Duke Clinical Research Institute, CHB Wordsmith, Inc, Raleigh, NC, USA.
Population Health Sciences and Duke Clinical Research Institute, Durham, NC, USA.
Contemp Clin Trials. 2023 Mar;126:107105. doi: 10.1016/j.cct.2023.107105. Epub 2023 Jan 26.
Conducting an embedded pragmatic clinical trial in the workflow of a healthcare system is a complex endeavor. 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.
We conducted a literature review, developed a tool, and conducted two rounds of phone calls with NIH Pragmatic Trials Collaboratory Demonstration Project principal investigators to develop the Intervention Delivery Complexity Tool. After refining the tool, we piloted it with Collaboratory demonstration projects and developed an online version of the tool using the R Shiny application (https://duke-som.shinyapps.io/ICT-ePCT/).
The 6-item tool consists of internal and external factors. Internal factors pertain to the intervention itself and include workflow, training, and the number of intervention components. External factors are related to intervention delivery at the system level including differences in healthcare systems, the dependency on setting for implementation, and the number of steps between the intervention and the outcome.
The Intervention Delivery Complexity Tool was developed as a standard way to overcome communication challenges of intervention delivery within an embedded pragmatic trial. This version of the tool is most likely to be useful to the trial team and its health system partners during trial planning and conduct. We expect further evolution of the tool as more pragmatic trials are conducted and feedback is received on its performance outside of the NIH Pragmatic Trials Collaboratory.
在医疗保健系统的工作流程中进行嵌入式实用临床试验是一项复杂的工作。干预措施的实施复杂性会对研究计划、在试验期间保持干预措施的保真度的能力以及/或检测结果中是否有有意义的差异的能力产生影响。
我们进行了文献回顾，开发了一种工具，并与 NIH 实用临床试验协作演示项目的主要研究者进行了两轮电话沟通，以开发干预措施传递复杂性工具。在对工具进行改进后，我们在协作演示项目中进行了试点，并使用 R Shiny 应用程序（https://duke-som.shinyapps.io/ICT-ePCT/）开发了该工具的在线版本。
该 6 项工具包括内部和外部因素。内部因素与干预本身有关，包括工作流程、培训和干预组件的数量。外部因素与系统层面的干预措施传递有关，包括医疗系统的差异、实施对环境的依赖程度以及干预措施与结果之间的步骤数量。
干预措施传递复杂性工具是作为克服嵌入式实用临床试验中干预措施传递沟通挑战的一种标准方法而开发的。该版本的工具最有可能在试验计划和实施期间对试验团队及其卫生系统合作伙伴有用。我们期望随着更多实用试验的进行以及在 NIH 实用临床试验协作之外对该工具性能的反馈，该工具会进一步发展。
