CLINICAL INFORMATICS TO PROMOTE PATIENT SAFETY Release Date: February 22, 2001 RFA: RFA-HS-01-006 Agency for Healthcare Research and Quality (formerly AHCPR) Letter of Intent Receipt Date: April 6, 2001 Application Receipt Date: April 23, 2001 PURPOSE The Agency for Healthcare Research and Quality (AHRQ) announces the availability of Research Demonstration and Dissemination Projects (R18) on the use of clinical informatics and information technology (IT) to reduce medical errors and improve patient safety. Specifically, AHRQ seeks projects to develop and test the use of innovative technologies, such as hand-held electronic medication and specimen management systems, training simulators for medical education, computerized bar-coding, patient bracelets, smart cards, and automated medication dispensing systems in clinical settings. The main objective of this RFA, Clinical Informatics to Promote Patient Safety (CLIPS), is to assess the extent to which such innovations, when applied in various health care settings, contribute to measurable and sustainable improvements in patient safety and quality of care. Research resulting from this RFA will help us to better understand the opportunities and barriers to using IT to improve the process and outcomes of care for patients and providers. Researchers are encouraged to propose projects that emphasize non-inpatient health care settings (including ambulatory and long-term care settings) and priority populations. AHRQ is strongly committed to supporting research in priority populations, which include women, children, elderly, minority, rural, urban, and low-income populations, as well as patients with special health care needs and disabilities. Applicants will be required to develop projects that use rigorous scientific methods to assess the effect of the IT innovation on medical error rates and other measures of patient safety. It is expected that a successful project will evaluate IT tools that alert providers to information that may be critical to the provision of high quality care, develop strategies to address barriers to successful adoption of innovative IT applications, document the costs and resources associated with the IT applications, or evaluate transferability to other settings. The objective of this RFA is to assess the extent to which innovative IT applications, when applied in various health care settings, contribute to measurable and sustainable improvements in patient safety. This RFA is one in a series of research solicitations to be issued by AHRQ over the next several months. The solicitations form an integrated set of activities to design and test best practices for reducing errors in multiple health care settings, develop the science base to inform these efforts, improve provider education to reduce errors, capitalize on the IT advances to translate proven effective strategies into widespread practice, and build capacity to further reduce errors. In addition to CLIPS, 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 (including systems that integrate acute and long-term care), and networks of providers (e.g., integrated delivery systems and primary care networks) to test reporting strategies and patient safety interventions. 2) 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 and develop new knowledge to support the work of the demonstrations. 3) Developing Centers for Patient Safety Research and Practice - 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. 4) 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 the interactions between the built environment impacts the provision of safe care. 5) 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 applying new knowledge on patient safety to curricula development, continuing education, simulation models, and other provider training strategies. At the heart of this competitive demonstration program is a portfolio of projects that test the effectiveness and costs of diverse reporting strategies and IT 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 networks, 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 Federal or State governments which can be enhanced to support research and action in patient safety. 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 between the entities funded under the Agency’s patient safety programs. The coordinating center will assure explicit translation of the new knowledge from the safety centers of excellence and informatics research projects to the demonstration sites. The coordinating center will also facilitate data transfers from the demonstration sites to the centers of excellence and process reporting data for transmittal to AHRQ. Research themes under this RFA have been generated through a variety of activities including key stakeholder meetings as well as public and private sector national summits and research agenda setting activities on medical errors, patient safety, and informatics. For example, the Agency sponsored a National Summit on Medical Errors and Patient Safety Research on September 11, 2000, and findings from the summit also contributed to the research themes. A summary of the summit is available on the Agency’s web page (http://www.ahrq.gov/). Research themes also developed from 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. In responding to this RFA, applicants should address the following central research topics: (1) the role of informatics in improving clinical decision- making, reducing errors, and advancing patient safety, (2) barriers to acceptance and adoption of health information technology for improved patient safety and quality, (3) utilization of effective strategies to improve patient safety while maintaining patient confidentiality. Definitions For the purpose of this document: Clinical informatics is broadly defined as the use of computers and information technology in the provision of patient care. It includes, but is not limited to, electronic records, electronic communication, computerized decision support systems, physician order entry, web-based applications, and hand-held wireless devices. Medical error is defined as the failure of a planned action to be completed as intended or the use of a wrong action to achieve an aim. Errors can include problems in practice, products, procedures, and systems (Quality Interagency Coordination Task Force, 2000) Patient safety 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). Adverse events are defined as undesirable and unintended incidents in care that may result in adverse outcomes or may require additional care efforts to thwart an adverse outcome. Preventable adverse events are a subset of adverse events that are judged to have been avoidable if appropriate and reasonable steps had been taken. An anaphylactic reaction to penicillin is an adverse event. It is a preventable adverse event if the patient’s intolerance of penicillin is noted in his or her chart and that chart is available to the clinician, or if the patient knows of his or her reaction to penicillin and is able to communicate it to the clinician. Adverse outcomes are defined as undesirable and unintended outcomes of care such as death, disability, or temporary disability. Near misses are events in which the unwanted consequences were prevented because there was a recovery by identification and correction of the failure (Van der Schaaf). Such a recovery could be by a planned or unplanned barrier. The term close calls is often used synonymously with near misses. 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 universities, clinics, units of State and local government, firms and foundations. For the purpose of this RFA, AHRQ will make grants only to non-profit organizations, however, for-profit organizations, such as IT vendors may only participate in grant projects as members of consortia or as subcontractors. Foreign institutions are not eligible to apply. 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. AHRQ strongly 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.hr.doe.gov/ed/index.html. MECHANISM OF SUPPORT Projects supported under this initiative will use the Research Demonstration and Dissemination Project (R18) grant mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The focus of the applications should be on the evaluation of clinical informatics tools. It is not the intent of this RFA to support extensive development of new IT tools, but rather to demonstrate and evaluate the application of IT strategies that patients and providers may use to improve patient safety. The total project period for an application submitted in response to this RFA may not exceed 5 years. The earliest possible award date is September 28, 2001. This RFA is a one-time solicitation. There are no plans to reissue this RFA at any time. FUNDS AVAILABLE AHRQ expects to award up to $3.5 million in total costs (i.e., including facilities and administrative costs) in fiscal year 2001 to support 10-14 projects with an average of $250,000-$300,000 per application for the first year R18s selected under this initiative. In addition, one or two projects may be funded as a collaboration with the HRSA/HIV/AIDS bureau. The focus would be to work with non-hospital based (community based) Ryan White medical care grantees who target underserved populations such as homeless, communities of color, women, youth, uninsured and multiple diagnosed clients. 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, the Agency reserves the right to fund additional applications under this RFA. The anticipated level of continuation funding across the awarded R18s for subsequent approved project years is at an equivalent level (i.e., about $3.5 million per year for total costs of the initiative). However, funding beyond the initial budget period will depend upon annual progress reviews by AHRQ and the availability of funds. RESEARCH OBJECTIVES Background For the past thirty years, AHRQ, and its predecessors (the National Center for Health Services Research, NCHSR , and the Agency for Health Care Policy Research, AHCPR ) have investigated and funded much of the seminal research in patient safety. In the late 1990s, as medical errors and patient safety issues moved higher on the national public policy agenda, AHRQ began to take on a leadership role in this area. For example, 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 on Quality First: Better Health Care for All Americans (1998), reduction of medical errors was listed as one of its top priorities. A year later, The Institute of Medicine released its report on medical errors and patient safety, To Err is Human, and called for a strong, comprehensive response to this urgent issue (Kohn, et al, 1999). In early 2000, the Quality Interagency Coordination Task Force (QuIC), with AHRQ as lead agency, responded with its report to the President, Doing What Counts for Patient Safety, Federal Action to Reduce Medical Errors and Their Impact. This report, which outlined a road map for action including more than 100 activities, addressed issues such as national focus and leadership, as well as 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 (QuIC, 2000). When Congress reauthorized (and renamed) the Agency in late 1999, it 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. AHRQ"s reauthorization also directed the Agency to evaluate informatics applications, decision support systems, and computerized patient records to reduce medical errors, improve patient safety, and promote quality improvement in diverse patient settings. Role of Informatics in Patient Safety As the delivery of health care becomes increasingly complex, the reliance on effective systems to prevent medical error will be increasingly critical. However, health care continues to take place in systems with little standardization and few safeguards, especially when compared to other industries (Bates, 2000). In this complicated environment, it is not surprising that medical errors would occur. The vast amount of medical information, coupled with the rapid growth in new pharmacotherapies and technologies, increasing time constraints placed on health care providers, mounting pressures to reduce costs, and suboptimal systems for delivering care, make it virtually impossible for individual clinicians to provide high-quality, error free care on a consistent basis. As stated by a leader in health care informatics, humans are inherently fallible information processors (McDonald, 1976). This reliance on imperfect memory can lead to compromised patient safety and increased rates of medical errors (Leape, 1994). As health care becomes increasingly more complex, information systems are needed to assist providers in making the best possible clinical decisions. As attention has turned to the role of systems in preventing medical errors and injuries, evidence has become available that computerized decision support systems can help to improve patient safety. The data processing capacity of computers has been harnessed by a number of electronic systems designed to assist in clinical decision-making. These systems range from computerized reminders about preventive services to alerts about drug-drug interactions to specific guidelines and therapeutic recommendations. There are numerous examples of clinical informatics applications that have been demonstrated to improve patient safety at a few premier medical institutions. At LDS Hospital in Salt Lake City, a computerized decision support system with physician order entry has reduced the incidence of adverse drug events related to antibiotic administration by 75% (Evans, 1995). This system also significantly reduced orders for drugs for which patients reported allergies and adverse effects caused by antibiotics (Evans, 1998). At the Regenstrief Institute for Health Care in Indianapolis, researchers demonstrated that automated computerized reminders increased orders for recommended interventions from 22% to 46% (Overhage, 1997). The physician order entry system at Brigham and Women’s Hospital has clearly demonstrated its role in reducing medical errors and improving patient safety. Investigators demonstrated that use of the physician order entry system with decision support led to increased use of appropriate medications for high-risk clinical situations, such as an increase in the use of subcutaneous heparin to prevent venous thromboembolism from 24 percent to 47 percent. Errors related to medication dosing were reduced by 23 percent, errors in medication choices by 44 percent, errors in delays by 77 percent, errors in ordering by 19 percent, transcription errors by 84 percent, known allergy errors by 56 percent, and overall serious medication errors by 55 percent (Bates, 1998). Perhaps most importantly, these changes persisted at the 1- and 2-year follow- up periods. (Teich, 2000) A recent systematic review that assessed the effects of 68 computer-based clinical decision support systems demonstrated a beneficial, though variable impact on physician performance in 43/65 studies (66%) and a beneficial effect on patient outcomes in 6/14 studies (43%) (Hunt, 1998). However, some applications, such as diagnostic expert systems, have met with disappointing results (Berner 1994, Kassirer 1994). While these examples illustrate that physician order entry systems and decision support can help reduce medication errors, improve prescribing patterns and guide treatment decisions, only a small number of health care systems in the United States have such systems in place. Though these systems require significant up-front capital investment, these costs may be superseded by annual savings of $5-10 million per year (Bates, 1998). While recent innovations in information technology have been touted over the past several years in the lay and industrial press, many of these applications have not been adequately evaluated in the health care arena. For example, wireless hand-held computers, also referred to as personal digital assistants (PDA) offer great potential in health care. In preliminary studies, these devices have demonstrated an improvement in the detection and prevention of adverse events (Shabot, 2000). PDAs, pagers, and other small portable electronic devices, such as digital cellular phones with wireless access, are promising new applications with the potential for improving the quality of healthcare. There are many other cutting edge technologies that could have a significant impact on medical errors and patient safety. Medication bar codes and automated dispensers are being utilized in some healthcare settings to reduce errors. The use of scannable patient bracelets containing drug, allergy and other medical information is also generating interest. Such devices could help ensure that medications, blood products, and other therapeutics that are administered to patients are appropriate. They could also be used to generate alerts about allergies, drug-drug interactions, and other potential problems before erroneous administration occurs. The Veterans Administration has been a national leader in the use of some of these technologies. Smart cards, electronic devices the size of credit cards that store and process medical information on a microprocessor chip, may also lead to safety improvements. This technology would give patients a portable means of carrying their own medical information, which could then be accessed electronically by their provider or healthcare facility. Interactive smart cards could also generate alerts about potential adverse events resulting from medication and other types of errors. This technology remains in the early stages of development and has not been utilized or evaluated to a significant degree in the clinical setting. While clinical informatics has demonstrated promise in patient safety and quality improvement, greater evaluation and research of these technologies are needed. Through support of diffusion of health information technologies to other healthcare settings, as well as support for research on the effectiveness of innovative information technology tools to improve patient safety, this RFA hopes to provide opportunities to harness the power of technology for improving healthcare delivery and outcomes. Objectives and Scope This RFA provides research opportunities to demonstrate the effectiveness of clinical informatics tools in improving quality of care. Research demonstration projects supported under this RFA should seek to generate new knowledge that can be used by providers, patients, payers, and policymakers to promote the use of information technology to reduce medical errors and improve patient safety. Applicants are encouraged to develop partnerships with developers and commercial vendors of IT tools and systems. AHRQ is especially interested in research on the development and use of technologies that reduce medical errors, such as hand-held electronic medication and specimen management systems, bar coding of medications, automated medication dispensers, training simulators for medical education, and patient-specific identifiers (e.g., bracelets, smart cards). AHRQ is also interested in further research on the opportunities and barriers to using information technology for improving the process and outcomes of care for patients and providers. While evidence is accumulating that real-time decision support tools, such as physician order entry, may result in improved patient safety, further research is needed to develop tools that optimize decision support and that assess their impact on other aspects of care such as satisfaction, productivity, outcomes, and overall quality. Researchers are encouraged to propose projects that evaluate the impact of IT on clinically important outcomes and to emphasize different health care settings and priority populations. Research in the following specific areas will be considered: 1. Evaluate the use of appropriate technology to improve patient safety: a) The effect of clinical IT tools in reducing medical errors and improving the quality of patient care. b) Real-time IT decision support systems that alert providers to information that may be critical to the provision of high quality care. c) The use of evidence-based, real-time decision support systems on patient/provider decision-making, patient safety, and outcomes. d) Standardized data elements required in information systems that allow the identification and classification of medical errors across health care settings. e) The impact of a minimum patient data set across information systems and health care settings on patient safety. f) The use of interactive technology, such as electronic mail, web-based medical records, hand-held wireless devices, computer kiosks, and electronic patient assessment tools that facilitate informed shared decision-making and patient safety. g) Data exploration technologies (e.g., data mining) to assess patterns of medical errors within health care systems. h) The strengths and limitations of existing systems in providing information on patient safety and medical errors in different health care settings, including hospital, ambulatory care, home care, and long-term care facilities. 2. Assess barriers to acceptance and adoption of health information technology for improved patient safety and quality by providers and patients: a) The impact of IT on efficiency, productivity, time management, workload, satisfaction (patient and provider), training, and return on investment. b) The influence of human factors on the acceptance and utilization of decision support systems. c) The sociology/culture of health care professionals that limit greater acceptance of new technology. d) The costs of informatics solutions, cost-effectiveness, value and return- on-investment of health information technology for improving the quality and safety of health care. e) Development of effective strategies to overcome identified barriers. 3. Utilize effective strategies to improve patient safety while maintaining patient confidentiality: a) Patient and provider preferences regarding privacy and use of medical information and explore methods of ensuring data security. b) The trade-offs between maintaining the confidentiality of personal health information and using data to improve patient safety and quality of care. Methods: Individual R18 projects may use a combination of qualitative and quantitative methods. Qualitative and quantitative methods should be rigorous and use state-of-the-art methodologies. Projects using such methods should be grounded in appropriate theoretical frameworks. Hypothesis-testing projects should clearly present competing hypotheses. Qualitative methods can be used on their own to heighten understanding of health care delivery systems or to complement quantitative methods and thereby strengthen the research design. Policy and Practice Relevance and Dissemination Studies under this RFA are expected to contribute to our basic understanding of medical errors and patient safety, build capacity to answer associated questions of policy relevance, and produce information that is useful to participants in delivering safer health care and to decision makers in formulating public policy. Applicants should be concrete in describing how their research results would translate into safer and higher quality health care. Dissemination strategies for effective informatics applications should not be limited to publication in peer reviewed journals but may encompass a variety of approaches, such as translating results into nontechnical monographs (e.g., healthcare guides to key features of physician order entry systems) and distributing them through associations of private and public officials, educating legislators, public administrators, health plan executives, employers, professional leaders, patients and patient advocacy groups, and others in seminars, partnerships, and collaboration with health care delivery organizations to implement results, and outreach to the media. In addition, applicants should budget for and plan to attend an annual conference with other centers of excellence and demonstration centers supported under the broader AHRQ patient safety program. These meetings will be organized by a central coordinating center. SPECIAL REQUIREMENTS 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. 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 is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. To the extent possible, AHRQ requires adherence to these NIH Guidelines. Investigators may obtain copies from the above sources or from the AHRQ Publications Clearinghouse, listed under INQUIRIES, or from the NIH Guide 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 also INQUIRIES). LETTER OF INTENT Prospective applicants are asked to submit a letter of intent by April 6, 2001. It should include 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 to plan the review. AHRQ will not provide responses to letters of intent. The Letter of Intent is to be sent to: Eduardo Ortiz, M.D., M.P.H. Senior Service Fellow Agency for Healthcare Research and Quality Center for Primary Care Research 6010 Executive Blvd., Suite 201 Rockville, MD 20852 Telephone 301-594-6236 Fax 301-594-3721 E-mail eortiz@ahrq.gov APPLICATION PROCEDURES The research grant application form PHS 398 (4/98) is to be used in applying for these 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. 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 form PHS 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). The AHRQ Revised Policy for IRB of Human Subjects Protocols in Grant Applications was published in the NIH Guide on September 27, 2000. All investigators proposing research involving human subjects should read this revised policy. (http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html) 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 prior to peer review of all applications submitted in response to this RFA. All investigators/applicants proposing research involving human subjects should pay particular attention to the instructions in the form PHS 398 regarding human subject involvement. AHRQ applicants are encouraged to obtain application materials from the AHRQ Publications Clearinghouse (see INQUIRIES). The Grant Application Form (PHS 398) is also available online at the following URL: http://grants.nih.gov/grants/funding/phs398/phs398.html. The RFA label and line 2 of the PHS 398 (4/98) form should both indicate the RFA number. The RFA label must be affixed to the bottom of the face page of the application. 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 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. A complete, signed, typewritten original of the application, including the Checklist, and three signed, legible 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 or courier service) At the time of submission, two additional copies of the application, labeled Advance Copy must also be sent to: Eduardo Ortiz, M.D., M.P.H. Agency for Healthcare Research and Quality Center for Primary Care Research 6010 Executive Blvd., Suite 201 Rockville, MD 20852 Telephone 301-594-6236 Fax 301-594-3721 Email eortiz@ahrq.gov Applications must be received by April 23, 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. Conference 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 on March 12, 2001, at AHRQ, 6010 Executive Blvd., Conference C, Rockville, MD, 20852 from 8:30 a.m. to 12:00 p.m. 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. Further information on the conference will be published through the Agency’s website at http://www.ahrq.gov. Application Preparation (including use of HCFA Data) For applications that propose to use Medicare or Medicaid data that are individually identifiable, applicants should state explicitly in the "Research Design and Methods" section of the Research Plan (form PHS 398) the specific files, time periods, and cohorts proposed for the research. In consultation with HCFA, AHRQ will use this information to develop a cost estimate for obtaining the data. This estimate will be included in the estimated total cost of the grant at the time funding decisions are made. Applicants should be aware that for individually identifiable Medicare and Medicaid data, Principal Investigators and their grantee institutions will be required to enter into a Data Use Agreement (DUA) with HCFA to protect the confidentiality of data in accordance with OMB Circular A-130, Appendix III--Security of Federal Automated Information Systems. The use of the data is restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee is required to return the data to HCFA or certify that the data have been destroyed. Grantees must also comply with the confidentiality requirements of Section 903(c) of the PHS Act. In carrying out its stewardship of assistance programs, 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 applications will be returned to the applicant without further consideration. Applications that are complete but are not responsive to the RFA will be returned to the applicant without further consideration, applicants may submit this project as an investigator initiated R01 grant application to AHRQ to compete with other unsolicited applications at the next review cycle. 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. All applications will be judged on the basis of the scientific merit of the proposed project and the documented ability of the investigators to meet the RESEARCH OBJECTIVES of the RFA. Although the technical merit of the proposed project is important, it will not be the sole criterion for evaluation of a study. Other considerations, such as importance and timeliness of the proposed study and access to patients/data will be part of the evaluation criteria. As part of the merit review, all applications will receive a written critique. Those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. General Review Criteria 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 research 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 and will be weighted as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus attain a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will the effect of these studies be on the concepts or methods driving this field? 2. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Are the proposed data sources appropriate and adequate? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation. Does the project employ innovative IT applications, concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator. Is the investigator 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? Does the proposed study team reflect the multi- disciplinary approach required to address patient safety issues? 5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? 6. Policy Relevance. Will the project provide Federal and State policymakers, and others participating in the formulation of such policy, with the evidence-based information they need to improve patient safety? Does the application provide a sound plan for achieving this purpose? 7. Responsiveness to the RFA. Does the application respond closely to the challenges and requirements identified in this RFA? Do the proposed studies appropriately target priorities identified at the QuIC Patient Safety Research Summit? The initial review group will also examine: proposed dissemination 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. In addition, the following criteria will be applied: o The extent to which the study results will be applicable and generalizable to situations beyond that of the study and contribute to the reduction or elimination of medical errors across a range of settings, levels of care, and populations. o The extent to which meaningful and sustainable linkages between researchers and change agents (e.g., organizations, institutions, practitioners, policy makers, patients and patient advocacy groups) are in place and used to accelerate the adoption of findings into practice. AWARD CRITERIA Applications will compete for available funds with all other applications. The following will be considered in making funding decisions: 1) scientific merit as determined by peer review, 2) availability of funds, 3) balance among target populations, with priority given to understudied populations, and among program areas, 4) balance among geographic areas, and 5) balance among all program areas. 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, should be addressed to: Eduardo Ortiz, MD, MPH Senior Service Fellow Center for Primary Care Research Agency for Healthcare Research and Quality 6010 Executive Boulevard, Suite 201 Rockville, MD 20852 Telephone (301) 594-6236FAX: (301) 594-3721 E-mail Address: eortiz@ahrq.gov Direct inquiries regarding fiscal and eligibility matters to: George (Skip) Moyer 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: smoyer@ahrq.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, Number 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 or 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. REFERENCES 1. Bates DW, Leape LL, Cullen DJ, Laird N, Peterson LA, Teich JM, et al. Effect of computerized physician order entry and a team intervention on prevention of serious medication errors. JAMA. 1998,280:1311-16. 2. Bates DW. Using information technology to reduce rates of medication errors in hospitals. Br Med J. 2000, 320: 788-790. 3. Berner ES, Webster GD, Shugerman AA, Jackson JR, Algina J, Baker AL, et al. Performance of four computer-based diagnostic systems. N Engl J Med. 1994,330:1792-96. 4. Evans RS, Classen DC, Pestotnik SL, Clemmer TP, Weaver LK, Burke JP. A decision support tool for antibiotic therapy. In: Gardner RM, ed. Proceedings from the Nineteenth Annual Symposium on Computer Applications in Medical Care. Philadelphia, PA: Hanley and Belfus, 1995:651-55 5. Evans RS, Pestotnik SL, Classen DC, Clemmer TP, Waever LK, Orme JF, et al. A computer-assisted management program for antibiotics and other antiinfective agents. N Engl J Med. 1998,338:232-38. 6. Hunt DL, Haynes RB, Hanna SE, Smith K. Effects of computer-based clinical decision support systems on physician performance and patient outcomes. JAMA. 1998,280:1339-45. 7. Kassirer JP. A report card on computer-assisted diagnosis the grade: C. N Engl J Med. 1994,330:1824-25. 8. Kohn LT., Corrigan JM., Donaldson MS., eds. To Err is Human, Building a Safer Health System. Washington, D.C.: National Academy Press, 1999. 9. Leape LL. Error in medicine. JAMA. 1994, 272(23): 1851-1857. 10. McDonald CL. Protocol-based computer reminders and the non- perfectability of man. N Engl J Med. 1976,295:1351-55. 11. Overhage JM, Tierney WM, Zhou XH, McDonald CJ. A randomized trial of corollary orders to prevent errors of omission. JAMIA. 1997,4:364-75. 12. 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. (http://www.quic.gov/report/) 13. Shabot MM, LoBue M, Chen J. Wireless clinical alerts for physiologic, laboratory, and medication data. Proceedings of the 2000 Annual Symposium of the American Medical Informatics Association, 789-93. 14. Teich JM, Merchia PR, Schmiz JL, Kuperman GJ, Spurr CD, Bates DW. Effects of computerized physician order entry on prescribing practices. Arch Intern Med. 2000,160:2741-47. 15. Van der Schaaf TW, Lucas DA, Hale AR, eds. Near miss reporting as a safety tool. Oxford: Butterworth and Heinemann. 1991.


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