Digital multi-component intervention to IMPROVE the care of older people living with Diabetes and chronic Kidney Disease: a type 2 hybrid effectiveness-implementation cluster randomised trial in primary care (Short title: IMPROVE DKD Trial)

Background: In the UK type-2 diabetes (T2D) accounts for 50% of chronic kidney disease (CKD), 30% of end-stage kidney disease (ESKD), and associated high morbidity, mortality, and NHS cost. Early intervention slows progression of diabetic CKD (DKD). The UK guidelines recommend multicomponent evidence-based intervention. Our recent analysis shows a stark unmet need and inequality in DKD management in primary care. Research shows point-of-care computer reminders are effective in delivering multiple clinical recommendations in primary care despite increasing workload, complexity of management and time pressure. Aim: To evaluate the implementation and effectiveness of a digital management tool to improve evidence-based care and outcomes for people with DKD in general practice (GP) Research questions: 1 Can a low cost, digital management tool be embedded in GP computer systems to improve clinician adherence to DKD guidelines recommendations? 2 Is the implementation of a digital management tool (intervention) clinically and cost-effective in slowing progression of DKD? Design: Type II hybrid effectiveness-implementation cluster randomised trial Setting: General practices in England Population: GP staff and patients with T2D, aged 60-80 years with estimated glomerular filtration rate (eGFR) 59-30 ml/min/1.73m2 Recruitment: General practices through Clinical Practice Research Datalink (CPRD) Interventional Research Service Platform (IRSP) Intervention: Multicomponent intervention based on UK guideline recommendations 1. Digital management tool: GP-facing automatic point-of-care computer reminders reinforcing 5 guideline recommendations: 1) optimising blood pressure (target systolic