PATIENT SAFETY RESEARCH DISSEMINATION AND EDUCATION Release Date: April 23, 2001 RFA: RFA-HS-01-008 Agency for Healthcare Research and Quality (formerly AHCPR) Letter of Intent Receipt Date: May 10, 2001 Application Receipt Date: May 24, 2001 PURPOSE The Agency for Healthcare Research and Quality (AHRQ) announces the availability of approximately four to seven Cooperative Agreements (U18) for up to three years of support for professional associations, educational leadership organizations and provider organizations to demonstrate and evaluate innovative approaches to provider education, to disseminate patient safety research results and best practices, and to promote positive safety culture. These projects are intended to enable these organizations to develop, demonstrate, and evaluate new approaches to improving provider education and practice in order to reduce medical errors and create a culture to improve patient safety. AHRQ seeks to support projects that can be replicated by others on a larger scale which develop, implement, and evaluate effective educational strategies to improve patient safety and reduce medical errors. These cooperative agreements are intended to capitalize on advances in knowledge about medical errors and translate established strategies to reduce medical errors into widespread use through provider education. AHRQ is interested in programs that make maximum use of active learning through the use of simulation, team training, and web-based instruction as well as traditional educational approaches to disseminate, implement, and evaluate provider education to improve patient safety. This Request for Applications (RFA) is the last in a series of patient safety research solicitations to be issued by AHRQ in FY01. The series of solicitations form an integrated set of activities to design and test best practices for reducing errors in various 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 which can be enhanced to support research and action in patient safety. RFAs 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) that will determine the causes of medical errors and 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 physical healthcare environment (facility design, aesthetics, etc.) impacts the provision of safe high quality care. Additional components of the Agency’s patient safety initiative will build on existing Agency programs. AHRQ will also support a contract for a coordinating center to provide guidance and facilitate interaction among the entities funded under the Agency’s patient safety programs. The coordinating center will assure translation of the new knowledge from the research projects to the demonstration sites. The coordinating center will also provide general guidance to the grantees supported under this RFA and organize meetings of these grantees and other components supported under the Agency’s patient safety research initiative. Research themes under this RFA and others to be released by the Agency have been generated by a variety of activities including public and private sector national summits and research agenda- setting activities on quality, medical errors and patient safety, as well as key stakeholder meetings. Research themes are the outgrowth of ongoing activities of the Quality Interagency Coordination Task Force (QuIC) and its report (See Ref. # 1) -- Doing What Counts for Patient Safety - Federal Actions to Reduce Medical Errors and Their Impact (http://www.quic.gov). Furthermore, the Agency sponsored a National Summit on Medical Errors and Patient Safety Research on September 11, 2000. Findings from the Summit also contribute to the research themes and define a set of focus areas for provider education efforts supported under this RFA. A research summary of the summit is available at http://www.quic.gov/summit/resagenda.htm. For the purpose of this RFA, medical errors are 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 error. The enhancement of patient safety encompasses three complementary activities: preventing errors, making errors visible, and mitigating the effects of errors: (See Ref. # 1) Provider education refers to planned learning experiences for individuals who provide care to patients. Providers include all health professionals and health care workers engaged in care to patients, including but not limited to physicians, nurses, pharmacists, allied health professionals, aides and others engaged in the care of patients directly or indirectly. Provider education can span the continuum of the educational process from basic entry level training, through advanced training, to continuous learning experiences for individuals in practice. The continuum is often referred to as undergraduate, graduate, and continuing education. For purposes of this RFA undergraduate education is the formal entry-level professional training of an individual provider leading to entry level degree or certification. Graduate education is advanced professional education such as formal graduate school leading to an advance degree or certification, including residency and fellowship education of physicians or advanced practitioner status for nurses and allied health professionals. Continuing education is organized learning experiences for providers to maintain or enhance their competency to provide optimal care. Continuing education activities are not normally associated with either degrees or formal certifications. Continuing education that is directed to the health professional teachers and faculty designed to improve their skills as faculty is generally referred to as faculty development. Faculty development is often considered an essential first step in bringing about changes in curriculum, instruction and the development of new attitudes. Because of this vital role of faculty development in patient safety, projects which address the needs of health care provider faculty can be included as a potential target audience under this RFA. 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 and private non-profit organizations, including professional societies, professional associations, educational leadership organizations, provider organizations, health care delivery organizations, health plans, units of State and local governments, and eligible agencies of the Federal government. Given the substantial impact of professional associations, educational leadership organizations, and provider organizations on the education of healthcare providers, AHRQ is particularly interested in applications from professional associations, educational leadership organizations, and provider organizations or entities which have a direct partnerships with them. Applications may include foreign components, but foreign organizations are not eligible to apply. Under recently enacted reauthorization legislation, AHRQ is authorized to enter into cooperative agreements with for- profit organizations as well as with public and not-for-profit entities. Thus, for-profits organizations are invited to respond to this solicitation for cooperative agreements. Applications will be administered in accordance with 45 CFR Part 74 and 42 CFR Part 67 Subpart A. The latter regulation was amended on December 6, 1999, and reflects changes in Agency name and authority. (See AHRQ reauthorization at (http://www.ahrq.gov/hrqa99a.htm). Organizations described in section 501(c)4 of the Internal Revenue Code as engaging 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 or organizations which focus on minority providers or patient populations to apply for funding under this RFA. AHRQ also encourages collaboration on projects between minority institutions and organizations with non-minority institutions and organizations. In accordance with AHRQ’s recent reauthorization, the Health Care Research and Quality Act of 1999, AHRQ is focusing 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 applicants for these cooperative agreements to include a focus on one or more of these priority areas and populations by targeted data collection, analysis, or safety improvement strategies. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U18), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial AHRQ scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under a cooperative agreement, AHRQ’s goal is to support and/or stimulate the recipient"s research activity by working jointly with the award recipient in a partner role, but AHRQ is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreement(s) are discussed later in this document under the section Terms and Conditions of Award. The total project period for applications submitted in response to the present RFA may not exceed three years. The anticipated award date is September 28, 2001. This RFA is a one- time solicitation. AHRQ has not determined whether or how this solicitation will be continued beyond the present RFA. FUNDS AVAILABLE AHRQ expects to award up to $1,500,000 in fiscal year 2001 to support the first year total costs (direct costs and facilities and administrative costs) of four to seven projects under this RFA. The actual number of applications funded is dependent on the number of high quality applications and their individual budget requirements. It is not the intent of AHRQ that the awards be equal in size. Although the financial plans of AHRQ provide for this program, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Should additional funds become available, however, and if AHRQ receives a sufficient number of meritorious applications, AHRQ reserves the right to fund additional applications under this RFA. Funding beyond the initial budget period will depend upon annual progress reviews by AHRQ and the availability of funds. RESEARCH OBJECTIVES Background This RFA is part of the Agency’s coordinated efforts to develop, demonstrate, and evaluate strategies for reducing errors and improving patient safety. It provides the opportunity for professional associations, educational leadership organizations, and provider organizations to develop, implement, disseminate, and evaluate the impact of educational strategies to enhance provider education on medical error reduction. Projects funded under this cooperative agreement are to be partnerships between awardees and AHRQ to translate evidence from patient safety research into educational programs to enhance patient safety. In November 1999, the Institute of Medicine (IOM) released a report entitled, To Err is Human, (2) which estimated that between 44,000 and 98,000 people die each year in hospitals from medical errors. It called for a a comprehensive and strong response to this most urgent issue facing the American people. The IOM called for leadership from the Department of Health and Human Services (DHHS) in reducing medical errors and identified one of its operating divisions, the Agency for Healthcare Research and Quality (AHRQ), as the national focal point for patient safety research. The Quality Interagency Coordination (QuIC) Task Force (www.quic.gov), a coordinating body for all health care quality improvement activities in the Federal government, developed an action plan detailing how the Federal government could respond to the IOM’s report and improve patient safety in Federally funded health care programs. As part of its reauthorization, AHRQ is required to conduct and support research and build private-public partnerships to reduce errors in medicine through the pursuit of the following three goals: (1) identifying the causes of preventable health care errors and patient injury in health care delivery, (2) developing, demonstrating, and evaluating strategies for reducing errors and improving patient safety, and (3) disseminating effective strategies throughout the health care industry. The report from the Council on Graduate Medical Education and the National Advisory Council on Nursing Education and Practice entitled Collaborative Education to Ensure Patient Safety (3) states that practice approaches have their foundation in the education and training system of health care providers. If improvements are to be made in patient safety, there must be efforts directed toward introducing patient safety as educational content into the provider education system at all levels of the continuum. The IOM also addressed the role of health professional societies and groups and their potential role in patient safety as follows: Professional societies, groups and associations can play an important role in improving patient safety by contributing to the creation of a culture that encourages the identification and prevention of errors. Few professional societies or groups have demonstrated a visible commitment to reducing errors in health care and improving patient safety. Although it is believed that the commitment exists among their members, there has been little collective action. (See Ref # 2, p. 144) As the IOM report suggests, professional associations, educational leadership organizations, and provider organizations can play a key role in helping to build a positive safety culture. Safety culture development begins within the professional education and orientation of new professionals and is re- enforced during practice. In addition to their influence on culture, professional associations, educational leadership organizations, and provider organizations can also play a role in developing, implementing, disseminating, and evaluating educational programs to address errors. Objectives and Scope Projects submitted in response to this RFA should propose innovative approaches to provider education. Projects are expected to contribute to our understanding of how to enhance provider education in order to reduce medical errors and create a positive safety culture in order to improve patient safety. AHRQ is interested in projects in which the results will be applicable and generalizable to situations beyond that of the project and contribute to enhancing provider education. Proposed educational strategies may encompass a variety of approaches. AHRQ is particularly interested in active modes of learning that can be easily replicated by others and demonstrate effective methods to enhance knowledge retention. Methods All projects must have clearly specified plans for the design, development, implementation, and evaluation of the proposed provider education program. The plan must include: 1. The specified target audience i.e., which group or groups of providers (physicians, nurses, allied health professionals, etc.) and at which level or levels of the educational continuum the program is intended to be delivered. Applicants should also describe the setting(s) in which interventions will be applied. 2. The curriculum development approach to be used to identify the knowledge, skills and attitudes to be addressed. As a cooperative agreement AHRQ will provide successful awardees with information on patient safety research and best practices generated from other funded activities and the patient safety literature. 3. The instructional methods to be used to reach the target audience. 4. The program evaluation plan which will outline the approach taken to document the program process and impact with the target audience. The evaluation, must, at a minimum, determine whether the educational program and materials were distributed to the target audience. It would be desirable to also assess whether provider knowledge was changed by the program, if provider behavior was changed, and any impact on patient outcomes. (See Ref. # 4) It is expected that most projects supported under this RFA will have difficulty in demonstrating an impact on provider behavior and patient outcomes but to the extent that such an impact is demonstrable, it would be highly desired. Applicants should also assess the generalizability of their program to other settings, provider groups, and areas. SPECIAL REQUIREMENTS The awardees of this RFA will meet annually with AHRQ staff, the coordinating center, and each other to discuss their programs, coordinate content focus, and set priorities for evaluation and dissemination. Budgets submitted in response to the RFA should include travel costs for the principal investigator and one co-investigator to attend these annual meetings in Rockville, MD. Data Privacy All information about identifiable individuals or organizations obtained for the research purpose of carrying out a demonstration project supported pursuant to this RFA under AHRQ’s statutory authority is protected by a federal confidentiality statute, section 924 of the Public Health Service Act , 42 USC 299c-3(c). Under this law, the only permissible uses or disclosures of the information are those agreed to by the subject individuals and organizations or by those who supply the information to the researchers. There are substantial statutory penalties (up to $10,000) for improper use or disclosure of this information. Thus 42 USC 299c-3(c) provides a Federal statutory basis for resisting any Federal or state court order or subpoena to the extent that carrying out the order or subpoena would violate the protective restrictions of the statute. Upon request, AHRQ will provide legal assistance in defending adherence to these statutory confidentiality protections with respect to identifiable data obtained in carrying out Agency research activities. Note that identifiable data obtained by AHRQ-supported researchers is protected by this law when it is obtained to carry out AHRQ-supported research, but this law would not protect against access to this same information in medical records if it were gathered and recorded there for other purposes. If providers collect certain information solely for purposes of this research, it should be so marked and if necessary to protect its confidentiality, kept separately. Note also that this law does not protect or restrict aggregate and nonidentifiable statistical or data analysis and conclusions developed by the researchers that would not disclose information about any identifiable individuals or establishments 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 through the media and other appropriate channels in coordination with AHRQ’s Office of Health Care Information but relies on grantees to publish research results in peer- reviewed journals and to market grant-supported products. The Agency is particularly interested in projects that would make educational and dissemination tools available to the Agency for further dissemination. 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 "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994, and updated August 2, 2000. 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 contractor, listed under INQUIRIES, or from the NIH Guide Website http://grants.nih.gov/grants/guide/index.html. AHRQ encourages investigators to consider including children in study populations, as appropriate. AHRQ program staff may also provide additional information concerning these policies (see INQUIRIES). TERMS AND CONDITIONS OF AWARD These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92, 42 CFR Part 67 Subpart A, and other HHS, PHS grants administration policy statements. Applicants should be familiar with the Agency’s grant regulations, 42 CFR Part 67 Subpart A, and particularly sections 67.18-67.22. Under the cooperative agreement, the AHRQ purpose is to support and/or stimulate the recipient"s activity by working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee for the project as a whole, although specific tasks and activities in carrying out the studies may be shared between the awardees and the AHRQ Program Official. 1. Awardee Rights and Responsibilities The Awardee will have primary and lead responsibility for the project as a whole, including research design and protocol development, participant recruitment and follow-up, data collection, quality control, preparation of publications exclusively about the data collection, analysis, information dissemination and testing of interventions to improve safety within their provider education project. They will be responsible for cooperating and collaborating with other AHRQ awardees working on patient safety improvement with assistance from the AHRQ Program Official and the coordinating center (described below). In addition, awardees are required to cooperate with AHRQ’s evaluation contractor that will be assessing the relative effectiveness of the Agency’s entire patient safety research portfolio. The Awardee retains custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current Department of Health and Human Services, Public Health Services, and AHRQ policies. The awardees of this RFA are required to meet annually with AHRQ staff, the coordinating center, and each other to discuss their programs, coordinate content focus, and set priorities for evaluation and dissemination. 2. AHRQ Staff Responsibilities The AHRQ Program Officials for the patient safety program include the project officers for the funded cooperative agreements and the patient safety staff of the AHRQ Center for Quality Improvement and Patient Safety (CQuIPS). Specifically, CQuIPS will promote collaboration and comparison of information gathered by the projects, the sharing of analytic methods and results, and information on effective instructional approaches and methods which have been shown to have an impact on reducing the risk to patients and improved patient safety. The AHRQ supported coordinating center will facilitate communication and sharing of ideas between the programs funded under this RFA and the Agency’s funded Centers of Excellence in Patient Safety Research, Developing Centers of Excellence in Research on Patient Safety, and Health System Error Reporting, Analysis, and Safety Improvement Demonstration projects. These other grantees supported under the Agency’s earlier patient safety RFAs could provide content to the dissemination and education programs supported under this RFA. A complete description of the purpose of these Centers can be found in the requests for applications for each, which are available at http://www.ahrq.gov/fund. The Agency will also provide the results of an Agency sponsored Evidence Based Practice Center report, Compendium of Patient Safety Practices, due in July 2001 to grantees to provide an additional source of potential content for the programs supported under this RFA. 3. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award) between award recipients and AHRQ may be brought to arbitration. An arbitration panel will be composed of three members, one selected by the Steering Committee (with the AHRQ members not voting), or by the individual awardee in the event of an individual disagreement, a second member selected by AHRQ, and the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee’s right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent by May 10, 2001 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 to which the application may respond. Although a letter of intent is not required, is not binding, and does not enter into consideration of any subsequent application, the information 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: Greta Drott Office of Research Review Education and Policy Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 400 W Rockville, MD 20852-4908 Telephone: (301) 594-3421 FAX: (301) 594-0154 E-mail Address: gdrott@ahrq.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these cooperative agreements. State and local government applicants may use PHS 5161-1, Application for Federal Assistance (rev. 7/00), and follow those requirements for copy submission. The PHS 398 type size requirements (p. 6) will be enforced rigorously, and non-compliant applications returned. In part, the PHS 398 states that the application must be clear, readily legible, and conform to all of the following requirements: 1) the height of the letters must not be smaller than 10 point, 2) type density must be no more than 15 characters per inch (cpi), and 3) no more than 6 lines of type must be within a vertical inch. Applicants are encouraged to read all PHS Forms 398 instructions prior to preparing an application in response to this RFA. 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 (rev. 4/98). 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 unless otherwise indicated by the Agency (http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html.) Given the nature of this project and the speed with which successful applicants will need to begin work, the Agency has determined that IRB approval is required by July 13, 2001 for all applications submitted in response to this RFA. IRB approval may be submitted to Greta Drott at the address listed above. All investigators/applicants proposing research involving human subjects should pay particular attention to the instructions in the form PHS 398 regarding human subject involvement. Applications kits are available at most institutional offices of sponsored research. They may be downloaded from http://grants.nih.gov/grants/funding/phs398/phs398.html. 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) 710-0267, E-mail: grantsInfo@nih.gov. AHRQ applicants are encouraged to obtain application materials from the AHRQ Publications Clearinghouse (see INQUIRIES). The RFA label and line 2 of the application form PHS 398 (rev. 4/98) should both indicate 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 and number must also 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. 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, labeled Advance Copy must also be sent to: Greta Drott Office of Research Review Education and Policy Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 400 W Rockville, MD 20852-4908 Telephone: (301) 594-3421 FAX: (301) 594-0154 E-mail Address: gdrott@ahrq.gov Applications must be received by May 24, 2001. 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. In carrying out its stewardship of assistance programs, the AHRQ, at some point in the future, may begin requesting 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 sponsored research. AHRQ expects grant recipients to keep the Agency informed of publications or the impact from Agency sponsored research. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness and responsiveness. Incomplete and/or 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 in accordance with the review criteria stated below by an appropriate peer review group convened by AHRQ. 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 The goals of AHRQ-supported research are to enhance the quality, appropriateness, and effectiveness of health care services, and access to such services. The reviewers will be asked to discuss the following aspects of the application in their written critiques in order to judge the likelihood that the proposed projects will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score, weighting them as appropriate for each application. 1. Significance. Does the proposed education and dissemination program address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced and patient safety improved? What will be the effect of the education and dissemination program on the concepts or methods that drive this field? 2. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the education and dissemination program? Are the proposed sources of evidence for dissemination appropriate and adequate? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation. Does the education and dissemination program employ novel concepts, approaches or methods? Are the aims original and innovative, challenge existing paradigms or develop new methodologies or technologies? 4. Investigators. Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Is the project (or work plan) well organized? 5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed education and dissemination programs take advantage of unique features of the provider environment or employ useful collaborative arrangements? Is there evidence of institutional or organization in kind support? 6. Responsiveness. Does the application respond closely to the challenges and requirements identified in this RFA? Does the proposed study target the priorities outlined in this RFA and the priorities identified at the Patient Safety Research Summit held on September 11, 2000? The initial review group will also examine: dissemination and evaluation activities, the appropriateness of proposed project budget and duration, the adequacy of plans to include both genders, children, and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, the provisions for the protection of human and animal subjects, and the safety of the research environment. Special Review Criteria In addition to the general review criteria above, the following special review criteria will also be applied: 1. The extent to which the team which will be conducting the education and training program encompasses experience in developing such programs and knowledge of patient safety issues. The qualifications of the project staff should include evidence of qualification in health professional education, curriculum and instructional design, and educational program evaluation. 2. The extent to which the educational or training program’s target audience is described and the degree of evidence the team provides as to their ability to get the target audience to participate in the educational or training programs. 3. The extent to which the application demonstrates an innovative approach to patient safety and education, drawing on prior proven innovations in provider education. 4. The extent to which the application can describe the proposed program. This description should focus primarily on the processes that will be used (e.g., curricula development, CME programs, simulation, etc.). It is anticipated that the actual content of these programs will vary among applications depending upon the availability of evidence and will be shaped by discussions with Agency program staff. 5. The extent to which the project results will be applicable and generalizable to situations beyond that of the project and contribute to enhancing provider education. Projects can be conducted by professional associations and provider organizations and with all types of health care providers (physicians, nurses, allied health professionals, pharmacists, aides at any level of the educational continuum). The Agency is particularly interested in projects that are generalizable to other settings and types of providers. 6. The extent to which the study will build in an evaluation of the program and the products of that evaluation. In order of preference, evaluations should strive to determine how the programs 1) changed patient care, 2) made current practice better, 3) improved healthcare provider knowledge, and 4) succeeded in dissemination of materials. It is anticipated that most programs will have difficultly delivering on the first 2 of these evaluation goals but AHRQ is particularly interested in those applications that can address all four evaluation topics. In addition the Agency is interested in applications which will evaluate whether the program resulted in new clinical policies or in some way changed the participating professional associations, educational leadership organizations, and/or provider organizations. 7. The extent to which approaches and products are evidence based. AWARD CRITERIA Applications will compete for available funds with all other applications under this RFA. The following will be considered in making funding decisions: 1) quality of the proposed project as determined by peer review, 2) availability of funds, 3) responsiveness to the goals and objectives of the RFA, 4) portfolio balance, including with respect to the foci of this RFA and AHRQ’s other patient safety projects (includes diversity in geographic area, professional type, specialty, population served, and educational program type), 5) compatibility with other awardees with respect to cooperative activities, and 6) relevance to the formulation of public policy. Special preference will be accorded to applications from principal investigators who are not recent (within 2 years) or current AHRQ funded principal investigators of an AHRQ grant for research related to health care quality. Awardees under this RFA will be required 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). Awardees 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 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 The 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 read the RFA. Written and telephone inquiries concerning this RFA are encouraged. Direct inquiries regarding programmatic issues, including information on the inclusion of women, minorities, and children in study populations to: Francis D. Chesley, M.D. Office of Research Review, Education, and Policy Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 400 W Rockville, MD 20852 Telephone: (301) 594-6410 FAX: (301) 594-0154 Email: training@ahrq.gov Direct inquiries regarding fiscal and administrative matters to: Michelle Burr Grants Management Specialist Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 594-1840 Fax: (301) 594-3210 Email: mburr@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 1. QuIC report to the President. Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact. February 21, 1999. 2. Kohn LT, Corrigan JM, Donaldson MS, eds. To Err is Human, Building a Safer Health System. Washington, D.C.: National Academy Press. November 29, 1999. 3. COGME/NACNEP Collaborative Education to Ensure Patient Safety Rockville, MD: Health Resources and Services Administration. 2001. 4. Stryer D, Tunis S, Hubbard H, Clancy C. The outcomes of outcomes and effectiveness research: impacts and lessons from the first decade. Health Serv Res 2000 35(5 Pt 1): 977-93.


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