Assessing the feasibility of a randomized embedded PCT (ePCT) is a crucial part of the planning phase, serving as a bridge from designing to conducting the trial—the point when investigators activate sites, randomize participants, and begin data collection. Because PCTs are embedded within healthcare delivery systems and typically use data extracted from electronic health records (EHRs), feasibility assessment may differ from what is done for explanatory clinical trials. Potential differences include the need to establish close partnerships with healthcare system leadership, clinical staff, patient partners, IT personnel, and other interest holders; develop and validate intervention-specific EHR tools; and incorporate the intervention into the clinical workflow as seamlessly as possible to reduce the burden on care providers.

One component of feasibility is assessing the logistics of embedding the trial within the healthcare system. Consider the resources that it will take to implement the intervention and how the study may modify the system’s current workflow. Another component is pilot testing the key aspects of the study (such as the randomization scheme, identification of study participants or sites, intervention specifics, or data collection) to determine if the procedures are well coordinated and able to generate results. The study team should also evaluate the intervention’s flexibility in both delivery and adherence and ensure that the outcomes will be relevant to patients, clinicians, and other decision makers. Pilot testing will be particularly critical for complex ePCT interventions in order to reduce uncertainties during the implementation phase. The following sections describe feasibility considerations.

Watch the video module: Pilot and Feasibility Testing: The LIRE Example