Embedded Randomised Control Trial Implementation in the Australian Paediatric Hospital Setting

Abstract

Background: Embedded trials are randomised trials embedded into electronic medical record (EMR) systems. These trials utilise existing patient data within the EMR. They have high translational value as information routinely collected within the EMR reflects real world, clinically relevant evidence1.They are inexpensive, require no extra data collection, and can facilitate consent using the clinical team. Embedded trials using Epic EMR are being piloted by Murdoch Children’s Research Institute (MCRI) at The Royal Children’s Hospital (RCH).

Aims: The EMR can be used for patient identification, randomisation, treatment allocation, and data extraction. Reviewing the steps taken to implement and optimise these trial procedures ensures embedded trials are an effective, efficient, and realistic option for future investigator researchers.

Methods: The first embedded trial at RCH opened in November 2021. This trial started with a staggered enrolment of patients to identify potential issues with the trial workflow. Any issues and optimisations throughout the implementation of the trial were addressed and logged. A review of the first 20 patient’s data was conducted to ensure completeness and accuracy.

Results: All the Epic EMR prompts performed as expected, however as implementation and recruitment progressed optimisations were identified and actioned. Data for the trial was successfully produced and extracted.

Conclusions: Embedded trials have minimal ongoing costs but require substantial upfront work and expertise to implement. Embedded trials with limited research contact with patients offer an exciting cost-effective and COVID safe trial design. This approach enabled investigators to be able open new RCTs affordably, it also permits monitoring of the trial remotely in real-time.