A research team has shown for the first time at UCLH that clinical trials can be embedded into everyday care using the hospital’s electronic health records system (EHRS).
The approach, developed by a BRC-supported team, is designed to reduce the cost and complexity of clinical trials, and enable much more learning from everyday care.
Randomised controlled trials (RCTs) are the ideal way of evaluating treatments and interventions. But they are expensive, and randomisation of patients can be labour-intensive.
In this new approach, a prompt in the EHRS asks clinicians making a routine care decision – particularly where no clear best option exists – to consider randomising the patient into a trial.
The team behind the PROSPECTOR study, led by UCL and UCLH clinical academic Dr Matthew Wilson, found that this approach is feasible, acceptable to clinicians, and safe.
For the study, published in BMJ Evidence-Based Medicine, the team looked at the feasibility of using computer prompts in UCLH’s EHRS, called Epic, to ask critical care clinicians deciding on magnesium supplementation whether to randomise the patient into a study looking at the effectiveness of liberal or restrictive approaches to magnesium supplementation.
Optimal practice in magnesium supplementation in critical care is unknown, making it a suitable question for this new approach to trials.
Where patients were randomised into the study, the digital system captured both treatment decisions and patient outcomes automatically. Patient consent to take part had taken place in advance.
The study found overall that the new, digital approach to research worked as intended, and clinicians followed the suggested action to randomise their patient into the magnesium study on two thirds of occasions.
When clinicians chose not to follow the prompt, patients still contributed valuable observational data. There were no serious adverse events related to the study.
The question around magnesium supplementation was not intended to be resolved by the PROSPECTOR study, as PROSPECTOR was designed to assess the feasibility of the digital randomisation prompts. But the initial data gathered on the magnesium question will enable researchers to plan a larger-scale trial of magnesium supplementation strategies in future.
Dr Wilson said: “This is a real milestone for us. We have shown that we can digitally integrate randomised trials into the everyday clinical workflow. It won’t replace all traditional trials, but it will be able to answer important questions we wouldn’t otherwise be able to study. That means we can give clinicians better evidence, faster – and ultimately improve care for more patients.”
The team is now planning future projects to refine this digital approach to research, and to test it at other hospitals who also use Epic. Projects include looking at optimal pain relief strategies for different types of surgery, and improving antibiotic prescribing for community-acquired pneumonia. In future, the team plans to trial the system at hospitals which use other EHR systems.
The team will also work to address some challenges around the new approach to research, highlighted by the feasibility study.
Dr Wilson said: “We have learnt a great deal from the feasibility study we’ve carried out, including what we need to improve. For example, in some cases, prompts were not always timed at the perfect time, or to the right clinicians. We are now working with developers within the UCLH Epic team to improve how prompts are delivered.
“But overall, for now we are pleased to be making steps towards rolling this approach out more widely in future, as we now know it can be done.”
Image credit: Adobe Stock / Rawf8
