Early-Stage Dissemination and Implementation Research in Communication Disorders (R21 Clinical Trial Optional)

NIDCD invites applications for formative dissemination and implementation (D and I) research projects in NIDCD mission areas of hearing, balance, taste, smell, voice, speech, and language. Given the focus of this funding opportunity on creating readiness for future, high-quality, D&I focused research, investigators are required to integrate a D&I process model (Nilsen, 2015) as a core component of their application. D&I process models outline activities that need to be accomplished at different points in the research process to set the foundation for subsequent activities, moving efficiently through the various stages of translational research. Many process models include a description of activities that should be accomplished prior to D&I research (e.g., Getting-to-Outcomes, Active Implementation, Quality Implementation Framework, EPIS-Exploration-Preparation-Implementation-Sustainment, EquIR-Equity-Focused Implementation Research, Intervention Mapping, Knowledge-to-Action). No specific model is required for this funding opportunity. Investigators should select a D&I process model that is appropriate for their current and future translational research goals. Applicants are highly encouraged to consult with a D&I expert in identifying and applying an appropriate D&I process model.

In addition to a D&I process model, other aspects of D&I research should be incorporated into the application, when appropriate to the aims. Examples of core D&I research elements include but are not limited to:

D&I theories, models and frameworks (e.g., theories or frameworks that guide understanding of the multi-level contextual factors that influence dissemination and implementation)
D&I strategies (i.e., methods or techniques used to enhance the dissemination, adoption, implementation, and sustainability of a clinical program or practice)
D&I outcomes and outcome measures (e.g., acceptability, appropriateness, cost, feasibility, adoption, fidelity, reach/penetration, maintenance/sustainment/sustainability) as well as health service outcomes and outcome measures (e.g., quality, equity)
Community engaged research approaches (i.e., research approaches that involve community partners to assist in guiding the research project, such as community advisory boards, co-design approaches, and community-based participatory research), including effective methods of involving individuals with communication disorders
Qualitative and mixed methods, including methods appropriate for data from individuals with communication disorders
Theories and methods to understand and reduce or eliminate health disparities, improving equity in care and outcomes
A D&I process model and other core D&I research elements should guide the research goals of the application. Examples of relevant early-stage D&I research goals, identified in multiple D&I process models, include, but are not limited to studies that aim to use:

A community-engaged research approach along with qualitative methods to understand the health needs of individuals and/or service-delivery needs of organizations and identify potential EBIs to address those needs
A determinants framework and a mixed-methods approach to identify potential individual- and systems-level barriers and facilitators to implementing an EBI in one or more real world contexts
A community-engaged research approach along with qualitative methods to co-develop and evaluate preliminary D&I strategies intended to support integration of an EBI into practice
The core functions and forms framework along with qualitative methods to differentiate underlying active ingredients in an EBI and then use a community-engaged research approach to develop and evaluate a community-adapted version of the EBI
A mixed-methods approach to identify which D&I outcomes and health service delivery outcomes are meaningful to partners and use a community-engaged research approach to co-develop and execute a measurement plan to establish baseline performance
A community-engaged research approach along with mixed methods to identify and quantify health inequities and identify or develop equity-sensitive EBIs to address disparities
A determinants framework and a mixed-methods approach to identify potential individual- and systems-level barriers and facilitators to equitable implementation of an EBI in one or more real world contexts
Clinical trials are optional for this funding opportunity. Responsive applications include those that (1) don't include clinical trials, (2) include low-risk clinical trials, or (3) include Basic Science Experimental Studies involving Humans (BESH). Low-risk clinical trials must meet ALL the following criteria: meet the budget limits of this NOFO, not require FDA oversight, are not intended to formally establish efficacy and have low risks to potentially cause physical or psychological harm. BESH clinical trials meet the NIH definition of a clinical trial and also meet the definition of basic research.