Point of Care RandOmisation Systems for Performing Embedded Comparative Effectiveness Trials Of Routine Treatments

• Status: Not yet recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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 little 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 comparative treatment questions.

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, warning them of potential problems. These systems may be modified to allow clinicians to randomise patients, under specific conditions.

The investigators 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London
• Collaborator: University College London Hospitals

Criteria

Inclusion Criteria:

Patients:

1. Age 18 years or over.

2. Undergoing elective surgery of complexity sufficient to warrant postoperative critical care admission (major/complex major surgery)

3. Must be able to give written informed consent to participate

Clinicians:

1. Must be regularly involved in the care of postoperative patients in critical care.

Exclusion Criteria:

1. Active treatment for bronchospasm preceding deployment of the electronic prompt, defined as patient receiving bronchodilator therapy or Magnesium infusion.

2. Any documented allergy or intolerance to any preparation of supplemental Magnesium.

3. Serum Magnesium result > 1.5 or < 0.5 mmol/L on blood tests obtained during critical care admission .

4. Pregnancy

5. Atrial Fibrillation on initial arrival to critical care.