CLINICAL TRIAL PLANNING GRANTS TO GUIDE TIMING, INTENSITY, AND DURATION OF REHABILITATION FOR STROKE AND HIP FRACTURE Release Date: September 20, 2001 RFA: RFA-HD-01-022 National Institute of Child Health and Human Development (http://www.nichd.nih.gov) Letter of Intent Receipt Date: January 18, 2002 Application Receipt Date: February 14, 2002 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING LESS THAN $250,000 PER YEAR IN ALL YEARS. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html. PURPOSE The purpose of the Clinical Trial Planning Grant is to provide support for the initial development and organization of an effective research team and the elements essential for conducting successful clinical trials. The National Center for Medical Rehabilitation Research (NCMRR) of the National Institute of Child Health and Human Development (NICHD) wishes to support clinical trials focused on evaluating the timing, intensity, and duration of rehabilitation interventions for stroke and hip fracture. Applications may address developing plans for patient recruitment, experimental design and protocols, testing of procedures, determining effect size in preparation for future clinical trials, data management, analysis techniques, facilities, administrative procedures, and collaborative arrangements. Detailed information regarding the rationale for the clinical trial based on preclinical and preliminary clinical research must be included in the application for the Clinical Trial Planning Grant. The purpose of the planning grant is, however, neither to obtain preliminary data nor to conduct studies to support the rationale for the clinical trial. 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) is related to one or more of the priority areas. Potential applicants may obtain "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and 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. Clinical trials planning support is for new projects and may not be used to supplement research projects already being supported or to provide interim support of projects under review. Simultaneous submissions of applications for both a planning grant under this RFA and standard clinical trial research grant (R01) on the same topic will not be accepted. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Exploratory/ Developmental Research Grant (R21) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This RFA is a one-time solicitation. Applicants may apply for continuation of projects developed under this program using traditional, unsolicited grant mechanisms (e.g., R01, P01). Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. Specific application instructions have been modified to reflect "MODULAR GRANT" and JUST-IN-TIME" streamlining efforts that have been adopted by the NIH. Complete and detailed instructions and information on Modular Grant applications have been incorporated into the PHS 398 (rev. 5/2001). Additional information on Modular Grants can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. FUNDS AVAILABLE The NICHD intends to commit approximately $1 million in total costs [direct plus Facilities and Administrative (F&A) costs] in FY 2002 to fund up to six new grants in response to this RFA. An applicant may request a project period of two years and a budget for direct costs of up to $100,000 per year. Although this program is provided for in the financial plans of the NICHD, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. RESEARCH OBJECTIVES Background Stroke and hip fracture are the leading health-care problems requiring rehabilitation services in older Americans. Both are common, enduring and expensive in terms of medical costs, rehabilitation costs, caregiving costs and lost productivity. Together, these two diagnoses account for the majority of days spent in rehabilitation, and are responsible for the largest expenditure of Medicare dollars spent in the area of rehabilitation. In the United States, the incidence of stroke is just over 500,000 individuals each year. Among those who survive stroke, 50 percent are alive more than five years after the event. The rehabilitation needs and goals of individuals with stroke vary considerably. For some, the goal may be to return to full independence and resumption of all previous life activities. For others, the goal may be to return home with family assistance. The challenge for the health care system is to determine the type and setting of rehabilitation that most effectively meet the needs of the individual. Rehabilitation is beneficial in promoting improvements in function areas such as mobility, performance of self- care and community integration. Important questions, however, remain regarding the effectiveness of individual treatment strategies, as well as the organization and intensity of rehabilitation services. The effectiveness of stroke rehabilitation must also consider the natural recovery that occurs following stroke, as well as the individual patient characteristics associated with functional outcome. In addition, stroke is a well-documented risk factor for hip fracture. Population studies suggest that the risk of fracture is increased approximately two- to four-fold. Hip fracture incidence increases exponentially with age for both men and women. Osteoporosis plays a central role in the pathogenesis underlying hip fracture. Although recent attention has focused on the growing array of pharmacologic agents that slow bone loss and reduce fracture risk, it is clear that large numbers of individuals will continue to experience hip fracture and that efficient and effective rehabilitation measures will become more important in the future. The annual number of hip fractures is expected to rise dramatically in the future with continued aging of the population. In the United States, for example, the number of individuals aged 65 years and over is expected to grow from 32 to 69 million between 1990 to 2050, while the number aged 85 years and over will grow from three to 15 million. Hip fracture in seniors is a serious and costly health problem, accounting for 350,000 hospital admissions each year. Americans spend more than $10 billion in direct cost of care for the 250,000 hip fractures that occur each year. Costs are expected to triple over the next 50 years. The majority of patients who sustain hip fracture are frail elderly with multiple comorbitities. The hip fracture itself imposes additional impairments and medical problems. Of note are the significant numbers of deaths directly attributed to hip fracture. In the initial stages of hip fracture recovery, emphasis traditionally has been placed on active range of motion exercises and functional training. Recent studies suggest that pre-fracture status may not be achievable in many patients. Rates of bone healing and reductions in average length of stay may preclude more aggressive rehabilitation during the sub-acute stay. Treatment to improve the ability to communicate and ambulate can dramatically increase the quality of life and functional independence for individuals following stroke or hip fracture. These factors underscore the need to determine efficacious rehabilitation strategies for these disorders. Patients beginning rehabilitation for either hip fracture or stroke, are faced with an imposing range of activities designed to help them regain lost skills or compensate for losses by acquiring new ones. Central to rehabilitation, is the primary goal of functional independence and return to pre-injury or pre-surgical status. The timing, intensity, and duration of therapeutic intervention influence how rapidly these rehabilitation goals are attained, affecting the duration and costs of care. Although these issues underlie medical rehabilitation practice, few studies have demonstrated the most appropriate treatment course to help guide clinical practice. Across the medical disciplines involved in the care of individuals with hip fracture or stroke, there is a lack of empirical evidence to demonstrate which components in the rehabilitation continuum are most critical. How best to maximize a patient’s ability to function in a given time frame has yet to be demonstrated empirically. Most obviously missing is information regarding the timing, intensity, and duration of treatment interventions. There is a paucity of empirical evidence regarding post-stroke rehabilitation. Because of the diversity of the needs and goals of the stroke population, there is little agreement among professionals as to treatment strategies, the efficacy of stroke rehabilitation, or desired outcomes. Neither is there clear evidence concerning the timing of interventions, nor the intensity of physical rehabilitation for patients following hip fracture. Different aspects of function appear to recover at different rates following hip fracture. What is the sequence by which different areas of function recover following hip fracture and how can this information be used to design/guide intervention? Can aggressive physical therapy directed to reduce the underlying impairment (strength and endurance) and regaining prior levels of activity be initiated earlier in the rehabilitation process. Is there an optimum time for aggressive intervention? Is twice-a-day physical therapy more effective than once-a-day? Is there a point in time when one or the other is more effective? The relationship among the timing, intensity, and duration of treatment is an issue that pervades all rehabilitation interventions. The importance and timeliness of this topic was highlighted at the NICHD Patient Learning During Medical Rehabilitation Conference (1998), the NICHD Hip Fracture and Stroke Conference (August 2000), as well as the National Consensus Conference on Improving the Continuum of Care for Patients with Hip Fracture (May 2001). The purpose of this initiative is to encourage studies that evaluate models of providing rehabilitation that consider timing, intensity, and duration of treatment. Patients with a diagnosis of hip fracture and/or stroke comprise the majority of patients admitted to rehabilitation units and, therefore, provide a good model for study. In addition, current practice has evolved in response to reimbursement guidelines, rather than clinical evidence. This RFA will build on the recommendations of these workshops and promote and support clinical research studies that will establish optimal delivery schedules and amount of rehabilitation services for patients in different diagnosis groups or categories. Research Scope Current constraints on clinical researchers make the complex and time-consuming process of planning Phase III clinical trials problematic, especially in the field of medical rehabilitation, where there is not a well-established clinical research infrastructure. These planning grants will provide a mechanism for early peer review of the rationale and design of the potential clinical trial, and provide successful applicants resources to assist development of detailed clinical trial study plans and collaborations. It is hoped that these Planning Grants will help to facilitate clinical trial projects in areas of research need relevant to the National Center for Medical Rehabilitation Research (NCMRR), NICHD. The range of activities that may be supported by this Clinical Trial Planning Grant includes: 1. Development of a detailed experimental design, including: translation of the clinical question into a statistical hypothesis, determination of the sample size and duration of the trial, selection of endpoint(s) and data to be collected, creation of inclusion/exclusion criteria. 2. Development of specific protocols, including: patient selection and informed consent procedures, randomization and masking procedures, data collection techniques, treatment administration and dose/quantity measurements, follow-up and quality control procedures. 3. Development of detailed plans for patient recruitment and retention, including women and minority individuals, and plans for recruitment outreach. 4. Identification of other personnel necessary to perform the proposed research, including statisticians, data managers, and study coordinators. 5. Identification of the physical resources necessary to perform the proposed research, including clinical space and equipment that are accessible to subjects and researchers with disabilities. 6. Selection of specific methods of data analysis. 7. Evaluation of models of the rehabilitation treatment process, including: involvement of various professional disciplines, team approaches, and treatment settings, coordination of health care systems and resources. 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 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. 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, published in the NIH Guide for Grants and Contracts, March 6, 1998, available on the Internet at: 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 INQURIES. Program staff may also provide additional relevant information concerning the policy. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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 this RFA. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NICHD staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to Dr. Beth Ansel at the address listed under INQUIRIES, below, by January 18, 2002. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable PDF format. Beginning January 10, 2002, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301-710-0267, Email: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and NIH staff. The research grant application form PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. Submission Instructions The RFA label available in the PHS 398 (rev. 5/2001) application form must be stapled to the bottom of the face page of the application and must display the RFA number HD-01-022. A sample RFA label is available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note this is in the pdf format. 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. 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 should be sent to: Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E03, MSC 7510 Bethesda, MD 20892-7510 Bethesda, MD 20852 (for express/courier service) Applications must be received by February 14, 2002. 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and for responsiveness to this RFA by NICHD. 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 NICHD in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and may 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 National Advisory Child Health and Human Development 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 frameworks, 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 employ novel 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 (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? In addition to the above criteria, in accordance with NIH policy, applications also will 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 also will 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 and the environment, to the extent they may be adversely affected by the project proposed in the application. SCHEDULE Letter of Intent Receipt Date: January 18, 2002 Application Receipt Date: February 14, 2002 Peer Review Date: June 2002 Council Review: September 2002 Earliest Anticipated Start Date: September 2002 AWARD CRITERIA 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 questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Beth M. Ansel, Ph.D., CCC-SLP Director, Clinical Practices Research Program National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 2A03, MSC 7510 Bethesda, MD 20892-7510 Telephone: 301-402-2242 FAX: 301-402-0832 E-mail: Beth_Ansel@nih.gov Direct inquiries regarding fiscal matters to: Christopher Myers Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17H, MSC 7510 Bethesda, MD 20892-7510 Telephone: 301-435-6996 FAX: 301-402-0915 E-mail: cm143g@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.929. 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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