Pain Rehabilitation to Optimize Major Orthopaedic Trauma REcovery (PROMOTE) compared with routine care

Aims: The aim of this study was to assess the feasibility of conducting a randomized controlled trial (RCT) to test the effectiveness of an online, biopsychosocial intervention for the management of recovery in patients with complex lower-limb orthopaedic trauma. Methods: This was a multicentre, parallel-group, randomized feasibility trial with an embedded qualitative study. Patients were recruited from four UK NHS major trauma centres if they were aged ≥ 16 years and had undergone surgery for complex lower-limb orthopaedic trauma. They were randomized to gain access to a biopsychosocial support website to target psychological predictive factors of poor outcomes for three months in addition to routine care, plus four one-to-one sessions with healthcare professionals to increase adherence, compared with routine care only. The primary outcome was patient acceptance, and secondary outcomes were the patients' adherence and intervention delivery fidelity. Results: A total of 57 of 112 eligible patients (51%) participated (≥ 50% study feasibility criterion) and a mean of 2.7 were recruited per centre per month (≥ 2 criterion). They attended a median of three out of four sessions (3 to 4 criterion). However, the intervention delivery fidelity criterion (≥ 90% of intervention providers deliver the intervention as per manual) was not met (58% observed). The retention criterion (< 20% loss to follow-up at three months) was also not met (49% observed). Conclusion: The intervention was feasible in terms of patient acceptance; however, it needs to be modified to increase patient adherence and delivery fidelity.