Embedded point of care randomisation for evaluating comparative effectiveness questions: PROSPECTOR-critical care...

Area of Science:

• Clinical Trials
• Health Informatics
• Comparative Effectiveness Research

Background:

• Routinely administered treatments often lack evidence of effectiveness, leading to variable patient care.
• Standard randomized controlled trials are not well-suited for comparing routine treatment strategies.
• Integrating clinical trial infrastructure into electronic health records offers potential for large-scale, cost-effective treatment comparisons.

Purpose of the Study:

• To investigate the feasibility of using computer prompts for flexible randomization at the point of clinical decision-making.
• To compare the effectiveness of two electronic randomization prompt designs.
• To explore patient and clinician acceptability of different consent models for comparative effectiveness research.

Main Methods:

• A single-center, mixed-methods feasibility study.
• Recruitment of 50 patients undergoing elective surgery requiring postoperative critical care admission.
• Randomization to either 'Nudge' or 'Preference' prompt designs and liberal or restrictive magnesium supplementation.

Main Results:

• Primary outcome: proportion of prompts leading to successful randomization (compliance with magnesium strategy).
• Secondary outcomes: acceptability of prompt designs to clinicians.
• Secondary outcomes: acceptability of pre-emptive and opt-out consent models to patients.

Conclusions:

• Feasibility will be judged by successful randomization rates and acceptability of prompt and consent models.
• This study aims to inform future large-scale comparative effectiveness research integrated with electronic health records.