Digital integration of research conduct into clinical care: results of the PROSPECTOR randomised feasibility study.

Abstract

Objectives: To evaluate the feasibility of conducting a clinically integrated randomised comparative effectiveness trial using digital clinical trial infrastructure within an electronic patient record (EPR).

Design: A mixed-methods, unblinded, feasibility study of digital clinical trial system incorporating testing of two designs of electronic point-of-care randomisation prompt.

Setting: The study was conducted at University College London Hospitals NHS Trust between March and November 2022. The study used a real clinical research question for context, comparing liberal vs restrictive strategies for magnesium supplementation to prevent new-onset atrial fibrillation in critical care.

Participants: Adult patients undergoing elective, non-cardiac surgical procedures expecting postoperative admission to critical care were recruited.

Interventions: A digital trial system screened participants continuously against eligibility criteria. Participants were automatically randomised (1:1) to (1) magnesium supplementation strategy and (2) one of two electronic randomisation prompt designs (nudge or preference).Electronic point-of-care randomisation prompts displayed to clinicians at regular intervals, inviting them to follow a randomised magnesium supplementation suggestion.

Main outcome measures: The primary outcome measure was a composite determination of study design feasibility (including recruitment, technical performance and concordance between the randomised suggestion and the observed clinician action).

Results: 23 patients were recruited and 11 successfully randomised. The implemented digital systems for automated eligibility screening, randomisation, data collection and follow-up demonstrated technical feasibility. 47 electronic point-of-care randomisation prompts successfully deployed across 11 patients. Clinician actions were concordant with randomised suggestions in 32 prompts (68%).Technical and implementational barriers to delivering the electronic point-of-care randomisation prompts were identified. Patients were followed up to 30 days following discharge from hospital, with no serious adverse events attributable to participation identified.There was insufficient data to make a quantitative determination on the superiority of either prompt design. Clinician feedback suggested the simplified design (nudge) had greater utility.

Conclusions: This study demonstrates that digitally embedding clinical trial infrastructure into a site-level EPR and integrating conduct into clinical care is safe and feasible. Future work will focus on improving and expanding the integrated digital trial design across multiple centres.

Trial registration number: NCT05149820.