Along with unforeseen external challenges noted earlier in this chapter, such as COVID-19, policy and guideline changes, and changes to technology and the EHR, other external challenges that an investigator could encounter include staff turnover, changes in healthcare system leadership, and health system acquisitions and mergers. These changes are hard to plan for, as they are not within the researcher’s influence like recruitment plans or intervention implementation

Staff turnover and changes in healthcare system leadership

Staff turnover is a perennial challenge in ePCTs, and investigators have found that developing and documenting training is critical. While it is difficult to prepare for leadership change, investigators can ensure that their research question is aligned with healthcare system priorities and will produce actionable information that healthcare systems can use to improve care at their sites.

Health system acquisitions and mergers

Health system acquisitions and mergers are not uncommon, making well-documented procedures essential to the long-term success of the trial. Maintaining partnerships with a variety of personnel at a system can help ease transitions and bolster ongoing support. Additionally, given the dynamic nature of health systems, a solid answer from a pragmatic trial may be irrelevant or impractical in 5 to 7 years. Therefore, making the actual intervention period as brief as possible, such as shortening the intervention period to 18 months or less, reduces the chance that an external factor could undermine the ability to get evidence from a trial.