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 301/435-
0714, 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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