Innovative trial designs using Electronic Health Record Systems
Clinical trials are increasingly being designed to fit more seamlessly within routine healthcare. Several innovative trial designs embed elements of the research process directly into Electronic Health Record (EHR) systems, allowing research to take place at the point of care.
One exciting development is the integration of randomisation into the EHR architecture. This has the potential to make trials more efficient, reduce the burden of conducting research, and generate evidence that is closely aligned with everyday healthcare practice.
Examples of emerging approaches include:
electronic Point Of Care Randomisation trials
Random Invitation Single Arm Trials
Decision Architecture Randomised Trials
The Decision Architecture Randomised Trial
EHR systems have a “decision architecture”. This refers to how prescribing choices are presented, such as the orderset of treatment options. Clinicians tend to choose the option that appears first in the orderset (the default option).
For example, an EHR order set might randomly default to one commonly used treatment or another. This gently nudges clinicians towards the randomly assigned option, while allowing them to override the default at any time. This allows different approaches to care to be compared while preserving clinician and patient autonomy and embedding research within routine healthcare.
Ongoing DART projects
1. Gabapentin And Breast Surgery Decision Architecture Randomization Trial (GABS-DART)
United States
First DART aiming to assess whether gabapentin should be a standard component of peri-operative pain control in mastectomy patients.
2. Tackling important (but hard to fund) questions in bowel disease: assessing the feasibility of decision architecture randomised trials in routine care
United Kingdom
A feasibility study funded by Bowel Research UK, exploring the acceptability and implementation of DARTs in NHS settings.
3. Developing publicly legitimate informed consent for DARTs using deliberative democracy methods
United Kingdom
A PhD project exploring what informed consent approaches the public finds acceptable and legitimate using a Citizens' Assembly approach.
DARTs and related publications
Decision architecture randomisation: extremely efficient clinical trials that preserve clinician and patient choice?
James Flory, Jessica S Ancker, Scott Yung Ho Kim, Gillard Kuperman, Andrew Vickers
2024
Individualized clinical decisions within standard-of-care pragmatic clinical trials: Implications for consent
Isabel M Astrachan, James Flory, Scott Yung Ho Kim
2024