“External changes can give rise to unexpected challenges for the trials, including decisions regarding how to respond to new clinical practice guidelines, increased difficulty in implementing trial interventions, achieving separation between treatment groups, and differential responses across sites.” (Curtis et al. 2019)

As described in the Assessing Feasibility chapter, it is important for study teams to pilot their ePCT intervention and assess feasibility with the partner health system as much as possible before launching the implementation phase. Piloting provides the real-world feedback needed to understand the capabilities, capacities, and workflows of sites delivering the intervention.

During the study’s implementation phase, a variety of changes within clinics, hospitals, and health systems may have an impact on the delivery of the embedded intervention. Researchers should expect changes to occur. One example could be when a component of the intervention is incorporated into usual care at a control site or cluster. This could be due to unintentional spill-over of intervention effects; healthcare system initiatives, guidelines, or policies that focus on solving a similar problem; or changes in staffing, clinic workflow, or leadership. In the early stages of intervention implementation, it will be beneficial to identify and monitor aspects that may be vulnerable to internal and external changes and that could drive adaptations. Also important is knowing in advance which features (core functions) of the embedded intervention are so essential to its effectiveness that modifying them could negatively affect the study’s outcomes and impact.

Examples of Changes That Can Drive Adaptations