Pain Rehabilitation to Optimize Major Orthopaedic Trauma REcovery (PROMOTE) compared with routine care : a multicentre, parallel-group, randomized feasibility trial with an embedded qualitative study.

Abstract

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. 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. 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). The intervention was feasible in terms of patient acceptance; however, it needs to be modified to increase patient adherence and delivery fidelity.