The NIH Pragmatic Trials Collaboratory developed an online tool to evaluate the complexity of intervention delivery in an ePCT (Staman et al. 2023). Principal investigators of NIH Collaboratory ePCTs shared critical drivers of complexity that affected their ability to implement an intervention for their trial. An article describing the tool and its development can be found in Contemporary Clinical Trials.

“The complexity of the intervention delivery can have implications for study planning, ability to maintain fidelity to the intervention during the trial, and/or ability to detect meaningful differences in outcomes.” (Staman et al. 2023)

The Intervention Delivery Complexity Tool consists of 6 domains comprised of internal and external factors.

• Internal factors pertain primarily to the intervention itself:
  • The degree to which the intervention requires re-engineering of existing work flows and tasks
  • The number of components in the intervention to be delivered
  • The level of familiarity or extra training needed for those delivering the intervention
• Accordingly, external factors are more related to intervention delivery at a system level:
  • The degree to which intervention delivery is dependent on setting in which it is implemented
  • The number of healthcare systems and clinics involved in delivering the intervention
  • The number of steps between the intervention and the intended outcome.

The goal of the Intervention Delivery Complexity Tool is to enable communication about potential challenges of intervention delivery. This tool can be used in a similar fashion to the PRECIS-2 tool, which describes the design of trials on an explanatory to pragmatic continuum and therefore may also contain information pertinent intervention complexity (Loudon et al 2015).

“By raising awareness about and increasing preparedness for the potential pitfalls of delivering the intervention within the ePCT design, we hope that this version of the tool will be useful to the trial team and its health system partners during trial planning and conduct.” (Staman et al. 2023)

Future work is planned to further refine the tool based on input from other clinical trial networks. The tool is free to use and available online.