A Novel Playbook for Pragmatic Trial Operations to Monitor and Evaluate Ambient Artificial Intelligence in Clinical Practice.

ABSTRACT:

Background

Ambient artificial intelligence (AI) offers the potential to reduce documentation burden and improve efficiency through clinical note generation. Widespread adoption, however, remains limited due to challenges in electronic health record (EHR) integration, coding compliance, and real-world evaluation. This study introduces a framework and protocols to design, monitor, and deploy ambient AI within routine care.

Methods

We launched an implementation phase to build technical workflows, establish governance, and inform a pragmatic randomized trial. A bidirectional governance model linked operations and research through multidisciplinary workgroups that incorporated the Systems Engineering Initiative for Patient Safety (SEIPS) framework. Integration into the EHR used F

SUBMITTER: Afshar M 

PROVIDER: S-EPMC12435388 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature