Can we enroll patients on an outpatient basis?

YES. Get With The Guidelines – Atrial Fibrillation is an in-patient registry, however, outpatient enrollment is not prohibited. If you encounter a person who meets the inclusion and exclusion criteria and has recently been diagnosed with atrial fibrillation in the past 120 days, then they can be enrolled and randomized from clinic or the outpatient setting. If this occurs, there are several important things to keep in mind.

  • As stated in the protocol, subjects must have a new diagnosis of atrial fibrillation within 120 days of randomization.
  • If a participant a subject is randomized to the intervention (dronedarone) arm, they must be registered in the Almac SimplifyTM IRT System to facilitate study drug shipment and dispensation.
  • Study teams are responsible for registration of intervention arm subjects in the IRT System, completing the study drug order request process, and conducting confirmation conversations of study drug delivery and dosing initiation.
  • Their baseline case report form needs to be filled out completely with information from their qualifying acute care encounter.
  • The redcap database will need to be completed to allow randomization and treatment assignment.