Drawing on experiences from the NIH Collaboratory Trials, authors of a new article in Contemporary Clinical Trials describe the challenges they encountered when relying on data from the electronic health record (EHR) to monitor outcomes and deliver interventions in pragmatic clinical trials embedded in healthcare systems.
“Teams need to be aware of—and perhaps proactively investigate—possible changes to EHR systems and data that will affect the delivery of interventions and the integrity and safety of pragmatic clinical trials,” the authors wrote.
The challenges can create delays and unanticipated work that require creativity and collaboration, and include:
- Rapid technology evolution: Over the course of a years-long trial, technology can become outdated.
- EHR updates: Periodic, routine updates may change the way data are represented, captured, or computed, causing the logic of the intervention delivery tool to function differently or not function at all.
- Switching EHR systems: Smaller clinics may switch EHR systems midtrial, causing disruptions in the research.
“We have learned that preparing for changes in the EHR by anticipating their effects, adapting, and reducing impact on the intervention is an important component in conducting embedded pragmatic clinical trials,” the authors wrote.