TRIALS ASSESSING INNOVATIVE STRATEGIES TO IMPROVE CLINICAL PRACTICE THROUGH GUIDELINES IN HEART, LUNG, AND BLOOD DISEASES Release Date: June 29, 2001 RFA: RFA-HL-01-011 National Heart, Lung, and Blood Institute (http://www.nhlbi.nih.gov) Letter of Intent Receipt Date: September 12, 2001 Application Receipt Date: October 12, 2001 PURPOSE The National Heart, Lung, and Blood Institute invites applications for research project (R01) grants to evaluate interventions that represent innovative strategies that can be employed in clinical practice to improve implementation of national, evidence-based clinical practice guidelines for the treatment of heart, lung and blood diseases and conditions. The application should propose an intervention that employs innovative strategies to address multiple barriers to guideline implementation or factors enhancing guideline adherence. Interventions should focus on delivery of medical care and should target the medical practice or hospital unit, the physician, or other providers through, for example, policies, programs, resources, procedures, and/or education. A range of payment systems (fee-for-service, managed care, and public health) may be included as appropriate. Applications should contain a detailed description of the proposed intervention, which should be feasible for delivery in a medical-care setting, along with evidence of its feasibility in that setting. Phase 1 will comprise needs assessment for the purpose of refining intervention design and implementation plan. In Phase 2, the intervention strategies will be evaluated in controlled trials of physicians, practices, or clinics. The primary outcome measure should evaluate the impact of the intervention on physician or provider implementation of the selected guideline, using appropriate delivery (process of care) measures. 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 priority areas. This Request for Applications (RFA), Trials Assessing Innovative Strategies to Improve Clinical Practice through Guidelines, is related to the priority areas of access to high quality health services and heart disease and stroke. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) regular research grant (R01) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed 5 years. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator- initiated applications and be reviewed according to the customary peer review procedures. The anticipated award date is July 1, 2002. FUNDS AVAILABLE The National Heart, Lung, and Blood Institute intends to commit approximately $2,500,000 in FY 2001 to fund 6 to 10 new grants in response to this RFA. Approximately $24,000,000 in total costs is available over 5 years for this RFA program. An applicant may request a project period of up to 5 years. Budgets in excess of $500,000 direct costs per year must be strongly justified. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Specifically, the annual budgets for Phase 1 are anticipated to be lower than those of Phase 2. Although the financial plans of the NHLBI provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, there are no plans to reissue this RFA. RESEARCH OBJECTIVES Background Evidence-based clinical practice guidelines, as defined by the Institute of Medicine, "are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances." (1) Nearly all guidelines have been produced under the auspices of a relevant professional organization (e.g., medical specialty society, government agency, health care organization, or health plan). The guideline development process typically includes a verifiable, systematic literature search and review of existing evidence published in peer-reviewed journals to identify proven therapies and define their appropriate utilization. Guidelines must be applied based on individual patient needs using professional judgment. A substantial and well-controlled body of published evidence demonstrates that a number of therapies for heart, lung, and blood diseases are effective in reducing morbidity and mortality. Many national evidence-based guidelines have been developed for the treatment of cardiovascular, lung and blood diseases, yet they remain inadequately followed in routine clinical practice. Although many gaps remain in physicians' adherence to these guidelines, both the precise reasons for the gaps and the ways of closing the gaps remain uncertain. For example, large proportions of dyslipidemic patients receiving lipid-lowering therapy are not achieving National Cholesterol Education Program (NCEP) low-density lipoprotein cholesterol (LDL-C) target levels (2). Numerous randomized clinical trial results supported the development of national guidelines to administer beta-blockers shortly after acute myocardial infarction, but it has been reported that only about half of such patients are prescribed beta-blockers (3). These results could be extrapolated to estimate that 18,000 people die each year due, in part, to failure to receive beta- blockers after acute myocardial infarction (4). In addition, recent studies have demonstrated substantial differences in physician decision-making for cardiac diagnostic and therapeutic interventions after controlling or adjusting for socioeconomic status and reimbursement system. Disturbing differences by patient race and sex in referral for diagnostic cardiac testing have been seen when these were the only factors that differed among "hypothetical" patients (5). Utilization of proven therapies such as aspirin and beta-blockers after myocardial infarction has been demonstrated to be lower in minorities for no discernible reasons such as contraindications, co-existing illnesses, or inability to pay. Although these disparities in care among majority and racial/ethnic minorities have been clearly demonstrated, reasons behind them and possible avenues for modifying them have not. Recent studies have focused on the relation of patient-level factors as major determinants of such differences, more commonly patient demographics (e.g., those which lead to disparities), less often patient knowledge and attitudes or those of the patient's family. However, the physician, other providers, and the health care system have rarely been closely examined. Most studies of barriers to implementation of guidelines have been limited to examining a single barrier (6). Barriers can be classified into categories including awareness, familiarity, agreement, self-efficacy, outcome expectancy, inertia, external or systemic, and environmental factors (6). Physician treatment decisions and their implementation may be influenced by cognitive and affective processes, even if evidence-based practice guidelines exist. It seems unlikely that major initiatives to reduce health disparities and improve medical care can be successful while so little is known of the reasons for differences in use of effective treatments, especially regarding potentially modifiable factors such as physician knowledge, attitudes, and behaviors. While health care organizations are required by accrediting bodies to conduct quality assurance and quality improvement activities, they are rarely developed using systematic data collection or evaluated using an intervention trial framework. Additionally, few studies have been supported to develop and evaluate interventions to promote more widespread adoption of evidence-based clinical treatment guidelines in medical practice. Areas of Emphasis This RFA will support a series of studies to evaluate innovative strategies to improve implementation of national, evidence-based clinical guidelines for the care of one or more target conditions, limited to heart, lung or blood diseases or conditions. Excluded are guidelines that are not national (including those developed for specific health care delivery institutions), based in countries other than the United States, not clinical or targeted only at patients. Clinical guidelines developed by the NHLBI, which can be accessed at http://www.nhlbi.nih.gov/guidelines/index.htm, are of particular interest. Examples of guideline topics include, but are not limited to, the following: o beta blocker, aspirin, blood pressure control, and lipid reduction in post-myocardial infarction patients; o blood pressure control in older adults; o thrombolytic therapy after acute myocardial infarction; o hydroxyurea therapy in sickle cell disease; o the use of iron chelation therapy in thalassemia; o use of inhaled corticosteroids to treat patients with persistent asthma and o directly observed therapy for tuberculosis. Target of intervention The intervention must be designed to target primarily the physician, provider or system level (e.g., policies, programs, resources and/or procedures at the practice or hospital unit level), to enhance the appropriate utilization of specific clinical guidelines for patient care. Justification for selection of a particular guideline should be provided, as should justification for the specific physician or provider group(s) to be targeted, for example, documentation of low guideline adherence for the proposed condition or treatment to be studied. Grant applications are sought from investigators at primary care clinics, managed care organizations and hospitals with large, stable patient populations and significant proportions of minorities and patients with the target conditions, or from academic institutions working collaboratively with such institutions. Applications should provide detailed information on the physicians, other health care providers, and medical systems to be studied. Applications should also provide detailed information on the patient population. Project Phases Applications in response to this RFA have 2 phases; all must propose research to evaluate interventions that seek to improve clinical guideline implementation for heart, lung, or blood diseases or conditions. Phase 1 is intervention refinement and Phase 2 is intervention implementation and evaluation. Applicants should describe the proposed intervention in their application, although some refinements may be made based upon the needs assessment. Applicants should present available background material relevant to the proposed intervention, and in certain instances may be able to justify an innovative quality improvement intervention (Phase 2) that can be implemented with a relatively brief Phase 1. The application must specify the condition(s) to be studied, the guideline to target, details of the proposed intervention, needs assessment approaches for refining the intervention, and the proposed analyses. Detailed justification for sample sizes for both phases is required, as are assurances that project sample sizes can be obtained. Phase 1: Intervention refinement Phase 1 will use needs assessment approaches to identify barriers to guideline implementation and adherence, factors enhancing guideline adherence, and best practices in an effort to refine the intervention. Needs assessment may include interviews, surveys, or focus groups of providers, patients, or others. Physician and other health care provider assessments may include: 1) knowledge of, attitudes toward, and beliefs regarding risk, presentation, and course of target conditions and any differences in these by race/ethnicity or other patient characteristics; 2) knowledge of, attitudes toward, and beliefs regarding current treatment strategies, their efficacy for the target conditions, and the evidence base for current treatment guidelines; 3) attitudes toward importance of diagnosing or treating disorders in racial/ethnic minorities, women, and older adults; 4) concerns about a patient's ability to reimburse the provider for expensive care; 5) time pressures and other professional demands; 6) perceived incentives; and 7) relevant skills. Prescribing patterns of physicians and other characteristics such as their care setting, mode of reimbursement, subspecialty training and years since training completed may also be examined for relationships to care delivered to various patient groups. Phase 1 will also refine the intervention design and the intervention implementation strategies, for example, through pilot testing. The focus of this RFA is provider behavior, however, in addition to proposing a provider study, investigators may propose to conduct limited patient needs assessments that are directly relevant to the patient-physician interaction for the target condition or to the targeted physician behavior. For example, patient data could include: 1) demographic and socioeconomic factors; 2) insurance status and access to health care; 3) current health status and treatment; 4) social support, self-efficacy, and care-giving status; 5) knowledge of risk factors and manifestations of target conditions; 6) understanding of effective treatments, their costs and adverse effects; and 7) attitudes toward treatment, prevention, and health care providers. It may be helpful to include family members (spouses, parents of young patients or offspring of elderly patients) in the needs assessment process. Health care decision-makers or administrators may be interviewed one-on-one or in focus groups to understand their knowledge, perceptions or beliefs about barriers to guideline implementation or adherence, and contributing factors. Secondary analysis of existing data on, for example, prescribing patterns, use of procedures, or other topics, may be used when available data permit. Phase 2: Intervention Implementation and Evaluation Applicants should specify the intervention to be evaluated in Phase 2, which will be refined using the results of the needs assessment and feasibility assessment. The intervention should address multiple barriers to guideline implementation or factors enhancing guideline adherence. It is desirable that a range of payment systems (fee-for-service, managed care, and public health) be included as appropriate. Applicants should propose an innovative approach to enhancing implementation of guidelines by physicians or providers, either by tailoring a proven guideline implementation method to achieve special needs (i.e., specialty or practice-specific needs) OR by using a novel intervention that, while based in theory and supported by previous literature in the area, represents a new approach that is uniquely suited to the specific clinical area. Examples of interventions follow, but are not a restrictive list. Approaches could include incentives directed at the physician, reminder systems, or use of case managers. Physician-oriented interventions may include use of opinion leaders, academic detailing, educational strategies, use of incentives, or physician-directed reminder systems. Patient-oriented approaches should be directed at changing or influencing physician or provider behavior, for example, empowerment strategies. Design of evaluation and outcomes The interventions should be evaluated in at least 4 practices or clinics. The study design should be a controlled trial or quasi-experimental study, with allocation of physicians, practices or clinics to intervention and comparison groups by the investigator. Although the design should match the intervention focus (e.g., physician-targeted interventions randomize physicians, practice- targeted interventions randomize practices, etc.) the design should also minimize or prevent contamination of the comparison group, which may mean allocating at a higher level. The unit of assignment should be the unit of analysis, and the statistical analysis and power calculations should match the design, i.e., they should take into account the unit of assignment. A single primary outcome should be specified. If multiple primary outcomes are desired, adjustment for multiple comparisons should be made. The objective of the intervention to be evaluated and the primary outcome of interest should be provider behavior with respect to the appropriate utilization of evidence- based guidelines. Appropriate delivery (process of care) measures may be obtained from medical record review, administrative data, or patient report, depending upon the condition selected for study. Secondary outcomes, if any, and the process evaluation methods for phase 2 should be specified. Cost- effectiveness analysis is encouraged as a secondary outcome. Recommendations for responsiveness Applicants responding to this solicitation must propose a study that evaluates the effects of an innovative quality improvement intervention on clinical practice. The proposed research must evaluate interventions that seek to improve implementation of a national evidence-based clinical practice guideline for the treatment of heart, lung or blood diseases and conditions. Adopting the following recommendations will strengthen an application and make it more competitive: o The study population should be physicians and/or other health care providers, and should be characterized with respect to mode of practice and payment system. o The selection of clinical guideline should be justified, based upon its source, evidence basis, and relevance to the clinical site and patient population. o The measurement of provider behavior should be based upon well-defined, valid and reliable instruments. The primary outcome measure should evaluate the impact of the intervention on the providers implementation of the selected guideline, using appropriate delivery of care measures obtained from record review, administrative data or patient reports, depending upon the condition selected for study. o The application should propose a specific randomized or quasi- experimental design to evaluate the effectiveness of one or more innovative practice improvement strategies. o Evidence of the feasibility of the intervention(s), its acceptability to the clinicians who will be targeted, and its ability to address the particular barriers to guideline implementation or factors enhancing guideline adherence, relevant to the population selected, should be provided. o Substantial data should be provided on the magnitude of the health problem in the specified clinical population, treatment practices, adherence to guidelines by providers, characteristics of the patient population, the data sources available, previous approaches to intervention, and needs assessment. Project Schedule The maximum duration of the proposed research will be five years. Variations in the project length within this period and variations of program phases may occur due to differences in the time needed for recruitment, intervention, and follow-up. For certain topics, Phase 1 information may already be available, and can be presented in the application in support of the need for the Phase 2 study. The projected timetable is: Phase 1 (up to 2 years): Needs assessment for protocol refinement, intervention refinement, piloting of interventions in selected practice settings. Phase 2 (2 to 4 years): Recruitment of practice settings and physicians, allocation, intervention delivery and follow-up, measurement, preliminary data analysis Close-out (6 months to 1 year): Final data analysis and publication REFERENCES 1) Institute of Medicine. (1990). Clinical Practice Guidelines: Directions for a New Program. M.J. Field and K.N. Lohr (eds.) Washington, DC: National Academy Press (page 39). 2) Pearson TA, Laurora I, Chu H, Kafonek S. The lipid treatment assessment project (L-TAP): a multicenter survey to evaluate the percentages of dyslipidemic patients receiving lipid-lowering therapy and achieving low- density lipoprotein cholesterol goals. Arch Intern Med. 2000;160:459-467. 3) McLaughlin TJ, Soumerai SB, Willison DJ, et al. Adherence to national guidelines for drug treatment of suspected acute myocardial infarction: evidence for undertreatment in women and the elderly. Arch Intern Med 1996;156:799-805. 4) Soumerai SB, McLaughlin TJ, Spiegelman D, Hertzmark E, Thibault G, Goldman L. Adverse outcomes of underuse of beta-blockers in elderly survivors of acute myocardial infarction. JAMA 1997; 277:115-21. 5) Schulman KA, Berlin JA, Harless W, et al. The effect of race and sex on physicians' recommendations for cardiac catheterization. N Engl J Med. 1999 Feb 25;340(8):618-26. 6) Cabana MD, Rand CS, Powe NR, Wu AW, Wilson MH, Abboud PA, Rubin HR. Why don't physicians follow clinical practice guidelines? A framework for improvement. JAMA 1999;282:1458-65. SPECIAL REQUIREMENTS Annual meetings Applicants funded under this RFA will be required to attend meetings in which study plans, findings and issues of common interest and concern will be shared and discussed. Investigators will meet: (1) at the beginning of funding to discuss study plans and share problems and solutions; (2) annually until the end of the study, to share experiences in the needs assessment, design, recruitment and implementation of the interventions; (3) after completion of the analyses to share results and materials. Applications should include in their budgets funds for attending (1) an initial meeting at or near the time of award; (2) an annual meeting thereafter until the end of funding. For budgeting purposes, applicants should assume that the meetings would be for 2 days in Bethesda, MD, at the National Institutes of Health and require the attendance of the Principal Investigator and up to one other person. Use of existing studies Applicants should consider taking advantage of other projects (e.g. quality improvement projects) that could be expanded by adding a randomized or quasi- experimental design with an evaluative component. Such projects might provide access to unique populations as well as reduce the costs of conducting research. Final report At the completion of the project, the Principal Investigator (PI) must provide a report to the NHLBI Project Office with: (1) detailed recommendations concerning the practice improvement intervention(s) evaluated, based on the study's findings; (2) a complete description of the intervention(s) used in the study, to include a description of the rationale for the intervention(s), a description of the intervention procedures used (e.g., manual of procedures), and any intervention materials used; (3) training, certification, and quality control procedures for ensuring effective implementation of the practice improvement intervention(s); and (4) description of how the interventions could be tailored for other modalities, populations, or diseases. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. Please specify the approximate percentage of women and each minority group expected in the total sample. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the Inclusion of Children as Participants in Research Involving Human Subjects that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at: http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, it is very important to NHLBI because the information that it contains allows Institute staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to Dr. Beebe at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and 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, email: GrantsInfo@nih.gov. Budgets should be in the standard (non-modular) format with a detailed budget, because it is expected that budgets for the Phase 2 years of the project will exceed $250,000 in annual direct costs. The RFA label available in the PHS 398 (rev. 4/98) at http://grants.nih.gov/grants/funding/phs398/phs398.html application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The 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. Please note that color figures or photos present in the body of the grant application should also be present in the appendix, or high-quality reproductions of the pages containing color or half-tone figures should be included in the appendix. The reviewers will receive a black-and-white copy of the grant application together with the appendix. 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 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application as well as all five collated sets of Appendix material must be sent to Dr. Deborah Beebe at the address listed under INQUIRIES. It is important to send these copies at the same time that the original and three copies are sent to the Center for Scientific Review (CSR). Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Principal investigators should not sent supplementary material without first contacting the Scientific Review Administrator (SRA). The SRA will be identified in the letter sent to you indicating that your application has been received. If you have not yet received such a letter, contact, Dr. Deborah Beebe at the address listed under Inquiries. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NHLBI staff. 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 by an appropriate peer review group convened by the NHLBI in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the NHLBI National Advisory Council. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application 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 in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies 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 project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project propose an innovative approach to enhancing implementation of guidelines by physicians or providers, either by tailoring a proven guideline implementation method to achieve special needs (i.e., specialty or practice-specific needs) OR by using a novel intervention that, while based in theory and supported by previous literature in the area, represents a new approach that is uniquely suited to the specific clinical area? (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 (if any)? (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) Translation: Do the intervention strategies evaluated have the ability to be translated into primary care settings (e.g. by using interventions that address generalist physicians, or that make use of providers other than physicians) or to be broadly applied by the target specialty (e.g., for critical care or emergency medicine)? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. Schedule Letter of Intent Receipt Date: September 12, 2001 Application Receipt Date: October 12, 2001 Peer Review Date: February/March 2002 Council Review: May 9-10, 2002 Earliest Anticipated Start Date: July 1, 2002 AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Marcel E. Salive Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute National Institutes of Health Rockledge 2, Room 8126, MSC 7936 6701 Rockledge Drive Bethesda, MD 20892 Telephone: (301) 435-0380 FAX: 301-480-1669 Email: SaliveM@nih.gov Ms. Virginia Taggart Division of Lung Diseases National Heart, Lung, and Blood Institute National Institutes of Health Rockledge 2, Room 10214 6701 Rockledge Drive Bethesda, MD 20892 Telephone: (301) 435-0202 e-mail: TaggartV@nih.gov Ms. Carol Webb Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute National Institutes of Health Rockledge 2, Room 9174 6701 Rockledge Drive Bethesda, MD 20892 Telephone: (301) 435-0515 e-mail: WebbCA@nhlbi.nih.gov Dr. Duane Bonds Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute National Institutes of Health Rockledge 2, Room 10148 6701 Rockledge Drive Bethesda, MD 20892 Telephone: (301) 435-0055 FAX: (301) 480-0868 e-mail: BondsD@nhlbi.nih.gov Direct inquiries regarding review issues and letter of intent, and send two copies of the application to: Dr. Deborah Beebe Chief, Review Branch Division of Extramural Affairs NHLBI, NIH 6701 Rockledge Drive Room 7178 Bethesda, MD 20892-7924 (20817 for express mail) Telephone: 301-435-0270 FAX: 301-480-3541 e-mail: BeebeD@nhlbi.nih.gov Direct inquiries regarding fiscal matters to: Ms. Carol Dangel Grants Operations Branch, Division of Extramural Affairs National Heart, Lung, and Blood Institute National Institutes of Health 6701 Rockledge Drive, Room 7140, MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0177 Email: DangelC@nhlbi.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.937, (NHLBI). Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 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 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.


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