DEVELOPMENTAL CENTERS FOR EVALUATION & RESEARCH IN PATIENT SAFETY Release Date: November 8, 2000 RFA: HS-01-007 Agency for Healthcare Research and Quality (formerly AHCPR) Letter of Intent Receipt Date: January 3, 2001 Application Receipt Date: January 24, 2001 PURPOSE The Agency for Healthcare Research and Quality (AHRQ) announces the availability of Exploratory Grants (P20) for up to three years to assist the advancement of approximately 10 Developmental Centers for Evaluation and Research in Patient Safety (DCERPS). These developmental grants include planning for activities that will enhance the capacity to conduct quality research and translate research findings into practice. Along with the planning activities, each DCERPS will be required to perform a pilot study in the subsequent years of funding. Each grant will support the development of a DCERPS-specific plan for growth in three key areas during Phase I: (1) multi- disciplinary team building to conduct fundamental research on patient safety, (2) ties to delivery systems for research (e.g., formal data sharing agreements) and demonstrations to enhance patient safety, and (3) educational programs on the importance of patient safety and evidence based mechanisms to improve it. It is anticipated that after completion of these planning objectives in Phase I, recipient organizations will be in a position to perform their own pilot study and propose means by which to disseminate those results appropriately in Phase II. It is anticipated that after successful completion of these developmental grants, recipient DCERPS will be in a position to submit competitive research applications to AHRQ and other patient safety funding entities. The long-term goal of the overall initiative is to improve the nation's capacity in patient safety research, to expand the patient safety knowledge base, and to establish mechanisms to assure that new knowledge is incorporated into actual practice and its impact is assessed. This Request for Applications (RFA) is one in a series of research solicitations to be issued by AHRQ over the next several months. They form an integrated set of activities to design and test best practices for reducing errors in multiple settings of care, develop the science base to inform these efforts, improve provider education to reduce errors, capitalize on the advances in information technology to translate proven effective strategies into widespread practice, and build the capacity to further reduce errors. At the heart of this competitive demonstration program is a portfolio of projects to test the effectiveness, costs, and cost-effectiveness of diverse reporting strategies and information technology innovation on the identification, management, and reduction of medical errors. These activities are supported and amplified by: 1) the establishment of multidisciplinary centers of excellence in patient safety; 2) targeted efforts to understand the impact of provider education, skills, staffing, and organization on error rates; 3) partnerships with health systems, professional organizations, states, and other groups to build capacity for error reduction activities, disseminate effective strategies, and coordinate public and private efforts; and 4) cross cutting activities that capitalize on data already collected by the Federal government which can be enhanced to support research and action in patient safety. RFAs to be released as part of this program include: 1) Health System Error Reporting, Analysis, and Safety Improvement Demonstrations -- to support large demonstrations in States, health care systems, and networks of providers (both integrated delivery systems and primary care networks) to test reporting strategies and patient safety interventions. 2) Clinical Informatics to Promote Patient Safety (CLIPS) -- to develop and test the use of appropriate technologies to reduce medical errors, such as hand-held electronic medication and specimen management systems and prescription pads, training simulators for medical education, bar-coding of prescription drugs, patient bracelets, and automated dispensing of medication in a hospital setting. 3) Centers of Excellence for Patient Safety Research and Practice -- to support established cross-cutting teams of researchers and health care facilities and organizations in geographically diverse locations (including rural and urban areas) which will determine the causes of medical errors, develop new knowledge to support the work of the demonstrations. 4) Developmental Centers for Evaluation and Research in Patient Safety (DCERPS) -- to develop new multidisciplinary research teams to improve the nation's capacity in patient safety research, to expand the patient safety knowledge base, and to establish mechanisms to assure that new knowledge is incorporated into actual practice and that its impact is assessed. 5) Effect of Working Conditions on Patient Safety -- to develop an understanding of how the environment of care impacts the ability of providers to improve safety (e.g. the effect of fatigue, stress, sleep deprivation, and shift work on cognitive ability and the relationship to patient safety) and how interactions with the built environment impact the provision of safe care. 6) Patient Safety Research Dissemination and Education -- to fund researchers and organizations (e.g., professional associations, hospital groups, national organizations) to develop, demonstrate, and evaluate new approaches to improving provider education in order to reduce errors, such as taking new knowledge on patient safety and developing curricula, continuing education, simulation models, and other provider training strategies. Additional components of the Agency's patient safety initiative will build on existing Agency programs. AHRQ will also support a coordinating center to provide guidance and facilitate interaction among the entities funded under the Agency's patient safety programs. The coordinating center will not be one of the funded DCERPS, but rather a separate entity under contract with AHRQ. The coordinating center will assure translation of the new knowledge from the research centers and informatics projects to the demonstration sites. The coordinating center will also provide general guidance to the DCERPS and facilitate communication among them and organize meetings of the DCERPS and other components supported under the Agency's patient safety research initiative, including the Centers of Excellence for Patient Safety Research and Practice. Research themes under this RFA and others to be released by the Agency will be generated by a variety of activities including public and private sector national summits and research agenda-setting activities on medical errors and patient safety, as well as key stakeholder meetings. Research themes will also be the outgrowth of ongoing activities of the Quality Interagency Coordination Task Force (QuIC) and its report to the President -- Doing What Counts for Patient Safety - Federal Actions to Reduce Medical Errors and Their Impact (http://www.quic.gov). In carrying out its responsibilities, the National Forum for Health Care Quality Measurement and Reporting may also influence themes for this research initiative. The Agency sponsored a National Summit on Medical Errors and Patient Safety Research on September 11, 2000. Findings from the Summit will also contribute to the research themes. A research summary of the summit is already available on the following web address B http://www.quic.gov/summit/resagenda.htm. Definitions For the purpose of this RFA, the goal of the DCERPS is to build capacity and knowledge-sharing such that research supported by this RFA as well as future research endeavors may concentrate on six major areas: (1) determining how to learn most effectively from medical errors and then communicate that information to patients and families; (2) developing and understanding the epidemiology of medical errors in a variety of settings, levels of care, and patient populations; (3) understanding the impact of systems, cultures, and education in reducing medical errors and improving patient safety; (4) describing the role of informatics in improving clinical decision- making, reducing errors, and advancing patient safety; (5) examining reporting mechanisms by studying the content, detail, level of confidentiality, analytical expertise, and the feedback strategies that promote quality improvement as it relates to patient safety; (6) determining the appropriate role(s) for patients and families in reducing medical errors. For the purpose of this document, medical error is defined as the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. Errors can include problems in practice, products, procedures, and systems. The term patient safety as used here applies to initiatives designed to prevent adverse outcomes from medical errors. The enhancement of patient safety encompasses three complementary activities: preventing errors, making errors visible, and mitigating the effects of errors (Quality Interagency Coordination Task Force, 2000). 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/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, public or private nonprofit organizations, including universities, clinics, units of State and local governments, and eligible agencies of the Federal government. Applications may include foreign components, but foreign organizations are not eligible to apply. For the purpose of this RFA, AHRQ, will make grants only to non-profit organizations; however, for-profit organizations may receive assistance through a cooperative agreement or may participate in grant projects as members of consortia or as subcontractors. Organizations described in section 501(c)4 of the Internal Revenue Code that engage in lobbying are not eligible. AHRQ encourages women, members of racial and ethnic minority groups and persons with disabilities to apply as Principal Investigators. Special preference will be accorded to applications from investigators who have not been funded by AHRQ as a Principal Investigator within the last two years. AHRQ also encourages minority institutions to apply for funding under this solicitation, and encourages collaboration on projects between minority institutions and non-minority institutions. Minority institutions have had a significant role in delivering health care to under-served communities and represent a valuable resource to facilitate collaboration with those communities, while non-minority institutions often bring greater research experience on quality of care improvement strategies. AHRQ's recent reauthorization, the Health Care Research and Quality Act of 1999, directed AHRQ to focus more extensively on a number of priority areas and populations: inner-city areas; rural areas, including frontier areas; 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 strongly encourages DCERPS to include a focus on one or more of these areas and populations as they develop capacity to conduct research in medical errors and patient safety. MECHANISM OF SUPPORT Projects supported under this initiative will use the Exploratory Grant (P20) mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The AHRQ-supported coordinating center will facilitate the sharing of ideas and encourage collaborations among recipient DCERPS. The total project period for an application submitted in response to this RFA may not exceed three years. The earliest possible award date is August 30, 2001. It is anticipated that after successful completion of these exploratory grants, recipient DCERPS will be in a position to submit competitive research applications to AHRQ and other funding entities. Note that the scope of this initiative and the capacity-building aspects of the P20 allow new investigators and institutions to be drawn together to work collaboratively with a team of experienced researchers. AHRQ particularly encourages collaboration with researchers from Historically Black Colleges and Universities, Hispanic Serving Institutions, and other minority and minority serving institutions. Information on minority institutions is available at http://www.galaxy.com/hytelnet/OTH023.html. This is a one time solicitation. AHRQ has not determined whether or how this solicitation will be continued beyond this present initiative. FUNDS AVAILABLE AHRQ expects to award up to $2.0 million in total costs (i.e., including facilities and administration costs) in fiscal year 2001 to support approximately ten P20s selected under this initiative. Annual budgets near $200,000 are suggested. AHRQ will also set-aside approximately $600,000 of the $2.0 million to support approximately three projects which collaborate directly with researchers from Historically Black Colleges and Universities, Hispanic Serving Institutions, and other minority and minority serving institutions. Applicants may request up to three years of support. The actual number of applications funded is dependent on the number of high quality applications. Representatives of recipient DCERPS will meet with AHRQ-supported coordinating center staff as many as two times during the first year. Budget requests should therefore include travel expenses for that purpose. Although the financial plans of AHRQ provide for this program, awards pursuant to this RFA are contingent upon the availability of funds. RESEARCH OBJECTIVES Background AHRQ has an ongoing focus on issues dealing with improved patient care and some of the Agency's previously funded research has revolved around medical error. Furthermore, in December 1999, AHRQ issued an RFA (HS-00-007) that focused on systems-related best practices to improve patient safety. In particular, the RFA's purpose was to test the effectiveness of the transfer and application of best practices to improve patient safety through the reduction of preventable systems-related medical errors with high prevalence and severe consequences. In late 1999, AHRQ's reauthorization language specifically directed the Agency to conduct and support research and build public-private partnerships to (1) identify the causes of preventable health care errors and patient injury in health care delivery; (2) develop, demonstrate, and evaluate strategies for reducing errors and improving patient safety; and (3) disseminate such effective strategies throughout the health care industry. Researching the causes and cures for medical error is a targeted response to the challenge of delivering the right care to the right patient at the right time in the right way, which has been exacerbated appreciably by modern medicine's complexities. These complexities include sophisticated treatment technology; an explosion of available medications and therapeutic agents (often with narrow margins of effectiveness and safety); and the changing settings in which complex care is delivered. One researcher notes that "error in medicine is real and common" (Leape, et al, 1998), and a reporter notes that ".... we commit thousands of errors every week nationally" (Gerlin, 1999). A recent report by the Institute of Medicine (IOM) synthesized the available evidence on patient safety and noted that medical errors are a leading cause of death and injury (Kohn et al, 1999). When the President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry presented its Final Report to the President of the United States [Quality First: Better Health Care for All Americans (1998)], reduction of medical errors was listed as one of its top priorities. The Institute of Medicine report on medical errors and patient safety called for "a comprehensive and strong response to this most urgent issue facing the American people" (Kohn, et al, 1999). This was followed by the report to the President, "Doing What Counts for Patient Safety, Federal Action to Reduce Medical Errors and Their Impact," which laid out a road map for action including more than 100 activities. This plan addresses issues such as national focus and leadership, identifying and learning from errors, setting performance standards and expectations for safety, building public and purchaser awareness, working with providers, using decision-support systems and information technologies, using standardized procedures, addressing and strengthening standards, and integrating data for reporting and analysis (Quality Interagency Coordination Task Force, 2000). The development of DCERPS is important for two reasons. First, DCERPS will help broaden the capacity for research with respect to patient safety. Second, DCERPS are more likely to develop solutions from unexpected sources as part of the innovative thinking that builds on new collaboration among disciplines (e.g., human factors psychology and systems engineering). The development of these new DCERPS relies on three main factors B (1) a multidisciplinary team, (2) direct ties to a medical delivery system (e.g., formal data sharing agreements), and (3) patient safety education programs. Because solving patient safety issues involves understanding the complete process surrounding the medical error, traditional medical staff disciplines are not sufficient alone. Rather, disciplines which have not necessarily worked together as research teams are likely to be more effective at identifying and developing appropriate interventions. These "new" health care research disciplines utilize expertise from human factor psychology, organizational management, and other fields that have already concentrated on significantly reducing errors (e.g., aviation and manufacturing). Combining traditional medical staff expertise with that gained from the "new" health care research disciplines ensures that the research team will not only understand the environment in which the medical error occurs but also the proper method by which to alleviate environmental stresses (e.g., time pressured atmosphere, routine exchanges of complex information) which impede patient safety. Resolving the issues related to patient safety requires an understanding of the interface between the patient and the medical staff. Within that interface is both the relationship of the patient to the health care system and the relationship to the medical staff. In examining the relationship of the patient to the medical staff, it is important to understand what information should be given to patients when an error occurs, in what manner that information should be conveyed, and in what timeframe the information exchange should occur. In the absence of a medical error, patients still need to be informed about patient safety issues and included within the patient safety debate in an appropriate manner. Thus, we need to examine ways in which to define the patient's role in reducing medical errors. Furthermore, any research team concentrating on patient safety issues should have a direct tie to a delivery system or organization. Not only will the delivery system or organization provide a means by which to understand the current patient safety issues, but it will also provide a medium by which to implement various strategies to test for their effectiveness and potential generalizability. SPECIAL REQUIREMENTS Each DCERPS funded by AHRQ will be expected to develop, by the first twelve months, a detailed plan for team growth specific to its current state of development. Team growth is the development of a working research team and of its coordination ties with the delivery system. Team growth may include recruitment of individuals for particular purposes, depending on the desired pilot study during Phase II, or even the establishment of goals and objectives for the current and future research team as a first step to designing an effective pilot study. At the same time, AHRQ recognizes that the power of individual teams to study health care events can be multiplied through regular communication and research collaborations among DCERPS. To encourage such collaborations and to assure the sharing of ideas across DCERPS during this planning phase (Phase I), an AHRQ-supported coordinating center will provide guidance to the DCERPS in their planning activities. In addition to hosting conference calls and list-serve discussions, the coordinating center will convene up to 2 meetings of representatives of recipient DCERPS during the first year of funding. After the approximately one year planning period (Phase I), each DCERPS will have a site visit conducted by staff from the coordinating center and AHRQ to serve as a consultative visit to aid recipient DCERPS in their design and completion of a pilot study. Each DCERPS will be expected to design and execute one small pilot study spanning one to two years that will demonstrate the team's ability to carry out a patient safety research project. Completion of the pilot study will demonstrate the DCERPS ability to conduct multidisciplinary research and prepare for future applications for research funding from AHRQ and other funding entities. Potential pilot study projects are intended to be small scale research designs that focus on at least one of four areas: learning from errors and communicating that information, epidemiology of errors, systems and cultures, and informatics. Each pilot study project design must also develop an appropriate plan for dissemination of the project findings. (1) Learning from Errors and Communicating that Information. In particular, AHRQ is interested in the answer to the following questions: What are the critical data components for reporting errors and close calls (close call are errors that do not result in harm or injury) that enable most effective learning? What are the most effective and efficient models and techniques for collecting and analyzing error and close call data? What are the most effective formats for reporting information on errors and close calls, and what are the impacts of different reporting and dissemination approaches? What effective methods are available for providing the necessary information about the error and close call data while still maintaining a high level of confidentiality? What are the most effective models for dissemination of information on medical errors and close calls? What are the most effective methods for educating clinicians about the patient safety issues and means by which to maintain quality improvement initiatives? What are the costs associated with developing, implementing, and maintaining effective data collection, reporting, and dissemination models? How should clinicians inform patients and families about a medical error? What is the level of information that should be disclosed to patients and families? How does disclosure of error affect the doctor-patient relationship and other critical factors within health care? How can the health system inform all patients about the medical error risks? What information about medical error/health care quality is most valuable to the patient and family as they make health care decisions? How can the health care system encourage patients to make decisions based on quality? What role can the patient and family play in determining the level of medical errors? (2) Epidemiology of Errors. AHRQ is interested in the following issues: What are the causes and types of medical errors and close calls among different clinical specialties and settings of care (e.g., acute, ambulatory, long term care, pre-hospital care)? What are the causes and types of medical errors in different patient populations such as by age group and racial and ethnic minority or disability status? What costs are attributed to errors by type and causation within different population groups, care settings, and clinical specialties? (3) Systems and Cultures. Questions to be addressed should include the following: What system differences impact medical error and patient safety changes? What types of culture(s) inhibit safety improvements, and what actions can be taken to address the problems? What are the barriers to implementing automated platforms and applications to reduce errors and improve safety? What types of culture(s) lead to positive behavior changes for organizations and individuals? What leadership characteristics help reduce medical error and improve patient safety, and what leadership characteristics and activities inhibit safety improvement changes? What organizational structures (e.g., staffing levels and conditions) are associated with medical error and/or its reduction? What staff reporting relationships promote medical error reduction and improved safety? What staff reporting relationships inhibit error reduction and improved safety and what actions are needed to address the problems? To what extent and how does information flow (e.g., web-based, electronic, hard copy) reduce error rates and improve patient safety? (4) Informatics. Researchable topics may include the following: What automated platforms (e.g., web-based, computerized) and applications (e.g., clinical decision support systems) most effectively reduce errors and improve safety? What, if any, errors or safety reductions are introduced with automated applications and what actions are necessary to cope with them? What are the costs of informatics solutions and what is their cost-effectiveness? Required Elements of Planning and Development Effort For up to twelve months of funding during Phase I, each DCERPS will be required to develop a plan for growth in three key areas: (1) multi- disciplinary team building to conduct fundamental research on patient safety, (2) ties to delivery systems for research and demonstrations to enhance patient safety (e.g., formal data sharing agreements), (3) educational programs on the importance of patient safety and evidenced based mechanisms to improve it, and (4) to develop a research proposal for the pilot study. The responsibility for directing the planning and development effort should be assigned to a senior level person familiar with patient safety research and competent in administration. This person should devote a significant proportion (e.g., a maximum of 30%) of his/her time to this endeavor, and it is expected that the senior level person receive some financial institutional support. The DCERPS may also choose to have an internal planning committee to assist the planning director. The director/planning committee should evaluate the current strengths and weaknesses of the proposed team in the key identified areas and consider all available resources in the planning process. Appropriate consultants may be called upon to assist. Specific required planning activities to be accomplished with funding through the present RFA are the following (Phase I - Up to twelve months): 1) To assemble a coherent team to include the necessary components (e.g., human factor psychology, organizational processes, error reporting, etc.) of a team to address issues related to patient safety (Team members need not be located within the same institution or geographic areas.); 2) To cultivate a relationship with a health care delivery organization to serve with the implementation phase of research findings (e.g., formation of formal data sharing agreements); 3) To begin to form collaborative relationships with professional organizations, consumer groups, and other interested parties so that they may provide input about relevant patient safety questions (These relationships may be formed with local, State, and national groups.); 4) To devise training protocols to address any knowledge deficiencies or information asymmetry within the core research group or within support staff and others connected to the DCERPS (These training programs should be viewed as an end product for the RFA, such that the development of the training protocols involves steps for actual product development and dissemination strategies.); 5) To incorporate different settings of care, specialties, and/or patient populations within its research proposal for the pilot study; 6) To examine other systems and cultures which have been successful in error reduction strategies (e.g., aviation and manufacturing); and 7) To develop a research proposal for the pilot study. This research proposal will not be formally evaluated but will serve as a guide to the DCERPS in conducting their first minor research project. This proposal will be reviewed by staff from the AHRQ-supported coordinating center and AHRQ during the consultative site visit in Phase II. Required Elements of the Site Visit and Pilot studying Phase (Phase II): After Phase I (up to twelve months of planning activities), each DCERPS will have a consultative site visit by staff from the AHRQ-supported coordinating center and AHRQ. DCERPS will also be required to perform their own pilot study to demonstrate their ability to design and execute a patient safety research project. These pilot studies must demonstrate newly-established collaborative efforts between two or more groups of investigators. The P20 application should contain up to but no more than three, three-page examples of possible pilot studies. These projects will not be reviewed as traditional research projects and will not be reviewed by grant application peer reviewers. Rather, the proposed pilot studies will serve as an indication of the priorities to be focused on by the group, a reflection of the decision- making abilities of the scientific leadership, and the initial ability of the group to interact productively and scientifically. The proposed pilot studies should identify the direction of the DCERPS (i.e., the concentration within one of the four areas -- learning from errors and communicating that information, epidemiology of errors, systems and cultures, and informatics) as well as the specific research questions and target populations to be studied (e.g., any concentration on AHRQ's priority populations). The actual pilot studies that are implemented may not necessarily be those that are submitted with the application since processes during the planning phase may determine other projects to be more meritorious. Specific required activities to be accomplished after Phase I of the RFA include: 1) Completion of a site visit, which may include working with the reviewers to determine suggested activities or alterations required by the DCERPS to perform a pilot study; 2) Execution of a sound pilot study which will produce a project concentrating on at least one of four areas -- learning from errors and communicating that information, epidemiology of errors, systems and cultures, and informatics, deliverable by the close of the grant; 3) Presentation of the educational materials (curriculum development materials, specific handouts and information sheets from the educational programs, etc.) from the educational program to a staff member at the AHRQ- supported coordinating center and AHRQ; and 4) Development of an appropriate plan for the dissemination of the research findings. Policy Relevance and Dissemination Studies under this RFA are expected not only to contribute to our basic understanding of medical errors and patient safety but also to build capacity -- tools, talent, and teams -- to answer associated questions of applied and policy relevance and to produce information in formats useful to participants in the formulation of public policy and changing operational behavior. Applicants should be concrete in describing (1) the operational, public policy, and other audiences most interested in the supported research and (2) how applicants anticipate their results being used for applied and public policy purposes. Proposed dissemination strategies should not be limited to publication in peer-reviewed journals but may encompass a variety of approaches, such as translating results into nontechnical monographs and distributing them through associations of private and public officials; educating legislators, public administrators, health plan executives, employers, and others in seminars; and outreach to the mass media. Any outreach through the mass media should be coordinated through AHRQ's Public Affairs Office. Supported projects may require investigators from more than one institution. In addition, partnering with other entities is encouraged under this RFA. This may include public-private partnerships which could include the Veterans Administration Centers of Safety and AHRQ's seven Centers for Education on Research and Therapeutics (CERTs). The VA's Centers of Safety are learning laboratories to facilitate cross- industry knowledge and technology transfer. In addition to researching new knowledge in this area, the centers focus on disseminating existing knowledge that can be immediately used. The four VA centers that work with universities or other public and private partners in their areas are: (1) the VA Palo Alto, California Health Care System; (2) VA Health Care System of Cincinnati, Ohio; (3) the New England Healthcare System/White River Junction, Vermont; and (4) the Tampa, Florida VA Medical Center (http://www.va.gov/pressrel/99psafet.htm). AHRQ's CERTs demonstration program is intended to improve the quality of health care and reduce costs by increasing awareness of the benefits and risks of new uses or combinations of medical products and by improving the effectiveness of existing uses. AHRQ administers the program in consultation with the Food and Drug Administration (http://www.ahcpr.gov/clinic/certsovr.htm). CERTs cooperative agreements to operate the centers have been awarded to the Duke University Medical Center in Durham; the University of North Carolina, Chapel Hill; Vanderbilt University; Georgetown University Medical Center in Washington, DC; the University of Alabama at Birmingham; the University of Pennsylvania,; and Harvard Pilgrim Health Care. Duke University also includes a coordinating center for the CERTs program. The centers are conducting pilot studies using state-of-the-art clinical, laboratory, and health services research methodologies. Letters of intent to collaborate with the applicant organization signed by the appropriate institutional official from each participating organization must be included in the application. Data Privacy Pursuant to section 924(c) of the Public Health Service Act (42 USC 299c- 3(c)), information obtained in the course of any AHRQ-study that identifies an individual or entity must be treated as confidential in accordance with any promises made or implied regarding the possible uses and purposes of the data collection. In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of such identifying information. 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. The grantee 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) has 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/handbook.pdf. The application of these confidentiality and security standards to subcontractors and vendors should be addressed as necessary. Rights in Data AHRQ grantees may copyright 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 research materials, data bases, 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 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. 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.access.gpo.gov/nara/cfr/index.html). INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS It is the policy of AHRQ that women and members of minority groups be 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 are 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 Website http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html). AHRQ also encourages investigators to consider including children in study populations, as appropriate. AHRQ program staff may also provide additional information concerning these policies (see INQUIRIES). LETTER OF INTENT Prospective applicants are asked to submit, by January 3, 2001, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into consideration of any subsequent application, the information that it contains allows AHRQ staff to estimate the potential review workload and avoid conflict of interest in the review. AHRQ will not provide responses to letters of intent. The Letter of Intent is to be sent to: Lisa Krever Center for Quality Measurement and Improvement Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 502 Rockville, MD 20852-4908 Telephone (301) 594-6625 FAX: (301) 594-2155 E-mail Address: lkrever@ahrq.gov APPLICATION PROCEDURES The research grant application form PHS 398 (4/98) is to be used in applying for these planning and development grants. State and local government applicants may use PHS 5161-1, Application for Federal Assistance (rev. 5/96), and follow those requirements for copy submission. Applicants are encouraged to read all PHS 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 returned. 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. Beginning with applications for AHRQ submitted for the February 1, 2001 receipt date, Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application. The "AHRQ Revised Policy for IRB 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) All investigators proposing research involving human subjects should read this revised policy. Applications kits are available at most institutional offices of sponsored research. They may also be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, E-mail: grantsInfo@nih.gov. AHRQ applicants may also obtain application materials from the AHRQ Publications Clearinghouse (see INQUIRIES). The RFA label and line 2 of the application form PHS 398 (4/98) should both indicate the RFA number. The RFA label must be affixed to the bottom of the face page. 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 must be typed on line 2 of the face page and the YES box must be marked. The sample RFA label available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Complete and signed, typewritten original of the application, including the Checklist, and three signed, photocopies, must be submitted 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 service) At the time of submission, two additional copies of the application, labeled "Advanced Copy(s)" must also be sent to: Lisa Krever Center for Quality Measurement and Improvement Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 502 Rockville, MD 20852-4908 Telephone (301) 594-6625 FAX: (301) 594-2155 E-mail Address: lkrever@ahrq.gov Applications must be received by January 24, 2000. An application received after the deadline may be acceptable if it carries a legible proof-of-mailing date, assigned by the carrier, and the proof-of-mailing is not later than 1 week prior to the deadline date. If an application is received after that date, it will be returned to the applicant without review. Application Preparation Complete information about the proposed planning effort must be submitted with the application. The narrative portions of the DCERPS application, described below under "Research Plan," should be limited to twenty-five pages of text. The application should be a complete document that includes all essential information necessary for its evaluation. While additional explanatory material may be submitted as appendices, such appendices should not be used to bypass page limitations in the application because only selected reviewers will receive copies of the appendices. Since the form PHS 398 was developed for research grant applications, the following supplemental instructions should be used as a guide in the preparation of the application. 1) Detailed Budget. In general, allowable budget items for up to twelve months of the planning and development grants are limited to a portion of the salaries of the planning director, consultation fees, key administrative and clerical support personnel, travel and per diem expenses for outside consultants/advisors, supplies, travel and per diem expenses for the planning director and/or other key personnel to be involved in 2 meetings with the AHRQ-supported coordinating center, and other justifiable operating expenses of the planning effort. The level of effort of personnel should reflect the commitment of the individual to the planning process. For Phase I funding (i.e., up to twelve months of funding), all expenses should be tied to the enhancement of the DCERPS. No expenses should be targeted toward completing the pilot study. Allowable budget expenses for funding years beyond the planning phase include all allowable expenses for the first year as well as any required expenses to complete the pilot study, including supplies and core facilities designed to support the pilot study. Since the planning process may influence the actual development of the pilot study, the budget for the pilot study, by definition, will be projected rather than absolute. The purchase of equipment is discouraged, and any request for equipment must be well justified. For applications proposing a third year, up to 20% of the budget should be targeted toward developmental/planning activities as defined in Phase I. 2) Resources available to the DCERPS should be described once, either in a separate section following the biographical sketches or included in the narrative text (see below). 3) Research Plan. This narrative part of the application should contain the following elements: Section I. The DCERPS a) Description of the planned DCERPS. Describe the desired elements of the multi-disciplinary team, the proposed ties to a delivery system, and the potential educational programs to be developed. The description of the potential educational programs should include means by which to produce an actual product and the dissemination of that product. b) Proposed infrastructure supporting the DCERPS. Describe and discuss the existing or planned infrastructure that supports the DCERPS research effort. This discussion (which may alternatively be included in the Resources section of the application) should include details of any computer-based or other information systems currently in use (or planned) to collect and aggregate research data or communicate with clinicians. The current, or proposed, director and any network support staff should be identified, including a description of their qualifications and source of salary support (if any). If the center is affiliated with an academic department or other research unit, the relationship with that institution should be described, including a list of consultants and other resources available to the network as a result of the affiliation. Senior officials in any DCERPS-affiliated organizations(s) should provide a letter documenting support for the proposed planning and development process. These and other letters of support should be included as an appendix and referenced in this section of the application. The discussion should also include references to the existing, or proposed, mechanism for obtaining advice/feedback from the communities of patients served by the center. c) Progress to date in conducting research. Include a summary of the research completed to date by the DCERPS (if any), including sources and amounts of funding received for the research. A complete list of publications (if any) resulting from DCERPS research should be included as an appendix and referenced in this section of the application. DCERPS should describe their research goals and objectives and provide an example of specific projects their teams are interested in (and capable of) pursuing. d) Progress to date in translating research into practice. Describe any formal or informal systems or mechanisms within the DCERPS, current or planned, to disseminate the results of research to network clinicians and evaluate the impact of this information on practices. Section II. The Proposed Planning Effort a) Description of the planning director and his/her responsibilities and authority to carry out the proposed planning process for the DCERPS. Discuss the selection of this individual as planning director (equivalent of principal investigator) and his/her future role in the DCERPS. This section should present an adequate description of his/her qualifications and administrative experience. b) Description of the planning committee. If an internal planning committee is being proposed, list and discuss the membership. List any external consultants to the planning committee, including collaboration with professional organizations, consumer groups, and other interested parties on either the local, state, or national level. c) Description of other key personnel and their duties. Discuss the selection and duties of the key personnel supporting the planning director and planning committee. d) Description of issues that will need to be resolved through the planning and development process. Discuss the issues/obstacles that must be considered in the planning and development process. An example of such an issue is finding the means to combine various departments and disciplines within a single effort to effect change with respect to patient safety. e) Detailed description of the planning proposed. Include discussions of the proposed approach to planning activities for each of the items listed under the Required Elements of Planning and Development Effort. Section III. The Proposed Pilot study/studies The P20 application should contain up to but no more than three, three-page examples of possible pilot studies. Each of these examples should include: a) Title of the pilot study. b) Investigator names and areas of scientific expertise. c) Hypothesis and specific aim(s). d) Background and significance. Included in this section should be a description of the unique scientific opportunity made possible by the collaboration. e) Research design and methods. (Limit the research design and methods description to 1 page.) Workshop for Prospective Applicants AHRQ plans to convene a special technical assistance workshop to assist potential applicants. The purpose of this conference is to give background information and respond to questions about the preparation of an application in response to this RFA. The workshop will be held in Rockville, MD on December 15, 200. Attendance is not a prerequisite to applying. Attendees must pay for their own travel and accommodation costs. The workshop will be open to any individual or organization intending to apply. Attendees are encouraged to submit questions prior to the session. A synthesis of pertinent Questions and Answers discussed at the prospective applicants' meeting will be available from the AHRQ Publications Clearinghouse, listed under "Inquiries" and the agency's web page. For further information on the conference, contact Lisa Krever at the address listed above. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness and responsiveness. Incomplete and non-responsive applications 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 appropriate peer review group convened by AHRQ in accordance with the review criteria stated below. As part of the merit review, all applications will receive a written critique, and also may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. General Review Criteria Applications will be assessed in two general areas: 1) technical merit of the proposed planning process; and 2) potential of the DCERPS to enhance its capacity to conduct research and translate research findings into practice. Peer reviewers will be asked to specifically comment in these two areas. An unacceptable evaluation in either category can also be grounds for disapproval of the application. The final priority scores will reflect the peer reviewer's overall assessment based on their judgements of the two review areas. 1. The technical merit of the proposed planning process. a) Clarity and appropriateness of planning goals and objectives; b) Extent to which the application appropriately defines the problems that need to be resolved in the planning process; c) Extent to which the proposed detailed planning effort has clear and appropriate goals consistent with the stated goals of AHRQ and is of adequate scope with regard to the Areas of Focus; d) Qualifications of the proposed planning director to lead the planning and development effort and his/her leadership experience, administrative skills and research background; e) Qualifications and appropriateness of the key personnel designated to assist the planning director; f) Appropriateness of the membership and stated functions, as well as potential effectiveness, of the proposed internal planning committee (or advisors to the planning director); g) Extent to which there is strong institutional commitment from both the research center(s) and the delivery system(s) to build and maintain a DCERPS as evidenced by a commitment to provide past, current, and/or future financial support for the planning and research activities; to allow key personnel to devote time to the project; and to facilitate communication between the various entities. h) Extent to which the proposed budget for the DCERPS supports the planning and research activities while still adhering strictly to the budget criterion, i.e., ~$200,000 per year; and, i) Extent to which the proposed budget provides an appropriate time scale for the development of the DCERPS and the execution of the pilot study (i.e., the appropriateness of the decision for two years versus three years of funding). 2. The potential of the DCERPS to enhance its capacity to conduct patient safety research and translate research findings into practice. a) Adequacy of the commitment of the center to patient safety research, as evidenced by published findings from DCERPS studies or letters of support from participating individuals; b) Adequacy of the populations served by the DCERPS practices to support patient safety research, and the potential for research that includes minority and/or other AHRQ priority populations; c) Adequacy and stability of the DCERPS's administrative, organizational and management capabilities; and, d) Extent to which the award of grant funds will enhance the ability of the DCERPS to plan future activities for enhancing patient safety research and translating research findings into practice. The initial review group will also examine the appropriateness of the proposed project budget. Additional Review Criteria for Set-aside Funds: Applicants for set-aside funds should explicitly note their intent to have the application considered for those funds. In addition to the review criteria above, these applications will be evaluated on the degree to which the project demonstrates a meaningful collaboration between a minority institution and a majority institution. AWARD CRITERIA Applications will compete for available funds with all other P20 applications under this RFA. Applications deemed eligible for set-aside funds will compete with other eligible applications for set-aside funds, and if not funded, will compete with all other applications under this RFA. The following will be considered in making funding decisions: 1) quality of the proposed P20 as determined by peer review; 2) availability of funds; 3) responsiveness to the goals and objectives of the RFA; 4) relevance to the formulation of public policy; 5) appropriate targeting of proposed projects to the priorities identified at the QuIC Patient Safety Research Summit; and 6) portfolio balance, including an emphasis to develop Centers of Excellence in areas throughout the United States and attention to AHRQ's priority areas and populations. Special preference will be accorded to applications from investigators not recently (i.e., not within the past two years) or currently funded as Principal Investigator of an AHRQ grant for research on quality improvement strategies. 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 (WP5.1 or WP6.0 is preferable). Applicants must also 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 active or has ended. INQUIRIES Copies of the RFA and copies of the grant application form PHS 398 (rev. 4/98) are available from: AHRQ Publications Clearinghouse P.O. Box 8547 Silver Spring, MD 20907-8547 Telephone: 1-800-358-9295 TDD Service: 888-586-6340 This RFA is also available on AHRQ's Web site, http://www.AHRQ.gov, and through AHRQ InstantFAX at (301) 594-2800. To use InstantFAX, you must call from a facsimile (FAX) machine with a telephone handset. Follow the voice prompt to obtain a copy of the table of contents, which has the document order number (not the same as the RFA number). The RFA will be sent at the end of the ordering process. AHRQ InstantFAX operates 24 hours a day, 7 days a week. For comments or problems concerning AHRQ InstantFax, please call (301) 594- 6344. AHRQ welcomes the opportunity to clarify any issues or questions from potential applicants who have obtained and read the RFA. Written and telephone inquiries concerning this RFA are encouraged. Direct inquiries regarding programmatic issues, including issues related to the inclusion of women, minorities, and children in study populations to: Shana Christrup Center for Quality Measurement and Improvement Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 502 Rockville, MD 20852-4908 Telephone (301) 594-6673 FAX: (301) 594-2155 E-mail Address: schristrup@AHRQ.gov Direct inquiries regarding fiscal and eligibility matters to: Al Deal Grants Management Specialist Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 594-1842 FAX: (301) 594-3210 Email: adeal@ahrq.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.226. Awards are made under authorization of 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 and 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 Gerlin A. For a Systematic Problem, No Easy Fix. "Philadelphia Online"(http://health.philly.com/specials/mistakes/hosp13.asp), September 13, 1999. Kohn LT, Corrigan JM, Donaldson MS, eds. To Err is Human; Building a Safer Health System. Washington, D.C.: National Academy Press, 1999. Koop CE, An Ounce of Error Prevention. The Washington Post. Thursday, December 23, 1999; Page A21. Leape LL, Woods DD, Hatlie MJ, et al. Promoting Patient Safety by Preventing Medical Error. "Journal of the American Medical Association." 280: 1444- 1447, 1998. Quality Interagency Task Force. "Report to the President: Doing what counts for patient safety-Federal actions to reduce medical errors and their impact." February, 2000.
Return to NIH Guide Main Index
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
||||||||
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, RealPlayer, Video or Flash files, see Help Downloading Files. |