The process of implementing research findings in clinical practice is complex, and diffusion, dissemination, and implementation strategies are needed to promote real change. Implementing clinical practice guidelines often requires organizational change at the health system or provider level, as well as individual change (Greenhalgh et al. 2004).

Dissemination Research

The process for dissemination has been rooted in the way we approach the scientific endeavor in the clinical research enterprise, which involves a step-wise approach from discovery, to clinical efficacy, effectiveness, and implementation research, the so-called bench to bedside approach (Glasgow et al. 2003; Glasgow et al. 2012). Although there has been increasing acknowledgement of the need to improve the dissemination of best practices into routine clinical care, the process has, until recently, been viewed as fairly linear: best practices and evidence-based guidelines are published and the clinician changes his or her behavior. However, there are many questions and considerations that are key aspects of dissemination research:

• What evidence is needed to motivate change within health systems?
• How is the message being framed and packaged?
• How are the messages being interpreted and received, and how does the information fit with other sources of information?
• How will the information transform into action?

Implementation Research

When research uncovers new information or new knowledge that will improve the care of patients, the findings may not—or may be slow to—be adopted or “translated” into clinical practice, creating a “translation gap.” These gaps persist between clinical research and the implementation because of complex provider-level and system-level barriers to rapid translation (Curran et al. 2012). Typically, clinical trials are intended to optimize what can be learned about the intervention and the associated outcomes. Implementation research looks at the black box between the intervention and the health outcomes and recognizes that broader public health outcomes are not just about what the intervention is, but also about how to get the intervention delivered in a way so that people can benefit from it. Proctor et al (Proctor et al. 2009) identified as set of key outcomes related to implementation that need to be considered:

• How feasibly can an intervention be delivered in a particular health system?
• How much fidelity to the intervention is needed?
• How acceptable is it to the variety of stakeholders within the health system?
• What will the uptake be?
• What are the costs associated with having the intervention integrated into a system of care?
• How sustainable can it be?

Dissemination and Implementation of Pragmatic Trial Results

Dissemination and implementation strategies vary for different types of interventions and trials, and are ultimately tied to the evidence that comes from a trial. For a new drug or intervention, the development pathway from discovery to implementation is well traveled (and complex): the process involves a sequence of explanatory clinical trials (Phases I, II, and III) that ultimately test the efficacy, effectiveness, and safety of an intervention. When this information is used for regulatory approval and labeling of drugs, there are known mechanisms to translate information about the drug or intervention into action and broader uptake. But with pragmatic research, there is no specific event at the end of a trial, such as regulatory approval, that signals the most appropriate dissemination and implementation pathway. Rather, when an intervention from a pragmatic clinical trial (PCT), such as those conducted by the Collaboratory, is shown to be beneficial, there are a multitude of different mechanisms for enabling uptake of the interventions in different healthcare settings.

This chapter provides a guide to different considerations for dissemination and implementation of pragmatic trial results. The chapter Dissemination Approaches for Different Stakeholders provides more specific guidance on dissemination strategies for specific types of stakeholders.

Key terms:

• Implementation science is the study of methods to promote the integration of research findings and evidence into healthcare policy and practice (Eccles and Mittman 2006). Implementation Science includes:
  • Dissemination research: the scientific study of targeted distribution of information and intervention materials to a specific public health or clinical practice audience.  The intent is to understand how best to spread and sustain knowledge and the associated evidence-based interventions (National Institutes of Health (NIH) Program Announcement PAR-16-236).
  • Implementation research: the scientific study of the use of strategies to adopt and integrate evidence-based health interventions into clinical and community settings in order to improve patient outcomes and benefit population health (NIH PAR-16-236).