Recruitment and randomisation
VTE
RECRUITMENT, RECRUITMENT
This is a cluster study, hence randomisation will be conducted at recruitment centre level rather than on an individual participant level. Each site will confirm capacity and capability with their local R&D team for participation in the trial prior to randomisation. Sites will be randomised by the Edinburgh Clinical Trials Unit by simple randomisation (1:1) via the Research Electronic Data Capture (REDCap) database, and will be adjusted for based on region, size and VTE compliance within the Trust. The trial manager will be informed of the treatment allocation via email, and the Trust will be informed via a treatment allocation letter. Sites and the study team will undertake local engagement to identify appropriate and willing specialties which form the basic centre unit. Recruiting centres will be randomised/allocated to either the intervention arm (where participants who undergo short-stay surgery will receive GCS to wear during their short-stay procedure) or the control arm (where no GCS will be provided to those undergoing short-stay surgery).Due to the nature of this cluster design, patients are only required to consent to be contacted for follow-up (at 7- and 90-days post procedure).Patients from a variety of surgical specialties will be included in this pragmatic trial. Adults who are scheduled to undergo short-stay surgery will be prescreened by a member of the direct care team and invited to speak to a member of the research team. Permission from the patient will be granted by the direct care team before any information is passed or approach made by the research team.Recruitment will commence on 1 October 2022 for 30 months. The study will close on 31 December 2025.