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 is randomized to the intervention (dronedarone) arm they must be contacted within 10 days of the randomization to confirm the fulfillment and dosing start of their dronedarone prescription.
  • 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.