[Federal Register: July 14, 1997 (Volume 62, Number 134)] [Notices] [Page 37645-37650] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr14jy97-150] [[Page 37645]] _______________________________________________________________________ Part II Department of Education _______________________________________________________________________ National Institute on Disability and Rehabilitation Research; Final Funding Priority for Fiscal Years 1997-1998 for a Rehabilitation Research and Training Center and Availability of Applications; Notices [[Page 37646]] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF EDUCATION National Institute on Disability and Rehabilitation Research Final Funding Priority for Fiscal Years 1997-1998 for a Rehabilitation Research and Training Center AGENCY: Department of Education. ACTION: Notice of a Final Funding Priority for Fiscal Years 1997-1998 for a Rehabilitation Research and Training Center. ----------------------------------------------------------------------- SUMMARY: The Secretary announces a final funding priority for the Rehabilitation Research and Training Center (RRTC) Program under the National Institute on Disability and Rehabilitation Research (NIDRR) for fiscal years 1997-1998. The Secretary takes this action to focus research attention on an area of national need to improve rehabilitation services and outcomes for individuals with disabilities, and to assist in the solutions to problems encountered by individuals with disabilities in their daily activities. EFFECTIVE DATE: This priority takes effect on August 13, 1997. FOR FURTHER INFORMATION CONTACT: David Esquith. Telephone: (202) 205- 8801. Individuals who use a telecommunications device for the deaf (TDD) may call the TDD number at (202) 205-2742. Internet: David__Esquith@ed.gov SUPPLEMENTARY INFORMATION: This notice contains a final priority to establish an RRTC for research related to medical rehabilitation services and outcomes. This final priority supports the National Education Goal that calls for all Americans to possess the knowledge and skills necessary to compete in a global economy and exercise the rights and responsibilities of citizenship. Note: This notice of final priority does not solicit applications. A notice inviting applications under this competition is published in a separate notice in this issue of the Federal Register. Analysis of Comments and Changes On April 21, 1997, the Secretary published a notice of proposed priority in the Federal Register (62 FR 19437-19438). The Department of Education received 22 letters commenting on the notice of proposed priority by the deadline date. Technical and other minor changes--and suggested changes the Secretary is not legally authorized to make under statutory authority--are not addressed. Rehabilitation Research and Training Centers Priority: Medical Rehabilitation Services and Outcomes Comment: Three commenters supported maintaining the priority's conceptual framework of addressing the topics of medical rehabilitative service delivery and functional assessment and outcome measurement in one RRTC. Twelve commenters suggested that NIDRR fund two centers instead of one. The commenters who supported establishing two centers indicated that one center would not be able to organize sufficient expertise to address all the priority's purposes adequately and that the unique aspects of the two topics require separate research activities. Discussion: The subject of the priority is improving medical rehabilitation services delivery and outcomes. Appropriate use of valid functional assessment measures is one important element toward improving services as well as justifying the availability, utilization, and financing of those services. This is a dynamic field and linking the assessment of functional outcomes with the medical rehabilitation services in which they will be used, while presenting many challenges to the RRTC, reflects the challenges that are occurring in the field of medical rehabilitation services. RRTCs conduct coordinated and advanced programs of research targeted toward the production of new knowledge to improve both rehabilitation methodology and services. In this priority, improved measurement of outcomes is a vital area of need for methodological research. There is a need for improved use of outcome measures to assess medical rehabilitation services. The RRTC will need to assemble and coordinate the work of experts from diverse fields. While this is a demanding undertaking, it is feasible and necessary in order to fulfill the purposes of the RRTC. NIDRR emphasizes the importance of involving a range of disciplines and collaborative efforts in centers of excellence. In regard to whether the unique aspects of the two topics require separate RRTCs, applicants have the discretion to propose specific research and training activities that will define the parameters of the RRTC. The priority and application evaluation process are designed to provide applicants with the freedom to address unique aspects of one or more issues. It is not necessary to establish two RRTCs in order to fulfill the purposes of the priority. Changes: None. Comment: The third purpose should focus on the development and validation of methods to evaluate the cost effectiveness and impact on functional performance of specific rehabilitation interventions in diverse settings and populations. The database elements and standards tasks that make-up part of the third purpose are independent of the development of measures. Discussion: The RRTC is intended to improve rehabilitation services and service delivery, applying measures of functional outcomes as a key strategy in this endeavor. Uniform database elements and standards are prerequisites to implementing any system of functional outcome measures in service delivery systems. Changes: None. Comment: One commenter suggested that methods are needed that will provide consumer perspectives on functional abilities and outcomes as well as the effectiveness of interventions. The commenter also indicated that methods are also needed to support the consumer in decision making about interventions including choices about appropriate rehabilitation settings and timing of service delivery, accommodations in the physical environment, and caregiver assistance options. A second commenter suggested that the priority should connect measures of specific disabilities or performances with the person's own values and perceptions. Discussion: All RRTCs are required to involve individuals with disabilities and, if appropriate, their family members, as well as rehabilitation service providers, in planning and implementing the research and training programs, in interpreting and disseminating the research findings, and in evaluating the Center. This requirement is sufficient to ensure that the RRTC addresses consumer perspectives on functional abilities and outcomes, the effectiveness of interventions, decision making about interventions, and the connection between measures of specific disabilities or performances with the person's own values and perceptions. Changes: None. Comment: The sixth purpose should be deleted from the priority because it is substantially different than the priority's main emphasis. Discussion: The emphasis of the sixth purpose relates to medical rehabilitation services system applications. The sixth purpose is necessary because it connects the RRTC's work on functional outcome measures to applied service settings. [[Page 37647]] Changes: None. Comment: The RRTC should establish a health policy research fellowship program targeted to people with disabilities seeking to become proficient in health policy research at either the masters or doctoral level within the context of a university-based degree-granting program. Discussion: The priority does not provide the RRTC with the authority to establish a research fellowship program on the general subject of health policy research. An applicant could propose to establish a research fellowship program related directly to medical rehabilitation services and outcomes. The peer review process will evaluate the merit of the proposal. Changes: None. Comment: Many commenters suggested numerous specific activities for the RRTC to carry out. These suggestions include, but are not limited to, developing a theoretical or conceptual model of the disablement process, establishing an interdisciplinary panel of experts to review and author a series of papers summarizing the state of science in their area of expertise and disseminate the papers, studying and emphasizing the relationship between treatment process to patient outcomes, and creating a common metric scale or platform for all functional disabilities. Discussion: Applicants have the discretion to propose the specific activities that the RRTC will undertake in order to fulfill the purposes of the RRTC as set forth in the priority. Providing this degree of discretion to applicants is an acknowledgement of the wide range of approaches that applicants could take. The peer review process will determine the merits of the suggested activities. Changes: None. Comment: The government should insist that any instruments that are developed through grant funds are placed in the public domain. Discussion: According to the Education Department General Administrative Regulations, the Federal government has the right to obtain, reproduce, publish, or otherwise use data first produced under an award, and authorize others to receive, reproduce, publish, or otherwise use these data for Federal purposes. NIDRR is planning to convene a public meeting to inform its decision making on this important issue as it relates to this and other grants. Changes: None. Comment: The terms ``rehabilitation centers'' and ``community- based'' appear in the background statement, but are not defined. It would be helpful if they were defined. Discussion: These terms, and many others that appear in the priority, are not defined in order to provide applicants with the option of proposing their own definitions if they consider it necessary. The peer review process will determine the merits of any proposed definition. Changes: None. Comment: This Center, and others, should publish their research findings in refereed journals. Discussion: The quality of an applicant's proposed dissemination activities are evaluated in the peer review process using applicable selection criteria. No further requirements are necessary. Changes: None. Comment: The reference to telemedicine and multimedia technology is overly prescriptive and should be deleted from the first purpose. Discussion: Community-based rehabilitation settings that use telemedicine and multimedia technology are increasingly common. If the RRTC did not include these settings in their research, the applicability of the research that it carries out under the first purpose would be significantly restricted. Changes: None. Comment: The second purpose should be revised to require the RRTC to develop and validate measures of social and physical environments, and evaluate the ways in which social and physical environments limit or enhance the community participation of medical rehabilitation service recipients. Discussion: The essential difference between the commenter's suggestion and the second purpose as set forth in the priority is that the commenter's suggestion focuses on the ``community participation'' of medical rehabilitation service recipients. An applicant could propose to emphasize community participation under the second purpose, and the peer review process will evaluate the merits of the emphasis. Changes: None. Comment: The third purpose should be revised to address evaluation activities rather than the development of the database elements and the fourth purpose should be revised to address how accrediting bodies can serve to enhance routine measurement. Discussion: Applicants have the discretion to propose to emphasize sundry aspects of a purpose. An applicant could propose to emphasize the evaluation components of the third purpose and propose to address how accrediting bodies can serve to enhance routine measurement under the fourth purpose. The peer review process will evaluate the merits of the proposals. Changes: None. Comment: Four commenters stated that the required purposes under the priority did not address sufficiently the problems discussed in the background statement related to changes in the organization and delivery of medical rehabilitation services. For example, one commenter suggested that the RRTC should document trends in the consolidation of medical rehabilitation services and evaluate the impact of those trends. Discussion: NIDRR assumed that these organization and service delivery issues would be addressed by applicants under existing requirements in the priority. NIDRR agrees with the commenters that the priority as written does not ensure that the RRTC will address these important topics. Changes: A new purpose has been added to the priority that focuses on issues of the organization, financing, and delivery of services, the impact of managed care on the delivery of medical rehabilitation services, consumer access to services, and the capacity of the field of medical rehabilitation. Comment: Two commenters suggested that the priority should identify the most important gaps in current outcome measurement systems and the need for better measures or methods of estimation of severity and case mix. Discussion: Under the first and second purposes, respectively, applicants could propose to identify and address the most important gaps in current outcome measurement systems and develop better measures or methods of estimation of severity and case mix. The peer review process will evaluate the merit of the activities. Changes: None. Comment: It is not necessary to conduct pilot projects in purpose four in order to fulfill the purpose's purpose. The RRTC should conduct research on obstacles to the use of validated functional outcome measures and identify strategies to overcome these obstacles and enhance valid use of these measures. Discussion: The commenter is correct that pilot projects are not the only means that could be used to identify and evaluate strategies to evaluate obstacles in the use of validated functional outcome measures. Applicants should be given the discretion to propose means to evaluate the strategies developed to identify [[Page 37648]] obstacles in the use of validated functional outcome measures. Changes: The requirement to conduct pilot projects has been eliminated from the fourth purpose. Comment: Instead of emphasizing the development of strategies for determining the long-term results of rehabilitation, the fifth purpose should identify factors that affect whether the results of medical rehabilitation are sustained in the community over the long term, identify linkages between short and long-term outcomes and methods of improving and sustaining rehabilitation outcomes in the long term. Discussion: There a large number of social, economic, and physical factors that could affect whether the results of medical rehabilitation are sustained in the community over the long term. The resources that would be necessary to properly carry out the commenter's suggestion are beyond those that will be provided to the RRTC without significantly limiting its capacity to carry out the RRTC's other purposes. An applicant could propose to identify linkages between short and long- term outcomes and methods of improving and sustaining rehabilitation outcomes in the long term. The peer review process will evaluate the merits of the proposal. Changes: None. Comment: The RRTC should hold a third conference on the cost- benefit and cost-effectiveness of medical and vocational rehabilitation. Discussion: The priority requires the RRTC to support two national conferences. An applicant could propose to support additional conferences, and the peer review process will evaluate the merits of the proposal. Changes: None. Comment: NIDRR should expand the RRTC to address the rehabilitation needs of individuals who are disabled by land mines. Discussion: The rehabilitation needs of individuals who are disabled by land mines is outside the scope of the priority. In developing future priorities, NIDRR will consider the rehabilitation needs of individuals who have been disabled by land mines. Changes: None. Rehabilitation Research and Training Centers Authority for the RRTC program of NIDRR is contained in section 204(b)(2) of the Rehabilitation Act of 1973, as amended (29 U.S.C. 760- 762). Under this program the Secretary makes awards to public and private organizations, including institutions of higher education and Indian tribes or tribal organizations for coordinated research and training activities. These entities must be of sufficient size, scope, and quality to effectively carry out the activities of the Center in an efficient manner consistent with appropriate State and Federal laws. They must demonstrate the ability to carry out the training activities either directly or through another entity that can provide that training. The Secretary may make awards for up to 60 months through grants or cooperative agreements. The purpose of the awards is for planning and conducting research, training, demonstrations, and related activities leading to the development of methods, procedures, and devices that will benefit individuals with disabilities, especially those with the most severe disabilities. Under the regulations for this program (see 34 CFR 352.32) the Secretary may establish research priorities by reserving funds to support particular research activities. Description of the Rehabilitation Research and Training Center Program RRTCs are operated in collaboration with institutions of higher education or providers of rehabilitation services or other appropriate services. RRTCs serve as centers of national excellence and national or regional resources for providers and individuals with disabilities and the parents, family members, guardians, advocates or authorized representatives of the individuals. RRTCs conduct coordinated and advanced programs of research in rehabilitation targeted toward the production of new knowledge to improve rehabilitation methodology and service delivery systems, to alleviate or stabilize disabling conditions, and to promote maximum social and economic independence of individuals with disabilities. RRTCs provide training, including graduate, pre-service, and in- service training, to assist individuals to more effectively provide rehabilitation services. They also provide training including graduate, pre-service, and in-service training, for rehabilitation research personnel and other rehabilitation personnel. RRTCs serve as informational and technical assistance resources to providers, individuals with disabilities, and the parents, family members, guardians, advocates, or authorized representatives of these individuals through conferences, workshops, public education programs, in-service training programs and similar activities. NIDRR encourages all Centers to involve individuals with disabilities and minorities as recipients in research training, as well as clinical training. Applicants have considerable latitude in proposing the specific research and related projects they will undertake to achieve the designated outcomes; however, the regulatory selection criteria for the program (34 CFR 352.31) state that the Secretary reviews the extent to which applicants justify their choice of research projects in terms of the relevance to the priority and to the needs of individuals with disabilities. The Secretary also reviews the extent to which applicants present a scientific methodology that includes reasonable hypotheses, methods of data collection and analysis, and a means to evaluate the extent to which project objectives have been achieved. The Department is particularly interested in ensuring that the expenditure of public funds is justified by the execution of intended activities and the advancement of knowledge and, thus, has built this accountability into the selection criteria. Not later than three years after the establishment of any RRTC, NIDRR will conduct one or more reviews of the activities and achievements of the Center. In accordance with the provisions of 34 CFR 75.253(a), continued funding depends at all times on satisfactory performance and accomplishment. General: The following requirements will apply to these RRTCs pursuant to the priorities unless noted otherwise: Each RRTC must conduct an integrated program of research to develop solutions to problems confronted by individuals with disabilities. Each RRTC must conduct a coordinated and advanced program of training in rehabilitation research, including training in research methodology and applied research experience, that will contribute to the number of qualified researchers working in the area of rehabilitation research. Each RRTC must disseminate and encourage the use of new rehabilitation knowledge. They must publish all materials for dissemination or training in alternate formats to make them accessible to individuals with a range of disabling conditions. Each RRTC must involve individuals with disabilities and, if appropriate, their family members, as well as rehabilitation service providers, in planning and implementing the research and training programs, in interpreting [[Page 37649]] and disseminating the research findings, and in evaluating the Center. Priorities: Under 34 CFR 75.105(c)(3), the Secretary gives an absolute preference to applications that meet one of the following priorities. The Secretary will fund under these competitions only applications that meets this absolute priority: Priority: Medical Rehabilitation Services and Outcomes Background Medical rehabilitation services are provided to individuals with disabilities to restore maximum function and independence. Traditionally, these services were provided by physicians, nurses, and allied health professionals in hospitals and rehabilitation centers. Medical rehabilitation service consumers comprise a wide range of diagnostic groups including individuals with stroke, orthopedic conditions, brain injury, spinal injury, and neurologic conditions. The need for medical rehabilitation services for persons with disabilities is expected to continue to grow in the coming decades because of increased chances of survival after trauma, disease, or birth anomaly, increased prevalence of disability related to the general aging of the population, and the increased incidence of individuals with disabilities acquiring secondary disabilities or chronic conditions as a result of increased longevity. Despite large growth projections, the impact of the projected increase in need for medical rehabilitation has not been extensively investigated in relation to long-term costs and outcomes. Changes in the organization and delivery of health services issues are having a significant impact on the delivery and outcomes of comprehensive medical rehabilitation services. Recent trends, such as decreased length of stay associated with the high costs of inpatient care, have contributed to the growth of rehabilitation programs in sub- acute facilities, such as skilled nursing homes, and increased use of outpatient and home health care. Many rehabilitation hospitals, as well as medical rehabilitation programs within hospitals, have been influenced significantly by program consolidations, changes in ownership, third-party reimbursement provisions, and related factors that have decreased the number of beds and the average length of patient stay. At the same time, demand is increasing for sub-acute rehabilitation and general outpatient physical medicine (``Adapting to a Managed Care World: The Challenge for Physical Medicine and Rehabilitation,'' Lewin-VHI Workforce Study, American Academy of Physical Medicine and Rehabilitation, 1995). The effectiveness of the treatments and therapeutic interventions that are generally used in clinical practice are, for the most part, not evaluated in terms of their impact on long-term functional outcomes or their cost. The cost-effectiveness and impact of alternative rehabilitative strategies should be evaluated rigorously in order to obtain information that will contribute to cost-effective, rational, and fair decisions regarding the provision of treatment and services. Medical rehabilitation services need an enhanced validated outcome measurement system to inform decisions in management issues facing health care consumers, providers, and insurers. Increasingly, payers are seeking to base decisions of whether to provide coverage for selected services or interventions on the basis of proven efficacy or cost-effectiveness as determined by rigorous scientific evidence such as that gained through randomized controlled trials. Functional Assessments (FAs) can be used to evaluate an individual's ability to carry out activities of daily living and instsrumental activities of daily living such as eating, bathing, moving from place to place, dressing, doing household chores or other necessary business, and taking care of personal hygiene. Data from FAs also are used to predict post-rehabilitation functioning, and to evaluate rehabilitation services. Improving rehabilitation practices and outcomes requires an ability to assess the status and changes in function in many areas. Multiple measures of function and activities of daily living are needed in all rehabilitation settings, including in the home and community. The increased use of telemedicine and multimedia technology is rapidly changing the manner in which functional assessment measures are generated and shared among members of the rehabilitation team. Functional outcome measures are of increasing importance in medical economics, benefits planning, managed care, and program evaluation (Ikegami, N., ``Functional Assessment and Its Place in Health Care,'' New England Journal of Medicine, Vol. 332, pgs. 598-599, 1995). There is a need to collect and analyze data to determine the organization and delivery of rehabilitative care, including parameters such as facility and program sizes (i.e., economies of scale) and the number and mix of health care providers needed to serve various disability groups. Few data are available to define optimal strategies for outpatient services, nor are there methods to apply FAs or gather patient outcome data in non-hospital settings. Improving rehabilitation medicine and ensuring that disabled individuals will have access to needed medical rehabilitation in the future requires: an ability to assess functional status and changes in status in many functional areas; the ability to evaluate rehabilitation outcomes for individuals with various diagnoses, characteristics, and interventions; and the ability to apply these measures in health services policy research in order to affect policy and funding decisions in the health care delivery context. In the past, NIDRR has supported the development and application of the ``Functional Independence Measure'' (FIM), a criterion-referenced scale that has been widely accepted in inpatient rehabilitation settings, and also the development of the ``Craig Handicap Assessment and Reporting Technique'' (CHART), which contains scales for assessing the World Health Organization (WHO) dimensions of handicap, and is currently being refined to measure cognitive components of handicap. NIDRR currently supports an RRTC on Functional Assessment that has contributed to the scientific measurement of medical rehabilitation through applications of the FIM, refinement of the CHART, and management and analysis of the Uniform Data System (UDS), a collection of data from the application of FIM measures in many institutions. Current measurement systems, such as the FIM and the UDS, have made significant contributions, but need modifications to increase their utility and applicability in the new environment of rehabilitation care. For example, many practitioners and theorists have suggested that the FIM does not make adequate provision for the role of assistive technology in attaining functional levels. Like the FIM, most functional assessment measurement systems were designed for use in an inpatient setting. These systems need to be evaluated and modified to measure functional status and functional change outside of hospital and clinical settings, either in community-based facilities or in real- world environments of daily living. The FIM, for example, needs further refinement to address the social and environmental dimensions of disablement. The UDS at present contains data on a limited number of disabilities, and those measurements again are not community-based. [[Page 37650]] NIDRR also has supported a center on medical rehabilitation services that has looked at factors such as supply and demand for rehabilitation facilities and practitioners, financing, and evaluation of the outcomes of rehabilitation medicine. This center has also addressed the changing context for the delivery of medical rehabilitation and access to medical rehabilitation by various population groups. Both of these centers have made contributions to the maturing of the field of medical rehabilitation and its ability to evaluate and document its interventions and outcomes. However, it is now clear that the field needs a larger and more integrated effort to refine measures of functional ability, changes in ability over the lifespan or in response to medical rehabilitation interventions, and to apply the measurement system in the changing environment in which medical rehabilitation is delivered. NIDRR therefore is proposing a large-scale effort to involve significant leaders in the classification and measurement of function, the evaluation of rehabilitation interventions, and the broader application of knowledge to the organization and management of medical rehabilitation services in today's environment. Priority: The Secretary will establish an RRTC for the purpose of examining the impact of changes in the field of rehabilitation medicine and developing improved measures for assessing individual function and the impact of medical rehabilitation services. The RRTC shall: (1) Identify and evaluate validated functional outcome measures that can be used or modified for assessing the impact of medical rehabilitation services in a wide range of rehabilitation settings, with particular emphasis on measures that can be adapted for use in outpatient and community-based settings, including those that use telemedicine and multimedia technology; (2) Develop or improve measures to assess the impact of the social and physical environment in achieving quality rehabilitation outcomes, including the use of assistive technology in attaining functional outcomes; (3) Identify or develop uniform database elements and standards based on validated individual measures at the person level for determining the cost-effectiveness and functional impact of specific rehabilitation interventions used by medical rehabilitation and allied-health disciplines across multiple settings and disability populations; (4) Identify obstacles to the use of validated functional outcomes measures in a wide range of settings in which medical rehabilitation services are provided, and in decisions to provide and assess the effectiveness of medical rehabilitation treatments, and develop and evaluate strategies to overcome those obstacles; (5) Identify strategies for determining the long-term results of medical rehabilitation care, including use of assistive technology; (6) Analyze how models for the organization of medical rehabilitation services affect outcomes and costs, and how the demographic, economic, and presenting conditions of consumers affect their utilization of rehabilitation services and the outcomes that are achieved; (7) Analyze the impact of new configurations of medical rehabilitation service delivery and financing, such as capitated managed care and risk adjustment strategies, on access to quality medical rehabilitation services; and (8) Develop an information dissemination and training program to enable consumers, providers, researchers, policy makers, and relevant others in health and rehabilitation settings to assess the quality of medical rehabilitation services. In carrying out the purposes of the priority, the RRTC shall: * Coordinate with rehabilitation medicine research and demonstration activities sponsored by NIDRR, including the RRTC on Health Care for Individuals with Disabilities--Issues in Managed Health Care, the National Center on Medical Rehabilitation Research, Veterans Administration, and the Health Care Financing Administration; and * Support two national conferences as follows: (1) a conference on the use of functional outcome measures to improve medical rehabilitation practices and interventions, and (2) a conference on improving validity and reliability in the measurement of rehabilitation outcomes. Applicable Program Regulations: 34 CFR Parts 350 and 352. Program Authority: 29 U.S.C. 760-762. (Catalog of Federal Domestic Assistance Numbers: 84.133B, Rehabilitation Research and Training Center Program) Dated: July 9, 1997. Judith E. Heumann, Assistant Secretary for Special Education and Rehabilitative Services. [FR Doc. 97-18418 Filed 7-11-97; 8:45 am] BILLING CODE 4000-01-P