Early pain intervention after total knee replacement (EPIK): A registry-nested randomised controlled trial (RCT)

Intervention group – EPIK model of care (in addition to usual care): Within 2 weeks of randomisation, participants receive an initial ~1-hour telehealth assessment by a trial clinician trained in study procedures. The assessment reviews medical history, surgical information and patient-reported outcome measures, alongside additional questionnaires to identify prognostic factors for poor outcomes. Based on findings, the clinician develops a personalised care plan that refers participants to existing services based on their needs (e.g. orthopaedic surgeon, GP, physiotherapy, psychological services). Participants are then followed up by the same clinician via telephone up to six times over 12 months (at ~2, 3, 4, 8, 9 and 10 months after the initial assessment). Follow-up calls last approximately 15–30 minutes and address progress, barriers, and further referrals if required. Training: Trial clinicians will be trained using a manual that will be developed from extensive qualitative and co-design research. The manual’s authors will deliver training before trial commencement, and all clinicians will also complete Online Pain Education Network (OPEN) e-learning modules. Adherence: Adherence will be assessed by the proportion of follow-up calls completed and the proportion of recommended services attended.