Embedded point of care randomisation for evaluating comparative effectiveness questions: PROSPECTOR-critical care feasibility study protocol

Abstract

IntroductionMany routinely administered treatments lack evidence as to their effectiveness. When treatments lack evidence, patients receive varying care based on the preferences of clinicians. Standard randomised controlled trials are unsuited to comparisons of different routine treatment strategies, and there remains little economic incentive for change.Integrating clinical trial infrastructure into electronic health record systems offers the potential for routine treatment comparisons at scale, through reduced trial costs. To date, embedded trials have automated data collection, participant identification and eligibility screening, but randomisation and consent remain manual and therefore costly tasks.This study will investigate the feasibility of using computer prompts to allow flexible randomisation at the point of clinical decision making. It will compare the effectiveness of two prompt designs through the lens of a candidate research question—comparing liberal or restrictive magnesium supplementation practices for critical care patients. It will also explore the acceptability of two consent models for conducting comparative effectiveness research.Methods and analysisWe will conduct a single centre, mixed-methods feasibility study, aiming to recruit 50 patients undergoing elective surgery requiring postoperative critical care admission. Participants will be randomised to either ‘Nudge’ or ‘Preference’ designs of electronic point-of-care randomisation prompt, and liberal or restrictive magnesium supplementation.We will judge feasibility through a combination of study outcomes. The primary outcome will be the proportion of prompts displayed resulting in successful randomisation events (compliance with the allocated magnesium strategy). Secondary outcomes will evaluate the acceptability of both prompt designs to clinicians and ascertain the acceptability of pre-emptive and opt-out consent models to patients.Ethics and disseminationThis study was approved by Riverside Research Ethics Committee (Ref: 21/LO/0785) and will be published on completion.Trial registration numberNCT05149820.

Decision architecture randomisation: extremely efficient clinical trials that preserve clinician and patient choice?

“…Healthcare is full of choices between standard-of-care approaches where one might be better but we do not know which. Examples include ‘at what threshold should magnesium be supplemented for critically ill patients?’ and ‘which insulin formulation should be started in a hospitalised patient with diabetes?’1–3…”

“…Information technology, with most treatment orders now placed through electronic health records (EHRs), has created opportunities to address these challenges by streamlining processes for participant screening, consent, enrolment, randomisation, intervention delivery and outcome ascertainment 1 6 7. For pragmatic trials that compare two standard-of-care interventions without masking treatment assignment, these innovations have lowered costs 8.…”

“…The difference between DART and typical randomised encouragement trials is that most randomised encouragement is explicit. Classic examples include mailed pamphlets or text messages; in the EHR setting, examples include explicit pop-up messages disclosing that a trial is underway and requesting the provider consider changing treatment 1 12 17. In contrast, DART relies on unobtrusive nudges that do not call for extra deliberation or intentional deviation from routine practice and can be scaled without disrupting care.…”

“…Another attribute DART shares with A/B testing is automated data collection. Baseline characteristics and outcomes of participants should be derived from routinely collected data in the EHR 1 7. The resulting trial should place no burden on patients or providers, allowing it to be run at any length of time or scale with no additional cost.…”