Shoulder Replacement Prehabillitation and Rehabilitating Early (SPRING study)

BACKGROUND: Prevalence of shoulder replacement is rising with associated increase in complications, most notably in those from underserved communities. Prehabilitation to help people mentally and physically prepare for surgery is not well described or tested. Early rehabilitation after surgery is considered essential to maximise recovery, however protocols are highly variable, and the safety and benefit are unknown. AIMS: To co-design prehabilitation and early rehabilitation interventions for people undergoing total shoulder replacement and test the clinical and cost-effectiveness of these interventions, in comparison to usual care, in improving function and reducing pain. DESIGN: A two-phase design: (1) Intervention co-design, piloting and refinement; (2) Randomised, single blind, multi-centre 2x2 factorial clinical and cost effectiveness trial and process evaluation. An 8-month internal pilot, with 2 assessment points, will determine progression. INTERVENTION CO-DESIGN: We will use intervention mapping, building on existing evidence of shoulder replacement pre and rehabilitation and self-management support, and pilot and refine the emergent interventions in 24 participants. TARGET POPULATION & SETTINGS: We will recruit 390 adults referred for shoulder replacement at 24 sites in England, Northern Ireland and Wales including those from underserved communities. RANDOMISATION: Initial 1:1 randomisation is to prehabilitation or usual care and second (post-surgery) 1:1 re-randomisation to early rehabilitation or usual care with stratification for sex, replacement type and recruitment site. INTERVENTIONS: Supported self-management prehabilitation and early rehabilitation focused on enhancing individuals' self-efficacy through acquiring knowledge, building confidence, and developing skills to manage and collaborate on actions to optimise recovery. Personalised 1:1 coaching will be delivered by trained healthcare practitioners. Participants will have access to co-designed resources. Intervention participants will revert to usual care rehabilitation at 6 weeks post-surgery. COMPARATOR: Usual care. OUTCOMES: Our primary outcome is total Shoulder Pain and Disability Index for Pain and Disability, tested at the 12-month post-surgery primary endpoint. Secondary outcomes include global impression of change, pain, disability, pain self-efficacy, anxiety and depression, sleep, length of stay, complications, serious adverse events, quality of life, healthcare resource use and costs. THEORY DRIVEN PROCESS EVALUATION: We will conduct interviews and focus groups with participants and healthcare practitioners. We will observe quality of practitioner intervention delivery to ensure intervention fidelity. DATA ANALYSIS: For the primary analysis we will estimate an “at the margins” effect using a linear mixed-effects model adjusted for baseline, site, gender and replacement type. Normalisation process theory will provide the framework for qualitative analyses to inform understanding of contextual and equity-related factors, and intervention implementation. The relative costs and intervention outcomes will be evaluated via a within-trial cost consequence analysis. PATIENT AND PUBLIC INVOLVEMENT AND ENGAGEMENT: Our work with stakeholders has informed a draft logic model of change to guide intervention development. IMPACT: Our approach has potential to lead to increased physical and mental preparedness for surgery, faster and greater functional recovery.