PA-00-138: TELEHEALTH INTERVENTIONS TO IMPROVE CLINICAL NURSING CARE

Department of Health
and Human Services (HHS)

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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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