In an interview at the annual NIH Pragmatic Trials Collaboratory Steering Committee meeting, Implementation Science Core cochairs Hayden Bosworth and Devon Check reflected on the Core’s goals and factors for implementation success.
The Implementation Science Core, which launched in 2022, supports implementation-related research aims in pragmatic clinical trials to promote the uptake and sustainability of effective interventions in routine practice.
While the Core is still in its early days, the cochairs have plans for how to best serve the NIH Collaboratory. One of their first initiatives is to develop standardized measurements for evaluating implementation. They are currently gaining consensus around those measurements among the Core’s members.
“We are in the phase of starting to understand the challenges related to implementation during the trial and then afterwards,” Bosworth said.
Stakeholder Engagement Early and Often
Check highlighted early, multilevel stakeholder engagement as a critical step to promoting implementation success.
“The buy-in that you get to conduct a trial can be very different than the buy-in necessary to stand an intervention up in practice,” she said.
Several NIH Collaboratory Trial representatives have highlighted logistics challenges across large health systems as a reoccurring issue.
“Even an intervention that is effective, and potentially also cost-effective, might not be sustained by health systems because it’s just not feasible with the existing resources,” Check said.
It can also be valuable to engage policymakers that can promote implementation.
“Early and ongoing engagement of policymakers who are in the position to make policy changes or requirements based on study findings can sometimes overcome health systems barriers,” she said.
Prioritizing Implementation in Study Design
Bosworth discussed the value of making implementation a priority from the very beginning.
“Are there ways that we can start thinking about implementation from the study design stage?” he said. “Even if it is a terrific study with great findings, if it’s not feasible or too complex to implement, it’s frustrating to wait to consider implementation.”
Engaging with staff can provide insight on the many complexities of multi-level health systems. The study design stage of a pragmatic clinical trial should be seen as an opportunity to promote future implementation, he said.
A Safe Space for Both Failures and Successes
The cochairs highlighted the importance of creating an environment where project teams can share their challenges and failures just as openly as their successes.
“For everything that works, there are probably 10 things that have gone wrong,” Bosworth said. “If we don’t report that, we do the same things over and over. It’s just as valuable to hear what didn’t work so that we can move forward.”
Within the Core, they hope to promote a culture of knowledge sharing as well as collecting and sharing the lessons learned among projects.
“We’re looking forward to consulting, collaborating, and being available as problems and successes arise,” Bosworth said. “And we want to share those lessons learned.”
“Documenting and collecting data on what the challenges are is a useful early step, so that we can characterize the challenges and think about solutions and recommendations for pragmatic trials.” Check said.