The final priority scores will reflect the peer reviewers overall assessments based on their judgments of these two areas as well as the other review criteria described above. 1. In evaluating the technical merit of the proposed project, peer reviewers will consider: - Clarity and appropriateness of the project’s goals and objectives. - Extent to which the application defines a problem or knowledge deficit that needs to be addressed. - Extent to which the proposed project has clear and unambiguous goals consistent with AHRQ’s stated goals. - Quality of the research and evaluation methodology, including the appropriateness of the outcome metrics used to gauge the project’s success. - Qualifications of the PI to lead the project, including his/her expertise in the subject area and his/her research, leadership and administrative skills. - Qualifications, appropriateness, and contributions of key project personnel. 2. The potential for knowledge, models, tools or other end-products resulting from the project to be useful to health care decision makers and stakeholders. - Identification of the target audiences to be impacted by the end-products. - Clear description of the knowledge, models, tools, or other end-products that will be generated from the project. - The utility of these end-products to populations or health care settings beyond the study sites and the ability of an awardee to develop and disseminate these end-products in a timely manner. ADDITIONAL REVIEW CONSIDERATIONS DATA SHARING: Data Confidentiality Pursuant to section 924(c) of the Public Health Service Act (42 USC 299c- 3(c)), information obtained in the course of any AHRQ supported-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data. There are now civil monetary penalties for violation of this confidentiality statute. [42 U.S.C.299c-3(d)) In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected. The description of the procedures should include a discussion of who will be permitted access to the information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by grantees under this RFA will also be managed in accordance with 42 CFR Parts 160 and 164, Federal regulations pertaining to the privacy of protected health information. These privacy regulations, developed by the Department of Health and Human Services pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA), became mandatory for covered entities on April 14, 2003. These regulations serve to limit the disclosure of personally identifiable patient information by covered entities and define when and how such information can be disclosed (e.g., to researchers). Thus, for example, health care plans, clearinghouses, and providers who engage in HIPAA-covered electronic transactions will require either patient authorization of disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations) upon being satisfied that any identifiable health information will be appropriately safeguarded by the investigators. Additional information about the regulations, their implementation, and alternative methods for permissible disclosures to researchers (limited data sets with data use agreements, de-identified data sets, data about deceased persons, and data use to develop research protocols) can be obtained from: http://www.aspe.hhs.gov/admnsimp or http://www.hhs.gov/ocr/hipaa/. The awardees should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds those established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) have published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application. Rights in Data AHRQ grantees may copyright, unless otherwise provided in grant awards, or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHRQ funds. Such copyrights and patents are subject to a worldwide irrevocable Federal government license to use and permit others to use these products and materials for government purposes. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers; and subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents, if such distribution would significantly increase access to a product and thereby produce substantial of valuable public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products. AHRQ's Office of Communication and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate these issuances with other AHRQ dissemination activities. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in the AHRQ's grants regulation at 42 CFR Part 67, Subpart A (Available in libraries and from the GPO's website (http://www.gpoaccess.gov/cfr/index.html). RECEIPT AND REVIEW SCHEDULE Technical Assistance Call: January 15, 2004 Letter of Intent Receipt Date: February 6, 2004 Application Receipt Date: April 22, 2004 Earliest Anticipated Start Date: September 30, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS: It is the policy of AHRQ that women and members of minority groups and their sub-populations are included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/not-od-00-048.html). A complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. To the extent possible, AHRQ requires adherence to these NIH Guidelines. Investigators may obtain copies from the above sources or from the AHRQ Publications Clearinghouse, listed under INQUIRIES, or from the NIH Guide Web site http://grants.nih.gov/grants/guide/index.html. AHRQ Program staff may also provide additional information concerning these policies (see INQUIRIES). AHRQ also encourages investigators to consider including children in study populations, as appropriate. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some 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) may be accessed through FOIA. If no Federal act is taken, having the force and effect of law, in reliance upon an AHRQ-supported research project, the underlying data is not subject to this disclosure requirement. Furthermore, even if a Federal regulation action is taken in reliance on AHRQ-supported data under FOIA, 5 USC 552(b), disclosure of statutorily protected confidential identifiable data from such study is exempted from disclosure under "the (b)(3) exemption." It is important for applicants to understand the scope of this requirement and its limited potential impact on data collected with AHRQ support. Proprietary data might also be exempted from FOIA disclosure requirements under "the (b)(4) exemption", for example, if it constituted trade secrets or commercial information collected. NIH has provided general related guidance at http://grants.nih.gov/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 RFA in a public archive, which can provide protections for the data (e.g., as required by the confidentiality statute applicable to AHRQ supported projects, 42 U.S.C. 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued the last modification the "Standards for Privacy of Individually Identifiable Health Information", was mandated by the "Privacy Rule," on August 14, 2002. This regulation was mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 which governs the protection of individually identifiable health information. It is administered and enforced by the DHHS Office for Civil Rights (OCR). Mandatory compliance with the Privacy Rule (for those classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with covered entities. The OCR website (http://www.hhs.gov/ocr/) 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 of a covered entity. Project Officers will assist grantees in resolving questions about the applicability of HIPAA requirements. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," 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 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance, Number 93.226. Awards are made under Title IX of the Public Health Service Act (42 USC 299-299c-7) as amended by P.L. 106-129 (1999). Awards are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 or 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. REFERENCES 1. Kohn LT, Corrigan JM, Donaldson MS, Eds. To err is human: building a safer health system. Washington, D.C. National Academy Press, 1999. 2. Corrigan JM, Donaldson MS, Kohn LT, Eds. Crossing the quality chasm: a new health system for the 21st century. Washington, D.C. National Academy Press, 2001. 3. Evans RS, Classen DC, Pestotnik SL, Clemmer TP, Weaver LK, Burke JP. A decision support tool for antibiotic therapy. In: Gardner RM, ed. Proceedings from the Nineteenth Annual Symposium on Computer Applications in Medical Care. Philadelphia, PA: Hanley and Belfus; 1995:651-55. 4. Evans RS, Pestotnik SL, Classen DC, Clemmer TP, Weaver LK, Orme JF, et al. A computer-assisted management program for antibiotics and other antiinfective agents. N Engl J Med. 1998;338:232-38. 5. Overhage JM, Tierney WM, Zhou XH, McDonald CJ. A randomized trial of corollary orders to prevent errors of omission. JAMIA. 1997;4:364-75. 6. Bates DW, Leape LL, Cullen DJ, Laird N, Peterson LA, Teich JM, et al. Effect of computerized physician order entry and a team intervention on prevention of serious medication errors. JAMA. 1998;280:1311-16. 7. Hunt DL, Haynes RB, Hanna SE, Smith K. Effects of computer-based clinical decision support systems on physician performance and patient outcomes. JAMA. 1998;280:1339-45. 8. Center for Information Technology Leadership. The Value of Computerized Provider Order Entry in Ambulatory Settings. March 2003.

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