Is check-up on demand non-inferior to routine follow-up at one year after total hip or knee arthroplasty in terms of clinical outcomes and cost-effectiveness? Protocol for a randomized stepped-wedge hybrid effectiveness de-implementation trial

This multicenter hybrid type II effectiveness de-implementation trial uses a stepped-wedge cluster randomized design across 10 Dutch hospitals. All hospitals will sequentially transition from RFU with scheduled follow-up visits at 6-12 weeks and 1 year postoperatively to Check-Up on Demand (COD), in which patients have a scheduled visit at 6-12 weeks and receive a leaflet with instructions on when and how to contact the hospital, without a scheduled 1-year visit. A total of 1,000 patients aged ≥50 years undergoing primary THA or TKA for osteoarthritis will be included. Each participating hospital will recruit 100 patients (50 THA and 50 TKA). The primary clinical outcome is PROMIS physical functioning at 2 years (i.e., 1 year after the 1-year follow-up moment). The primary process outcome is the number of patients who have a clinical visit or X-ray related to surgery at 1 year postoperatively. Secondary outcomes include complications, surgical interventions, additional healthcare consumption, quality of life, pain, satisfaction, and costs. An economic evaluation and budget impact analysis will be conducted from healthcare and societal perspectives. The trial is registered at ClinicalTrials.gov (NCT06971757).