Within healthcare systems, the ways an intervention might be adopted or implemented can happen through a number of different mechanisms. Passive diffusion or “let it happen” is an approach wherein new practices are spread in an untargeted way. To "help it happen" the investigators can work with health system leaders and other stakeholders to enable the intervention. Or, in conjunction with stakeholders, investigators can "make it happen" (Greenhalgh et al. 2004).

(Modified from Greenhalgh et al. 2004)

No matter how pragmatic the trial is, to “make it happen” the actual intervention needs to be adopted, providers need to be trained to deliver it, and they need to consistently choose to deliver it. Not only that, some consideration should be given to ensuring that patients who would benefit from the intervention are able to receive it and that the leaders of the healthcare systems are willing to champion the use of the intervention in their system.

The NIH Collaboratory Trials

Pragmatic Trial Design Strategies That Facilitate “Make It Happen” Research to Health Care System Practice Change

The NIH Collaboratory trials use several strategies during the conduct of the trial to prepare the intervention and health systems for future implementation (if the intervention is shown to be effective). Thinking about implementation early in the process of development will help with the eventual implementation of the intervention.

Key considerations for potential future implementation of the trials were:

• Who is going to deliver the intervention?
• How does the intervention fit with the ultimate patient population for whom it is intended? (And what are the differences between that population and the population in the trial?)
• To what degree can we build-in tests of provider training, support, adherence, mediators and moderators of high quality delivery
• Will implementation occur in only the trial sites or in sites across the region or country?

With the Collaboratory trials, the leadership involved in the health systems where the intervention will be implemented has recognized the demand for the intervention to solve a particular problem. This will always be paramount and should be considered during the design phase of the trail. If the intervention is shown to be effective, several methods are planned to “make it happen.”

We will discuss case examples in the remaining sections of this chapter. Some of the trials described are in progress. As the implementation phase for each study evolves, there will likely be other lessons to share.