kristoff@GENBANK.BIO.NET (Dave Kristofferson) (02/22/91)
EFFECTIVE DISSEMINATION OF HEALTH SERVICES RESEARCH FINDINGS AND
MEDICAL PRACTICE GUIDELINES
RFA AVAILABLE: AHCPR-91-01
P.T. 16; K.W. 0730050, 0730000, 0403004
Agency for Health Care Policy and Research
Application Receipt Dates: April 26, June 1, October 1, 1991,
and February 1, 1992
BACKGROUND
The Agency for Health Care Policy and Research (AHCPR) invites
applications to conduct applied research on effective
dissemination of clinical knowledge and medical practice
guidelines to effect changes in practitioner and consumer
behavior, improve patient outcomes and, thereby, improve the
effectiveness, quality, and appropriateness of health care. The
term "effective dissemination" encompasses the broader concept of
diffusion as well as the actual distribution of knowledge and new
information. Additionally, the process through which target
groups become aware of, receive, accept, and utilize disseminated
information and knowledge is reflected in this term.
AHCPR has lead responsibility for the Medical Treatment
Effectiveness Program (MEDTEP), a program of the Department of
Health and Human Services. Under MEDTEP, projects are supported
that systematically study the relationships between medical
treatments and procedures and its outcomes. Research findings
will be an important part of the knowledge base that will be used
by non-Federal experts to develop medical practice guidelines, as
mandated by Sections 903 and 914(c) of the Omnibus Reconciliation
Act of 1989 (P.L. 101-239).
Research conducted under the MEDTEP program addresses fundamental
questions about what difference medical care makes: Do patients
benefit? What treatments work best? Are health care resources
well spent? MEDTEP research projects build on work that
documents numerous and substantial variations in patterns of care
that can neither be attributed to patient need nor clearly linked
to patient outcomes (Wennberg, 1987; Connell, 1981). MEDTEP is
concerned with those practice variations that result from
uncertainty or controversy about the relative effectiveness or
appropriateness of alternative interventions, and those that
result from differences in the knowledge, skill, or "practice
styles" of health care providers. When practice variations are
associated with disparate patient outcomes, or equivalent
outcomes but significant differences in resource use, serious
questions arise about the quality, appropriateness, and cost
effectiveness of health care.
A critical assumption is that inappropriate practice patterns can
be changed if relevant scientific evidence is effectively
disseminated to health care providers and patients. There is
growing evidence that health care providers will voluntarily
change their practice patterns if they are made aware that the
patterns deviate markedly from local or national norms (Wennberg,
1977; Wennberg, 1984; McCormick, 1990). For example, recent
reports from hospitals in all parts of the country indicate that
educational forums to disseminate research findings on quality
and costs of care have led to voluntary reductions in practice
patterns (McCormick, 1990). A recent article that summarized the
literature on educational interventions to modify physician drug
prescribing behavior concluded that sustained change in physician
prescribing occurs, but only when information is provided to
physicians by physicians (Soumerai, 1990).
Although some health services research has occurred in the area
of dissemination of new knowledge, it has focused primarily on
the introduction of medical technology or the flow of new
information into practice. A substantial amount of research has
examined the role of continuing medical education (CME) in
providing physicians with new information and knowledge.
Research findings suggest that traditional CME programs tend to
be ineffective in changing physician behavior over time (Haynes,
et.al., 1984).
Research has begun to accumulate in the area of physician
behavior change resulting from the diffusion of new information
or medical practice guidelines. This literature has highlighted
the following:
o Studies examining the flow and utility of information to
physicians have emphasized: the inability to keep abreast of the
volume of literature; the uncertainty associated with applying
particular clinical research findings to medical practice; and
the uncertainty associated with continually changing clinical
findings of new studies. Peer review, journal articles,
interaction at professional meetings, and opinion leaders emerge
as key aspects of knowledge transfer and use and as potential
channels for dissemination (Backer, et. al., 1986; Backer and
Ohara, 1989; Greer, 1988; Lomas and Haynes, 1988).
o Issues related to the adoption of innovations by physicians in
hospital settings have been studied, focusing on the use of
computerized medical records in quality assurance programs to
provide feedback to physicians and other hospital staff (Lomas
and Haynes, 1988; McDonald, 1990). However, research is needed
on structural and process variables within a wide variety of
provider settings and how these variables can facilitate or
hinder the dissemination of new information and knowledge. These
variables include: multifaceted organizational relationships
within provider organizations; administrative governance; medical
direction; type of medical equipment available within an
institution; degree of compliance with recommended guidelines;
and level of internal communication. These variables are often
important considerations when examining outcomes of care, and
they can be critical factors affecting the capacity to
disseminate clinical information and medical practice guidelines.
o More recent literature has focused on changes in physician
behavior as a result of dissemination of medical guidelines and
diffusion of new medical information and related research
findings. An assessment of the Consensus Development Program
conducted by the National Institutes of Health found that despite
relative success in disseminating information from that program,
physician practice often remained unaffected. The evidence
suggests that either simply disseminating clinical
recommendations or offering them in a didactic manner has not
demonstrated substantial impact in changing physician behavior.
Thus, there is a need for innovative strategies that utilize
multiple mechanisms in conjunction with one another (Backer,
1988; Kanouse and Jacoby, 1988; Lomas and Haynes, 1988; Lomas,
et. al., 1989).
Patients' expectations regarding their health and their health
care can also be influenced by salient information that is
effectively presented. Clearly, desired changes in practice are
not automatic, and more empirical evidence is needed on ways to
bring changes about.
MEDTEP generates and evaluates scientific information to expand
and strengthen the information base for decisions by health care
providers and patients regarding choice of health care services
and procedures. To accomplish this, information must be
delivered in a form and manner that encourages its acceptance and
use by providers and its comprehension by patients and other
members of the public. Health care providers need methods to
explain treatment options to patients and then, to incorporate
patients' preferences and values into their professional
judgments. Policymakers and planners need good science to make
more informed decisions about incentives and the use of health
care resources under public and private programs.
PURPOSE AND OBJECTIVES
This Request for Applications (RFA) describes the range of studies that
AHCPR encourages and intends to support at this time in the field
of dissemination research. The objective is to stimulate new
grant applications on issues dealing with the ways in which
scientific information can be presented and disseminated to
foster its assimilation and use by health care providers and
patients and, ultimately, to improve the effectiveness, quality,
and appropriateness of medical care.
The process and structural factors influencing dissemination and
assimilation need to be examined. This RFA
encourages studies that evaluate the dissemination of, and
outcomes associated with, clinical practice guidelines or
parameters assisted by AHCPR and other public and private
entities. It also encourages the assessment and use of
particular models and techniques that effectively disseminate
clinical information and clinical practice guidelines.
Broad and timely dissemination of MEDTEP research findings is
critical. Research, however, is needed to identify the relative
effectiveness of various ways to disseminate findings to diverse
audiences and to evaluate the effect of alternative dissemination
strategies. Research is required to explore innovative methods
to assess audience needs and to translate the findings of patient
outcomes research into formats that will be most useful to
different target groups. The effectiveness of dissemination is a
measure of the speed and completeness with which information is
assimilated and adopted, and the degree to which dissemination
activities motivate and sustain voluntary changes in provider or
patient behavior.
The following questions are illustrative examples of the research
issues and questions concerning dissemination of research
findings that merit investigation at this time.
How do factors such as timeliness of dissemination, acceptability
and retention of information, and appropriateness of the format
affect its assimilation and use by health care providers?
How can communication and computer technologies be designed to
affect assimilation and retention of information by health care
providers?
What is the comparative effectiveness of existing or new models
and techniques in disseminating clinical information and clinical
practice guidelines to providers?
What is the profile of the characteristics of successful
dissemination efforts in the health care sector or in other
industries that can serve as models or strategies for use in the
dissemination of clinical practice guidelines or other research-
related knowledge?
How do cultural, socioeconomic, and access factors affect the
assimilation of clinical information by providers and patients
within special population or target groups and geographic areas
(e.g., rural and minority)?
What is the effect of process and structural variables (e.g.,
organizational, personnel mix, work environment, and roles and
incentives) on the relationship between the assimilation of
practice guidelines by the health care provider and patient
outcomes?
How does type of provider organization (e.g., HMO, fee-for-
service sector) affect assimilation and retention of new
information and what is the effect of this on patient outcomes?
How do economic and regulatory incentives affect the timing and
nature of decisions to adopt and utilize medical practice
guidelines?
How do the socioeconomic, demographic, and professional
characteristics of providers affect the assimilation and
retention of new scientific information about health care
practices?
What are the barriers to the assimilation and adoption of medical
practice guidelines and how can these be overcome?
ELIGIBILITY
Applicants must be public entities or nonprofit organizations and
institutions. Proposed Principal Investigators must have
demonstrated expertise in dissemination of health services
research findings, clinical research findings, or medical
practice guidelines. Applicants must also have demonstrated (1)
capability to conduct and manage applied research or
demonstration and evaluation projects in the area(s) that will be
the subject of the dissemination project; and (2) expertise in
communications. Eligibility is restricted to U.S. institutions.
Project staff will need a combination of clinical, research, and
administrative expertise.
LENGTH OF SUPPORT
It is anticipated that projects will vary from one to three years
in length. Project lengths could be up to five years in rare
cases in which the complexity or breadth of the subject area so
mandated, or in areas proposing to research the longer term
effects of particular forms of dissemination.
MECHANISM OF SUPPORT
All projects will be funded as research grants (RO1). The start date
for funded projects with under $250,000 total direct costs will
be September 30, 1991. The start date for funded projects with
total direct costs greater than $250,000 will be December 1,
1991.
Approximately four to ten grant awards will be issued during FY
1991 and FY 1992 depending upon the number and cost of approved
applications. It is expected that $4 million will be spent.
Applications for dissemination research grants in
subsequent years will compete equally for funding with other
applications to AHCPR.
PREPARATION OF APPLICATIONS
Each application will be submitted in accordance with the
instructions of form PHS 398 (rev. 10/88). State and local
governments using form DHHS 5161 must submit an original and two
copies of the application. The following requirements must be
discussed in the Project narrative in addition to the
requirements specified in the application kit:
Specific Aims
o Where appropriate, the long-term objectives of the project must
specify the product(s) to be disseminated and the audiences to be
targeted.
o The dissemination methods and questions to be addressed should
be discussed in terms of ascertaining the effects of
dissemination on behavior change, characteristics or
effectiveness of dissemination techniques, or the development of
an innovative dissemination model.
Progress Report/Preliminary Studies
o Prior studies conducted by the Principal Investigator pertaining
to dissemination, health services research (especially in the
areas where AHCPR has ongoing work) or communications research
that will contribute to the proposed project should be described.
Experimental Design and Methods
o The specific dissemination model that will be used or developed
in the project should be explicitly addressed in terms of:
audiences; type of product or the knowledge to be disseminated;
technique of dissemination; characteristics or variables of
dissemination to be used and/or examined; and the relationship of
the project to the structure of the health care system, clinical
management, health care outcomes, and health status.
REVIEW PROCEDURES AND CRITERIA
Applications must be submitted to:
Application Receipt Office
Division of Research Grants
Westwood Building, Room 240
Bethesda, MD 20892**
Applications will be referred to an AHCPR study section for
initial review. Applications requesting total direct costs in
excess of $250,000 will also be reviewed by the National Advisory
Council for Health Care Policy, Research, and Evaluation.
Applications will be reviewed in accordance with the standard
AHCPR peer review procedures. The review criteria for these
applications are the considerations of scientific and technical
excellence, which include: adequacy of the method to carry out
the project; availability of data or the proposed plan to collect
data required for the project; qualifications and experience of
the Principal Investigator and proposed staff; adequacy of the
plan for organizing and carrying out the project; reasonableness
of the proposed budget; and adequacy of the facilities and
resources available to the grantee. In addition, the following
criteria will be considered: ability of the project's results to
be applied to the dissemination of AHCPR products now and in the
future; adherence of the project approach to accepted principles
of communication and dissemination; and ability to analyze the
effects of dissemination on behavior change among practitioners
and consumers.
APPLICATION PROCEDURES
Those considering an application to this RFA are strongly
encouraged to discuss their project with AHCPR program
administrators in advance of formal submission.
Applications must address all requirements as presented in this
RFA.
Use application form PHS 398 (rev. 10/88). State and local
governments may use form DHHS 5161. These forms may be secured
from the Office of Scientific Review, Agency for Health Care
Policy and Research, Room 18A-20, Parklawn Building, 5600 Fishers
Lane, Rockville, Maryland 20857 (telephone 301-443-3091) and from
most institutional business offices.
Type in line 2 of the face page of the application the words "RFA
AHCPR-91-01: AHCPR Dissemination Effectiveness" and use the RFA label
in the application package.
The original and 6 copies of the application should be submitted
to DRG as directed in the application instructions. State and
local governments using form DHHS 5161 must submit an original
and two copies of the application.
Applications must be received at DRG by the close of business
April 26, June 1, October 1, 1991, and February 1,
1992. Applications submitted after the deadline date will be
considered in the next review cycle.
INQUIRIES
For further assistance and consultation on program requirements,
contact:
Margaret VanAmringe
Director, Center for Research Dissemination and Liaison
Parklawn Building, Room 18A-10
5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 443-2904
For information regarding budgetary/administrative issues
contact:
Ralph Sloat
Grants Management Officer
Agency for Health Care Policy and Research
Parklawn Building, Room 18A-27
5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 443-4033
This program is described in the Catalog of Federal Domestic
Assistance No. 93.180 and 93.226.
Executive Order 12372 does not apply to AHCPR grant programs.
REFERENCES
Backer, TE, "Research Utilization and Managing Utilization in
Rehabilitative Organizations," Journal of Rehabilitation, Vol.
54, No. 2, pp 18-22, 1988.
Backer, TE, Liberman, RP, and Kuehnel, TG, "Dissemination and
Adoption of Innovative Psychosocial Interventions," Journal of
Consulting and Clinical Psychology, Vol. 54, No. 1, pp 111-118,
1986.
Backer, TE, and Ohara, KB, Knowledge Transfer and Utilization in
Health Care: A Review for the National Emergency Medical
Services for Children Program, Human Interaction Research
Institute, December, 1989.
Connell, FA, Day, RW, and Logerfo, JP, "Hospitalization of
Medicaid Children: Analysis of Small Area Variations in
Admission Rates," American Journal of Public Health, Vol. 71, No.
6, pp 606-613.
Greer, AL, "The State of the Art Versus the State of the Science
-- the Diffusion of New Medical Technologies into Practice,"
International Journal of Technology Assessment in Health Care,
Vol. 4, pp 5-26, 1988.
Haynes, RB, Davis, DA, McKibbon, DA, and Tugwell, P, "A Critical
Appraisal of the Efficacy of Continuing Medical Education,"
Journal of the American Medical Association, Vol. 251, pp 61-64,
1984.
Kanouse, DE and Jacoby, I, "When Does Information Change
Behavior?" International Journal of Technology Assessment in
Health Care, Vol. 4, pp 27-33, 1988.
Lomas, J, "Holding Back the Tide of Cesareans -- Publishing
Recommendations is Not Enough," British Medical Journal, Vol 297,
pp 569-570, 1988 (editorial).
Lomas, J, Anderson, GM, Domnick-Pierre, K, Vayda, E, Enkin, MW,
and Hannah, WJ, "Do Practice Guidelines Guide Practice? The
Effect of a Consensus Statement on the Practice of Physicians,"
New England Journal of Medicine, Vol. 321, No. 19, pp 1306-1311,
1989.
Lomas, J and Haynes, RB, "A Taxonomy and Critical Review of
Tested Strategies for the Application of Clinical Practice
Recommendations: From "Official" to "Individual" Clinical
Policy," American Journal of Preventive Medicine, Vol 4 (Suppl),
pp 77-84, 1988.
McCormick, B, "Can Research Change the Way MDs Practice
Medicine?" Hospitals, October 5, pp 32-38, 1990.
McDonald, C, "Effect of Computer Feedback on Physician Test-
Ordering," New England Journal of Medicine, Vol. 322, pp 1499-
1504, 1990.
Soumerai, SB, and Avorn, J, "Principles of Educational Outreach
('Academic Detailing') to Improve Clinical Decision Making,"
Journal of the American Medical Association, Vol. 263, No. 4, pp
549-556, 1990,
Wennberg, JE, Blowers, L, Parker, R, and Gittelsohn, A, "Changes
in Tonsillectomy Rates Associated with Feedback and Review,"
Pediatrics, Vol. 59, pp 821-826, 1977.
Wennberg, JE, "Dealing With Medical Practice Variations: A
Proposal for Action," Health Affairs, Vol. 3, pp 6-32, 1984.
Wennberg, JR, Freeman, JL, and Culp, WJ, "Are Hospital Services
Rationed in New Haven or Over-Utilized in Boston?" Lancet, pp
1185-1189, 1987.
CLAUDE D. PEPPER OLDER AMERICANS INDEPENDENCE CENTERS
RFA: AG-91-05
P.T. 04; K.W. 0710010, 0745027, 0414005
National Institute on Aging
Letter of Intent Receipt Date: April 15, 1991
Application Receipt Date: May 17, 1991
INTRODUCTION
The National Institute on Aging (NIA) invites applications for
the support of Claude D. Pepper Older Americans Independence
Centers (OAICs). These centers will provide support for research
to develop and test clinical interventions that promote the
independence of older Americans. OAICs will also train
individuals in research approaches to develop and test methods of
maintaining and increasing independence, and will conduct
demonstration projects and information dissemination concerning
the applications of such research. Applications for these center
grants (P60) must include one or more clinical intervention
research projects. First year budgets may not exceed $1,500,000
(direct plus indirect costs). Future year budgets are limited to
cost-of-living increases.
BACKGROUND
Millions of older Americans suffer from loss of abilities needed
to live a fully independent life. Loss of independence imposes
enormous personal and financial burdens on older persons and
their families. The annual cost to the Nation for care of
dependent older persons totals billions of dollars.
Dependence is not inevitable in old age. It results from
disabling conditions that are potentially, if not currently,
preventible or reversible. The development and testing of
interventions to reduce disability and increase independence thus
offer immense benefits and potential savings in health care
costs.
To date, efforts to develop such interventions and test their
efficacy in maintaining and increasing independence have been
modest, and the number of researchers with the abilities to
conduct such research has been small. There is a need for more
researchers and research teams with the ability to:
1) Conduct controlled clinical trials of promising interventions
against disabling conditions of older persons.
2) Fill gaps in knowledge of the pathophysiology of disabling
conditions and of the mechanisms affecting their responses to
treatment, and develop and test improved treatments based on this
knowledge.
3) Develop and test ways of applying independence-enhancing advances
in treatment within the American health care system.
The combination of these three abilities would allow the conduct
of concerted research programs to continually improve
opportunities for increased independence for older Americans.
The Claude D. Pepper OAIC program is designed to expand this
research and the number of researchers capable of conducting it.
Specifically, as authorized under amendments to Section 445A of
the Public Health Service Act, each OAIC will conduct: "research
into the aging processes and into the diagnosis and treatment of
diseases, disorders and complications related to aging, including
menopause, which research includes research on such treatments,
and on medical devices and other medical interventions regarding
such diseases, disorders and complications, that can assist
individuals in avoiding institutionalization and prolonged
hospitalization and in otherwise increasing the independence of
the individuals and programs to develop individuals capable of
conducting research in these areas." As defined by Section 445A
of the Public Health Service Act, "the term independence, with
respect to diseases, disorders, and complications of aging, means
the functional ability of individuals to perform activities of
daily living or instrumental activities of daily living without
assistance or supervision."
GOALS AND SCOPE
The overall goals of the OAIC program are:
1) To facilitate the development and testing of interventions to
increase or maintain abilities needed for independence of older
persons.
2) To use knowledge gained in these intervention studies in developing
and testing improved interventions.
3) To train researchers capable of leading and conducting research
programs as described in 1) and 2) above. OAIC research projects
should provide an environment for the training of such researchers.
4) To translate OAIC research findings into improvements in health
care practice through demonstration and dissemination projects.
The components of OAICs derive from these goals. OAICs will
support:
INTERVENTION STUDIES:
At least one approved intervention study is required for approval
of an OAIC.
Proposed intervention studies must test the efficacy of
interventions to prevent or ameliorate functional impairments
contributing to loss of independence. Studies may be of effects
on long-term disability and/or temporary disability following
illness or injury. In studies of prevention interventions, a
focus on subgroups at high risk for disability is encouraged
where appropriate.
All studies should measure direct effects on functional status
and have adequate statistical power to determine important
intervention effects on functional abilities should these occur.
Measures of related medical and physiologic endpoints are
encouraged wherever pertinent.
Because older persons with multiple health problems are at
especially high risk for disability, determinations of the
efficacy of interventions in such persons, and analyses of the
effects of different health problems on treatment efficacy, are
encouraged where feasible. Tests of interventions specifically
designed against disabilities resulting from the interaction of
two or more comorbid conditions are also encouraged.
Besides measurements of intervention effects on the above
outcomes, each proposed intervention study must also include
planned investigations of:
o Mechanisms underlying the interventions' effects (or lack of
effects) on functional status, to provide a basis for further
improvements in interventions. Intervention interactions with
intermediary response variables such as underlying disease
mechanisms, symptoms, and behavioral factors should be measured
and analyzed as needed for this purpose.
o Factors affecting recruitment into the study and participants'
compliance once enrolled, and to provide data for potentially
wider applications of the interventions are considered pertinent
and should be included.
o Cost-effectiveness and effects on health care utilization
(e.g., hospitalizations, nursing home admissions and stays, use
of home care services) of the intervention(s) tested.
Proposals for intervention studies that do not contain the above
elements will be returned to applicants.
Examples of types of interventions for study include:
o Interventions to prevent or reduce frailty and increase
physical performance abilities. Exercise, nutritional,
pharmacologic, rehabilitative, surgical, and other interventions
against disorders such as osteoarthritis, congestive heart
failure, chronic pulmonary disease, pathologic loss of muscle
mass and/or strength, protein-calorie malnutrition, dizziness,
Parkinson's disease, and gait and balance problems are
encouraged.
o Interventions to prevent or reduce cognitive disability,
affective disorders, sensory disabilities, and/or co-morbidity
associated with these conditions. Studies on interventions to
reduce impairments from problems such as dementing disorders,
depression, and vision impairments are encouraged. In addition,
interventions are encouraged against medical problems associated
with these disorders, such as falls, weight loss, or incontinence
in demented patients.
o Interventions to reduce risk of disabling events such as hip
fractures and strokes, and to reduce impairments following these
events. Studies of interventions against osteoporosis and to
prevent hip fracture, and studies of techniques to improve
functional status after hip fracture and strokes are encouraged.
o Interventions to prevent or reduce disabilities in complex
functions involving combined motor, sensory, and cognitive
performance. Examples include interventions to reduce urinary
and fecal incontinence, and impaired driving abilities.
o Interventions to prevent or reduce disabling side effects from
medication use. Examples include drug withdrawal studies and
testing of non-pharmacologic therapeutic alternatives, as well as
testing improved pharmacologic agents or regimens.
o Interventions to prevent, lessen, or shorten temporary
disability from exacerbation or complications of chronic diseases
of older person. Examples include transient disability
associated with exacerbations of chronic pulmonary disease,
deconditioning during hospitalization, and acute confusional
states.
o Interventions to prevent or reduce disabling sequelae of
menopause and associated estrogen deficiency. Examples include
osteoporotic fractures and urge incontinence.
o Combined intervention strategies to prevent or ameliorate
disabilities in older persons with multiple impairments.
The above list is not exhaustive and the order does not reflect
NIA priorities. All studies of promising interventions to
enhance independence in older persons are encouraged. No
priority is placed on having a diversity of intervention topics
associated with a single OAIC. Applicants may find it
advantageous to concentrate on one or a few topics in which their
strengths are greatest.
Subjects for these studies may include older persons living at
home, recipients of home care, nursing home residents,
hospitalized patients, and those in other pertinent clinical
settings, as appropriate to each intervention study.
Organizational liaisons involving one or more medical centers,
nursing homes, home care services, and other care organizations
are encouraged whenever appropriate for the conduct of OAIC
activities.
INTERVENTION DEVELOPMENT STUDIES:
While OAIC intervention studies (described above) are the major
OAIC research component, the OAIC center grant will support other
studies to identify, develop, or refine potential interventions
to preserve or increase independence. Each proposed intervention
development study should present a complete plan for conduct of
the proposed research, analogous in the level of detail to an
individual research project grant application, in sufficient
detail to allow full scientific review.
Types of such studies include:
o Tests of therapies on physiologic and/or behavioral factors
known to affect functional status. Both beneficial and adverse
effects may be studied.
o Studies to identify or confirm reversible or preventible risk
factors for disability and/or disabling events. Examples include
behavioral factors, diseases, and previously unidentified
pathophysiologic changes leading to functional impairment and/or
disabling events. Large-scale epidemiologic studies are outside
the scope of this RFA.
RESEARCH RESOURCES CORES:
Applicants may request core resource support to enhance the
quality of OAIC research projects, i.e., intervention studies,
intervention development studies and pilot research projects.
Normally, applicants should not propose a core unless it would
support at least two projects (otherwise the core could simply be
included in the one project it supported). The justification for
proposed cores (including the number of projects they would
support) will be evaluated by peer reviewers. Routine patient
care costs may not be requested, but research-related patient
care costs are eligible for support. Proposed core activities
must be exclusively for support of OAIC research, i.e., pilot
projects, intervention studies and intervention development
studies, and must be fully justified as such.
Examples of possible cores include:
o Recruitment/screening/assessment/registry units for potential
subjects for different OAIC intervention study research protocols.
o Functional assessment units to monitor functional status of
subjects in OAIC studies.
o Diagnostic/pathophysiologic units for studies of mechanisms of
treatment response and interactions with disease mechanisms.
o Biostatistical/data management units.
o Cost-effectiveness analysis units.
The above list is not intended to describe the full range of
possible activities to be supported, nor to direct applicants
towards these areas. Inclusion of research resources cores of
any or all these types in a single proposed OAIC is not required
or even necessarily advisable. Innovative organizational
approaches are encouraged. Institutions that are recipients of
NIA Geriatric Research and Training Center awards or NIH General
Clinical Research Center awards who wish to apply for an OAIC
award are encouraged to use core resources from these Centers for
support of OAIC projects where appropriate.
A Director should be named, and plans for the scientific and
administrative functioning of each Research Resources Core
proposed must be presented. The method for prioritizing access
to core resources requested by multiple projects must be
described.
RESEARCH DEVELOPMENT CORE:
The Research Development Core is a required component of all
OAICs. This core will provide salary and other support for
junior faculty and research associates to acquire abilities in
all phases of research to develop interventions to enhance
independence, including clinical trials, studies of mechanisms of
treatment response, and cost-effectiveness/health care
utilization studies. The development of persons who will have
the necessary breadth and depth of experience needed to lead
teams spanning this range of research is of particular priority.
The components of the Research Development Core are:
Junior Faculty Development Support. Support may be requested for
salary and fringe benefits for junior faculty participating in
OAIC intervention studies and other OAIC research. The Research
Development Core should present a plan for achieving development
of junior faculty supported under this component, including a
mechanism for monitoring their scientific progress and
development toward independence. Applicants should clearly
specify the role of senior mentors in training and supervising
junior faculty and research associates in their roles on these
projects. A current biographical sketch (two pages maximum), a
list of active research support, and a brief description of the
mentor's role in proposed OAIC activities should be provided for
all proposed mentors.
Junior faculty and research associates receiving support through
this component must participate in all phases of at least one
OAIC intervention study. Although applicants are not required to
identify individual junior faculty, research associates, and
their specific roles in advance, they are encouraged to do so if
possible, because this information is extremely useful to peer
reviewers. If support is requested for "to-be-named" junior
faculty or research associates, applicants must present their
plans for recruiting, training, and supervising these persons.
The Research Development Core may also serve to encourage the
research career development of other junior faculty and research
associates (in addition to those receiving salary support from
this core) by coordinating the participation in OAIC research
projects of other junior faculty and research associates whose
salary support may come from other sources such as NIA's
Geriatric Academic Program Award (GAP), Geriatric Research
Institutional Training Award (GRIT), Physician Scientist Award
(PSA), NIA Academic Award or Clinical Investigator Award (CIA),
and Geriatric Research and Training Centers (GRTC). The overall
contribution of the OAIC to the development of researchers
throughout the grantee institution who can contribute to the
development of independence-enhancing interventions will be
considered in the evaluation of OAIC applications and funded
OAICs.
Didactic Training. Support may be requested for didactic
training in such topics as clinical trials methodology,
biostatistics, pertinent topics in disease mechanisms and related
basic sciences, behavioral sciences, and health services
research. Such support is not restricted to individuals
receiving salary support from the core, but also may be provided
to other personnel on OAIC research projects or OAIC intervention
development studies.
Pilot Research Projects. Support may be requested for pilot
projects on topics related to the activities of the OAIC.
Examples of project topics include pilot studies of new
interventions and probes of disease mechanisms and their
interactions with interventions. The procedures by which
awardees will solicit, select, monitor, and evaluate the results
of pilot projects should be specified in the application, but
applicants are not required to present specific pilot projects as
part of the application. Pilot projects are limited to a maximum
of one year in duration, a maximum of $25,000 (direct costs) per
pilot project, and a maximum of $100,000 (direct costs) per year
for the total allocated to all pilot projects contained in an
OAIC. Pilot project funds may be used for salaries, equipment,
and supplies.
Research Development Core Director. Support may be requested for
a core director who will be responsible for coordination of the
above activities and must report annually on the progress of all
individuals supported thorough this core and other core
activities.
A maximum of $250,000 in total (direct plus indirect) first-year
costs may be requested for the Research Development Core. Budget
increments in future years will generally be limited to four
percent.
DEMONSTRATION AND INFORMATION DISSEMINATION PROJECTS:
OAICs must include activities to translate findings from their
research into health care practice. These activities would
normally be expected to be conducted beginning in the second year
of the project, with the first year devoted to planning. A
maximum of $50,000 first-year total (direct plus indirect) costs
and $80,000 annual total costs for project years two through five
may be requested for these activities. Specific projects for
demonstration/information dissemination activities should be
described. The staffing plan and a rationale for the
organization of this core should be presented. The methods and
techniques to be employed for information dissemination and the
audience(s) targeted and their size(s) should be defined.
Examples of projects that may be supported include dissemination
of research results to the public, professionals, and
paraprofessionals, through symposia and in-service training.
Planning and pilot activities for larger scale demonstration
projects to evaluate the practicability of interventions tested
in OAICs within various health care settings are also
appropriate.
LEADERSHIP/ADMINISTRATIVE CORE:
Applicants may request funds for the OAIC Director, OAIC
Administrator, and support staff. The OAIC Director should be a
scientist who can provide effective administrative and scientific
leadership and coordination with OAIC intervention studies. An
OAIC Administrator who will assist the Director in managing the
Center, addressing issues of fiscal management and compliance
with institutional, PHS, NIH, and NIA policies, should be
identified. A maximum of $120,000 (direct plus indirect costs)
per year for this core, for salary, travel, and other expenses of
the Director, Administrator, and appropriate administrative staff
may be requested. Future year annual increases will generally be
limited to no more than four percent.
OAIC Advisory Panel. OAIC applications, regardless of whether a
Leadership/Administrative Core is requested, must describe a plan
and budget for the selection of experts from outside the OAIC who
will meet yearly to review the progress of the OAIC and provide a
written report to the OAIC Director. This review will be
included in the annual OAIC Progress Report to the NIA. (A
member of the NIA extramural staff assigned to each Center will
routinely attend the Advisory Panel meetings and should be
notified well in advance of the date scheduled).
Coordination Among OAIC's. OAICs are expected to meet together
every six months to compare research results and to explore
possibilities for collaborative efforts. Funds should be
requested to permit travel of the OAIC Director, Administrator,
and Principal Investigators on all OAIC intervention studies, and
intervention development studies for meetings with NIA staff and
staff from other OAICs. Responsibility for organizing these
meetings will rotate among OAIC sites.
Required Components for an OAIC. It should be noted that the
minimum required components that must be approved by the peer
reviewers in order to qualify for an OAIC Award are 1) at least
one intervention development study 2) a Research Development Core
and 3) a Demonstration and Information Dissemination Project.
III. MECHANISM AND SCALE OF SUPPORT
Older Americans Independence Centers will be supported through
the comprehensive center grant (P60) mechanism. The awarding of
funds pursuant to this RFA is contingent on availability of
funds. All pertinent DHHS, PHS, and NIH grant regulations,
policies and procedures are applicable. Business management
aspects of the awards will be administered in accordance with
DHHS and PHS grant administration requirements by the NIH, as
stated in the Public Health Service Grants policy statement, DHHS
Publication No. (OASH) 90-50,000, revised October 1, 1990.
Applications and management of grants will be subject to
applicable PHS and NIH grant policies and NIA guidelines.
Support may be requested for a period of five years. The total
costs (direct plus indirect) requested for the first year may not
exceed $1,500,000. Applications with budget requests exceeding
this amount will not be accepted by NIA and will be returned to
the applicant. Budget increments for subsequent years generally
will be limited to no more than four percent.
METHOD OF APPLYING AND APPLICATION REQUIREMENTS
Guidelines
Detailed instructions for applicants are found in "NIA Older
Americans Independence Center (P60) Guidelines" (hereafter called
OAIC (P60) Guidelines). This document may be obtained from:
Geriatrics Program
National Institute on Aging
Building 3l, Room 5C27
9000 Rockville Pike
Bethesda, MD 20892
Telephone: (30l) 496-6761
Eligibility
Only U.S. organizations are eligible to apply.
Letter of Intent
If an investigator is satisfied that his/her institution is
eligible and elects to apply for an OAIC grant, a letter of
intent is requested (but not required) to be submitted to the
Geriatrics Program at the address given above. The letter of
intent should name the OAIC Director and Principal Investigators,
and, if possible, should include the titles of the major research
projects and cores proposed. It should be submitted by April 15,
1991.
The Application
The applicant must submit the application using PHS 398 (revised
10/88 - reprinted 9/89), following the OAIC (P60) Guidelines.
Application kits containing this form and the necessary general
instructions are available in most institutional business offices
and may be obtained from the Office of Grants Inquiries, Division
of Research Grants, NIH (telephone 301-496-7441).
On item 2 of the face page of the application, applicants must
enter: NIA RFA--Claude Pepper Older Americans Independence
Center, AG-91-05. The RFA label available in the 10/88 revision
of the application form PHS 398 must be affixed to the bottom of
the face page and placed on top of the entire package. Failure
to use this label may result in delayed processing of the
application and prevent it from reaching the review committee in
time for review. Please note that special OAIC Guidelines
mentioned above must be used to complete the application. The
NIA recommends that the application be developed in consultation
with program staff.
TIMETABLE FOR RECEIPT AND REVIEW OF APPLICATIONS
Receipt Date
The original and four copies of the application are due in the
Division of Research Grants on or before May 17, 1991.
Applications must be sent to:
Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
At the same time the application is submitted to the Division of Research
Grants and two copies of the application
should be sent to:
Chief, Scientific Review Office
National Institute on Aging
Building 3l, Room 5C12
9000 Rockville Pike
Bethesda, MD 20892
The six sets of appendices may be sent to the Chief, NIA
Scientific Review Office with two copies of the application.
Failure of these copies to be received may prevent the
application from being reviewed in time to be considered for an
award.
Review Schedule
Applications will be received by the NIH Division of Research
Grants and will be assigned to the NIA. Responsive applications
will be assigned to a special review group for review. Proposals
judged by the NIA Program Staff to be non-responsive (those not
directed at the goals of this RFA) will be returned to the
applicant without review. Because no site visits will be
conducted, each application should be thorough and complete
enough to stand on its own. Applications may first receive a
preliminary review by a subcommittee of the review panel to
establish those applications deemed to be competitive. Those
proposals judged non-competitive for award will be so designated,
and an abbreviated summary statement noting the major areas of
concern will be sent to the Principal Investigator. Applications
judged to be competitive will be given full review. The
second-level review will be by the National Advisory Council on
Aging. The earliest start date will be September 30, 1991.
REVIEW CRITERIA
The primary criterion for review by the NIA review committee in
evaluating each OAIC grant application will be the effectiveness
of the proposed program in contributing to increasing
independence for older Americans through the conduct of research,
demonstration, and dissemination projects; and development of
academic leaders in geriatrics with effective research, teaching
and clinical capabilities. Specific criteria related to this
standard include:
1. Scientific merit of research and its expected impact on the
maintenance of independent functioning of older persons.
2. Contribution of Research Resources Cores, where included, to
enhancement of ongoing research, training, and pilot projects.
3. Role of the Research Development Core in providing educational and
other career development opportunities for fellows and junior
faculty and other professional and paraprofessional personnel
associated with the Center in research techniques.
Other review criteria include:
1. Leadership ability and scientific stature of the program director
and his/her ability to meet the program's demands of time and
effort.
2. Qualifications, experience, and commitment of the investigators
responsible for core units and their ability to devote the required
time and effort to the program.
3. Presence of an administrative and organizational structure
conducive to attaining the objectives of the proposed program.
4. Arrangements for internal quality control of ongoing research, the
allocation of funds, day-to-day management, contractual agreements,
the internal communication and cooperation among investigators in
the program.
5. Quality of proposed external review process.
6. Appropriateness of the total budget and budgetary requests for the
individual components.
7. Academic and physical environment as it bears on patients, space,
and equipment and on the potential for interaction among scientists
within the center and with scientists from other departments,
institutions, and Claude D. Pepper Centers.
8. Institutional commitment to the requirements of the program.
9. The adequacy of the means for protecting against risks to human
subjects, animals, and/or the environment.
10. Issues relating to inclusion of women and minorities (see following
special instructions).
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF
NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN
CLINICAL RESEARCH STUDY POPULATIONS:
NIH policy is that, as appropriate, applicants and offerors for
NIH grants, cooperative agreements, and contracts will be
required to include minorities and women in study populations so
that research findings can be of benefit to all persons at risk
of the diseases, disorders, or conditions under study; special
emphasis should be placed on the need for inclusion of minorities
and women in studies of diseases, disorders, and conditions that
disproportionately affect them. This policy is intended to apply
to males as well as females of all ages. If women or minorities
are excluded or inadequately represented in clinical research,
particularly in proposed population-based studies, a clear
compelling rationale for exception to the policy must be
provided.
The composition of the proposed study population must be
described in terms of gender and racial/ethnic groups, together
with a rationale for its choice. In addition, gender and
racial/ethnic issues should be addressed in developing a research
design and sample size appropriate for the scientific objectives
of the study. This information should be included in the form
PHS 398 in Section 2, A-D of the Research Plan AND summarized in
Section 2, E, Human Subjects.
Applicants are urged to assess carefully the feasibility of
including the broadest possible representation of minority
groups. However, NIH recognizes that it may not be feasible or
appropriate in all research projects to include representation of
the full array of United States racial/ethnic minority
populations (i.e, Native Americans (including American Indians or
Alaskan Natives, Asian/Pacific Islanders, Blacks, Hispanics) The
rationale for studies on single minority populations should be
provided. For the purpose of this policy, clinical research
includes human biomedical and behavioral studies of etiology,
diagnosis, or treatment of diseases, disorders or conditions,
including but not limited to clinical trials.
The usual NIH policies concerning research on human subjects also
apply. Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are exempt.
However, every effort tissues from women and racial/ethnic
minorities when it is important to apply the results of the study
broadly, and this should be addressed by applicants.
If the required information is not contained within the
application, the application will be returned.
Peer reviewers will address specifically whether the research
plan in the application conforms to these policies. If the
representation of women or minorities in a study is inadequate to
answer the scientific questions(s) addressed AND the
justification for the selected study population is inadequate, it
will be considered a scientific weakness or deficiency in the
study design and will be reflected in assigning the priority
score to the application.
All applications for clinical research submitted to NIH are
required to address these policies. NIH funding components will
not award grants or cooperative agreements that do not comply
with these policies.
FUNDING
Although it is anticipated that up to $3.9 million will be
directed to the support of OAICs in Fiscal Year 1991, issuance of
OAIC awards is contingent upon the receipt of scientifically
meritorious applications and allocation of appropriated funds for
this purpose.
In addition to FY 1991 awards, other applications responding to
this RFA may be funded in Fiscal Year 1992, depending on quality
of applications and availability of funds. Issuance of awards
pursuant to this RFA is contingent on the availability of funds
for this purpose.
STAFF CONTACT
Potential applicants interested in obtaining further information
may write or call:
Stanley L. Slater, M.D.
Geriatrics Program
National Institute on Aging
Building 31, Room 5C27
Bethesda, MD 20892
Telephone: (301) 496-6761
This program is described in the Catalog of Federal Domestic
Assistance, Number 93.866. Awards are made under the authority
of the Public Health Service Act, Section 301 (42 USC 241) and
administered under PHS grant policies and Federal Regulations,
most specifically at 42 CFR Part 52 and 45 CFR Part 74. Special
Terms of Awards applying to projects funded in response to this
RFA are in addition to, and not in lieu of, otherwise applicable
OMB administrative guidelines, HHS grant administrative
regulations at 45 CFR Part 74, and other HHS, PHS, and NIH grant
administration policies. Awardees will maintain custody of and
primary rights to their data developed under their awards,
subject to Government rights of access, consistent with current
HHS, PHS, and NIH policies. This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.JAPPLE@UKCC.UKY.EDU (jim applegate) (02/27/91)
sounds like somthing that should be up our alley. Let's talk about it over lunc h or whenever.