NIH Pragmatic Trials Collaboratory - Implementation and Intervention Complexity in Pragmatic Clinical Trials (May 13, 2022): 9-min video.

• Summary: Dr. Steven George discusses implementation and intervention complexity in pragmatic trials. The interview focuses on themes around flexibility of intervention delivery, variation in care processes, building trust and partnerships to secure buy-in, adjusting intervention complexity for feasibility reasons, piloting the intervention, and establishing a culture of collaboration and information-sharing among pragmatic trialists.

Staman KL, et al. Intervention delivery for embedded pragmatic clinical trials: Development of a tool to measure complexity. Contemp Clin Trials. 2023 Mar;126:107105. (9-page paper)

• Summary: Describes the process of the creation of a Intervention Delivery Complexity Tool for pragmatic trials. The tool was developed as a standard approach to overcome communication challenges of intervention delivery and is most likely to be useful to the trial team and its health system partners during trial planning and conduct. 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 to intervention complexity.

NIH Pragmatic Trials Collaboratory (Living Textbook): Section 3 - Intervention Delivery Complexity Tool (Chapter: Design - Intervention Delivery and Complexity): 1-page website & online tool.

• Summary: The tool consists of 6 domains - internal domains refer to factors pertaining to the intervention, such as how the intervention is incorporated into workflow, the level of training needed for the intervention, and the number of components in the intervention. The external domains contain factors that impact the delivery of the intervention, such as differences in health care systems, the dependency on setting for implementation, and the number of steps between the intervention and the outcome.

NIH Pragmatic Trials Collaboratory (Living Textbook): Section 4 - Examples of Tool Output (Chapter: Design - Intervention Delivery and Complexity): 1-page website.

• Summary: Examples demonstrating what can be understood from using the Intervention Delivery Complexity Tool, which allows a researcher to categorize an intervention from "less to more complex" based on workflow, training demand, intervention components, organizational levels, number of steps, and dependency on setting.

O'Cathain A, et al. Guidance on how to develop complex interventions to improve health and healthcare. BMJ Open. 2019 Aug 15;9(8):e029954. (9-page paper)

• Summary: Presents key principles and actions for consideration when developing interventions to improve health. These include seeing intervention development as a dynamic iterative process, involving partners, reviewing published research, drawing on existing theories, articulating program theory, undertaking primary data collection, understanding context, paying attention to future implementation in the real-world, and designing and refining an intervention using iterative cycles of development with partner input throughout.