Full Text HS-96-007
NIH GUIDE, Volume 25, Number 10, March 29, 1996
RFA:  HS-96-007
P.T. 34

  Neural Stimulation 

Agency for Health Care Policy and Research
Letter of Intent Receipt Date:  May 7, 1996
Application Receipt Date:  June 12, 1996
The Agency for Health Care Policy and Research (AHCPR) invites
applications to conduct research on computerized decision support
systems (CDSS) as a component of electronic medical record systems.
The goal of this research is to assist providers' decisionmaking and
to improve the cost- effective delivery of health services.  This
Request for Application (RFA) solicits applications to address one or
more of the following elements for incorporating CDSS into electronic
medical records:  1) Use of clinical practice guidelines in decision
support systems while maintaining security and confidentiality of
patient care data in different patient care settings, 2) The impact
of CDSS on the effectiveness of the patient care process, patient
outcomes of care, and/or cost impact on patient care, and 3)
Identification and testing of factors that influence practitioner use
of CDSS.
Important factors surrounding the use of CDSS include: current
restructuring within the health care system; a focus on a national
information infrastructure (NII); progress toward establishing an
electronic medical record; and the use of high performance computing
and communication (HPCC) in health care.  Of particular interest are
studies involving the comparative effectiveness and/or cost and
benefits of using CDSS within the changing health care system and the
use of CDSS to disseminate practice guidelines and monitor their
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  AHCPR urges
applicants to submit grant applications with relevance to the
specific objectives of this initiative.  Potential applicants may
obtain a copy of "Healthy People 2000" (Full Report: Stock No.
017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through
the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325, telephone 202-512-1800.
Applications may be submitted by domestic, non-profit organizations,
public or private, including universities, clinics, units of State
and local governments, non-profit firms, and non-profit foundations.
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigator.
This RFA will use the research project grant (R01). Responsibility
for the planning, direction, and execution of the proposed project
will be solely that of the applicant. The total requested project
period may not exceed three years.  This RFA is a one-time
solicitation.  The earliest anticipated award date is September 1,
Dependent upon the availability of funds, AHCPR expects to award up
to approximately $1.5 million in FY 1996 to support the first year of
approximately 6-10 projects under this RFA.  The number of awards is
dependent on the number of high quality applications and their
individual budget requirements; it is not the intent of AHCPR that
the awards be equal in size.  Funding beyond the initial budget
period will depend upon annual progress reviews by AHCPR and the
availability of funds.
AHCPR, as of October 1994, became a participant in the
government-wide High Performance Computing and Communication (HPCC)
initiative, which is an effort designed to apply high-speed and
high-performance computers to help solve the nation's problems in
education, energy, weather, and health. As a result of this HPCC
activity, AHCPR jointly sponsored with the National Library of
Medicine (NLM) an RFA entitled "Applied Research Relevant to an
Electronic Medical Record." Cooperative agreements funded under this
RFA and other grants continue AHCPR's history of funding research in
development of databases; accessing data and retrieval of
information; advancement of expert systems, decision aids, and
reminder systems; and assessment of quality of care.
For the purpose of this RFA, computerized decision support systems
(CDSS) are computer programs that use knowledge such as clinical
practice guidelines and clinical research findings, to support
practitioners' decisions with evidence-based information in a patient
electronic medical record.
Clinical practice guidelines are defined as systematically developed
statements to assist practitioner and patient decisions about
appropriate health care for specific clinical conditions.
The studies supported by AHCPR that deal with CDSS typically involve
a multidisciplinary team of researchers with clinical, informatics
and methodological expertise, along with an understanding of the
perspectives of providers, information behavior, health services
research, and economics.
Objectives and Scope
The changing mix of payment mechanisms, benefit plans, and
cost-containment strategies has widespread implications for CDSS in
patient care.  Of particular interest are studies involving the
comparative effectiveness and/or cost and benefits of decision
support systems within the changing health care system.  This would
include studies of applications across delivery settings and
reimbursement systems; studies should consider the application of
CDSS by clinicians in everyday practice, including primary care, and
other office based practices.  This would include the use of CDSS to
disseminate practice guidelines and monitor their impact.
Choice of condition and treatment options should be justified in
terms of clinical and policy relevance.  Topics of interest for
decision support may include, but are not limited to, conditions
addressed by AHCPR clinical practice guidelines.  A list of guideline
topics and order form may be obtained from Global Exchange, Inc. (See
AHCPR desires to fund studies that focus on how to improve: 1) the
outcomes of patient care, 2) the process of patient care, and 3) the
cost effectiveness of care, or a combination of these.  Studies
addressing the following areas will receive highest program priority;
however, this does not preclude applications focusing on other areas
within the scope of the RFA.
Studies may include:
o  Decision support models integrating clinical practice guidelines
on networked systems which can be translated to products to improve
quality of care and performance across institutional boundaries
(e.g., primary care to hospitals to long-term care or home care
settings).  Maintenance of security and confidentiality of data
requirements should be addressed.
o  The utility of these systems for generating performance data
required by internal or external quality reporting and accountability
systems, such as Health Plan Employer Data Information Set (HEDIS).
o  Decision support systems that are designed to facilitate
prevention, early detection, diagnosis, treatment, and prescribing
practices.  These systems, when matched to medical review criteria
and performance measures, allow assessment of improved quality of
care, outcomes, and cost effectiveness.  These decision support tools
range from computer-generated reminders to adoption of clinical
practice guidelines and treatment algorithms.
o  Evaluations of the medical effectiveness and economic impact (cost
and benefits) of using CDSS.
o  Cost-utility studies that include user-friendly methods or
measures for assessing patient preferences, values, and utilities, as
well as improvements in provider productivity.
o  Identification and testing of factors that influence practitioner
use of CDSS applications.
o  Dissemination strategies utilizing CDSS and their effect on
awareness and use of information, with particular emphasis on
comparing these strategies with more traditional dissemination
mechanisms and processes to ascertain relative effectiveness and cost
Applications must be explicit and detailed in describing databases,
methods, data to be collected, instruments for data collection, and
approaches to data analysis.  The research plan must be justified in
terms of potential for answering the proposed research question(s).
AHCPR's decision support research initiative draws on a wide range of
methods for applying existing medical knowledge into computerized
systems.  The description and rationale for choice of:  hardware,
software, protocols/guidelines, technology assessments,
decision-analysis models, mathematical models, algorithms, logic
rules, standards, vocabulary, and potential linkages to networks
should be specified.  The decision support systems should be existing
working models or working systems.
Data sources should allow for the detection, measurement, and/or
control of:  clinical content (based upon protocols), consensus
statements, guidelines, or structured care processes; and translation
of such content to algorithms for medical review criteria,
performance measures, protocol algorithms, and logic rules, all
within network systems.
The study of sharing information across sites and standards,
including content, data-exchange, and common vocabulary issues is
encouraged.  Proposed systems should be considered for linkage into
large enterprise and national networks of aggregate knowledge
sources.  These systems should be capable of being accessed by
multiple providers.  Use of computer-generated and digital-video
technology for assisting decisionmaking for health providers is
Data sources should especially identify severity of illness,
timeliness of diagnosis and treatment, utilization-based indicators
of patient outcomes, comorbidities, relevant confounders, and costs
of care when appropriate.  Measures of short and long-term outcomes,
as well as pre-treatment health status information, are highly valued
Confidentiality of Data
Information obtained in the course of this study that identifies an
individual or entity must be treated as confidential in accordance
with section 903(c) of the Public Health Service Act.  Applicants
must describe in the Human Subjects section of the application
procedures for ensuring the confidentiality of identifying
information.  The description of the procedure should include a
discussion of who will be permitted access to the information, both
raw data and machine readable files, and how personal identifiers
will be safeguarded.
Rights in Data
AHCPR grantees may copyright or seek patents, as appropriate, for
final and interim products and materials including, but not limited
to, methodological tools, measures, software with documentation,
literature searches, and analyses, which are developed in whole or in
part with AHCPR funds.  Such copyrights and patents are subject to a
Federal Government license to use these products and materials for
AHCPR purposes.  AHCPR purposes may include, subject to statutory
confidentiality protections, making research materials, data bases,
and algorithms available for verification or replication by other
researchers; and subject to AHCPR budget constraints, final products
may be made available to the health care community and the public by
AHCPR, or its agents, if such distribution would significantly
increase access to a product and thereby produce public health
benefits.  Ordinarily, to accomplish distribution, AHCPR publishes
research findings but relies on grantee efforts to market
grant-supported products.  In keeping with AHCPR's legislative
mandates to make both research results and data available, copies of
all products and materials developed under a grant supported in whole
or in part by AHCPR funds are to be made available to AHCPR promptly
and without restriction, upon request by AHCPR.
It is the policy of AHCPR that women and members of minority groups
be included in all AHCPR-supported research projects involving human
subjects, unless a clear and compelling rationale and justification
are provided that inclusion is inappropriate with respect to the
health of the subjects or the purpose of the research.  The NIH
policy resulting from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43) supersedes and strengthens NIH's previous
policies (Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
were in effect since 1990 and which AHCPR had adopted.  The new NIH
policy contains provisions that are substantially different from the
1990 policies.
All investigators proposing research involving human subjects should
read the "NIH Guidelines on the Inclusion of Women and Minorities as
Subjects in Clinical Research," which has been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513), and printed
in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume
23, Number 11.  AHCPR follows the revised NIH Guidelines, as
Investigators may obtain copies from those sources or from the AHCPR
contractor, Global Exchange, Inc., listed under INQUIRIES.  AHCPR
program staff may also provide information concerning this policy
Prospective applicants are asked to submit, by May 7, 1996, a letter
of intent that includes the name, address, and telephone number of
the proposed Principal Investigator and other key personnel; 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 consideration
of any subsequent application, the information allows AHCPR to
estimate the potential review workload and avoid conflicts of
interest in the review.  AHCPR will not provide responses to letters
of intent.
The letter of intent is to be sent to:
Kathleen A. McCormick, Ph.D., R.N.
Center for Information Technology
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 602
Rockville, MD  20852-4908
Email:  kmccormi@po5.ahcpr.gov
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  State and local government applicants
may use form PHS-5161-1, Application for Federal Assistance (rev.
9/92), and follow those requirements for copy submission.
Application kits are available at most institutional offices of
sponsored research and may be obtained from the Office of Extramural
Outreach and Information Resources, National Institutes of Health,
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone
301/710-0267, email: ASKNIH@odrockm1.od.nih.gov.
AHCPR applicants are encouraged to obtain application materials from
the AHCPR contractor:  Global Exchange, Inc. (See INQUIRIES).
The RFA label available in the PHS 398 (rev. 5/95) application form
must be affixed to the bottom of the face page of the original
application.  Failure to do so 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 must
be marked.
Submit a signed, typewritten original of the application, including
the Checklist, and three signed photocopies, in one package to:
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)
At the time of submission, two additional copies of the application
must be sent to:
Kathleen A. McCormick, Ph.D., R.N.
Center for Information Technology
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 602
Rockville, MD  20852-4908
Applications submitted under this RFA must be received in the
Division of Research Grants, NIH, by June 12, 1996.  If an
application is received after that date, it will be returned to the
applicant without review.
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened in accordance with AHCPR peer review
procedures.  As part of the initial merit review, all applications
will receive a written critique, and also may undergo a process in
which only those applications deemed to have the highest scientific
merit will be discussed and assigned a priority score.
Recommendations of the peer review committee may be reviewed
subsequently by AHCPR's National Advisory Council.
General Review Criteria
Review criteria for AHCPR grant applications are: significance and
originality from a scientific and technical viewpoint; adequacy of
the method(s); availability of data or 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 and achieving outcome
measures; reasonableness of the proposed budget; and adequacy of the
facilities and resources available to the applicant.
Special Review Criteria
In addition to the general criteria above, the reviewers will assess
the application's responsiveness to the RFA; generalizability of
results; feasibility of answering the proposed research question(s)
within the project period; and, the validity, specificity, and
sensitivity of outcome(s) measures.
Reviewers will also assess the applicant's description and rationale
for choice of:  hardware, software, protocols/guidelines, technology
assessments, decision- analysis model, mathematical models,
algorithms, logic rules, standards, vocabulary, and potential
linkages to networks; and whether the decision support system is a
working model or working system.
Applications will compete for available funds with all other
applications under this RFA.  The following will be considered in
making the funding decisions:  quality of the proposed project as
determined by peer review, program balance, and availability of
Written and telephone inquiries concerning this RFA are encouraged.
Copies of the RFA and related background materials are available
Global Exchange, Inc.
7910 Woodmont Avenue, Suite 400
Bethesda, MD  20814-3015
Telephone:  (301) 656-3100
FAX:  (301) 652-5264
Direct inquiries regarding programmatic issues, including information
on the policy of inclusion of women and minorities in study
populations, to:
J. Michael Fitzmaurice, Ph.D.
Center for Information Technology
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 602
Rockville, MD  20852-4908
Telephone:  (301) 594-1483
Email:  mfitzmau@po5.ahcpr.gov
Direct inquiries regarding fiscal matters to:
Carol Roache
Grants Management Staff
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 601
Rockville, MD  20852-4908
Telephone:  (301) 594-1447
FAX:  (301) 594-3210
Email:  croache@po7.ahcpr.gov
This program is described in the Catalog of Federal Domestic
Assistance Number 93.226 and 93.180.  Awards are made under
authorization of Title IX of the Public Health Service Act (42 U.S.C.
299-299c-6) and Section 1142 of the Social Security Act (42 U.S.C.
1320b-12).  Awards are administered under the PHS Grants Policy
Statement and Federal regulations 42 CFR 67, Subpart A, 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 and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, The Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development
services are provided to children.  This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.

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