PROSPECTOR-Critical Care
Research type
Research Study
Full title
A Single-Centre Feasibility Study of PROSPECTOR - Point of care RandOmisation Systems for Performing Embedded Comparative effectiveness Trials Of Routine treatments in Critical Care
IRAS ID
279737
Contact name
Matthew G Wilson
Contact email
Sponsor organisation
University College London Hospitals/ University College London Joint Research Office
Clinicaltrials.gov Identifier
Z6364106/2021/06/165, UCL Data Protection Number
Duration of Study in the UK
0 years, 6 months, 22 days
Research summary
Every day, doctors and nurses make hundreds of decisions about treatments - like when to start or stop them, or how frequently to give them. Ideally, decisions are based on gold standard evidence from Randomised Controlled Trials (RCTs). Unfortunately, for many treatments little or no evidence exists, and clinicians must use knowledge and experience to decide what is best.
As clinicians are all different, this leads to random variation in how treatments are given to patients. For example, magnesium is routinely given in intensive care to prevent abnormal heart rhythms. There is no evidence supporting this, and clinicians vary in how they administer magnesium. Traditional RCTs might be used to examine whether more magnesium is better than less magnesium, but this method is inefficient and expensive for investigating multiple treatment strategies.
Clinical trials are becoming more efficient by using existing hospital computer systems to run them. However, research teams continue to perform tasks like randomisation manually. For questions like magnesium supplementation, which occur daily, this is labour intensive and infeasible.Hospital computer systems also possess mechanisms for prompting and alerting clinicians for particular decisions, reminding them of best practices, or warning them of potential problems. These systems may be modified to allow clinicians to randomise patients, under specific conditions.
We propose to assess whether modified computer prompts can be used to highlight the magnesium supplementation decision to clinicians. They would prompt the clinician to evaluate the uncertainty around giving or withholding magnesium in that instance. If the clinician agrees the optimal decision is unclear, they can choose to randomise the patient within a predetermined trial structure. If the clinician knows better, they may override the prompt and continue with their preference. In both cases, the system learns from the decision, and the patient receives optimal care determined by their clinician.REC name
London - Riverside Research Ethics Committee
REC reference
21/LO/0785
Date of REC Opinion
23 Nov 2021
REC opinion
Further Information Favourable Opinion