TELEHEALTH INTERVENTIONS TO IMPROVE CLINICAL NURSING CARE
Release Date: September 22, 2000
PA NUMBER: PA-00-138
National Institute of Nursing Research
National Library of Medicine
THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA.
PURPOSE
This Program Announcement (PA) solicits applications for investigator-
initiated research related to telehealth interventions designed to improve
clinical nursing care. Telehealth is defined as the use of communications
technologies to provide and support health care at a distance. Examples
include the use of communications to provide patient treatment, often via
still images or video, and the exchange and distribution of public health
information. Nursing has taken a leadership role in the development and
application of telehealth approaches to clinical care, but few research data
are available to provide a scientific base for the efficacy of these
interventions. The goal of this PA is to stimulate clinical research on
innovative nursing telehealth interventions, particularly their use among a
wide variety of clinical situations, diverse patient populations, and
different clinical settings.
HEALTHY PEOPLE 2010
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2010," a
PHS led national activity for setting priority areas. This Program
Announcement (PA), Telehealth Interventions to Improve Clinical Nursing Care,
is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople/.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic and foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and eligible
agencies of the Federal government. Racial/ethnic minority individuals,
women, and persons with disabilities are encouraged to apply as principal
investigators.
MECHANISM OF SUPPORT
This PA will use the National Institutes of Health (NIH) R01 (Research
Project Grant)award mechanism. Responsibility for the planning, direction,
and execution of the proposed project will be solely that of the applicant.
The total project period for an application submitted in response to this PA
may not exceed 5 years.
Specific application instructions have been modified to reflect "MODULAR
GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH.
Complete and detailed instructions and information on Modular Grant
applications can be found at
http://grants.nih.gov/grants/funding/modular/modular.htm
RESEARCH OBJECTIVES
Background
In 1993, NINR published a report entitled Nursing Informatics: Enhancing
Patient Care. This report is available at
http://www.ninr.nih.gov/vol4/index.html. Subsequently, a Program
Announcement Enhancing Clinical Care Through Nursing Informatics (PA95-010;
12/2/94) was published. This report and program announcement were focused on
research on the use of nursing information systems to strengthen the quality
of clinical care provided, specifically in the areas of management and
processing of clinical nursing data, processes and outcomes of care, and
clinical decision making. This current program announcement builds on these
prior initiatives, but moves beyond the realm of clinical language and
hospital-based clinical information systems, to define the current area of
research interest as telehealth interventions.
Telehealth is defined by the Federal Communication Commission and by the DHHS
Office of Health Promotion and Disease Prevention as the use of
communications technologies to provide and support health care at a distance.
Examples include the use of communications to provide patient treatment,
often via still images or video, and the exchange and distribution of public
health information.
Telehealth interventions, which include telemedicine applications, have been
used in various forms for the past 40 years. Specifically, nursing
telehealth interventions have been applied to a wide array of clinical
practice situations. Research has demonstrated the utility of some of these
interventions, including the use of telephone calls to deliver all or part of
the nursing intervention, the use of computer network systems for patients
and their caregivers, the use of home monitoring devices to transmit data
electronically to practitioners at a distance, and the use of computer-based
instructional programs for patients and their caregivers.
The rapid proliferation of recent computer, communications, and other
technological advances allows new and creative ways to provide telehealth
interventions, supporting the delivery of nursing care for patients at a
distant location. This is particularly evident in the recent wide-spread use
of the internet to deliver health-related information, partially in response
to the increasing consumer/patient demand for accessing electronic health
information. Another example is the increasing use of telephone systems in
which nurses provide health information and advice. In addition, creative
new telehealth strategies are used to support decision-making by nurses and
other health care practitioners about patients who are located at distant
sites, including rural areas.
These current telehealth interventions are consistent with the National
Institutes of Health’s biomedical engineering initiatives, by integrating
multidisciplinary approaches to develop innovative informatics approaches for
the prevention, diagnosis, and treatment of disease, for patient
rehabilitation, and for improving health. Additional information about this
NIH initiative is found at http://www.nibib.nih.gov/
Today’s telehealth approaches, particularly those related to nursing care,
have the potential to serve a wide range of populations and to make a
significant contribution to the nature and delivery of health care. They are
envisioned to improve quality of care, improve clinical outcomes, achieve
better individualization or tailoring of health care, improve access to
health care practitioners, and improve cost efficiency of interventions.
There is a lack of research data, however, to support the efficacy of
recently-developed telehealth interventions and systems, and to support the
use of telehealth interventions among a wide variety of clinical situations,
with diverse patients, and in a variety of settings.
References:
Balas, EA and Iakovidis, I. (1999). Distance Technologies for Patient
Monitoring. BMJ: 319: 1309-1311.
Committee on Enhancing the Internet for Health Applications. (2000).
Networking Health: Prescriptions for the Internet. Washington, DC: National
Academy Press.
Eng, TR and Gustafson, DH (Eds.). (1999). Wired for Health and Well-Being:
The Emergence of Interactive Health Communication. Washington, DC: DHHS.
Eysenbach, G; Sa, ER; and Diepgen, TL. (1999). Shopping Around the Internet
Today and Tomorrow: Towards the Millennium of Cybermedicine. BMJ: 319: 1294-
1298.
Field, MJ (Ed.). (1996). Telemedicine: A Guide to Assessing
Telecommunications in Health Care. Washington, DC: Institute of Medicine.
National Center for Nursing Research. (1993). Nursing Informatics: Enhancing
Patient Care. Bethesda, MD: NIH Publication No. 93-2419.
Scope
This PA solicits applications that investigate innovative and creative
telehealth interventions that are used in clinical nursing care and that are
designed to contribute to high-quality, cost-effective patient-oriented care
for patients at a distant location. Of particular interest are those
proposals that investigate telehealth interventions resulting from recent
technological advances, including the internet and telemetric interfaces.
Applications that seek to test new telehealth interventions for minority or
underserved patient populations, diverse clinical situations, and/or diverse
clinical settings are particularly encouraged. Applications that involve
multidisciplinary collaborations are also encouraged.
Listed below are examples of studies that would be appropriate for this
program announcement. They are not listed in any priority order and are not
intended to be inclusive or restrictive. These examples are only
illustrative examples, and applicants are encouraged to propose other topics
consistent with the goals of this program.
Evaluate the effect of telehealth interventions on a range of patient
outcomes, including physiologic and psychosocial outcomes and quality of
life, as well as cost effectiveness of these interventions;
Determine the ability of internet and other telehealth intervention
approaches to achieve better individualization or tailoring of nursing care;
Determine which types of patients are most likely to benefit from the use of
specific nursing telehealth interventions;
Evaluate the ability of telehealth approaches to enhance patients and/or
caregivers access to health care;
Investigate the efficacy of nursing telehealth interventions for a broad
range of patient populations, including healthy populations and those with
chronic illnesses; children and elderly; individual patients vs. populations;
and patients in diverse settings (e.g., rural locations, nursing homes);
Explore the effect of innovative telehealth interventions for assessing and
monitoring biological, immunological, and other physiological patient
parameters;
Determine whether age-, gender-, culture-, or ethnically-related factors are
associated with the effective use of nursing telehealth interventions;
Test the effect of telehealth interventions in improving coordination and
care delivery for specific patient populations, e.g., those with disabilities
and multiple chronic illnesses;
Evaluate the efficacy of nurse advice systems in promoting improved patient
outcomes, improving quality of life, access to care, and improving patient
satisfaction;
Determine ways to integrate bioimaging information with other patient data in
communicating from small rural hospitals with large teaching hospitals;
Test effective ways of integrating telehealth interventions with other types
of interventions; and
Investigate effective ways to maximize consumer use of and satisfaction with
telehealth interventions.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups and
their sub-populations must be included in all NIH-supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification are provided indicating that inclusion
is inappropriate with respect to the health of the subjects or the purpose of
the research. This policy results from the NIH Revitalization Act of 1993
Section 492B of Public Law 103-43).
All investigators proposing research involving human subjects should read the
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research," published in the NIH Guide for Grants and Contracts on
August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The
revisions relate to NIH defined Phase III clinical trials and require: a) all
applications or proposals and/or protocols to provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b) all
investigators to report accrual, and to conduct and report analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by
the NIH, unless there are scientific and ethical reasons not to include them.
This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html
Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
URLS IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH
solicitation, internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
APPLICATION PROCEDURES
Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) and will be accepted at the standard application deadlines as indicated
in the application kit. Application kits are available at most institutional
offices of sponsored research and may be obtained from the Division of
Extramural Outreach and Information Resources, National Institutes of Health,
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: GrantsInfo@nih.gov.
Applicants planning to submit an investigator-initiated new (type 1),
competing continuation (type 2), competing supplement, or any amended/revised
version of the preceding grant application types requesting $500,000 or more
in direct costs for any year are advised that he or she must contact the
Institute or Center (IC) program staff before submitting the application,
i.e., as plans for the study are being developed. Furthermore, the
application must obtain agreement from the IC staff that the IC will accept
the application for consideration for award. Finally, the applicant must
identify, in a cover letter sent with the application, the staff member and
Institute or Center who agreed to accept assignment of the application.
This policy requires an applicant to obtain agreement for acceptance of both
any such application and any such subsequent amendment. Refer to the NIH
Guide for Grants and Contracts, March 20, 1998 at
http://grants.nih.gov/grants/guide/notice-files/not98-030.html
The modular grant concept establishes specific modules in which direct costs
may be requested as well as a maximum level for requested budgets. Only
limited budgetary information is required under this approach. The just-in-
time concept allows applicants to submit certain information only when there
is a possibility for an award. It is anticipated that these changes will
reduce the administrative burden for the applicants, reviewers and Institute
staff. The research grant application form PHS 398 (rev. 4/98) is to be used
in applying for these grants, with the modifications noted below.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS
BUDGET INSTRUCTIONS
Modular Grant R01 applications will request direct costs in $25,000 modules,
up to a total direct cost request of $250,000 per year. (Applications that
request more than $250,000 direct costs in any year must follow the
traditional PHS 398 application instructions.) The total direct costs must be
requested in accordance with the program guidelines and the modifications
made to the standard PHS 398 application instructions described below:
PHS 398
o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in
$25,000 increments up to a maximum of $250,000) and Total Costs [Modular
Total Direct plus Facilities and Administrative (F&A) costs] for the initial
budget period Items 8a and 8b should be completed indicating the Direct and
Total Costs for the entire proposed period of support.
o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4
of the PHS 398. It is not required and will not be accepted with the
application.
o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398. It is not required
and will not be accepted with the application.
o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative
page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for
sample pages.) At the top of the page, enter the total direct costs requested
for each year. This is not a Form page.
o Under Personnel, List all project personnel, including their names, percent
of effort, and roles on the project. No individual salary information should
be provided. However, the applicant should use the NIH appropriation language
salary cap and the NIH policy for graduate student compensation in developing
the budget request.
For Consortium/Contractual costs, provide an estimate of total costs (direct
plus facilities and administrative) for each year, each rounded to the
nearest $1,000. List the individuals/organizations with whom consortium or
contractual arrangements have been made, the percent effort of key personnel,
and the role on the project. Indicate whether the collaborating institution
is foreign or domestic. The total cost for a consortium/contractual
arrangement is included in the overall requested modular direct cost amount.
Include the Letter of Intent to establish a consortium.
Provide an additional narrative budget justification for any variation in the
number of modules requested.
o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual's qualifications for a
specific role in the proposed project, as well as to evaluate the overall
qualifications of the research team. A biographical sketch is required for
all key personnel, following the instructions below. No more than three pages
may be used for each person. A sample biographical sketch may be viewed at:
http://grants.nih.gov/grants/funding/modular/modular.htm
- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations;
o CHECKLIST - This page should be completed and submitted with the
application. If the F&A rate agreement has been established, indicate the
type of agreement and the date. All appropriate exclusions must be applied in
the calculation of the F&A costs for the initial budget period and all future
budget years.
o The applicant should provide the name and phone number of the individual to
contact concerning fiscal and administrative issues if additional information
is necessary following the initial review.
The title and number of the program announcement must be typed on line 2 of
the face page of the application form and the YES box must be marked.
Submit a signed, typewritten original of the application, including the
Checklist, and five signed photocopies in one package to:
CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)
REVIEW CONSIDERATIONS
Applications will be assigned on the basis of established PHS referral
guidelines. Applications will be evaluated for scientific and technical merit
by an appropriate scientific review group convened in accordance with the
standard NIH peer review procedures. As part of the initial merit review, all
applications will receive a written critique and undergo a process in which
only those applications deemed to have the highest scientific merit,
generally the top half of applications under review, will be discussed,
assigned a priority score, and receive a second level review by the
appropriate national advisory council or board.
Review Criteria
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments reviewers will be asked to discuss the following aspects
of the application in order to judge the likelihood that the proposed
research will have a substantial impact on the pursuit of these goals. Each
of these criteria will be addressed and considered in assigning the overall
score, weighting them as appropriate for each application. Note that the
application does not need to be strong in all categories to be judged likely
to have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
(1) Significance: Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge be advanced?
What will be the effect of these studies on the concepts or methods that
drive this field?
(2) Approach: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
(3) Innovation: Does the project employ novel concepts, approaches or method?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?
(4) Investigator: Is the investigator appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the principal investigator and other researchers (if any)?
(5) Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support?
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will also be
evaluated.
o The reasonableness of the proposed budget and duration in relation to the
proposed research
o The adequacy of the proposed protection for humans, animals or the
environment, to the extent they may be adversely affected by the project
proposed in the application.
AWARD CRITERIA
Applications will compete for available funds with all other recommended
applications. The following will be considered in making funding decisions:
Quality of the proposed project as determined by peer review, availability of
funds, and program priority.
INQUIRIES
Inquiries are encouraged. The opportunity to clarify any issues or questions
from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Dr. Carole Hudgings
Office of Extramural Programs
National Institute of Nursing Research
Building 45, Room 3AN12
45 Center Drive, MSC 6300
Bethesda, MD 20892-6300
Telephone: (301) 594-5976
FAX: (301) 480-8260
Email: carole_hudgings@nih.gov
Dr. Milton Corn
Acting Associate Director
Division of Extramural Programs
National Library of Medicine
Rockledge One Building
6705 Rockledge Drive, Suite 301
Bethesda, MD 20892
Telephone: (301) 496-4621
FAX: (301) 402-2952
Email: milton_corn@nlm.nih.gov
Direct inquiries regarding fiscal matters to:
Mr. Jeff Carow
Office of Grants and Contracts Management
National Institute of Nursing Research
Building 45, Room 3AN12
45 Center Drive, MSC 6300
Bethesda, MD 20892-6300
Telephone: (301) 594-6869
FAX: (301) 480-8260
Email: jeff_carow@nih.gov
Mr. Dwight Mowery
Grants Management Office
Division of Extramural Programs
National Library of Medicine
Rockledge One Building
6705 Rockledge Drive, Suite 301
Bethesda, MD 20892
Telephone: (301) 406-4221
FAX: (301) 402-0421
Email: Dwight_mowery@nlm.nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.361 (NINR) and 93.879 (NLM). Awards are made under authorization of
sections 301 and 405 of the Public Health Service Act as amended (42 USC 241
and 284) and administered under NIH grants policies and Federal Regulations
42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review.
The PHS strongly encourages all grant 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, and 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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