Assessing the feasibility of a randomized embedded PCT (ePCT) is a crucial part of the planning phase, serving as a bridge from trial design 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 stakeholders; 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 to reduce uncertainties during the implementation phase. The following sections describe feasibility considerations.
- Developing the Trial Documentation
- Establishing Close Partnerships With Participating Healthcare System Leaders and Staff
- Delineating the Roles of All Stakeholders to Determine Training Needs
- Pilot Testing
- Feasibility Assessment Scenarios From the Collaboratory’s Demonstration Projects
- Spotlight on Four Demonstration Projects
- Additional Resources