biostudies-literatureUnknown2(9)Afshar MNCATS NIH HHS<h4>Background</h4>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.<h4>Methods</h4>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 FNEJM AIhttps://www.ebi.ac.uk/biostudies/studies/S-EPMC12435388biostudies-literatureA Novel Playbook for Pragmatic Trial Operations to Monitor and Evaluate Ambient Artificial Intelligence in Clinical Practice.PMC12435388UL1 TR002373Twedt HKunstman DStordalen AAbramson KResnik FRasmussen SLong JSullivan AGGoswami CHintzke JShah TOberst MLemmon KMrotek LAWills GBrazelton TQuinn MLiao FJBaumann MRKleinschmidt PAfshar MGordon JEBurnside EDambach JPatterson BWfalseA Novel Playbook for Pragmatic Trial Operations to Monitor and Evaluate Ambient Artificial Intelligence in Clinical Practice.<h4>Background</h4>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.<h4>Methods</h4>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 F2025-01-01T00:00:00Z2025 Sep2026-06-01T15:46:06.821Z2026-04-08T13:49:07.214ZS-EPMC124353884095919210.1056/aidbp2401267