National Heart, Lung, and Blood Institute
National Institutes of Health
August 16, 2011
This document outlines National Heart, Lung, and Blood Institute (NHLBI) policy and procedures for investigator-initiated Research Dissemination and Implementation grant applications (R18). It provides guidelines for the preparation and submission of these applications. This document is intended to provide background information relating to program areas. This is not a solicitation for applications.
These guidelines are designed specifically for applications that will be assigned for review by the NHLBI Office of Scientific Review in an ad hoc Special Emphasis Panel (SEP), for initial merit review. They are not designed for investigator-initiated multi-site clinical trials or multi-site observational studies.
For applications submitted electronically (see Application and Submission section below) this document is intended to complement, and should be used in conjunction with, Funding Opportunity Announcement (FOA) Program Announcement (PA): PAR-10-114 Research Dissemination and Implementation Grants (R18).
Efficacy is the extent to which an intervention can be shown to be beneficial under optimal study conditions.
Effectiveness is the extent to which an intervention can be shown to be beneficial under real world conditions.
Intervention is a method or technique used as part of a program or protocol that introduces a change for individuals, patients, groups, or populations.
Dissemination and Implementation (D&I) research is an integral part of the NHLBI’s systematic approach to the support of research throughout the biomedical spectrum. D&I research involves extension or adaptation of generally accepted and efficacious interventions that have been previously carried out in well-controlled settings to broader populations or settings. In issuing these guidelines, NHLBI intends to provide information to assist members of the scientific community interested in applying for D&I research grants in the cardiovascular, pulmonary, blood, and sleep areas.
DEFINITION OF DISSEMINATION AND IMPLEMENTATION RESEARCH
For the purpose of these guidelines, we make a distinction between "dissemination" and "implementation."
- Dissemination is the targeted distribution of information and intervention materials to a specific public health or clinical practice audience. The intent is to spread knowledge and the associated evidence-based interventions.
- Implementation is the use of strategies to adopt and integrate evidence-based health interventions and change practice patterns within specific settings.
This distinction needs to be made because interventions developed in the context of efficacy and effectiveness trials are rarely transferable without adaptations to broader and less-controlled settings.
D&I research studies involve extending or adapting generally accepted, efficacious, and/or guideline-based interventions such as behavioral techniques; educational, environmental, or organizational strategies; and the delivery of healthcare services such as pharmacotherapies and more. The aim of extending such interventions is to be able to apply them to broader real-world populations, settings, and conditions such as clinic, community, school, and work environments, and other real-world settings. In other words, the ultimate goal is to determine feasible and effective strategies to translate research findings into practice, to identify determinants of implementation effectiveness at all levels, and to identify ways to accelerate the adoption, integration, and sustainability of evidence into practice and medical decision-making.
Studies of the characteristics that determine whether an effective program will be successfully implemented (including but not limited to patient, provider, demographic, clinic, or system characteristics) are of interest. Studies of intervention or treatment efficacy are not supported by the D&I mechanism but are supported by other mechanisms.
D&I research is a critical step in the medical research discovery process, and provides the bridge linking findings of well controlled trials to community, primary care, and other real-world settings. D&I research is one of many translational phases along the biomedical research spectrum.
CHARACTERISTICS OF NHLBI DISSEMINATION AND IMPLEMENTATION RESEARCH
- D&I research involves testing translational strategies for interventions designed to increase health-promoting behaviors and therapies, prevent disease, and ameliorate and treat disease in defined populations. The interventions should be based on the application of valid theories and strategies drawn from the biomedical, behavioral, and social sciences; studies should be based on our current medical understanding of heart, vascular, lung, and blood diseases and sleep disorders.
- The focus could be on the general population, patients, providers, or systems studied in a variety of settings. Examples include studying a general population living in a geographically defined area; employees in work sites; children and adolescents in school settings; patients, physicians, or health care providers in physicians’ offices, ambulatory care clinics, health maintenance organizations, or other clinical care delivery sites; and other community organizations and settings. Other appropriate populations might be those identified by common demographics or other characteristics such as ethnic group membership, socioeconomic status, disease or at-risk status, age, gender, or other relevant characteristics. Investigations of how effective implementation and dissemination strategies are impacted by such individual differences are also of interest.
- The strongest, most rigorous research design possible should be used. The delivery of the intervention needs to be documented and evaluated as part of the research design. D&I investigations have historically used randomized controlled trial (RCT) designs. This initiative would continue to encourage the use of rigorous study designs, including RCTs, but other design and analytic strategies may be appropriate as well. For example, in some cases RCTs may not be feasible or timely, may have particularly limited external validity, or would raise ethical concerns that are difficult to address. In such instances, investigators could propose alternative, high-quality study designs with good internal validity. These designs might include systems- and population-based approaches, quasi-experimental strategies, qualitative research approaches, adaptive interventions and/or designs, among others. Health services research, which takes a systems-based approach to studying the delivery, quality, cost, access to, and outcomes of health care, is also encouraged. The delivery and fidelity of the intervention must be documented and evaluated as part of the research design.
- For such investigations, multi-disciplinary investigator teams with complementary, multi-component and multi-faceted skill sets in all relevant aspects of the proposed designs, interventions, populations of interest, disease areas, health information technology, outcomes, and social marketing are encouraged.
- D&I research may focus on the processes of implementation and diffusion of knowledge. However, this program does not support the transfer of specific technology, development of educational programs, or the implementation of specific innovations by themselves outside of a research study. Direct service programs intended solely to provide preventive or therapeutic care for heart, lung, and blood diseases and sleep disorders would not be appropriate for this initiative. Clinical testing of a new technology or a new drug for treatment and guideline development would also not be appropriate for this research program.
AREAS OF INTEREST FOR DISSEMINATION AND IMPLEMENTATION RESEARCH
This section lists the major areas of research interest at the NHLBI. Topics are based on the research areas identified in the NHLBI Strategic Plan for the program areas of heart, lung, and blood diseases and sleep disorders.
The following topics are intended as examples and are not all-inclusive, exhaustive, or listed in order of priority.
- Implementation and dissemination strategies to prevent, treat, and reduce risk for (or complications of) coronary heart disease in children or adults including hypertension, elevated blood lipids, smoking, inadequate physical activity, obesity, diabetes, and stress; studies of approaches to improving the clinical delivery of proven efficacious treatments for cardiovascular disease and its risk factors; studies of strategies to implement rehabilitation interventions after a myocardial infarction, cardiac surgery, or complications of heart and vascular diseases, arrhythmias, and sudden cardiac death.
- Studies investigating implementation of techniques to prevent complications of atherosclerosis, hypertension, coronary heart disease, peripheral vascular disease, congenital and rheumatic heart disease, cardiomyopathy, infections of the heart or cerebrovascular disease, excluding the neurological components of completed stroke.
- Studies testing implementation and dissemination approaches for the promotion and maintenance of respiratory health; asthma, emphysema, and chronic bronchitis; cystic fibrosis; sleep apnea; interstitial lung disease; occupational lung diseases; respiratory failure; pulmonary vascular disease; pulmonary complications of AIDS; and risk factors for lung disease, including smoking, occupational exposure, and environmental exposure. Cancers of the lung and upper respiratory infections are the responsibilities of other components of the National Institutes of Health and are not included in this program.
- Research investigating implementation and dissemination of appropriate use and safety of the blood supply and prevention and treatment of hematologic disorders: acquired immune deficiency syndrome or HIV-infection in blood donors; genetic and acquired risk factors for blood disorders, thromboembolic disorders, hemophilia and other bleeding disorders, platelet abnormalities, sickle cell anemia, Cooley's anemia, aplastic anemia, and other hemoglobin disorders. Strategies for improving blood donor recruitment and blood collection; safety of blood therapy (transfusion-transmitted disorders and immunohematology); blood component therapy; and blood center and transfusion service management. Cancers of the blood are the responsibilities of other components of the National Institutes of Health and are not included in this program.
- Dissemination and implementation strategies for translating behavioral interventions in the treatment, prevention and reduction of obesity, asthma, hypertension, diabetes, and heart disease in high-risk populations.
- Investigations that test implementation approaches to applying clinical guidelines and efficacious treatments in settings such as schools, worksites, homes, neighborhoods, community clinics, and broader communities.
APPLICATION AND SUBMISSION INFORMATION
Consultation with NHLBI program staff prior to submission of a D&I research grant application is not a prerequisite for submission of an application; however, it is highly recommended. Investigators are urged to contact program staff early in the process of preparing a grant application.
Applications prepared in response to PAR-10-114 must be submitted using the SF424 Research and Related (R&R) forms and the SF424 R&R Application Guide, through Grants.gov (http://www.grants.gov/). To download a SF424 R&R Application Package for FOA PAR-10-114, click on “Apply for Grant Electronically” on page 1 of the FOA.
All new, resubmission (formerly “revised” or “amended”), and revision (formerly “competing supplement”) applications seeking support from NHLBI for D&I research studies must be submitted electronically. Such applications must be prepared in response to Funding Opportunity Announcement (FOA) Program Announcement (PA) Number: PAR-10-114 Research Dissemination and Implementation Grants (R18).
Standard submission/receipt dates apply. Please see http://grants.nih.gov/grants/funding/submissionschedule.htm.
Applications with Direct Costs Equal To Or Greater Than $500,000 In Any One Year
Any application requesting more than $500,000 in direct costs in any year must be formally approved for acceptance by the NHLBI by following the process described on the NHLBI Internet site (http://www.nhlbi.nih.gov/research/funding/500k-costs.htm), as required by NIH policy.
Inquiries about possible new D&I research grant applications may be directed to the offices listed. Applicants should consult Institute staff early in the planning phases. Consultation about renewal and supplemental grant applications should be sought from the NHLBI staff member who administers the current grant.
Division of Cardiovascular Sciences
Dr. Michael Lauer
Two Rockledge Center, Room 8124
6701 Rockledge Drive, MSC 7940
Bethesda, MD 20892-7940
Division of Lung Diseases
Dr. James Kiley
Two Rockledge Center, Room 10042
6701 Rockledge Drive, MSC 7952
Bethesda, MD 20892-7952
Division of Blood Diseases and Resources
Dr. W. Keith Hoots
Two Rockledge Center, Room 9136
6701 Rockledge Drive, MSC 7950
Bethesda, MD 20892-7950